AIxCrypto Holdings, Inc. 10-K

Item 7A. Quantitative and Qualitative Disclosures about Market Risk. We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this Item. 37 Item 8. Consolidated Financial Statements and Supplementary Data INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 23 ) 38 Consolidated Balance Sheets 41 Consolidated Statements of Operations and Comprehensive Loss 42 Consolidated Statements of Stockholders’ Equity 43 Consolidated Statements of Cash Flows 44 Notes to Consolidated Financial Statements 45 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID 23 ) To the Board of Directors and Stockholders of Qualigen Therapeutics, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Qualigen Therapeutics, Inc. (the “Company”) as of December 31, 2022 and December 31, 2021, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and December 31, 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America. Going Concern Uncertainty 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’s current liquidity position and projected cash needs raise substantial doubt about its ability to continue as a going concern. Management’s plans 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 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 consolidated 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 consolidated 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 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. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate. Valuation of Intangible Assets – Business Combination Critical Audit Matter Description As described in Note 3 of the consolidated financial statements, the Company completed its majority interest acquisition of NanoSynex, Ltd. (“NanoSynex”) on May 26, 2022, in a business combination. In connection with this acquisition, the Company recorded an in-process research and development (“IPR&D”) intangible asset in the amount of $5.7 million based on the fair value of the IPR&D at the acquisition date. The fair value of this acquired intangible asset was estimated using the excess earnings method which is a form of an income-based approach. The excess earnings valuation model requires certain significant assumptions in estimating fair value of the IPR&D. 38 We identified the assessment of the fair value of the IPR&D intangible asset as a critical audit matter. This required a high degree of auditor judgment and an increased audit effort in determining the reasonableness of the fair value of the IPR&D due to the measurement uncertainty related to the selection of the valuation methodology and the significant assumptions used in the estimation. How We Addressed the Matter in Our Audit The primary procedures we performed to address this critical audit matter included: ● Obtaining an understanding of the Company’s process and control over the valuation of IPR&D intangible asset including the significant assumptions used in the valuation. ● Testing the clerical accuracy of the valuation model prepared by the Company’s specialist. ● Evaluating the reasonableness of the key assumptions by considering past performance and third-party market data where appropriate, and whether such assumptions were consistent with our understanding and evidence obtained in other areas of the audit. ● Involving internal valuation professionals as an auditor’s specialist to assist in evaluating the valuation methodology used by management by comparing with methodologies commonly used to value IPR&D intangible assets and to review and opine on significant assumptions utilized in the valuation model. Goodwill and IPR&D Impairment Assessment Critical Audit Matter Description As described in Notes 1 and 7 to the consolidated financial statements, the Company recorded goodwill and indefinite-lived intangible assets in connection with its acquisition of majority ownership of NanoSynex. Goodwill represents the excess of the purchase price over the fair market value of assets acquired and liabilities assumed, and the intangible asset represents the estimated acquisition date fair value of acquired IPR&D. Goodwill and indefinite-lived intangible assets are tested for impairment at least annually, or more frequently if events or changes in circumstances indicate that these assets may be impaired. Goodwill is tested for impairment at the reporting unit level and indefinite-lived intangible assets are tested at the individual asset level. The Company determined that its goodwill was impaired and recorded an impairment loss of approximately $4.2 million. Management’s estimates of the fair value of the reporting unit and of the IPR&D were determined using the discounted cash flow method and excess earnings method, respectively. The determination of fair value using these income approach techniques involves significant assumptions which are highly subjective. We identified goodwill and IPR&D impairment assessments as a critical audit matter due to the significant judgment and subjectivity exercised by management when developing the fair value measurements, and a high degree of auditor judgment and an increased audit effort required in evaluating management’s significant assumptions. How We Addressed the Matter in Our Audit The primary procedures we performed to address this critical audit matter included: ● Obtaining an understanding and evaluating the design of internal controls related to the impairment of goodwill and IPR&D. ● Evaluating the appropriateness of methods used in developing the fair value measurements by management. ● Testing the completeness and accuracy of underlying data used in management’s fair value estimates, including mathematical accuracy. ● Evaluating the reasonableness of the key assumptions by considering past performance and third-party market data where appropriate, and whether such assumptions were consistent with our understanding and evidence obtained in other areas of the audit. ● Involving internal valuation professionals as an auditor’s specialist to assist in evaluating the valuation methodologies used by management for the goodwill impairment assessment by comparing the methodologies to those utilized by other companies holding similar assets, and to review and opine on significant assumptions utilized in the valuation model. 39 Accounting for Financial Instruments – Convertible Debt with Warrants Critical Audit Matter Description As described in Notes 11 to the consolidated financial statements, the Company issued a convertible debenture and common stock purchase warrants in the principal amount of $3.3M during the year ended December 31, 2022. We identified the accounting for this complex financial instrument as a critical audit matter. This includes both the evaluation of the various features as potential embedded derivatives and the determination of the respective fair value of the instruments and the embedded features, as well as the determination of the appropriate classification of warrants between equity and liabilities. The application of the accounting guidance applicable to issuing a complex financial instrument requires significant judgment. Determination of appropriate classification of warrants requires management’s judgments relating to the interpretations of relevant accounting guidance based on specific provisions of the warrant agreement. And accounting for the convertible notes and embedded conversion features requires management’s judgments related to initial and subsequent recognition of the debt and related features, use of a valuation model, and key inputs used in the selected valuation model. How We Addressed the Matter in Our Audit The primary procedures we performed to address this critical audit matter included: ● Obtaining an understanding of the Company’s process and controls over the execution of complex financial instruments. ● Inspecting the agreements associated with the transactions and evaluating management’s technical accounting analysis, including the identification of potential embedded derivatives, and the application of the relevant accounting literature. ● Utilizing an auditor’s specialist to assist in assessing management’s analysis of the transaction, including (i) evaluating the contracts to identify relevant terms that affect the recognition of the financial instruments, (ii) assessing the appropriateness of conclusions reached by management, and (iii) reviewing the valuation model for derivatives, performing independent calculations, and examining the significant assumptions utilized in the valuation model. /s/ BAKER TILLY US, LLP We have served as the Company’s auditor since 2018. San Diego, California May 2, 2023 40 QUALIGEN THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS December 31, December 31, 2022 2021 ASSETS Current assets Cash $ 7,034,434 $ 17,538,272 Accounts receivable, net 538,587 822,351 Inventory, net 1,586,297 1,055,878 Prepaid expenses and other current assets 1,661,220 1,379,896 Total current assets 10,820,538 20,796,397 Restricted cash 5,690 — Right-of-use assets 1,422,538 1,645,568 Property and equipment, net 345,087 204,217 Intangible assets, net 5,845,702 171,190 Goodwill 625,602 — Other assets 18,334 18,334 Total Assets $ 19,083,491 $ 22,835,705 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 857,311 $ 886,224 Accrued vacation 467,948 282,910 Accrued expenses and other current liabilities 1,511,856 1,510,990 R&D grant liability 780,682 — Deferred revenue, current portion 116,161 135,063 Operating lease liability, current portion 240,645 134,091 Short term debt - related party 950,722 — Warrant liabilities 788,100 1,686,200 Warrant liabilities - related party 2,834,547 — Convertible debt - related party 60,197 — Total current liabilities 8,608,169 4,635,479 Operating lease liability, net of current portion 1,301,919 1,542,564 Deferred revenue, net of current portion 49,056 92,928 Deferred tax liability 357,757 — Total liabilities 10,316,901 6,270,971 Commitments and Contingencies (Note 13) - - Stockholders’ equity Qualigen Therapeutics, Inc. stockholders’ equity: Common stock, $ 0.001 par value; 225,000,000 shares authorized; 4,210,737 and 3,529,018 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively 42,110 35,290 Additional paid-in capital 110,528,050 101,274,073 Accumulated other comprehensive income 50,721 — Accumulated deficit ( 103,385,172 ) ( 84,744,629 ) Total Qualigen Therapeutics, Inc. stockholders’ equity 7,235,709 16,564,734 Noncontrolling interest 1,530,881 — Total Stockholders’ Equity 8,766,590 16,564,734 Total Liabilities & Stockholders’ Equity $ 19,083,491 $ 22,835,705 The accompanying notes are an integral part of these consolidated financial statements. 41 QUALIGEN THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 2022 2021 For the Years Ended December 31, 2022 2021 REVENUES Net product sales $ 4,983,556 $ 5,021,721 License revenue — 632,004 Total revenues 4,983,556 5,653,725 EXPENSES Cost of product sales 4,302,755 4,332,485 General and administrative 10,835,647 11,724,964 Research and development 6,837,133 11,716,718 Sales and marketing 950,420 542,594 Goodwill and fixed asset impairment 4,239,000 — Total expenses 27,164,955 28,316,761 LOSS FROM OPERATIONS ( 22,181,399 ) ( 22,663,036 ) OTHER EXPENSE (INCOME), NET Gain on change in fair value of warrant liabilities ( 907,203 ) ( 4,723,187 ) Interest (income) expense, net 26,646 ( 42,693 ) Other income, net ( 1,125 ) ( 5,446 ) Total other expense (income), net ( 881,682 ) ( 4,771,326 ) LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES ( 21,299,717 ) ( 17,891,710 ) (BENEFIT) PROVISION FOR INCOME TAXES ( 265,074 ) 5,427 NET LOSS ( 21,034,643 ) ( 17,897,137 ) Net loss attributable to noncontrolling interest ( 2,394,100 ) — Net loss attributable to Qualigen Therapeutics, Inc. $ ( 18,640,543 ) $ ( 17,897,137 ) Net loss per common share, basic and diluted $ ( 4.85 ) $ ( 6.10 ) Weighted—average number of shares outstanding, basic and diluted 3,840,340 2,933,487 Other comprehensive loss, net of tax Net loss $ ( 21,034,643 ) $ ( 17,897,137 ) Foreign currency translation adjustment 50,721 — Other comprehensive loss ( 20,983,922 ) ( 17,897,137 ) Comprehensive loss attributable to noncontrolling interest ( 2,394,100 ) — Comprehensive loss attributable to Qualigen Therapeutics, Inc. $ ( 18,589,822 ) $ ( 17,897,137 ) The accompanying notes are an integral part of these consolidated financial statements. 42 QUALIGEN THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY Common Stock Additional Paid-In Accumulated Other Comprehensive Accumulated Total Qualigen Therapeutics, Inc. Stockholders’ Noncontrolling Total Stockholders’ Shares Amount Capital Income Deficit Equity Interest Equity Balance at December 31, 2021 - 3,529,018 $ 35,290 $ 101,274,073 $ — $ ( 84,744,629 ) $ 16,564,734 $ — $ 16,564,734 Stock issued upon exercise of warrants 332,000 3,320 4,711 — — 8,031 — 8,031 Stock-based compensation — — 5,484,044 — — 5,484,044 — 5,484,044 Common stock and prefunded warrants issued for business acquisition 350,000 3,500 3,740,417 — — 3,743,917 3,882,225 7,626,142 Noncontrolling interest adjustments relating to Stock-based compensation and other — — ( 42,756 ) — — ( 42,756 ) 42,756 — Foreign currency translation adjustment — — — 50,721 — 50,721 — 50,721 Fair value of warrant modification for professional services — — 67,370 — — 67,370 — 67,370 Fair value of warrant modification for business acquisition — — 696 — — 696 — 696 Issuance of rounded shares as a result of the reverse stock split ( 281 ) — ( 505 ) — — ( 505 ) — ( 505 ) Net loss - — — — — ( 18,640,543 ) ( 18,640,543 ) ( 2,394,100 ) ( 21,034,643 ) Balance at December 31, 2022 - 4,210,737 $ 42,110 $ 110,528,050 $ 50,721 $ ( 103,385,172 ) $ 7,235,709 $ 1,530,881 $ 8,766,590 Shares Amount Shares Amount Capital Deficit Equity Series Alpha Convertible Additional Total Preferred Stock Common Stock Paid-In Accumulated Stockholders’ Shares Amount Shares Amount Capital Deficit Equity Balance at December 31, 2020 18 $ 1 2,729,606 $ 27,296 $ 85,114,755 $ ( 66,847,492 ) $ 18,294,560 Balance. value 18 $ 1 2,729,606 $ 27,296 $ 85,114,755 $ ( 66,847,492 ) $ 18,294,560 Stock issued upon cash-exercise of warrants — — 161,830 1,619 2,358,570 — 2,360,189 Stock issued upon net-exercise of warrants — — 22,740 227 ( 227 ) — — Issuance of common stock for conversion of preferred stock ( 18 ) ( 1 ) 24,342 243 ( 243 ) — ( 1 ) Fair value of warrants issued for professional services — — — — 298,651 — 298,651 Shares issued pursuant to Securities Purchase Agreements — — 588,000 5,880 8,814,120 — 8,820,000 Commission and offering costs of Securities Purchase Agreements — — — — ( 2,960,465 ) — ( 2,960,465 ) Fair value of warrant modifications pursuant to Securities Purchase Agreements — — — — 2,253,536 — 2,253,536 Stock issued for professional services — — 2,500 25 101,725 — 101,750 Stock-based compensation — — — — 5,293,651 — 5,293,651 Net Loss — — — — — ( 17,897,137 ) ( 17,897,137 ) Balance at December 31, 2021 — $ — 3,529,018 $ 35,290 $ 101,274,073 $ ( 84,744,629 ) $ 16,564,734 Balance, value — $ — 3,529,018 $ 35,290 $ 101,274,073 $ ( 84,744,629 ) $ 16,564,734 The accompanying notes are an integral part of these consolidated financial statements. 43 QUALIGEN THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS 2022 2021 For the Years Ended December 31 2022 2021 CASH FLOWS FROM OPERATING ACTIVITIES Net loss $ ( 21,034,643 ) $ ( 17,897,137 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 152,573 113,218 Amortization of right-of-use assets 223,030 225,059 Accounts receivable reserves and allowances ( 59,982 ) ( 247,845 ) Inventory reserves 18,943 ( 108,138 ) Common stock issued for professional services — 101,750 Fair value of warrants issued for professional services — 298,651 Stock-based compensation 5,484,044 5,293,651 Fair value of warrant modification for professional services 67,370 — Goodwill and fixed asset impairment 4,239,000 — Change in fair value of warrant liabilities ( 906,345 ) ( 4,723,187 ) Changes in operating assets and liabilities: Accounts receivable 417,708 41,250 Inventory and equipment held for lease ( 637,410 ) 111,422 Prepaid expenses and other assets ( 99,251 ) 1,298,998 Accounts payable ( 33,397 ) 385,455 Accrued expenses and other current liabilities ( 76,266 ) 1,047,163 R&D grant liability ( 534,426 ) — Operating lease liability ( 134,091 ) ( 254,740 ) Deferred revenue ( 62,775 ) ( 416,312 ) Deferred tax liability ( 271,622 ) — Net cash used in operating activities ( 13,247,540 ) ( 14,730,742 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of property and equipment ( 164,684 ) ( 134,471 ) Purchases of equipment held for lease ( 154,433 ) — Payments for patents and licenses — ( 6,893 ) Net cash acquired in business combination 135,354 — Net cash used in investing activities ( 183,763 ) ( 141,364 ) CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from warrant exercises 7,173 459,476 Proceeds from issuance of shares and warrants pursuant to Securities Purchase Agreements — 8,820,000 Proceeds from issuance of convertible debt - related party 2,903,847 — Offering costs of Securities Purchase Agreements — ( 706,929 ) Principal payments on notes payable — ( 138,739 ) Fractional share payments related to the reverse stock split ( 505 ) — Net cash provided by financing activities 2,910,515 8,433,808 Net change in cash and restricted cash ( 10,520,787 ) ( 6,438,298 ) Effect of exchange rate changes on cash and restricted cash 22,639 — Cash and restricted cash - beginning of period 17,538,272 23,976,570 Cash and restricted cash - end of period $ 7,040,123 $ 17,538,272 SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION Cash paid during the year for: Interest $ — $ 1,233 Taxes $ 5,571 $ 5,133 NONCASH FINANCING AND INVESTING ACTIVITIES: Issuance of common stock for conversion of preferred stock after closing of reverse recapitalization $ — $ 243 Right-of-use assets obtained in exchange for operating lease liabilities $ — $ 1,439,830 Fair value of shares issued for cashless warrant exercises $ — $ 764,657 Net transfers to inventory from equipment held for lease $ — $ 1,304 Fair value of warrant modifications pursuant to Securities Purchase Agreements $ 9,439 $ 2,253,536 Fair value of warrant liabilities on date of exercise $ 858 $ 1,900,713 Fair value of warrant modifications for business acquisition $ 33,543 $ — ACQUISITION: Fair value of assets acquired $ ( 5,896,278 ) — Fair value of liabilities assumed, net of goodwill 2,321,845 — Fair value of Alpha Capital/Qualigen warrants repriced due to acquisition 696 — Fair value of Qualigen prefunded warrant issued in exchange for NanoSynex stock 1,804,102 — Fair value of Qualigen common stock issued in exchange for NanoSynex stock 1,904,989 — Net cash acquired in business combination (Note 3) $ 135,354 $ — The accompanying notes are an integral part of these consolidated financial statements. 44 QUALIGEN THERAPEUTICS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES Organization Qualigen, Inc., now a subsidiary of Qualigen Therapeutics, Inc., was incorporated in Minnesota in 1996 to design, develop, manufacture and sell Physician Office Laboratory (“POL”) market quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. In May 2020, Qualigen, Inc. completed a reverse recapitalization transaction with Ritter Pharmaceuticals, Inc. (“Ritter”) and Ritter was renamed Qualigen Therapeutics, Inc. All shares of Qualigen, Inc.’s capital stock were exchanged for Qualigen Therapeutics, Inc.’s capital stock in the merger. Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,” commenced trading on the Nasdaq Capital Market, on a post-reverse-stock-split adjusted basis, under the trading symbol “QLGN” on May 26, 2020. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. . On May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha Capital Anstalt (“Alpha Capital”), a related party, in exchange for 350,000 reverse split adjusted shares of the Company’s common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company’s common stock at an exercise price of $ 0.001 per share. These warrants were subsequently exercised on September 13, 2022 . Concurrently with this transaction, the Company also purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $ 600,000 . The transactions resulted in the Company acquiring a 52.8 % interest in NanoSynex. The Company envisions future synergies from the integration of its own proprietary results-proven FastPack diagnostics platform with the innovative NanoSynex technology. NanoSynex is a micro-biologics diagnostics company domiciled in Israel. Basis of Presentation The accompanying consolidated financial statements of the Company have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), Regulation S-X and rules and regulations of the Securities and Exchange Commission (“SEC”). Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its majority owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment. In general, the functional currency of the Company and its subsidiaries is the U.S. dollar, however for NanoSynex, the functional currency is the local currency, New Israeli Shekels (NIS). As such, assets and liabilities for NanoSynex are translated into U.S. dollars and the effects of foreign currency translation adjustments are reflected as a component of accumulated other comprehensive income within the Company’s consolidated statements of changes in stockholders’ equity. Accounting Estimates Management uses estimates and assumptions in preparing its consolidated financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses. The most significant estimates relate to the estimated fair value of in-process research and development, goodwill, warrant liabilities, stock-based compensation, amortization and depreciation, inventory reserves, allowances for doubtful accounts and returns, and warranty costs. Actual results could vary from the estimates that were used. Reverse Stock Split On November 23, 2022, the Company effected a 1-for-10, as determined by the Company’s board of directors, reverse stock split of its outstanding shares of common stock (the “Reverse Stock Split”). The Reverse Stock Split reduced the Company’s shares of outstanding common stock, stock options, and warrants to purchase shares of our common stock. Fractional shares of common stock that would have otherwise resulted from the Reverse Stock Split were rounded down to the nearest whole share and cash in lieu of payments were made to stockholders. All share and per share data for all periods presented in the accompanying financial statements and the related disclosures have been adjusted retrospectively to reflect the Reverse Stock Split. The number of authorized shares of common stock and the par value per share remains unchanged. 45 Cash The Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash equivalents. Restricted cash includes cash that is restricted due to Israeli banking regulations. The Company maintains the majority of its cash in accounts at banking institutions in the U.S. that are of high quality. Cash held in these accounts often exceed the FDIC insurance limits. If such banking institutions were to fail, the Company could lose all or a portion of amounts held in excess of such insurance limitations. The FDIC recently took control of two such banking institutions, Silicon Valley Bank on March 10, 2023 and Signature Bank on March 12, 2023. While the Company did not have an account at either of these two banks, in the event of failure of any of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position. Inventory, Net Inventory is recorded at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The Company reviews the components of its inventory on a periodic basis for excess or obsolete inventory, and records reserves for inventory components identified as excess or obsolete. Impairment of Long-Lived Assets The Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between the net book value of the assets and their estimated fair values. During the fiscal year ending December 31, 2022 the Company recorded an impairment loss of $ 4,239,000 related to the NanoSynex acquisition. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and managed its business as one segment operating primarily within the United States and Israel. Accounts Receivable, Net The Company grants credit to domestic physicians, clinics, and distributors. The Company performs ongoing credit evaluations of its customers and generally requires no collateral. Customers can purchase certain products through a financing agreement that the Company has with an outside leasing company. Under the agreement, the leasing company evaluates the credit worthiness of the customer. Upon acceptance of the product by the customer, the leasing company remits payment to the Company at a discount. This financing arrangement is without recourse to the Company. The Company records an allowance for doubtful accounts and returns equal to the estimated uncollectible amounts or expected returns. The Company’s estimates are based on historical collections and returns and a review of the current status of trade accounts receivable. Accounts receivable is comprised of the following at: SCHEDULE OF ACCOUNTS RECEIVABLE December 31, December 31, 2022 2021 Accounts Receivable $ 726,449 $ 958,448 Less Reserves and Allowances ( 187,862 ) ( 136,097 ) Accounts receivable, net $ 538,587 $ 822,351 Research and Development Except for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including therapeutics license costs. 46 R&D Grants NanoSynex has received R&D grants from Israel Innovation Authority (IIA) and from the European Commission. These grants may provide cash funding to NanoSynex from time to time in advance of the applicable costs being incurred. When such cash funding is received from these grants in advance, the proceeds are recorded as a current or non-current R&D grant liability based on the time from the consolidated balance sheets date to the expected future date of recognition as a reduction to research and development expenses. Patent Costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated statement of operations. Shipping and Handling Costs The Company includes shipping and handling fees billed to customers in net sales. Shipping and handling costs associated with inbound and outbound freight are generally recorded in cost of sales; such shipping and handling costs totaled approximately $ 267,000 and $ 113,000 , respectively, for the years December 31, 2022 and 2021. Other shipping and handling costs included in general and administrative, research and development, and sales and marketing expenses totaled approximately $ 14,000 and $ 12,000 for the years ended December 31, 2022 and 2021, respectively. Revenue from Contracts with Customers The Company applies the following five-step model in accordance with ASC 606, Revenue from Contracts with Customers, in order to determine revenue: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Product Sales The Company generates revenue from selling FastPack System analyzers, accessories and disposable products used with the FastPack System. Disposable products include reagent packs, which are diagnostic tests for prostate-specific antigen, testosterone, thyroid disorders, pregnancy, and Vitamin D. The Company provides disposable products and equipment in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposable products and equipment at the agreed upon prices in the invoice. Generally, customers purchase disposable products using separate purchase orders after the equipment (“analyzer”) has been provided to the customer. The initial delivery of the equipment and reagent packs represents a single performance obligation and is completed upon receipt by the customer. The delivery of each subsequent individual reagent pack represents a separate performance obligation because the reagent packs are standardized, are not interrelated in any way, and the customer can benefit from each reagent pack without any other product. There are no significant discounts, rebates, returns or other forms of variable consideration. Customers are generally required to pay within 30 days. The performance obligation arising from the delivery of the equipment is satisfied upon the delivery of the equipment to the customer. The disposable products are shipped Free on Board (“FOB”) shipping point. For disposable products that are shipped FOB shipping point, the customer has the significant risks and rewards of ownership and legal title to the assets when the disposable products leave the Company’s shipping facilities, thus the customer obtains control and revenue is recognized at that point in time. The Company has elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation. The Company’s contracts with customers generally have an expected duration of one year or less, and therefore the Company has elected the practical expedient in ASC 606 to not disclose information about its remaining performance obligations. Any incremental costs to obtain contracts are recorded as selling, general and administrative expense as incurred due to the short duration of the Company’s contracts. License Revenue The Company entered into an out-license agreement with Yi Xin to develop and/or commercialize its products in exchange for nonrefundable upfront license fees and/or sales-based royalties. 47 If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from nonrefundable upfront fees allocated to the license when the license is transferred to the customer and the customer can benefit from the license. For licenses that are bundled with other performance obligations, management uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. During years ended December 31, 2022 and 2021, the Company recognized license revenue of approximately $ 0 and $ 632,000 , respectively. Contract Asset and Liability Balances The timing of the Company’s revenue recognition may differ from the timing of payment by the Company’s customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the performance of the related services, the Company records deferred revenue until the performance obligations are satisfied. Multiple performance obligations include contracts that combine both the Company’s analyzer and a customer’s future reagent purchases under a single contract. In some sales contracts, the Company provides analyzers at no charge to customers. Title to the analyzer is maintained by the Company and the analyzer is returned by the customer to the Company at the end of the purchase agreement. During the years December 31, 2022 and 2021, product sales are stated net of an allowance for estimated returns of approximately $ 96,000 and $ 150,000 , respectively. Deferred Revenue Payments received in advance from customers pursuant to certain collaborative research license agreements, deposits against future product sales, multiple element arrangements and extended warranties are recorded as a current or non-current deferred revenue liability based on the time from the Consolidated Balance Sheet date to the future date of revenue recognition. Operating Leases Effective April 1, 2020, the Company adopted Accounting Standards Update (“ASU”) No. 2018-11, Leases (Topic 842) Targeted Improvements (“Topic 842”). In accordance with the guidance in Topic 842, the Company recognizes lease liabilities and corresponding right-of-use-assets for all leases with terms of greater than 12 months. Leases with a term of 12 months or less will be accounted for in a manner similar to the guidance for operating leases prior to the adoption of Topic 842. (See Note 13-Commitments and Contingencies). Property and Equipment, Net Property and equipment are stated at cost and are presented net of accumulated depreciation. Depreciation is provided for on a straight-line basis over the estimated useful lives of the related assets as follows: SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT Machinery and equipment 5 years Computer equipment 3 years Molds and tooling 5 years Furniture and fixtures 5 years Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or their estimated useful lives. The Company occasionally designs and builds its own machinery. The costs of these projects, which includes the cost of construction and other direct costs attributable to the construction, are capitalized as construction in progress. No provision for depreciation is made on construction in progress until the relevant assets are completed and placed in service. The Company’s policy is to evaluate the remaining lives and recoverability of long-term assets on at least an annual basis or when conditions are present that indicate impairment. 48 Business Combinations The Company accounts for business combinations using the acquisition method pursuant to FASB ASC Topic 805. This method requires, among other things, that results of operations of acquired companies are included in Qualigen’s financial results beginning on the respective acquisition dates, and that assets acquired and liabilities assumed and noncontrolling interests are recognized at fair value as of the acquisition date. Intangible assets acquired in a business combination are recorded at fair value using a discounted cash flow model. We have third-party valuations completed for intangible assets in a business combination using a discounted cash flow analysis, incorporating various assumptions. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, the cost of capital and terminal values from the perspective of a market participant. Each of these factors can significantly affect the value of the intangible asset. Any excess of the fair value of consideration transferred (the “Purchase Price”) over the fair values of the net assets acquired is recognized as goodwill. The fair value of assets acquired and liabilities assumed in certain cases may be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition date. Legal costs, due diligence costs, business valuation costs and all other acquisition-related costs are expensed when incurred. Goodwill Goodwill represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired, when accounted for using the purchase method of accounting. Goodwill has an indefinite useful life and is not amortized but is reviewed for impairment annually and whenever events or changes in circumstances indicate that the carrying value of the goodwill may not be recoverable. In testing for impairment, the fair value of the reporting unit is compared to the carrying value. If the net assets assigned to the reporting unit exceed the fair value of the reporting unit, an impairment loss equal to the difference is recorded. As a result of the annual goodwill impairment analysis, the Company recognized a $ 4,239,000 non-cash goodwill and fixed asset impairment charge in the valuation of its business acquisition of NanoSynex for the year ended December 30, 2022. For more information, refer to Note 1 - Organization and Summary of Significant Accounting Policies and Estimates and Note 7 - Goodwill, IPR&D and other Intangibles. Intangible Assets In Process R&D Acquired in process R&D (IPR&D) represents the fair value assigned to the research and development assets that have not reached technological feasibility. The value assigned to IPR&D is determined by estimating the costs to develop the acquired technology into commercially viable products, estimating the resulting revenue from the projects, and discounting the net cash flow to present value. The revenue and cost projections used to value acquired IPR&D are, as applicable, reduced based on the probability of success of developing the new product. Additionally, projections consider relevant market sizes and growth factors, expected trends in technology and the nature and expected timing of new product introductions. The rates utilized to discount the net cash flow to its present value are commensurate with the stage of development of the project and uncertainties in the economic estimates used in the projections. Upon the acquisition of acquired IPR&D, an assessment is completed as to whether the acquisition constitutes an acquisition of a single asset or a group of assets. Multiple factors are considered in this assessment, including the nature of the technology acquired, the presence or absence of separate cash flows, the development process and stage of completion, quantitative significance, and the Company’s rationale for entering into the transaction. If a business is acquired, as defined under the applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset. If an asset or group of assets is acquired that do not meet the definition under the applicable accounting standards, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense in the Company’s consolidated statements of operations and comprehensive loss as they are incurred. IPR&D is evaluated for impairment annually using the same methodology as described above for calculating fair value. If the carrying value of the acquired IPR&D exceeds the fair value, then the intangible asset is written down to its fair value, with the resulting adjustment recorded as a charge to operations. Changes in estimates and assumptions used in determining the fair value of acquired IPR&D could result in an impairment. Other Intangible Assets, Net Other intangible assets consist of patent-related costs and costs for license agreements. Management reviews the carrying value of other intangible assets that are being amortized on an annual basis or sooner when there is evidence that events or changes in circumstances may indicate that impairment exists. The Company considers relevant cash flow and profitability information, including estimated future operating results, trends and other available information, in assessing whether the carrying value of intangible assets being amortized can be recovered. If the Company determines that the carrying value of other intangible assets will not be recovered from the undiscounted future cash flows expected to result from the use and eventual disposition of the underlying assets, the Company considers the carrying value of such intangible assets as impaired and reduces them by a charge to operations in the amount of the impairment. 49 Costs related to acquiring patents and licenses are capitalized and amortized over their estimated useful lives, which is generally 5 to 17 years, using the straight-line method. Amortization of patents and licenses commences once final approval of the patent or license has been obtained. Patent and license costs are charged to operations if it is determined that the patent or license will not be obtained. Derivative Financial Instruments and Warrant Liabilities The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations and comprehensive loss. Depending on the features of the derivative financial instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (See Note 10-Warrant Liabilities and Note 11- Convertible Debt - Related Party). Fair Value Measurements The Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows: ● Level 1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date; ● Level 2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs in markets that are not considered to be active; and ● Level 3 - Inputs that are unobservable. Fair Value of Financial Instruments Cash, accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. Advertising Advertising expense consists primarily of print and digital media promotional materials for a distributor. Advertising costs are expensed as incurred. Advertising expense for the years ended December 31, 2022 and 2021 amounted to $ 50,000 and $ 0 , respectively. 50 Comprehensive Loss Comprehensive loss consists of net income and foreign currency translation adjustments. Comprehensive gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements of stockholders’ equity for all periods presented. Stock-Based Compensation Stock-based compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in an increase to stock-based compensation expense to employees and non-employees determined at the date of grant. Income Taxes Deferred income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses, and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income in future years. For more information, refer to Note 17-Income Taxes. Sales and Excise Taxes Sales and other taxes collected from customers and subsequently remitted to government authorities are recorded as accounts receivable with corresponding tax payable. These balances are removed from the consolidated balance sheet as cash is collected from customers and remitted to the tax authority. Warranty Costs The Company’s warranty policy generally provides for one year of coverage against defects and nonperformance within published specifications for sold analyzers and for the term of the contract for equipment held for lease. The Company accrues for estimated warranty costs in the period in which the revenue is recognized based on historical data and the Company’s best estimates of analyzer failure rates and costs to repair. Accrued warranty liabilities were approximately $ 138,000 and $ 60,000 , respectively, at December 31, 2022 and December 31, 2021 and are included in accrued expenses and other current liabilities on the Consolidated Balance Sheets. Warranty costs were approximately $ 69,000 and $ 57,000 for the years ended December 31, 2022 and 2021, respectively, and are included in cost of product sales in the Consolidated Statements of Operations. Foreign Currency Translation The functional currency for the Company is the U.S. dollar. The functional currency for NanoSynex, the Company’s newly acquired majority owned subsidiary, is the New Israeli Shekel (NIS). The financial statements of NanoSynex are translated into U.S. dollars using exchange rates in effect at each period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex is reflected as a separate component of other comprehensive income (loss). Other comprehensive loss related to the effects of foreign currency translation adjustments attributable to NanoSynex was $ 50,721 and $ 0 at December 31, 2022 and 2021, respectively. 51 Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments , which supersedes current guidance by requiring recognition of credit losses when it is probable that a loss has been incurred. The new standard requires the establishment of an allowance for estimated credit losses on financial assets including trade and other receivables at each reporting date. The new standard will result in earlier recognition of allowances for losses on trade and other receivables and other contractual rights to receive cash. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842) , which extended the effective date of Topic 326 for certain companies until fiscal years beginning after December 15, 2022. The new standard will be effective for the Company in the first quarter of fiscal year beginning January 1, 2023, and early adoption is permitted. The Company adopted ASU 2016-13 on January 1, 2023. Adoption did not have a material impact on the Company’s consolidated financial statements and related disclosures. Global Economic Conditions War in Ukraine In February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the conflict and its impact on regional and global economic conditions. Inflationary Cost Environment During the year ended 2022 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary pressures attributable to ongoing economic recovery and supply chain issues. The Company is subject to inflationary pressures with respect to raw materials, labor and transportation. Accordingly, the Company continues to take actions with its customers and suppliers to mitigate the impact of these inflationary pressures in the future. Actions to mitigate inflationary pressures with suppliers include aggregation of purchase requirements to achieve optimal volume benefits, negotiation of cost-reductions and identification of more cost competitive suppliers. While these actions are designed to offset the impact of inflationary pressures, the Company cannot provide assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. Impact of COVID-19 Pandemic The COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. Sales of diagnostic products fell significantly during 2020 and the Company’s net loss increased significantly, as deferral of patients’ non-emergency visits to physician offices, clinics and small hospitals sharply reduced demand for FastPack tests. Since then we have experienced some recovery in demand. Other accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s consolidated financial statements. NOTE 2 — LIQUIDITY AND GOING CONCERN As of December 31, 2022, the Company had approximately $ 7.0 million in cash and an accumulated deficit of $ 103.4 million. For the years ended December 31, 2022 and 2021, the Company used cash of $ 13.2 million and $ 14.7 million, respectively, in operations. The Company’s cash balances are expected to fund operations into the third quarter of 2023. As a pre-clinical development-stage therapeutics biotechnology company, the Company expects to continue to have net losses and negative cash flow from operations, which over time will challenge its liquidity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for the one-year period following the date that these financial statements were issued. There is no assurance that profitable operations will ever be achieved, or, if achieved, could be sustained on a continuing basis. In order to fully execute its business plan, the Company will require significant additional financing for planned research and development activities, capital expenditures, clinical and pre-clinical testing for its QN-302 clinical trials, preclinical development of RAS and QN-247, and funding for NanoSynex operations (See Note 3-Acquisition), as well as commercialization activities. Historically, the Company’s principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds from the issuance of debt. In December 2021, the Company raised $ 8.8 million from the issuance of common stock to several institutional investors, and in December 2022 the Company raised $ 3.0 million from the sale of a convertible debt - related party (see Note 11-Convertible Debt - Related Party). 52 There can be no assurance that further financing can be obtained on favorable terms, or at all. If we are unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business prospects. As a condition to the NanoSynex closing, the Company agreed to provide NanoSynex with up to $ 10.4 million of future funding based on NanoSynex’s achievement of certain future development milestones and subject to other terms and conditions described in the Master Agreement for the Operational and Technological Funding of NanoSynex (the “Funding Agreement”) entered into with NanoSynex. These funding commitments are in the form of convertible promissory notes to be issued to the Company with a face value equal to the amount paid by the Company to NanoSynex upon satisfaction of the applicable performance milestone, bearing interest at the rate of 9% per annum on the principal balance from time to time outstanding under the particular promissory note, convertible at the option of the Company into additional shares of NanoSynex in order for the Company to maintain at least a 50.1% controlling ownership interest in NanoSynex, should NanoSynex issue additional shares. The principal of the convertible notes are due and payable upon the sooner to occur of: i) five years from the date of issuance of the particular promissory note; ii) the acquisition by any person or entity of all or substantially all of the share capital of NanoSynex, through share purchase, issuance or shares or merger of NanoSynex, or the purchase of all or substantially all of the assets of NanoSynex; or iii) the initial public offering of NanoSynex. The Company provided funding to NanoSynex of $ 2.4 million during 2022 pursuant to this agreement. The Company may terminate the Funding Agreement upon 120 days’ notice, but would still be liable for any payments due for milestones achieved prior to termination. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, the ownership interests of its common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the Company raises additional funds through government or other third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, it may have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to the Company. Additional funding may not be available to the Company on acceptable terms, or at all. In addition, any future financing (depending on the terms and conditions) may be subject to the approval of Alpha Capital, the holder of the Company’s 8% Senior Convertible Debenture (the “Debenture”), or trigger certain adjustments to the Debenture or warrants held by Alpha Capital. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial statements do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ from those reflected in the accompanying financial statements NOTE 3 — ACQUISITION Business Combination The Company acquired a 52.8 % voting equity interest in NanoSynex on May 26, 2022 (the “NanoSynex Acquisition Date”) through: (1) the purchase of 2,232,861 shares Preferred A-1 Stock of NanoSynex from Alpha Capital (a related party) for 350,000 reverse split adjusted shares of the Company’s common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company’s common stock at a purchase price of $ 0.001 per share ( these warrants were subsequently exercised on September 13, 2022) , and (2) the purchase of 381,786 shares of Series B preferred stock of NanoSynex from NanoSynex in exchange for $ 600,000 (collectively, the “NanoSynex Acquisition”). The acquisition of the majority interest of NanoSynex was accounted for as a business combination using the acquisition method, in accordance with FASB ASC Topic 805. Identifiable assets acquired, liabilities assumed and any noncontrolling interest in the acquiree are recognized and measured as of the acquisition date at fair value. Determining the fair value of assets acquired, liabilities assumed and noncontrolling interest requires management’s judgment and often involves the use of significant estimates and assumptions, including assumptions with respect to future cash flows, discount rates and asset lives among other items. The Company uses third-party valuations for intangible assets in a business combination using a discounted cash flow analysis, incorporating various assumptions. 53 A summary of the consideration transferred and fair value of assets acquired and liabilities assumed in the NanoSynex Acquisition is as follows (all shares shown post 1 for 10 reverse split on November 23, 2022): SCHEDULE OF CONSIDERATION TRANSFERRED Consideration transferred, net of cash acquired Cash paid for NanoSynex preferred stock: $ 600,000 FMV of 350,000 shares of Qualigen stock issued to Alpha Capital Anstalt $ 1,904,989 FMV of 331,464 shares of Qualigen stock related to prefunded warrant issued to Alpha Capital Anstalt (See Note 15) $ 1,804,102 Total consideration paid for NanoSynex preferred stock $ 3,709,091 FMV of consideration related to related to repricing of 7,048 shares of Alpha Capital/Qualigen warrants * $ 696 NanoSynex cash acquired ( 735,354 ) Total consideration transferred, net of cash acquired $ 3,574,433 * See disclosure under Noncompensatory Equity Classified Warrants regarding May 26, 2022 transaction-Note 15-Stockholders’ Equity SCHEDULE OF ASSETS ACQUIRED AND LIABILITIES Purchase Price Allocation Accounts receivable $ 75,336 Property and equipment 120,942 In process R&D 5,700,000 Accounts payable ( 4,588 ) Accrued expenses and other payables ( 291,093 ) R&D grant liability ( 1,362,264 ) Short term debt ( 941,898 ) Deferred tax liability ( 629,379 ) Noncontrolling interest assumed ( 3,882,225 ) Identifiable net assets acquired ( 1,215,169 ) Goodwill 4,789,602 Total consideration transferred, net of cash acquired $ 3,574,433 During the year ended December 31, 2022, the Company made measurement period adjustments to the preliminary purchase price allocation which included: (i) a decrease to noncontrolling interest of $ 117,775 , (ii) a decrease to goodwill of $ 106,621 . The measurement period adjustments were made to reflect facts and circumstances that existed as of the acquisition date and is reflected in the table above. Company transaction costs, which were immaterial, have been expensed as incurred and charged to the Company’s consolidated statements of operations and comprehensive loss. There was no provision for reimbursement of transaction costs from the Company to NanoSynex. Goodwill represents the excess of the purchase price over the fair value of the net assets acquired as of the acquisition date. Goodwill represents the value of the future technology to be developed in excess of the identifiable assets as well as the operational synergies of the combined companies to be recognized. Goodwill has an indefinite useful life and is not amortized. None of the Goodwill is expected to be deductible for tax purposes. As a condition to the closing, the Company agreed to provide NanoSynex with up to $ 10.4 million of future funding based on NanoSynex’s achievement of certain future development milestones and subject to other terms and conditions described in the Funding Agreement entered into with NanoSynex. (See Note 2-Liquidity for further details regarding the terms and conditions of the Funding Agreement). The Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2022 and 2021 include approximately $ 5.1 million and $ 0 , respectively, of net loss associated with the results of operations of NanoSynex from the NanoSynex Acquisition Date. 54 The following proforma information has been prepared as if the NanoSynex Acquisition occurred on January 1, 2021. The following unaudited supplemental proforma consolidated results do not purport to reflect what the combined Company’s results of operations would have been, nor do they project the future results of operations of the combined Company. The unaudited supplemental proforma consolidated results reflect the historical financial information of the Company and NanoSynex, adjusted to give effect to the NanoSynex Acquisition as if it had occurred on January 1, 2021, as well as to record NanoSynex stock compensation expense and to record the net loss related to the non-controlling interest, in accordance with generally accepted accounting principles: SCHEDULE OF PRO FORMA INFORMATION Consolidated Pro Forma Financial Results for the Years Ending December 31, 2022 2021 Net revenue $ 4,983,556 $ 5,653,725 Net loss attributable to Qualigen Therapeutics, Inc. $ ( 19,538,959 ) $ ( 17,897,137 ) NOTE 4 — INVENTORY, NET Inventory, net consisted of the following at December 31, 2022 and December 31, 2021: SCHEDULE OF INVENTORY December 31, 2022 December 31, 2021 Raw materials $ 949,796 $ 823,315 Work in process 200,318 188,135 Finished goods 436,183 44,428 Total inventory $ 1,586,297 $ 1,055,878 NOTE 5 — PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following at December 31, 2022 and December 31, 2021: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS December 31, December 31, 2022 2021 Prepaid insurance $ 1,377,323 $ 1,197,726 Prepaid manufacturing expenses 43,820 67,410 Other prepaid expenses 227,451 111,183 Other current assets 12,626 3,577 Prepaid expenses and other current assets $ 1,661,220 $ 1,379,896 NOTE 6 — PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following at December 31, 2022 and December 31, 2021: SCHEDULE OF PROPERTY AND EQUIPMENT December 31, December 31, 2022 2021 Machinery and equipment $ 2,510,148 $ 2,482,841 Computer equipment 395,836 345,117 Leasehold improvements 333,271 333,271 Molds and tooling 260,002 260,002 Furniture and fixtures 144,832 143,013 Equipment held for lease 1,399,444 1,181,211 Property and equipment, gross 5,043,533 4,745,455 Accumulated depreciation ( 4,623,446 ) ( 4,541,238 ) Fixed asset impairment ( 75,000 ) — Property and equipment, net $ 345,087 $ 204,217 Depreciation expense relating to property and equipment was approximately $ 92,000 and $ 73,000 for the years ended December 31, 2022 and 2021, respectively. Upon termination of the Sekisui Distribution Agreement on March 31, 2022, the Company had a commitment to purchase leased FastPack rental systems back from Sekisui at Sekisui’s net book value, which was determined to be approximately $ 154,000 . This amount is included in equipment held for lease in the table above and in accrued expenses at December 31, 2022. An assignment agreement is to be executed by both parties to legally transfer title to this equipment from Sekisui to Qualigen. 55 NOTE 7 — GOODWILL, IPR&D AND OTHER INTANGIBLES SCHEDULE OF GOODWILL AND OTHER INTANGIBLE December 31, December 31, 2022 2021 Estimated Useful Lives Gross carrying amounts Gross carrying amounts Goodwill $ 625,602 $ — Finite-lived intangible assets: Developed-product-technology rights 8 - 17 years $ 479,103 $ 479,103 Licensing rights 10 years 418,836 418,836 Less: Accumulated amortization ( 752,237 ) ( 726,749 ) Total finite-lived intangible assets, net 145,702 171,190 Indefinite-lived intangible assets: In-process research and development 5,700,000 — Total other intangible assets, net $ 5,845,702 $ 171,190 The Company periodically reviews goodwill for impairment in accordance with relevant accounting standards. Goodwill is attributable to the NanoSynex Acquisition. Goodwill and intangible assets are recognized at fair value during the period in which an acquisition is completed, from updated estimates during the measurement period, or when they are considered to be impaired. These non-recurring fair value measurements, primarily for goodwill and intangible assets acquired, were based on Level 3 inputs. The Company estimates the fair value of long-lived assets on a non-recurring basis based on a market valuation approach, engaging independent valuation experts to assist in the determination of fair value. In the fourth quarter of fiscal 2022, in conjunction with the annual impairment assessment, the Company determined that the fair value of the reporting unit was less than the carrying value. In addition to continued losses in the reporting unit, the Company considered macroeconomic conditions including a deterioration in the equity markets evidenced by sustained declines in the Company’s stock price, peer companies, and major market indices since the acquisition date. The Company engaged independent valuation experts to assist in determining the fair value of the reporting unit. As a result of this analysis, the Company recorded a $ 4,239,000 goodwill and fixed asset impairment charge associated with the reporting unit. There were no impairments to intangible assets and goodwill during the year ended December 31, 2021. The carrying value of the patents of approximately $ 140,000 and $ 159,000 at December 31, 2022 and December 31, 2021, respectively, are stated net of accumulated amortization of approximately $ 339,000 and $ 320,000 , respectively. Amortization of patents charged to operations for the year ended December 31, 2022 and December 31, 2021 were approximately $ 18,000 and $ 17,000 , respectively. Total future estimated amortization of patent costs for the five succeeding years is approximately $ 18,000 for the year ending December 31, 2023, approximately $ 15,000 for the year ending December 31, 2024, approximately $ 14,000 for years 2025, 2026 and 2027, and approximately $ 65,000 thereafter. The carrying value of the licenses of approximately $ 5,000 and $ 12,000 at December 31, 2022 and December 31, 2021 are stated net of accumulated amortization of approximately $ 414,000 and $ 407,000 , respectively. Amortization of licenses charged to operations for the year ended December 31, 2022 and December 31, 2021 was approximately $ 7,000 and $ 7,000 , respectively. Total future estimated amortization of license costs for the five succeeding years is approximately $ 5,000 for the year ending December 31, 2023. 56 NOTE 8 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consisted of the following at December 31, 2022 and December 31, 2021: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES December 31, December 31, 2022 2021 Board compensation $ 70,000 $ 17,500 Equipment held for lease 154,433 — Franchise, sales and use taxes 27,531 14,090 Income taxes 4,663 3,620 Interest (Convertible debt - related party) 2,829 — Payroll 209,303 682,036 Professional fees 238,211 225,308 Research and development 322,987 232,712 Royalties 13,158 10,152 Warranty liability 137,568 60,281 License fees 150,130 — Other 181,043 265,292 Accrued liabilities $ 1,511,856 $ 1,510,990 NOTE 9 – SHORT TERM DEBT - RELATED PARTY NanoSynex has four separate Notes Payable (the “Notes”) outstanding to Alpha Capital, dated between March 26, 2020 and September 2, 2021, aggregating to a total principal outstanding balance of $ 905,000 , and aggregate accrued interest of $ 45,722 for a total outstanding balance of $ 950,722 as of December 31, 2022. The Notes all accrue interest at 2.62 % per annum, accrued daily, and provide that the full amount of principal and interest under each Note shall be due immediately prior to a Liquidation Event (the Maturity Date) unless due earlier in accordance with the terms of the Notes. “Liquidation Event” means either i) the merger or consolidation of NanoSynex into any other entity, other than one in control or under control of NanoSynex or NanoSynex’s majority shareholder; ii) a transaction or series of transactions resulting in the transfer of all or substantially all of NanoSynex’s assets or issued and outstanding share capital (other than to a company under the control of NanoSynex or NanoSynex’s majority shareholders; or iii) an underwritten public offering by NanoSynex of its ordinary shares. Notwithstanding the above, if NanoSynex receives subsequent debt, convertible debt, or equity funding with gross proceeds of USD $ 3,000,000 or more, then these Notes shall be due and payable upon the actual receipt of such funding. NOTE 10 – WARRANT LIABILITIES In 2004, the Company issued warrants to various investors and brokers for the purchase of Series C preferred stock in connection with a private placement (the “Series C Warrants”). The Series C Warrants were subsequently extended and, upon closing of the reverse recapitalization transaction with Ritter, exchanged for warrants to purchase common stock of the Company, pursuant to the Series C Warrant terms as adjusted. In exchange for the Series C Warrants, upon closing of the merger with Ritter, the holders received warrants to purchase shares of the Company’s common stock at $ 7.195 per share, subject to adjustment. As of December 31, 2022, the warrants have remaining terms ranging from 0.90 to 1.49 years. The warrants were determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, resulting from inclusion of a leveraged ratchet provision for subsequent dilutive issuances. On April 25, 2022 the warrants were repriced from $ 7.195 to $ 6.00 with an additional 49,318 ratchet shares issued, and on May 26 2022 the warrants were repriced from $ 6.00 to $ 5.136 with an additional 49,952 ratchet shares issued. On December 22, 2022 the warrants were repriced again from $ 5.136 to $ 1.32 with an additional 1,002,717 ratchet shares issued. Additionally, on December 22, 2022, in conjunction with the issuance of Convertible Debt - Related Party (Note 11), the Company issued to Alpha Capital a warrant to purchase 2,500,000 shares of the Company’s common stock. The exercise price of the warrant is $ 1.65 (equal to 125 % of the conversion price of the Debenture on the closing date). The warrant may be exercised by Alpha, in whole or in part, at any time on or after June 22, 2023 and before June 22, 2028, subject to certain terms conditions described in the warrant, including the Company’s receipt of the necessary stockholder approvals. 57 The following table summarizes the activity in liability classified warrants for the year ended December 31, 2022: SCHEDULE OF WARRANTS ACTIVITY Common Stock Warrants Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2021 248,162 $ 7.20 $ 7.20 2.00 Exercised ( 536 ) 7.20 Forfeited ( 247,625 ) 7.20 Expired — — Granted 3,849,570 1.53 Total outstanding – December 31, 2022 3,849,571 $ 1.53 1.32 - 1.65 3.9 Exercisable 1,349,571 $ 1.32 $ 1.32 1.00 The following table summarizes the activity in the Common Stock Warrants received in exchange for the Series C Warrants for the year ended December 31, 2021: Common Stock Warrants Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding –December 31, 2020 337,860 $ 7.20 Exercised ( 80,731 ) 7.20 Forfeited ( 8,967 ) 7.20 Expired — — Granted — — Total outstanding – December 31, 2021 248,162 $ 7.20 Exercisable 248,162 $ 7.20 $ 7.20 2.00 The following table presents the Company’s fair value hierarchy for its Common Stock Warrant liabilities measured at fair value on a recurring basis as of December 31, 2022: SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES Quoted Market Significant Prices for Other Significant Identical Observable Unobservable Assets Inputs Inputs Common Stock Warrant liabilities (Level 1) (Level 2) (Level 3) Total Balance as of December 31, 2021 $ — $ — $ 1,686,200 $ 1,686,200 Exercises — — ( 858 ) ( 858 ) Issuance of Alpha warrants — — 2,834,547 2,834,547 Gain on change in fair value of warrant liabilities — — ( 897,242 ) ( 897,242 ) Balance as of December 31, 2022 $ — $ — $ 3,622,647 $ 3,622,647 The following table presents the Company’s fair value hierarchy for its Common Stock Warrant liabilities (all of which arose under the warrants received in exchange for the Series C Warrants) measured at fair value on a recurring basis as of December 31, 2021: Quoted Market Significant Prices for Other Significant Identical Observable Unobservable Assets Inputs Inputs Common Stock Warrant liabilities (Level 1) (Level 2) (Level 3) Total Balance as of December 31, 2020 $ — $ — $ 8,310,100 $ 8,310,100 Exercises — — ( 1,900,713 ) ( 1,900,713 ) Gain on change in fair value of warrant liabilities — — ( 4,723,187 ) ( 4,723,187 ) Balance as of December 31, 2021 $ — $ — $ 1,686,200 $ 1,686,200 58 There were no transfers of financial assets or liabilities between category levels for the year ended December 31, 2022. The value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo simulation. For volatility, the Company considers comparable public companies as a basis for its expected volatility to calculate the fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate history as a public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term of the common stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly higher or lower fair value measurements. The following are the weighted average and the range of assumptions used in estimating the fair value of warrant liabilities (weighted average calculated based on the number of outstanding warrants on each issuance) as of December 31, 2022 and December 31, 2021: SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES December 31, 2022 December 31, 2021 Range Weighted Average Range Weighted Average Risk-free interest rate 3.906% — 4.628 % 4.15 % 0.69 % — 0.84 % 0.72 % Expected volatility (peer group) 88% — 103 % 98 % 84% — 87 % 85 % Term of warrants (in years) .90 — 5.48 3.9 1.90 — 2.50 2.01 Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % The value of the warrant liabilities is based on a valuation received from an independent valuation firm determined using a Monte-Carlo simulation. NOTE 11 — CONVERTIBLE DEBT - RELATED PARTY On December 22, 2022, the Company issued to Alpha Capital, an 8 % Senior Convertible Debenture in the aggregate principal amount of $ 3,300,000 for a purchase price of $ 3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “Alpha Purchase Agreement”). The Debenture is convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company (the “Conversion Shares”), at a price equal to $ 1.32 per share, subject to adjustment as described in the Debenture (the “Conversion Price”) and other terms and conditions described in the Debenture, including the Company’s receipt of the requisite stockholder approvals. Additionally, on December 22, 2022, the Company issued to Alpha Capital a liability classified warrant to purchase 2,500,000 shares of the Company’s common stock (see Note 10-Warrant Liabilities). The exercise price of the warrant is $ 1.65 (equal to 125 % of the conversion price of the Debenture on the closing date). The warrant may be exercised by Alpha Capital, in whole or in part, at any time on or after June 22, 2023 and before June 22, 2028, subject to certain terms conditions described in the warrant, including the Company’s receipt of the necessary stockholder approvals. The proceeds from the transaction will be dedicated to the Company’s efforts of advancing its QN-302 Investigative New Drug candidate towards clinical trials and other working capital purposes. Commencing June 1, 2023 and continuing on the first day of each month thereafter until the earlier of (i) December 22, 2025 and (ii) the full redemption of the Debenture (each such date, a “Monthly Redemption Date”), the Company will redeem $ 110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the Debenture (the “Monthly Redemption Amount”). The Monthly Redemption Amount will be paid in cash; provided that after the first two monthly redemptions, the Company may elect to pay all or a portion of a Monthly Redemption Amount in shares of common stock of the Company, based on a conversion price equal to the lesser of (i) the then Conversion Price of the Debenture and (ii) 85 % of the average of the VWAPs (as defined in the Debenture) for the five consecutive trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption Date. The Company may also redeem some or all of the then outstanding principal amount of the Debenture at any time for cash in an amount equal to 105 % of the then outstanding principal amount of the Debenture being redeemed plus accrued but unpaid interest, liquidated damages and any amounts then owing under the Debenture. These monthly redemption and optional redemptions are subject to the satisfaction of the Equity Conditions (as defined in the Debenture), which includes a condition that we have obtained stockholder approval for such share issuances. The Debenture accrues interest at the rate of 8 % per annum, which does not begin accruing until December 1, 2023, and will be payable on a quarterly basis. Interest may be paid in cash or shares of common stock of the Company or a combination thereof at the option of the Company; provided that interest may only be paid in shares if the Equity Conditions have been satisfied, including the stockholder approval condition as described above. Both the Debenture and the Alpha Warrant provide for adjustments to the Conversion Price and Exercise Price, respectively, in connection with stock dividends and splits, subsequent equity sales and rights offerings, pro rata distributions, and certain fundamental transactions. Both the Debenture and the Alpha Warrant include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha Capital upon 61 days’ notice to the Company. 59 The Company filed a registration statement on Form S-3 (No. 333-269088) with the Securities and Exchange Commission on December 30, 2022 registering the resale by Alpha Capital of an aggregate of 5,157,087 shares of our common stock, which may be issuable to the selling stockholder pursuant to the terms of the Debenture and Alpha Warrant. The Company evaluated the Debenture and Alpha Warrants (“Warrants”) and determined that the Warrants are freestanding financial instruments. The Warrants are not considered indexed to an entity’s own stock, because the settlement amount would not equal the difference between the fair value of a fixed number of the entity’s equity shares and a fixed strike price and all of the adjustment features in Section 3(b) of the warrant agreement are not down round provisions, as defined in ASU 2017-11. Accordingly, the warrants are classified as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings. The proceeds were allocated to the initial fair value of the Warrants, with the residual balance allocated to the initial carrying value of the Debenture. The Company has not elected the fair value option for the Debenture. The Debenture was recognized at proceeds received after allocating the proceeds to the Warrants, and then allocating remaining proceeds to a suite of bifurcated embedded derivative features (conversion option, contingent acceleration upon an Event of Default, and contingent interest upon an Event of Default), with the resulting difference, if any, allocated to the loan host instrument. The suite of derivative features was measured and determined to have no fair value. The original issue discount ($ 0.3 million), the initial fair value of the Warrant ($ 2.8 million), the initial fair value of the suite of bifurcated embedded derivative features ($ 0 ), and the fees and costs paid to Alpha Capital and other third parties ($ 0.1 million) comprise the debt discount. The debt discount shall be amortized to interest expense over the expected term of the Debenture using the effective interest method, in accordance with ASC 835-30. The debt host instrument of the Debenture will subsequently be measured at amortized cost using the effective interest method to accrete interest over its term to bring the Debenture’s initial carrying value to the principal balance at maturity. The senior secured convertible debt comprises the following: SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT December 31, 2022 December 31, 2021 Senior secured convertible debenture $ 3,300,000 $ — Discount on convertible debenture ( 3,239,803 ) — Total convertible debt - related party $ 60,197 $ — As of December 31, 2022, there were no events of default or violation of any covenants under our financing obligations. NOTE 12 — EARNINGS (LOSS) PER SHARE Basic earnings (loss) per share (“EPS”) is computed by dividing net income (loss) by the weighted-average number of common shares outstanding. Diluted EPS is computed based on the sum of the weighted-average number of common shares and potentially dilutive common shares outstanding during the period. Potentially dilutive common shares consist of shares issuable from stock options and warrants as shown below. The following table reconciles net loss and the weighted-average shares used in computing basic and diluted EPS in the respective periods: SCHEDULE OF EARNINGS PER SHARE BASIC AND DILUTED 2022 2021 For the Years Ended December 31, 2022 2021 Net loss used for basic earnings per share $ ( 18,640,543 ) $ ( 17,897,137 ) Basic weighted-average common shares outstanding 3,840,340 2,933,487 Dilutive potential shares issuable from stock options and warrants — — Diluted weighted-average common shares outstanding 3,840,340 2,933,487 SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE As of December 31, 2022 2021 Shares of common stock subject to outstanding options 608,012 484,186 Shares of common stock subject to outstanding warrants 4,575,617 982,140 Total common stock equivalents 5,183,629 1,466,326 60 Potentially dilutive common shares excluded from the calculation above represent stock options and warrants because their effect would be anti-dilutive. NOTE 13 — COMMITMENTS AND CONTINGENCIES Leases The Company leases its facilities under a long-term operating lease agreement. On December 15, 2021, our wholly-owned subsidiary Qualigen, Inc. entered into a Second Amendment to Lease with Bond Ranch LP. This Amendment extended the Company’s triple-net leasehold on the Company’s existing 22,624 -square-feet headquarters/manufacturing facility at 2042 Corte del Nogal, Carlsbad, California for the 61 -month period of November 1, 2022 to November 30, 2027 . Over the 61 months, the base rent payable by Qualigen, Inc. will total $ 1,950,710 ; however, the base rent for the first 12 months of the 61 -month period is only $ 335,966 . Additionally, under the Second Amendment to Lease Qualigen, Inc. is entitled to a $ 339,360 tenant improvement allowance. The tables below show the operating lease right-of-use assets and operating lease liabilities and the balances as of December 31, 2022 and 2021, including the changes during the periods: SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES Operating lease right-of-use assets Net right-of-use assets at December 31, 2021 $ 1,645,568 Less amortization of operating lease right-of-use assets ( 223,030 ) Operating lease right-of-use assets at December 31, 2022 $ 1,422,538 Operating lease liabilities Lease liabilities at December 31, 2021 $ 1,676,655 Less principal payments on operating lease liabilities ( 134,091 ) Lease liabilities at December 31, 2022 1,542,564 Less non-current portion ( 1,301,919 ) Current portion at December 31, 2022 $ 240,645 As of December 31, 2022, the Company’s operating leases have a weighted-average remaining lease term of 4.9 years and a weighted-average discount rate of 8.9 % . As of December 31, 2022, the maturities of operating lease liabilities are as follows: SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES Year Ending December 31, Amount 2023 368,341 2024 379,392 2025 390,773 2026 402,497 2027 379,164 Total 1,920,168 Less present value discount ( 377,604 ) Operating lease liabilities $ 1,542,564 Total lease expense was approximately $ 462,000 and $ 342,000 , respectively, for the years ended December 31, 2022 and December 31, 2021. Lease expense was recorded in cost of product sales, general and administrative expenses, research and development and sales and marketing expenses. Termination of Sekisui Distribution Agreement Sekisui’s Distribution Arrangement expired on March 31, 2022. Following the expiration of the Sekisui Distribution Agreement on March 31, 2022, the Company had a commitment to purchase leased FastPack rental systems back from Sekisui at Sekisui’s net book value, in the amount of $ 154,000 which is included in equipment held for lease and accrued expenses on the consolidated balance sheet. NanoSynex Funding Commitment As a condition to the NanoSynex Acquisition, the Company agreed to provide NanoSynex with up to $ 10.4 million of future funding in the form of promissory notes to the Company based on NanoSynex’s achievement of certain future development milestones and subject to other terms and conditions described in the Funding Agreement entered into with NanoSynex. Of this amount approximately $ 2.4 million was funded during the year ended December 31, 2022, and an additional $ 0.5 million was funded in February 2023 (See Note 2-Liquidity for further details regarding the terms and conditions of the Funding Agreement). 61 Litigation and Other Legal Proceedings On November 9, 2021, the Company was named as a defendant in an action brought by Mediant Communications Inc. (“Mediant”) in the U.S. District Court for the Southern District of New York. The complaint alleged that Qualigen entered into an implied contract with Mediant, whereby Qualigen retained Mediant to distribute proxy materials and subsequently conduct shareholder vote tabulations. The Company filed a Motion to Dismiss with the District Court and on March 14, 2022 a hearing was held during which the presiding judge ruled in favor of the Motion to Dismiss. The Company and Mediant settled the litigation on April 5, 2022 in the amount of $ 96,558 , at which time the amount was paid. NOTE 14 — RESEARCH AND LICENSE AGREEMENTS The University of Louisville Research Foundation In March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with ULRF for development of several small-molecule RAS interaction inhibitor drug candidates. Under the terms of this agreement, the Company was to reimburse ULRF for sponsored research expenses of up to $ 693,000 for this program. In February 2021, March 2022, and October 2022, the Company extended the term of this agreement until September 2023 and increased the amount that the Company will reimburse ULRF for sponsored research expenses to approximately $ 2.7 million. In July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under the agreement, the Company will take over development, regulatory approval and commercialization of the candidates from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an upfront license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative $250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by Licensed Patents), (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to July 2020, and (iv) payments ranging from $ 50,000 to $ 5,000,000 upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $ 50,000 for first dosing in a Phase 1 clinical trial, $ 100,000 for first dosing in a Phase 2 clinical trial, $ 150,000 for first dosing in a Phase 3 clinical trial, $ 300,000 for regulatory marketing approval and $ 5,000,000 upon achieving a cumulative $ 500,000,000 of Licensed Product sales. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $ 20,000 to $ 100,000 ) for such year. Sponsored research expenses related to these agreements for the years ended December 31, 2022 and December 31, 2021 were approximately $ 758,000 and $ 646,000 , respectively, and are recorded in research and development expenses in the Consolidated Statements of Operations. License costs related to these agreements for the years ended December 31, 2022 and December 31, 2021 were approximately $ 40,000 and $ 60,000 , respectively, and are included in research and development expenses in the Consolidated Statements of Operations. Between June 2018 and September 2020, the Company entered into license and sponsored research agreements with the University of Louisville Research Foundation (“ULRF”) for QN-247, a novel aptamer-based compound that has shown promise as an anticancer drug. Under the agreements, the Company took over development, regulatory approval and commercialization of the compound from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received a $ 50,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s common stock, and the Company agreed to reimburse ULRF for sponsored research expenses of up to $ 830,000 and prior patent costs of up to $ 200,000 . The sponsored research agreement ended on August 31, 2022. In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative $250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to June 2018, and (iv) payments ranging from $ 100,000 to $ 5,000,000 upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $ 100,000 for first dosing in a Phase 1 clinical trial, $ 200,000 for first dosing in a Phase 2 clinical trial, $ 350,000 for first dosing in a Phase 3 clinical trial, $ 500,000 for regulatory marketing approval and $ 5,000,000 upon achieving a cumulative $ 500,000,000 of Licensed Product sales; the Company would also pay another $ 500,000 milestone payment for any additional regulatory marketing approval for each additional therapeutic (or diagnostic) indication. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $ 10,000 to $ 50,000 ) for such year. Sponsored research expenses related to these agreements for the years ended December 31, 2022 and December 31, 2021 were approximately $ 164,000 and $ 325,000 , respectively, and these amounts are recorded in research and development expenses in the Consolidated Statements of Operations. Minimum annual royalties of $ 0 and $ 0 related to these agreements are included in research and development expenses in the Consolidated Statements of Operations for the years ended December 31, 2022 and December 31, 2021, respectively. License costs related to these agreements were approximately $ 94,000 and $ 118,000 for the years ended December 31, 2022 and December 31, 2021, respectively, and are included in research and development expenses in the Consolidated Statements of Operations. 62 In June 2020, the Company entered into an exclusive license agreement with ULRF for its intellectual property in the use of QN-165 as a treatment for COVID-19. Under the agreement, the Company took over development, regulatory approval and commercialization of the compound (for such use) from ULRF and was responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $ 24,000 for an upfront license fee and reimbursement of prior patent costs. In addition, the Company executed a sponsored research agreement with ULRF (for QN-165 as a treatment for COVID-19) supporting up to $ 430,000 . This sponsored research agreement expired in November 2021 and effective October 31, 2022 the license agreement for QN-165 was terminated. Sponsored research expenses related to these agreements for the years ended December 31, 2022 and December 31, 2021 were approximately $ 14,000 and $ 243,000 , respectively, and are recorded in research and development expenses in the Consolidated Statements of Operations. License costs related to these agreements for the years ended December 31, 2022 and December 31, 2021 were approximately $ 2,000 and $ 28,000 , respectively, and are included in research and development expenses in the Consolidated Statements of Operations. Advanced Cancer Therapeutics In December 2018, the Company entered into a license agreement with Advanced Cancer Therapeutics, LLC (“ACT”), granting the Company exclusive rights to develop and commercialize QN-165, an aptamer-based drug candidate . In return, ACT received a $ 25,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s common stock. In addition, the Company agreed to pay ACT (i) royalties, on net sales associated with the commercialization of QN-165, of 2% (only if patent-covered and only on net sales above a cumulative $ 3,000,000 ) or 1% (if not patent-covered, but only on net sales above a cumulative $ 3,000,000 ), until the 15th anniversary of the ACT license agreement and (ii) milestone payments of $ 100,000 for the Company raising a cumulative total of $ 2,000,000 in new equity financing after the date of the ACT license agreement, $ 100,000 upon any first QN-165-based licensed product receiving the CE Mark or similar FDA status, and $ 500,000 upon cumulative worldwide QN-165-based licensed product net sales reaching $ 3,000,000 . For the years ended December 31, 2022 and December 31, 2021, there were approximately $ 0 and $ 2,000 , respectively in costs related to this agreement which are included in research and development expenses in the Consolidated Statements of Operations. Yi Xin In October 2020, through our wholly-owned diagnostics subsidiary Qualigen, Inc. we entered into a Technology Transfer Agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd. (“Yi Xin”), of Suzhou, China, for Yi Xin to develop, manufacture and sell new generations of diagnostic test systems based on the Company’s core FastPack technology. In addition, the Technology Transfer Agreement authorized Yi Xin to manufacture and sell the Company’s current generations of FastPack System diagnostic products (1.0, IP and PRO) in China. The Company will receive low- to mid-single-digit royalties on any future new-generations and current-generations product sales by Yi Xin. We received total net cash payments of approximately $ 670,000 , of which approximately $ 632,000 is classified as license revenue, and approximately $ 38,000 is classified as product sales on the Consolidated Statements of Operations for the fiscal year ended December 31, 2021. The Company provided technology transfer and patent/know-how license rights to facilitate Yi Xin’s development and commercialization. 63 The Company gave Yi Xin the exclusive rights for China – which is a market we have not otherwise entered – both for Yi Xin’s new generations of FastPack-based products and for Yi Xin-manufactured versions of our existing FastPack product lines. Yi Xin also has the right to sell its new generations of FastPack-based diagnostic test systems throughout the world (but not to or toward current customers of our existing generations of FastPack products). After March 31, 2022, Yi Xin has the right to sell Yi Xin-manufactured versions of existing FastPack 1.0, IP and PRO product lines worldwide (other than in the United States and other than to or toward current non-US customers of those products), as well as the right to buy Qualigen-manufactured FastPack 1.0, IP and PRO products from us at distributor prices for resale in and for the United States (but not to or toward current U.S. customers of those products). The Company did not license Yi Xin to sell in the U.S. market any Yi Xin-manufactured versions of those legacy FastPack 1.0, IP and PRO product lines. In the Technology Transfer Agreement the Company also confirmed that after March 31, 2022 it would not seek new FastPack customers outside the U.S. STA Pharmaceutical In November 2020, the Company entered into a contract with STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, for GMP production of QN-165, which was the Company’s lead drug candidate for the treatment of COVID-19 and other viral diseases. In connection with this agreement, the Company paid an upfront deposit of approximately $ 1.1 million which was classified as a prepaid expense on the December 31, 2020 Consolidated Balance Sheet date, and all of which was included in research and development expenses in the statement of operations for the year ended December 31, 2021. Research and development expenses related to this agreement for the years ended December 31, 2022 and December 31, 2021 were approximately $ 9,000 and $ 3.2 million, respectively, and are recorded in research and development expenses in the Consolidated Statements of Operations. UCL Business Limited In January 2022, the Company entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London, including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for University College London.) The program’s lead compound is now being developed at Qualigen under the name QN-302 as a candidate for treatment for pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers. The License Agreement required a $ 150,000 upfront payment, reimbursement of past patent prosecution expenses (approximately $ 160,000 ), and (if and when applicable) tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments and a percentage of any non-royalty sublicensing consideration paid to Qualigen. For the years ended December 31, 2022 and 2021 there were license costs of approximately $ 338,000 and $ 0 , respectively, related to this agreement which are included in research and development expenses in the Consolidated Statements of Operations. NOTE 15 — STOCKHOLDERS’ EQUITY As of December 31, 2022, and 2021 the Company had two classes of capital stock: common stock and preferred stock. Common Stock Holders of common stock generally vote as a class with the holders of the preferred stock and are entitled to one vote for each share held. Subject to the rights of the holders of the preferred stock to receive preferential dividends, the holders of common stock are entitled to receive dividends when and if declared by the Board of Directors. Following payment of the liquidation preference of the preferred stock, any remaining assets will be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of any preferred stock upon liquidation, dissolution or winding up of the affairs of the Company. The holders of common stock have no preemptive, subscription or conversion rights and there are no redemption or sinking fund provisions. On December 1, 2021, the Company closed a Securities Purchase Agreement (dated November 29, 2021) with several institutional investors for the purchase and sale of 588,000 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 15.00 per share, for aggregate gross proceeds of $ 8.82 million. On December 22, 2022, the Company issued to Alpha Capital, an 8 % Senior Convertible Debenture in the aggregate principal amount of $ 3,300,000 for a purchase price of $ 3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. The Debenture is convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company, at a price equal to $ 1.32 per share, and other terms and conditions described in the Debenture (see Note 11 -Convertible Debt - Related Party). As part of this transaction, the Company issued to Alpha Capital a warrant to purchase 2,500,000 shares of the Company’s common stock (see Note 10-Warrant Liabilities). At December 31, 2022, the Company has reserved 5,183,629 shares of authorized but unissued common stock for possible future issuance. At December 31, 2022, 5,183,629 shares were reserved as follows: SCHEDULE OF RESERVED SHARES Exercise of issued and future grants of stock options 608,012 Exercise of stock warrants 4,575,617 Total 5,183,629 64 Preferred Stock At December 31, 2022 and 2021, there were no shares of preferred stock outstanding. All shares of Series A, B, C, D, D-1 convertible preferred stock were converted into common stock at the time of the May 2020 reverse recapitalization transaction. During the year ended December 31, 2021, the holder of Series Alpha convertible preferred stock converted 180 of its shares of Series Alpha convertible preferred stock into an aggregate of 243,416 shares of the Company’s common stock. Stock Options and Equity Classified Warrants Stock Options The Company recognizes all compensatory stock-based payments as compensation expense over the service period, which is generally the vesting period. In April 2020, the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”) which provides for the grant of incentive or non-statutory common stock options, restricted stock, stock bonus awards, stock appreciation rights, restricted stock units and performance awards to qualified employees, officers, directors, consultants and other service providers. At December 31, 2022 and December 31, 2021 there were 608,012 and 484,186 outstanding stock options, respectively, under the 2020 Plan and there were 147,690 and 280,916 of Plan shares available, respectively, for future grant. The following represents a summary of the options granted to employees and non-employee service providers that were outstanding at December 31, 2022, and changes during the twelve months then ended: SCHEDULE OF STOCK OPTION ACTIVITY Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2021 484,186 $ 60.70 $ 12.40 — $ 14,657.50 8.52 Granted 134,469 5.24 5.14 — 10.50 5.99 Expired ( 9,379 ) 932.75 57.50 - 14,657.50 — Forfeited ( 1,264 ) 22.64 5.14 - 49.70 — Total outstanding – December 31, 2022 608,012 $ 35.02 $ 5.14 — $ 51.30 8.09 Exercisable (vested) 288,704 $ 46.32 $ 12.40 — $ 51.30 7.59 Non-Exercisable (non-vested) 319,308 $ 24.80 $ 5.14 — $ 10.50 8.59 The following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers that were outstanding at December 31, 2021, and changes during the twelve months then ended: Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2020 401,136 $ 70.50 $ 35.20 — $ 14,657.50 9.29 Granted 83,500 13.70 12.40 — 32.90 9.79 Expired — — — — Forfeited ( 450 ) 36.80 35.20 — 49.70 — Total outstanding – December 31, 2021 484,186 $ 60.70 $ 12.40 — $ 14,657.50 8.52 Exercisable (vested) 140,820 $ 108.80 $ 35.20 — $ 14,657.50 7.94 Non-Exercisable (non-vested) 343,366 $ 41.00 $ 12.40 — $ 51.30 8.81 There was approximately $ 5.4 million and $ 5.3 million of compensation costs related to outstanding options for the year ended December 31, 2022 and December 31, 2021, respectively. As of December 31, 2022, there was approximately $ 3.3 million of total unrecognized compensation cost related to unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 0.93 years. No stock options were exercised during the year ended December 31, 2022 or 2021. The exercise price for an option issued under the 2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the date of grant. The options awarded under the 2020 Plan will vest as determined by the Board of Directors but will not exceed a 10-year period. The weighted average grant date fair value per share of the shares underlying options granted during the year ended December 31, 2022 was $ 3.96 and during the year ended December 31, 2021 was $ 11.00 . 65 Fair Value of Equity Awards The Company utilizes the Black-Scholes option pricing model to value awards under the 2020 Plan, and for equity classified compensatory warrants. Key valuation assumptions include: ● Expected dividend yield. The expected dividend is assumed to be zero, as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock. ● Expected stock-price volatility. The Company’s expected volatility is derived from the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term. ● Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term. ● Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. The material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted for the periods presented were as follows: SCHEDULE OF ASSUMPTION USED IN BLACK-SCHOLES OPTION-PRICING METHOD For the Years Ended December 31, 2022 2021 Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility 103 % 102 % Risk-free interest rate 1.58 % — 3.77 % 0.84 % — 1.51 % Expected average term of options (in years) 5.99 6.27 Stock price 5.14 - 10.50 12.40 — 32.90 The Company recorded stock-based compensation expense and classified it in the Consolidated Statements of Operations as follows: SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE 2022 2021 For the Years Ended December 31, 2022 2021 General and administrative $ 4,649,649 $ 4,465,911 Research and development 834,395 827,740 Total $ 5,484,044 $ 5,293,651 Equity Classified Compensatory Warrants In connection with the $ 4.0 million equity capital raise as part of the May 2020 reverse recapitalization transaction, the Company issued common stock warrants to an advisor and its designees for the purchase of 81,143 reverse split adjusted shares of the Company’s common stock at a reverse split adjusted exercise price of $ 11.1 0 per share. The issuance cost of these warrants was charged to additional paid-in capital, and did not result in expense in the Company’s consolidated statements of operations and comprehensive loss. In addition, various service providers hold equity classified compensatory warrants issued in 2017 and earlier (originally exercisable to purchase Series C convertible preferred stock, and now instead exercisable to purchase common stock) for the purchase of 66,802 reverse split adjusted s hares of Company common stock at a weighted average exercise price of $ 23.40 per share. These are to be differentiated from the Series C Warrants described in Note 10- Warrant Liabilities. During the year ended December 31, 2021, the Company issued equity classified compensatory warrants to a service provider for the purchase of 60,000 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 13.20 per share. The fair value issuance cost of approximately $ 0.3 million using the Black-Scholes options pricing model for these warrants was charged to general and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss. On April 25, 2022, 60,000 warrants were repriced from $ 13.20 to a reverse split adjusted exercise price of $6.00 and extended from June 3, 2023 to September 14, 2023 . The increase in fair value of $ 67,370 using a Monte Carlo pricing model for the modification of these warrants was charged to general and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss. On April 25, 2022 and May 26, 2022 an additional 67,619 reverse split adjusted warrants were repriced from reverse split adjusted $11 .10 to $ 5.136 . The increase in fair value of $ 31,010 using a Monte Carlo pricing model for the modification of these warrants was charged to additional paid-in capital and did not result in expense on the Company’s consolidated statements of operations and comprehensive loss. On December 22, 2022 67,620 warrants were repriced from $ 5.136 to $ 1.32 . The increase in fair value of $ 8,548 using a Monte Carlo pricing model for the modification of these warrants was charged to additional paid-in capital and did not result in expense on the Company’s consolidated statements of operations and comprehensive loss. 66 No new compensatory warrants were issued during the year ended December 31, 2022. The following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2022: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2021 179,046 $ 15.20 $ 11.10 — $ 25.40 2.64 Granted to advisor and its designees — — Exercised — — Expired — — Forfeited — — Total outstanding – December 31, 2022 179,046 $ 9.12 $ 1.32 — $ 25.40 1.73 Exercisable 179,046 $ 9.12 $ 1.32 - $ 25.40 1.73 Non-Exercisable — $ — $ — — The following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2021: Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2020 129,403 $ 16.60 Granted to advisor and its designees 60,000 13.20 Exercised ( 3,839 ) 20.90 Expired — — Forfeited ( 6,518 ) 20.70 Total outstanding – December 31, 2021 179,046 $ 15.20 $ 11.10 — $ 25.40 2.64 Exercisable 179,046 $ 15.20 $ 11.10 — $ 25.40 2.64 Non-Exercisable — $ — $ — — There were $ 67,370 in compensation costs related to outstanding warrants for the year ended December 31, 2022 and $ 0.3 million for the year ended December 31, 2021. As of December 31, 2022 and December 31, 2021, there was no unrecognized compensation cost related to nonvested warrants. Noncompensatory Equity Classified Warrants In May 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha Capital (a related party) for the purchase of 27,048 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 11.10 per share (of which warrants for 20,000 shares were subsequently exercised in December 2020). In July 2020 the Company issued noncompensatory equity classified warrants to Alpha Capital for the purchase of 78,019 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 0.01 per share (which were subsequently exercised in July 2020), and 192,068 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 52.50 per share. In August 2020, the Company issued noncompensatory equity classified warrants to Alpha Capital for the purchase of 128,783 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 60.00 per share. In December 2020, the Company issued noncompensatory equity classified warrants to Alpha Capital for the purchase of 100,000 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 0.10 per share (which were exercised in February 2021) and 219,101 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 40.70 per share. In May 2022, the Company issued noncompensatory equity classified warrants to Alpha Capital for the purchase of 331,464 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 0.01 per share (See Note 3 -Acquisition). 67 On November 29, 2021, with the exception of the warrants to purchase 27,048 reverse split adjusted shares of the Company’s common stock at a reverse split adjusted exercise price of $ 11.10 per share, the exercise prices of all outstanding warrants to purchase a total of 539,951 reverse split adjusted shares of the Company’s common stock were modified to a reverse split adjusted exercise price of $ 20.00 per share and each of their remaining terms extended by six months. The fair value of the modification cost of these warrant modifications of approximately $ 2.3 million was charged to additional paid-in capital and did not result in expense on the Company’s consolidated statements of operations and comprehensive loss. In May 2022, pre-funded warrants to purchase 331,464 reverse split adjusted shares of the Company’s common stock at a reverse split adjusted exercise price of $ 0.01 per share with no expiration date were issued. These warrants were subsequently exercised during the period ended September 30, 2022. In conjunction with the NanoSynex Acquisition (See Note 3-Acquisition), on April 25, 2022 the exercise price of 7,048 reverse split adjusted outstanding warrants at $ 11.10 was modified to a reverse split adjusted exercise price of $ 6.00 . The increase in fair value of $ 2,533 , using a Monte Carlo pricing model for the modification of these warrants, was charged to additional paid-in capital and did not result in expense on the Company’s consolidated statements of operations and comprehensive loss. On May 26, 2022, the reverse split adjusted exercise price of these warrants was modified again to $ 5.136 , and the increase in fair value of $ 696 , using a Monte Carlo pricing model for the modification of these warrants, was included in consideration transferred in the NanoSynex Acquisition. On December 22, 2022 the exercise price of these warrants was modified again to $ 1.32 . The increase in fair value of $ 891 , using a Monte Carlo pricing model for the modification of those warrants, was charged to additional paid-in capital and did not result in expense on the Company’s consolidated statements of operations and comprehensive loss. The following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2022: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2021 554,914 $ 20.10 11.10 — 37.78 1.32 Granted 331,464 0.01 0.01 Exercised ( 331,464 ) 0.01 0.01 Expired ( 7,911 ) 37.78 37.78 Forfeited — — — Total outstanding – December 31, 2022 547,003 19.76 1.32 - 20.00 0.33 Exercisable 547,003 19.76 1.32 - 20.00 0.33 Non-Exercisable — $ — $ — — The following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2021: Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2020 654,978 $ 43.60 Granted — — Exercised ( 100,000 ) 0.01 Expired ( 64 ) 23,250.00 Forfeited — — Total outstanding – December 31, 2021 554,914 20.10 Exercisable 554,914 20.10 11.10 — 37.78 1.32 Non-Exercisable — $ — $ — — NOTE 16 — RELATED PARTY TRANSACTIONS Convertible Debt On December 22, 2022, the Company issued to Alpha Capital, an 8 % Senior Convertible Debenture in the aggregate principal amount of $ 3,300,000 for a purchase price of $ 3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “Alpha Purchase Agreement”). The Debenture is convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company (the “Conversion Shares”), at a price equal to $ 1.32 per share, subject to adjustment as described in the Debenture (the “Conversion Price”) and other terms and conditions described in the Debenture, including the Company’s receipt of the requisite stockholder approvals (See Note 11 -Convertible Debt - Related Party). Short-Term Debt NanoSynex has four separate notes payable (the “Notes”) outstanding to Alpha Capital, dated between March 26, 2020 and September 2, 2021, aggregating to a total principal outstanding balance of $ 905,000 , and aggregate accrued interest of $ 45,722 for a total outstanding balance of $ 950,722 as of December 31, 2022. The Notes all accrue interest at 2.62 % per annum, accrued daily, and provide that the full amount of principal and interest under each Note shall be due immediately prior to a Liquidation Event (the Maturity Date) unless due earlier in accordance with the terms of the Notes. “Liquidation Event” means either i) the merger or consolidation of NanoSynex into any other entity, other than one in control or under control of NanoSynex or NanoSynex’s majority shareholder; ii) a transaction or series of transactions resulting in the transfer of all or substantially all of NanoSynex’s assets or issued and outstanding share capital (other than to a company under the control of NanoSynex or NanoSynex’s majority shareholders; or iii) an underwritten public offering by NanoSynex of its ordinary shares. Notwithstanding the above, if NanoSynex receives subsequent debt, convertible debt, or equity funding with gross proceeds of USD $ 3,000,000 or more, then these Notes shall be due and payable upon the actual receipt of such funding (See Note 9 -Short-term Debt - Related Party). Nanosynex Acquisition The Company acquired a 52.8 % voting equity interest in NanoSynex on May 26, 2022 (the “NanoSynex Acquisition Date”) through: (1) the purchase of 2,232,861 shares Preferred A-1 Stock of NanoSynex from Alpha Capital (a related party) for 350,000 reverse split adjusted shares of the Company’s common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company’s common stock at a purchase price of $ 0.001 per share ( these warrants were subsequently exercised on September 13, 2022) , and (2) the purchase of 381,786 shares of Series B preferred stock of NanoSynex from NanoSynex in exchange for $ 600,000 (See Note 3 - Acquisition). NOTE 17 — INCOME TAXES The following table presents domestic and foreign components of consolidated loss before income taxes for the periods presented: SCHEDULE OF DOMESTIC AND FOREIGN COMPONENTS December 31, 2022 December 31, 2021 Domestic $ ( 15,954,750 ) $ ( 17,891,710 ) Foreign ( 5,344,967 ) — Loss before provision for income taxes $ ( 21,299,717 ) $ ( 17,891,710 ) 68 A reconciliation of the statutory income tax rates and the Company’s effective tax rate is as follows: SCHEDULE OF RECONCILIATIONS OF STATUTORY INCOME TAX RATE December 31, 2022 December 31, 2021 Statutory federal income tax rate 21.00 % 21.00 % State taxes, net of federal tax benefit 5.46 % 6.63 % Non-deductible expenses - 1.36 % - 1.19 % NOL expiration - 12.96 % - 2.71 % Tax credit 2.42 % 0.86 % Goodwill impairment - 4.50 % 0.00 % Foreign rate differential 0.50 % 0.00 % Change in FV of warrant liability 0.89 % 5.54 % True-up 1.47 % - 2.72 % Change in valuation allowance - 11.68 % - 27.44 % Income taxes provision (benefit) 1.24 % - 0.03 % Income tax expense for the year ended December 31, 2022 and 2021 consisted of the following: SCHEDULE OF PROVISION FOR INCOME TAXES December 31, 2022 December 31, 2021 For the Years Ended December 31, 2022 December 31, 2021 Current US Federal $ — $ — US State 7,000 5,000 Foreign — — Total current provision 7,000 5,000 Deferred US Federal ( 236,000 ) ( 1,268,000 ) US State ( 2,252,000 ) ( 3,641,000 ) Foreign ( 272,000 ) — Total deferred benefit ( 2,760,000 ) ( 4,909,000 ) Change in valuation allowance 2,488,000 4,909,000 Total provision (benefit) for income taxes $ ( 265,000 ) $ 5,000 The components of deferred tax assets and liabilities are as follows: SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES December 31, 2022 December 31, 2021 Deferred tax assets: Net operating loss $ 33,540,000 $ 33,362,000 Research and development credits 7,857,000 6,185,000 Accrued expenses 1,020,000 757,000 Patent — 262,000 Stock compensation 3,069,000 2,747,000 Research and development expenses 1,196,000 — Fixed assets 280,000 282,000 Total deferred income tax assets 46,962,000 43,595,000 Deferred tax liabilities: Intangible assets ( 1,324,000 ) ( 34,000 ) Right-of-use asset ( 382,000 ) ( 436,000 ) Total deferred income tax liabilities ( 1,706,000 ) ( 470,000 ) Net deferred income tax assets 45,256,000 43,125,000 Valuation allowance ( 45,614,000 ) ( 43,125,000 ) Deferred tax asset, net of allowance $ ( 358,000 ) $ — Based on the available objective evidence, including the Company’s history of cumulative losses, management believes it is likely that the Company’s U.S. federal and state net deferred tax assets will not be realizable. Accordingly, the Company provided for a full valuation allowance against its U.S. federal and state net deferred tax assets at December 31, 2022 and December 31, 2021. 69 Due to the full valuation allowance already in place on the Company’s U.S. federal and state net deferred tax assets, the Company does not anticipate significant changes in the Company’s effective tax rate. However, there is no valuation allowance recorded against the Company’s foreign net operating loss deferred tax assets, as the Company’s foreign IPR&D deferred tax liabilities and foreign net operating loss deferred tax assets are both indefinite-lived and thus they may be netted to arrive at a net foreign deferred tax liability. This results in $ 272,000 of foreign deferred tax benefit recorded to the income statement in 2022. The Tax Cuts and Jobs Act resulted in significant changes to the treatment of research or experimental (“R&E”) expenditures under Section 174. For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&E expenditures that are paid or incurred in connection with their trade or business which represent costs in the experimental or laboratory sense. Specifically, costs for U.S. based R&E activities must be amortized over five years and costs for foreign R&E activities must be amortized over 15 years; both using a midyear convention. The Company has incorporated the impact of this new tax legislation into its 2022 consolidated financial statements, noting that the impact on the Company’s consolidated financial statements was immaterial. At December 31, 2022, the Company has U.S. federal and state net operating loss carryforwards of approximately $ 119,254,000 and $ 110,227,000 , respectively, which are available to offset future taxable income. U.S. federal and state net operating loss carryovers began to expire in 2020. As a result of the May 2020 reverse recapitalization, an ownership change has occurred. The Company has not completed an Internal Revenue Code Section 382 analysis. As a result, there could be substantial limitations on the Company’s ability to utilize its pre-ownership change net operating loss and tax credit carryforwards. These substantial limitations may result in both a permanent loss of certain tax benefits related to net operating loss carryforwards and federal research and development credits, and an annual utilization limitation. At December 31, 2022, the Company has foreign net operating loss carryforwards of approximately $ 953,000 , which are available to offset future taxable income. Foreign net operating loss carryovers are indefinite lived and do not expire. The Company also has research and development credit carryforwards for federal and state tax purposes of approximately $ 5,484,000 and $ 2,373,000 , respectively. The research and development credit carryforwards began to expire in 2020 for federal tax purposes and have an indefinite life for state tax purposes . U.S. income tax has not been recognized on the excess of the amount for financial reporting over the tax basis of investments in foreign subsidiaries that is indefinitely reinvested outside the United States. This amount becomes taxable upon a repatriation of assets from the subsidiary or a sale or liquidation of the subsidiary. Determination of the amount of any unrecognized deferred income tax liability on this temporary difference is not practicable because of the complexities of the hypothetical calculation. The Company files income tax returns in the U.S. federal jurisdiction and in various states. The Company’s U.S. federal income tax returns remain subject to examination by the Internal Revenue Service. The Company’s California income tax returns remain subject to examination by the California Franchise Tax Board. Due to net operating losses, research and development credits and other tax credit carryforwards that may be utilized in future years, all U.S. federal and state tax years are open to examination. Generally accepted accounting principles clarify the accounting for uncertainty in income taxes recognized in the Company’s financial statements and prescribe thresholds for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return, and also provide guidance on de-recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company adopted these provisions effective April 1, 2009. The Company did no t have any unrecognized tax benefits as of December 31, 2022 and December 31, 2021 and does not expect this to change significantly over the next 12 months. In accordance with generally accepted accounting principles, the Company will recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. As of December 31, 2022, the Company has not accrued any interest or penalties related to uncertain tax positions. NOTE 18 — SUBSEQUENT EVENTS Between January 9 and 12, 2023 Alpha Capital voluntarily converted $ 1,111,078 of its outstanding Senior Convertible Debenture principal into 841,726 shares of common stock at a conversion price of $ 1.32 per share. On January 13, 2023, the Company’s board of directors, as part of certain cost-cutting measures, approved a temporary 20 % reduction to the base salaries of all executive officers of the Company and a 20 % reduction to the non-employee directors’ annual cash compensation. The Company also terminated the employment of certain employees, including its Senior Vice President/Chief Operating Officer and Vice President/Chief Scientific Officer. The Company filed a Notification of Late Filing on Form 12b-25 on March 31, 2023, indicating that the filing of this Annual Report would be delayed on account of the Company and its registered public accounting firm requiring additional time to complete the accounting and disclosures related to the Company’s acquisition of a majority interest in NanoSynex, Ltd., which accounting and disclosures have been included in this Annual Report. On April 20, 2023, the Company received a notification letter from the Listing Qualifications Department of Nasdaq indicating that, as a result of the Company’s delay in filing this Annual Report, the Company was not in compliance with the timely filing requirements for continued listing under Nasdaq Listing Rule 5250(c)(1). The notification letter has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market. The notification letter stated that, under Nasdaq rules, the Company has 60 calendar days, or until June 20, 2023, to submit a plan to regain compliance with Nasdaq’s continued listing requirements. The Company may also regain compliance with Nasdaq’s continued listing requirements at any time before June 20, 2023, by filing this Annual Report with the SEC, as well as any subsequent periodic financial reports that may become due, and continuing to comply with Nasdaq’s other continued listing requirements. The filing of this Annual Report was the Company’s action to regain compliance. 70 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. Not applicable.