Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-37428 | |
Entity Registrant Name | Qualigen Therapeutics, Inc. | |
Entity Central Index Key | 0001460702 | |
Entity Tax Identification Number | 26-3474527 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 2042 Corte Del Nogal | |
Entity Address, City or Town | Carlsbad | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92011 | |
City Area Code | (760) | |
Local Phone Number | 918-9165 | |
Title of 12(b) Security | Common Stock, par value $.001 per share | |
Trading Symbol | QLGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 5,052,463 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash | $ 1,341,659 | $ 7,034,434 |
Accounts receivable, net | 679,380 | 538,587 |
Inventory, net | 1,563,399 | 1,586,297 |
Prepaid expenses and other current assets | 1,278,077 | 1,661,220 |
Total current assets | 4,862,515 | 10,820,538 |
Restricted cash | 5,434 | 5,690 |
Right-of-use assets | 1,305,970 | 1,422,538 |
Property and equipment, net | 498,647 | 345,087 |
Intangible assets, net | 5,833,070 | 5,845,702 |
Goodwill | 625,602 | 625,602 |
Other assets | 18,334 | 18,334 |
Total Assets | 13,149,572 | 19,083,491 |
Current liabilities | ||
Accounts payable | 1,756,183 | 857,311 |
Accrued vacation | 332,617 | 467,948 |
Accrued expenses and other current liabilities | 1,980,555 | 1,511,856 |
R&D grant liability | 151,620 | 780,682 |
Deferred revenue, current portion | 94,474 | 116,161 |
Operating lease liability, current portion | 257,155 | 240,645 |
Short term debt-related party | 965,155 | 950,722 |
Warrant liabilities | 133,500 | 788,100 |
Warrant liabilities - related party | 2,010,180 | 2,834,547 |
Convertible debt - related party | 812,419 | 60,197 |
Total current liabilities | 8,493,858 | 8,608,169 |
Operating lease liability, net of current portion | 1,168,653 | 1,301,919 |
Deferred revenue, net of current portion | 28,648 | 49,056 |
Deferred tax liability | 150,369 | 357,757 |
Total liabilities | 9,841,528 | 10,316,901 |
Commitments and Contingencies (Note 12) | ||
Qualigen Therapeutics, Inc. stockholders’ equity: | ||
Common stock, $0.001 par value; 225,000,000 shares authorized; 5,052,463 and 4,210,737 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 42,952 | 42,110 |
Additional paid-in capital | 112,554,830 | 110,528,050 |
Accumulated other comprehensive income | 131,891 | 50,721 |
Accumulated deficit | (110,695,598) | (103,385,172) |
Total Qualigen Therapeutics, Inc. stockholders’ equity | 2,034,075 | 7,235,709 |
Noncontrolling interest | 1,273,969 | 1,530,881 |
Total Stockholders’ Equity | 3,308,044 | 8,766,590 |
Total Liabilities & Stockholders’ Equity | $ 13,149,572 | $ 19,083,491 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 5,052,463 | 4,210,737 |
Common stock, shares outstanding | 5,052,463 | 4,210,737 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Other Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
REVENUES | ||||
Total revenues | $ 1,627,031 | $ 1,430,534 | $ 3,234,201 | $ 2,152,563 |
EXPENSES | ||||
Cost of product sales | 1,016,542 | 1,099,677 | 2,281,368 | 1,928,524 |
General and administrative | 2,665,849 | 2,660,857 | 4,380,283 | 5,559,608 |
Research and development | 1,326,544 | 1,506,227 | 3,448,095 | 3,370,972 |
Sales and marketing | 169,223 | 305,103 | 368,337 | 443,426 |
Total expenses | 5,178,158 | 5,571,864 | 10,478,083 | 11,302,530 |
LOSS FROM OPERATIONS | (3,551,127) | (4,141,330) | (7,243,882) | (9,149,967) |
OTHER EXPENSE (INCOME), NET | ||||
Gain on change in fair value of warrant liabilities | (440,294) | (14,800) | (1,478,967) | (698,042) |
Interest expense (income), net | 377,416 | (4,824) | 921,652 | (11,132) |
Loss on voluntary conversion of convertible debt | 1,077,287 | |||
Loss on disposal of equipment held for lease | 63,302 | 63,302 | ||
Other income, net | (5,680) | 376 | (10,559) | 341 |
Loss on fixed asset disposal | 300 | |||
Total other expense (income), net | (5,256) | (19,248) | 573,015 | (708,833) |
LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES | (3,545,871) | (4,122,082) | (7,816,897) | (8,441,134) |
(BENEFIT) PROVISION FOR INCOME TAXES | (38,182) | 5,438 | (201,959) | 6,173 |
Net loss | (3,507,689) | (4,127,520) | (7,614,938) | (8,447,307) |
Net loss attributable to noncontrolling interest | (43,484) | (4,116) | (304,512) | (4,116) |
Net loss attributable to Qualigen Therapeutics, Inc. | $ (3,464,205) | $ (4,123,404) | $ (7,310,426) | $ (8,443,191) |
Net loss per common share, basic | $ (0.69) | $ (1.12) | $ (1.46) | $ (2.35) |
Net loss per common share, diluted | $ (0.69) | $ (1.12) | $ (1.46) | $ (2.35) |
Weighted—average number of shares outstanding, basic | 5,052,463 | 3,668,016 | 5,006,050 | 3,599,093 |
Weighted-average number of shares outstanding, diluted | 5,052,463 | 3,668,016 | 5,006,050 | 3,599,093 |
Other comprehensive loss, net of tax | ||||
Foreign currency translation adjustment | $ (56,747) | $ 65,540 | $ 119,473 | $ 65,540 |
Other comprehensive loss | (3,564,436) | (4,061,980) | (7,495,465) | (8,381,767) |
Comprehensive loss attributable to noncontrolling interest | (43,484) | (4,116) | (304,512) | (4,116) |
Comprehensive loss attributable to Qualigen Therapeutics, Inc. | (3,520,952) | (4,057,864) | (7,190,953) | (8,377,651) |
Net Product Sales [Member] | ||||
REVENUES | ||||
Total revenues | $ 1,627,031 | $ 1,430,534 | $ 3,234,201 | $ 2,152,563 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Parent [Member] | Noncontrolling Interest [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 35,290 | $ 101,274,073 | $ (84,744,629) | $ 16,564,734 | $ 16,564,734 | ||
Balance, shares at Dec. 31, 2021 | 3,529,018 | ||||||
Stock-based compensation | 1,267,166 | 1,267,166 | 1,267,166 | ||||
Net loss | (4,319,787) | (4,319,787) | (4,319,787) | ||||
Stock issued upon exercise of warrants | $ 5 | 4,711 | 4,716 | 4,716 | |||
Stock issued upon exercise of warrants, shares | 536 | ||||||
Ending balance, value at Mar. 31, 2022 | $ 35,295 | 102,545,950 | (89,064,416) | 13,516,829 | 13,516,829 | ||
Balance, shares at Mar. 31, 2022 | 3,529,554 | ||||||
Beginning balance, value at Dec. 31, 2021 | $ 35,290 | 101,274,073 | (84,744,629) | 16,564,734 | 16,564,734 | ||
Balance, shares at Dec. 31, 2021 | 3,529,018 | ||||||
Net loss | (8,447,307) | ||||||
Ending balance, value at Jun. 30, 2022 | $ 38,795 | 107,557,744 | 65,540 | (93,187,820) | 14,474,259 | 3,995,884 | 18,470,143 |
Balance, shares at Jun. 30, 2022 | 3,879,554 | ||||||
Beginning balance, value at Mar. 31, 2022 | $ 35,295 | 102,545,950 | (89,064,416) | 13,516,829 | 13,516,829 | ||
Balance, shares at Mar. 31, 2022 | 3,529,554 | ||||||
Stock-based compensation | 1,423,282 | 1,423,282 | 1,423,282 | ||||
Foreign currency translation adjustment | 65,540 | 65,540 | 65,540 | ||||
Net loss | (4,123,404) | (4,123,404) | (4,116) | (4,127,520) | |||
Common stock issued for business acquisition | $ 3,500 | 1,841,000 | 1,844,500 | 1,844,500 | |||
Common stock issued shares for business acquisition | 350,000 | ||||||
Prefunded warrants issued for business acquisition | 1,746,816 | 1,746,816 | 1,746,816 | ||||
Estimated fair value of noncontrolling interest related to business acquisition | 4,000,000 | 4,000,000 | |||||
Fair value of warrant modification for business acquisition | 696 | 696 | 696 | ||||
Ending balance, value at Jun. 30, 2022 | $ 38,795 | 107,557,744 | 65,540 | (93,187,820) | 14,474,259 | 3,995,884 | 18,470,143 |
Balance, shares at Jun. 30, 2022 | 3,879,554 | ||||||
Beginning balance, value at Dec. 31, 2022 | $ 42,110 | 110,528,050 | 50,721 | (103,385,172) | 7,235,709 | 1,530,881 | 8,766,590 |
Balance, shares at Dec. 31, 2022 | 4,210,737 | ||||||
Voluntary conversion of convertible debt into common stock | $ 842 | 1,111,740 | 1,112,582 | 1,112,582 | |||
Voluntary conversion of convertible debt into common stock, shares | 841,726 | ||||||
Stock-based compensation | 247,657 | 247,657 | 4,569 | 252,226 | |||
Foreign currency translation adjustment | 119,723 | 119,723 | 56,497 | 176,220 | |||
Net loss | (3,846,221) | (3,846,221) | (261,028) | (4,107,249) | |||
Ending balance, value at Mar. 31, 2023 | $ 42,952 | 111,887,447 | 170,444 | (107,231,393) | 4,869,450 | 1,330,919 | 6,200,369 |
Balance, shares at Mar. 31, 2023 | 5,052,463 | ||||||
Beginning balance, value at Dec. 31, 2022 | $ 42,110 | 110,528,050 | 50,721 | (103,385,172) | 7,235,709 | 1,530,881 | 8,766,590 |
Balance, shares at Dec. 31, 2022 | 4,210,737 | ||||||
Net loss | (7,614,938) | ||||||
Ending balance, value at Jun. 30, 2023 | $ 42,952 | 112,554,830 | 131,891 | (110,695,598) | 2,034,075 | 1,273,969 | 3,308,044 |
Balance, shares at Jun. 30, 2023 | 5,052,463 | ||||||
Beginning balance, value at Mar. 31, 2023 | $ 42,952 | 111,887,447 | 170,444 | (107,231,393) | 4,869,450 | 1,330,919 | 6,200,369 |
Balance, shares at Mar. 31, 2023 | 5,052,463 | ||||||
Stock-based compensation | 667,383 | 667,383 | 4,728 | 672,111 | |||
Foreign currency translation adjustment | (38,553) | (38,553) | (18,194) | (56,747) | |||
Net loss | (3,464,205) | (3,464,205) | (43,484) | (3,507,689) | |||
Ending balance, value at Jun. 30, 2023 | $ 42,952 | $ 112,554,830 | $ 131,891 | $ (110,695,598) | $ 2,034,075 | $ 1,273,969 | $ 3,308,044 |
Balance, shares at Jun. 30, 2023 | 5,052,463 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
Net loss | $ (3,507,689) | $ (4,107,249) | $ (4,127,520) | $ (4,319,787) | $ (7,614,938) | $ (8,447,307) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 122,523 | 66,258 | |||||
Amortization of right-of-use assets | 116,567 | 109,803 | |||||
Accounts receivable reserves and allowances | (133,278) | (75,295) | |||||
Inventory reserves | (22,992) | (16,405) | |||||
Stock-based compensation | 906,145 | 2,690,447 | |||||
Change in fair value of warrant liabilities | (1,478,967) | (698,042) | |||||
Loss on voluntary conversion of convertible debt | 1,077,287 | ||||||
Accretion of discount on convertible debt | 787,517 | ||||||
Loss on disposal of fixed assets and equipment held for lease | 63,602 | ||||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | (8,614) | 250,201 | |||||
Inventory and equipment held for lease | (37,390) | (237,930) | |||||
Prepaid expenses and other assets | 382,893 | (548,487) | |||||
Accounts payable | 899,753 | 27,941 | |||||
Accrued expenses and other current liabilities | 357,508 | (828,229) | |||||
R&D grant liability | (613,793) | ||||||
Operating lease liability | (116,756) | (73,408) | |||||
Deferred revenue | (42,095) | (47,345) | |||||
Deferred tax liability | (207,388) | ||||||
Net cash used in operating activities | (5,562,416) | (7,827,798) | $ (13,200,000) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
Purchases of property and equipment | (246,418) | (63,483) | |||||
Net cash acquired in business combination | 135,354 | ||||||
Net cash (used in)/provided by investing activities | (246,418) | 71,871 | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Net proceeds from warrant exercises | 3,859 | ||||||
Net cash provided by financing activities | 3,859 | ||||||
Net change in cash and restricted cash | (5,808,834) | (7,752,068) | |||||
Effect of exchange rate changes on cash and restricted cash | 115,803 | (34,228) | |||||
Cash and restricted cash - beginning of period | $ 7,040,124 | $ 17,538,272 | 7,040,124 | 17,538,272 | 17,538,272 | ||
Cash and restricted cash - end of period | $ 1,347,093 | $ 9,751,976 | 1,347,093 | 9,751,976 | $ 7,040,124 | ||
Cash paid during the year for: | |||||||
Interest | |||||||
Taxes | 6,293 | 3,501 | |||||
NONCASH FINANCING AND INVESTING ACTIVITIES: | |||||||
Net transfers to equipment held for lease from inventory | 83,271 | ||||||
Fair value of warrant liabilities on date of exercise | 858 | ||||||
Voluntary conversion of convertible debt into common stock | $ 1,112,582 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES | NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES Organization Qualigen, Inc., a subsidiary of Qualigen Therapeutics, Inc., was incorporated in Minnesota in 1996 to design, develop, manufacture and sell point-of-care quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. 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. 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 “NanoSynex Acquisition”). NanoSynex is a micro-biologics diagnostics company domiciled in Israel. Amendment and Settlement Agreement with NanoSynex Ltd. Basis of Presentation The accompanying condensed 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 condensed 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 condensed 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 fractional shares was paid 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. 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 government money market mutual funds and 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. In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity concerns and taken over by the Federal Deposit Insurance Corporation (FDIC). While the Company did not have an account at any of these 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 three and six months ended June 30, 2023 and 2022, no 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, net is comprised of the following at: SCHEDULE OF ACCOUNTS RECEIVABLE June 30, 2023 December 31, 2022 Accounts Receivable $ 733,964 $ 726,449 Less Reserves and Allowances (54,584 ) (187,862 ) Accounts receivable, net $ 679,380 $ 538,587 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. 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 condensed 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 condensed 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 which totaled approximately $ 78,000 72,000 144,000 111,000 0 4,000 and approximately $ 4,000 8,000 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. 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 three months ended June 30, 2023 and 2022, product sales are stated net of an allowance for estimated returns of approximately $ 28,000 10,000 33,000 53,000 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 condensed consolidated balance sheets 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 Note 12 - Commitments and Contingencies for more information). 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 Computer equipment 3 Molds and tooling 5 Furniture and fixtures 5 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. 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 date, and that assets acquired and liabilities assumed 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. 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 no 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 condensed consolidated statements of operations and other comprehensive income (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. Costs related to acquiring patents and licenses are capitalized and amortized over their estimated useful lives, which is generally 5 17 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 condensed consolidated statements of operations and other comprehensive income (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 9- Warrant Liabilities). 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. 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. 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 condensed 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 $ 140,000 138,000 63,000 22,000 104,000 41,000 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 ($56,747) 65,540 for the three months ending June 30, 2023 and 2022, respectively, and $119,473 and $65,540 for the six months ending June 30, 2023 and 2022, respectively. 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. Inflation and Global Economic Conditions 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. In addition, the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession in the near future. If the global economy slows, our business would be adversely affected. 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. During the height of the pandemic sales of diagnostic products decreased significantly 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. For 2023 we continue to experience 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 condensed consolidated financial statements. |
LIQUIDITY
LIQUIDITY | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY | NOTE 2 — LIQUIDITY As of June 30, 2023, we had approximately $ 1.3 110.7 5.6 13.2 On July 20, 2023, the Company entered into a stock purchase agreement (the “Purchase Agreement”) with Chembio Diagnostics, Inc. (“Chembio”), Biosynex, S.A. and Qualigen, Inc., a wholly-owned subsidiary of the Company (see Note 16 - Subsequent Events). Pursuant to the Purchase Agreement, the Company agreed to sell to the Buyer all of the issued and outstanding shares of common stock (collectively, the “Shares”) of Qualigen, Inc., which was the legal entity operating the Company’s FastPack™ diagnostics business (the “Transaction”). The Transaction closed on July 20, 2023. Following the consummation of the Transaction, our Qualigen, Inc. subsidiary became a wholly-owned subsidiary of Chembio. The aggregate net purchase price paid to the Company for the Shares was $ 5.2 5.8 5.2 450,000 The Company’s cash balances as of the date that these financial statements were issued along with the proceeds from the above sale to Chembio, without additional financing, are expected to fund operations into the first quarter of 2024. 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 testing for its QN-302 clinical trials, preclinical development of RAS and QN-247, and funding for NanoSynex operations, 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 3.0 On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex Ltd. (the “NanoSynex Amendment”), which amended the Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”), a majority owned subsidiary of the Company, to, among other things, provide for the further funding of NanoSynex, as contemplated by the NanoSynex Funding Agreement (see Note 16 - Subsequent Events: Amendment and Settlement Agreement with NanoSynex Ltd. Pursuant to the terms of the NanoSynex Amendment, the Company agreed to advance to NanoSynex an aggregate amount of $ 1,610,000 380,000 560,000 670,000 In the event we fail to make any future advances, we have agreed to forfeit additional shares in a number that will be equal to a fraction, the numerator of which is the amount of the default ( i.e 1.5716 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 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 |
INVENTORY, NET
INVENTORY, NET | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORY, NET | NOTE 3 — INVENTORY, NET Inventory, net consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF INVENTORY June 30, 2023 December 31, 2022 Raw materials $ 1,027,455 $ 949,796 Work in process 177,591 200,318 Finished goods 358,353 436,183 Total inventory $ 1,563,399 $ 1,586,297 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 6 Months Ended |
Jun. 30, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | NOTE 4 — PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS June 30, 2023 December 31, 2022 Prepaid insurance $ 938,106 $ 1,377,323 Prepaid manufacturing expenses 51,710 43,820 Other prepaid expenses 65,288 227,451 Prepaid research and development expenses 211,337 — Other current assets 11,636 12,626 Prepaid expenses and other current assets $ 1,278,077 $ 1,661,220 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 5 — PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF PROPERTY AND EQUIPMENT June 30, 2023 December 31, 2022 Machinery and equipment $ 2,735,507 $ 2,510,148 Computer equipment 369,589 395,836 Leasehold improvements 336,916 333,271 Molds and tooling 260,002 260,002 Furniture and fixtures 144,832 144,832 Equipment held for lease 1,405,384 1,399,444 Property and equipment, gross 5,252,230 5,043,533 Accumulated depreciation (4,678,583 ) (4,623,446 ) Fixed asset impairment (75,000 ) (75,000 ) Property and equipment, net $ 498,647 $ 345,087 Depreciation expense relating to property and equipment was approximately $ 19,000 24,000 37,000 48,000 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 |
GOODWILL, IPR&D AND OTHER INTAN
GOODWILL, IPR&D AND OTHER INTANGIBLES | 6 Months Ended |
Jun. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
GOODWILL, IPR&D AND OTHER INTANGIBLES | NOTE 6 — GOODWILL, IPR&D AND OTHER INTANGIBLES SCHEDULE OF GOODWILL AND OTHER INTANGIBLES June 30, December 31, 2023 2022 Estimated Useful Lives Gross carrying amounts Gross carrying amounts Goodwill $ 625,602 $ 625,602 Finite-lived intangible assets: Developed-product-technology rights 8 17 $ 479,103 $ 479,103 Licensing rights 10 418,836 418,836 Less: Accumulated amortization (764,869 ) (752,237 ) Total finite-lived intangible assets, net 133,070 145,702 Indefinite-lived intangible assets: In-process research and development 5,700,000 5,700,000 Total other intangible assets, net $ 5,833,070 $ 5,845,702 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 no The carrying value of the patents of approximately $ 131,000 and $ 140,000 at June 30, 2023 and December 31, 2022, respectively, are stated net of accumulated amortization of approximately $ 348,000 and $ 339,000 , respectively. Amortization of patents charged to operations for the three months ended June 30, 2023 and 2022 was approximately $ 9,000 and $ 5,000 respectively, and for the six months ended June 30, 2023 and 2022 was approximately $ 9,000 and $ 9,000 , respectively. The carrying value of the in-licenses of approximately $ 2,000 and $ 5,000 at June 30, 2023 and December 31, 2022, respectively, are stated net of accumulated amortization of approximately $ 417,000 and $ 414,000 , respectively, and amortization of licenses charged to both the three months ended June 30, 2023 and 2022 was approximately $ 3,000 . Amortization of licenses charged to operations for both the six months ended June 30, 2023 and 2022 was approximately $ 3,000 . On July 20, 2023, the Company entered into a Purchase Agreement with Chembio, Biosynex, S.A. (“Biosynex”), and Qualigen, Inc., a wholly-owned subsidiary of the Company. Pursuant to the Purchase Agreement, the Company agreed to sell to Chembio all of the issued and outstanding shares of common stock of Qualigen, Inc. (see Note 16 - Subsequent Events: Stock Purchase Agreement with Chembio Diagnostics, Inc. and Biosynex, S.A. ). five |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | NOTE 7 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES June 30, 2023 December 31, 2022 Board compensation $ 84,000 70,000 Equipment held for lease — 154,433 Franchise, sales and use taxes 30,407 27,531 Income taxes 6,921 4,663 Interest (Convertible debt - related party) 50,101 2,829 License fees 100,026 150,130 Payroll 484,048 209,303 Professional fees 368,032 238,211 Research and development 523,490 322,987 Royalties 16,383 13,158 Warranty liability 140,370 137,568 Other 176,777 181,043 Accrued expenses and other current liabilities $ 1,980,555 $ 1,511,856 |
SHORT TERM DEBT-RELATED PARTY
SHORT TERM DEBT-RELATED PARTY | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
SHORT TERM DEBT-RELATED PARTY | NOTE 8 – 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 60,155 965,155 2.62 3,000,000 Amendment and Settlement Agreement with NanoSynex Ltd. |
WARRANT LIABILITIES
WARRANT LIABILITIES | 6 Months Ended |
Jun. 30, 2023 | |
Warrant Liabilities | |
WARRANT LIABILITIES | NOTE 9 – 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 .40 .99 7.195 6.00 49,318 6.00 5.136 49,952 247,625 346,896 5.136 1.32 1,002,717 Additionally, on December 22, 2022, in conjunction with the issuance of the Debenture to Alpha Capital (see Note 10 – Convertible Debt – Related Party), the Company issued to Alpha Capital a warrant to purchase 2,500,000 1.65 125 The following table summarizes the activity in liability classified warrants for the six months ended June 30, 2023: SCHEDULE OF WARRANTS ACTIVITY Common Stock Warrants Shares Weighted– Range of Exercise Weighted– Total outstanding – December 31, 2022 3,849,571 $ 1.53 $ 1.32 1.65 3.9 Exercised — — — — Forfeited — — — — Expired — — — — Granted — — — — Total outstanding – June 30, 2023 3,849,571 $ 1.53 $ 1.32 1.65 3.41 Exercisable 3,849,571 $ 1.53 $ 1.32 1.65 3.41 The following table summarizes the activity in liability classified warrants for the six months ended June 30, 2022: Common Stock Warrants Shares Weighted– Average Range of Exercise Weighted– Total outstanding –December 31, 2021 248,161 $ 7.20 2.00 Exercised (536 ) 7.20 Forfeited (247,625 ) 7.20 Expired — — Granted 346,896 5.10 Total outstanding – June 30, 2022 346,896 $ 5.10 Exercisable 346,896 $ 5.10 $ 5.10 1.51 The following table presents the Company’s fair value hierarchy for its liabilities measured at fair value on a recurring basis as of June 30, 2023: 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, 2022 $ — $ — $ 3,622,647 $ 3,622,647 Exercises — — — — Gain on change in fair value of warrant liabilities — — (1,478,967 ) (1,478,967 ) Balance as of June 30, 2023 $ — $ — $ 2,143,680 $ 2,143,680 There were no transfers of financial assets or liabilities between category levels for the three and six months ended June 30, 2023. 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 June 30, 2023 and 2022: SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES June 30, 2023 June 30, 2022 Range Weighted Range Weighted Risk-free interest rate 4.05 5.31 4.49 % 2.80 2.87 2.82 % Expected volatility (peer group) 66.3 134 110.55 % 74 96 78.6 % Term of warrants (in years) .39 4.98 3.41 1.39 1.99 1.51 Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % |
CONVERTIBLE DEBT- RELATED PARTY
CONVERTIBLE DEBT- RELATED PARTY | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
CONVERTIBLE DEBT- RELATED PARTY | NOTE 10 — CONVERTIBLE DEBT- RELATED PARTY On December 22, 2022, the Company issued to Alpha Capital, an 8 3,300,000 3,000,000 1.32 2,500,000 1.65 125 The proceeds from the transaction are being used to advance the Company’s 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 The Debenture accrues interest at the rate of 8 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 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 The Company evaluated the Debenture and the Alpha Warrant and determined that the Alpha Warrant is a freestanding financial instrument. The Alpha Warrant is not considered indexed to the Company’s own stock, because the settlement amount would not equal the difference between the fair value of a fixed number of the Company’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 Alpha Warrant is classified as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings. The proceeds from the Debenture were allocated to the initial fair value of the Alpha Warrant, 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 as proceeds received after allocating the proceeds to the Alpha Warrant, 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 of $ 0.3 2.8 0 0.1 Between January 9 and 12, 2023, the Company issued 841,726 1.32 1,111,078 1.1 383,000 945,000 364,000 898,000 2.0 0 Convertible debt-related party is comprised of the following as of June 30, 2023 and December 31, 2022: SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT June 30, 2023 December 31, 2022 Senior secured convertible debenture $ 2,078,922 $ 3,300,000 Discount on convertible debenture (1,266,503 ) (3,239,803 ) Total convertible debt-related party $ 812,419 $ 60,197 As of June 30, 2023, there were no events of default or violation of any covenants under our financing obligations. |
EARNINGS (LOSS) PER SHARE
EARNINGS (LOSS) PER SHARE | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
EARNINGS (LOSS) PER SHARE | NOTE 11 — EARNINGS (LOSS) PER SHARE Basic loss per share (“EPS”) is computed by dividing net 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. The following potentially dilutive securities have been excluded from diluted net loss per share as of June 30, 2023 and 2022 because their effect would be anti-dilutive: SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE As of June 30, 2023 2022 Shares of common stock subject to outstanding options 445,163 476,783 Shares of common stock subject to outstanding warrants 4,119,934 1,412,338 Total common stock equivalents 4,565,097 1,889,121 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 12 — 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 61 November 1, 2022 to November 30, 2027 61 1,950,710 61 335,966 339,360 The tables below show the operating lease right-of-use assets and operating lease liabilities as of June 30, 2023, 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, 2022 $ 1,422,538 Less amortization of operating lease right-of-use assets (116,568 ) Operating lease right-of-use assets at June 30, 2023 $ 1,305,970 Operating lease liabilities Lease liabilities at December 31, 2022 $ 1,542,564 Less principal payments on operating lease liabilities (116,756 ) Lease liabilities at June 30, 2023 1,425,808 Less non-current portion (1,168,653 ) Current portion at June 30, 2023 $ 257,155 As of June 30, 2023, the Company’s operating leases have a weighted-average remaining lease term of 4.3 8.9 As of June 30, 2023, future minimum payments during the next five fiscal years and thereafter are as follows: SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES Year Ending December 31, Amount 2023 (six months) 184,171 2024 379,392 2025 390,773 2026 402,497 2027 379,164 Total 1,735,997 Less present value discount (310,189 ) Operating lease liabilities $ 1,425,808 Total lease expense was approximately $ 114,000 119,000 230,000 233,000 On July 20, 2023, the Company entered into a Purchase Agreement with Chembio, Biosynex, S.A. (“Biosynex”), and Qualigen, Inc., a wholly-owned subsidiary of the Company. Pursuant to the Purchase Agreement, the Company agreed to sell to Chembio all of the issued and outstanding shares of common stock of Qualigen, Inc. The lease commitments described above transferred to Chembio upon the closing of this transaction. (see Note 16 - Subsequent Events: Stock Purchase Agreement with Chembio Diagnostics, Inc. and Biosynex, S.A. ). NanoSynex Funding Commitment On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex Ltd. (the “NanoSynex Amendment”), which amended the Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”), a majority owned subsidiary of the Company, to, among other things, provide for the further funding of NanoSynex, as contemplated by the NanoSynex Funding Agreement (see Note 16 - Subsequent Events: Amendment and Settlement Agreement with NanoSynex Ltd. Pursuant to the terms of the NanoSynex Amendment, the Company agreed to advance to NanoSynex an aggregate amount of $ 1,610,000 380,000 560,000 670,000 In the event we fail to make any future advances, we have agreed to forfeit additional shares in a number that will be equal to a fraction, the numerator of which is the amount of the default ( i.e 1.5716 per share. The Nanosynex Amendment supersedes any payments contemplated by the Original Nanosynex Agreement, such that except as described in the Nanosynex Amendment, the Company will have no further payment obligations to NanoSynex under the Original Nanosynex Agreement or otherwise (including by way of equity investment, loan financing or credit lines), and Nanosynex will have no further payment obligations to the Company for advances previously received under the Original Nanosynex Agreement. 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. |
RESEARCH AND LICENSE AGREEMENTS
RESEARCH AND LICENSE AGREEMENTS | 6 Months Ended |
Jun. 30, 2023 | |
Research And License Agreements | |
RESEARCH AND LICENSE AGREEMENTS | NOTE 13 — RESEARCH AND LICENSE AGREEMENTS The University of Louisville Research Foundation Between June 2018 and April 2022, 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 $ 50,000 805,000 200,000 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 5,000,000 100,000 200,000 350,000 500,000 5,000,000 500,000,000 500,000 10,000 50,000 Sponsored research expenses related to these agreements for the three months ended June 30, 2023 and 2022 were approximately $ 0 77,000 0 164,000 1,000 14,000 22,000 69,000 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 agreed to reimburse ULRF for sponsored research expenses of up to $ 693,000 2.7 In July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under the agreement, the Company took 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, 50,000 5,000,000 50,000 100,000 150,000 300,000 5,000,000 500,000,000 20,000 100,000 Sponsored research expenses related to these agreements for the three months ended June 30, 2023 and 2022 were approximately $ 333,000 220,000 556,000 405,000 15,000 16,000 29,000 18,000 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 is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $ 24,000 250,000 430,000 In addition, under the exclusive license agreement the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization of QN-165 as a treatment for COVID-19, 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 patents, 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 June 2020, and (iv) payments ranging from $ 50,000 5,000,000 50,000 100,000 150,000 300,000 5,000,000 500,000,000 5,000 50,000 There were no sponsored research expenses or license costs related to these agreements for the three months ended June 30, 2023 and 2022, or for the six months ended June 30, 2023 and 2022. Yi Xin In October 2020, through its wholly-owned diagnostics subsidiary Qualigen, Inc., the Company 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 authorizes 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. Under the Technology Transfer Agreement, during the fiscal year ended December 31, 2021 we recognized revenues of approximately $ 670,000 no The Company gave Yi Xin the exclusive rights for China, which is a market it has 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 the Company’s 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 United States, European Union, Canada and Mexico. On July 20, 2023, the Company entered into a Purchase Agreement with Chembio, Biosynex, S.A. (“Biosynex”), and Qualigen, Inc., a wholly-owned subsidiary of the Company. Pursuant to the Purchase Agreement, the Company agreed to sell to Chembio all of the issued and outstanding shares of common stock of Qualigen, Inc. The Technology Transfer Agreement with Yi Xin described above transferred to Chembio upon the closing of this transaction. See Note 16 - Subsequent Events: Stock Purchase Agreement with Chembio Diagnostics, Inc. and Biosynex, S.A. 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 $ 150,000 160,000 For both the three months ended June 30, 2023 and 2022, there were license costs of $ 0 0 310,000 Prediction Biosciences In November 2015, the Company entered into a long-term development and supply agreement with Prediction Biosciences SAS to develop and manufacture diagnostic tests for use in the stroke Physician Office Laboratory (POL) market. The Company recognizes development revenue and product sales over the performance period of the contract. Product sales related to this agreement for the three months ended June 30, 2023 and 2022 were $ 0 86,000 0 QN-302 Phase 1 Study In June 2023, the Company entered into a Master Clinical Research Services Agreement with Translational Drug Development, LLC (“TD2”) where TD2 agreed to perform certain clinical research and development services for the Company including but not limited to trial management, side identification and selection, site monitoring/management, medical monitoring, project management, data collection, statistical programming or analysis, quality assurance auditing, scientific and medical communications, regulatory affairs consulting and submissions, strategic consulting, and/or other related services. From time to time, the Company shall enter into Statements of Work (“SOW”) with TD2 for the performance of specific services under this Master Clinical Research Services Agreement (see Note 16 - Subsequent Events: QN-302 Phase 1 Study). In June 2023, the Company entered into a Master Laboratory Services Agreement with MLM Medical Labs, LLC (“MLM”) where MLM agreed to perform certain clinical research and development services for the Company including but not limited to laboratory, supply, testing, validation, data management, and storage services. From time to time, the Company shall enter into work orders with MLM for the performance of specific services under this Master Laboratory Services Agreement (see Note 16 - Subsequent Events: QN-302 Phase 1 Study). In June 2023, the Company entered into a Master Services Agreement with Clinigen Clinical Supplies Management, Inc. (“Clinigen”) where Clinigen agreed to provide certain pharmaceutical products and/or services. From time to time, the Company shall enter into Statements of Work (“SOW”) with Clinigen for the performance of specific services under this Master Services Agreement (see Note 16 - Subsequent Events: QN-302 Phase 1 Study). |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 14 — STOCKHOLDERS’ EQUITY As of June 30, 2023 and December 31, 2022, the Company had two classes of authorized 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 22, 2022, the Company issued to Alpha Capital, an 8 3,300,000 3,000,000 1.32 2,500,000 1,111,078 841,726 1.32 At June 30, 2023, the Company has reserved 4,565,097 SCHEDULE OF RESERVED SHARES Exercise of issued and future grants of stock options 445,163 Exercise of stock warrants 4,119,934 Total 4,565,097 Preferred Stock At June 30, 2023 and December 31, 2022, there were no shares of preferred stock outstanding. Stock Options and Warrants Stock Options The Company recognizes all compensatory share-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 granting of incentive or non-statutory common stock options and other types of awards to qualified employees, officers, directors, consultants and other service providers. At June 30, 2023 and December 31, 2022, there were 445,163 608,012 310,539 147,690 The following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers that are outstanding at June 30, 2023, and changes during the six-month period then ended: SCHEDULE OF STOCK OPTION ACTIVITY Shares Weighted– Range of Weighted– Total outstanding – December 31, 2022 608,012 $ 35.02 $ 5.14 51.30 8.09 Granted — — — — Expired — — — — Forfeited (162,849 ) 36.01 5.14 51.30 — Total outstanding – June 30, 2023 445,163 $ 34.68 $ 5.14 51.30 7.59 Exercisable (vested) 323,355 $ 44.79 $ 5.14 51.30 7.13 Non-Exercisable (non-vested) 121,808 $ 7.83 $ 5.14 35.20 8.85 There was approximately $ 0.9 2.7 0.5 1.47 Shares Weighted– Range of Weighted– Total outstanding – December 31, 2021 484,186 $ 60.70 $ 12.40 14,657.50 8.52 Granted 2,500 10.50 10.50 9.54 Expired (9,386 ) 935.90 57.50 14,657.50 — Forfeited (517 ) 35.10 12.40 49.70 — Total outstanding – June 30, 2022 476,783 $ 43.30 $ 10.50 51.30 8.19 Exercisable (vested) 264,366 $ 48.40 $ 12.40 50.13 8.00 Non-Exercisable (non-vested) 212,417 $ 36.80 $ 10.50 51.30 8.48 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 ten-year period. Fair Value of Equity Awards The Company utilizes the Black-Scholes option pricing model to value awards under its equity plans. Key valuation assumptions include: ● Expected dividend yield. ● Expected stock-price volatility. ● Risk-free interest rate. ● Expected term. 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 Six Months Ended 2023 2022 Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility — 102 % Risk-free interest rate — 1.58 1.67 % Expected average term of options (in years) — 6.00 Stock price $ — $ 1.05 The Company recorded share-based compensation expense and classified it in the unaudited condensed consolidated statements of operations as follows: SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE 2023 2022 For the Six Months 2023 2022 General and administrative $ 807,980 $ 2,329,418 Research and development 98,165 361,029 Total $ 906,145 $ 2,690,447 Equity Classified Compensatory Warrants In connection with the $ 4.0 81,143 11.10 In addition, various service providers hold equity classified compensatory warrants issued in 2017 and earlier for the purchase of 66,802 23.40 During the year ended December 31, 2021, the Company issued equity classified compensatory warrants to a service provider for the purchase of 60,000 13.20 0.3 60,000 13.20 6.00 June 3, 2023 to September 14, 2023 67,370 67,619 11.10 5.136 31,010 67,620 5.136 1.32 8,548 No compensatory warrants were issued during the six months ended June 30, 2023. The following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30, 2023: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Range of Weighted– Total outstanding – December 31, 2022 179,046 $ 9.12 $ 1.32 25.40 1.73 Granted to advisor and its designees — — Exercised — — Expired — — Forfeited — — Total outstanding – June 30, 2023 179,046 $ 9.12 $ 1.32 25.40 1.24 Exercisable 179,046 $ 9.12 $ 1.32 25.40 1.24 Non-Exercisable — $ — $ — — The following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30, 2022: Common Stock Shares Weighted– Average Range of Weighted– Total outstanding – December 31, 2021 179,065 $ 15.20 $ 11.10 25.40 2.64 Granted to advisor and its designees — — Exercised — — Expired — — Forfeited — — Total outstanding – June 30, 2022 179,065 $ 10.60 $ 5.14 25.40 2.23 Exercisable 179,065 $ 10.60 $ 5.14 25.40 2.23 Non-Exercisable — $ — $ — — There were no 67,370 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 11.10 20,000 78,019 0.01 192,068 52.50 128,783 60.00 100,000 0.10 219,101 40.70 331,464 0.01 On November 29, 2021, with the exception of the warrants to purchase 27,048 11.10 539,951 20.00 2.3 331,464 0.01 In conjunction with the NanoSynex Acquisition, on April 25, 2022 the exercise price of 7,048 11.10 6.00 2,533 5.136 696 1.32 891 No noncompensatory equity classified warrants were issued during the six months ended June 30, 2023. The following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2023: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Range of Weighted– Total outstanding – December 31, 2022 547,003 $ 19.76 $ 1.32 20.00 0.33 Legacy Ritter warrants — — Granted — — Exercised — — Expired (455,685 ) 20.00 20.00 Forfeited — — Total outstanding – June 30, 2023 91,318 $ 18.56 - Exercisable 91,318 $ 18.56 $ 1.32 20.00 0.58 Non-Exercisable — $ — $ — — The following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2022: Common Stock Shares Weighted– Range of Weighted– Total outstanding – December 31, 2021 554,914 $ 20.10 Legacy Ritter warrants — — Granted 331,464 0.01 0.01 Exercised — — Expired — — Forfeited — — Total outstanding – June 30, 2022 886,378 $ 12.60 Exercisable 886,378 $ 12.60 $ 0.01 37.70 0.82 Non-Exercisable — $ — $ — — |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 15 — RELATED PARTY TRANSACTIONS Convertible Debt On December 22, 2022, the Company issued to Alpha Capital, an 8 3,300,000 3,000,000 1.32 1,111,078 841,726 1.32 Short-Term Debt NanoSynex has four separate notes payable outstanding to Alpha Capital, issued between March 26, 2020 and September 2, 2021, aggregating to a total principal outstanding balance of $ 905,000 965,155 2.62 3,000,000 NanoSynex Acquisition The Company acquired a 52.8 2,232,861 350,000 331,464 0.001 381,786 600,000 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 16 — SUBSEQUENT EVENTS QN-302 Phase 1 Study Between July 5-13, 2023, pursuant to the Master Clinical Research Services Agreement with TD2, Master Services Agreement with Clinigen, and Master Laboratory Services Agreement with MLM (see Note 13 - Research and License Agreements), the Company entered into work orders with these vendors to provide clinical trial services for the conduct of the QN-302 Phase 1 study. The estimated project timeline was set to start in July 2023 and continue until July 2026. The total amount to be paid under these work orders is currently expected to be approximately $ 7.6 Stock Purchase Agreement with Chembio Diagnostics, Inc. and Biosynex, S.A. On July 20, 2023, the Company entered into the Purchase Agreement with Chembio, Biosynex, S.A. (“Biosynex”), and Qualigen, Inc., a wholly-owned subsidiary of the Company. Pursuant to the Purchase Agreement, the Company agreed to sell to Chembio all of the issued and outstanding shares of common stock of Qualigen, Inc., which was the legal entity operating the Company’s FastPack™ diagnostics business. The Transaction closed on July 20, 2023. Following the consummation of the Transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio. 5.2 5.8 5.2 450,000 Amendment and Settlement Agreement with NanoSynex Ltd. On July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the NanoSynex Funding Agreement with NanoSynex, to, among other things, provide for the further funding of NanoSynex, as contemplated by the NanoSynex Funding Agreement. Pursuant to the terms of the NanoSynex Amendment, the Company agreed to advance to NanoSynex an aggregate amount of $ 1,610,000 380,000 560,000 670,000 In the event we fail to make any future advances, we have agreed to forfeit additional shares in a number that will be equal to a fraction, the numerator of which is the amount of the default ( i.e 1.5716 The NanoSynex Amendment supersedes any payments contemplated by the Original NanoSynex Agreement, such that except as described in the NanoSynex Amendment, the Company will have no further payment obligations to NanoSynex under the Original NanoSynex Agreement or otherwise (including by way of equity investment, loan financing or credit lines), and NanoSynex will have no further payment obligations to the Company for advances previously received under the Original NanoSynex Agreement. Stockholder Approval of Alpha Stock Issuance Proposal On July 13, 2023, the Company held its 2023 annual meeting of stockholders, at which the issuance to Alpha Capital of common stock pursuant to the terms and conditions of (a) the Debenture and (b) the Alpha Warrant were approved in accordance with Nasdaq Listing Rule 5635(d), which requires stockholder approval prior to the issuance of more than 20% of the Company’s issued and outstanding common stock. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Qualigen, Inc., a subsidiary of Qualigen Therapeutics, Inc., was incorporated in Minnesota in 1996 to design, develop, manufacture and sell point-of-care quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. 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. 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 “NanoSynex Acquisition”). NanoSynex is a micro-biologics diagnostics company domiciled in Israel. Amendment and Settlement Agreement with NanoSynex Ltd. |
Basis of Presentation | Basis of Presentation The accompanying condensed 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 | Principles of Consolidation The accompanying condensed 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 | Accounting Estimates Management uses estimates and assumptions in preparing its condensed 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 | 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 fractional shares was paid 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. |
Cash | 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 government money market mutual funds and 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. In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity concerns and taken over by the Federal Deposit Insurance Corporation (FDIC). While the Company did not have an account at any of these 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, 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 | 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 three and six months ended June 30, 2023 and 2022, no |
Segment Reporting | 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 | 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, net is comprised of the following at: SCHEDULE OF ACCOUNTS RECEIVABLE June 30, 2023 December 31, 2022 Accounts Receivable $ 733,964 $ 726,449 Less Reserves and Allowances (54,584 ) (187,862 ) Accounts receivable, net $ 679,380 $ 538,587 |
Research and Development | 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. |
R&D Grants | 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 condensed consolidated balance sheets date to the expected future date of recognition as a reduction to research and development expenses. |
Patent Costs | 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 condensed consolidated statement of operations. |
Shipping and Handling Costs | 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 which totaled approximately $ 78,000 72,000 144,000 111,000 0 4,000 and approximately $ 4,000 8,000 |
Revenue from Contracts with Customers | 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. 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 three months ended June 30, 2023 and 2022, product sales are stated net of an allowance for estimated returns of approximately $ 28,000 10,000 33,000 53,000 |
Deferred Revenue | 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 condensed consolidated balance sheets date to the future date of revenue recognition. |
Operating Leases | Operating Leases Effective April 1, 2020, the Company adopted Accounting Standards Update (“ASU”) No. 2018-11, Leases (Topic 842) Targeted Improvements Note 12 - Commitments and Contingencies for more information). |
Property and Equipment, Net | 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 Computer equipment 3 Molds and tooling 5 Furniture and fixtures 5 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. |
Business Combinations | 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 date, and that assets acquired and liabilities assumed 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. 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 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 no |
Intangible Assets | 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 condensed consolidated statements of operations and other comprehensive income (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. Costs related to acquiring patents and licenses are capitalized and amortized over their estimated useful lives, which is generally 5 17 |
Derivative Financial Instruments and Warrant Liabilities | 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 condensed consolidated statements of operations and other comprehensive income (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 9- Warrant Liabilities). 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 | 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. |
Comprehensive Loss | 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 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 | 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. |
Sales and Excise 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 condensed consolidated balance sheet as cash is collected from customers and remitted to the tax authority. |
Warranty Costs | 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 $ 140,000 138,000 63,000 22,000 104,000 41,000 |
Foreign Currency Translation | 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 ($56,747) 65,540 for the three months ending June 30, 2023 and 2022, respectively, and $119,473 and $65,540 for the six months ending June 30, 2023 and 2022, respectively. |
War in Ukraine | 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. |
Inflation and Global Economic Conditions | Inflation and Global Economic Conditions 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. In addition, the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession in the near future. If the global economy slows, our business would be adversely affected. |
Impact of COVID-19 Pandemic | 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. During the height of the pandemic sales of diagnostic products decreased significantly 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. For 2023 we continue to experience 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 condensed consolidated financial statements. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SCHEDULE OF ACCOUNTS RECEIVABLE | Accounts receivable, net is comprised of the following at: SCHEDULE OF ACCOUNTS RECEIVABLE June 30, 2023 December 31, 2022 Accounts Receivable $ 733,964 $ 726,449 Less Reserves and Allowances (54,584 ) (187,862 ) Accounts receivable, net $ 679,380 $ 538,587 |
SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT | 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 Computer equipment 3 Molds and tooling 5 Furniture and fixtures 5 |
INVENTORY, NET (Tables)
INVENTORY, NET (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory, net consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF INVENTORY June 30, 2023 December 31, 2022 Raw materials $ 1,027,455 $ 949,796 Work in process 177,591 200,318 Finished goods 358,353 436,183 Total inventory $ 1,563,399 $ 1,586,297 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS June 30, 2023 December 31, 2022 Prepaid insurance $ 938,106 $ 1,377,323 Prepaid manufacturing expenses 51,710 43,820 Other prepaid expenses 65,288 227,451 Prepaid research and development expenses 211,337 — Other current assets 11,636 12,626 Prepaid expenses and other current assets $ 1,278,077 $ 1,661,220 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | Property and equipment, net consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF PROPERTY AND EQUIPMENT June 30, 2023 December 31, 2022 Machinery and equipment $ 2,735,507 $ 2,510,148 Computer equipment 369,589 395,836 Leasehold improvements 336,916 333,271 Molds and tooling 260,002 260,002 Furniture and fixtures 144,832 144,832 Equipment held for lease 1,405,384 1,399,444 Property and equipment, gross 5,252,230 5,043,533 Accumulated depreciation (4,678,583 ) (4,623,446 ) Fixed asset impairment (75,000 ) (75,000 ) Property and equipment, net $ 498,647 $ 345,087 |
GOODWILL, IPR&D AND OTHER INT_2
GOODWILL, IPR&D AND OTHER INTANGIBLES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF GOODWILL AND OTHER INTANGIBLES | SCHEDULE OF GOODWILL AND OTHER INTANGIBLES June 30, December 31, 2023 2022 Estimated Useful Lives Gross carrying amounts Gross carrying amounts Goodwill $ 625,602 $ 625,602 Finite-lived intangible assets: Developed-product-technology rights 8 17 $ 479,103 $ 479,103 Licensing rights 10 418,836 418,836 Less: Accumulated amortization (764,869 ) (752,237 ) Total finite-lived intangible assets, net 133,070 145,702 Indefinite-lived intangible assets: In-process research and development 5,700,000 5,700,000 Total other intangible assets, net $ 5,833,070 $ 5,845,702 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | Accrued expenses and other current liabilities consisted of the following at June 30, 2023 and December 31, 2022: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES June 30, 2023 December 31, 2022 Board compensation $ 84,000 70,000 Equipment held for lease — 154,433 Franchise, sales and use taxes 30,407 27,531 Income taxes 6,921 4,663 Interest (Convertible debt - related party) 50,101 2,829 License fees 100,026 150,130 Payroll 484,048 209,303 Professional fees 368,032 238,211 Research and development 523,490 322,987 Royalties 16,383 13,158 Warranty liability 140,370 137,568 Other 176,777 181,043 Accrued expenses and other current liabilities $ 1,980,555 $ 1,511,856 |
WARRANT LIABILITIES (Tables)
WARRANT LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Warrant Liabilities | |
SCHEDULE OF WARRANTS ACTIVITY | The following table summarizes the activity in liability classified warrants for the six months ended June 30, 2023: SCHEDULE OF WARRANTS ACTIVITY Common Stock Warrants Shares Weighted– Range of Exercise Weighted– Total outstanding – December 31, 2022 3,849,571 $ 1.53 $ 1.32 1.65 3.9 Exercised — — — — Forfeited — — — — Expired — — — — Granted — — — — Total outstanding – June 30, 2023 3,849,571 $ 1.53 $ 1.32 1.65 3.41 Exercisable 3,849,571 $ 1.53 $ 1.32 1.65 3.41 The following table summarizes the activity in liability classified warrants for the six months ended June 30, 2022: Common Stock Warrants Shares Weighted– Average Range of Exercise Weighted– Total outstanding –December 31, 2021 248,161 $ 7.20 2.00 Exercised (536 ) 7.20 Forfeited (247,625 ) 7.20 Expired — — Granted 346,896 5.10 Total outstanding – June 30, 2022 346,896 $ 5.10 Exercisable 346,896 $ 5.10 $ 5.10 1.51 |
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES | The following table presents the Company’s fair value hierarchy for its liabilities measured at fair value on a recurring basis as of June 30, 2023: 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, 2022 $ — $ — $ 3,622,647 $ 3,622,647 Exercises — — — — Gain on change in fair value of warrant liabilities — — (1,478,967 ) (1,478,967 ) Balance as of June 30, 2023 $ — $ — $ 2,143,680 $ 2,143,680 |
SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES | 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 June 30, 2023 and 2022: SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES June 30, 2023 June 30, 2022 Range Weighted Range Weighted Risk-free interest rate 4.05 5.31 4.49 % 2.80 2.87 2.82 % Expected volatility (peer group) 66.3 134 110.55 % 74 96 78.6 % Term of warrants (in years) .39 4.98 3.41 1.39 1.99 1.51 Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % |
CONVERTIBLE DEBT- RELATED PAR_2
CONVERTIBLE DEBT- RELATED PARTY (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT | Convertible debt-related party is comprised of the following as of June 30, 2023 and December 31, 2022: SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT June 30, 2023 December 31, 2022 Senior secured convertible debenture $ 2,078,922 $ 3,300,000 Discount on convertible debenture (1,266,503 ) (3,239,803 ) Total convertible debt-related party $ 812,419 $ 60,197 |
EARNINGS (LOSS) PER SHARE (Tabl
EARNINGS (LOSS) PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE | The following potentially dilutive securities have been excluded from diluted net loss per share as of June 30, 2023 and 2022 because their effect would be anti-dilutive: SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE As of June 30, 2023 2022 Shares of common stock subject to outstanding options 445,163 476,783 Shares of common stock subject to outstanding warrants 4,119,934 1,412,338 Total common stock equivalents 4,565,097 1,889,121 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES | The tables below show the operating lease right-of-use assets and operating lease liabilities as of June 30, 2023, 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, 2022 $ 1,422,538 Less amortization of operating lease right-of-use assets (116,568 ) Operating lease right-of-use assets at June 30, 2023 $ 1,305,970 Operating lease liabilities Lease liabilities at December 31, 2022 $ 1,542,564 Less principal payments on operating lease liabilities (116,756 ) Lease liabilities at June 30, 2023 1,425,808 Less non-current portion (1,168,653 ) Current portion at June 30, 2023 $ 257,155 |
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES | As of June 30, 2023, future minimum payments during the next five fiscal years and thereafter are as follows: SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES Year Ending December 31, Amount 2023 (six months) 184,171 2024 379,392 2025 390,773 2026 402,497 2027 379,164 Total 1,735,997 Less present value discount (310,189 ) Operating lease liabilities $ 1,425,808 |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
SCHEDULE OF RESERVED SHARES | SCHEDULE OF RESERVED SHARES Exercise of issued and future grants of stock options 445,163 Exercise of stock warrants 4,119,934 Total 4,565,097 |
SCHEDULE OF STOCK OPTION ACTIVITY | The following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers that are outstanding at June 30, 2023, and changes during the six-month period then ended: SCHEDULE OF STOCK OPTION ACTIVITY Shares Weighted– Range of Weighted– Total outstanding – December 31, 2022 608,012 $ 35.02 $ 5.14 51.30 8.09 Granted — — — — Expired — — — — Forfeited (162,849 ) 36.01 5.14 51.30 — Total outstanding – June 30, 2023 445,163 $ 34.68 $ 5.14 51.30 7.59 Exercisable (vested) 323,355 $ 44.79 $ 5.14 51.30 7.13 Non-Exercisable (non-vested) 121,808 $ 7.83 $ 5.14 35.20 8.85 There was approximately $ 0.9 2.7 0.5 1.47 Shares Weighted– Range of Weighted– Total outstanding – December 31, 2021 484,186 $ 60.70 $ 12.40 14,657.50 8.52 Granted 2,500 10.50 10.50 9.54 Expired (9,386 ) 935.90 57.50 14,657.50 — Forfeited (517 ) 35.10 12.40 49.70 — Total outstanding – June 30, 2022 476,783 $ 43.30 $ 10.50 51.30 8.19 Exercisable (vested) 264,366 $ 48.40 $ 12.40 50.13 8.00 Non-Exercisable (non-vested) 212,417 $ 36.80 $ 10.50 51.30 8.48 |
SCHEDULE OF ASSUMPTION USED IN BLACK-SCHOLES OPTION-PRICING METHOD | 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 Six Months Ended 2023 2022 Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility — 102 % Risk-free interest rate — 1.58 1.67 % Expected average term of options (in years) — 6.00 Stock price $ — $ 1.05 |
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE | The Company recorded share-based compensation expense and classified it in the unaudited condensed consolidated statements of operations as follows: SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE 2023 2022 For the Six Months 2023 2022 General and administrative $ 807,980 $ 2,329,418 Research and development 98,165 361,029 Total $ 906,145 $ 2,690,447 |
Compensatory Warrant Activity [Member] | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
SCHEDULE OF WARRANT ACTIVITY | The following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30, 2023: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Range of Weighted– Total outstanding – December 31, 2022 179,046 $ 9.12 $ 1.32 25.40 1.73 Granted to advisor and its designees — — Exercised — — Expired — — Forfeited — — Total outstanding – June 30, 2023 179,046 $ 9.12 $ 1.32 25.40 1.24 Exercisable 179,046 $ 9.12 $ 1.32 25.40 1.24 Non-Exercisable — $ — $ — — The following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30, 2022: Common Stock Shares Weighted– Average Range of Weighted– Total outstanding – December 31, 2021 179,065 $ 15.20 $ 11.10 25.40 2.64 Granted to advisor and its designees — — Exercised — — Expired — — Forfeited — — Total outstanding – June 30, 2022 179,065 $ 10.60 $ 5.14 25.40 2.23 Exercisable 179,065 $ 10.60 $ 5.14 25.40 2.23 Non-Exercisable — $ — $ — — |
Non Compensatory Warrant Activity [Member] | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
SCHEDULE OF WARRANT ACTIVITY | The following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2023: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Range of Weighted– Total outstanding – December 31, 2022 547,003 $ 19.76 $ 1.32 20.00 0.33 Legacy Ritter warrants — — Granted — — Exercised — — Expired (455,685 ) 20.00 20.00 Forfeited — — Total outstanding – June 30, 2023 91,318 $ 18.56 - Exercisable 91,318 $ 18.56 $ 1.32 20.00 0.58 Non-Exercisable — $ — $ — — The following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2022: Common Stock Shares Weighted– Range of Weighted– Total outstanding – December 31, 2021 554,914 $ 20.10 Legacy Ritter warrants — — Granted 331,464 0.01 0.01 Exercised — — Expired — — Forfeited — — Total outstanding – June 30, 2022 886,378 $ 12.60 Exercisable 886,378 $ 12.60 $ 0.01 37.70 0.82 Non-Exercisable — $ — $ — — |
SCHEDULE OF ACCOUNTS RECEIVABLE
SCHEDULE OF ACCOUNTS RECEIVABLE (Details) - USD ($) | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accounts Receivable | $ 726,449 | $ 733,964 | |
Less Reserves and Allowances | (187,862) | (54,584) | |
Accounts receivable, net | $ 538,587 | $ 679,380 | $ 538,587 |
SCHEDULE OF USEFUL LIVES OF PRO
SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT (Details) | Jun. 30, 2023 |
Machinery and Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 5 years |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 3 years |
Molds and Tooling [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 5 years |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 5 years |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
May 26, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jul. 20, 2023 | Dec. 22, 2022 | Apr. 25, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Warrants to purchase common stock | 219,101 | ||||||||||
Warrants exercise price | $ 13.20 | $ 40.70 | |||||||||
Reverse stock split | These warrants were subsequently exercised on September 13, 2022 | ||||||||||
Stock issued during period, value, acquisitions | $ 1,844,500 | ||||||||||
Impairment losses on construction-in-progress | $ 0 | 0 | $ 0 | $ 0 | |||||||
Allowance for estimated returns | 28,000 | 10,000 | 33,000 | 53,000 | |||||||
Goodwill impairment charges | $ 4,239,000 | ||||||||||
Goodwill and intangible asset impairment | 0 | 0 | |||||||||
Estimated useful lives | 5 years | ||||||||||
Accrued warranty liabilities | 140,370 | 140,370 | 137,568 | ||||||||
Warranty costs | 63,000 | 22,000 | 104,000 | 41,000 | |||||||
Adjustment net of tax | $ (56,747) | 65,540 | $ 119,473 | 65,540 | |||||||
Minimum [Member] | Patents and Licenses [Member] | |||||||||||
Estimated useful lives | 5 years | 5 years | |||||||||
Maximum [Member] | Patents and Licenses [Member] | |||||||||||
Estimated useful lives | 17 years | 17 years | |||||||||
Selling and Marketing Expense [Member] | |||||||||||
Other shipping and handling costs | $ 0 | 4,000 | $ 4,000 | 8,000 | |||||||
Shipping and Handling [Member] | |||||||||||
Other shipping and handling costs | 78,000 | $ 72,000 | 144,000 | $ 111,000 | |||||||
Pre-funded Warrant [Member] | |||||||||||
Warrants to purchase common stock | 331,464 | ||||||||||
Warrants exercise price | $ 0.001 | ||||||||||
Warrant [Member] | |||||||||||
Warrants to purchase common stock | 67,619 | 67,620 | 67,619 | ||||||||
Warrants exercise price | $ 6 | ||||||||||
Accrued warranty liabilities | $ 140,000 | $ 140,000 | 138,000 | ||||||||
Warrant [Member] | Minimum [Member] | |||||||||||
Warrants exercise price | $ 11.10 | $ 5.136 | 11.10 | ||||||||
Warrant [Member] | Maximum [Member] | |||||||||||
Warrants exercise price | $ 5.136 | $ 1.32 | $ 5.136 | ||||||||
Series B Preferred Stock [Member] | |||||||||||
Stock issued during period shares acquisitions | 381,786 | ||||||||||
NanoSynex Ltd [Member] | |||||||||||
Stock issued during period shares acquisitions | 350,000 | ||||||||||
Voting interests acquired | 52.80% | ||||||||||
Adjustment net of tax | $ 65,540 | ||||||||||
NanoSynex Ltd [Member] | Series A-1 Preferred Stock [Member] | |||||||||||
Stock issued during period shares acquisitions | 2,232,861 | ||||||||||
NanoSynex Ltd [Member] | Series B Preferred Stock [Member] | |||||||||||
Stock issued during period shares acquisitions | 381,786 | ||||||||||
Stock issued during period, value, acquisitions | $ 600,000 |
LIQUIDITY (Details Narrative)
LIQUIDITY (Details Narrative) - USD ($) | 1 Months Ended | 6 Months Ended | 12 Months Ended | 13 Months Ended | |||||
Jul. 20, 2023 | Dec. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2023 | Mar. 31, 2024 | Nov. 30, 2023 | Jan. 12, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Cash | $ 5,200,000 | $ 7,034,434 | $ 1,341,659 | $ 7,034,434 | |||||
Accumulated deficit | 103,385,172 | 110,695,598 | 103,385,172 | ||||||
Net cash used in operating activities | 5,562,416 | $ 7,827,798 | $ 13,200,000 | ||||||
Share based compensation | $ 5,800,000 | 906,145 | $ 2,690,447 | ||||||
Escrow deposit | $ 450,000 | ||||||||
Proceeds from issuance of common stock | $ 8,800,000 | ||||||||
Proceeds from issuance of debt | $ 3 | ||||||||
Aggregrate amount | $ 1,111,078 | ||||||||
Subsequent Event [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Sale of stock price per share | $ 1.5716 | ||||||||
Subsequent Event [Member] | Amendment and Settlement Agreement [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Aggregrate amount | $ 380,000 | ||||||||
Subsequent Event [Member] | Amendment and Settlement Agreement [Member] | NanoSynex Ltd [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Aggregrate amount | $ 1,610,000 | $ 670,000 | $ 560,000 | ||||||
NanoSynex Ltd [Member] | Subsequent Event [Member] | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Business acquisition, description of acquired entity | Pursuant to the terms of the NanoSynex Amendment, the Company agreed to advance to NanoSynex an aggregate amount of $1,610,000 as follows: (i) $380,000 within five business days of the execution of the NanoSynex Amendment, (ii) $560,000 on or before November 30, 2023, against which NanoSynex will issue a promissory note to the Company with a face value in the amount of such funding, and (iii) $670,000 on or before March 31, 2024, against which NanoSynex will issue a promissory note to the Company with a face value in the amount of such funding. The NanoSynex Amendment further provides that the initial payment of $380,000 will be satisfied by the Company’s surrender of the 281,000 Preferred B Shares of NanoSynex currently held by the Company, resulting in the Company’s ownership in NanoSynex being reduced from approximately 52.8% to approximately 49.97% of the issued and outstanding voting equity of NanoSynex. |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,027,455 | $ 949,796 |
Work in process | 177,591 | 200,318 |
Finished goods | 358,353 | 436,183 |
Total inventory | $ 1,563,399 | $ 1,586,297 |
SCHEDULE OF PREPAID EXPENSES AN
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid insurance | $ 938,106 | $ 1,377,323 |
Prepaid manufacturing expenses | 51,710 | 43,820 |
Other prepaid expenses | 65,288 | 227,451 |
Prepaid research and development expenses | 211,337 | |
Other current assets | 11,636 | 12,626 |
Prepaid expenses and other current assets | $ 1,278,077 | $ 1,661,220 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,252,230 | $ 5,043,533 |
Accumulated depreciation | (4,678,583) | (4,623,446) |
Fixed asset impairment | (75,000) | (75,000) |
Property and equipment, net | 498,647 | 345,087 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,735,507 | 2,510,148 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 369,589 | 395,836 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 336,916 | 333,271 |
Molds and Tooling [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 260,002 | 260,002 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 144,832 | 144,832 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,405,384 | $ 1,399,444 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Depreciation expense | $ 19,000 | $ 24,000 | $ 37,000 | $ 48,000 | |
Payments to acquire assets | $ 246,418 | $ 63,483 | |||
Sekisui Distribution Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Payments to acquire assets | $ 154,000 |
SCHEDULE OF GOODWILL AND OTHER
SCHEDULE OF GOODWILL AND OTHER INTANGIBLES (Details) - USD ($) | Jul. 20, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | |||
Goodwill | $ 625,602 | $ 625,602 | |
Finite lived intangible asset useful life | 5 years | ||
Less: Accumulated amortization | (764,869) | (752,237) | |
Total finite-lived intangible assets, net | 133,070 | 145,702 | |
Total other intangible assets, net | 5,833,070 | 5,845,702 | |
In Process Research and Development [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Total other intangible assets, net | 5,700,000 | 5,700,000 | |
Developed-Product-Technology Rights [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Licensing rights | $ 479,103 | 479,103 | |
Developed-Product-Technology Rights [Member] | Minimum [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Finite lived intangible asset useful life | 8 years | ||
Developed-Product-Technology Rights [Member] | Maximum [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Finite lived intangible asset useful life | 17 years | ||
Licensing Rights [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Licensing rights | $ 418,836 | $ 418,836 | |
Finite lived intangible asset useful life | 10 years |
GOODWILL, IPR&D AND OTHER INT_3
GOODWILL, IPR&D AND OTHER INTANGIBLES (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jul. 20, 2023 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Goodwill, impairment loss | $ 4,239,000 | |||||
Impairment of intangible assets | $ 0 | $ 0 | $ 0 | $ 0 | ||
Accumulated amortization | 764,869 | 764,869 | 752,237 | |||
Estimated useful life | 5 years | |||||
Patents [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite lived intangible assets gross | 131,000 | 131,000 | 140,000 | |||
Accumulated amortization | 348,000 | 348,000 | 339,000 | |||
Amortization of intangible assets | 9,000 | 5,000 | 9,000 | 9,000 | ||
License [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite lived intangible assets gross | 2,000 | 2,000 | 5,000 | |||
Accumulated amortization | 417,000 | 417,000 | $ 414,000 | |||
Amortization of intangible assets | $ 3,000 | $ 3,000 | $ 3,000 | $ 3,000 |
SCHEDULE OF ACCRUED EXPENSES AN
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Board compensation | $ 84,000 | $ 70,000 |
Equipment held for lease | 154,433 | |
Franchise, sales and use taxes | 30,407 | 27,531 |
Income taxes | 6,921 | 4,663 |
Interest (Convertible debt - related party) | 50,101 | 2,829 |
License fees | 100,026 | 150,130 |
Payroll | 484,048 | 209,303 |
Professional fees | 368,032 | 238,211 |
Research and development | 523,490 | 322,987 |
Royalties | 16,383 | 13,158 |
Warranty liability | 140,370 | 137,568 |
Other | 176,777 | 181,043 |
Accrued expenses and other current liabilities | $ 1,980,555 | $ 1,511,856 |
SHORT TERM DEBT-RELATED PARTY (
SHORT TERM DEBT-RELATED PARTY (Details Narrative) - USD ($) | 17 Months Ended | ||||
Sep. 02, 2021 | Jun. 30, 2023 | Jan. 12, 2023 | Dec. 31, 2022 | Dec. 22, 2022 | |
Short-Term Debt [Line Items] | |||||
Short term debt principal outstanding | $ 1,111,078 | ||||
Accrued interest | $ 50,101 | $ 2,829 | |||
Short term debt outstanding balance | 965,155 | $ 950,722 | |||
Accrued interest rate | 8% | ||||
Notes Payable [Member] | Nano Synex Ltd [Member] | |||||
Short-Term Debt [Line Items] | |||||
Short term debt principal outstanding | $ 905,000 | ||||
Accrued interest | 60,155 | ||||
Short term debt outstanding balance | $ 965,155 | ||||
Accrued interest rate | 2.62% | ||||
Proceeds from related party debt | $ 3,000,000 |
SCHEDULE OF WARRANTS ACTIVITY (
SCHEDULE OF WARRANTS ACTIVITY (Details) - Series C Warrants [Member] - Common Stock Warrants [Member] - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Number of Shares, Warrants Outstanding Beginning | 3,849,571 | 248,161 |
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning | $ 1.53 | $ 7.20 |
Weighted Average Remaining Contractual Term | 3 years 10 months 24 days | |
Number of Shares, Warrants Exercised | (536) | |
Weighted Average Exercise Price Per Share Warrants Exercised | $ 7.20 | |
Number of Shares, Warrants Forfeited | (247,625) | |
Weighted Average Exercise Price Per Share Warrants Forfeited | $ 7.20 | |
Number of Shares, Warrants Expired | ||
Weighted Average Exercise Price Per Share Warrants Expired | ||
Number of Shares, Warrants Granted | 346,896 | |
Weighted Average Exercise Price Per Share Warrants Granted | $ 5.10 | |
Number of Shares, Warrants Outstanding Ending | 3,849,571 | 346,896 |
Weighted Average Exercise Price Per Share Warrants Outstanding Ending | $ 1.53 | $ 5.10 |
Weighted Average Remaining Contractual Term | 3 years 4 months 28 days | 2 years |
Number of Shares, Warrants Exercisable | 3,849,571 | 346,896 |
Weighted Average Exercise Price Per Share Exercisable | $ 1.53 | $ 5.10 |
Range of Exercise Price, Exercisable | $ 5.10 | |
Exercisable Weighted Averag Remaining Contractual Term | 3 years 4 months 28 days | 1 year 6 months 3 days |
Minimum [Member] | ||
Range of Exercise Beginning | $ 1.32 | |
Range of Exercise Ending | 1.32 | |
Range of Exercise Price, Exercisable | 1.32 | |
Maximum [Member] | ||
Range of Exercise Beginning | 1.65 | |
Range of Exercise Ending | 1.65 | |
Range of Exercise Price, Exercisable | $ 1.65 |
SCHEDULE OF FAIR VALUE HIERARCH
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Platform Operator, Crypto-Asset [Line Items] | ||
Fair value for warrant liabilities, beginning balance | $ 3,622,647 | |
Common Stock Warrant liabilities, Exercises | $ (858) | |
Change in fair value of warrant liabilities | (1,478,967) | |
Fair value for warrant liabilities, ending balance | 2,143,680 | |
Fair Value, Inputs, Level 1 [Member] | ||
Platform Operator, Crypto-Asset [Line Items] | ||
Fair value for warrant liabilities, beginning balance | ||
Common Stock Warrant liabilities, Exercises | ||
Change in fair value of warrant liabilities | ||
Fair value for warrant liabilities, ending balance | ||
Fair Value, Inputs, Level 2 [Member] | ||
Platform Operator, Crypto-Asset [Line Items] | ||
Fair value for warrant liabilities, beginning balance | ||
Common Stock Warrant liabilities, Exercises | ||
Change in fair value of warrant liabilities | ||
Fair value for warrant liabilities, ending balance | ||
Fair Value, Inputs, Level 3 [Member] | ||
Platform Operator, Crypto-Asset [Line Items] | ||
Fair value for warrant liabilities, beginning balance | 3,622,647 | |
Common Stock Warrant liabilities, Exercises | ||
Change in fair value of warrant liabilities | (1,478,967) | |
Fair value for warrant liabilities, ending balance | $ 2,143,680 |
SCHEDULE OF ASSUMPTIONS OF WARR
SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES (Details) | Jun. 30, 2023 | Jun. 30, 2022 |
Measurement Input, Expected Dividend Rate [Member] | ||
Fair value assumptions, measurement input, percentages | 0 | 0 |
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair value assumptions, measurement input, percentages | 4.05 | 2.80 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value assumptions, measurement input, percentages | 66.3 | 74 |
Minimum [Member] | Measurement Input, Expected Term [Member] | ||
Fair value assumptions, measurement input, term | 4 months 20 days | 1 year 4 months 20 days |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair value assumptions, measurement input, percentages | 5.31 | 2.87 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value assumptions, measurement input, percentages | 134 | 96 |
Maximum [Member] | Measurement Input, Expected Term [Member] | ||
Fair value assumptions, measurement input, term | 4 years 11 months 23 days | 1 year 11 months 26 days |
Weighted Average [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair value assumptions, measurement input, percentages | 4.49 | 2.82 |
Weighted Average [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value assumptions, measurement input, percentages | 110.55 | 78.6 |
Weighted Average [Member] | Measurement Input, Expected Term [Member] | ||
Fair value assumptions, measurement input, term | 3 years 4 months 28 days | 1 year 6 months 3 days |
Weighted Average [Member] | Measurement Input, Expected Dividend Rate [Member] | ||
Fair value assumptions, measurement input, percentages | 0 | 0 |
WARRANT LIABILITIES (Details Na
WARRANT LIABILITIES (Details Narrative) - $ / shares | Dec. 22, 2022 | May 26, 2022 | Apr. 25, 2022 | Jun. 30, 2023 | Dec. 31, 2021 | Dec. 31, 2020 |
Exercise price of warrant | $ 13.20 | $ 40.70 | ||||
Warrant to purchase shares | 60,000 | |||||
Minimum [Member] | Series C Warrants [Member] | ||||||
Exercise price of warrant | $ 1.32 | $ 5.136 | $ 6 | |||
Warrants and rights outstanding term | 4 months 24 days | |||||
Maximum [Member] | Series C Warrants [Member] | ||||||
Exercise price of warrant | $ 5.136 | $ 6 | $ 7.195 | |||
Warrants and rights outstanding term | 11 months 26 days | |||||
Series C Warrants [Member] | ||||||
Exercise price of warrant | $ 7.195 | |||||
Warrants issued | 1,002,717 | 49,952 | 49,318 | |||
Warrants forfeited | 247,625 | |||||
Warrants reissued | 346,896 | |||||
Series C Warrants [Member] | Alpha Capital [Member] | ||||||
Exercise price of warrant | $ 1.65 | |||||
Warrant to purchase shares | 2,500,000 | |||||
Conversion price percentage | 125% |
SCHEDULE OF SENIOR SECURED CONV
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Short-Term Debt [Line Items] | ||
Total convertible debt-related party | $ 812,419 | $ 60,197 |
Senior Secured Convertible Debt [Member] | ||
Short-Term Debt [Line Items] | ||
Senior secured convertible debenture | 2,078,922 | 3,300,000 |
Discount on convertible debenture | (1,266,503) | (3,239,803) |
Total convertible debt-related party | $ 812,419 | $ 60,197 |
CONVERTIBLE DEBT- RELATED PAR_3
CONVERTIBLE DEBT- RELATED PARTY (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||||||
Jan. 12, 2023 | Dec. 22, 2022 | Jun. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Short-Term Debt [Line Items] | |||||||||
Conversion price | $ 1.32 | ||||||||
Warrant to purchase shares | 60,000 | ||||||||
Exercise price of warrant | $ 13.20 | $ 40.70 | |||||||
Debenture accrues interest rate | 8% | ||||||||
Shares of Common stock, issued | 5,052,463 | 5,052,463 | 4,210,737 | ||||||
Debt discount amortization | $ 364,000 | $ 898,000 | |||||||
Fair value of warrants | (1,478,967) | $ (698,042) | |||||||
Shares of common stock | 841,726 | ||||||||
Debenture voluntarily converted | $ 1,111,078 | ||||||||
Debt conversion of convertible debt | $ 1,100,000 | ||||||||
Accrued interest | 383,000 | 945,000 | |||||||
Fair value of warrants | 2,000,000 | 2,000,000 | |||||||
Derivative fair value of warrants | $ 0 | $ 0 | |||||||
Alpha Capital [Member] | |||||||||
Short-Term Debt [Line Items] | |||||||||
Beneficial ownership percentage | 9.99% | ||||||||
Shares of Common stock, issued | 5,157,087 | ||||||||
Series C Warrants [Member] | |||||||||
Short-Term Debt [Line Items] | |||||||||
Exercise price of warrant | $ 7.195 | $ 7.195 | |||||||
Senior Convertible Debenture [Member] | |||||||||
Short-Term Debt [Line Items] | |||||||||
Principal amount percentage | 105% | ||||||||
Alpha Capital [Member] | Series C Warrants [Member] | |||||||||
Short-Term Debt [Line Items] | |||||||||
Warrant to purchase shares | 2,500,000 | ||||||||
Exercise price of warrant | $ 1.65 | ||||||||
Conversion price percentage | 125% | ||||||||
Alpha Capital [Member] | Senior Convertible Debenture [Member] | |||||||||
Short-Term Debt [Line Items] | |||||||||
Senior convertible debenture rate | 8% | ||||||||
Principal amount | $ 3,300,000 | ||||||||
Purchase Price | $ 3,000,000 | ||||||||
Conversion price | $ 1.32 | ||||||||
Alpha Capital Other Third Parties [Member] | |||||||||
Short-Term Debt [Line Items] | |||||||||
Debt discount amortization | $ 300,000 | ||||||||
Fair value of warrants | 2,800,000 | ||||||||
Fair value of embedded derivative features | $ 0 | 0 | |||||||
Fees and costs paid | $ 100,000 |
SCHEDULE OF DILUTIVE SECURITIES
SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents | 4,565,097 | 1,889,121 |
Shares of Common Stock Subject to Outstanding Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents | 445,163 | 476,783 |
Shares of Common Stock Subject to Outstanding Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents | 4,119,934 | 1,412,338 |
SCHEDULE OF OPERATING LEASE RIG
SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Operating lease right-of-use assets | $ 1,422,538 | ||
Less amortization of operating lease right-of-use assets | (116,567) | $ (109,803) | |
Operating lease right-of-use assets | 1,305,970 | ||
Lease liabilities at December 31, 2022 | 1,425,808 | ||
Less non-current portion | (1,168,653) | $ (1,301,919) | |
Current portion at Decebmer 31, 2022 | 257,155 | $ 240,645 | |
Long term Operating Lease Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Operating lease right-of-use assets | 1,422,538 | ||
Less amortization of operating lease right-of-use assets | (116,568) | ||
Operating lease right-of-use assets | 1,305,970 | ||
Lease liabilities at December 31, 2021 | 1,542,564 | ||
Less principal payments on operating lease liabilities | (116,756) | ||
Lease liabilities at December 31, 2022 | 1,425,808 | ||
Less non-current portion | (1,168,653) | ||
Current portion at Decebmer 31, 2022 | $ 257,155 |
SCHEDULE OF MATURITIES OF OPERA
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) | Jun. 30, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2023 (six months) | $ 184,171 |
2024 | 379,392 |
2025 | 390,773 |
2026 | 402,497 |
2027 | 379,164 |
Total | 1,735,997 |
Less present value discount | (310,189) |
Operating lease liabilities | $ 1,425,808 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | 3 Months Ended | 6 Months Ended | ||||||||
Jul. 20, 2023 USD ($) $ / shares | Apr. 05, 2022 USD ($) | Dec. 15, 2021 USD ($) ft² | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2024 USD ($) | Nov. 30, 2023 USD ($) | Jan. 12, 2023 USD ($) | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Area of land | ft² | 22,624 | |||||||||
Operating lease term | 61 months | |||||||||
Operating lease term description | November 1, 2022 to November 30, 2027 | |||||||||
Payments for Rent | $ 1,950,710 | |||||||||
Tenant improvement allowance | 339,360 | |||||||||
Weighted-average remaining lease term | 4 years 3 months 18 days | 4 years 3 months 18 days | ||||||||
Weighted-average discount rate | 8.90% | 8.90% | ||||||||
Operating lease expense | $ 114,000 | $ 119,000 | $ 230,000 | $ 233,000 | ||||||
Aggregrate amount | $ 1,111,078 | |||||||||
Litigation Settlement, Amount Awarded to Other Party | $ 96,558 | |||||||||
Subsequent Event [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Sale of Stock, Price Per Share | $ / shares | $ 1.5716 | |||||||||
Subsequent Event [Member] | Amendment and Settlement Agreement [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Aggregrate amount | $ 380,000 | |||||||||
Subsequent Event [Member] | Amendment and Settlement Agreement [Member] | NanoSynex Ltd [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Aggregrate amount | $ 1,610,000 | $ 670,000 | $ 560,000 | |||||||
NanoSynex Ltd [Member] | Subsequent Event [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Business acquisition, description of acquired entity | Pursuant to the terms of the NanoSynex Amendment, the Company agreed to advance to NanoSynex an aggregate amount of $1,610,000 as follows: (i) $380,000 within five business days of the execution of the NanoSynex Amendment, (ii) $560,000 on or before November 30, 2023, against which NanoSynex will issue a promissory note to the Company with a face value in the amount of such funding, and (iii) $670,000 on or before March 31, 2024, against which NanoSynex will issue a promissory note to the Company with a face value in the amount of such funding. The NanoSynex Amendment further provides that the initial payment of $380,000 will be satisfied by the Company’s surrender of the 281,000 Preferred B Shares of NanoSynex currently held by the Company, resulting in the Company’s ownership in NanoSynex being reduced from approximately 52.8% to approximately 49.97% of the issued and outstanding voting equity of NanoSynex. | |||||||||
First 12 Months [Member] | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||
Payments for Rent | $ 335,966 |
RESEARCH AND LICENSE AGREEMEN_2
RESEARCH AND LICENSE AGREEMENTS (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 13 Months Ended | 47 Months Ended | |||||||||
Mar. 31, 2022 | Jan. 31, 2022 | Feb. 28, 2021 | Nov. 30, 2020 | Jul. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2019 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2023 | Apr. 30, 2022 | Dec. 31, 2021 | |
Proceeds from convertible debt | $ 3 | |||||||||||||
Research and development expense | $ 1,326,544 | $ 1,506,227 | $ 3,448,095 | $ 3,370,972 | ||||||||||
Revenue from contract with customer excluding assessed tax | 1,627,031 | 1,430,534 | 3,234,201 | 2,152,563 | ||||||||||
Yi Xin Zhen Duan Jishu Ltd [Member] | ||||||||||||||
Deferred revenue | 0 | 0 | 0 | 0 | $ 670,000 | |||||||||
Prediction Biosciences SAS [Member] | Product [Member] | ||||||||||||||
Revenue from contract with customer excluding assessed tax | 0 | 86,000 | 0 | |||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | ||||||||||||||
Proceeds from convertible debt | $ 50,000 | |||||||||||||
Reimbursement of research expenses | 805,000 | |||||||||||||
Patent costs | $ 200,000 | |||||||||||||
Agreement term payment description | 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. | |||||||||||||
Marketing approval expenses | $ 500,000 | |||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Licensed Product Sales [Member] | ||||||||||||||
Cumulative sales | $ 5,000,000 | 5,000,000 | ||||||||||||
Regulatory marketing approval, expenses | 500,000 | |||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Phase 1 Clinical Trial [Member] | ||||||||||||||
Milestone payment | 50,000 | 100,000 | ||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Phase 2 Clinical Trial [Member] | ||||||||||||||
Milestone payment | 100,000 | 200,000 | ||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Phase 3 Clinical Trial [Member] | ||||||||||||||
Milestone payment | 150,000 | 350,000 | ||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Minimum [Member] | ||||||||||||||
Milestone payment | 50,000 | 100,000 | ||||||||||||
Shortfall payments | 10,000 | |||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Maximum [Member] | ||||||||||||||
Milestone payment | $ 5,000,000 | 5,000,000 | ||||||||||||
Shortfall payments | 50,000 | |||||||||||||
Sponsored Research and License Agreement [Member] | ||||||||||||||
Research and development expense | 0 | 77,000 | 0 | 164,000 | ||||||||||
License cost | 1,000 | 14,000 | 29,000 | 18,000 | ||||||||||
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | ||||||||||||||
Reimbursement of research expenses | $ 2,700,000 | $ 2,700,000 | $ 693,000 | |||||||||||
Agreement term payment description | In July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under the agreement, the Company took 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, | |||||||||||||
Marketing approval expenses | $ 300,000 | |||||||||||||
Revenue | 500,000,000 | $ 500,000,000 | ||||||||||||
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | Minimum [Member] | ||||||||||||||
Upfront license fee | 20,000 | |||||||||||||
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | Maximum [Member] | ||||||||||||||
Upfront license fee | $ 100,000 | |||||||||||||
Sponsored Research Agreements And License [Member] | ||||||||||||||
Research and development expense | 333,000 | 220,000 | 556,000 | 405,000 | ||||||||||
License cost | 15,000 | 16,000 | 22,000 | 69,000 | ||||||||||
License Agreement [Member] | ||||||||||||||
License cost | $ 0 | $ 0 | $ 0 | $ 310,000 | ||||||||||
Reimbursement of patent | $ 160,000 | |||||||||||||
License Agreement [Member] | Upfront Payment [Member] | ||||||||||||||
Reimbursement of patent | $ 150,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | ||||||||||||||
Agreement term payment description | the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization of QN-165 as a treatment for COVID-19, 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 patents, 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 June 2020, and (iv) payments ranging from $50,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones. | |||||||||||||
Marketing approval expenses | $ 300,000 | |||||||||||||
Revenue | 500,000,000 | |||||||||||||
Upfront license fee | 24,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Licensed Product Sales [Member] | ||||||||||||||
Cumulative sales | 5,000,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Phase 1 Clinical Trial [Member] | ||||||||||||||
Milestone payment | 50,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Phase 2 Clinical Trial [Member] | ||||||||||||||
Milestone payment | 100,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Phase 3 Clinical Trial [Member] | ||||||||||||||
Milestone payment | 150,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Minimum [Member] | ||||||||||||||
Milestone payment | 50,000 | |||||||||||||
Research and development expense | $ 430,000 | 250,000 | ||||||||||||
Upfront license fee | 5,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Maximum [Member] | ||||||||||||||
Milestone payment | 5,000,000 | |||||||||||||
Upfront license fee | $ 50,000 |
SCHEDULE OF RESERVED SHARES (De
SCHEDULE OF RESERVED SHARES (Details) | Jun. 30, 2023 shares |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total | 4,565,097 |
Equity Option [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total | 445,163 |
Warrant [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total | 4,119,934 |
SCHEDULE OF STOCK OPTION ACTIVI
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending | 1 year 5 months 19 days | |
Employees and Non-employee Service Provider [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Number of shares, options outstanding, beginning | 608,012 | 484,186 |
Range of Exercise price, Options Outstanding | $ 35.02 | $ 60.70 |
Weighted- Average Remaining Contractual Life (in Years), Outstanding, Beginning | 8 years 1 month 2 days | 8 years 6 months 7 days |
Number of shares, options granted | 2,500 | |
Weighted average exercise price, options granted | $ 10.50 | |
Number of shares, options expired | (9,386) | |
Weighted average exercise price, options expired | $ 935.90 | |
Number of shares, options forfeited | (162,849) | (517) |
Weighted average exercise price, options forfeited | $ 36.01 | $ 35.10 |
Number of Shares, Options Outstanding at Ending | 445,163 | 476,783 |
Range of Exercise price, Options Outstanding | $ 34.68 | $ 43.30 |
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending | 7 years 7 months 2 days | 8 years 2 months 8 days |
Number of shares, options exercisable (vested) | 323,355 | 264,366 |
Range of exercise price, options exercisable (vested) | $ 44.79 | $ 48.40 |
Weighted- Average Remaining Contractual Life (in Years), Options Exercisable (vested) | 7 years 1 month 17 days | 8 years |
Number of shares, options non-exercisable (non-vested) | 121,808 | 212,417 |
Weighted average exercise price, options non-exercisable (non-vested) | $ 7.83 | $ 36.80 |
Weighted- Average Remaining Contractual Life (in Years), Options Non-exercisable (non-vested) | 8 years 10 months 6 days | 8 years 5 months 23 days |
Range of Exercise price, Options Outstanding | $ 10.50 | |
Weighted- Average Remaining Contractual Life (in Years), Options Granted | 9 years 6 months 14 days | |
Employees and Non-employee Service Provider [Member] | Minimum [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Range of Exercise price, Options Outstanding | $ 5.14 | $ 12.40 |
Range of Exercise price, Options Forfeited | 5.14 | 12.40 |
Range of Exercise price, Options Outstanding | 5.14 | 10.50 |
Range of exercise price, options exercisable (vested) | 5.14 | 12.40 |
Range of exercise price, options non-exercisable (non-vested) | 5.14 | 10.50 |
Range of Exercise price, Options Outstanding | 57.50 | |
Employees and Non-employee Service Provider [Member] | Maximum [Member] | ||
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | ||
Range of Exercise price, Options Outstanding | 51.30 | 14,657.50 |
Range of Exercise price, Options Forfeited | 51.30 | 49.70 |
Range of Exercise price, Options Outstanding | 51.30 | 51.30 |
Range of exercise price, options exercisable (vested) | 51.30 | 50.13 |
Range of exercise price, options non-exercisable (non-vested) | $ 35.20 | 51.30 |
Range of Exercise price, Options Outstanding | $ 14,657.50 |
SCHEDULE OF ASSUMPTION USED IN
SCHEDULE OF ASSUMPTION USED IN BLACK-SCHOLES OPTION-PRICING METHOD (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Equity [Abstract] | ||
Expected dividend yield | 0% | 0% |
Expected stock-price volatility | 102% | |
Risk-free interest rate, minimum | 1.58% | |
Risk-free interest rate, maximum | 1.67% | |
Expected average term of options (in years) | 6 years | |
Share price | $ 1.05 |
SCHEDULE OF SHARE-BASED COMPENS
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Total | $ 906,145 | $ 2,690,447 |
General and Administrative Expense [Member] | ||
Total | 807,980 | 2,329,418 |
Research and Development Expense [Member] | ||
Total | $ 98,165 | $ 361,029 |
SCHEDULE OF WARRANT ACTIVITY (D
SCHEDULE OF WARRANT ACTIVITY (Details) - $ / shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Non Compensatory Warrant Activity [Member] | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Number of Shares, Warrants Outstanding Beginning | 547,003 | 554,914 | 554,914 | |
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning | $ 19.76 | $ 20.10 | $ 20.10 | |
Weighted average remaining life (Years) exercisable | 3 months 29 days | |||
Number of shares, warrants granted | 331,464 | |||
Weighted average exercise price per share warrants granted | $ 0.01 | |||
Number of Shares, Warrants Exercised | ||||
Weighted average exercise price per share warrants exercised | ||||
Number of Shares, Warrants Expired | (455,685) | |||
Weighted average exercise price per share warrants expired | $ 20 | |||
Number of Shares, Warrants Forfeited | ||||
Weighted average exercise price per share warrants forfeited | ||||
Number of Shares, Warrants Outstanding Ending | 91,318 | 886,378 | 547,003 | 554,914 |
Weighted Average Exercise Price Per Share Warrants Outstanding Ending | $ 18.56 | $ 12.60 | $ 19.76 | $ 20.10 |
Number of Shares, Warrants Exercisable | 91,318 | 886,378 | ||
Weighted Average Exercise Price Per Share Exercisable | $ 18.56 | $ 12.60 | ||
Weighted average remaining life (Years) exercisable | 6 months 29 days | 9 months 25 days | ||
Number of shares legal ritter warrants | ||||
Weighted average exercise price per share warrants expired | $ 20 | |||
Number of Shares, Warrants Exercisable | ||||
Weighted Average Exercise Price Per Share Exercisable | ||||
Range of exercise price, granted | 0.01 | |||
Minimum [Member] | Non Compensatory Warrant Activity [Member] | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Range of exercise price | 1.32 | |||
Range of exercise price - ending | 1.32 | |||
Range of exercise price - Exercisable | 1.32 | 0.01 | ||
Maximum [Member] | Non Compensatory Warrant Activity [Member] | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Range of exercise price | 20 | |||
Range of exercise price - ending | $ 20 | |||
Range of exercise price - Exercisable | $ 20 | $ 37.70 | ||
Compensatory Warrant Activity [Member] | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Number of Shares, Warrants Outstanding Beginning | 179,046 | 179,065 | 179,065 | |
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning | $ 9.12 | $ 15.20 | $ 15.20 | |
Weighted average remaining life (Years) exercisable | 1 year 2 months 26 days | 2 years 2 months 23 days | 1 year 8 months 23 days | 2 years 7 months 20 days |
Number of shares, warrants granted | ||||
Weighted average exercise price per share warrants granted | ||||
Number of Shares, Warrants Exercised | ||||
Weighted average exercise price per share warrants exercised | ||||
Number of Shares, Warrants Expired | ||||
Weighted average exercise price per share warrants expired | ||||
Number of Shares, Warrants Forfeited | ||||
Weighted average exercise price per share warrants forfeited | ||||
Number of Shares, Warrants Outstanding Ending | 179,046 | 179,065 | 179,046 | 179,065 |
Weighted Average Exercise Price Per Share Warrants Outstanding Ending | $ 9.12 | $ 10.60 | $ 9.12 | $ 15.20 |
Number of Shares, Warrants Exercisable | 179,046 | 179,065 | ||
Weighted Average Exercise Price Per Share Exercisable | $ 9.12 | $ 10.60 | ||
Weighted average remaining life (Years) exercisable | 1 year 2 months 26 days | 2 years 2 months 23 days | ||
Number of shares, warrants non-exercisable | ||||
Weighted Average Exercise Price Per Share Non-Exercisable | ||||
Range of Exercise Price, Non-Exercisable | ||||
Compensatory Warrant Activity [Member] | Minimum [Member] | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Range of exercise price | 1.32 | 11.10 | 11.10 | |
Range of exercise price - ending | 1.32 | 5.14 | 1.32 | 11.10 |
Range of exercise price - Exercisable | 1.32 | 5.14 | ||
Compensatory Warrant Activity [Member] | Maximum [Member] | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Range of exercise price | 25.40 | 25.40 | 25.40 | |
Range of exercise price - ending | 25.40 | 25.40 | $ 25.40 | $ 25.40 |
Range of exercise price - Exercisable | $ 25.40 | $ 25.40 |
STOCKHOLDERS_ EQUITY (Details N
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||||
Jul. 20, 2023 | Jan. 12, 2023 | Dec. 22, 2022 | May 26, 2022 | Apr. 25, 2022 | Dec. 31, 2020 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | May 31, 2022 | Nov. 29, 2021 | Aug. 31, 2020 | Jul. 31, 2020 | May 31, 2020 | Dec. 31, 2017 | |
Class of Stock [Line Items] | ||||||||||||||||
Conversion price | $ 1.32 | |||||||||||||||
Purchase of warrants | 60,000 | |||||||||||||||
Debenture voluntarily converted | $ 1,111,078 | |||||||||||||||
Shares of common stock | 841,726 | |||||||||||||||
Plan shares available | 4,565,097 | |||||||||||||||
Compensation cost | $ 5,800,000 | $ 906,145 | $ 2,690,447 | |||||||||||||
Unrecognized compensation cost | $ 500,000 | |||||||||||||||
Cost is expected to be recognized over a weighted average period | 1 year 5 months 19 days | |||||||||||||||
Purchase of warrants | 219,101 | |||||||||||||||
Class of warrant or right, exercise | $ 40.70 | $ 13.20 | ||||||||||||||
Fair value of issuance cost | $ 300,000 | |||||||||||||||
Fair value adjustment of warrants | $ (1,478,967) | (698,042) | ||||||||||||||
Compensation cost | 906,145 | 2,690,447 | ||||||||||||||
Nano Synex Ltd [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Purchase of warrants | 7,048 | |||||||||||||||
Class of warrant or right, exercise | $ 1.32 | $ 5.136 | $ 11.10 | |||||||||||||
Fair value adjustment of warrants | $ 891 | $ 696 | $ 2,533 | |||||||||||||
Modified to exercise price | $ 6 | |||||||||||||||
General and Administrative Expense [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Compensation cost | 807,980 | 2,329,418 | ||||||||||||||
Warrant [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Purchase of warrants | 60,000 | |||||||||||||||
Purchase of warrants | 67,620 | 67,619 | 67,619 | |||||||||||||
Class of warrant or right, exercise | $ 6 | |||||||||||||||
Reverse stock split, price per share | $ 13.20 | |||||||||||||||
Warrants extended date description | June 3, 2023 to September 14, 2023 | |||||||||||||||
Fair value adjustment of warrants | $ 8,548 | |||||||||||||||
Warrant [Member] | Minimum [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Class of warrant or right, exercise | $ 5.136 | $ 11.10 | $ 11.10 | |||||||||||||
Warrant [Member] | Maximum [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Class of warrant or right, exercise | $ 1.32 | $ 5.136 | $ 5.136 | |||||||||||||
Warrant [Member] | General and Administrative Expense [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Fair value adjustment of warrants | $ 67,370 | |||||||||||||||
Additional Paid-in Capital [Member] | Warrant [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Fair value adjustment of warrants | $ 31,010 | |||||||||||||||
Compensatory Warrant Activity [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Compensation cost | $ 0 | 67,370 | ||||||||||||||
Equity Option [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Plan shares available | 445,163 | |||||||||||||||
Equity Option [Member] | 2020 Stock Incentive Plan [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Plan shares available | 310,539 | 147,690 | ||||||||||||||
Options outstanding | 445,163 | 608,012 | ||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Description | 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 | |||||||||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Compensation cost | $ 900,000 | $ 2,700,000 | ||||||||||||||
Compensatory Warrants [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Issuance or sale of equity | $ 4,000,000 | |||||||||||||||
Purchase of warrants | 81,143 | 66,802 | ||||||||||||||
Class of warrant or right, exercise | $ 11.10 | $ 23.40 | ||||||||||||||
Noncompensatory Equity Classified Warrants [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Purchase of warrants | 331,464 | 27,048 | 192,068 | 27,048 | ||||||||||||
Class of warrant or right, exercise | $ 0.01 | $ 20 | $ 52.50 | $ 11.10 | ||||||||||||
Fair value adjustment of warrants | $ 2,300,000 | |||||||||||||||
Warrants exercised | 20,000 | |||||||||||||||
Number of outstanding warrants to purchase, shares | 539,951 | |||||||||||||||
Noncompensatory Equity Classified Warrants [Member] | Warrant [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Class of warrant or right, exercise | $ 11.10 | |||||||||||||||
Series C Warrants [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Class of warrant or right, exercise | $ 7.195 | |||||||||||||||
Alpha Capital [Member] | Noncompensatory Equity Classified Warrants [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Purchase of warrants | 100,000 | 78,019 | ||||||||||||||
Class of warrant or right, exercise | $ 0.10 | $ 0.01 | ||||||||||||||
Alpha Capital [Member] | Noncompensatory Equity Classified Warrants [Member] | Warrant [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Purchase of warrants | 128,783 | |||||||||||||||
Class of warrant or right, exercise | $ 60 | |||||||||||||||
Alpha Capital [Member] | Series C Warrants [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Purchase of warrants | 2,500,000 | |||||||||||||||
Class of warrant or right, exercise | $ 1.65 | |||||||||||||||
Alpha Capital [Member] | Senior Convertible Debenture [Member] | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Senior convertible debenture rate | 8% | |||||||||||||||
Principal amount | $ 3,300,000 | |||||||||||||||
Purchase Price | $ 3,000,000 | |||||||||||||||
Conversion price | $ 1.32 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($) | 3 Months Ended | 17 Months Ended | |||||||
Jan. 12, 2023 | Dec. 22, 2022 | May 26, 2022 | Jun. 30, 2022 | Sep. 02, 2021 | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transaction [Line Items] | |||||||||
Conversion price | $ 1.32 | ||||||||
Short term debt principal outstanding | $ 1,111,078 | ||||||||
Shares of common stock | 841,726 | ||||||||
Short term debt outstanding balance | $ 965,155 | $ 950,722 | |||||||
Accrued interest rate | 8% | ||||||||
Warrants to purchase shares | 60,000 | ||||||||
Warrants exercise price | $ 13.20 | $ 40.70 | |||||||
Stock issued during period value acquisitions | $ 1,844,500 | ||||||||
Pre-funded Warrant [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Warrants to purchase shares | 331,464 | ||||||||
Warrants exercise price | $ 0.001 | ||||||||
Series B Preferred Stock [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued during period shares acquisitions | 381,786 | ||||||||
NanoSynex Ltd [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Business acquisition, voting equity rate | 52.80% | ||||||||
Stock issued during period shares acquisitions | 350,000 | ||||||||
NanoSynex Ltd [Member] | Series A-1 Preferred Stock [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued during period shares acquisitions | 2,232,861 | ||||||||
NanoSynex Ltd [Member] | Series B Preferred Stock [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Stock issued during period shares acquisitions | 381,786 | ||||||||
Stock issued during period value acquisitions | $ 600,000 | ||||||||
Notes Payable [Member] | Nano Synex Ltd [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Short term debt principal outstanding | $ 905,000 | ||||||||
Short term debt outstanding balance | $ 965,155 | ||||||||
Accrued interest rate | 2.62% | ||||||||
Proceeds from related party debt | $ 3,000,000 | ||||||||
Alpha Capital [Member] | Senior Convertible Debenture [Member] | |||||||||
Related Party Transaction [Line Items] | |||||||||
Senior convertible debenture rate | 8% | ||||||||
Principal amount | $ 3,300,000 | ||||||||
Purchase Price | $ 3,000,000 | ||||||||
Conversion price | $ 1.32 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||||
Jul. 20, 2023 | Jul. 13, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Mar. 31, 2024 | Nov. 30, 2023 | Jan. 12, 2023 | Dec. 31, 2022 | |
Subsequent Event [Line Items] | ||||||||||
Research and Development Expense | $ 1,326,544 | $ 1,506,227 | $ 3,448,095 | $ 3,370,972 | ||||||
Cash | $ 5,200,000 | 1,341,659 | 1,341,659 | $ 7,034,434 | ||||||
Escrow | $ 450,000 | $ 450,000 | ||||||||
Aggregrate amount | $ 1,111,078 | |||||||||
Subsequent Event [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Sale of stock price per share | $ 1.5716 | |||||||||
Subsequent Event [Member] | NanoSynex Ltd [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Business acquisition, description of acquired entity | Pursuant to the terms of the NanoSynex Amendment, the Company agreed to advance to NanoSynex an aggregate amount of $1,610,000 as follows: (i) $380,000 within five business days of the execution of the NanoSynex Amendment, (ii) $560,000 on or before November 30, 2023, against which NanoSynex will issue a promissory note to the Company with a face value in the amount of such funding, and (iii) $670,000 on or before March 31, 2024, against which NanoSynex will issue a promissory note to the Company with a face value in the amount of such funding. The NanoSynex Amendment further provides that the initial payment of $380,000 will be satisfied by the Company’s surrender of the 281,000 Preferred B Shares of NanoSynex currently held by the Company, resulting in the Company’s ownership in NanoSynex being reduced from approximately 52.8% to approximately 49.97% of the issued and outstanding voting equity of NanoSynex. | |||||||||
Master Laboratory Services Agreement [Member] | Subsequent Event [Member] | MLM Medical Labs [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Research and Development Expense | $ 7,600,000 | |||||||||
Stock Purchase Agreement [Member] | Subsequent Event [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Cash | $ 5,200,000 | |||||||||
Purchase Price | 5,800,000 | |||||||||
Escrow | 450,000 | |||||||||
Amendment and Settlement Agreement [Member] | Subsequent Event [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Aggregrate amount | 380,000 | |||||||||
Amendment and Settlement Agreement [Member] | Subsequent Event [Member] | NanoSynex Ltd [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Aggregrate amount | $ 1,610,000 | $ 670,000 | $ 560,000 |