Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 11, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
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 $.001 per share | |
Trading Symbol | QLGN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 42,110,182 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash | $ 6,618,141 | $ 17,538,272 |
Accounts receivable, net | 603,291 | 822,351 |
Inventory, net | 1,481,524 | 1,055,878 |
Prepaid expenses and other current assets | 1,692,472 | 1,379,896 |
Total current assets | 10,395,428 | 20,796,397 |
Restricted cash | 5,624 | |
Right-of-use assets | 1,479,618 | 1,645,568 |
Property and equipment, net | 311,531 | 204,216 |
Intangible assets, net | 5,852,074 | 171,190 |
Goodwill | 4,896,223 | |
Other assets | 18,334 | 18,334 |
Total Assets | 22,958,832 | 22,835,705 |
Current liabilities | ||
Accounts payable | 596,039 | 886,224 |
Accrued expenses and other current liabilities | 1,471,327 | 1,793,901 |
R&D grant liability | 905,603 | |
Deferred revenue, current portion | 102,640 | 135,063 |
Operating lease liability, current portion | 198,373 | 134,091 |
Short term debt-related party | 941,261 | |
Warrant liabilities | 666,000 | 1,686,200 |
Total current liabilities | 4,881,243 | 4,635,479 |
Operating lease liability, net of current portion | 1,365,459 | 1,542,564 |
Deferred revenue, net of current portion | 60,521 | 92,928 |
Deferred tax liability | 736,000 | |
Total liabilities | 7,043,223 | 6,270,971 |
Qualigen Therapeutics, Inc. stockholders’ equity: | ||
Common stock, $0.001 par value; 225,000,000 shares authorized; 42,110,182 and 35,290,178 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 42,110 | 35,290 |
Additional paid-in capital | 108,967,248 | 101,274,073 |
Accumulated other comprehensive income | 154,063 | |
Accumulated deficit | (97,012,929) | (84,744,629) |
Total Qualigen Therapeutics, Inc. stockholders’ equity | 12,150,492 | 16,564,734 |
Noncontrolling interest | 3,765,117 | |
Total Stockholders’ Equity | 15,915,609 | 16,564,734 |
Total Liabilities & Stockholders’ Equity | $ 22,958,832 | $ 22,835,705 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
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 outstanding | 42,110,182 | 35,290,178 |
Common stock, shares issued | 42,110,182 | 35,290,178 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Other Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
REVENUES | ||||
Total revenues | $ 1,441,065 | $ 1,155,065 | $ 3,593,628 | $ 4,172,496 |
EXPENSES | ||||
Cost of product sales | 1,278,029 | 993,120 | 3,206,553 | 3,112,224 |
General and administrative | 2,618,021 | 2,756,323 | 8,177,627 | 8,582,361 |
Research and development | 1,688,096 | 2,083,315 | 5,059,067 | 10,091,155 |
Sales and marketing | 239,865 | 130,217 | 683,291 | 402,347 |
Total expenses | 5,824,011 | 5,962,975 | 17,126,538 | 22,188,087 |
LOSS FROM OPERATIONS | (4,382,946) | (4,807,910) | (13,532,910) | (18,015,591) |
OTHER INCOME, NET | ||||
Gain on change in fair value of warrant liabilities | 321,300 | 1,763,936 | 1,019,342 | 4,299,000 |
Interest income, net | 4,631 | 6,801 | 15,763 | 36,863 |
Other income, net | 1,139 | 702 | 795 | 3,596 |
Total other income, net | 327,070 | 1,771,439 | 1,035,900 | 4,339,459 |
LOSS BEFORE PROVISION FOR INCOME TAXES | (4,055,876) | (3,036,471) | (12,497,010) | (13,676,132) |
PROVISION FOR INCOME TAXES | 1,011 | 6,173 | 2,146 | |
Net loss | (4,055,876) | (3,037,482) | (12,503,183) | (13,678,278) |
Net loss attributable to noncontrolling interest | (230,767) | (234,883) | ||
Net loss attributable to Qualigen Therapeutics, Inc. | $ (3,825,109) | $ (3,037,482) | $ (12,268,300) | $ (13,678,278) |
Net loss per common share, basic and diluted | $ (0.10) | $ (0.10) | $ (0.33) | $ (0.48) |
Weighted—average number of shares outstanding, basic and diluted | 39,444,058 | 29,026,211 | 37,154,623 | 28,683,972 |
Other comprehensive loss, net of tax | ||||
Foreign currency translation adjustment | $ 88,523 | $ 154,063 | ||
Other comprehensive loss | (3,967,353) | (3,037,482) | (12,349,120) | (13,678,278) |
Comprehensive loss attributable to noncontrolling interest | (230,767) | (234,883) | ||
Comprehensive loss attributable to Qualigen Therapeutics, Inc. | (3,736,586) | (3,037,482) | (12,114,237) | (13,678,278) |
Net Product Sales [Member] | ||||
REVENUES | ||||
Total revenues | 1,441,065 | 1,155,065 | 3,593,628 | 3,693,842 |
License Revenue [Member] | ||||
REVENUES | ||||
Total revenues | $ 478,654 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock [Member] Series Alpha Convertible Preferred Stock [Member] | 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, 2020 | $ 1 | $ 27,296 | $ 85,114,755 | $ (66,847,492) | $ 18,294,560 | $ 18,294,560 | ||
Beginning balance, shares at Dec. 31, 2020 | 180 | 27,296,061 | ||||||
Stock issued upon cash exercise of warrants | $ 1,320 | 1,813,353 | 1,814,673 | 1,814,673 | ||||
Stock issued upon cash-exercise of warrants, shares | 1,319,625 | |||||||
Net loss | (5,242,719) | (5,242,719) | (5,242,719) | |||||
Stock-based compensation | 1,262,123 | 1,262,123 | 1,262,123 | |||||
Stock issued upon net-exercise of warrants | $ 192 | (192) | ||||||
Stock issued upon net-exercise of warrants, shares | 192,373 | |||||||
Stock issued for professional services | $ 25 | 101,725 | 101,750 | 101,750 | ||||
Stock issued for professional services, shares | 25,000 | |||||||
Ending balance, value at Mar. 31, 2021 | $ 1 | $ 28,833 | 88,291,764 | (72,090,211) | 16,230,387 | 16,230,387 | ||
Ending balance, shares at Mar. 31, 2021 | 180 | 28,833,059 | ||||||
Beginning balance, value at Dec. 31, 2020 | $ 1 | $ 27,296 | 85,114,755 | (66,847,492) | 18,294,560 | 18,294,560 | ||
Beginning balance, shares at Dec. 31, 2020 | 180 | 27,296,061 | ||||||
Net loss | (13,678,278) | |||||||
Foreign currency translation adjustment | ||||||||
Ending balance, value at Sep. 30, 2021 | $ 1 | $ 29,082 | 91,163,805 | (80,525,770) | 10,667,118 | 10,667,118 | ||
Ending balance, shares at Sep. 30, 2021 | 180 | 29,082,069 | ||||||
Beginning balance, value at Mar. 31, 2021 | $ 1 | $ 28,833 | 88,291,764 | (72,090,211) | 16,230,387 | 16,230,387 | ||
Beginning balance, shares at Mar. 31, 2021 | 180 | 28,833,059 | ||||||
Stock issued upon cash exercise of warrants | $ 69 | 142,513 | 142,582 | 142,582 | ||||
Stock issued upon cash-exercise of warrants, shares | 69,129 | |||||||
Net loss | (5,398,077) | (5,398,077) | (5,398,077) | |||||
Stock-based compensation | 1,286,926 | 1,286,926 | 1,286,926 | |||||
Ending balance, value at Jun. 30, 2021 | $ 1 | $ 28,902 | 89,721,203 | (77,488,288) | 12,261,818 | 12,261,818 | ||
Ending balance, shares at Jun. 30, 2021 | 180 | 28,902,188 | ||||||
Stock issued upon cash exercise of warrants | $ 180 | 129,245 | 129,425 | 129,425 | ||||
Stock issued upon cash-exercise of warrants, shares | 179,881 | |||||||
Net loss | (3,037,482) | (3,037,482) | (3,037,482) | |||||
Foreign currency translation adjustment | ||||||||
Stock-based compensation | 1,313,357 | 1,313,357 | 1,313,357 | |||||
Ending balance, value at Sep. 30, 2021 | $ 1 | $ 29,082 | 91,163,805 | (80,525,770) | 10,667,118 | 10,667,118 | ||
Ending balance, shares at Sep. 30, 2021 | 180 | 29,082,069 | ||||||
Beginning balance, value at Dec. 31, 2021 | $ 35,290 | 101,274,073 | (84,744,629) | 16,564,734 | 16,564,734 | |||
Beginning balance, shares at Dec. 31, 2021 | 35,290,178 | |||||||
Stock issued upon cash exercise of warrants | $ 5 | 4,711 | 4,716 | 4,716 | ||||
Stock issued upon cash-exercise of warrants, shares | 5,363 | |||||||
Stock-based compensation | 1,267,166 | 1,267,166 | 1,267,166 | |||||
Net loss | (4,319,787) | (4,319,787) | (4,319,787) | |||||
Ending balance, value at Mar. 31, 2022 | $ 35,295 | 102,545,950 | (89,064,416) | 13,516,829 | 13,516,829 | |||
Ending balance, shares at Mar. 31, 2022 | 35,295,541 | |||||||
Beginning balance, value at Dec. 31, 2021 | $ 35,290 | 101,274,073 | (84,744,629) | 16,564,734 | 16,564,734 | |||
Beginning balance, shares at Dec. 31, 2021 | 35,290,178 | |||||||
Net loss | (12,503,183) | |||||||
Foreign currency translation adjustment | 154,063 | |||||||
Ending balance, value at Sep. 30, 2022 | $ 42,110 | 108,967,248 | 154,063 | (97,012,929) | 12,150,492 | 3,765,117 | 15,915,609 | |
Ending balance, shares at Sep. 30, 2022 | 42,110,182 | |||||||
Beginning balance, value at Mar. 31, 2022 | $ 35,295 | 102,545,950 | (89,064,416) | 13,516,829 | 13,516,829 | |||
Beginning balance, shares at Mar. 31, 2022 | 35,295,541 | |||||||
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 for business acquisition, shares | 3,500,000 | |||||||
Prefunded warrants issued for business acquisition | 1,746,816 | 1,746,816 | 1,746,816 | |||||
Foreign currency translation adjustment | 65,540 | 65,540 | 65,540 | |||||
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 | |||||
Stock-based compensation | 1,423,282 | 1,423,282 | 1,423,282 | |||||
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 | |
Ending balance, shares at Jun. 30, 2022 | 38,795,541 | |||||||
Stock issued upon cash exercise of warrants | $ 3,315 | 3,315 | 3,315 | |||||
Stock issued upon cash-exercise of warrants, shares | 3,314,641 | |||||||
Net loss | (3,825,109) | (3,825,109) | (230,767) | (4,055,876) | ||||
Foreign currency translation adjustment | 88,523 | |||||||
Foreign currency translation adjustment | 88,523 | 88,523 | 88,523 | |||||
Ending balance, value at Sep. 30, 2022 | $ 42,110 | $ 108,967,248 | $ 154,063 | $ (97,012,929) | $ 12,150,492 | $ 3,765,117 | $ 15,915,609 | |
Ending balance, shares at Sep. 30, 2022 | 42,110,182 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
Net loss | $ (4,055,876) | $ (4,319,787) | $ (3,037,482) | $ (5,242,719) | $ (12,503,183) | $ (13,678,278) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 99,661 | 82,404 | |||||
Amortization of right-of-use assets | 165,949 | 166,657 | |||||
Accounts receivable reserves and allowances | 87,370 | 15,295 | |||||
Inventory reserves | 12,417 | 20,040 | |||||
Common stock issued for professional services | 101,750 | ||||||
Stock-based compensation | 4,099,952 | 3,862,406 | |||||
Change in fair value of warrant liabilities | (1,019,342) | (4,299,000) | $ 300,000 | ||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | 203,697 | (33,088) | |||||
Inventory and equipment held for lease | (438,063) | (138,885) | |||||
Prepaid expenses and other assets | (313,166) | 1,077,381 | |||||
Accounts payable | (294,513) | 407,933 | |||||
Accrued expenses and other current liabilities | (539,907) | 1,052,693 | |||||
R&D grant liability | (393,033) | ||||||
Operating lease liability | (112,823) | (187,671) | |||||
Deferred revenue | (64,830) | (267,047) | |||||
Net cash used in operating activities | (11,009,814) | (11,817,410) | 14,700,000 | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
Purchases of property and equipment | (74,743) | (117,463) | |||||
Payments for patents and licenses | (6,893) | ||||||
Net cash acquired in business combination | 135,354 | ||||||
Net cash provided by (used in) investing activities | 60,611 | (124,356) | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Net proceeds from warrant exercises | 7,173 | 423,744 | |||||
Principal payments on notes payable | (138,739) | ||||||
Net cash provided by financing activities | 7,173 | 285,005 | |||||
Net change in cash and restricted cash | (10,942,030) | (11,656,761) | |||||
Effect of exchange rate changes on cash and restricted cash | 27,523 | ||||||
Cash and restricted cash - beginning of period | $ 17,538,272 | $ 23,976,570 | 17,538,272 | 23,976,570 | 23,976,570 | ||
Cash and restricted cash - end of period | 6,623,765 | 12,319,809 | 6,623,765 | 12,319,809 | 17,538,272 | ||
Cash paid during the year for: | |||||||
Interest | 1,233 | ||||||
Taxes | 3,501 | 2,200 | |||||
NONCASH FINANCING AND INVESTING ACTIVITIES: | |||||||
Net transfers from equipment held for lease to inventory | 1,304 | ||||||
Fair value of shares issued for cashless warrant exercises | 722,970 | ||||||
Fair value of warrant liabilities on date of exercise | 858 | 1,841,900 | |||||
ACQUISITION: | |||||||
Fair value of assets acquired | (5,896,278) | ||||||
Fair value of liabilities assumed, net of goodwill | 2,439,620 | ||||||
Fair value of Alpha Capital/Qualigen warrants repriced due to acquisition | 696 | ||||||
Fair value of Qualigen prefunded warrant issued in exchange for NanoSynex stock | 1,746,816 | ||||||
Fair value of Qualigen common stock issued in exchange for NanoSynex stock | 1,844,500 | ||||||
Net cash acquired in business combination (Note 3) | 135,354 | ||||||
Cash and restricted cash included in the accompanying balance sheet was as follows: | |||||||
Cash | 6,618,141 | 12,319,809 | 6,618,141 | 12,319,809 | 17,538,272 | ||
Restricted cash | 5,624 | 5,624 | |||||
Total cash and restricted cash | $ 6,623,765 | $ 12,319,809 | $ 6,623,765 | $ 12,319,809 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES | 9 Months Ended |
Sep. 30, 2022 | |
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., now a subsidiary of Qualigen Therapeutics, Inc., was incorporated in Minnesota in 1996 to design, develop, manufacture and sell Physician Office Laboratory (“POL”) market quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. In May 2020, Qualigen, Inc. completed a reverse recapitalization transaction with Ritter Pharmaceuticals, Inc. (“Ritter”) and Ritter was renamed Qualigen Therapeutics, Inc. All shares of Qualigen, Inc.’s capital stock were exchanged for Qualigen Therapeutics, Inc.’s capital stock in the merger. Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,” commenced trading on the Nasdaq Capital Market, on a post-reverse-stock-split adjusted basis, under the trading symbol “QLGN” on May 26, 2020. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. . On May 26, 2022, the Company acquired 2,232,861 3,500,000 3,314,641 0.001 381,786 600,000 52.8 Basis of Presentation The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules of the Securities and Exchange Commission (“SEC”) applicable to interim reports of companies filing as a smaller reporting company. These financial statements should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities Exchange Commission on March 31, 2022, as amended on April 29, 2022 (the “2021 Annual Report”). In the opinion of management, the accompanying condensed consolidated interim financial statements include all adjustments necessary in order to make the financial statements not misleading. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year or any other future period. Certain notes to the financial statements that would substantially duplicate the disclosures contained in the audited financial statements for the most recent fiscal year as reported in the Company’s 2021 Annual Report have been omitted. The accompanying condensed consolidated balance sheet at December 31, 2021 has been derived from the audited balance sheet at December 31, 2021 contained in the 2021 Annual Report. 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 unaudited condensed 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. Cash, cash equivalents and restricted 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 its cash in bank deposits which exceed federally insured limits and could potentially be subject to significant concentrations of credit risk on cash. The Company reviews the financial stability of its depository institutions on a regular basis, and has not experienced any losses in such accounts. 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. 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 nine months ended September 30, 2022 and 2021, no 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 September 30, December 31, 2022 2021 Accounts Receivable $ 763,766 $ 1,070,196 Less Allowances (160,475 ) (247,845 ) Accounts receivable, net $ 603,291 $ 822,351 Research and Development Except for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including therapeutics license costs. 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. 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 $ 91,000 29,000 and approximately $ 201,000 88,000 4,000 3,000 and approximately $ 12,000 8,000 Revenue from Contracts with Customers We apply 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 (“PSA”), testosterone, thyroid disorders, pregnancy, and Vitamin D. The Company provides disposable products and equipment in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposable products and equipment at the agreed upon prices in the invoice. Generally, customers purchase disposable products using separate purchase orders after the equipment (“analyzer”) has been provided to the customer. The initial delivery of the equipment and reagent packs represents a single performance obligation and is completed upon receipt by the customer. The delivery of each subsequent individual reagent pack represents a separate performance obligation because the reagent packs are standardized, are not interrelated in any way, and the customer can benefit from each reagent pack without any other product. There are no significant discounts, rebates, returns or other forms of variable consideration. Customers are generally required to pay within 30 days. The performance obligation arising from the delivery of the equipment is satisfied upon the delivery of the equipment to the customer. The disposable products are shipped Free on Board (“FOB”) shipping point. For disposable products that are shipped FOB shipping point, the customer has the significant risks and rewards of ownership and legal title to the assets when the disposable products leave the Company’s shipping facilities, thus the customer obtains control and revenue is recognized at that point in time. The Company has elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation. The Company’s contracts with customers generally have an expected duration of one year or less, and therefore the Company has elected the practical expedient in ASC 606 to not disclose information about its remaining performance obligations. Any incremental costs to obtain contracts are recorded as selling, general and administrative expense as incurred due to the short duration of the Company’s contracts. License Revenue The Company enters into out-license agreements with counterparties to develop and/or commercialize its products in exchange for nonrefundable upfront license fees and/or sales-based royalties. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from nonrefundable upfront fees allocated to the license when the license is transferred to the customer and the customer can benefit from the license. For licenses that are bundled with other performance obligations, management uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. During the three months ended September 30, 2022 and 2021, the Company recognized no license revenue, and during the nine months ended September 30, 2022 and 2021, the Company recognized license revenue of $ 0 479,000 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 September 30, 2022 and 2021, product sales are stated net of an allowance for estimated returns of approximately $ 56,000 0 109,000 1,000 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 years Computer equipment 3 years Molds and tooling 5 years Furniture and fixtures 5 years Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or their estimated useful lives. The Company occasionally designs and builds its own machinery. The costs of these projects, which include 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 dates, 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. 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 (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 (loss). Depending on the features of the derivative financial instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (See Note 10- Warrant Liabilities). 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. 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 $ 137,000 60,000 91,000 28,000 41,000 72,000 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 $ 88,523 Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) Leases (Topic 842) Global Economic Conditions Russia’s Invasion of Ukraine In February 2022, Russia invaded Ukraine. While the Company has limited exposure in Russia and Ukraine, the Company continues to monitor any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the conflict and its impact on regional and global economic conditions. Inflationary Cost Environment During fiscal 2021 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. Ongoing COVID-19 Pandemic The COVID-19 pandemic has had a dramatic impact on businesses globally and our business as well. Our sales of diagnostic products fell significantly during 2020 and our net loss increased significantly, as deferral of patients’ non-emergency visits to physician offices, clinics and small hospitals sharply reduced demand for FastPack tests. Since then we have experienced some recovery in demand. To mitigate risks, we continue to evaluate the extent to which COVID-19 may impact our business and operations and adjust risk mitigation planning and business continuity activities as needed. Other accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s unaudited condensed financial statements. |
LIQUIDITY AND GOING CONCERN
LIQUIDITY AND GOING CONCERN | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY AND GOING CONCERN | NOTE 2 — LIQUIDITY AND GOING CONCERN As of September 30, 2022, the Company had approximately $ 6.6 97.0 11.0 14.7 As a pre-clinical development-stage therapeutics biotechnology company, we expect to continue to have net losses and negative cash flow from operations, which over time will challenge our liquidity. 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 our business plan, we will require significant additional financing for planned research and development activities, capital expenditures, clinical and pre-clinical testing for QN-302 clinical trials, to continue preclinical development of RAS and QN-247, and to continue funding the NanoSynex operations (See Note 3-Acquisition), as well as commercialization activities. Historically, the Company’s principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds from the issuance of debt. In December 2021, the Company raised $ 8.82 As a condition to the NanoSynex closing, the Company agreed to provide NanoSynex with up to $ 10.4 the Company with a face value equal to the amount paid by the Company to NanoSynex upon satisfaction of the applicable performance milestone, bearing interest at the rate of 9% per annum on the principal balance from time to time outstanding under the particular promissory note, convertible at the option of the Company into additional shares of NanoSynex in order for the Company to maintain at least a 50.1% controlling ownership interest in NanoSynex, should NanoSynex issue additional shares. The principal of the convertible notes are due and payable upon the sooner to occur of: i) five years from the date of issuance of the particular promissory note 1.5 To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our 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 we raise 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, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. 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. |
ACQUISITION
ACQUISITION | 9 Months Ended |
Sep. 30, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
ACQUISITION | NOTE 3 — ACQUISITION Business Combination The Company acquired a 52.8 2,232,861 3,500,000 3,314,641 0.001 381,786 600,000 The acquisition of the majority interest of NanoSynex was accounted for as a business combination using the acquisition method, in accordance with FASB ASC Topic 805. A summary of the consideration transferred and provisional fair value of assets acquired and liabilities assumed in the NanoSynex acquisition is as follows: SCHEDULE OF CONSIDERATION TRANSFERRED Consideration transferred, net of cash acquired Cash paid for NanoSynex preferred stock: $ 600,000 Purchase of NanoSynex preferred stock: Price per share of Qualigen Stock on May 26, 2022 $ 0.527 FMV of 3,500,000 $ 1,844,500 FMV of 3,314,641 $ 1,746,816 Total consideration paid for NanoSynex preferred stock $ 3,591,316 FMV of consideration related to related to repricing of 70,478 $ 696 NanoSynex cash acquired (735,354 ) Total consideration transferred, net of cash acquired $ 3,456,658 * See disclosure under Noncompensatory Equity Classified Warrants regarding May 26, 2022 transaction-Note 14-Stockholders’ Equity SCHEDULE OF ASSETS ACQUIRED AND LIABILITIES Purchase Price Allocation Accounts receivable $ 75,336 Property and equipment 120,942 In process R&D 5,700,000 Accounts payable (4,588 ) Accrued expenses and other payables (291,093 ) R&D grant liability (1,362,264 ) Short term debt (941,898 ) Deferred tax liability (736,000 ) Noncontrolling interest assumed (4,000,000 ) Identifiable net assets acquired (1,439,565 ) Goodwill 4,896,223 Total consideration transferred, net of cash acquired $ 3,456,658 The purchase accounting adjustments are preliminary and subject to revision within the measurement period provided by ASC Topic 805. Qualigen transaction costs, which were immaterial, have been expensed as incurred and charged to the Company’s consolidated statements of operations and other comprehensive loss. There was no provision for reimbursement of transaction costs from Qualigen to NanoSynex. Goodwill represents the excess of the purchase price over the fair value of the net assets acquired as of the acquisition date. Goodwill represents the value of the future technology to be developed in excess of the identifiable assets as well as the operational synergies of the combined companies to be recognized. Goodwill has an indefinite useful life and is not amortized. As a condition to the closing, the Company agreed to provide NanoSynex with up to $ 10.4 The Company’s condensed consolidated statement of operations and other comprehensive loss for three and nine months ended September 30, 2022 include $ 488,914 497,636 The following pro forma information has been prepared as if the NanoSynex acquisition occurred on January 1, 2021. The following unaudited supplemental pro forma consolidated results do not purport to reflect what the combined Company’s results of operations would have been, nor do they project the future results of operations of the combined Company. The unaudited supplemental pro forma consolidated results reflect the historical financial information of Qualigen and NanoSynex, adjusted to give effect to the NanoSynex acquisition as if it had occurred on January 1, 2021, as well as to record NanoSynex stock compensation expense and to record the net loss related to the noncontrolling interest, in accordance with generally accepted accounting principles: SCHEDULE OF PRO FORMA INFORMATION Consolidated Pro Forma Financial Results for the Nine Months Ending September 30, September 30, 2022 2021 Net revenue $ 3,593,628 $ 4,172,496 Net loss attributable to Qualigen Therapeutics, Inc. $ (12,748,015 ) $ (14,026,542 ) |
INVENTORY, NET
INVENTORY, NET | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
INVENTORY, NET | NOTE 4 — INVENTORY, NET Inventory, net consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF INVENTORY September 30, 2022 December 31, 2021 Raw materials $ 1,023,263 $ 823,315 Work in process 228,882 188,135 Finished goods 229,379 44,428 Total inventory $ 1,481,524 $ 1,055,878 |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expenses And Other Current Assets | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | NOTE 5 — PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS September 30, December 31, 2022 2021 Prepaid insurance $ 1,564,161 $ 1,197,726 Prepaid manufacturing expenses 38,056 67,410 Other prepaid expenses 90,255 114,760 Prepaid expenses and other current assets $ 1,692,472 $ 1,379,896 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 6 — PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF PROPERTY AND EQUIPMENT September 30, December 31, 2022 2021 Machinery and equipment $ 2,506,367 $ 2,482,841 Computer equipment 506,034 345,117 Leasehold improvements 333,271 333,271 Molds and tooling 260,002 260,002 Furniture and fixtures 144,832 143,013 Equipment held for lease, net 74 296 Property and equipment, gross 3,750,580 3,564,540 Accumulated depreciation (3,439,049 ) (3,360,324 ) Property and equipment, net $ 311,531 $ 204,216 Depreciation expense relating to property and equipment was approximately $ 24,000 19,000 and $ 72,000 51,000 |
GOODWILL, IPR&D AND OTHER INTAN
GOODWILL, IPR&D AND OTHER INTANGIBLES | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
GOODWILL, IPR&D AND OTHER INTANGIBLES | NOTE 7 — GOODWILL, IPR&D AND OTHER INTANGIBLES SCHEDULE OF GOODWILL AND OTHER INTANGIBLE September 30, December 31, 2022 2021 Estimated Useful Lives Gross carrying amounts Gross carrying amounts Goodwill $ 4,896,223 $ - Finite-lived intangible assets: Developed-product-technology rights 8 17 479,103 479,103 Licensing rights 10 years 418,836 418,836 Less: Accumulated amortization (745,865 ) (726,749 ) Total finite-lived intangible assets, net 152,074 171,190 Indefinite-lived intangible assets: In-process research and development 5,700,000 — Total other intangible assets, net $ 5,852,074 $ 171,190 The carrying value of the patents of approximately $ 145,000 159,000 334,000 320,000 5,000 and for the nine months ended September 30, 2022 and 2021 was approximately $ 14,000 12,000 5,000 18,000 15,000 14,000 The carrying value of the in-licenses of approximately $ 7,000 12,000 412,000 407,000 nd amortization of licenses charged to both the three months ended September 30, 2022 and 2021 was 2,000 of licenses charged to operations for both the nine months ended September 30, 2022 and 2021 was approximately $ 5,000 2,000 5,000 |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | NOTE 8 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES September 30, December 31, 2022 2021 Board compensation $ 26,500 $ 17,500 Franchise, sales and use taxes 22,685 14,090 Income taxes 4,356 3,620 Payroll 225,270 682,036 Professional fees 76,555 225,308 Research and development 210,419 232,712 Royalties 13,009 10,152 Vacation 439,324 282,910 Warranty liability 137,293 60,281 Other 315,916 265,292 Accrued liabilities $ 1,471,327 $ 1,793,901 |
SHORT TERM DEBT-RELATED PARTY
SHORT TERM DEBT-RELATED PARTY | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
SHORT TERM DEBT-RELATED PARTY | NOTE 9 – SHORT TERM DEBT-RELATED PARTY NanoSynex has four separate Notes Payable (the “Notes”) outstanding to Alpha Capital, dated between March 26, 2020 and September 2, 2021, aggregating to a total principal outstanding balance of $ 905,000 36,261 941,261 2.62 3,000,000 |
WARRANT LIABILITIES
WARRANT LIABILITIES | 9 Months Ended |
Sep. 30, 2022 | |
Warrant Liabilities | |
WARRANT LIABILITIES | NOTE 10 – WARRANT LIABILITIES In 2004, the Company issued warrants to various investors and brokers for the purchase of Series C preferred stock in connection with a private placement (the “Series C Warrants”). The Series C Warrants were subsequently extended and, upon closing of the reverse recapitalization transaction with Ritter, exchanged for warrants to purchase common stock of the Company, pursuant to the Series C Warrant terms as adjusted. In exchange for the Series C Warrants, upon closing of the merger with Ritter, the holders received warrants to purchase an aggregate of 4,713,490 0.72 1.15 1.74 0.7195 0.60 493,187 0.60 0.5136 499,520 2,476,251 3,468,958 0.5136 The following table summarizes the activity in the Common Stock Warrants (received in exchange for the Series C Warrants) for the nine months ended September 30, 2022: SCHEDULE OF WARRANTS ACTIVITY Common Stock Warrants (received in exchange for the Shares Weighted– Range of Exercise Weighted– Total outstanding – December 31, 2021 2,481,614 $ 0.72 2.00 Exercised (5,363 ) 0.72 Forfeited (2,476,251 ) 0.72 Expired — — Granted 3,468,958 0.51 Total outstanding – September 30, 2022 3,468,958 $ 0.51 Exercisable 3,468,958 $ 0.51 $ 0.51 1.26 The following table summarizes the activity in the Common Stock Warrants (received in exchange for the Series C Warrants) activity for the nine months ended September 30, 2021: Common Stock Warrants (received in exchange for the Shares Weighted– Average Range of Exercise Weighted– Total outstanding –December 31, 2020 3,378,596 $ 0.72 Exercised (722,618 ) 0.72 Forfeited (36,097 ) 0.72 Expired — — Granted — — Total outstanding – September 30, 2021 2,619,881 $ 0.72 Exercisable 2,619,881 $ 0.72 $ 0.72 2.25 The following table presents the Company’s fair value hierarchy for its warrant liabilities and exercises (all of which arise under the warrants received in exchange for the Series C Warrants) measured at fair value on a recurring basis using Level 3 inputs as of September 30, 2022: SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES Quoted Market Significant Prices for Other Significant Identical Observable Unobservable Assets Inputs Inputs Common Stock Warrant liabilities (Level 1) (Level 2) (Level 3) Total Balance as of December 31, 2021 $ — $ — $ 1,686,200 $ 1,686,200 Exercises — — (858 ) (858 ) Gain on change in fair value of warrant liabilities — — (1,019,342 ) (1,019,342 ) Balance as of September 30, 2022 $ — $ — $ 666,000 $ 666,000 There were no transfers of financial assets or liabilities between category levels for the three and nine months ended September 30, 2022. The value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo simulation. For volatility, the Company considers comparable public companies as a basis for its expected volatility to calculate the fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate history as a public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term of the common stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly higher or lower fair value measurements. The following table shows the range of assumptions used in estimating the fair value of warrant liabilities as of September 30, 2022 and 2021: SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES September 30, 2022 September 30, 2021 Range Weighted Average Range Weighted Average Risk-free interest rate 3.99 4.09 4.01 % 0.31 0.46 0.34 % Expected volatility (peer group) 91 93 92 % 82 86 85 % Term of warrants (in years) 1.14 1.74 1.26 2.14 2.74 2.25 Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % |
LOSS PER SHARE
LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE | NOTE 11 — 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 table reconciles net loss and the weighted-average shares used in computing basic and diluted EPS in the respective periods: SCHEDULE OF EARNINGS PER SHARE BASIC AND DILUTED For the Three Months Ended For the Three Months Ended For the Nine Months Ended For the Nine Months Ended 2022 2021 2022 2021 Net loss used for basic earnings per share $ (3,825,109 ) $ (3,037,482 ) $ (12,268,300 ) $ (13,678,278 ) Basic weighted-average common shares outstanding 39,444,058 29,026,211 37,154,623 28,683,972 Dilutive potential shares issuable from stock options and warrants — — — — Diluted weighted-average common shares outstanding 39,444,058 29,026,211 37,154,623 28,683,972 The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2022 and 2021 because their effect would be antidilutive: SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE As of September 30, As of September 30, 2022 2021 Shares of common stock subject to outstanding options 6,071,750 4,133,856 Shares of common stock subject to outstanding warrants 10,808,739 9,360,302 Shares of common stock subject to conversion of Series Alpha Convertible Preferred Stock — 243,418 Total common stock equivalents 16,880,489 13,737,576 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2022 | |
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 1,950,710 335,966 339,360 The tables below show the operating lease right-of-use assets and operating lease liabilities as of September 30, 2022, including the changes during the periods: SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES Operating lease right-of-use assets Net right-of-use assets at December 31, 2021 $ 1,645,568 Less amortization of operating lease right-of-use assets (165,950 ) Operating lease right-of-use assets at September 30, 2022 $ 1,479,618 Operating lease liabilities Lease liabilities at December 31, 2021 $ 1,676,655 Less principal payments on operating lease liabilities (112,823 ) Lease liabilities at September 30, 2022 1,563,832 Less non-current portion (1,365,459 ) Current portion at September 30, 2022 $ 198,373 As of September 30, 2022, the Company’s operating leases have a weighted-average remaining lease term of 5.2 8.9 As of September 30, 2022, 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 2022 (three months) $ 55,721 2023 368,341 2024 379,392 2025 390,773 2026 402,497 2027 379,165 Total 1,975,889 Less present value discount (412,056 ) Operating lease liabilities $ 1,563,832 Total lease expense was approximately $ 114,000 83,000 348,000 255,000 Termination of Sekisui Distribution Agreement In March 2018, the Company extended a strategic partnership entered into in May 2016 with Sekisui Diagnostics, LLC (“Sekisui”). The Company appointed Sekisui as its diagnostics commercial partner and exclusive worldwide distributor with the exception of certain customer accounts retained by Qualigen; Sekisui’s distribution arrangement expired on March 31, 2022. Subsequent to the expiration of the agreement, the Company has a a commitment to purchase leased FastPack rental systems back from Sekisui at Sekisui’s net book value, the amount of which has not yet been determined. NanoSynex Funding Commitment As a condition to the closing, the Company agreed to provide NanoSynex with up to $ 10.4 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 |
RESEARCH AND LICENSE AGREEMENTS
RESEARCH AND LICENSE AGREEMENTS | 9 Months Ended |
Sep. 30, 2022 | |
Research And License Agreements | |
RESEARCH AND LICENSE AGREEMENTS | NOTE 13 — RESEARCH AND LICENSE AGREEMENTS The University of Louisville Research Foundation In March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with University of Louisville Research Foundation (“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, and (iv) payments ranging from $ 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 this agreement for the three months ended September 30, 2022 and 2021 were approximately $ 196,000 264,000 601,000 469,000 27,000 18,000 44,000 58,000 Between June 2018 and April 2022, the Company entered into license and sponsored research agreements with ULRF for QN-247, a novel aptamer-based compound that has shown promise as an anticancer drug. Under the agreements, the Company will take 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 this agreement for the three months ended September 30, 2022 and 2021 were $ 0 83,000 164,000 235,000 5,000 50,000 74,000 103,000 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, 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 The license agreement with ULRF for its intellectual property in the use of QN-165 as a treatment for COVID-19 was terminated effective October 31, 2022. Sponsored research expenses related to this agreement for the three months ended September 30, 2022 and 2021 were $ 0 12,000 0 106,000 0 11,000 0 27,000 Advanced Cancer Therapeutics In December 2018, the Company entered into a license agreement with Advanced Cancer Therapeutics, LLC (“ACT”), granting the Company exclusive rights to develop and commercialize QN-165, an aptamer-based drug candidate. In return, ACT received a $ 25,000 In addition, the Company agreed to pay ACT (i) royalties, on net sales associated with the commercialization of QN-165, of 2% (only if patent-covered and only on net sales above a cumulative $3,000,000) or 1% (if not patent-covered, but only on net sales above a cumulative $3,000,000), until the 15th anniversary of the ACT license agreement and (ii) milestone payments of $100,000 for the Company raising a cumulative total of $2,000,000 in new equity financing after the date of the ACT license agreement, $100,000 upon any first QN-165-based licensed product receiving the CE Mark or similar FDA status, and $500,000 upon cumulative worldwide QN-165-based licensed product net sales reaching $3,000,000 no , and for the nine months ended September 30, 2022 and 2021, there were $ 0 2,000 respectively, related to this agreement which are included in research and development expenses in the condensed consolidated statements of operations and other comprehensive loss. 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. For both the three and nine months ended September 30, 2022 and 2021, there was no Sekisui Diagnostics In March 2018, the Company extended a strategic partnership entered into in May 2016 with Sekisui. The Company appointed Sekisui as its diagnostics commercial partner and exclusive worldwide distributor with the exception of certain customer accounts retained by Qualigen. Sekisui’s distribution arrangement expired on March 31, 2022. Under the terms of the arrangement, there were product sales to Sekisui of $ 0 810,000 403,000 2.5 Yi Xin In October 2020, 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 authorized Yi Xin to manufacture and sell the Company’s current generations of FastPack System diagnostic products (1.0, IP and PRO) in China. The Company will receive low- to mid-single-digit royalties on any future new-generations and current-generations product sales by Yi Xin. The Company recognized $ 0 38,000 0 479,000 The Company gave Yi Xin the exclusive rights for China – which is a market the Company has not otherwise entered – both for Yi Xin’s new generations of FastPack-based products and for Yi Xin-manufactured versions of the Company’s existing FastPack product lines. Yi Xin will also have 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-U.S. customers of those products), as well as the right to buy Company-manufactured FastPack 1.0, IP and PRO products from the Company 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 it would not, after March 31, 2022, seek new FastPack customers outside the United States. STA Pharmaceutical In November 2020, the Company entered into a contract with STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, for Good Manufacturing Practice production of QN-165, which was the Company’s lead drug candidate for the treatment of COVID-19 and other viral diseases, for potential clinical trials in 2021. Research and development expenses related to this agreement for the three months ended September 30, 2022 and 2021 were $ 0 118,000 and for the nine months ended September 30, 2022 and 2021 were 9,000 3.2 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 September 30, 2022 and 2021, there were license costs of $ 0 310,000 0 |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 14 — STOCKHOLDERS’ EQUITY As of September 30, 2022 and December 31, 2021, the Company had two classes of authorized capital stock: common stock and Series Alpha convertible 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, as of September 30, 2022 any remaining assets would be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of Series Alpha convertible 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. At September 30, 2022, the Company has reserved 16,880,489 At September 30, 2022, shares were reserved in connection with the following: SCHEDULE OF RESERVED SHARES Exercise of issued and future grants of stock options 6,071,750 Exercise of stock warrants 10,808,739 Total 16,880,489 Series Alpha Convertible Preferred Stock As of September 30, 2022 and December 31, 2021, there were no Stock Options and Warrants 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 September 30, 2022 and December 31, 2021 there were 6,071,750 4,748,000 1,485,407 2,809,157 3,500,000 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 September 30, 2022, and changes during the nine month period then ended: SCHEDULE OF STOCK OPTION ACTIVITY Shares Weighted– Range of Weighted– Total outstanding – December 31, 2021 4,841,856 $ 6.07 $ 1.24 1,465.75 8.52 Granted 1,329,750 0.51 0.51 1.05 9.77 Expired (93,856 ) 93.59 5.75 1,465.75 — Forfeited (6,000 ) 3.55 1.24 4.97 — Total outstanding – September 30, 2022 6,071,750 $ 3.51 $ 0.51 5.13 8.33 Exercisable (vested) 2,660,163 $ 4.84 $ 1.24 5.13 7.76 Non-Exercisable (non-vested) 3,411,587 $ 3.68 $ 0.51 5.13 8.82 There was approximately $ 4.0 3.9 4.7 1.07 Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2020 4,011,356 $ 7.05 $ 3.52 1,465.75 9.29 Granted 127,000 2.12 1.80 3.29 9.58 Expired — — — — Forfeited (4,500 ) 3.68 3.52 4.97 — Total outstanding – September 30, 2021 4,133,856 $ 6.90 $ 1.80 1,465.75 8.57 Exercisable (vested) 1,314,194 $ 11.41 $ 3.52 1,465.75 8.12 Non-Exercisable (non-vested) 2,819,662 $ 4.80 $ 1.80 5.13 8.79 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 0.40 Fair Value of Equity Awards The Company utilizes the Black-Scholes option pricing model to value awards under its 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 ASSUMPTIONS USED IN BLACK-SCHOLES OPTION-PRICING METHOD For the Nine Months Ended September 30, 2022 2021 Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility 103 % 102 % Risk-free interest rate 1.58% 3.03% 0.84% 1.18% Expected average term of options (in years) 6.00 6.00 Stock price $ 0.52 $ 2.12 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 2022 2021 For the Nine Months 2022 2021 General and administrative $ 3,522,108 $ 3,329,310 Research and development 577,844 533,096 Total $ 4,099,952 $ 3,862,406 Equity Classified Compensatory Warrants In connection with the $ 4.0 811,431 1.11 In addition, various service providers hold equity classified compensatory warrants issued in 2017 and earlier (originally exercisable to purchase Series C convertible preferred stock, and now instead exercisable to purchase common stock) for the purchase of 668,024 2.34 During the year ended December 31, 2021, the Company issued equity classified compensatory warrants to a service provider for the purchase of 600,000 1.32 0.3 On April 25, 2022, 600,000 1.32 0.60 June 3, 2023 to September 14, 2023 67,370 676,194 1.11 0.5136 31,010 No compensatory warrants were issued during the nine months ended September 30, 2022. The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2022: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Range of Weighted– Total outstanding – December 31, 2021 1,790,648 $ 1.52 $ 1.11 2.54 2.64 Granted to advisor and its designees — — Exercised — — Expired — — Forfeited — — Total outstanding – September 30, 2022 1,790,648 $ 1.06 $ 0.5136 2.54 1.98 Exercisable 1,790,648 $ 1.06 $ 0.5136 2.54 1.98 Non-Exercisable — $ — $ — — The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2021: Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2020 1,294,217 $ 1.66 Granted — — Exercised (38,390 ) 2.09 Expired — — Forfeited (65,179 ) 2.07 Total outstanding – September 30, 2021 1,190,648 $ 1.62 Exercisable 1,190,648 $ 1.62 $ 1.11 2.54 3.50 Non-Exercisable - - - - There were $ 67,370 0 Noncompensatory Equity Classified Warrants In May 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to an investor for the purchase of 270,478 1.11 200,000 780,198 0.001 1,920,678 5.25 1,287,829 6.00 1,000,000 0.01 2,191,010 4.07 3,314,641 0.001 During the year ended December 31, 2021, with the exception of the warrants to purchase 270,478 1.11 5,399,517 2.00 2.3 3,314,641 0.001 In conjunction with the NanoSynex acquisition, on April 25, 2022 the exercise price of 70,478 1.11 0.60 2,533 0.5136 696 included in consideration transferred in the NanoSynex acquisition (See Note 3-Acquisition). The following table summarizes the noncompensatory equity classified warrant activity for the nine months ended September 30, 2022: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2021 5,549,137 $ 2.01 Granted 3,314,641 0.001 0.001 Exercised (3,314,641 ) 0.001 0.001 Expired — — Forfeited — — Total outstanding – September 30, 2022 5,549,137 2.01 Exercisable 5,549,137 $ 2.01 $ 0.51 3.77 0.57 Non-Exercisable — $ — $ — — |
QUARTERLY FINANCIAL DATA (UNAUD
QUARTERLY FINANCIAL DATA (UNAUDITED) | 9 Months Ended |
Sep. 30, 2022 | |
Quarterly Financial Information Disclosure [Abstract] | |
QUARTERLY FINANCIAL DATA (UNAUDITED) | NOTE 15 - QUARTERLY FINANCIAL DATA (UNAUDITED) the 2021 Annual Report, the Company’s management identified an error in the previously issued March 31, 2021, June 30, 2021 and September 30, 2021 unaudited interim condensed consolidated financial statements in which the fair value of the Company’s exercised liability classified warrants had been inadvertently excluded from reclassification into shareholders’ equity. All financial information contained in the accompanying notes to these condensed consolidated financial statements has been revised to reflect the correction of this error as shown in the table below. SCHEDULE OF ERROR CORRECTIONS AND PRIOR PERIOD ADJUSTMENTS As reported Corrected As reported Corrected For the Quarter For the Nine Months As reported Corrected As reported Corrected Gain on change in fair value of warrant liabilities $ (1,942,900 ) $ (1,763,936 ) $ (6,140,900 ) $ (4,299,000 ) Net loss $ (2,858,518 ) $ (3,037,482 ) $ (11,836,378 ) $ (13,678,278 ) Net loss per common share $ (0.10 ) $ (0.10 ) $ (0.41 ) $ (0.48 ) |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 16 — SUBSEQUENT EVENTS On October 28, 2022, the Company held its reconvened 2022 annual meeting of stockholders, and the stockholders approved Proposal 4, a proposal to approve an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended, to effect a reverse stock split of the outstanding shares of the Company’s common stock, at a ratio within a range of 1-for-5 to 1-for-10, as determined by the Company’s board of directors. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Qualigen, Inc., now a subsidiary of Qualigen Therapeutics, Inc., was incorporated in Minnesota in 1996 to design, develop, manufacture and sell Physician Office Laboratory (“POL”) market quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. In May 2020, Qualigen, Inc. completed a reverse recapitalization transaction with Ritter Pharmaceuticals, Inc. (“Ritter”) and Ritter was renamed Qualigen Therapeutics, Inc. All shares of Qualigen, Inc.’s capital stock were exchanged for Qualigen Therapeutics, Inc.’s capital stock in the merger. Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,” commenced trading on the Nasdaq Capital Market, on a post-reverse-stock-split adjusted basis, under the trading symbol “QLGN” on May 26, 2020. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. . On May 26, 2022, the Company acquired 2,232,861 3,500,000 3,314,641 0.001 381,786 600,000 52.8 |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules of the Securities and Exchange Commission (“SEC”) applicable to interim reports of companies filing as a smaller reporting company. These financial statements should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the Securities Exchange Commission on March 31, 2022, as amended on April 29, 2022 (the “2021 Annual Report”). In the opinion of management, the accompanying condensed consolidated interim financial statements include all adjustments necessary in order to make the financial statements not misleading. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year or any other future period. Certain notes to the financial statements that would substantially duplicate the disclosures contained in the audited financial statements for the most recent fiscal year as reported in the Company’s 2021 Annual Report have been omitted. The accompanying condensed consolidated balance sheet at December 31, 2021 has been derived from the audited balance sheet at December 31, 2021 contained in the 2021 Annual Report. |
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 unaudited condensed 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. |
Cash, cash equivalents and restricted cash | Cash, cash equivalents and restricted 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 its cash in bank deposits which exceed federally insured limits and could potentially be subject to significant concentrations of credit risk on cash. The Company reviews the financial stability of its depository institutions on a regular basis, and has not experienced any losses in such accounts. |
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. |
Long-Lived Assets | 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 nine months ended September 30, 2022 and 2021, no |
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 September 30, December 31, 2022 2021 Accounts Receivable $ 763,766 $ 1,070,196 Less Allowances (160,475 ) (247,845 ) Accounts receivable, net $ 603,291 $ 822,351 |
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 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. |
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 $ 91,000 29,000 and approximately $ 201,000 88,000 4,000 3,000 and approximately $ 12,000 8,000 |
Revenue from Contracts with Customers | Revenue from Contracts with Customers We apply 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 (“PSA”), testosterone, thyroid disorders, pregnancy, and Vitamin D. The Company provides disposable products and equipment in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposable products and equipment at the agreed upon prices in the invoice. Generally, customers purchase disposable products using separate purchase orders after the equipment (“analyzer”) has been provided to the customer. The initial delivery of the equipment and reagent packs represents a single performance obligation and is completed upon receipt by the customer. The delivery of each subsequent individual reagent pack represents a separate performance obligation because the reagent packs are standardized, are not interrelated in any way, and the customer can benefit from each reagent pack without any other product. There are no significant discounts, rebates, returns or other forms of variable consideration. Customers are generally required to pay within 30 days. The performance obligation arising from the delivery of the equipment is satisfied upon the delivery of the equipment to the customer. The disposable products are shipped Free on Board (“FOB”) shipping point. For disposable products that are shipped FOB shipping point, the customer has the significant risks and rewards of ownership and legal title to the assets when the disposable products leave the Company’s shipping facilities, thus the customer obtains control and revenue is recognized at that point in time. The Company has elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation. The Company’s contracts with customers generally have an expected duration of one year or less, and therefore the Company has elected the practical expedient in ASC 606 to not disclose information about its remaining performance obligations. Any incremental costs to obtain contracts are recorded as selling, general and administrative expense as incurred due to the short duration of the Company’s contracts. License Revenue The Company enters into out-license agreements with counterparties to develop and/or commercialize its products in exchange for nonrefundable upfront license fees and/or sales-based royalties. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from nonrefundable upfront fees allocated to the license when the license is transferred to the customer and the customer can benefit from the license. For licenses that are bundled with other performance obligations, management uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition. During the three months ended September 30, 2022 and 2021, the Company recognized no license revenue, and during the nine months ended September 30, 2022 and 2021, the Company recognized license revenue of $ 0 479,000 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 September 30, 2022 and 2021, product sales are stated net of an allowance for estimated returns of approximately $ 56,000 0 109,000 1,000 |
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 years Computer equipment 3 years Molds and tooling 5 years Furniture and fixtures 5 years Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or their estimated useful lives. The Company occasionally designs and builds its own machinery. The costs of these projects, which include 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 dates, 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. |
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 (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 (loss). Depending on the features of the derivative financial instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (See Note 10- Warrant Liabilities). 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. |
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 $ 137,000 60,000 91,000 28,000 41,000 72,000 |
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 $ 88,523 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) Leases (Topic 842) |
Global Economic Conditions | Global Economic Conditions Russia’s Invasion of Ukraine In February 2022, Russia invaded Ukraine. While the Company has limited exposure in Russia and Ukraine, the Company continues to monitor any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the conflict and its impact on regional and global economic conditions. Inflationary Cost Environment During fiscal 2021 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. Ongoing COVID-19 Pandemic The COVID-19 pandemic has had a dramatic impact on businesses globally and our business as well. Our sales of diagnostic products fell significantly during 2020 and our net loss increased significantly, as deferral of patients’ non-emergency visits to physician offices, clinics and small hospitals sharply reduced demand for FastPack tests. Since then we have experienced some recovery in demand. To mitigate risks, we continue to evaluate the extent to which COVID-19 may impact our business and operations and adjust risk mitigation planning and business continuity activities as needed. Other accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s unaudited condensed financial statements. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, December 31, 2022 2021 Accounts Receivable $ 763,766 $ 1,070,196 Less Allowances (160,475 ) (247,845 ) Accounts receivable, net $ 603,291 $ 822,351 |
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 years Computer equipment 3 years Molds and tooling 5 years Furniture and fixtures 5 years |
ACQUISITION (Tables)
ACQUISITION (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
SCHEDULE OF CONSIDERATION TRANSFERRED | SCHEDULE OF CONSIDERATION TRANSFERRED Consideration transferred, net of cash acquired Cash paid for NanoSynex preferred stock: $ 600,000 Purchase of NanoSynex preferred stock: Price per share of Qualigen Stock on May 26, 2022 $ 0.527 FMV of 3,500,000 $ 1,844,500 FMV of 3,314,641 $ 1,746,816 Total consideration paid for NanoSynex preferred stock $ 3,591,316 FMV of consideration related to related to repricing of 70,478 $ 696 NanoSynex cash acquired (735,354 ) Total consideration transferred, net of cash acquired $ 3,456,658 * See disclosure under Noncompensatory Equity Classified Warrants regarding May 26, 2022 transaction-Note 14-Stockholders’ Equity |
SCHEDULE OF ASSETS ACQUIRED AND LIABILITIES | SCHEDULE OF ASSETS ACQUIRED AND LIABILITIES Purchase Price Allocation Accounts receivable $ 75,336 Property and equipment 120,942 In process R&D 5,700,000 Accounts payable (4,588 ) Accrued expenses and other payables (291,093 ) R&D grant liability (1,362,264 ) Short term debt (941,898 ) Deferred tax liability (736,000 ) Noncontrolling interest assumed (4,000,000 ) Identifiable net assets acquired (1,439,565 ) Goodwill 4,896,223 Total consideration transferred, net of cash acquired $ 3,456,658 |
SCHEDULE OF PRO FORMA INFORMATION | SCHEDULE OF PRO FORMA INFORMATION Consolidated Pro Forma Financial Results for the Nine Months Ending September 30, September 30, 2022 2021 Net revenue $ 3,593,628 $ 4,172,496 Net loss attributable to Qualigen Therapeutics, Inc. $ (12,748,015 ) $ (14,026,542 ) |
INVENTORY, NET (Tables)
INVENTORY, NET (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORY | Inventory, net consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF INVENTORY September 30, 2022 December 31, 2021 Raw materials $ 1,023,263 $ 823,315 Work in process 228,882 188,135 Finished goods 229,379 44,428 Total inventory $ 1,481,524 $ 1,055,878 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expenses And Other Current Assets | |
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS September 30, December 31, 2022 2021 Prepaid insurance $ 1,564,161 $ 1,197,726 Prepaid manufacturing expenses 38,056 67,410 Other prepaid expenses 90,255 114,760 Prepaid expenses and other current assets $ 1,692,472 $ 1,379,896 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT | Property and equipment, net consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF PROPERTY AND EQUIPMENT September 30, December 31, 2022 2021 Machinery and equipment $ 2,506,367 $ 2,482,841 Computer equipment 506,034 345,117 Leasehold improvements 333,271 333,271 Molds and tooling 260,002 260,002 Furniture and fixtures 144,832 143,013 Equipment held for lease, net 74 296 Property and equipment, gross 3,750,580 3,564,540 Accumulated depreciation (3,439,049 ) (3,360,324 ) Property and equipment, net $ 311,531 $ 204,216 |
GOODWILL, IPR&D AND OTHER INT_2
GOODWILL, IPR&D AND OTHER INTANGIBLES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
SCHEDULE OF GOODWILL AND OTHER INTANGIBLE | SCHEDULE OF GOODWILL AND OTHER INTANGIBLE September 30, December 31, 2022 2021 Estimated Useful Lives Gross carrying amounts Gross carrying amounts Goodwill $ 4,896,223 $ - Finite-lived intangible assets: Developed-product-technology rights 8 17 479,103 479,103 Licensing rights 10 years 418,836 418,836 Less: Accumulated amortization (745,865 ) (726,749 ) Total finite-lived intangible assets, net 152,074 171,190 Indefinite-lived intangible assets: In-process research and development 5,700,000 — Total other intangible assets, net $ 5,852,074 $ 171,190 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | Accrued expenses and other current liabilities consisted of the following at September 30, 2022 and December 31, 2021: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES September 30, December 31, 2022 2021 Board compensation $ 26,500 $ 17,500 Franchise, sales and use taxes 22,685 14,090 Income taxes 4,356 3,620 Payroll 225,270 682,036 Professional fees 76,555 225,308 Research and development 210,419 232,712 Royalties 13,009 10,152 Vacation 439,324 282,910 Warranty liability 137,293 60,281 Other 315,916 265,292 Accrued liabilities $ 1,471,327 $ 1,793,901 |
WARRANT LIABILITIES (Tables)
WARRANT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Warrant Liabilities | |
SCHEDULE OF WARRANTS ACTIVITY | The following table summarizes the activity in the Common Stock Warrants (received in exchange for the Series C Warrants) for the nine months ended September 30, 2022: SCHEDULE OF WARRANTS ACTIVITY Common Stock Warrants (received in exchange for the Shares Weighted– Range of Exercise Weighted– Total outstanding – December 31, 2021 2,481,614 $ 0.72 2.00 Exercised (5,363 ) 0.72 Forfeited (2,476,251 ) 0.72 Expired — — Granted 3,468,958 0.51 Total outstanding – September 30, 2022 3,468,958 $ 0.51 Exercisable 3,468,958 $ 0.51 $ 0.51 1.26 The following table summarizes the activity in the Common Stock Warrants (received in exchange for the Series C Warrants) activity for the nine months ended September 30, 2021: Common Stock Warrants (received in exchange for the Shares Weighted– Average Range of Exercise Weighted– Total outstanding –December 31, 2020 3,378,596 $ 0.72 Exercised (722,618 ) 0.72 Forfeited (36,097 ) 0.72 Expired — — Granted — — Total outstanding – September 30, 2021 2,619,881 $ 0.72 Exercisable 2,619,881 $ 0.72 $ 0.72 2.25 |
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES | The following table presents the Company’s fair value hierarchy for its warrant liabilities and exercises (all of which arise under the warrants received in exchange for the Series C Warrants) measured at fair value on a recurring basis using Level 3 inputs as of September 30, 2022: SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES Quoted Market Significant Prices for Other Significant Identical Observable Unobservable Assets Inputs Inputs Common Stock Warrant liabilities (Level 1) (Level 2) (Level 3) Total Balance as of December 31, 2021 $ — $ — $ 1,686,200 $ 1,686,200 Exercises — — (858 ) (858 ) Gain on change in fair value of warrant liabilities — — (1,019,342 ) (1,019,342 ) Balance as of September 30, 2022 $ — $ — $ 666,000 $ 666,000 |
SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES | The following table shows the range of assumptions used in estimating the fair value of warrant liabilities as of September 30, 2022 and 2021: SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES September 30, 2022 September 30, 2021 Range Weighted Average Range Weighted Average Risk-free interest rate 3.99 4.09 4.01 % 0.31 0.46 0.34 % Expected volatility (peer group) 91 93 92 % 82 86 85 % Term of warrants (in years) 1.14 1.74 1.26 2.14 2.74 2.25 Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % |
LOSS PER SHARE (Tables)
LOSS PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF EARNINGS PER SHARE BASIC AND DILUTED | The following table reconciles net loss and the weighted-average shares used in computing basic and diluted EPS in the respective periods: SCHEDULE OF EARNINGS PER SHARE BASIC AND DILUTED For the Three Months Ended For the Three Months Ended For the Nine Months Ended For the Nine Months Ended 2022 2021 2022 2021 Net loss used for basic earnings per share $ (3,825,109 ) $ (3,037,482 ) $ (12,268,300 ) $ (13,678,278 ) Basic weighted-average common shares outstanding 39,444,058 29,026,211 37,154,623 28,683,972 Dilutive potential shares issuable from stock options and warrants — — — — Diluted weighted-average common shares outstanding 39,444,058 29,026,211 37,154,623 28,683,972 |
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 September 30, 2022 and 2021 because their effect would be antidilutive: SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE As of September 30, As of September 30, 2022 2021 Shares of common stock subject to outstanding options 6,071,750 4,133,856 Shares of common stock subject to outstanding warrants 10,808,739 9,360,302 Shares of common stock subject to conversion of Series Alpha Convertible Preferred Stock — 243,418 Total common stock equivalents 16,880,489 13,737,576 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, 2022, including the changes during the periods: SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES Operating lease right-of-use assets Net right-of-use assets at December 31, 2021 $ 1,645,568 Less amortization of operating lease right-of-use assets (165,950 ) Operating lease right-of-use assets at September 30, 2022 $ 1,479,618 Operating lease liabilities Lease liabilities at December 31, 2021 $ 1,676,655 Less principal payments on operating lease liabilities (112,823 ) Lease liabilities at September 30, 2022 1,563,832 Less non-current portion (1,365,459 ) Current portion at September 30, 2022 $ 198,373 |
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES | As of September 30, 2022, 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 2022 (three months) $ 55,721 2023 368,341 2024 379,392 2025 390,773 2026 402,497 2027 379,165 Total 1,975,889 Less present value discount (412,056 ) Operating lease liabilities $ 1,563,832 |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
SCHEDULE OF RESERVED SHARES | At September 30, 2022, shares were reserved in connection with the following: SCHEDULE OF RESERVED SHARES Exercise of issued and future grants of stock options 6,071,750 Exercise of stock warrants 10,808,739 Total 16,880,489 |
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 September 30, 2022, and changes during the nine month period then ended: SCHEDULE OF STOCK OPTION ACTIVITY Shares Weighted– Range of Weighted– Total outstanding – December 31, 2021 4,841,856 $ 6.07 $ 1.24 1,465.75 8.52 Granted 1,329,750 0.51 0.51 1.05 9.77 Expired (93,856 ) 93.59 5.75 1,465.75 — Forfeited (6,000 ) 3.55 1.24 4.97 — Total outstanding – September 30, 2022 6,071,750 $ 3.51 $ 0.51 5.13 8.33 Exercisable (vested) 2,660,163 $ 4.84 $ 1.24 5.13 7.76 Non-Exercisable (non-vested) 3,411,587 $ 3.68 $ 0.51 5.13 8.82 Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2020 4,011,356 $ 7.05 $ 3.52 1,465.75 9.29 Granted 127,000 2.12 1.80 3.29 9.58 Expired — — — — Forfeited (4,500 ) 3.68 3.52 4.97 — Total outstanding – September 30, 2021 4,133,856 $ 6.90 $ 1.80 1,465.75 8.57 Exercisable (vested) 1,314,194 $ 11.41 $ 3.52 1,465.75 8.12 Non-Exercisable (non-vested) 2,819,662 $ 4.80 $ 1.80 5.13 8.79 |
SCHEDULE OF ASSUMPTIONS 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 ASSUMPTIONS USED IN BLACK-SCHOLES OPTION-PRICING METHOD For the Nine Months Ended September 30, 2022 2021 Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility 103 % 102 % Risk-free interest rate 1.58% 3.03% 0.84% 1.18% Expected average term of options (in years) 6.00 6.00 Stock price $ 0.52 $ 2.12 |
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 2022 2021 For the Nine Months 2022 2021 General and administrative $ 3,522,108 $ 3,329,310 Research and development 577,844 533,096 Total $ 4,099,952 $ 3,862,406 |
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 nine months ended September 30, 2022: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Range of Weighted– Total outstanding – December 31, 2021 1,790,648 $ 1.52 $ 1.11 2.54 2.64 Granted to advisor and its designees — — Exercised — — Expired — — Forfeited — — Total outstanding – September 30, 2022 1,790,648 $ 1.06 $ 0.5136 2.54 1.98 Exercisable 1,790,648 $ 1.06 $ 0.5136 2.54 1.98 Non-Exercisable — $ — $ — — The following table summarizes the activity in the common stock equity classified compensatory warrants for the nine months ended September 30, 2021: Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2020 1,294,217 $ 1.66 Granted — — Exercised (38,390 ) 2.09 Expired — — Forfeited (65,179 ) 2.07 Total outstanding – September 30, 2021 1,190,648 $ 1.62 Exercisable 1,190,648 $ 1.62 $ 1.11 2.54 3.50 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 nine months ended September 30, 2022: SCHEDULE OF WARRANT ACTIVITY Common Stock Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 2021 5,549,137 $ 2.01 Granted 3,314,641 0.001 0.001 Exercised (3,314,641 ) 0.001 0.001 Expired — — Forfeited — — Total outstanding – September 30, 2022 5,549,137 2.01 Exercisable 5,549,137 $ 2.01 $ 0.51 3.77 0.57 Non-Exercisable — $ — $ — — |
QUARTERLY FINANCIAL DATA (UNA_2
QUARTERLY FINANCIAL DATA (UNAUDITED) (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Quarterly Financial Information Disclosure [Abstract] | |
SCHEDULE OF ERROR CORRECTIONS AND PRIOR PERIOD ADJUSTMENTS | SCHEDULE OF ERROR CORRECTIONS AND PRIOR PERIOD ADJUSTMENTS As reported Corrected As reported Corrected For the Quarter For the Nine Months As reported Corrected As reported Corrected Gain on change in fair value of warrant liabilities $ (1,942,900 ) $ (1,763,936 ) $ (6,140,900 ) $ (4,299,000 ) Net loss $ (2,858,518 ) $ (3,037,482 ) $ (11,836,378 ) $ (13,678,278 ) Net loss per common share $ (0.10 ) $ (0.10 ) $ (0.41 ) $ (0.48 ) |
SCHEDULE OF ACCOUNTS RECEIVABLE
SCHEDULE OF ACCOUNTS RECEIVABLE (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accounts Receivable | $ 763,766 | $ 1,070,196 |
Less Allowances | (160,475) | (247,845) |
Accounts receivable, net | $ 603,291 | $ 822,351 |
SCHEDULE OF USEFUL LIVES OF PRO
SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT (Details) | 9 Months Ended |
Sep. 30, 2022 | |
Machinery and Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Molds and Tooling [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant 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 | 9 Months Ended | ||||||||
May 26, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Apr. 25, 2022 | Apr. 24, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock issued during period shares acquisitions | 70,478 | |||||||||
Warrants to purchase common stock | 2,191,010 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.32 | $ 4.07 | ||||||||
Stock issued during period, value, acquisitions | $ 1,844,500 | |||||||||
Impairment losses on construction-in-progress | $ 0 | $ 0 | $ 0 | $ 0 | ||||||
Cost of goods and services sold | 91,000 | 29,000 | 201,000 | 88,000 | ||||||
Revenue | 1,441,065 | 1,155,065 | 3,593,628 | 4,172,496 | ||||||
Allowances for sales return | 56,000 | 0 | 109,000 | 1,000 | ||||||
Accrued warranty liabilities | 137,293 | 137,293 | $ 60,281 | |||||||
Product warranty expense | 91,000 | 28,000 | 41,000 | 72,000 | ||||||
Adjustment net of tax | 88,523 | $ 65,540 | $ 154,063 | |||||||
Minimum [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.5136 | $ 0.60 | ||||||||
Minimum [Member] | Patents and Licenses [Member] | ||||||||||
Estimated useful lives | 5 years | |||||||||
Maximum [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.60 | 0.7195 | ||||||||
Maximum [Member] | Patents and Licenses [Member] | ||||||||||
Estimated useful lives | 17 years | |||||||||
License Revenue [Member] | ||||||||||
Revenue | 478,654 | |||||||||
General Administrative Research and Development Expenses [Member] | ||||||||||
Cost of goods and services sold | 4,000 | $ 3,000 | 12,000 | $ 8,000 | ||||||
Pre-funded Warrant [Member] | ||||||||||
Stock issued during period shares acquisitions | 3,314,641 | |||||||||
Warrants to purchase common stock | 3,314,641 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.001 | |||||||||
Warrant [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.60 | $ 1.32 | ||||||||
Accrued warranty liabilities | $ 137,000 | 137,000 | $ 60,000 | |||||||
Nano Synex Ltd [Member] | ||||||||||
Stock issued during period shares acquisitions | 3,500,000 | |||||||||
Series A-1 Preferred Stock [Member] | ||||||||||
Stock issued during period shares acquisitions | 2,232,861 | |||||||||
Nano Synex Ltd [Member] | ||||||||||
Stock issued during period shares acquisitions | 3,500,000 | |||||||||
Stock issued during period, value, acquisitions | $ 1,844,500 | |||||||||
Voting interests acquired | 52.80% | |||||||||
Adjustment net of tax | $ 88,523 | |||||||||
Nano Synex Ltd [Member] | Pre-funded Warrant [Member] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.001 | |||||||||
Nano Synex Ltd [Member] | Series A-1 Preferred Stock [Member] | ||||||||||
Stock issued during period shares acquisitions | 2,232,861 | |||||||||
Nano Synex Ltd [Member] | Series B Preferred Stock [Member] | ||||||||||
Stock issued during period shares acquisitions | 381,786 | |||||||||
Stock issued during period, value, acquisitions | $ 600,000 |
LIQUIDITY AND GOING CONCERN (De
LIQUIDITY AND GOING CONCERN (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Dec. 31, 2021 | Jun. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Cash | $ 17,538,272 | $ 6,618,141 | $ 12,319,809 | $ 17,538,272 | |
Accumulated deficit | 84,744,629 | 97,012,929 | 84,744,629 | ||
Net cash used in operating activities | 11,009,814 | 11,817,410 | (14,700,000) | ||
Net cash used in operating activities | $ (11,009,814) | $ (11,817,410) | $ 14,700,000 | ||
Proceeds from issuance or sale of equity and debt | $ 8,820,000 | ||||
Stock issued during period value acquisitions | $ 1,844,500 | ||||
Stockholders equity note stock split | the Company with a face value equal to the amount paid by the Company to NanoSynex upon satisfaction of the applicable performance milestone, bearing interest at the rate of 9% per annum on the principal balance from time to time outstanding under the particular promissory note, convertible at the option of the Company into additional shares of NanoSynex in order for the Company to maintain at least a 50.1% controlling ownership interest in NanoSynex, should NanoSynex issue additional shares. The principal of the convertible notes are due and payable upon the sooner to occur of: i) five years from the date of issuance of the particular promissory note | ||||
Nano Synex Ltd [Member] | |||||
Stock issued during period value acquisitions | $ 10,400,000 | ||||
Stock issued during period value new issues | $ 1,500,000 |
SCHEDULE OF CONSIDERATION TRANS
SCHEDULE OF CONSIDERATION TRANSFERRED (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
May 26, 2022 | Jun. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | ||
Business Acquisition [Line Items] | |||||
Common stock issued for business acquisition | $ 1,844,500 | ||||
Total consideration paid for NanoSynex common stock | $ 135,354 | ||||
FMV of consideration related to related to repricing of 70,478 shares of Alpha Capital/Qualigen warrants * | $ 696 | ||||
NanoSynex cash acquired | $ (135,354) | ||||
Nano Synex Ltd [Member] | |||||
Business Acquisition [Line Items] | |||||
Cash paid for NanoSynex preferred stock: | $ 600,000 | ||||
Price per share of Qualigen Stock on May 26, 2022 | $ 0.527 | ||||
Common stock issued for business acquisition | $ 1,844,500 | ||||
FMV of 3,314,641 shares of Qualigen stock related to prefunded warrant issued to Alpha Capital Anstalt | 1,746,816 | ||||
Total consideration paid for NanoSynex common stock | 3,591,316 | ||||
FMV of consideration related to related to repricing of 70,478 shares of Alpha Capital/Qualigen warrants * | [1] | 696 | |||
NanoSynex cash acquired | (735,354) | ||||
Total consideration transferred, net of cash acquired | $ 3,456,658 | ||||
[1]See disclosure under |
SCHEDULE OF CONSIDERATION TRA_2
SCHEDULE OF CONSIDERATION TRANSFERRED (Details) (Parenthetical) | May 26, 2022 shares |
Business Acquisition [Line Items] | |
Common stock issued for business acquisition | 70,478 |
Nano Synex Ltd [Member] | |
Business Acquisition [Line Items] | |
Common stock issued for business acquisition | 3,500,000 |
Alpha Capital Anstalt [Member] | |
Business Acquisition [Line Items] | |
Common stock issued for business acquisition | 3,314,641 |
SCHEDULE OF ASSETS ACQUIRED AND
SCHEDULE OF ASSETS ACQUIRED AND LIABILITIES (Details) - USD ($) | Sep. 30, 2022 | May 26, 2022 | Dec. 31, 2021 |
Business Combination and Asset Acquisition [Abstract] | |||
Accounts receivable | $ 75,336 | ||
Property and equipment | 120,942 | ||
In process R&D | 5,700,000 | ||
Accounts payable | (4,588) | ||
Accrued expenses and other payables | (291,093) | ||
R&D grant liability | (1,362,264) | ||
Short term debt | (941,898) | ||
Deferred tax liability | (736,000) | ||
Noncontrolling interest assumed | (4,000,000) | ||
Identifiable net assets acquired | (1,439,565) | ||
Goodwill | $ 4,896,223 | 4,896,223 | |
Total consideration transferred, net of cash acquired | $ 3,456,658 |
SCHEDULE OF PRO FORMA INFORMATI
SCHEDULE OF PRO FORMA INFORMATION (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Business Combination and Asset Acquisition [Abstract] | ||
Business acquisitions pro forma revenue | $ 3,593,628 | $ 4,172,496 |
Business acquisitions pro forma net income loss | $ (12,748,015) | $ (14,026,542) |
ACQUISITION (Details Narrative)
ACQUISITION (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
May 26, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Business Acquisition [Line Items] | ||||||
Stock issued during period shares acquisitions | 70,478 | |||||
Warrants or rights | $ 1.32 | $ 4.07 | ||||
Stock issued during period value acquisitions | $ 1,844,500 | |||||
Nano Synex Ltd [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Stock issued during period value acquisitions | $ 10,400,000 | |||||
Pre-funded Warrant [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Stock issued during period shares acquisitions | 3,314,641 | |||||
Warrants or rights | $ 0.001 | |||||
Series A-1 Preferred Stock [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Stock issued during period shares acquisitions | 2,232,861 | |||||
Nano Synex Ltd [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Business acquisition, voting equity rate | 52.80% | |||||
Stock issued during period shares acquisitions | 3,500,000 | |||||
Stock issued during period value acquisitions | $ 1,844,500 | |||||
Other comprehensive income loss tax | $ 488,914 | $ 497,636 | ||||
Nano Synex Ltd [Member] | Pre-funded Warrant [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Warrants or rights | $ 0.001 | |||||
Nano Synex Ltd [Member] | Series A-1 Preferred Stock [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Stock issued during period shares acquisitions | 2,232,861 | |||||
Nano Synex Ltd [Member] | Series B Preferred Stock [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Stock issued during period shares acquisitions | 381,786 | |||||
Stock issued during period value acquisitions | $ 600,000 |
SCHEDULE OF INVENTORY (Details)
SCHEDULE OF INVENTORY (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,023,263 | $ 823,315 |
Work in process | 228,882 | 188,135 |
Finished goods | 229,379 | 44,428 |
Total inventory | $ 1,481,524 | $ 1,055,878 |
SCHEDULE OF PREPAID EXPENSES AN
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expenses And Other Current Assets | ||
Prepaid insurance | $ 1,564,161 | $ 1,197,726 |
Prepaid manufacturing expenses | 38,056 | 67,410 |
Other prepaid expenses | 90,255 | 114,760 |
Prepaid expenses and other current assets | $ 1,692,472 | $ 1,379,896 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,750,580 | $ 3,564,540 |
Accumulated depreciation | (3,439,049) | (3,360,324) |
Property and equipment, net | 311,531 | 204,216 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,506,367 | 2,482,841 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 506,034 | 345,117 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 333,271 | 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 | 143,013 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 74 | $ 296 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 24,000 | $ 19,000 | $ 72,000 | $ 51,000 |
SCHEDULE OF GOODWILL AND OTHER
SCHEDULE OF GOODWILL AND OTHER INTANGIBLE (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | May 26, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | |||
Goodwill | $ 4,896,223 | $ 4,896,223 | |
Less: Accumulated amortization | (745,865) | (726,749) | |
Total finite-lived intangible assets, net | 152,074 | 171,190 | |
Total other intangible assets, net | 5,852,074 | 171,190 | |
In Process Research and Development [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Total other intangible assets, net | 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 | 9 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Jun. 30, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Accumulated amortization | $ 745,865 | $ 745,865 | $ 726,749 | |||
2022 | $ 5,000 | |||||
2023 | 18,000 | 18,000 | ||||
2024 | 15,000 | 15,000 | ||||
2027 | 14,000 | 14,000 | ||||
Patents [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite lived intangible assets gross | 145,000 | 145,000 | 159,000 | |||
Accumulated amortization | 334,000 | 334,000 | 320,000 | |||
Amortization of intangible assets | 5,000 | $ 5,000 | 14,000 | $ 12,000 | ||
License [Member] | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Finite lived intangible assets gross | 7,000 | 7,000 | 12,000 | |||
Accumulated amortization | 412,000 | 412,000 | $ 407,000 | |||
Amortization of intangible assets | 2,000 | $ 2,000 | 5,000 | $ 5,000 | ||
2022 | 2,000 | 2,000 | ||||
2023 | $ 5,000 | $ 5,000 |
SCHEDULE OF ACCRUED EXPENSES AN
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Board compensation | $ 26,500 | $ 17,500 |
Franchise, sales and use taxes | 22,685 | 14,090 |
Income taxes | 4,356 | 3,620 |
Payroll | 225,270 | 682,036 |
Professional fees | 76,555 | 225,308 |
Research and development | 210,419 | 232,712 |
Royalties | 13,009 | 10,152 |
Vacation | 439,324 | 282,910 |
Warranty liability | 137,293 | 60,281 |
Other | 315,916 | 265,292 |
Accrued liabilities | $ 1,471,327 | $ 1,793,901 |
SHORT TERM DEBT-RELATED PARTY (
SHORT TERM DEBT-RELATED PARTY (Details Narrative) - USD ($) | 5 Months Ended | ||
Sep. 02, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | |
Short-Term Debt [Line Items] | |||
Short term debt outstanding balance | $ 941,261 | ||
Notes Payable [Member] | Nano Synex Ltd [Member] | |||
Short-Term Debt [Line Items] | |||
Short term debt principal outstanding | $ 905,000 | ||
Accrued interest | 36,261 | ||
Short term debt outstanding balance | $ 941,261 | ||
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] - $ / shares | 9 Months Ended | ||
May 26, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Number of Shares, Warrants Forfeited | (2,476,251) | ||
Number of Shares, Warrants Granted | 3,468,958 | ||
Common Stock Warrants [Member] | |||
Number of Shares, Warrants Outstanding Beginning | 2,481,614 | 3,378,596 | |
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning | $ 0.72 | $ 0.72 | |
Weighted Averag Remaining Contractual Term | 2 years | ||
Number of Shares, Warrants Exercised | (5,363) | (722,618) | |
Weighted Average Exercise Price Per Share Warrants Exercised | $ 0.72 | $ 0.72 | |
Number of Shares, Warrants Forfeited | (2,476,251) | (36,097) | |
Weighted Average Exercise Price Per Share Warrants Forfeited | $ 0.72 | $ 0.72 | |
Number of Shares, Warrants Expired | |||
Weighted Average Exercise Price Per Share Warrants Expired | |||
Number of Shares, Warrants Granted | 3,468,958 | ||
Weighted Average Exercise Price Per Share Warrants Granted | $ 0.51 | ||
Number of Shares, Warrants Outstanding Ending | 3,468,958 | 2,619,881 | |
Weighted Average Exercise Price Per Share Warrants Outstanding Ending | $ 0.51 | $ 0.72 | |
Number of Shares, Warrants Exercisable | 3,468,958 | 2,619,881 | |
Weighted Average Exercise Price Per Share Exercisable | $ 0.51 | $ 0.72 | |
Range of Exercise Price, Exercisable | $ 0.51 | $ 0.72 | |
Exercisable Weighted Averag Remaining Contractual Term | 1 year 3 months 3 days | 2 years 3 months |
SCHEDULE OF FAIR VALUE HIERARCH
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Fair value for warrant liabilities, beginning balance | $ 1,686,200 | |
Common Stock Warrant liabilities, Exercises | (858) | $ (1,841,900) |
Change in fair value of warrant liabilities | (1,019,342) | |
Fair value for warrant liabilities, ending balance | 666,000 | |
Fair Value, Inputs, Level 1 [Member] | ||
Defined Benefit Plan Disclosure [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] | ||
Defined Benefit Plan Disclosure [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] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Fair value for warrant liabilities, beginning balance | 1,686,200 | |
Common Stock Warrant liabilities, Exercises | (858) | |
Change in fair value of warrant liabilities | (1,019,342) | |
Fair value for warrant liabilities, ending balance | $ 666,000 |
SCHEDULE OF ASSUMPTIONS OF WARR
SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES (Details) | Sep. 30, 2022 | Sep. 30, 2021 |
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 | 3.99 | 0.31 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value assumptions, measurement input, percentages | 91 | 82 |
Minimum [Member] | Measurement Input, Expected Term [Member] | ||
Fair value assumptions, measurement input, term | 1 year 1 month 20 days | 2 years 1 month 20 days |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair value assumptions, measurement input, percentages | 4.09 | 0.46 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value assumptions, measurement input, percentages | 93 | 86 |
Maximum [Member] | Measurement Input, Expected Term [Member] | ||
Fair value assumptions, measurement input, term | 1 year 8 months 26 days | 2 years 8 months 26 days |
Weighted Average [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair value assumptions, measurement input, percentages | 4.01 | 0.34 |
Weighted Average [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value assumptions, measurement input, percentages | 92 | 85 |
Weighted Average [Member] | Measurement Input, Expected Term [Member] | ||
Fair value assumptions, measurement input, term | 1 year 3 months 3 days | 2 years 3 months |
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 | May 26, 2022 | Apr. 26, 2022 | Apr. 25, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Warrants to purchase common stock | 2,191,010 | ||||||
Warrants or rights exercise price | $ 1.32 | $ 4.07 | |||||
Share price | $ 0.52 | $ 2.12 | |||||
Series C Warrants [Member] | |||||||
Stock issued during period shares new issues | 499,520 | 493,187 | |||||
Warrants forfeited | 2,476,251 | ||||||
Warrants issued | 3,468,958 | ||||||
Share price | $ 0.5136 | ||||||
Minimum [Member] | |||||||
Warrants or rights exercise price | 0.5136 | $ 0.60 | |||||
Maximum [Member] | |||||||
Warrants or rights exercise price | $ 0.60 | $ 0.7195 | |||||
Series C Warrants [Member] | |||||||
Warrants to purchase common stock | 4,713,490 | ||||||
Warrants or rights exercise price | $ 0.72 | ||||||
Series C Warrants [Member] | Minimum [Member] | |||||||
Warrants and rights outstanding, term | 1 year 1 month 24 days | ||||||
Series C Warrants [Member] | Maximum [Member] | |||||||
Warrants and rights outstanding, term | 1 year 8 months 26 days |
SCHEDULE OF EARNINGS PER SHARE
SCHEDULE OF EARNINGS PER SHARE BASIC AND DILUTED (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net loss used for basic earnings per share | $ (3,825,109) | $ (3,037,482) | $ (12,268,300) | $ (13,678,278) |
Basic weighted-average common shares outstanding | 39,444,058 | 29,026,211 | 37,154,623 | 28,683,972 |
Dilutive potential shares issuable from stock options and warrants | ||||
Diluted weighted-average common shares outstanding | 39,444,058 | 29,026,211 | 37,154,623 | 28,683,972 |
SCHEDULE OF DILUTIVE SECURITIES
SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents | 16,880,489 | 13,737,576 |
Shares of Common Stock Subject to Outstanding Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents | 6,071,750 | 4,133,856 |
Shares of Common Stock Subject to Outstanding Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents | 10,808,739 | 9,360,302 |
Shares of Common Stock Subject to Conversion of Series Alpha Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents | 243,418 |
SCHEDULE OF OPERATING LEASE RIG
SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Operating lease right-of-use assets | $ 1,645,568 | ||
Less amortization of operating lease right-of-use assets | (165,949) | $ (166,657) | |
Operating lease right-of-use assets | 1,479,618 | ||
Operating lease liabilities, ending balance | 1,563,832 | ||
Less non-current portion | (1,365,459) | $ (1,542,564) | |
Current portion at March 31, 2022 | 198,373 | $ 134,091 | |
Long term Operating Lease Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Operating lease right-of-use assets | 1,645,568 | ||
Less amortization of operating lease right-of-use assets | (165,950) | ||
Operating lease right-of-use assets | 1,479,618 | ||
Operating lease liabilities, beginning balance | 1,676,655 | ||
Less principal payments on operating lease liabilities | (112,823) | ||
Operating lease liabilities, ending balance | 1,563,832 | ||
Less non-current portion | (1,365,459) | ||
Current portion at March 31, 2022 | $ 198,373 |
SCHEDULE OF MATURITIES OF OPERA
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) | Sep. 30, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 (three months) | $ 55,721 |
2023 | 368,341 |
2024 | 379,392 |
2025 | 390,773 |
2026 | 402,497 |
2027 | 379,165 |
Total | 1,975,889 |
Less present value discount | (412,056) |
Operating lease liabilities | $ 1,563,832 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | 3 Months Ended | 9 Months Ended | ||||
Apr. 05, 2022 USD ($) | Dec. 15, 2021 USD ($) ft² | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
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 | 5 years 2 months 12 days | 5 years 2 months 12 days | ||||
Weighted-average discount rate | 8.90% | 8.90% | ||||
Lease expense | $ 114,000 | $ 83,000 | $ 348,000 | $ 255,000 | ||
Litigation settlement amount | $ 96,558 | |||||
Nano Synex Ltd [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Maximum future funding amount | $ 10,400,000 | $ 10,400,000 | ||||
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 | 9 Months Ended | |||||||||||
Jan. 31, 2022 | Apr. 30, 2022 | Mar. 31, 2022 | Nov. 30, 2020 | Jul. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Research expense | $ 1,688,096 | $ 2,083,315 | $ 5,059,067 | $ 10,091,155 | ||||||||||
Product sales | 1,441,065 | 1,155,065 | 3,593,628 | 4,172,496 | ||||||||||
Upfront payment | $ 150,000 | |||||||||||||
Other Expenses | $ 160,000 | |||||||||||||
License [Member] | ||||||||||||||
License cost | 0 | 0 | 310,000 | 0 | ||||||||||
University of Louisville Research Foundation [Member] | ||||||||||||||
Research expense | 0 | 12,000 | 0 | 106,000 | ||||||||||
License cost | 0 | 11,000 | 0 | 27,000 | ||||||||||
Prediction Biosciences SAS [Member] | Collaborative Research Revenue [Member] | ||||||||||||||
Product sales | 0 | 0 | 0 | 0 | ||||||||||
Sekisui Diagnostics, LLC [Member] | ||||||||||||||
Product sales | 0 | 810,000 | 403,000 | 2,500,000 | ||||||||||
Yi Xin Zhen Duan Jishu Ltd [Member] | ||||||||||||||
Product sales | 0 | 38,000 | 0 | 479,000 | ||||||||||
STA Pharmaceutical Co Ltd [Member] | ||||||||||||||
Research expense | 0 | 118,000 | 9,000 | 3,200,000 | ||||||||||
Sponsored Research and License Agreement [Member] | ||||||||||||||
Research expense | 0 | 83,000 | 164,000 | 235,000 | ||||||||||
License cost | 5,000 | 50,000 | 74,000 | 103,000 | ||||||||||
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | ||||||||||||||
Regulatory marketing approval expenses | $ 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, and (iv) payments ranging from $50,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones | In addition, 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 | ||||||||||||
Regulatory marketing approval expenses | 300,000 | |||||||||||||
Cumulative sales | $ 500,000,000 | |||||||||||||
Licensed product net sale | 500,000,000 | |||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | ||||||||||||||
Regulatory marketing approval expenses | $ 805,000 | |||||||||||||
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. | |||||||||||||
Regulatory marketing approval expenses | 500,000 | |||||||||||||
Cumulative sales | $ 5,000,000 | |||||||||||||
Licensed product net sale | 500,000,000 | |||||||||||||
Research expense | 196,000 | 264,000 | 601,000 | 469,000 | ||||||||||
License cost | 27,000 | 18,000 | 44,000 | 58,000 | ||||||||||
Proceeds from convertible debt | $ 50,000 | |||||||||||||
Patent costs | 200,000 | |||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Licensed Product Sales [Member] | ||||||||||||||
Regulatory marketing approval expenses | 5,000,000 | |||||||||||||
Cumulative sales | $ 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 | 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 | 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 | 150,000 | 350,000 | |||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Regulatory Marketing Approval [Member] | ||||||||||||||
Regulatory marketing approval expenses | 300,000 | |||||||||||||
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Minimum [Member] | ||||||||||||||
Milestone payment | 50,000 | 50,000 | 100,000 | |||||||||||
Research expense | 5,000 | |||||||||||||
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 | $ 5,000,000 | |||||||||||
Research expense | 50,000 | |||||||||||||
Shortfall payments | $ 50,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | ||||||||||||||
Upfront license fee | 24,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Minimum [Member] | ||||||||||||||
Upfront license fee | 20,000 | |||||||||||||
License Agreement [Member] | University of Louisville Research Foundation [Member] | Maximum [Member] | ||||||||||||||
Upfront license fee | $ 100,000 | |||||||||||||
Research expense | $ 430,000 | $ 250,000 | ||||||||||||
License Agreement [Member] | Advanced Cancer Therapeutics, LLC [Member] | ||||||||||||||
Agreement term payment, description | In addition, the Company agreed to pay ACT (i) royalties, on net sales associated with the commercialization of QN-165, of 2% (only if patent-covered and only on net sales above a cumulative $3,000,000) or 1% (if not patent-covered, but only on net sales above a cumulative $3,000,000), until the 15th anniversary of the ACT license agreement and (ii) milestone payments of $100,000 for the Company raising a cumulative total of $2,000,000 in new equity financing after the date of the ACT license agreement, $100,000 upon any first QN-165-based licensed product receiving the CE Mark or similar FDA status, and $500,000 upon cumulative worldwide QN-165-based licensed product net sales reaching $3,000,000 | |||||||||||||
License cost | $ 0 | $ 0 | $ 0 | $ 2,000 | ||||||||||
Proceeds from convertible debt | $ 25,000 |
SCHEDULE OF RESERVED SHARES (De
SCHEDULE OF RESERVED SHARES (Details) | Sep. 30, 2022 shares |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total | 16,880,489 |
Equity Option [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total | 6,071,750 |
Warrant [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Total | 10,808,739 |
SCHEDULE OF STOCK OPTION ACTIVI
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
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 25 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 | 4,841,856 | 4,011,356 |
Range of Exercise price, Options Outstanding | $ 6.07 | $ 7.05 |
Weighted- Average Remaining Contractual Life (in Years), Outstanding, Beginning | 8 years 6 months 7 days | 9 years 3 months 14 days |
Number of shares, options granted | 1,329,750 | 127,000 |
Weighted average exercise price, options granted | $ 0.51 | $ 2.12 |
Weighted- Average Remaining Contractual Life (in Years), Options Granted | 9 years 9 months 7 days | 9 years 6 months 29 days |
Number of shares, options expired | (93,856) | |
Weighted average exercise price, options expired | $ 93.59 | |
Range of exercise price, options expired | ||
Number of shares, options forfeited | (6,000) | (4,500) |
Weighted average exercise price, options forfeited | $ 3.55 | $ 3.68 |
Number of Shares, Options Outstanding at Ending | 6,071,750 | 4,133,856 |
Range of Exercise price, Options Outstanding | $ 3.51 | $ 6.90 |
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending | 8 years 3 months 29 days | 8 years 6 months 25 days |
Number of shares, options exercisable (vested) | 2,660,163 | 1,314,194 |
Range of exercise price, options exercisable (vested) | $ 4.84 | $ 11.41 |
Weighted- Average Remaining Contractual Life (in Years), Options Exercisable (vested) | 7 years 9 months 3 days | 8 years 1 month 13 days |
Number of shares, options non-exercisable (non-vested) | 3,411,587 | 2,819,662 |
Weighted average exercise price, options non-exercisable (non-vested) | $ 3.68 | $ 4.80 |
Weighted- Average Remaining Contractual Life (in Years), Options Non-exercisable (non-vested) | 8 years 9 months 25 days | 8 years 9 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 | $ 1.24 | $ 3.52 |
Range of exercise price, options granted | 0.51 | 1.80 |
Range of exercise price, options expired | 5.75 | |
Range of exercise price, options forfeited | 1.24 | 3.52 |
Range of Exercise price, Options Outstanding | 0.51 | 1.80 |
Range of exercise price, options exercisable (vested) | 1.24 | 3.52 |
Range of exercise price, options non-exercisable (non-vested) | 0.51 | 1.80 |
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 | 1,465.75 | 1,465.75 |
Range of exercise price, options granted | 1.05 | 3.29 |
Range of exercise price, options expired | 1,465.75 | |
Range of exercise price, options forfeited | 4.97 | 4.97 |
Range of Exercise price, Options Outstanding | 5.13 | 1,465.75 |
Range of exercise price, options exercisable (vested) | 5.13 | 1,465.75 |
Range of exercise price, options non-exercisable (non-vested) | $ 5.13 | $ 5.13 |
SCHEDULE OF ASSUMPTIONS USED IN
SCHEDULE OF ASSUMPTIONS USED IN BLACK-SCHOLES OPTION-PRICING METHOD (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Equity [Abstract] | ||
Expected dividend yield | 0% | 0% |
Expected stock-price volatility | 103% | 102% |
Risk-free interest rate, minimum | 1.58% | 0.84% |
Risk-free interest rate, maximum | 3.03% | 1.18% |
Expected average term of options (in years) | 6 years | 6 years |
Share price | $ 0.52 | $ 2.12 |
SCHEDULE OF SHARE-BASED COMPENS
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Total | $ 4,099,952 | $ 3,862,406 |
General and Administrative Expense [Member] | ||
Total | 3,522,108 | 3,329,310 |
Research and Development Expense [Member] | ||
Total | $ 577,844 | $ 533,096 |
SCHEDULE OF WARRANT ACTIVITY (D
SCHEDULE OF WARRANT ACTIVITY (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Non Compensatory Warrant Activity [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of Shares, Warrants Outstanding Beginning | 5,549,137 | |
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning | $ 2.01 | |
Number of shares, warrants granted | 3,314,641 | |
Weighted average exercise price per share warrants granted | $ 0.001 | |
Number of Shares, Warrants Exercised | (3,314,641) | |
Weighted average exercise price per share warrants exercised | $ 0.001 | |
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 | 5,549,137 | |
Weighted Average Exercise Price Per Share Warrants Outstanding Ending | $ 2.01 | |
Weighted average remaining life (Years) exercisable | 6 months 25 days | |
Number of Shares, Warrants Exercisable | 5,549,137 | |
Weighted Average Exercise Price Per Share Exercisable | $ 2.01 | |
Number of shares, warrants non-exercisable | ||
Weighted Average Exercise Price Per Share Non-Exercisable | ||
Range of Exercise Price, Non-Exercisable | ||
Weighted average remaining life (Years) non-exercisable | ||
Range of exercise price - granted | $ 0.001 | |
Range of exercise price - Expired | 0.001 | |
Minimum [Member] | Non Compensatory Warrant Activity [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Range of exercise price - Exercisable | 0.51 | |
Maximum [Member] | Non Compensatory Warrant Activity [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Range of exercise price - Exercisable | $ 3.77 | |
Compensatory Warrant Activity [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of Shares, Warrants Outstanding Beginning | 1,790,648 | 1,294,217 |
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning | $ 1.52 | $ 1.66 |
Weighted Average Remaining Life (Years) - outstanding | 2 years 7 months 20 days | |
Number of shares, warrants granted | ||
Weighted average exercise price per share warrants granted | ||
Number of Shares, Warrants Exercised | (38,390) | |
Weighted average exercise price per share warrants exercised | $ 2.09 | |
Number of Shares, Warrants Expired | ||
Weighted average exercise price per share warrants expired | ||
Number of Shares, Warrants Forfeited | (65,179) | |
Weighted average exercise price per share warrants forfeited | $ 2.07 | |
Number of Shares, Warrants Outstanding Ending | 1,790,648 | 1,190,648 |
Weighted Average Exercise Price Per Share Warrants Outstanding Ending | $ 1.06 | $ 1.62 |
Weighted average remaining life (Years) exercisable | 1 year 11 months 23 days | 3 years 6 months |
Number of Shares, Warrants Exercisable | 1,790,648 | 1,190,648 |
Weighted Average Exercise Price Per Share Exercisable | $ 1.06 | $ 1.62 |
Number of shares, warrants non-exercisable | ||
Weighted Average Exercise Price Per Share Non-Exercisable | ||
Range of Exercise Price, Non-Exercisable | ||
Weighted average remaining life (Years) non-exercisable | ||
Compensatory Warrant Activity [Member] | Minimum [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Range of exercise price - beginning | 1.11 | |
Range of exercise price - ending | 0.5136 | |
Range of exercise price - Exercisable | 0.5136 | $ 1.11 |
Compensatory Warrant Activity [Member] | Maximum [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Range of exercise price - beginning | 2.54 | |
Range of exercise price - ending | 2.54 | |
Range of exercise price - Exercisable | $ 2.54 | $ 2.54 |
STOCKHOLDERS_ EQUITY (Details N
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||
May 26, 2022 | Apr. 25, 2022 | Dec. 31, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | May 31, 2022 | May 25, 2022 | Apr. 24, 2022 | Nov. 29, 2021 | Aug. 31, 2020 | Jul. 31, 2020 | May 31, 2020 | Dec. 31, 2017 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Common stock, shares reserved for future issuance | 16,880,489 | |||||||||||||
Series Alpha convertible preferred stock, shares outstanding | 0 | 0 | ||||||||||||
Compensation cost | $ 4,000,000 | $ 3,900,000 | ||||||||||||
Unrecognized compensation cost | $ 4,700,000 | |||||||||||||
Cost is expected to be recognized over a weighted average period | 1 year 25 days | |||||||||||||
Purchase of warrants | 2,191,010 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.07 | $ 1.32 | ||||||||||||
Class of warrant | 600,000 | |||||||||||||
Fair value adjustment of warrants | $ (1,019,342) | (4,299,000) | $ 300,000 | |||||||||||
Nano Synex Ltd [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Purchase of warrants | 70,478 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.5136 | $ 1.11 | ||||||||||||
Fair value adjustment of warrants | $ 696 | $ 2,533 | ||||||||||||
Modified to exercise price | $ 0.60 | |||||||||||||
Warrant [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.60 | $ 1.32 | ||||||||||||
Class of warrant | 600,000 | |||||||||||||
Warrants extended date, description | June 3, 2023 to September 14, 2023 | |||||||||||||
Warrant [Member] | General and Administrative Expense [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Fair value adjustment of warrants | $ 67,370 | |||||||||||||
Warrant One [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.5136 | $ 1.11 | ||||||||||||
Class of warrant | 676,194 | 676,194 | ||||||||||||
Warrant One [Member] | General and Administrative Expense [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Fair value adjustment of warrants | $ 31,010 | |||||||||||||
Compensatory Warrant Activity [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Compensation cost | $ 67,370 | $ 0 | ||||||||||||
2020 Plan [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Common stock, shares reserved for future issuance | 3,500,000 | |||||||||||||
Equity Option [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Common stock, shares reserved for future issuance | 6,071,750 | |||||||||||||
Stock option granted exercise price | $ 0.40 | |||||||||||||
Equity Option [Member] | 2020 Stock Incentive Plan [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Common stock, shares reserved for future issuance | 1,485,407 | 2,809,157 | ||||||||||||
Options outstanding | 6,071,750 | 4,748,000 | ||||||||||||
Stock options 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 | |||||||||||||
Compensatory Warrants [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Proceeds from issuance or sale of equity | $ 4,000,000 | |||||||||||||
Purchase of warrants | 811,431 | 668,024 | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 1.11 | $ 2.34 | ||||||||||||
Noncompensatory Equity Classified Warrants [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Purchase of warrants | 3,314,641 | 270,478 | 3,314,641 | 5,399,517 | 780,198 | 270,478 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.001 | $ 1.11 | $ 0.001 | $ 2 | $ 0.001 | $ 1.11 | ||||||||
Fair value adjustment of warrants | $ 2,300,000 | |||||||||||||
Warrants exercised | 200,000 | |||||||||||||
Noncompensatory Equity Classified Warrants [Member] | Investor [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Purchase of warrants | 1,000,000 | 1,920,678 | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.01 | $ 5.25 | ||||||||||||
Noncompensatory Equity Classified Warrants [Member] | Warrant [Member] | Investor [Member] | ||||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||||
Purchase of warrants | 1,287,829 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6 |
SCHEDULE OF ERROR CORRECTIONS A
SCHEDULE OF ERROR CORRECTIONS AND PRIOR PERIOD ADJUSTMENTS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Gain on change in fair value of warrant liabilities | $ (1,019,342) | $ (4,299,000) | $ 300,000 | ||
Net loss | $ (3,825,109) | $ (3,037,482) | $ (12,268,300) | $ (13,678,278) | |
Net loss per common share | $ (0.10) | $ (0.10) | $ (0.33) | $ (0.48) | |
Previously Reported [Member] | |||||
Gain on change in fair value of warrant liabilities | $ (1,942,900) | $ (6,140,900) | |||
Net loss | $ (2,858,518) | $ (11,836,378) | |||
Net loss per common share | $ (0.10) | $ (0.41) | |||
Revision of Prior Period, Error Correction, Adjustment [Member] | |||||
Gain on change in fair value of warrant liabilities | $ (1,763,936) | $ (4,299,000) | |||
Net loss | $ (3,037,482) | $ (13,678,278) | |||
Net loss per common share | $ (0.10) | $ (0.48) |