Qualigen Therapeutics (QLGN) 10-Q 15 Nov 21 2021 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Sep. 30, 2021	Nov. 11, 2021
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2021
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2021
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		29,117,100

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Current assets
Cash and cash equivalents	$ 12,319,809	$ 23,976,570
Accounts receivable, net	633,550	615,757
Inventory, net	1,178,007	953,458
Prepaid expenses and other current assets	1,601,512	2,678,894
Total current assets	15,732,878	28,224,679
Right-of-use assets	264,140	430,795
Property and equipment, net	208,958	247,323
Equipment held for lease, net	2,693	17,947
Intangible assets, net	177,562	187,694
Other assets	18,334	18,334
Total Assets	16,404,564	29,126,772
Current liabilities
Accounts payable	908,703	500,768
Accrued expenses and other current liabilities	1,799,431	746,738
Notes payable, current portion		131,766
Deferred revenue, current portion	270,761	486,031
Operating lease liability, current portion	278,901	254,739
Warrant liabilities	2,169,200	8,310,100
Total current liabilities	5,426,996	10,430,142
Notes payable, net of current portion		6,973
Operating lease liability, net of current portion	24,993	236,826
Deferred revenue, net of current portion	106,493	158,271
Total liabilities	5,558,482	10,832,212
Stockholders’ equity
Series Alpha convertible preferred stock, $0.001 par value; 7,000 shares authorized; 180 shares issued and outstanding as of September 30, 2021 and December 31, 2020	1	1
Common stock, $0.001 par value; 225,000,000 shares authorized; 29,082,069 and 27,296,061 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively	29,082	27,296
Additional paid-in capital	89,500,869	85,114,755
Accumulated deficit	(78,683,870)	(66,847,492)
Total stockholders’ equity	10,846,082	18,294,560
Total Liabilities & Stockholders’ Equity	$ 16,404,564	$ 29,126,772

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2021	Dec. 31, 2020
Statement of Financial Position [Abstract]
Series Alpha convertible preferred stock, par value	$ 0.001	$ 0.001
Series Alpha convertible preferred stock, shares authorized	7,000	7,000
Series Alpha convertible preferred stock, shares issued	180	180
Series Alpha convertible preferred stock, shares outstanding	180	180
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	225,000,000	225,000,000
Common stock, shares issued	29,082,069	27,296,061
Common stock, shares outstanding	29,082,069	27,296,061

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
REVENUES
Total revenues	$ 1,155,065	$ 837,714	$ 4,172,496	$ 3,198,536
EXPENSES
Cost of product sales	993,120	921,475	3,112,224	2,721,049
General and administrative	2,756,323	2,664,658	8,582,362	5,562,650
Research and development	2,083,315	870,876	10,091,155	1,706,280
Sales and marketing	130,217	98,045	402,347	279,151
Total expenses	5,962,976	4,555,054	22,188,087	10,269,130
LOSS FROM OPERATIONS	(4,807,910)	(3,717,340)	(18,015,591)	(7,070,594)
OTHER (INCOME) EXPENSE, NET
Loss (gain) on change in fair value of warrant liabilities	(1,942,900)	4,395,300	(6,140,900)	20,596,700
Interest (income) expense, net	(6,801)	715	(36,862)	148,836
Other (income) expense, net	(702)	(2,447)	(3,596)	(253,719)
Total other (income) expense, net	(1,950,403)	4,393,568	(6,181,358)	20,491,817
LOSS BEFORE PROVISION FOR INCOME TAXES	(2,857,507)	(8,110,908)	(11,834,233)	(27,562,411)
PROVISION FOR INCOME TAXES	1,011	2,305	2,146	2,283
NET LOSS	$ (2,858,518)	$ (8,113,213)	$ (11,836,378)	$ (27,564,694)
Net loss per common share, basic and diluted	$ (0.10)	$ (0.41)	$ (0.41)	$ (2.41)
Weighted—average number of shares outstanding, basic and diluted	29,026,211	19,799,468	28,683,972	11,434,649
Net Product Sales [Member]
REVENUES
Total revenues	$ 1,155,065	$ 837,714	$ 3,693,842	$ 3,153,536
License Revenue [Member]
REVENUES
Total revenues			478,654
Collaborative Research Revenue [Member]
REVENUES
Total revenues				$ 45,000

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)	Series A Convertible Preferred Stock [Member]Preferred Stock [Member]	Series B Convertible Preferred Stock [Member]Preferred Stock [Member]	Series C Convertible Preferred Stock [Member]Preferred Stock [Member]	Series D Convertible Preferred Stock [Member]Preferred Stock [Member]	Series D One Convertible Preferred Stock [Member]Preferred Stock [Member]	Series Alpha Convertible Preferred Stock [Member]Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance at Dec. 31, 2019	$ 24,129	$ 77,077	$ 33,007	$ 15,083	$ 6,435		$ 56,026	$ 45,153,733	$ (46,428,550)	$ (1,063,060)
Balance, shares at Dec. 31, 2019	2,412,887	7,707,736	3,300,715	1,508,305	643,511		5,602,214
Stock-based compensation								7,866		7,866
Net Loss									(872,576)	(872,576)
Balance at Mar. 31, 2020	$ 24,129	$ 77,077	$ 33,007	$ 15,083	$ 6,435		$ 56,026	45,161,599	(47,301,126)	(1,927,770)
Balance, shares at Mar. 31, 2020	2,412,887	7,707,736	3,300,715	1,508,305	643,511		5,602,214
Balance at Dec. 31, 2019	$ 24,129	$ 77,077	$ 33,007	$ 15,083	$ 6,435		$ 56,026	45,153,733	(46,428,550)	(1,063,060)
Balance, shares at Dec. 31, 2019	2,412,887	7,707,736	3,300,715	1,508,305	643,511		5,602,214
Net Loss										(27,564,694)
Balance at Sep. 30, 2020						$ 1	$ 22,530	71,082,072	(73,993,244)	(2,888,641)
Balance, shares at Sep. 30, 2020						698	22,529,905
Balance at Mar. 31, 2020	$ 24,129	$ 77,077	$ 33,007	$ 15,083	$ 6,435		$ 56,026	45,161,599	(47,301,126)	(1,927,770)
Balance, shares at Mar. 31, 2020	2,412,887	7,707,736	3,300,715	1,508,305	643,511		5,602,214
Issuance of common stock for conversion of preferred stock	$ (24,129)	$ (77,077)	$ (33,007)	$ (15,083)	$ (6,435)	$ (1)	$ 7,042	148,690
Issuance of common stock for conversion of preferred stock, shares	(2,412,887)	(7,707,736)	(3,300,715)	(1,508,305)	(643,511)	(740)	7,042,660
Issuance of common stock for conversion of notes payable and accrued interest							$ 1,775	1,582,633		1,584,408
Issuance of common stock for conversion of notes payable and accrued interest, shares							1,775,096
Issuance of Series Alpha preferred shares upon closing of private placement						$ 5		4,009,995		4,010,000
Issuance of Series Alpha preferred shares upon closing of private placement, shares						5,010
Effect of reverse recapitalization							$ (52,519)	863,405		810,886
Effect of reverse recapitalization, shares							(2,095,826)
Issuance of Series Alpha preferred stock for conversion of notes payable								350,000		350,000
Issuance of Series Alpha preferred stock for conversion of notes payable, shares						350
Shares and warrants issued to advisor upon closing of private placement							$ 1,217	1,103,891		1,105,108
Shares and warrants issued to advisor upon closing of private placement, shares							1,217,147
Fair value of shares issued to advisor upon closing of private placement								902,250		902,250
Fair value of warrants issued to advisor upon closing of private placement								(202,858)		(202,858)
Stock issued for professional services							$ 47	239,953		240,000
Stock issued for professional services, shares							46,967
Stock-based compensation								358,625		358,625
Net Loss									(18,578,905)	(18,578,905)
Balance at Jun. 30, 2020						$ 4	$ 13,588	52,713,683	(65,880,031)	(13,152,756)
Balance, shares at Jun. 30, 2020						4,620	13,588,258
Issuance of common stock for conversion of preferred stock						$ (3)	$ 5,303	(5,300)
Issuance of common stock for conversion of preferred stock, shares						(3,922)	5,303,773
Shares and (exercised) warrants issued pursuant to Securities Purchase Agreements							$ 3,639	17,997,142		18,000,781
Shares and (exercised) warrants issued pursuant to Securities Purchase Agreements, shares							3,637,874
Commission and offering costs of Securities Purchase Agreements								(835,904)		(835,904)
Stock-based compensation								1,212,451		1,212,451
Net Loss									(8,113,213)	(8,113,213)
Balance at Sep. 30, 2020						$ 1	$ 22,530	71,082,072	(73,993,244)	(2,888,641)
Balance, shares at Sep. 30, 2020						698	22,529,905
Balance at Dec. 31, 2020						$ 1	$ 27,296	85,114,755	(66,847,492)	18,294,560
Balance, shares at Dec. 31, 2020						180	27,296,061
Stock issued upon cash-exercise of warrants							$ 1,320	243,261		244,581
Stock issued upon cash-exercise of warrants, shares							1,319,625
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
Stock issued for professional services, shares							25,000
Stock-based compensation								1,262,123		1,262,123
Net Loss									(3,672,627)	(3,672,627)
Balance at Mar. 31, 2021						$ 1	$ 28,833	86,721,672	(70,520,119)	16,230,387
Balance, shares at Mar. 31, 2021						180	28,833,059
Balance at Dec. 31, 2020						$ 1	$ 27,296	85,114,755	(66,847,492)	18,294,560
Balance, shares at Dec. 31, 2020						180	27,296,061
Net Loss										(11,836,378)
Balance at Sep. 30, 2021						$ 1	$ 29,082	89,500,869	(78,683,870)	10,846,082
Balance, shares at Sep. 30, 2021						180	29,082,069
Balance at Mar. 31, 2021						$ 1	$ 28,833	86,721,672	(70,520,119)	16,230,387
Balance, shares at Mar. 31, 2021						180	28,833,059
Stock issued upon cash-exercise of warrants							$ 69	49,669		49,738
Stock issued upon cash-exercise of warrants, shares							69,129
Stock-based compensation								1,286,926		1,286,926
Net Loss									(5,305,233)	(5,305,233)
Balance at Jun. 30, 2021						$ 1	$ 28,902	88,058,267	(75,825,352)	12,261,818
Balance, shares at Jun. 30, 2021						180	28,902,188
Stock issued upon cash-exercise of warrants							$ 180	129,245		129,425
Stock issued upon cash-exercise of warrants, shares							179,881
Stock-based compensation								1,313,357		1,313,357
Net Loss									(2,858,518)	(2,858,518)
Balance at Sep. 30, 2021						$ 1	$ 29,082	$ 89,500,869	$ (78,683,870)	$ 10,846,082
Balance, shares at Sep. 30, 2021						180	29,082,069

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (11,836,378)	$ (27,564,694)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Depreciation and amortization	82,404	110,279
Amortization of right-of-use assets	166,657	101,869
Accounts receivable reserves and allowances	15,295	(11,441)
Inventory reserves	20,040	76,233
Common stock issued for professional services	101,750
Stock-based compensation	3,862,406	1,578,942
Change in fair value of warrant liabilities	(6,140,900)	20,596,700
Changes in operating assets and liabilities:
Accounts receivable	(33,088)	798,097
Inventory and equipment held for lease	(138,885)	(223,948)
Prepaid expenses and other assets	1,077,381	(623,647)
Accounts payable	407,933	(295,088)
Accrued expenses and other current liabilities	1,052,693	(485,604)
Operating lease liability	(187,671)	(112,166)
Deferred revenue	(267,047)	(243,887)
Net cash used in operating activities	(11,817,410)	(6,298,355)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(117,463)	(137,945)
Payments for patents and licenses	(6,893)	(542,190)
Net cash used in investing activities	(124,356)	(680,135)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of Series Alpha preferred shares upon closing of private placement		4,010,000
Proceeds from issuance of shares and warrants to investor upon closing of Securities Purchase Agreement		18,000,781
Commission and offering costs of Securities Purchase Agreements		(835,904)
Net proceeds from the issuance of notes payable		1,682,661
Net proceeds from warrant exercises	423,744
Principal payments on notes payable	(138,739)	(1,542,203)
Net cash provided by financing activities	285,005	21,315,335
Net change in cash and cash equivalents	(11,656,761)	14,336,844
CASH AND CASH EQUIVALENTS - beginning of period	23,976,570	128,696
CASH AND CASH EQUIVALENTS - end of period	12,319,809	14,465,541
Cash paid during the year for:
Interest	1,233	47,729
Taxes	2,200	5,272
NONCASH FINANCING AND INVESTING ACTIVITIES:
Issuance of common stock for professional services		240,000
Issuance of common stock for conversion of debt		1,350,198
Issuance of common stock for conversion of accrued interest		234,210
Issuance of common stock for conversion of preferred stock		148,690
Issuance of preferred stock for conversion of debt		350,000
Fair value of shares issued to advisor upon closing of private placement		902,250
Fair value of warrants issued to advisor upon closing of private placement		202,858
Effect of reverse recapitalization		810,886
Initial measurement of operating lease right-of-use assets		663,110
Fair value of shares issued for cashless warrant exercises	722,970
Net transfers to inventory from equipment held for lease	$ 1,304	$ 5,439

ORGANIZATION AND SUMMARY OF SIG

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES	9 Months Ended
	Sep. 30, 2021
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 point-of-care quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. In May 2020, Qualigen, Inc. completed a reverse recapitalization transaction with Ritter Pharmaceuticals, Inc. (“Ritter”) and Ritter was renamed Qualigen Therapeutics, Inc. All shares of Qualigen, Inc.’s capital stock were exchanged for Qualigen Therapeutics, Inc.’s capital stock in the merger. Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,” commenced trading on the Nasdaq Capital Market, on a post-reverse-stock-split adjusted basis, under the trading symbol “QLGN” on May 26, 2020. Qualigen, Inc. was determined to be the accounting acquirer in a reverse recapitalization based upon the terms of the merger and other factors. All references to financial figures of the Company presented in the accompanying condensed consolidated financial statements and in these Notes through May 22, 2020 are to those of Qualigen, Inc. All references to financial figures after May 22, 2020 are to those of Qualigen Therapeutics, Inc. and Qualigen, Inc. Basis of Presentation The accompanying 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 Transition Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC on March 31, 2021. 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 Transition Report on Form 10-K have been omitted. The accompanying condensed consolidated balance sheet at December 31, 2020 has been derived from the audited balance sheet at December 31, 2020 contained in such Form 10-K. Principles of Consolidation The Company’s unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. 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. Accounting Estimates Management uses estimates and assumptions in preparing its condensed consolidated financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses. The most significant estimates relate to the estimated fair value of warrant liabilities, stock-based compensation, amortization and depreciation, inventory reserves, allowances for doubtful accounts and returns, and warranty reserve. Actual results could vary from the estimates that were used. Cash and Cash Equivalents 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. The Company maintains its cash and cash equivalents in bank deposits which at times may exceed federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risks on cash and cash equivalents. 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 specific reserves for identified items. 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, 2021 and 2020, 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 creditworthiness 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 provides an allowance for doubtful accounts and returns equal to the estimated uncollectible amounts or expected returns. The Company’s estimates are based on historical collections and returns and a review of the current status of trade accounts receivable. Accounts receivable is comprised of the following at: SCHEDULE OF ACCOUNTS RECEIVABLE September 30, 2021 December 31, 2020 Accounts Receivable $ 662,718 $ 629,630 Less Allowances (29,168 ) (13,873 ) Accounts receivable, net $ 633,550 $ 615,757 Research and Development The Company expenses research and development costs as incurred. 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 $ 29,000 32,000 88,000 86,000 3,000 2,000 8,000 Revenue from Contracts with Customers Effective April 1, 2020, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers The core principle of ASC 606 is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. 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 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, 2021 and 2020, the Company recognized license revenue of $ 0 0 479 0 Collaborative Research Revenue Prior to the adoption of ASC 606, the Company recognized research revenue over the term of various agreements, as negotiated contracted amounts were earned or reimbursable costs were incurred related to those agreements. Negotiated contracted amounts were earned in relative proportion to the performance required under the applicable contracts. Any amounts received prior to satisfying these revenue recognition criteria were recorded as deferred revenue. To determine revenue recognition for contracts with customers within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies the relevant performance obligations. Collaborative research revenue is recognized as research services are performed over the development periods for each agreement. During the three months ended September 30, 2021 and 2020, the Company recognized collaborative research revenue of $ 0 0 0 45,000 Contract 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 provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. Prior to the adoption of ASC 606 effective April 1, 2020 (using the modified retrospective approach), the Company accounted for its revenue arrangements under ASC 605, Revenue Recognition (“ASC 605”). Under ASC 605, revenue arrangements with multiple deliverables were evaluated for proper accounting treatment. In these arrangements, the Company recorded revenue as separate units of accounting if the delivered items have value to the customer on a stand-alone basis, if the arrangement includes a general right of return relative to the delivered items, and if delivery or performance of the undelivered items is considered probable and substantially within the Company’s control. Under ASC 605, revenues from product sales which included both the analyzer and various immunoassay products (“reagents”) were generally recognized upon shipment, as no significant continuing performance obligations remained post shipment. Cash payments received in advance were classified as deferred revenue and recorded as a liability. The Company was generally not contractually obligated to accept returns, except for defective products. Revenue was recorded net of an allowance for estimated returns. Multiple element arrangements included contracts that combined both the Company’s analyzer and a customer’s future reagent purchases under a single contract. In some sales contracts, the Company provided analyzers at no charge to customers. Title to the analyzer was maintained by the Company and the analyzer was returned by the customer to the Company at the end of the purchase agreement. During the three months ended September 30, 2021 and 2020, product sales are stated net of an allowance for estimated returns of approximately $ 0 30,000 1,000 6,000 Deferred Revenue Prior to the adoption of ASC 606, payments received in advance from customers pursuant to certain collaborative research and 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 balance sheet date to the future date of revenue recognition. The adoption of ASC 606 had no material effect on deferred revenue. Operating Leases The Company adopted ASC Topic 842, Leases nd Note 8 for more information. Property and Equipment, Net Property and equipment are stated at cost and are presented net of accumulated depreciation. Depreciation is provided for on a straight-line basis over the estimated useful lives of the related assets as follows: SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT Machinery and equipment 5 Computer equipment 3 Molds and tooling 5 Furniture and fixtures 5 Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or their estimated useful lives. The Company occasionally designs and builds its own machinery. The costs of these projects, which includes the cost of construction and other direct costs attributable to the construction, are capitalized as construction in progress. No provision for depreciation is made on construction in progress until the relevant assets are completed and placed in service. The Company’s policy is to evaluate the remaining lives and recoverability of long-term assets on at least an annual basis or when conditions are present that indicate impairment. Intangible Assets, Net Intangibles consist of patent-related costs and costs for in-license agreements. Management reviews the carrying value of 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 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 The carrying value of the patents of approximately $ 164,000 169,000 315,000 303,000 4,000 3,000 12,000 10,000 4,000 19,000 18,000 15,000 14,000 94,000 The carrying value of the in-licenses of approximately $ 14,000 19,000 405,000 400,000 2,000 5,000 2,000 7,000 5,000 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. 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 7). 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 and cash equivalents, accounts receivable, accounts payable, accrued liabilities, and debt 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-issued stock options could change significantly. Higher volatility 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. The components of the deferred tax asset and liability are individually classified as current and noncurrent based on their characteristics. 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 balance sheet as cash is collected from customers and remitted to the tax authority. Warranty Reserve 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 $ 51,000 25,000 24,000 28,000 72,000 89,000 Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, employee stock purchase plan rights, restricted stock units, and warrants, and convertible preferred stock are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be anti-dilutive. The Company incurred net losses for all periods presented and there were no reconciling items for potentially dilutive securities. More specifically, at September 30, 2021 and 2020, stock options, warrants, and convertible preferred stock exercisable or convertible for approximately 13.7 14.8 Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments, which supersedes current guidance by requiring recognition of credit losses when it is probable that a loss has been incurred. The new standard requires the establishment of an allowance for estimated credit losses on financial assets including trade and other receivables at each reporting date. The new standard will result in earlier recognition of allowances for losses on trade and other receivables and other contractual rights to receive cash. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842), which extends the effective date of Topic 326 for certain companies until fiscal years beginning after December 15, 2022. The new standard will be effective for the Company in the first quarter of the fiscal year beginning January 1, 2023, and early adoption is permitted. The Company has not completed its review of the impact of this standard on its consolidated financial statements. However, based on the Company’s history of immaterial credit losses from trade receivables, management does not expect that the adoption of this standard will have a material effect on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement,” an amendment to the accounting guidance on fair value measurements. The guidance modifies the disclosure requirements on fair value measurements, including the removal of disclosures of the amount of and reasons for transfers between Level 1 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements. The guidance also adds certain disclosure requirements related to Level 3 fair value measurements. The guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted ASU No. 2018-13 on April 1, 2020 and the adoption of this guidance did not have a material impact on its financial statements. In August 2020, the FASB issued ASU No. 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under prior U.S. GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. ASU 2020-06 is effective for the Company for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020 and adoption must be as of the beginning of the Company’s annual fiscal year. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. Other accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s condensed consolidated financial statements.

LIQUIDITY

LIQUIDITY	9 Months Ended
	Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
LIQUIDITY	NOTE 2 — LIQUIDITY The Company has incurred recurring losses from operations and has an accumulated deficit at September 30, 2021, and the Company expects to continue to incur losses subsequent to the balance sheet date of September 30, 2021. The Company’s reverse recapitalization transaction with Ritter closed in May 2020 together with an associated new equity capital raise of approximately $ 4.0 1.9 30.0

INVENTORY, NET

INVENTORY, NET	9 Months Ended
	Sep. 30, 2021
Inventory Disclosure [Abstract]
INVENTORY, NET	NOTE 3 — INVENTORY, NET Inventory, net consisted of the following at September 30, 2021 and December 31, 2020: SCHEDULE OF INVENTORY September 30, 2021 December 31, 2020 Raw materials $ 749,730 $ 579,765 Work in process 345,913 309,826 Finished goods 82,364 63,867 Inventory net $ 1,178,007 $ 953,458 As of September 30, 2021 and December 31, 2020, total inventory is recorded net of inventory reserves of $ 128,000 108,000

PREPAID EXPENSES AND OTHER CURR

PREPAID EXPENSES AND OTHER CURRENT ASSETS	9 Months Ended
	Sep. 30, 2021
Prepaid Expenses And Other Current Assets
PREPAID EXPENSES AND OTHER CURRENT ASSETS	NOTE 4 — PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following at September 30, 2021 and December 31, 2020: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS September 30, 2021 December 31, 2020 Prepaid insurance $ 1,528,472 $ 1,307,864 Prepaid manufacturing expenses 45,579 1,181,029 Prepaid investor relations expenses — 150,000 Other prepaid expenses 27,461 40,001 Prepaid expenses and other current assets $ 1,601,512 $ 2,678,894

PROPERTY AND EQUIPMENT, NET

PROPERTY AND EQUIPMENT, NET	9 Months Ended
	Sep. 30, 2021
Property, Plant and Equipment [Abstract]
PROPERTY AND EQUIPMENT, NET	NOTE 5 — PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following at September 30, 2021 and December 31, 2020: SCHEDULE OF PROPERTY AND EQUIPMENT September 30, 2021 December 31, 2020 Machinery and equipment $ 2,477,913 $ 2,401,470 Construction in progress–equipment — 104,400 Computer equipment 338,415 443,865 Leasehold improvements 327,894 321,033 Molds and tooling 260,002 260,002 Furniture and fixtures 143,013 138,699 3,547,237 3,669,469 Less Accumulated depreciation (3,338,279 ) (3,422,146 ) $ 208,958 $ 247,323 Depreciation expense relating to property and equipment was approximately $ 19,000 10,000 51,000 28,000

ACCRUED EXPENSES AND OTHER CURR

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	9 Months Ended
	Sep. 30, 2021
Payables and Accruals [Abstract]
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES	NOTE 6 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consisted of the following at September 30, 2021 and December 31, 2020: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES September 30, 2021 December 31, 2020 Board compensation $ 17,500 $ 15,091 Bonus 280,839 — Consulting 154,400 — Franchise, sales and use taxes 15,771 30,353 Income taxes 3,272 3,326 Patent and license fees — 7,204 Payroll 101,514 4,566 Professional fees 107,686 58,261 Research and development 751,820 237,504 Royalties 8,294 491 Vacation 267,766 230,457 Warranty costs 50,783 24,871 Other 39,786 134,614 Accrued expenses and other current liabilities $ 1,799,431 $ 746,738

WARRANT LIABILITIES

WARRANT LIABILITIES	9 Months Ended
	Sep. 30, 2021
Warrant Liabilities
WARRANT LIABILITIES	NOTE 7 – 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. The Series C Warrants were classified as liabilities, but had minimal fair value prior to the merger with Ritter. 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 2.1 2.7 The following table summarizes the activity in the warrants received in exchange for the Series C Warrants for the nine months ended September 30, 2021: SCHEDULE OF WARRANTS ACTIVITY Common Stock Warrants (received in exchange for the Series C Warrants) Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining (Years) 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 Of the 722,618 156,861 The following table summarizes the activity in the warrants received in exchange for the Series C Warrants activity for the nine months ended September 30, 2020: Common Stock Warrants (received in exchange for the Series C Warrants) Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Lifevv (Years) Total outstanding – December 31, 2019 — $ — Series C preferred stock warrants exchanged for common stock warrants upon reverse recapitalization 4,713,490 0.72 Forfeited — — Expired — — Granted — — Total outstanding – September 30, 2020 4,713,490 $ 0.72 Exercisable 4,713,490 $ 0.72 $ 0.72 3.57 The following table presents the Company’s fair value hierarchy for its warrant liabilities (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, 2021: SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES Warrant liabilities Quoted Significant Significant Total Balance as of December 31, 2020 $ — $ — $ 8,310,100 $ 8,310,100 Change in fair value of warrant liabilities — — (6,140,900 ) (6,140,900 ) Balance as of September 30, 2021 $ — $ — $ 2,169,200 $ 2,169,200 There were no transfers of financial assets or liabilities between category levels for the three and nine months ended September 30, 2021. During the nine months ended September 30, 2021 the Company recorded $ 6.1 2.2 8.31 20.6 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, 2021 and December 31, 2020: SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES September 30, 2021 December 31, 2020 Range Risk-free interest rate 0.31 0.46 % 0.17 0.22 % Expected volatility (peer group) 82.00 — 86.00 % 82.00 % Term of warrants (in years) 2.14 2.74 2.90 3.49 Expected dividend yield 0.00 % 0.00 %

LEASES

LEASES	9 Months Ended
	Sep. 30, 2021
Leases
LEASES	NOTE 8 — LEASES The Company leases its facilities under a long-term operating lease agreement expiring in October 2022. The tables below show the operating lease right-of-use assets and operating lease liabilities as of December 31, 2020 and September 30, 2021, including the changes during the periods: SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES Operating lease right-of-use assets Net right-of-use assets at December 31, 2020 $ 430,795 Less amortization of operating lease right-of-use assets (166,655 ) Operating lease right-of-use assets at September 30, 2021 $ 264,140 Operating lease liabilities Lease liabilities arising from obtaining right-of-use assets at April 1, 2020: $ 491,565 Less principal payments on operating lease liabilities (187,671 ) Lease liabilities at September 30, 2021 303,894 Less non-current portion (24,993 ) Current portion at September 30, 2021 $ 278,901 As of September 30, 2021, the Company’s operating leases have a weighted-average remaining lease term of 1.1 8.9 As of September 30, 2021, 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 2021 (nine months) $ 73,335 2022 246,650 2023 — Total 319,985 Less present value discount (16,091 ) Operating lease liabilities $ 303,894 Total lease expense was approximately $ 83,000 86,000 255,000 257,000

RESEARCH AND LICENSE AGREEMENTS

RESEARCH AND LICENSE AGREEMENTS	9 Months Ended
	Sep. 30, 2021
Research And License Agreements
RESEARCH AND LICENSE AGREEMENTS	NOTE 9 — RESEARCH AND LICENSE AGREEMENTS The University of Louisville Research Foundation Between June 2018 and September 2020, the Company entered into license and sponsored research agreements with the University of Louisville Research Foundation (“ULRF”) for QN-247, a novel aptamer-based compound that has shown promise as an anticancer drug. Under the agreements, the Company 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 5,000,000 100,000 200,000 350,000 500,000 500,000,000 10,000 50,000 Sponsored research expenses related to these agreements for the three months ended September 30, 2021 and 2020 were approximately $ 83,000 0 235,000 2,000 0 0 0 10,000 50,000 0 103,000 0 In March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with ULRF for development of several small-molecule RAS interaction inhibitor drug candidates. Under the terms of this agreement, the Company will reimburse ULRF for sponsored research expenses of up to $693,000 for this program. In February 2021, the Company extended the term of this agreement for an additional 18 months (expires July 2022) and increased the amount that the Company will reimburse ULRF for sponsored research expenses from $ 693,000 1.8 112,000 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 these agreements for the three months ended September 30, 2021 and 2020 were approximately $ 264,000 50,000 469,000 297,000 18,000 0 58,000 0 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 will take 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 has 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 Sponsored research expenses related to these agreements for the three months ended September 30, 2021 and 2020 were approximately $ 12,000 and $ 0 , respectively, and for the nine months ended September 30, 2021 and 2020 were approximately $ 106,000 and $ 0 , respectively, and are recorded in research and development expenses in the statements of operations. License costs related to these agreements for the three months ended September 30, 2021 and 2020 were approximately $ 11,000 and $ 0 , respectively, and for the nine months ended September 30, 2021 and 2020 were approximately $ 27,000 and $ 0 , respectively, and are recorded in research and development expenses in the statements of operations. Advanced Cancer Therapeutics In December 2018, the Company entered into a license agreement with Advanced Cancer Therapeutics, LLC (“ACT”), granting the Company exclusive rights to develop and commercialize QN-165, an aptamer-based drug candidate. In return, ACT received a $ 25,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s common stock. In addition, the Company agreed to pay ACT (i) royalties, on net sales associated with the commercialization of QN-165, of 2% (only if patent-covered and only on net sales above a cumulative $3,000,000) or 1% (if not patent-covered, but only on net sales above a cumulative $3,000,000) , until the 15th anniversary of the ACT license agreement and (ii) milestone payments of $ 100,000 for the Company raising a cumulative total of $ 2,000,000 in new equity financing after the date of the ACT license agreement, $ 100,000 upon any first QN-165-based licensed product receiving the CE Mark or similar FDA status, and $ 500,000 upon cumulative worldwide QN-165-based licensed product net sales reaching $ 3,000,000 . For the three months ended September 30, 2021 and 2020, there were $0 and $100,000 in license costs, respectively, and for the nine months ended September 30, 2021 and 2020, there were approximately $ 2,000 and $ 110,000 , Prediction Biosciences In November 2015, the Company entered into a long-term development and supply agreement with Prediction Biosciences SAS to develop and manufacture diagnostic tests for use in the stroke point-of-care market. The Company recognizes development revenue and product sales over the performance period of the contract. For the three months ended September 30, 2021 and 2020 there was $ 0 0 45,000 Sekisui Diagnostics 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 is currently set to expire on March 31, 2022. The agreement contains a right of first refusal for Sekisui against any potential acquisition of the Company; the right of first refusal is currently set to expire on March 31, 2022. There were product sales to Sekisui of approximately $ 810,000 476,000 2.5 1.9 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. Under the Technology Transfer Agreement, the Company received net cash payments of $ 250,000 420,000 38,000 479,000 153,000 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); any such non-China sales would, until March 31, 2022, need to be through Sekisui. In addition, after March 31, 2022, Yi Xin will have the right to sell Yi Xin-manufactured versions of existing FastPack 1.0, IP and PRO product lines worldwide (other than in the United States and other than to or toward current non-US customers of those products). Also, after March 31, 2022, Yi Xin will have 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 US customers of those products); the Company did not license Yi Xin to sell in the United States market any Yi Xin-manufactured versions of those legacy FastPack 1.0, IP and PRO product lines, even after March 31, 2022. In the Technology Transfer Agreement, the Company confirmed that it would not, after March 31, 2022, seek new FastPack customers outside the United States. All of the March 31, 2022 dates in this paragraph are as established by an August 2021 amendment of the Technology Transfer Agreement. STA Pharmaceutical In November 2020, the Company entered into a contract with STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, for GMP production of QN-165, the Company’s lead drug candidate for the treatment of COVID-19 and other viral diseases, for potential clinical trials in 2021. In connection with this agreement, the Company paid an upfront deposit of approximately $ 1.1 Research and development expenses related to this agreement for the three months ended September 30, 2021 and 2020 were approximately $ 118,000 0 3.2 0

STOCKHOLDERS_ EQUITY

STOCKHOLDERS’ EQUITY	9 Months Ended
	Sep. 30, 2021
Equity [Abstract]
STOCKHOLDERS’ EQUITY	NOTE 10 — STOCKHOLDERS’ EQUITY As of September 30, 2021 and December 31, 2020, the Company had two classes of 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, 2021 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, 2021, the Company has reserved 13,737,576 SCHEDULE OF RESERVED SHARES Exercise of outstanding stock options 4,133,856 Exercise of outstanding stock warrants 9,360,302 Conversion of outstanding Series Alpha preferred stock 243,418 Total 13,737,576 Series Alpha Preferred Stock In the nine-month period ended September 30, 2021, no shares of Series Alpha convertible preferred stock were converted into shares of the Company’s common stock, and there were 180 Alpha Securities Purchase Agreements On July 10, 2020, the Company closed a Securities Purchase Agreement (dated July 8, 2020) with a single institutional investor for the purchase and sale for $ 8.0 1,140,570 780,198 1,920,768 5.25 9.99 780,198 On August 4, 2020, the Company closed a Securities Purchase Agreement (dated August 2, 2020) with a single institutional investor for the purchase and sale for $ 10.0 1,717,106 1,287,829 6.00 9.99 On December 18, 2020, the Company closed a Securities Purchase Agreement (dated December 16, 2020) with a single institutional investor for the purchase and sale for $ 12,000,000 2,370,786 1,000,000 1,348,314 4.07 842,696 4.07 9.99 1,000,000 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 nonstatutory common stock options to qualified employees, officers, directors, consultants and other service providers. At September 30, 2021 and December 31, 2020 there were 4,040,000 3,917,500 3,517,157 139,657 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, 2021, and changes during the nine-month period then ended: SCHEDULE OF STOCK OPTION ACTIVITY Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 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 There was approximately $ 1.3 1.2 3.9 1.6 8.9 1.73 No 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. 1.68 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 For the nine Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility 102 % 102 % Risk-free interest rate 0.84 1.18 % 0.33 0.59 % Expected average term of options 6.0 6.0 Stock price $ 2.12 $ 4.70 5.13 The Company recorded share-based compensation expense and classified it in the condensed consolidated statements of operations as follows: SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE For the nine months ended 2021 2020 General and administrative $ 3,329,310 $ 1,317,263 Research and development 533,096 261,679 Total $ 3,862,406 $ 1,578,942 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 No compensatory warrants were issued during the nine months ended September 30, 2021. The following table summarizes the activity in the common stock equity classified compensatory warrants received in exchange for the Series C convertible preferred stock equity classified compensatory warrants for the nine months ended September 30, 2021: SCHEDULE OF WARRANT ACTIVITY Common Stock Weighted– Range of Weighted– Exercise Exercise Life Shares Price Price (Years) Total outstanding – December 31, 2020 1,294,217 $ 1.66 Common stock warrants received in exchange for Series C preferred stock warrants upon reverse recapitalization - - 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 — $ — $ — — Of the 38,390 35,512 The following table summarizes the activity in the common stock equity classified compensatory warrants received in exchange for the Series C convertible preferred stock equity classified compensatory warrants for the nine months ended September 30, 2020: SCHEDULE OF WARRANT ACTIVITY Common Stock Weighted– Range of Weighted– Exercise Exercise Remaining Shares Price Price Life (Years) Total outstanding – December 31, 2019 — $ — Common stock warrants received in exchange for Series C preferred stock warrants upon reverse recapitalization 668,024 2.34 Granted to advisor and its designees 811,431 1.11 Expired — — Forfeited — — Total outstanding – September 30, 2020 1,479,455 $ 1.67 Exercisable 664,428 $ 2.34 $ 2.07 2.54 3.78 Non-Exercisable 815,027 $ 1.11 $ 1.11 2.54 4.65 There were no 8,000 no 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 The following table summarizes the noncompensatory equity classified warrant activity for the nine months ended September 30, 2021: SCHEDULE OF WARRANT ACTIVITY Common Stock Weighted– Range of Weighted– Exercise Exercise Life Shares Price Price (Years) Total outstanding – December 31, 2020 6,549,777 $ 4.37 Granted — — Exercised (1,000,000 ) 0.01 Expired — — Forfeited — — Total outstanding – September 30, 2021 5,549,777 $ 5.15 Exercisable 5,549,777 $ 5.15 $ 1.11 2,325.00 1.08 Non-Exercisable — $ — — —

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	9 Months Ended
	Sep. 30, 2021
Related Party Transactions [Abstract]
RELATED PARTY TRANSACTIONS	NOTE 11 — RELATED PARTY TRANSACTIONS In October 2017, Sekisui purchased all outstanding shares of the Company’s Series D and Series D-1 preferred stock from Gen-Probe Incorporated. As such, Sekisui became a related party as of October 2017. These Series D and Series D-1 preferred stock shares were converted into 1,980,233

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Sep. 30, 2021
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 12 — SUBSEQUENT EVENTS Management has evaluated subsequent events pursuant to the requirements of ASC Topic 855, Subsequent Events

ORGANIZATION AND SUMMARY OF S_2

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Policies)	9 Months Ended
	Sep. 30, 2021
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 point-of-care quantitative immunoassay diagnostic products for use in physician offices and other point-of-care settings worldwide, and was reincorporated in Delaware in 1999. Qualigen Therapeutics, Inc. (the “Company”) operates in one business segment. In May 2020, Qualigen, Inc. completed a reverse recapitalization transaction with Ritter Pharmaceuticals, Inc. (“Ritter”) and Ritter was renamed Qualigen Therapeutics, Inc. All shares of Qualigen, Inc.’s capital stock were exchanged for Qualigen Therapeutics, Inc.’s capital stock in the merger. Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,” commenced trading on the Nasdaq Capital Market, on a post-reverse-stock-split adjusted basis, under the trading symbol “QLGN” on May 26, 2020. Qualigen, Inc. was determined to be the accounting acquirer in a reverse recapitalization based upon the terms of the merger and other factors. All references to financial figures of the Company presented in the accompanying condensed consolidated financial statements and in these Notes through May 22, 2020 are to those of Qualigen, Inc. All references to financial figures after May 22, 2020 are to those of Qualigen Therapeutics, Inc. and Qualigen, Inc.
Basis of Presentation	Basis of Presentation The accompanying 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 Transition Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC on March 31, 2021. 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 Transition Report on Form 10-K have been omitted. The accompanying condensed consolidated balance sheet at December 31, 2020 has been derived from the audited balance sheet at December 31, 2020 contained in such Form 10-K.
Principles of Consolidation	Principles of Consolidation The Company’s unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. 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.
Accounting Estimates	Accounting Estimates Management uses estimates and assumptions in preparing its condensed consolidated financial statements in accordance with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues and expenses. The most significant estimates relate to the estimated fair value of warrant liabilities, stock-based compensation, amortization and depreciation, inventory reserves, allowances for doubtful accounts and returns, and warranty reserve. Actual results could vary from the estimates that were used.
Cash and Cash Equivalents	Cash and Cash Equivalents 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. The Company maintains its cash and cash equivalents in bank deposits which at times may exceed federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risks on cash and cash equivalents.
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 specific reserves for identified items.
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, 2021 and 2020, 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 creditworthiness 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 provides an allowance for doubtful accounts and returns equal to the estimated uncollectible amounts or expected returns. The Company’s estimates are based on historical collections and returns and a review of the current status of trade accounts receivable. Accounts receivable is comprised of the following at: SCHEDULE OF ACCOUNTS RECEIVABLE September 30, 2021 December 31, 2020 Accounts Receivable $ 662,718 $ 629,630 Less Allowances (29,168 ) (13,873 ) Accounts receivable, net $ 633,550 $ 615,757
Research and Development	Research and Development The Company expenses research and development costs as incurred.
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 $ 29,000 32,000 88,000 86,000 3,000 2,000 8,000
Revenue from Contracts with Customers	Revenue from Contracts with Customers Effective April 1, 2020, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers The core principle of ASC 606 is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. 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 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, 2021 and 2020, the Company recognized license revenue of $ 0 0 479 0 Collaborative Research Revenue Prior to the adoption of ASC 606, the Company recognized research revenue over the term of various agreements, as negotiated contracted amounts were earned or reimbursable costs were incurred related to those agreements. Negotiated contracted amounts were earned in relative proportion to the performance required under the applicable contracts. Any amounts received prior to satisfying these revenue recognition criteria were recorded as deferred revenue. To determine revenue recognition for contracts with customers within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies the relevant performance obligations. Collaborative research revenue is recognized as research services are performed over the development periods for each agreement. During the three months ended September 30, 2021 and 2020, the Company recognized collaborative research revenue of $ 0 0 0 45,000 Contract 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 provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. Prior to the adoption of ASC 606 effective April 1, 2020 (using the modified retrospective approach), the Company accounted for its revenue arrangements under ASC 605, Revenue Recognition (“ASC 605”). Under ASC 605, revenue arrangements with multiple deliverables were evaluated for proper accounting treatment. In these arrangements, the Company recorded revenue as separate units of accounting if the delivered items have value to the customer on a stand-alone basis, if the arrangement includes a general right of return relative to the delivered items, and if delivery or performance of the undelivered items is considered probable and substantially within the Company’s control. Under ASC 605, revenues from product sales which included both the analyzer and various immunoassay products (“reagents”) were generally recognized upon shipment, as no significant continuing performance obligations remained post shipment. Cash payments received in advance were classified as deferred revenue and recorded as a liability. The Company was generally not contractually obligated to accept returns, except for defective products. Revenue was recorded net of an allowance for estimated returns. Multiple element arrangements included contracts that combined both the Company’s analyzer and a customer’s future reagent purchases under a single contract. In some sales contracts, the Company provided analyzers at no charge to customers. Title to the analyzer was maintained by the Company and the analyzer was returned by the customer to the Company at the end of the purchase agreement. During the three months ended September 30, 2021 and 2020, product sales are stated net of an allowance for estimated returns of approximately $ 0 30,000 1,000 6,000 Deferred Revenue Prior to the adoption of ASC 606, payments received in advance from customers pursuant to certain collaborative research and 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 balance sheet date to the future date of revenue recognition. The adoption of ASC 606 had no material effect on deferred revenue.
Operating Leases	Operating Leases The Company adopted ASC Topic 842, Leases nd Note 8 for more information.
Property and Equipment, Net	Property and Equipment, Net Property and equipment are stated at cost and are presented net of accumulated depreciation. Depreciation is provided for on a straight-line basis over the estimated useful lives of the related assets as follows: SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT Machinery and equipment 5 Computer equipment 3 Molds and tooling 5 Furniture and fixtures 5 Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or their estimated useful lives. The Company occasionally designs and builds its own machinery. The costs of these projects, which includes the cost of construction and other direct costs attributable to the construction, are capitalized as construction in progress. No provision for depreciation is made on construction in progress until the relevant assets are completed and placed in service. The Company’s policy is to evaluate the remaining lives and recoverability of long-term assets on at least an annual basis or when conditions are present that indicate impairment.
Intangible Assets, Net	Intangible Assets, Net Intangibles consist of patent-related costs and costs for in-license agreements. Management reviews the carrying value of 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 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 The carrying value of the patents of approximately $ 164,000 169,000 315,000 303,000 4,000 3,000 12,000 10,000 4,000 19,000 18,000 15,000 14,000 94,000 The carrying value of the in-licenses of approximately $ 14,000 19,000 405,000 400,000 2,000 5,000 2,000 7,000 5,000
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. 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 7).
Fair Value Measurements	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 and cash equivalents, accounts receivable, accounts payable, accrued liabilities, and debt 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-issued stock options could change significantly. Higher volatility 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. The components of the deferred tax asset and liability are individually classified as current and noncurrent based on their characteristics. 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 balance sheet as cash is collected from customers and remitted to the tax authority.
Warranty Reserve	Warranty Reserve 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 $ 51,000 25,000 24,000 28,000 72,000 89,000
Net Loss Per Share	Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, employee stock purchase plan rights, restricted stock units, and warrants, and convertible preferred stock are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be anti-dilutive. The Company incurred net losses for all periods presented and there were no reconciling items for potentially dilutive securities. More specifically, at September 30, 2021 and 2020, stock options, warrants, and convertible preferred stock exercisable or convertible for approximately 13.7 14.8
Recent Accounting Pronouncements	Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments, which supersedes current guidance by requiring recognition of credit losses when it is probable that a loss has been incurred. The new standard requires the establishment of an allowance for estimated credit losses on financial assets including trade and other receivables at each reporting date. The new standard will result in earlier recognition of allowances for losses on trade and other receivables and other contractual rights to receive cash. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842), which extends the effective date of Topic 326 for certain companies until fiscal years beginning after December 15, 2022. The new standard will be effective for the Company in the first quarter of the fiscal year beginning January 1, 2023, and early adoption is permitted. The Company has not completed its review of the impact of this standard on its consolidated financial statements. However, based on the Company’s history of immaterial credit losses from trade receivables, management does not expect that the adoption of this standard will have a material effect on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement,” an amendment to the accounting guidance on fair value measurements. The guidance modifies the disclosure requirements on fair value measurements, including the removal of disclosures of the amount of and reasons for transfers between Level 1 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements. The guidance also adds certain disclosure requirements related to Level 3 fair value measurements. The guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted ASU No. 2018-13 on April 1, 2020 and the adoption of this guidance did not have a material impact on its financial statements. In August 2020, the FASB issued ASU No. 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under prior U.S. GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. ASU 2020-06 is effective for the Company for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020 and adoption must be as of the beginning of the Company’s annual fiscal year. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. Other accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s condensed consolidated financial statements.

ORGANIZATION AND SUMMARY OF S_3

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Tables)	9 Months Ended
	Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
SCHEDULE OF ACCOUNTS RECEIVABLE	Accounts receivable is comprised of the following at: SCHEDULE OF ACCOUNTS RECEIVABLE September 30, 2021 December 31, 2020 Accounts Receivable $ 662,718 $ 629,630 Less Allowances (29,168 ) (13,873 ) Accounts receivable, net $ 633,550 $ 615,757
SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT	Property and equipment are stated at cost and are presented net of accumulated depreciation. Depreciation is provided for on a straight-line basis over the estimated useful lives of the related assets as follows: SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT Machinery and equipment 5 Computer equipment 3 Molds and tooling 5 Furniture and fixtures 5

INVENTORY, NET (Tables)

INVENTORY, NET (Tables)	9 Months Ended
	Sep. 30, 2021
Inventory Disclosure [Abstract]
SCHEDULE OF INVENTORY	Inventory, net consisted of the following at September 30, 2021 and December 31, 2020: SCHEDULE OF INVENTORY September 30, 2021 December 31, 2020 Raw materials $ 749,730 $ 579,765 Work in process 345,913 309,826 Finished goods 82,364 63,867 Inventory net $ 1,178,007 $ 953,458

PREPAID EXPENSES AND OTHER CU_2

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)	9 Months Ended
	Sep. 30, 2021
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, 2021 and December 31, 2020: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS September 30, 2021 December 31, 2020 Prepaid insurance $ 1,528,472 $ 1,307,864 Prepaid manufacturing expenses 45,579 1,181,029 Prepaid investor relations expenses — 150,000 Other prepaid expenses 27,461 40,001 Prepaid expenses and other current assets $ 1,601,512 $ 2,678,894

PROPERTY AND EQUIPMENT, NET (Ta

PROPERTY AND EQUIPMENT, NET (Tables)	9 Months Ended
	Sep. 30, 2021
Property, Plant and Equipment [Abstract]
SCHEDULE OF PROPERTY AND EQUIPMENT	Property and equipment, net consisted of the following at September 30, 2021 and December 31, 2020: SCHEDULE OF PROPERTY AND EQUIPMENT September 30, 2021 December 31, 2020 Machinery and equipment $ 2,477,913 $ 2,401,470 Construction in progress–equipment — 104,400 Computer equipment 338,415 443,865 Leasehold improvements 327,894 321,033 Molds and tooling 260,002 260,002 Furniture and fixtures 143,013 138,699 3,547,237 3,669,469 Less Accumulated depreciation (3,338,279 ) (3,422,146 ) $ 208,958 $ 247,323

ACCRUED EXPENSES AND OTHER CU_2

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2021
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, 2021 and December 31, 2020: SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES September 30, 2021 December 31, 2020 Board compensation $ 17,500 $ 15,091 Bonus 280,839 — Consulting 154,400 — Franchise, sales and use taxes 15,771 30,353 Income taxes 3,272 3,326 Patent and license fees — 7,204 Payroll 101,514 4,566 Professional fees 107,686 58,261 Research and development 751,820 237,504 Royalties 8,294 491 Vacation 267,766 230,457 Warranty costs 50,783 24,871 Other 39,786 134,614 Accrued expenses and other current liabilities $ 1,799,431 $ 746,738

WARRANT LIABILITIES (Tables)

WARRANT LIABILITIES (Tables)	9 Months Ended
	Sep. 30, 2021
Warrant Liabilities
SCHEDULE OF WARRANTS ACTIVITY	The following table summarizes the activity in the warrants received in exchange for the Series C Warrants for the nine months ended September 30, 2021: SCHEDULE OF WARRANTS ACTIVITY Common Stock Warrants (received in exchange for the Series C Warrants) Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining (Years) 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 Common Stock Warrants (received in exchange for the Series C Warrants) Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Lifevv (Years) Total outstanding – December 31, 2019 — $ — Series C preferred stock warrants exchanged for common stock warrants upon reverse recapitalization 4,713,490 0.72 Forfeited — — Expired — — Granted — — Total outstanding – September 30, 2020 4,713,490 $ 0.72 Exercisable 4,713,490 $ 0.72 $ 0.72 3.57
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES	The following table presents the Company’s fair value hierarchy for its warrant liabilities (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, 2021: SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES Warrant liabilities Quoted Significant Significant Total Balance as of December 31, 2020 $ — $ — $ 8,310,100 $ 8,310,100 Change in fair value of warrant liabilities — — (6,140,900 ) (6,140,900 ) Balance as of September 30, 2021 $ — $ — $ 2,169,200 $ 2,169,200
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, 2021 and December 31, 2020: SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES September 30, 2021 December 31, 2020 Range Risk-free interest rate 0.31 0.46 % 0.17 0.22 % Expected volatility (peer group) 82.00 — 86.00 % 82.00 % Term of warrants (in years) 2.14 2.74 2.90 3.49 Expected dividend yield 0.00 % 0.00 %

LEASES (Tables)

LEASES (Tables)	9 Months Ended
	Sep. 30, 2021
Leases
SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES	The Company leases its facilities under a long-term operating lease agreement expiring in October 2022. The tables below show the operating lease right-of-use assets and operating lease liabilities as of December 31, 2020 and September 30, 2021, including the changes during the periods: SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES Operating lease right-of-use assets Net right-of-use assets at December 31, 2020 $ 430,795 Less amortization of operating lease right-of-use assets (166,655 ) Operating lease right-of-use assets at September 30, 2021 $ 264,140 Operating lease liabilities Lease liabilities arising from obtaining right-of-use assets at April 1, 2020: $ 491,565 Less principal payments on operating lease liabilities (187,671 ) Lease liabilities at September 30, 2021 303,894 Less non-current portion (24,993 ) Current portion at September 30, 2021 $ 278,901
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES	As of September 30, 2021, 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 2021 (nine months) $ 73,335 2022 246,650 2023 — Total 319,985 Less present value discount (16,091 ) Operating lease liabilities $ 303,894

STOCKHOLDERS_ EQUITY (Tables)

STOCKHOLDERS’ EQUITY (Tables)	9 Months Ended
	Sep. 30, 2021
Accumulated Other Comprehensive Income (Loss) [Line Items]
SCHEDULE OF RESERVED SHARES	SCHEDULE OF RESERVED SHARES Exercise of outstanding stock options 4,133,856 Exercise of outstanding stock warrants 9,360,302 Conversion of outstanding Series Alpha preferred stock 243,418 Total 13,737,576
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, 2021, and changes during the nine-month period then ended: SCHEDULE OF STOCK OPTION ACTIVITY Shares Weighted– Average Exercise Price Range of Exercise Price Weighted– Average Remaining Life (Years) Total outstanding – December 31, 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 For the nine Expected dividend yield 0.00 % 0.00 % Expected stock-price volatility 102 % 102 % Risk-free interest rate 0.84 1.18 % 0.33 0.59 % Expected average term of options 6.0 6.0 Stock price $ 2.12 $ 4.70 5.13
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE	The Company recorded share-based compensation expense and classified it in the condensed consolidated statements of operations as follows: SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE For the nine months ended 2021 2020 General and administrative $ 3,329,310 $ 1,317,263 Research and development 533,096 261,679 Total $ 3,862,406 $ 1,578,942
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 received in exchange for the Series C convertible preferred stock equity classified compensatory warrants for the nine months ended September 30, 2021: SCHEDULE OF WARRANT ACTIVITY Common Stock Weighted– Range of Weighted– Exercise Exercise Life Shares Price Price (Years) Total outstanding – December 31, 2020 1,294,217 $ 1.66 Common stock warrants received in exchange for Series C preferred stock warrants upon reverse recapitalization - - 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 — $ — $ — — SCHEDULE OF WARRANT ACTIVITY Common Stock Weighted– Range of Weighted– Exercise Exercise Remaining Shares Price Price Life (Years) Total outstanding – December 31, 2019 — $ — Common stock warrants received in exchange for Series C preferred stock warrants upon reverse recapitalization 668,024 2.34 Granted to advisor and its designees 811,431 1.11 Expired — — Forfeited — — Total outstanding – September 30, 2020 1,479,455 $ 1.67 Exercisable 664,428 $ 2.34 $ 2.07 2.54 3.78 Non-Exercisable 815,027 $ 1.11 $ 1.11 2.54 4.65
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, 2021: SCHEDULE OF WARRANT ACTIVITY Common Stock Weighted– Range of Weighted– Exercise Exercise Life Shares Price Price (Years) Total outstanding – December 31, 2020 6,549,777 $ 4.37 Granted — — Exercised (1,000,000 ) 0.01 Expired — — Forfeited — — Total outstanding – September 30, 2021 5,549,777 $ 5.15 Exercisable 5,549,777 $ 5.15 $ 1.11 2,325.00 1.08 Non-Exercisable — $ — — —

SCHEDULE OF ACCOUNTS RECEIVABLE

SCHEDULE OF ACCOUNTS RECEIVABLE (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Accounts Receivable	$ 662,718	$ 629,630
Less Allowances	(29,168)	(13,873)
Accounts receivable, net	$ 633,550	$ 615,757

SCHEDULE OF USEFUL LIVES OF PRO

SCHEDULE OF USEFUL LIVES OF PROPERTY AND EQUIPMENT (Details)	9 Months Ended
	Sep. 30, 2021
Machinery and Equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	5 years
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	3 years
Molds And Tooling [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	5 years
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	5 years

ORGANIZATION AND SUMMARY OF S_4

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Details Narrative) - USD ($) shares in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Impairment, Long-Lived Asset, Held-for-Use	$ 0		$ 0
Cost of Goods and Services Sold	29,000	$ 32,000	88,000	$ 86,000
Revenue from Contract with Customer, Excluding Assessed Tax	1,155,065	837,714	4,172,496	3,198,536
Estimated returns net of allowances	0	30,000	1,000	6,000
Amortization of Intangible Assets	4,000	3,000	12,000	10,000
Accrued Liabilities, Current	1,799,431		1,799,431		$ 746,738
Warranty costs	24,000	28,000	$ 72,000	$ 89,000
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount			13.7	14.8
Warrant [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Accrued Liabilities, Current	51,000		$ 51,000		25,000
Patents [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Carrying value	164,000		164,000		169,000
Accumulated amortization	315,000		315,000		303,000
Finite-Lived Intangible Asset, Expected Amortization, Remainder of Fiscal Year	4,000		4,000
Finite-Lived Intangible Asset, Expected Amortization, Year One	19,000		19,000
Finite-Lived Intangible Asset, Expected Amortization, Year Two	18,000		18,000
Finite-Lived Intangible Asset, Expected Amortization, Year Three	15,000		15,000
Finite-Lived Intangible Asset, Expected Amortization, Year Four	14,000		14,000
Finite lived intangible assets amortization expense, Thereafter	94,000		94,000
License [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Carrying value	14,000		14,000		19,000
Accumulated amortization	405,000		405,000		$ 400,000
Amortization of Intangible Assets	2,000	2,000	5,000	$ 5,000
Finite-Lived Intangible Asset, Expected Amortization, Remainder of Fiscal Year	2,000		2,000
Finite-Lived Intangible Asset, Expected Amortization, Year One	7,000		7,000
Finite-Lived Intangible Asset, Expected Amortization, Year Two	5,000		$ 5,000
Minimum [Member] | Patents and Licenses [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Estimated useful lives			5 years
Maximum [Member] | Patents and Licenses [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Estimated useful lives			17 years
License Revenue [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax			$ 478,654
Collaborative Research Revenue [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Revenue from Contract with Customer, Excluding Assessed Tax				45,000
General Administrative Research and Development Expenses [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Cost of Goods and Services Sold	$ 3,000	$ 2,000	$ 8,000	$ 8,000

LIQUIDITY (Details Narrative)

LIQUIDITY (Details Narrative) - USD ($) $ in Millions	1 Months Ended
	Dec. 31, 2020	Aug. 31, 2020	Jul. 31, 2020	May 31, 2020
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
New equity capital raise				$ 4
Convertible notes payable				$ 1.9
Investor [Member] | Securities Purchase Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Proceeds from sale of equity	$ 30	$ 30	$ 30

SCHEDULE OF INVENTORY (Details)

SCHEDULE OF INVENTORY (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Inventory Disclosure [Abstract]
Raw materials	$ 749,730	$ 579,765
Work in process	345,913	309,826
Finished goods	82,364	63,867
Inventory net	$ 1,178,007	$ 953,458

INVENTORY, NET (Details Narrati

INVENTORY, NET (Details Narrative) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Inventory Disclosure [Abstract]
Inventory Valuation Reserves	$ 128,000	$ 108,000

SCHEDULE OF PREPAID EXPENSES AN

SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Prepaid Expenses And Other Current Assets
Prepaid insurance	$ 1,528,472	$ 1,307,864
Prepaid manufacturing expenses	45,579	1,181,029
Prepaid investor relations expenses		150,000
Other prepaid expenses	27,461	40,001
Prepaid expenses and other current assets	$ 1,601,512	$ 2,678,894

SCHEDULE OF PROPERTY AND EQUIPM

SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 3,547,237	$ 3,669,469
Less Accumulated depreciation	(3,338,279)	(3,422,146)
Property and equipment, net	208,958	247,323
Machinery and Equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	2,477,913	2,401,470
Construction In Progress Equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross		104,400
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	338,415	443,865
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	327,894	321,033
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	$ 143,013	$ 138,699

PROPERTY AND EQUIPMENT, NET (De

PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 19,000	$ 10,000	$ 51,000	$ 28,000

SCHEDULE OF ACCRUED EXPENSES AN

SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Payables and Accruals [Abstract]
Board compensation	$ 17,500	$ 15,091
Bonus	280,839
Consulting	154,400
Franchise, sales and use taxes	15,771	30,353
Income taxes	3,272	3,326
Patent and license fees		7,204
Payroll	101,514	4,566
Professional fees	107,686	58,261
Research and development	751,820	237,504
Royalties	8,294	491
Vacation	267,766	230,457
Warranty costs	50,783	24,871
Other	39,786	134,614
Accrued expenses and other current liabilities	$ 1,799,431	$ 746,738

SCHEDULE OF WARRANTS ACTIVITY (

SCHEDULE OF WARRANTS ACTIVITY (Details) - Series C Warrants [Member] - Common Stock Warrants [Member] - $ / shares	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Number of Shares, Warrants Outstanding Beginning	3,378,596
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning	$ 0.72
Number of Shares, Warrants Exercised	(722,618)
Weighted Average Exercise Price Per Share Warrants Exercised	$ 0.72
Number of Shares, Warrants Forfeited	(36,097)
Weighted Average Exercise Price Per Share Warrants Forfeited	$ 0.72
Number of Shares, Warrants Expired
Weighted Average Exercise Price Per Share Warrants Expired
Number of Shares, Warrants Granted
Weighted Average Exercise Price Per Share Warrants Granted
Number of Shares, Warrants Outstanding Ending	2,619,881	4,713,490
Weighted Average Exercise Price Per Share Warrants Outstanding Ending	$ 0.72	$ 0.72
Number of Shares, Warrants Exercisable	2,619,881	4,713,490
Weighted Average Exercise Price Per Share Exercisable	$ 0.72	$ 0.72
Range of Exercise Price, Exercisable	$ 0.72	$ 0.72
Weighted Average Remaining Life (Years) Exercisable	2 years 3 months	3 years 6 months 25 days
Number of Shares, Warrants Series C preferred stock warrants exchanged for common stock warrants upon reverse merger		4,713,490
Weighted Average Exercise Price Per Share Warrants Series C Preferred Stock Warrants Exchanged For Common Stock Warrants Upon Reverse Merger		$ 0.72

SCHEDULE OF FAIR VALUE HIERARCH

SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2021	Dec. 31, 2020
Defined Benefit Plan Disclosure [Line Items]
Fair value for warrant liabilities	$ 2,169,200	$ 8,310,100
Change in fair value of warrant liabilities		(6,140,900)
Fair Value, Inputs, Level 1 [Member]
Defined Benefit Plan Disclosure [Line Items]
Fair value for warrant liabilities
Change in fair value of warrant liabilities
Fair Value, Inputs, Level 2 [Member]
Defined Benefit Plan Disclosure [Line Items]
Fair value for warrant liabilities
Change in fair value of warrant liabilities
Fair Value, Inputs, Level 3 [Member]
Defined Benefit Plan Disclosure [Line Items]
Fair value for warrant liabilities	$ 2,169,200	8,310,100
Change in fair value of warrant liabilities		$ (6,140,900)

SCHEDULE OF ASSUMPTIONS OF WARR

SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES (Details)	Sep. 30, 2021	Dec. 31, 2020
Measurement Input, Price Volatility [Member]
Fair value assumptions, measurement input, percentages		82
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	0.31	0.17
Minimum [Member] | Measurement Input, Price Volatility [Member]
Fair value assumptions, measurement input, percentages	82
Minimum [Member] | Measurement Input, Expected Term [Member]
Fair value assumptions, measurement input, term	2 years 1 month 20 days	2 years 10 months 24 days
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member]
Fair value assumptions, measurement input, percentages	0.46	0.22
Maximum [Member] | Measurement Input, Price Volatility [Member]
Fair value assumptions, measurement input, percentages	86
Maximum [Member] | Measurement Input, Expected Term [Member]
Fair value assumptions, measurement input, term	2 years 8 months 26 days	3 years 5 months 26 days

WARRANT LIABILITIES (Details Na

WARRANT LIABILITIES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Fair Value Adjustment of Warrants	$ (1,942,900)	$ 4,395,300	$ (6,140,900)	$ 20,596,700
Series C Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right	4,713,490		4,713,490
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 0.72		$ 0.72
Series C Warrants [Member] | Minimum [Member]
Warrants and Rights Outstanding, Term	2 years 1 month 6 days		2 years 1 month 6 days
Series C Warrants [Member] | Maximum [Member]
Warrants and Rights Outstanding, Term	2 years 8 months 12 days		2 years 8 months 12 days
Warrant [Member]
Shares issued upon the exercise of warrants			722,618
Shares issued upon net-exercise of warrants			156,861
Fair Value Adjustment of Warrants			$ 6,100,000	$ 20,600,000
Warrants and Rights Outstanding	$ 2,200,000		$ 2,200,000		$ 8,310,000

SCHEDULE OF OPERATING LEASE RIG

SCHEDULE OF OPERATING LEASE RIGHT OF USE ASSETS AND OPERATING LEASE LIABILITIES (Details) - USD ($)	6 Months Ended	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2021	Dec. 31, 2020
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Operating lease right-of-use assets		$ 430,795
Operating lease right-of-use assets	$ 264,140	264,140
Operating lease liabilities, ending balance	303,894	303,894
Less non-current portion	(24,993)	(24,993)	$ (236,826)
Current portion at June 30, 2021	278,901	278,901	$ 254,739
Longterm Operating Lease Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Operating lease right-of-use assets		430,795
Less amortization of operating lease right-of-use assets		(166,655)
Operating lease right-of-use assets	264,140	264,140
Operating lease liabilities, beginning balance	491,565
Less principal payments on operating lease liabilities	(187,671)
Operating lease liabilities, ending balance	303,894	303,894
Less non-current portion	(24,993)	(24,993)
Current portion at June 30, 2021	$ 278,901	$ 278,901

SCHEDULE OF MATURITIES OF OPERA

SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details)	Sep. 30, 2021USD ($)
Leases
2021 (nine months)	$ 73,335
2022	246,650
2023
Total	319,985
Less present value discount	(16,091)
Operating lease liabilities	$ 303,894

LEASES (Details Narrative)

LEASES (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Leases
Weighted-average remaining lease term	1 year 1 month 6 days		1 year 1 month 6 days
Discount rate operating lease	8.90%		8.90%
Lease expense	$ 83,000	$ 86,000	$ 255,000	$ 257,000

RESEARCH AND LICENSE AGREEMEN_2

RESEARCH AND LICENSE AGREEMENTS (Details Narrative) - USD ($)	1 Months Ended								3 Months Ended		9 Months Ended
	Nov. 30, 2020	Sep. 30, 2020	Jun. 30, 2020	Jun. 30, 2019	Mar. 31, 2019	Mar. 31, 2019	Dec. 31, 2018	Jun. 30, 2018	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Research and development									$ 2,083,315	$ 870,876	$ 10,091,155	$ 1,706,280
License costs									18,000	0	58,000	0
Product sales									1,155,065	837,714	4,172,496	3,198,536
Collaborative Research Revenue [Member]
Product sales												45,000
License Revenue [Member]
Product sales											478,654
University Of Louisville Research Foundation [Member]
Research and development									12,000	0	106,000	0
University Of Louisville Research Foundation [Member] | Maximum [Member] | Royalties and Non-royalty Sublicensee Income [Member]
Shortfall payments											50,000
Prediction Biosciences SAS [Member] | Collaborative Research Revenue [Member]
Product sales										0		45,000
Sekisui Diagnostics, LLC [Member]
Product sales									810,000	476,000	2,500,000	1,900,000
Yi Xin Zhen Duan Jishu Ltd [Member]
Product sales											38,000
Deferred revenue									420,000		420,000		$ 250,000
Yi Xin Zhen Duan Jishu Ltd [Member] | License Revenue [Member]
Product sales											479,000
STA Pharmaceutical Co Ltd [Member]
Research and development									118,000	0	3,200,000	0
Upfront deposit													$ 1,100,000
License And Sponsored Research Agreements [Member] | University Of Louisville Research Foundation [Member]
Payment of convertible promissory note		$ 50,000
Reimbursement of research 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
Milestone payment for marketing expenses								$ 500,000			5,000,000
Licensed product sales, revenue		$ 500,000,000									500,000,000
Research and development									264,000	50,000	469,000	297,000
License costs									11,000	0	27,000	0
License And Sponsored Research Agreements [Member] | University Of Louisville Research Foundation [Member] | Licensed Product Sales [Member]
Regulatory marketing approval, expenses					$ 5,000,000
License And Sponsored Research Agreements [Member] | University Of Louisville Research Foundation [Member] | Minimum [Member]
Milestone payment								100,000
Milestone payment for marketing expenses			$ 50,000
Shortfall payments		10,000									5,000
License And Sponsored Research Agreements [Member] | University Of Louisville Research Foundation [Member] | Maximum [Member]
Milestone payment					5,000,000			5,000,000
Shortfall payments		50,000			50,000						50,000
License And Sponsored Research Agreements [Member] | University Of Louisville Research Foundation [Member] | Phase 2 Clinical Trial [Member]
Milestone payment		200,000			100,000			200,000
License And Sponsored Research Agreements [Member] | University Of Louisville Research Foundation [Member] | Phase 1 Clinical Trial [Member]
Milestone payment		$ 100,000			50,000			100,000
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
Sponsored Research and License Agreement [Member]
Research and development									83,000	0	235,000	2,000
Minimum annual royalties									0	0	0	10,000
License costs									50,000	0	103,000	0
Sponsored Research and License Agreement [Member] | University Of Louisville Research Foundation [Member]
Reimbursement of research expenses					$ 693,000	$ 1,800,000
Agreement term payment, description				In addition, the Company has 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	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
Licensed product sales, revenue					$ 500,000,000
Reimbursement patent cost					112,000
Regulatory marketing approval, expenses					300,000
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	20,000
License Agreement [Member] | University Of Louisville Research Foundation [Member] | Maximum [Member]
Research and development	$ 430,000		$ 250,000
Upfront license fee					$ 100,000	$ 100,000
License Agreement [Member] | Advanced Cancer Therapeutics, LLC [Member]
Licensed product sales, revenue											300,000
License costs										$ 0	2,000	$ 110,000
[custom:AgreementDescription]							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 $
Proceeds from Convertible Debt							$ 25,000
[custom:MilestoneMethodRevenueRecognized]							100,000
[custom:CumulativeAmount]							2,000,000
License Agreement [Member] | Advanced Cancer Therapeutics, LLC [Member] | CE Mark [Member]
Licensed product sales, revenue							3,000,000
[custom:MilestoneMethodRevenueRecognized]							100,000
[custom:CumulativeAmount]							$ 500,000
Technology Transfer Agreement [Member] | Yi Xin Zhen Duan Jishu Ltd [Member]
Deferred revenue									$ 153,000		$ 153,000

SCHEDULE OF RESERVED SHARES (De

SCHEDULE OF RESERVED SHARES (Details)	Sep. 30, 2021shares
Class of Stock [Line Items]
Total	13,737,576
Exercise of Outstanding Stock Options [Member]
Class of Stock [Line Items]
Total	4,133,856
Exercise of Outstanding Stock Warrant [Member]
Class of Stock [Line Items]
Total	9,360,302
Series Alpha Preferred Stock [Member]
Class of Stock [Line Items]
Total	243,418

SCHEDULE OF STOCK OPTION ACTIVI

SCHEDULE OF STOCK OPTION ACTIVITY (Details) - Employees and Non-employee Service Provider [Member]	9 Months Ended
	Sep. 30, 2021$ / sharesshares
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items]
Number of Shares, Options Outstanding, Beginning | shares	4,011,356
Weighted Average Exercise Price, Outstanding, Beginning	$ 7.05
Weighted- Average Remaining Contractual Life (in Years), Outstanding, Beginning	9 years 3 months 14 days
Number of Shares, Options Granted | shares	127,000
Weighted Average Exercise Price, Options Granted	$ 2.12
Weighted- Average Remaining Contractual Life (in Years), Options Granted	9 years 6 months 29 days
Number of Shares, Options Expired | shares
Weighted Average Exercise Price, Options Expired
Range of Exercise price, Options Expired
Number of Shares, Options Forfeited | shares	(4,500)
Weighted Average Exercise Price, Options Forfeited	$ 3.68
Number of Shares, Options Outstanding at Ending | shares	4,133,856
Weighted Average Exercise Price, Outstanding at Ending	$ 6.90
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending	8 years 6 months 25 days
Number of Shares, Options Exercisable (vested) | shares	1,314,194
Weighted Average Exercise Price, Options Exercisable (vested)	$ 11.41
Weighted- Average Remaining Contractual Life (in Years), Options Exercisable (vested)	8 years 1 month 13 days
Number of Shares, Options Non-Exercisable (non-vested) | shares	2,819,662
Weighted Average Exercise Price, Options Non-Exercisable (non-vested)	$ 4.80
Weighted- Average Remaining Contractual Life (in Years), Options Non-exercisable (non-vested)	8 years 9 months 14 days
Minimum [Member]
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items]
Range of Exercise price, Options Outstanding	$ 3.52
Range of Exercise price, Options Granted	1.80
Range of Exercise price, Options Forfeited	3.52
Range of Exercise price, Options Outstanding	1.80
Range of Exercise price, Options Exercisable (vested)	3.52
Range of Exercise price, Options Non-Exercisable (non-vested)	1.80
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
Range of Exercise price, Options Granted	3.29
Range of Exercise price, Options Forfeited	4.97
Range of Exercise price, Options Outstanding	1,465.75
Range of Exercise price, Options Exercisable (vested)	1,465.75
Range of Exercise price, Options Non-Exercisable (non-vested)	$ 5.13

SCHEDULE OF ASSUMPTIONS USED IN

SCHEDULE OF ASSUMPTIONS USED IN BLACK-SCHOLES OPTION-PRICING METHOD (Details) - $ / shares	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Expected dividend yield	0.00%	0.00%
Expected stock-price volatility	102.00%	102.00%
Risk-free interest rate, minimum	0.84%	0.33%
Risk-free interest rate, maximum	1.18%	0.59%
Average expected remaining years of life of options	6 years	6 years
Share price	$ 2.12
Minimum [Member]
Share price		$ 4.70
Maximum [Member]
Share price		$ 5.13

SCHEDULE OF SHARE-BASED COMPENS

SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE (Details) - USD ($)	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Total	$ 3,862,406	$ 1,578,942
General and Administrative Expense [Member]
Total	3,329,310	1,317,263
Research and Development Expense [Member]
Total	$ 533,096	$ 261,679

SCHEDULE OF WARRANT ACTIVITY (D

SCHEDULE OF WARRANT ACTIVITY (Details) - $ / shares	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of Shares, Warrants Outstanding Beginning	1,294,217
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning	$ 1.66
Number of Shares, Warrants Series C preferred stock compensatory warrants exchanged for common stock warrants upon reverse recapitalization		668,024
Weighted Average Exercise Price Per Share compensatory Warrants Series C Preferred Stock Warrant Exchanged For Common Stock Warrant Upon Reverse Recapitalization		$ 2.34
Number of Shares, Warrants Granted		811,431
Weighted Average Exercise Price Per Share Warrants Granted		$ 1.11
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	1,190,648	1,479,455
Weighted Average Exercise Price Per Share Warrants Outstanding Ending	$ 1.62	$ 1.67
Number of Shares, Warrants Exercisable	1,190,648	664,428
Weighted Average Exercise Price Per Share Exercisable	$ 1.62	$ 2.34
Weighted Average Remaining Life (Years) Exercisable	3 years 6 months	3 years 9 months 10 days
Number of shares, warrants non-exercisable		815,027
Weighted Average Exercise Price Per Share Non-Exercisable		$ 1.11
Exercisable non- vested per share
Weighted Average Remaining Life (Years) Non-Exercisable	0 years	4 years 7 months 24 days
Number of Shares, Warrants Forfeited	65,179
Compensatory Warrant Activity [Member] | Minimum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Exercisable vested per share	$ 1.11	$ 2.07
Exercisable non- vested per share		1.11
Compensatory Warrant Activity [Member] | Maximum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Exercisable vested per share	$ 2.54	2.54
Exercisable non- vested per share		$ 2.54
Non Compensatory Warrant Activity [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of Shares, Warrants Outstanding Beginning	6,549,777
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning	$ 4.37
Number of Shares, Warrants Granted
Weighted Average Exercise Price Per Share Warrants Granted
Number of Shares, Warrants Exercised	(1,000,000)
Weighted Average Exercise Price Per Share Warrants Exercised	$ 0.01
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	5,549,777
Weighted Average Exercise Price Per Share Warrants Outstanding Ending	$ 5.15
Number of Shares, Warrants Exercisable	5,549,777
Weighted Average Exercise Price Per Share Exercisable	$ 5.15
Weighted Average Remaining Life (Years) Exercisable	1 year 29 days
Number of shares, warrants non-exercisable
Weighted Average Exercise Price Per Share Non-Exercisable
Exercisable non- vested per share
Number of Shares, Warrants Forfeited
Non Compensatory Warrant Activity [Member] | Minimum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Exercisable vested per share	$ 1.11
Non Compensatory Warrant Activity [Member] | Maximum [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Exercisable vested per share	$ 2,325

STOCKHOLDERS_ EQUITY (Details N

STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)	Feb. 04, 2021	Dec. 18, 2020	Aug. 04, 2020	Jul. 22, 2020	Jul. 10, 2020	Dec. 31, 2020	Sep. 30, 2021	Sep. 30, 2020	Jun. 30, 2021	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020	Dec. 30, 2020	Aug. 31, 2020	Jul. 31, 2020	May 31, 2020	Dec. 31, 2017
Accumulated Other Comprehensive Income (Loss) [Line Items]
Shares of authorized but unissued common stock							13,737,576			13,737,576
Preferred stock, shares outstanding						180	180			180		180	180
Stock based compensation expense										$ 3,862,406	$ 1,578,942
Two Thousand Twenty Plan [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Common stock for future issuance							3,500,000			3,500,000
Stock Options and Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Stock based compensation expense							$ 1,300,000	$ 1,200,000		$ 3,900,000	$ 1,600,000
Unrecognized compensation cost							$ 8,900,000			$ 8,900,000
Weighted averge term										1 year 8 months 23 days
Stock options exercised										0	0
Stock option granted exercise price										$ 1.68
Stock Options and Warrants [Member] | 2020 Stock Incentive Plan [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Share based compensation arrangement by share based payment award options grants										4,040,000		3,917,500
Stock options shares future grant										3,517,157	139,657
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.
Common Stock [Member] | Noncompensatory Equity Classified Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of stock warrants						2,191,010						2,191,010
Warrant exercise price						$ 4.07						$ 4.07
Warrant [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Shares issued upon the exercise of warrants										722,618
Compensatory Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of stock warrants							811,431			811,431							668,024
Warrant exercise price							$ 1.11			$ 1.11							$ 2.34
Stock based compensation expense										$ 0	$ 8,000
Unrecognized compensation cost							$ 0	$ 0		0	$ 0
Stock options exercised									38,390
Equity capital raise							$ 4,000,000			$ 4,000,000
Shares issued upon net exercises									35,512
Noncompensatory Equity Classified Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of stock warrants														1,920,678	780,198	270,478
Warrant exercise price														$ 5.25	$ 0.001	$ 1.11
Shares issued upon the exercise of warrants						200,000
Investor [Member] | Noncompensatory Equity Classified Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of stock warrants						1,000,000						1,000,000		1,287,829
Warrant exercise price						$ 0.01						$ 0.01		$ 6
Securities Purchase Agreement [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Beneficial-ownership percentage		9.99%	9.99%		9.99%
Securities Purchase Agreement [Member] | Two-year Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of stock warrants		1,348,314	1,287,829		1,920,768
Warrant exercise price		$ 4.07	$ 6		$ 5.25
Securities Purchase Agreement [Member] | Common Stock [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of shares common stock		2,370,786	1,717,106		1,140,570
Securities Purchase Agreement [Member] | Pre-funded Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of stock warrants		1,000,000			780,198
Share based compensation Exercised	1,000,000			780,198
Securities Purchase Agreement [Member] | Warrant [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Purchase of stock warrants		842,696
Warrant exercise price		$ 4.07
Securities Purchase Agreement [Member] | Single Institutional Investor [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Sale of stock		$ 12,000,000	$ 10,000,000		$ 8,000,000

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details Narrative)	1 Months Ended
	May 31, 2020shares
Series D and Series D-1 Preferred Stock [Member]
Conversion of preferred stock	1,980,233