Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Entity Registrant Name | QUOIN PHARMACEUTICALS LTD. | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Entity File Number | 001-37846 | |
Entity Registrant Name | QUOIN PHARMACEUTICALS LTD. | |
Entity Incorporation, State or Country Code | L3 | |
Entity Tax Identification Number | 92-2593104 | |
Entity Address, Address Line One | 42127 Pleasant Forest Court | |
Entity Address, State or Province | VA | |
Entity Address, City or Town | Ashburn | |
Entity Address, Postal Zip Code | 20148 | |
City Area Code | 703 | |
Local Phone Number | 980-4182 | |
Title of 12(g) Security | American Depositary Shares | |
Trading Symbol | QNRX | |
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 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Entity Central Index Key | 0001671502 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
ADS | ||
Entity Common Stock, Shares Outstanding | 11,846,532 | |
Ordinary Shares | ||
Entity Common Stock, Shares Outstanding | 59,233,024,799 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 3,371,854 | $ 2,860,628 |
Investments | 13,618,026 | 9,992,900 |
Prepaid expenses | 398,906 | 516,584 |
Total current assets | 17,388,786 | 13,370,112 |
Prepaid expenses - long term | 383,390 | 383,390 |
Intangible assets, net | 678,550 | 704,561 |
Total assets | 18,450,726 | 14,458,063 |
Current liabilities: | ||
Accounts payable | 281,094 | 605,600 |
Accrued expenses | 2,085,205 | 1,175,705 |
Accrued interest and financing expense | 1,146,251 | 1,146,251 |
Due to officers - short term | 650,000 | 600,000 |
Total current liabilities | 4,162,550 | 3,527,556 |
Due to officers - long term | 3,373,733 | 3,523,733 |
Total liabilities | 7,536,283 | 7,051,289 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Ordinary shares, no par value per share, 500,000,000,000 ordinary shares authorized - 59,233,024,799 (11,846,532 ADS's) ordinary shares issued and outstanding at March 31, 2023 and 24,233,024,799 (4,846,605 ADS's) at December 31, 2022 | 0 | 0 |
Treasury stock, 2,641,693, ordinary shares | (2,932,000) | (2,932,000) |
Additional paid in capital | 53,966,259 | 47,855,521 |
Accumulated deficit | (40,119,816) | (37,516,747) |
Total shareholders' equity | 10,914,443 | 7,406,774 |
Total liabilities and shareholders' equity | $ 18,450,726 | $ 14,458,063 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Ordinary shares, par value | $ 0 | $ 0 |
Ordinary shares, authorized | 500,000,000,000 | 500,000,000,000 |
Ordinary shares, shares issued | 59,233,024,799 | 24,233,024,799 |
Ordinary shares, shares outstanding | 59,233,024,799 | 24,233,024,799 |
Treasury stock, ordinary shares | 2,641,693 | 2,641,693 |
ADS | ||
Ordinary shares, shares issued | 11,846,532 | 4,846,605 |
Ordinary shares, shares outstanding | 11,846,605 | 4,846,605 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses | ||
General and administrative | $ 1,683,817 | $ 1,588,470 |
Research and development | 1,091,733 | 587,569 |
Total operating expenses | 2,775,550 | 2,176,039 |
Other (income) and expenses | ||
Forgiveness of accounts payable | (416,000) | |
Warrant liability (income) expense | (77,237) | |
Unrealized gain | (20,427) | |
Interest income | (152,054) | |
Total other (income) and expenses | (172,481) | (493,237) |
Net loss | $ (2,603,069) | $ (1,682,802) |
ADS | ||
Loss per ADS | ||
Basic | $ (0.34) | $ (2.51) |
Fully-diluted | $ (0.34) | $ (2.51) |
Weighted average number of ADS's outstanding | ||
Basic | 7,646,605 | 670,930 |
Fully-diluted | 7,646,605 | 670,930 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) | Ordinary Shares | Treasury Stock | Additional paid in Capital | Accumulated Deficit | ADS | Total |
Balance at beginning of period at Dec. 31, 2021 | $ (2,932,000) | $ 31,659,017 | $ (28,069,985) | $ 657,032 | ||
Balance at beginning of period (in shares) at Dec. 31, 2021 | 3,354,650,799 | 670,930 | ||||
Net loss | (1,682,802) | (1,682,802) | ||||
Cashless exercise of warrants (in shares) | 3,200 | 1 | ||||
Reclassification of warrant liability upon issuance of Exchange warrant | 296,362 | 296,362 | ||||
Balance at end of period at Mar. 31, 2022 | (2,932,000) | 31,955,379 | (29,752,787) | (729,408) | ||
Balance at ending of period (in shares) at Mar. 31, 2022 | 3,354,653,999 | 670,931 | ||||
Balance at beginning of period at Dec. 31, 2022 | (2,932,000) | 47,855,521 | (37,516,747) | $ 7,406,774 | ||
Balance at beginning of period (in shares) at Dec. 31, 2022 | 24,233,024,799 | 4,846,605 | 24,233,024,799 | |||
Net loss | (2,603,069) | $ (2,603,069) | ||||
Stock based compensation | 261,472 | 261,472 | ||||
Issuance of ADS and Pre-Funded Warrants, net | 5,849,266 | 5,849,266 | ||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 35,000,000,000 | 7,000,000 | ||||
Balance at end of period at Mar. 31, 2023 | $ (2,932,000) | $ 53,966,259 | $ (40,119,816) | $ 10,914,443 | ||
Balance at ending of period (in shares) at Mar. 31, 2023 | 59,233,024,799 | 11,846,605 | 59,233,024,799 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows used in operating activities: | ||
Net loss | $ (2,603,069) | $ (1,682,802) |
Change in fair value of warrant liability | (77,237) | |
Stock based compensation | 261,472 | |
Forgiveness of accounts payable | (416,000) | |
Amortization of intangibles | 26,011 | 26,010 |
Increase in accrued interest and financing expense | (311,670) | |
Unrealized gain and accrued interest on investments | (133,621) | |
Changes in assets and liabilities: | ||
Increase in accounts payable and accrued expenses | 584,994 | 162,133 |
Decrease in prepaid expenses & other assets | 117,678 | 206,008 |
Net cash used in operating activities | (1,746,535) | (2,093,558) |
Cash flows used in investing activities: | ||
Purchase of investments | (13,491,505) | |
Proceeds from maturity of investments | 10,000,000 | |
Payment for license acquisition | (50,000) | |
Net cash used in investing activities | (3,491,505) | (50,000) |
Cash flows provided by (used in) financing activities: | ||
Payment of amounts due to officers | (100,000) | (150,000) |
Proceeds from sale of equity securities, net | 5,849,266 | |
Net cash provided by (used in) financing activities | 5,749,266 | (150,000) |
Net change in cash and cash equivalents: | 511,226 | (2,293,558) |
Cash and cash equivalents - beginning of period | 2,860,628 | 7,482,773 |
Cash and cash equivalents - end of period | 3,371,854 | 5,189,215 |
Supplemental information - Non cash items: | ||
Reclassification of warrant liability to equity upon issuance of "Exchange warrants" | $ 296,362 | |
Offering expenses associated with warrant modification | $ 238,231 |
ORGANIZATION AND BUSINESS
ORGANIZATION AND BUSINESS | 3 Months Ended |
Mar. 31, 2023 | |
ORGANIZATION AND BUSINESS | |
ORGANIZATION AND BUSINESS | NOTE 1 – ORGANIZATION AND BUSINESS Quoin Pharmaceuticals Ltd. (“Quoin Ltd.,” or the “Company”), formerly known as Cellect Biotechnology Ltd. (“Cellect”), is the holding company for Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin Inc.”). On October 28, 2021, Cellect completed the business combination with Quoin Inc., with Quoin Inc. surviving as a wholly-owned subsidiary of Cellect (the “Merger”). Immediately after completion of the Merger, Cellect changed its name to “Quoin Pharmaceuticals Ltd.” Quoin Inc. was incorporated in Delaware on March 5, 2018. Quoin Inc. is clinical stage specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products that treat rare and orphan diseases for which there are currently no approved treatments or cures. The Company’s initial focus is on the development of products, using proprietary owned and in-licensed drug delivery technologies, that could help address rare skin diseases. The Company’s first lead product is QRX003, a once daily, topical lotion comprised of a broad-spectrum serine protease inhibitor, formulated with the proprietary in-licensed Invisicare® technology, is under development as a potential treatment for Netherton Syndrome (“NS”), a rare hereditary genetic disease. QRX003 is currently being tested in two clinical studies in the United States (“U.S.”) under an open Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”). Dosing of patients has commenced for both studies. The Company is also developing QRX004 as a potential treatment for Recessive Dystrophic Epidermolysis Bullosa (“RDEB”). In addition, the Company has entered into Research Agreements with the Queensland University of Technology (“QUT”), which include an option for global licenses to QRX007 for the potential treatment of NS and QRX008 for the potential treatment of scleroderma. To date, no products have been commercialized and revenue has not been generated. |
LIQUIDITY RISKS AND OTHER UNCER
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | 3 Months Ended |
Mar. 31, 2023 | |
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | |
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | NOTE 2 - LIQUIDITY RISKS AND OTHER UNCERTAINTIES The unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”), which contemplates continuation of the Company as a going concern. The Company has incurred net losses every year since inception and has an accumulated deficit of approximately $40.1 million at March 31, 2023. The Company has limited operating history and has historically funded its operations through debt and equity financings. The Company incurred net losses of approximately $2.6 million, and negative cash flows from operations of $1.8 million for the three months ended March 31, 2023. At March 31, 2023, the Company had cash balances totaling $3.4 million and investments of $13.6 million. The Company has determined that it has sufficient cash and liquidity to effect its business plan for at least one year from the issuance of these unaudited condensed consolidated financial statements. Additional financing will still be required to complete the research and development of the Company’s therapeutic targets and its other operating requirements until it achieves commercial profitability, if ever. Such financing may not be available at acceptable terms, if at all. If the Company is unable to obtain additional funding when it becomes necessary, the development of its product candidates will be impacted and the Company would likely be forced to delay, reduce, or terminate some or all of its development programs, all of which could have a material adverse effect on the Company’s business and financial condition. Other risks and uncertainties: The Company is subject to risks common to development stage biopharmaceutical companies including, but not limited to, new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, product liability, pre-clinical and clinical trial outcome risks, regulatory approval risks, uncertainty of market acceptance and additional financing requirements. The Company’s products require approval or clearance from the FDA prior to commencing commercial sales in the United States. There can be no assurance that the Company’s products will receive all of the required approvals or clearances. Approvals or clearances are also required in foreign jurisdictions in which the Company may license or sell its products. There can be no assurance that the Company’s products, if approved, will be accepted in the marketplace, nor can there be any assurance that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed. The Company is also dependent on several third party suppliers, in some cases a single-source supplier which includes the supplier of the active pharmaceutical ingredient (API), as well as the contract manufacturer of the drug substance for the expected clinical development. See Note 16, Subsequent Events. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements of the Company as of March 31, 2023 and for the three months then ended. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the operating results for the year or any other period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures as of December 31, 2022 and for the year then ended which are included in the Company’s Annual Report on Form 10- K, filed with the SEC on March 15, 2023. The Company operates in one segment. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: stock-based compensation and warrants, research and development expense recognition, intangible asset estimated useful lives and impairment assessments, allowances of deferred tax assets, and cash flow assumptions regarding going concern considerations. Cash and cash equivalents: The Company considers all highly liquid investments and short-term debt instruments with original maturities of three months or less to be cash equivalents. The Company, from time to time during the periods presented, has had bank account balances in excess of federally insured limits where substantially all cash is held in the United States. The Company has not experienced losses in such accounts. The Company believes that it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Warrants: The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) provide the Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement) provided that such contracts are indexed to the Company’s own stock. The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control) or (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). The Company assesses classification of its warrants and other free-standing derivatives at each reporting date to determine whether a change in classification between assets, liabilities and equity is required. The Company evaluated the warrants to assess their proper classification using the applicable criteria enumerated under U.S. GAAP and determined that such warrants meet the criteria for equity classification in the accompanying unaudited condensed consolidated balance sheets as of March 31, 2023 and December 31, 2022, respectively. Investments: Investments as of March 31, 2023 and December 31, 2022 consist of U.S. Treasury Bills, which are classified as trading securities, totaling $ 13.6 million and $10.0 million, respectively. The Company determines the appropriate balance sheet classification of its investments at the time of purchase and evaluates the classification at each balance sheet date. Long-lived assets: Long-lived assets are comprised of acquired technology and licensed rights to use technology, which are considered platform technology with alternative future uses beyond the current products in development. Such intangible assets are being amortized on a straight-line basis over their expected useful life of 10 years. The Company assesses the impairment for long-lived assets whenever events or circumstances indicate the carrying value may not be recoverable. Factors we consider that could trigger an impairment review include the following: ● Significant changes in the manner of the Company’s use of the acquired assets or the strategy for its overall business, ● Significant underperformance relative to expected historical or projected development milestones, ● Significant negative regulatory or economic trends, and ● Significant technological changes which could render the platform technology obsolete. The Company recognizes impairment when the sum of the expected undiscounted future cash flows is less than the carrying amount of the asset. Impairment losses, if any, are measured as the excess of the carrying amount of the asset over its estimated fair value. During the three months ended March 31, 2023, there were no impairment indicators which required an impairment loss measurement. Research and development: Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by third parties, patient enrollment in clinical trials when applicable, administrative costs incurred by third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expenses in future periods as the related services are rendered. Income taxes: The Company accounts for its income taxes using the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company maintains a full valuation allowance on its existing deferred tax assets. The Company also accounts for uncertain tax positions using the more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken in the Company’s income tax returns. As of March 31, 2023 and December 31, 2022, the Company had no uncertain tax positions which affected its financial position and its results of operations or its cash flows and will continue to evaluate for uncertain tax positions in the future. If at any time the Company should record interest and penalties in connection with income taxes, the interest and the penalties will be expensed within the interest and general and administrative expenses, respectively. Stock based compensation: The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock-based award. The fair value of each option grant is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company’s expected stock volatility is based on the historical data regarding the volatility of a publicly traded set of peer companies, since it has a limited history of trading as a public company. The Company utilizes the simplified method to estimate the expected term. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield was assumed to be zero as the Company has not paid and dividends since its inception and does not anticipate paying dividends in the foreseeable future. Fair value of financial instruments: The Company considers its cash and cash equivalents, investments, accounts payable, accrued expenses to meet the definition of financial instruments. The carrying amounts of these financial instruments approximated their fair values due to the short maturities. The Company measures fair value as required by ASC Topic 820, Fair Value Measurements and Disclosures Earnings (loss) per share: The Company reports loss per share in accordance with ASC 260-10, Earnings Per Share For the three months ended March 31, 2023 and 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 10,368,820 ADS and outstanding stock options to purchase 307,142 ADS, and outstanding warrants to purchase 1,395,005 ADS and outstanding stock options to purchase 4,655 ADS, respectively, as their inclusion in the denominator would be anti-dilutive. |
CONVERTIBLE NOTES AND WARRANTS
CONVERTIBLE NOTES AND WARRANTS | 3 Months Ended |
Mar. 31, 2023 | |
CONVERTIBLE NOTES AND WARRANTS | |
CONVERTIBLE NOTES AND WARRANTS | NOTE 4 – CONVERTIBLE NOTES PAYABLE On October 2, 2020, Quoin Inc. commenced an offering of promissory notes (the “2020 Notes”) and warrants to certain investors (“2020 Noteholders”). 2020 Notes were mandatorily convertible into 5,183 ADSs in 2021. The ADSs issued to the 2020 Noteholders did not include the accrued interest which was estimated to be approximately $744,000 at December 31, 2021 of which $312,000 was paid to two of the five 2020 Noteholders during the year ended December 31, 2022. Based on the terms of the cash settlement with these two 2020 Noteholders, the Company’s estimate of the liability to the remaining three 2020 Noteholders was $1,146,000 as of March 31, 2023 and December 31, 2022. There was no interest expense recognized in both the three month periods ended March 31, 2023 and 2022. |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 3 Months Ended |
Mar. 31, 2023 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | NOTE 5 - FAIR VALUE OF FINANCIAL INSTRUMENTS The Company applies fair value accounting for all assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities the Company considers the principal or most advantageous market in which it would transact and the market-based risk measurements or assumptions that market participants would use in pricing the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risk. For certain instruments, including cash and cash equivalents, accounts payable, and accrued expenses, it was estimated that the carrying amount approximated fair value because of the short maturities of these instruments. Fair value is estimated using various valuation models, which utilize certain inputs and assumptions that market participants would use in pricing the asset or liability. The inputs and assumptions used in valuation models are classified in the fair value hierarchy as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Quoted market prices for similar instruments in an active market; quoted prices for identical or similar assets and liabilities in markets that are not active; and model-derived valuations inputs of which are observable and can be corroborated by market data. Level 3: Unobservable inputs and assumptions that are supported by little or no market activity and that are significant to the fair value of the asset and liability. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining the appropriate hierarchy levels, the Company analyzes the assets and liabilities that are subject to fair value disclosure. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to their fair value measurement. The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis by fair value hierarchy at March 31, 2023 and December 31, 2022: March 31, 2023 Level 1 Level 2 Level 3 Total US Treasury Bills $ 13,618,026 $ — $ — $ 13,618,026 Total US Treasury Bills Asset $ 13,618,026 $ — $ — $ 13,618,026 December 31, 2022 Level 1 Level 2 Level 3 Total US Treasury Bills $ 9,992,900 $ — $ — $ 9,992,900 Total US Treasury Bills Asset $ 9,992,900 $ — $ — $ 9,992,900 |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2023 | |
STOCK BASED COMPENSATION | |
STOCK BASED COMPENSATION | NOTE 6 – STOCK BASED COMPENSATION In March 2022, the Board of Directors of the Company approved the Amended and Restated Equity Incentive Plan (the “Amended Plan”), which was approved by the shareholders at the Company’s Annual General Meeting of Shareholders held on April 12, 2022. The Amended Plan increased the number of ordinary shares reserved for issuance under such equity incentive plan to 15% of the Company’s outstanding ordinary shares on a fully-diluted basis, or 16,891,925,220 ordinary shares represented by 3,378,385 ADSs as of March 31, 2023. Under the Amended Plan, the Company may grant options to its directors, officers, employees, consultants, advisers and service providers. As of March 31, 2023, 3,071,243 ADSs remained available for grant under the Amended Plan. The following table summarizes stock-based activities under the Amended Plan: Weighted Weighted Average Average ADS Underlying Exercise Contractual Options Price Terms Outstanding at December 31, 2022 307,142 $ 17.50 9.28 Granted — $ — Forfeited/Cancelled — $ — Outstanding at March 31, 2023 307,142 $ 17.50 9.03 Exercisable options at March 31, 2023 — $ — — The intrinsic value of outstanding options at March 31, 2023 was $0. Stock based compensation expense was approximately $261,000 ($34,000 included in research and development expense and $227,000 included in general and administrative expenses) in the three months ended March 31, 2023. There was no stock-based compensation in the three months ended March 31, 2022. At March 31, 2023, the total unrecognized compensation expense related to non-vested options was approximately $2,944,000 and is expected to be recognized over the remaining weighted average service period of approximately 2.83 years. |
PREPAID EXPENSES
PREPAID EXPENSES | 3 Months Ended |
Mar. 31, 2023 | |
PREPAID EXPENSES | |
PREPAID EXPENSES | NOTE 7 – PREPAID EXPENSES Prepaid expenses are as follows: March 31, December 31, 2023 2022 Prepaid R&D costs $ 383,390 $ 383,390 Prepaid insurance 355,156 508,084 Prepaid expense 43,750 8,500 Total $ 782,296 $ 899,974 Less: Short-term portion (398,906) (516,584) Long-term portion $ 383,390 $ 383,390 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2023 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | NOTE 8 - ACCRUED EXPENSES Accrued expenses are as follows: March 31, December 31, 2023 2022 Research contract expenses (note 12) $ 483,830 $ 105,071 Payroll (note 11) 976,306 788,169 Payroll taxes (note 11) 153,552 159,593 Professional fees 346,891 44,278 Other Expenses 124,626 78,594 Total $ 2,085,205 $ 1,175,705 |
IN-LICENSED TECHNOLOGY
IN-LICENSED TECHNOLOGY | 3 Months Ended |
Mar. 31, 2023 | |
IN-LICENSED TECHNOLOGY | |
IN-LICENSED TECHNOLOGY | NOTE 9 – IN-LICENSED TECHNOLOGY Polytherapeutics: On March 24, 2018, Quoin Inc. entered into a securities purchase agreement (the “Acquisition Agreement”), in which it agreed to acquire all of the equity interests in Polytherapeutics, Inc. (the “Seller” or “Polytherapeutics”) for $40,833 and future royalties provided Quoin Inc. commercializes products using the technology developed by the Seller. The terms of any royalty payments to the Seller are 4.0% of the net revenue of royalty products, as defined in the Acquisition Agreement during the ten (10) year period commencing from the date of first sale of a royalty product. If a generic product is introduced by a third party to the market, during the royalty period, the royalty fees shall be reduced from 4% to 2%. If, during the royalty period, two or more generic products are introduced, the royalty fees shall be reduced from 2% to 0%. Skinvisible: In October 2019, Quoin Inc. entered into the Exclusive Licensing Agreement (as amended from time to time, the “License Agreement”) with Skinvisible Pharmaceuticals, Inc. (“Skinvisible”), under which Skinvisible granted the Company a exclusive royalty-bearing license relating to the production and manufacture of prescription drug products related to certain patents held by Skinvisible, including those related to QRX003 and QRX004. The Company made Skinvisible a one-time non-refundable, non-creditable license fee of $1 million (the “License Fee”). In addition, the Company agreed to pay Skinvisible a single digit royalty percentage of the Company’s net sales revenues for any licensed product covered by the patent rights licensed under the License Agreement. The Company also agreed to pay Skinvisible 25% of any revenues the Company receives as royalties in the event that the Company sublicense any licensed products to a third party. The License Agreement also requires that the Company make a $5 million payment to Skinvisible upon receiving approval in the U.S. or European Union, whichever occurs first, for the first drug product developed using intellectual property licensed thereunder. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 3 Months Ended |
Mar. 31, 2023 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | NOTE 10 - INTANGIBLE ASSETS Intangible assets are as follows: March 31, December 31, 2023 2022 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (361,883) (335,872) Net book value $ 678,550 $ 704,561 The Company recorded amortization expense of approximately $26,000 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2023 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 11 - RELATED PARTY TRANSACTIONS Employment Agreements and Due to Officers/Founders: Due to the limited funding of Quoin Inc. prior to the consummation of the Merger, the compensation, including salary, office and car allowances and other benefits, due to Dr. Myers and Ms. Carter under their respective employment agreements, as well as reimbursement of expenses and other amounts paid by Dr. Myers and Ms. Carter to third parties on behalf of Quoin Inc., were not paid by Quoin Inc. to Dr. Myers and Ms. Carter, and were accrued as indebtedness to Dr. Myers and Ms. Carter. Following the closing of the Merger, Quoin Inc. began making payments of $25,000 per month to each of Dr. Myers and Ms. Carter to repay Amounts due to officers at March 31, 2023 and December 31, 2022 consisted of the following: March 31, December 31, 2023 2022 Salaries and other compensation $ 4,023,732 $ 4,108,500 Invoices paid on behalf of the Company — 15,232 Total $ 4,023,732 $ 4,123,732 Less: Short-term portion (650,000) (600,000) Long-term portion $ 3,373,733 $ 3,523,733 Expenses: Research and development expenses in the amount of $12,000 were paid during the three months ended March 31, 2023 and 2022, respectively, to the CEO Dr. Myers’ son, who had been consulting for the Company on research and development matters from time to time. As of March 31, 2023, Dr. Myers’ son no longer provides consulting services to the Company. Interest Payable: See Note 4 for interest payable on the 2020 Notes. |
RESEARCH, CONSULTING AGREEMENTS
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | 3 Months Ended |
Mar. 31, 2023 | |
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | NOTE 12 – RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS Research agreements In November 2020, Quoin Inc. entered into a Master Service Agreement for an initial term of three years with Therapeutics Inc. for managing preclinical and clinical development for new products in the field of dermatology. The agreement required the execution of individual work orders. Quoin Inc. may terminate any work order for any reason with 90 days written notice subject to costs incurred through termination and a defined termination fee, unless there is a material breach by Therapeutics Inc. A work order was entered into in June 2022 for the first QRX003 clinical study at an expected estimated cost of approximately $4.4 million through 2024. A further work order was entered into in December 2022 for the second QRX003 clinical study at an expected estimated cost of approximately $830,000 through 2024. For the three months ended March 31, 2023 and 2022, the Company incurred a research and development expense under these agreements of approximately $599,000 and $185,000 respectively. In November 2021, the Company entered into a commitment with Queensland University of Technology for research related services associated with Netherton Syndrome of approximately $250,000 for an expected period of eighteen months. For the three months ended March 31, 2023 and 2022, the Company incurred research and development costs related to this agreement of approximately $50,000 and $-0-, respectively. In May 2022, the Company entered into a commitment with Queensland University of Technology for research related services associated with Scleroderma of approximately $610,000 for an expected period of eighteen months. The Company incurred research and development expenses of approximately $88,000 for the three months ended March 31, 2023. Consulting agreement: Quoin Inc. entered into a consulting agreement with an Investor Relations (IR) firm, which provides for a monthly fee of $14,000. The agreement had an automatic annual renewal clause and has been in effect since November 2017. The Company owed the IR firm $584,000 as of December 31, 2021. In March 2022, the Company entered into a settlement agreement with the IR firm reducing the liability to $168,000 and recognized $416,000 as other income in the accompanying consolidated statement of operations. No expenses were incurred in both the three months ended March 31, 2023 and 2022, respectively. Performance milestones and Royalties See Note 9 for asset and in-licensed technology commitments. |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2023 | |
SHAREHOLDERS' EQUITY | |
SHAREHOLDERS' EQUITY | NOTE 13 – SHAREHOLDERS’ EQUITY The Company held a Special General Meeting on February 28, 2022, at which the Company’s shareholders adopted the Amended and Restated Articles of Association of the Company. The Company held its Annual General Meeting on April 12, 2022, at which the Company’s shareholders approved an increase to the authorized share capital to 50,000,000,000 ordinary shares from 12,500,000,000, no par value. The Company held a further Annual General Meeting on November 3, 2022, at which the Company’s shareholders approved an increase to the authorized share capital to 500,000,000,000 ordinary shares from 50,000,000,000, no par value. These ordinary shares are not redeemable and do not have any preemptive rights. Holders of the Company’s ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders at a shareholders meeting. The board of directors shall determine and provide a record date for each shareholders meeting and all shareholders at such record date may vote. Unless stipulated differently in the Companies Law or in the articles of association, all shareholders’ resolutions shall be approved by a simple majority vote. Under Israeli law, the Company may declare and pay dividends only if, upon the determination of its board of directors, there is no reasonable concern that the distribution will prevent the Company from being able to meet the terms of its existing and foreseeable obligations as they become due. Under the Companies Law, the distribution amount is further limited to the greater of retained earnings or earnings generated over the two most recent years legally available for distribution according to the Company’s then last reviewed or audited financial statements, provided that the date of the financial statements is not more than six months prior to the date of distribution. In the event that the Company does not have retained earnings or earnings generated over the two most recent years legally available for distribution, the Company may seek the approval of the court in order to distribute a dividend. The court may approve the Company’s request if it determines that there is no reasonable concern that the payment of a dividend will prevent the Company from satisfying existing and foreseeable obligations as they become due. The Bank of New York Mellon, as depositary, has registered and delivered American Depositary Shares, also referred to as ADSs. Effective August 1, 2022, the ratio of ADSs evidencing ordinary shares changed from 1 ADS representing four hundred (400) ordinary shares to 1 ADS representing five thousand (5,000) ordinary shares, which resulted in a one for 12.5 reverse split of the issued and outstanding ADSs (the “Ratio Change”). All ADSs and related option and warrant information presented in these financial statements and accompanying footnotes has been retroactively adjusted to reflect the reduced number of ADSs resulting from the Ratio Change. Unless otherwise indicated, ADSs outstanding presented in these financial statements and accompanying footnotes assume all outstanding ordinary shares are represented by ADSs. Each ADS will also represent any other securities, cash or other property which may be held by the depositary. ADSs may be held either (a) directly (1) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs or (2) by having uncertificated ADSs, or (b) indirectly by holding a security entitlement in ADSs through a broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, also called DTC. February 2023 Offering On February 24, 2023 (the “February Closing Date”), the Company completed an offering (the “February Offering”) of 24,750,000,000 ordinary shares represented by 4,950,000 ADSs at a purchase price of $1.00 per ADS and a pre-funded warrant (the “February Pre-Funded Warrant”) to purchase 10,250,000,000 ordinary shares represented by 2,050,000 ADSs at a per pre-funded warrant price of $0.9999, with each ADS and February Pre-Funded Warrant accompanied by an ordinary warrant (the “February Common Warrant”) for aggregate gross proceeds of $7.0 million, resulting in net proceeds of approximately $5.8 million, after deducting the placement agent’s fees and offering expenses. Each February Common Warrant has an exercise price of $1.00 per ADS and expires on the fifth anniversary of the February Closing Date. On the February Closing Date, the holder of the February Pre-Funded Warrant exercised its Pre-Funded Warrant in full. In connection with the February Offering, the Company entered into a Securities Purchase Agreement (the “February Purchase Agreement”) with certain institutional investors. Under the February Purchase Agreement, subject to certain exemptions, the Company agreed not to: (i) for a period of ninety (90) days after the closing date of the February Offering, issue, enter into any agreement to issue or announce the issuance or proposed issuance of any ADSs, ordinary shares or ordinary share equivalents or (ii) file any registration statement or amendment or supplement thereto, other than a registration statement on Form S-8 in connection with any employee benefit plan or any post-effective amendment to a registration statement declared effective by the Securities and Exchange Commission (the “SEC”) and (ii) for a period of 180 days after the closing date of the February Offering, enter into an agreement to effect a “variable rate transaction” as defined in the Purchase Agreement. In connection with the February Offering, the Company entered into an Amendment No. 1 to Warrant to Purchase Ordinary Shares Represented by American Depositary Shares, dated February 24, 2023 (collectively, the “Warrant Amendments”), with each of the purchasers (the “2022 Purchasers”) who participated in both the Company’s offering completed in August 2022 (the “August Offering”) and February Offering. The Warrant Amendments amended certain terms of the Common Warrants issued in the August Offering to such 2022 Purchasers. Specifically, the Warrant Amendments reduced the exercise price of Common Warrants to purchase 2,830,000 ADSs out of the total 3,360,000 issued in the August Offering from $5.00 to $1.10 and extended the term during which those warrants could remain exercisable until February 24, 2028. The incremental fair value of the modified warrants was approximately $238,000, which was accounted for as an offering expense in connection with the February Offering. Warrants The 2020 Noteholders received warrants exercisable at any time after the issuance date for 29,388 ADSs at an initial exercise price of $49.75 per ADS. Effective March 13, 2022, each holder agreed to exchange these warrants for warrants with the same number of shares issuable upon the exercise of the original warrant and the same exercise price with a contractual term of 5 years (the “Exchange Warrants”). The Exchange Warrants issued to the 2020 Noteholders effective as of March 13, 2022 were determined to be an equity-classified instrument, and accordingly the warrant liability on such date of The following table summarizes warrant activities during the three months ended March 31, 2023: Weighted ADSs Average Underlying Exercise Price Warrants Per ADS Outstanding at December 31, 2022 3,368,820 $ 5.35 Granted Common and Pre-Funded Warrants 9,050,000 0.77 Exercised Pre-Funded Warrants (2,050,000) 0.00 Outstanding and exercisable at March 31, 2023 10,368,820 $ 1.35 * * For investors who participated in both the Company’s August Offering and February Offering, the exercise price of Common Warrants to purchase 2,830,000 ADSs out of the total 3,360,000 issued in the August offering was reduced from $ 5.00 per ADS to $ 1.10 per ADS, see above. |
CONTINGENCIES
CONTINGENCIES | 3 Months Ended |
Mar. 31, 2023 | |
CONTINGENCIES | |
CONTINGENCIES | NOTE 14 – CONTINGENCIES From time to time, the Company may become involved in various legal matters arising in the ordinary course of business. Management is unaware of any matters requiring accrual for related losses in the financial statements. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2023 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | NOTE 15 – LICENSE AGREEMENTS As of March 31, 2023, the Company has entered into eight license and supply agreements, whereby the Company will receive a royalty or other proceeds from the specified product revenues in select non-US markets from the licensor, if and when the underlying products are approved and commercialized. No royalty revenues have been received through March 31, 2023 under any of these agreements. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2023 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 16 - SUBSEQUENT EVENTS On April 5, 2023, the Company received a letter from the Listing Qualifications staff (the “Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying the Company that the closing bid price per ADS of the Company was below the required minimum of $1.00 for a period of 30 180 10 180 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation: | Basis of Presentation: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements of the Company as of March 31, 2023 and for the three months then ended. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the operating results for the year or any other period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures as of December 31, 2022 and for the year then ended which are included in the Company’s Annual Report on Form 10- K, filed with the SEC on March 15, 2023. The Company operates in one segment. |
Use of estimates: | Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: stock-based compensation and warrants, research and development expense recognition, intangible asset estimated useful lives and impairment assessments, allowances of deferred tax assets, and cash flow assumptions regarding going concern considerations. |
Cash and cash equivalents: | Cash and cash equivalents: The Company considers all highly liquid investments and short-term debt instruments with original maturities of three months or less to be cash equivalents. The Company, from time to time during the periods presented, has had bank account balances in excess of federally insured limits where substantially all cash is held in the United States. The Company has not experienced losses in such accounts. The Company believes that it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. |
Warrants: | Warrants: The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) provide the Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement) provided that such contracts are indexed to the Company’s own stock. The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control) or (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). |
Investments: | Investments: Investments as of March 31, 2023 and December 31, 2022 consist of U.S. Treasury Bills, which are classified as trading securities, totaling $ 13.6 million and $10.0 million, respectively. The Company determines the appropriate balance sheet classification of its investments at the time of purchase and evaluates the classification at each balance sheet date. |
Long-lived assets: | Long-lived assets: Long-lived assets are comprised of acquired technology and licensed rights to use technology, which are considered platform technology with alternative future uses beyond the current products in development. Such intangible assets are being amortized on a straight-line basis over their expected useful life of 10 years. The Company assesses the impairment for long-lived assets whenever events or circumstances indicate the carrying value may not be recoverable. Factors we consider that could trigger an impairment review include the following: ● Significant changes in the manner of the Company’s use of the acquired assets or the strategy for its overall business, ● Significant underperformance relative to expected historical or projected development milestones, ● Significant negative regulatory or economic trends, and ● Significant technological changes which could render the platform technology obsolete. The Company recognizes impairment when the sum of the expected undiscounted future cash flows is less than the carrying amount of the asset. Impairment losses, if any, are measured as the excess of the carrying amount of the asset over its estimated fair value. During the three months ended March 31, 2023, there were no impairment indicators which required an impairment loss measurement. |
Research and development: | Research and development: Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by third parties, patient enrollment in clinical trials when applicable, administrative costs incurred by third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expenses in future periods as the related services are rendered. |
Income taxes: | Income taxes: The Company accounts for its income taxes using the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company maintains a full valuation allowance on its existing deferred tax assets. The Company also accounts for uncertain tax positions using the more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken in the Company’s income tax returns. As of March 31, 2023 and December 31, 2022, the Company had no uncertain tax positions which affected its financial position and its results of operations or its cash flows and will continue to evaluate for uncertain tax positions in the future. If at any time the Company should record interest and penalties in connection with income taxes, the interest and the penalties will be expensed within the interest and general and administrative expenses, respectively. |
Stock based compensation: | Stock based compensation: The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock-based award. The fair value of each option grant is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company’s expected stock volatility is based on the historical data regarding the volatility of a publicly traded set of peer companies, since it has a limited history of trading as a public company. The Company utilizes the simplified method to estimate the expected term. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield was assumed to be zero as the Company has not paid and dividends since its inception and does not anticipate paying dividends in the foreseeable future. |
Fair value of financial instruments: | Fair value of financial instruments: The Company considers its cash and cash equivalents, investments, accounts payable, accrued expenses to meet the definition of financial instruments. The carrying amounts of these financial instruments approximated their fair values due to the short maturities. The Company measures fair value as required by ASC Topic 820, Fair Value Measurements and Disclosures |
Earnings (loss) per share: | Earnings (loss) per share: The Company reports loss per share in accordance with ASC 260-10, Earnings Per Share For the three months ended March 31, 2023 and 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 10,368,820 ADS and outstanding stock options to purchase 307,142 ADS, and outstanding warrants to purchase 1,395,005 ADS and outstanding stock options to purchase 4,655 ADS, respectively, as their inclusion in the denominator would be anti-dilutive. |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
Schedule of assets and liabilities measured at fair value on a recurring basis | March 31, 2023 Level 1 Level 2 Level 3 Total US Treasury Bills $ 13,618,026 $ — $ — $ 13,618,026 Total US Treasury Bills Asset $ 13,618,026 $ — $ — $ 13,618,026 December 31, 2022 Level 1 Level 2 Level 3 Total US Treasury Bills $ 9,992,900 $ — $ — $ 9,992,900 Total US Treasury Bills Asset $ 9,992,900 $ — $ — $ 9,992,900 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
STOCK BASED COMPENSATION | |
Summary of stock-based activities | Weighted Weighted Average Average ADS Underlying Exercise Contractual Options Price Terms Outstanding at December 31, 2022 307,142 $ 17.50 9.28 Granted — $ — Forfeited/Cancelled — $ — Outstanding at March 31, 2023 307,142 $ 17.50 9.03 Exercisable options at March 31, 2023 — $ — — |
PREPAID EXPENSES (Tables)
PREPAID EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
PREPAID EXPENSES | |
Schedule of prepaid expenses | March 31, December 31, 2023 2022 Prepaid R&D costs $ 383,390 $ 383,390 Prepaid insurance 355,156 508,084 Prepaid expense 43,750 8,500 Total $ 782,296 $ 899,974 Less: Short-term portion (398,906) (516,584) Long-term portion $ 383,390 $ 383,390 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
ACCRUED EXPENSES | |
Schedule of accrued expenses | March 31, December 31, 2023 2022 Research contract expenses (note 12) $ 483,830 $ 105,071 Payroll (note 11) 976,306 788,169 Payroll taxes (note 11) 153,552 159,593 Professional fees 346,891 44,278 Other Expenses 124,626 78,594 Total $ 2,085,205 $ 1,175,705 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
INTANGIBLE ASSETS | |
Schedule of intangible assets | March 31, December 31, 2023 2022 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (361,883) (335,872) Net book value $ 678,550 $ 704,561 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
RELATED PARTY TRANSACTIONS | |
Schedule of amounts due to officers | March 31, December 31, 2023 2022 Salaries and other compensation $ 4,023,732 $ 4,108,500 Invoices paid on behalf of the Company — 15,232 Total $ 4,023,732 $ 4,123,732 Less: Short-term portion (650,000) (600,000) Long-term portion $ 3,373,733 $ 3,523,733 |
SHAREHOLDERS' EQUITY (Tables)
SHAREHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
SHAREHOLDERS' EQUITY | |
Summary of warrant activities | Weighted ADSs Average Underlying Exercise Price Warrants Per ADS Outstanding at December 31, 2022 3,368,820 $ 5.35 Granted Common and Pre-Funded Warrants 9,050,000 0.77 Exercised Pre-Funded Warrants (2,050,000) 0.00 Outstanding and exercisable at March 31, 2023 10,368,820 $ 1.35 * |
LIQUIDITY RISKS AND OTHER UNC_2
LIQUIDITY RISKS AND OTHER UNCERTAINTIES (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 | Aug. 09, 2022 |
Substantial Doubt About Going Concern Line Items | |||
Accumulated deficit | $ 40,100,000 | ||
Cash balances | 3,371,854 | $ 2,860,628 | |
Investments | $ 13,600,000 | $ 10,000,000 | |
2020 Notes | |||
Substantial Doubt About Going Concern Line Items | |||
Proceeds received | $ 2,600,000 | ||
Deferred Offering Costs | $ 1,800,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Basis of Presentation (Details) | 3 Months Ended |
Mar. 31, 2023 segment | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Number of operating segment | 1 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Long-lived assets & Income taxes (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Intangible assets, useful life | 10 years | |
Impairment loss measurement | $ 0 | |
U.S. Treasury Bills | $ 13.6 | $ 10 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings per share (Details) - ADS - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock options | ||
Antidilutive securities excluded from diluted computation | ||
Antidilutive securities | 307,142 | 4,655 |
Outstanding warrants | ||
Antidilutive securities excluded from diluted computation | ||
Antidilutive securities | 10,368,820 | 1,395,005 |
CONVERTIBLE NOTES AND WARRANTS
CONVERTIBLE NOTES AND WARRANTS (Details) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2023 USD ($) item | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) item | Dec. 31, 2021 USD ($) shares | |
CONVERTIBLE NOTES AND WARRANTS | ||||
Expected accrued interest | $ 312,000 | |||
Total number of notes holders | item | 5 | |||
Number of notes holders who received consideration | item | 2 | 2 | ||
Number of remaining noteholders | item | 3 | |||
Convertible Notes Warrants, Common Stock | ||||
CONVERTIBLE NOTES AND WARRANTS | ||||
Accrued interest | $ 744,000 | |||
2020 Notes | ||||
CONVERTIBLE NOTES AND WARRANTS | ||||
Accrued interest | $ 1,146,000 | $ 1,146,000 | ||
Interest expense | $ 0 | $ 0 | ||
2020 Notes | Convertible Notes Warrants, Common Stock | ||||
CONVERTIBLE NOTES AND WARRANTS | ||||
Shares issued upon conversion | shares | 5,183 |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair value on a recurring basis (Details) - Recurring - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Assets and liabilities measured on a recurring basis | ||
Warrant liability | $ 13,618,026 | $ 9,992,900 |
US Treasury Bills | ||
Assets and liabilities measured on a recurring basis | ||
Warrant liability | $ 13,618,026 | 9,992,900 |
Level 1 | ||
Assets and liabilities measured on a recurring basis | ||
Warrant liability | 9,992,900 | |
Level 1 | US Treasury Bills | ||
Assets and liabilities measured on a recurring basis | ||
Warrant liability | $ 9,992,900 |
STOCK BASED COMPENSATION (Detai
STOCK BASED COMPENSATION (Details) - shares | 1 Months Ended | 3 Months Ended |
Mar. 31, 2022 | Mar. 31, 2023 | |
ADS | ||
STOCK BASED COMPENSATION | ||
Granted | 9,050,000 | |
Amended and Restated Equity Incentive Plan | ||
STOCK BASED COMPENSATION | ||
Percentage of ordinary shares reserved for issuance | 15% | |
Number of ordinary shares reserved for future issuance | 16,891,925,220 | |
Amended and Restated Equity Incentive Plan | ADS | ||
STOCK BASED COMPENSATION | ||
Number of ordinary shares reserved for future issuance | 3,378,385 | |
Granted | 3,071,243 |
STOCK BASED COMPENSATION - Opti
STOCK BASED COMPENSATION - Option activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Weighted Average Exercise Price | ||
Balance at the beginning (in dollars per share) | $ 5.35 | |
Granted (in dollars per share) | 0.77 | |
Balance at the end (in dollars per share) | $ 1.35 | $ 5.35 |
ADS | ||
ADS Underlying Options | ||
Outstanding at beginning (in shares) | 3,368,820 | |
Granted (in shares) | 9,050,000 | |
Outstanding at ending (in shares) | 10,368,820 | 3,368,820 |
Amended Plan | ADS | ||
ADS Underlying Options | ||
Outstanding at beginning (in shares) | 307,142 | |
Granted (in shares) | 3,071,243 | |
Outstanding at ending (in shares) | 307,142 | 307,142 |
Weighted Average Exercise Price | ||
Balance at the beginning (in dollars per share) | $ 17.50 | |
Balance at the end (in dollars per share) | $ 17.50 | $ 17.50 |
Weighted Average Contractual Terms | ||
Contractual term (in years) | 9 years 10 days | 9 years 3 months 10 days |
Exercisable options (in years) | 0 years |
STOCK BASED COMPENSATION - Stoc
STOCK BASED COMPENSATION - Stock based compensation expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock-Based Compensation Expense | ||
Intrinsic value of outstanding options | $ 0 | |
Stock-based compensation expense | 261,000 | $ 0 |
Unrecognized stock compensation expense | $ 2,944,000 | |
Unrecognized stock compensation expense expected to be recognized over the remaining weighted average service period | 2 years 9 months 29 days | |
Research and development | ||
Stock-Based Compensation Expense | ||
Stock-based compensation expense | $ 34,000 | |
General and administrative | ||
Stock-Based Compensation Expense | ||
Stock-based compensation expense | $ 227,000 |
PREPAID EXPENSES (Details)
PREPAID EXPENSES (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
PREPAID EXPENSES | ||
Prepaid R&D costs | $ 383,390 | $ 383,390 |
Prepaid insurance | 355,156 | 508,084 |
Prepaid expense | 43,750 | 8,500 |
Total | 782,296 | 899,974 |
Less: Short-term portion | (398,906) | (516,584) |
Long-term portion | $ 383,390 | $ 383,390 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
ACCRUED EXPENSES | ||
Research contract expenses | $ 483,830 | $ 105,071 |
Payroll | 976,306 | 788,169 |
Payroll taxes | 153,552 | 159,593 |
Professional fees | 346,891 | 44,278 |
Other Expenses | 124,626 | 78,594 |
Total | $ 2,085,205 | $ 1,175,705 |
IN-LICENSED TECHNOLOGY - Polyth
IN-LICENSED TECHNOLOGY - Polytherapeutics (Details) - Polytherapeutics - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 24, 2018 | Mar. 31, 2023 | Dec. 31, 2022 | |
Asset acquisitions and in-licensed technology | |||
Purchase price agreement | $ 40,833 | ||
Royalty payments, net revenue (as a percent) | 4% | ||
Royalty payment period | 10 years | ||
Royalty payments with one generic product introduced, as a percent of net revenue | 2% | 4% | |
Royalty payments with two generic product introduced, as a percent of net revenue | 0% | 2% |
IN-LICENSED TECHNOLOGY - Skinvi
IN-LICENSED TECHNOLOGY - Skinvisible (Details) - Skinvisable $ in Millions | 1 Months Ended |
Oct. 31, 2019 USD ($) | |
Asset acquisitions and in-licensed technology | |
License fee | $ 1 |
Percentage of revenues payable from sublicensed product | 25% |
Payment for first drug product development | $ 5 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 |
Intangible assets | |||
Total cost | $ 1,040,433 | $ 1,040,433 | |
Accumulated amortization | (361,883) | (335,872) | $ (3) |
Net book value | 678,550 | 704,561 | |
Acquired technology - Polytherapeutics | |||
Intangible assets | |||
Total cost | 40,433 | 40,433 | |
Technology license - Skinvisible | |||
Intangible assets | |||
Total cost | $ 1,000,000 | $ 1,000,000 |
INTANGIBLE ASSETS - Additional
INTANGIBLE ASSETS - Additional information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
INTANGIBLE ASSETS | ||
Amortization of intangibles | $ 26,011 | $ 26,010 |
Expected amortization expense | ||
2023 | 78,000 | |
2024 | 104,000 | |
2025 | 104,000 | |
2026 | 104,000 | |
Thereafter | $ 288,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Related Party Transaction | ||
Non-bearing interest indebtedness | $ 100,000 | $ 150,000 |
Consulting expense | ||
Related Party Transaction | ||
Consulting expense from related party | 12,000 | 12,000 |
Dr. Myers | ||
Related Party Transaction | ||
Monthly payment amounts due to related party | 25,000 | |
Non-bearing interest indebtedness | 75,000 | 75,000 |
Outstanding indebtedness | 2,184,000 | |
Ms. Carter | ||
Related Party Transaction | ||
Monthly payment amounts due to related party | 25,000 | |
Non-bearing interest indebtedness | 25,000 | $ 75,000 |
Outstanding indebtedness | $ 1,840,000 |
RELATED PARTY TRANSACTIONS - Am
RELATED PARTY TRANSACTIONS - Amounts due to officers (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Amounts due to officers | ||
Due to officers | $ 4,023,732 | $ 4,123,732 |
Less: Short-term portion | (650,000) | (600,000) |
Long-term portion | 3,373,733 | 3,523,733 |
Salaries and other compensation | ||
Amounts due to officers | ||
Due to officers | $ 4,023,732 | 4,108,500 |
Invoices paid on behalf of the Company | ||
Amounts due to officers | ||
Due to officers | $ 15,232 |
RESEARCH, CONSULTING AGREEMEN_2
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||||||
Dec. 31, 2022 | Mar. 31, 2022 | Nov. 30, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2022 | May 31, 2022 | Dec. 31, 2021 | Nov. 30, 2021 | |
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |||||||||
Research and development | $ 1,091,733 | $ 587,569 | |||||||
Accrued expenses | $ 1,175,705 | 2,085,205 | |||||||
Gain on reduction in liability | 416,000 | ||||||||
Other income | 172,481 | 493,237 | |||||||
Research and consulting agreement | Netherton Syndrome | |||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |||||||||
Research and development | 50,000 | 0 | |||||||
Research and consulting agreement | Therapeutics Inc. | |||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |||||||||
Research and development | $ 830,000 | 599,000 | $ 185,000 | ||||||
Research and consulting agreement | Scleroderma | |||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |||||||||
Total amount of agreement | $ 610,000 | ||||||||
Research and development | 88,000 | ||||||||
Consulting agreements | Netherton Syndrome | |||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |||||||||
Total amount of agreement | $ 250,000 | ||||||||
Consulting agreements | Therapeutics Inc. | |||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |||||||||
Initial term | 3 years | ||||||||
Written termination notice period | 90 days | ||||||||
Total amount of agreement | $ 4,400,000 | ||||||||
Consulting agreements | Investor Relations firm | |||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |||||||||
Accrued expenses | $ 584,000 | ||||||||
Gain on reduction in liability | $ 168,000 | ||||||||
Other income | $ 416,000 | ||||||||
Monthly payments | $ 14,000 |
SHAREHOLDERS' EQUITY (Details)
SHAREHOLDERS' EQUITY (Details) | 3 Months Ended | ||||||||||
Feb. 24, 2023 USD ($) $ / shares shares | Aug. 09, 2022 USD ($) $ / shares shares | Aug. 01, 2022 shares | Mar. 13, 2022 USD ($) | Mar. 31, 2023 Y Vote $ / shares shares | Mar. 31, 2022 USD ($) | Dec. 31, 2022 $ / shares shares | Nov. 03, 2022 $ / shares shares | Nov. 02, 2022 shares | Apr. 12, 2022 $ / shares shares | Apr. 11, 2022 shares | |
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Ordinary shares, authorized | 500,000,000,000 | 500,000,000,000 | |||||||||
Ordinary shares, par value | $ / shares | $ 0 | $ 0 | $ 0 | ||||||||
Number of vote for each ordinary share | Vote | 1 | ||||||||||
Number of years of income that limits distribution | Y | 2 | ||||||||||
Maximum period between date of financial statements and distribution date | 6 months | ||||||||||
Reverse stock split | 12.5 | ||||||||||
Warrant liability reclassified to additional paid in capital | $ | $ 296,362 | ||||||||||
Threshold period for not to enter in to an agreement for variable rate transaction from the date of closing of the Offering | 180 days | ||||||||||
Threshold period for not to issue or proposed issuance of any ADSs or ordinary shares | 90 days | ||||||||||
Noteholders 2020 [Member] | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Warrants, term | 5 years | ||||||||||
Warrant liability reclassified to additional paid in capital | $ | $ 296,362 | ||||||||||
Number of warrants outstanding | 0 | ||||||||||
Warrant amendments | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Incremental fair value | $ | $ 238,000 | ||||||||||
ADS | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Number of ordinary shares for each ADS | 400 | 5,000 | |||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 7,000,000 | ||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 5 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,360,000 | ||||||||||
ADS | Noteholders 2020 [Member] | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 49.75 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 29,388 | ||||||||||
ADS | Warrant amendments | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 1.10 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,830,000 | ||||||||||
Offering | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 24,750,000,000 | ||||||||||
Offering | Pre-Funded Warrants | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Warrants, number of securities called by warrants (in shares) | 10,250,000,000 | ||||||||||
Offering | ADS | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Purchase price | $ / shares | $ 1 | ||||||||||
Offering | ADS | Pre-Funded Warrants | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Purchase price | $ / shares | $ 0.9999 | ||||||||||
Warrants, number of securities called by warrants (in shares) | 2,050,000 | ||||||||||
Gross proceeds from offering | $ | $ 7,000,000 | ||||||||||
Net proceeds from offering | $ | $ 5,800,000 | ||||||||||
Offering | ADS | Common Warrant | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 1 | ||||||||||
Quoin | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Ordinary shares, authorized | 500,000,000,000 | 50,000,000,000 | 50,000,000,000 | 12,500,000,000 | |||||||
Ordinary shares, par value | $ / shares | $ 0 | $ 0 | |||||||||
Quoin | Offering | ADS | |||||||||||
SHARE OWNERSHIP AND RIGHTS | |||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 4,950,000 |
SHAREHOLDERS' EQUITY - Warrants
SHAREHOLDERS' EQUITY - Warrants (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Weighted Average Exercise Price Per Share | |
Balance at the beginning (in dollars per share) | $ / shares | $ 5.35 |
Granted (in dollars per share) | $ / shares | 0.77 |
Exercised Pre Funded Warrants (in dollars per share) | $ / shares | 0 |
Balance at the end (in dollars per share) | $ / shares | $ 1.35 |
ADS | |
ADS Underlying Warrants | |
Outstanding at beginning (in shares) | shares | 3,368,820 |
Granted (in shares) | shares | 9,050,000 |
Exercised Pre Funded Warrants | shares | (2,050,000) |
Outstanding at ending (in shares) | shares | 10,368,820 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) | 3 Months Ended |
Mar. 31, 2023 USD ($) agreement | |
LICENSE AGREEMENTS | |
Number of license and supply agreements entered | agreement | 8 |
Royalty revenues | $ | $ 0 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - SUBSEQUENT EVENTS - ADS | Apr. 05, 2023 $ / shares |
SUBSEQUENT EVENTS | |
Minimum closing bid price required per ADS | $ 1 |
Threshold number of consecutive business days for calculating closing bid price per ads | 30 days |
Number of calender days to regain compliance with minimum bid price requirement | 180 days |
Minimum consecutive business days with minimum bid price requirement to regain complaince | 10 days |
Additional calender grace day period to regain compliance with minimum bid price requirement | 180 days |