Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2023 | Mar. 13, 2024 | Mar. 12, 2024 | Jun. 30, 2023 | |
Document and Entity Information | ||||
Document Type | 10-K | |||
Document Transition Report | false | |||
Document Period End Date | Dec. 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(b) Security | American Depositary Shares | |||
Trading Symbol | QNRX | |||
Security Exchange Name | NASDAQ | |||
Entity Well-known Seasoned Issuer | No | |||
Entity Voluntary Filers | No | |||
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 | |||
ICFR Auditor Attestation Flag | false | |||
Document Financial Statement Error Correction | false | |||
Entity Shell Company | false | |||
Entity Public Float | $ 5.8 | |||
Current Fiscal Year End Date | --12-31 | |||
Amendment Flag | false | |||
Entity Central Index Key | 0001671502 | |||
Document Fiscal Year Focus | 2023 | |||
Document Fiscal Period Focus | FY | |||
Document Annual Report | true | |||
Auditor Name | Marcum LLP | |||
Auditor Location | East Hanover, New Jersey | |||
Auditor Firm ID | 688 | |||
Ordinary shares | ||||
Document and Entity Information | ||||
Entity Common Stock, Shares Outstanding | 3,685,970 | |||
ADS | ||||
Document and Entity Information | ||||
Entity Common Stock, Shares Outstanding | 3,685,970 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 2,401,198 | $ 2,860,628 |
Investments | 8,293,663 | 9,992,900 |
Prepaid expenses and other current assets | 591,034 | 516,584 |
Total current assets | 11,285,895 | 13,370,112 |
Prepaid expenses - long term | 300,000 | 383,390 |
Intangible assets, net | 583,334 | 704,561 |
Total assets | 12,169,229 | 14,458,063 |
Current liabilities: | ||
Accounts payable | 526,523 | 605,600 |
Accrued expenses | 1,308,706 | 1,175,705 |
Accrued interest and financing expense | 1,146,251 | 1,146,251 |
Due to officers - short term | $ 600,000 | $ 600,000 |
Other liability, current, related party, type extensible enumeration | srt:OfficerMember | srt:OfficerMember |
Total current liabilities | $ 3,581,480 | $ 3,527,556 |
Due to officers - long term | $ 2,923,733 | $ 3,523,733 |
Other liability, noncurrent, related party, type extensible enumeration | srt:OfficerMember | srt:OfficerMember |
Total liabilities | $ 6,505,213 | $ 7,051,289 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Ordinary shares, no par value per share, 100,000,000 and 8,333,334 ordinary shares authorized at December 31, 2023 and 2022, respectively - 987,220 (987,220 ADS's) ordinary shares issued and outstanding at December 31, 2023 and 403,887 (403,887 ADS's) at December 31, 2022 | 0 | 0 |
Treasury stock, -0- ordinary shares issued at December 31, 2023 and 45 ordinary shares issued at December 31, 2022 | (2,932,000) | |
Additional paid in capital | 51,867,336 | 47,855,521 |
Accumulated deficit | (46,203,320) | (37,516,747) |
Total shareholders' equity | 5,664,016 | 7,406,774 |
Total liabilities and shareholders' equity | $ 12,169,229 | $ 14,458,063 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Ordinary shares, par value | $ 0 | $ 0 |
Ordinary shares, shares authorized | 100,000,000 | 8,333,334 |
Ordinary shares, shares issued | 987,220 | 403,887 |
Ordinary shares, shares outstanding | 987,220 | 403,887 |
Treasury Stock, ordinary shares issued | 0 | 45 |
ADS | ||
Ordinary shares, shares issued | 987,220 | 403,887 |
Ordinary shares, shares outstanding | 987,220 | 403,887 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses | ||
General and administrative | $ 6,070,517 | $ 6,584,868 |
Research and development | 3,307,987 | 2,672,836 |
Total operating expenses | 9,378,504 | 9,257,704 |
Other (income) and expenses | ||
Forgiveness of accounts payable | (416,000) | |
Warrant liability (income) expense | (77,237) | |
Unrealized loss (gain) | 2,683 | (1,307) |
Realized and accrued interest income | (694,614) | (95,745) |
Interest and financing expense | 714,081 | |
Total other (income) expense | (691,931) | 123,792 |
Net loss | (8,686,573) | (9,381,496) |
Deemed dividend on warrant modification | (65,266) | |
Net loss attributable to shareholders | $ (8,686,573) | $ (9,446,762) |
ADS | ||
Loss per ADS | ||
Basic | $ (9.64) | $ (46.81) |
Fully-diluted | $ (9.64) | $ (46.81) |
Weighted average number of ADS's outstanding | ||
Basic | 900,919 | 201,826 |
Fully-diluted | 900,919 | 201,826 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Deficit) - USD ($) | Common Stock ADS | Common Stock | Treasury Stock | Additional Paid In Capital | Accumulated Deficit | ADS | Total |
Balance at beginning of year at Dec. 31, 2021 | $ (2,932,000) | $ 31,659,017 | $ (28,069,985) | $ 657,032 | |||
Balance at beginning of year (in shares) at Dec. 31, 2021 | 55,913 | 55,913 | |||||
Net Income (Loss) | (9,381,496) | (9,381,496) | |||||
Stock based compensation | 764,007 | 764,007 | |||||
Reclassification of warrant liability upon issuance of Exchange warrant | 296,362 | 296,362 | |||||
Issuance of ADS and Pre-Funded Warrants, net | 14,877,332 | 14,877,332 | |||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 280,000 | 280,000 | |||||
Cashless exercise of warrants (in shares) | 64,292 | 64,292 | |||||
Settlement of accrued expenses | 193,537 | 193,537 | |||||
Settlement of accrued expenses (in shares) | 3,682 | 3,682 | |||||
Deemed dividend on warrant modification | 65,266 | (65,266) | |||||
Balance at end of year at Dec. 31, 2022 | (2,932,000) | 47,855,521 | (37,516,747) | $ 7,406,774 | |||
Balance at ending of year (in shares) at Dec. 31, 2022 | 403,887 | 403,887 | 403,887 | 403,887 | |||
Net Income (Loss) | (8,686,573) | $ (8,686,573) | |||||
Stock based compensation | 1,094,549 | 1,094,549 | |||||
Retirement of Treasury Stock | $ 2,932,000 | (2,932,000) | |||||
Issuance of ADS and Pre-Funded Warrants, net | 5,849,266 | 5,849,266 | |||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 583,333 | 583,333 | |||||
Balance at end of year at Dec. 31, 2023 | $ 51,867,336 | $ (46,203,320) | $ 5,664,016 | ||||
Balance at ending of year (in shares) at Dec. 31, 2023 | 987,220 | 987,220 | 987,220 | 987,220 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows used in operating activities: | ||
Net loss | $ (8,686,573) | $ (9,381,496) |
Change in fair value of warrant liability | (77,237) | |
Stock based compensation | 1,094,549 | 764,007 |
Forgiveness of trade payable | (416,000) | |
Amortization of intangibles | 103,706 | 104,043 |
Asset impairment | 17,521 | |
Increase in accrued interest and financing expense | 714,081 | |
Unrealized gain and accrued interest on investments | (489,079) | (93,779) |
Changes in assets and liabilities: | ||
Increase in accounts payable and accrued expenses | 53,924 | (217,806) |
Decrease in prepaid expenses & other assets | 41,523 | 123,455 |
Net cash used in operating activities | (7,864,429) | (8,480,732) |
Cash flows provided by (used in) investing activities: | ||
Purchase of investments | (18,090,684) | (9,899,121) |
Proceeds from maturity of investments | 20,279,000 | |
Payment for license acquisition | (250,000) | |
Cash flows provided by (used in) investing activities: | 2,188,316 | (10,149,121) |
Cash flows provided by financing activities: | ||
Payments of deferred financing costs | (32,583) | 42,045 |
Payment of interest on "Bridge Notes" | (600,000) | (599,999) |
Payment of interest on "Bridge Notes" | (311,670) | |
Proceeds from sale of equity securities, net | 5,849,266 | 14,877,332 |
Net cash provided by (used in) investing activities | 5,216,683 | 14,007,708 |
Net change in cash and cash equivalents: | (459,430) | (4,622,145) |
Cash and cash equivalents - beginning of year | 2,860,628 | 7,482,773 |
Cash and cash equivalents - end of year | 2,401,198 | 2,860,628 |
Supplemental information - Non cash items: | ||
Reclassification of warrant liability to equity upon issuance of "Exchange warrants" | 296,362 | |
Deemed dividend on warrant modification | 65,266 | |
Offering expenses associated with warrant modification | $ 238,231 | 491,601 |
Settlement of accrued expenses | $ 193,537 |
ORGANIZATION AND BUSINESS
ORGANIZATION AND BUSINESS | 12 Months Ended |
Dec. 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.”). Quoin Inc. was incorporated in Delaware on March 5, 2018. 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.” The Company is a 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, QRX003, is a 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 commenced in December 2022 for the first study and in March 2023 for the second study. 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 no revenue has been generated. |
LIQUIDITY RISKS AND OTHER UNCER
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | 12 Months Ended |
Dec. 31, 2023 | |
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | |
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | NOTE 2 - LIQUIDITY RISKS AND OTHER UNCERTAINTIES The Company has incurred net losses every year since inception and has an accumulated deficit of approximately $46.2 million at December 31, 2023. The Company has historically funded its operations through debt and equity financings. At December 31, 2023, the Company had cash balances totaling $2.4 million and investments of $8.3 million. On March 7, 2024, the Company completed an offering of ordinary shares represented by ADSs and pre-funded warrants to purchase ordinary shares represented by ADSs with each ADS and pre-funded warrant accompanied by warrants to purchase ordinary shares represented by ADSs, for aggregate gross proceeds of approximately $6.5 million, before offering costs (See Note 18). The Company believes that it has sufficient cash and liquidity to effect its business plan for at least one year from the issuance of these 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, results of operations 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 including the contract research organization managing both of the Company’s current clinical studies, the supplier of the active pharmaceutical ingredient (API), as well as the contract manufacturer of the drug product for clinical development. On April 5, 2023, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying the Company that the closing bid price per ADS was below the required minimum of $1.00 for a period of 30 consecutive business days and that the Company did not meet the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2).Pursuant to Nasdaq Rule 5810(c)(3)(A), the Company had a period of one hundred eighty (180) calendar days, or until October 2, 2023 (the “Compliance Period”), to regain compliance with Nasdaq’s minimum bid price requirement. On August 1, 2023, the Company received a letter from Nasdaq stating that the Company’s closing bid price per ADS was at $1.00 or greater for the last 10 consecutive business days. Accordingly, the Company regained compliance with Listing Rule 5550(a)(2) and the matter was closed. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation: The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”), which have been consistently applied. All intercompany accounts and transactions have been eliminated in consolidation. Effective July 18, 2023, the ratio of American Depositary Shares (“ADSs”) evidencing ordinary shares changed from 1 ADS representing five thousand ( 5,000 ) ordinary shares to 1 ADS representing sixty thousand ( 60,000 ) ordinary shares, which resulted in a 1 for 12 reverse split of the issued and outstanding ADSs. Effective November 8, 2023, the Company completed a 1 for 60,000 reverse split of the ordinary shares which resulted in the ratio of ADSs evidencing ordinary shares to be changed from 1 ADS representing sixty thousand ( 60,000 ) ordinary shares to 1 ADS representing one ( 1 ) ordinary share. All ordinary share, ADSs and related option and warrant information presented in these financial statements and accompanying footnotes has been retroactively adjusted to reflect the number of ordinary shares and ADSs resulting from the aforementioned ordinary share reverse split and ADS ratio changes. 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: settlement of debt or other obligations, stock-based compensation, 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 consolidated balance sheets as of December 31, 2023 and December 31, 2022, respectively. Investments: Investments as of December 31, 2023 and 2022 consist of U.S. Treasury Bills, which are classified as trading securities, totaling $8.3 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. All of the Company’s U.S. Treasury Bills held on December 31, 2023 have maturities within four months from the balance sheet date. As of December 31, 2023, the carrying value of the Company’s U.S. Treasury Bills approximates their fair value due to their short-term maturities. 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 our use of the acquired assets or the strategy for our 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 year ended December 31, 2023 there was one impairment indicator which required an impairment loss measurement (see Note 11). During the year ended December 31, 2022, 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 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 December 31, 2023 and 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. Since the Company has a limited history of trading as a public company, the Company’s expected stock volatility is based on a weighting of its historical volatility along with a group of a publicly traded set of peer companies. 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 year ended December 31, 2023, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 864,081 ADS and outstanding stock options to purchase 278,011 ADS. For the year ended December 31, 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 280,735 ADS and outstanding stock options to purchase 25,595 ADS. The inclusion of these warrants and stock options for both 2023 and 2022 in the denominator would be anti-dilutive. Recent Accounting Pronouncements: In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. |
ACCRUED INTEREST AND FINANCING
ACCRUED INTEREST AND FINANCING EXPENSE | 12 Months Ended |
Dec. 31, 2023 | |
ACCRUED INTEREST AND FINANCING EXPENSE | |
ACCRUED INTEREST AND FINANCING EXPENSE | NOTE 4 – On October 2, 2020, Quoin Inc. issued promissory notes (the “2020 Notes”) to certain investors (“2020 Noteholders”). The 2020 Notes were mandatorily convertible into 432 ADSs, subject to adjustment and were converted in 2021. The ADSs issued to the 2020 Noteholders did not include accrued interest. Two of the five 2020 Noteholders received their amount due during the year ended December 31, 2022 and the Company’s estimate of the liability to the remaining three 2020 Noteholders was estimated to be $1,146,000 as of December 31, 2023 and December 31, 2022. There was no interest expense during the year ended December 31, 2023. The holders also received warrants exercisable at any time after the issuance date for 2,449 ADSs at an initial exercise price of $597 per ADS. At the time of grant, the Company determined that these warrants met the criteria to be recorded as a liability instrument. Effective March 13, 2022, each holder agreed to exchange these warrants for warrants on the substantially same terms as the Investor Exchange Warrants (See Note 5) 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 “Noteholder Warrants”). The Noteholder Warrants have been determined to have equity classification. The change in the fair value of the warrants through the exchange date was included in other income (expense) in the accompanying statement of operations, and then reclassified from liability to additional paid in capital. On July 14, 2022, as a result of the Altium Agreement (see Note 5), the exercise price of the Noteholder Warrants was reduced to $0 and the 2020 Noteholders subsequently exercised all of their warrants. The change in the exercise price of the Noteholder Warrants resulted in a deemed dividend of approximately $65,000 recorded during the year ended December 31, 2022. |
FINANCING
FINANCING | 12 Months Ended |
Dec. 31, 2023 | |
FINANCING | |
FINANCING | NOTE 5 – FINANCING In connection with the Merger Agreement and the Securities Purchase Agreement with Altium Growth Fund LLP (the “Investor”) (described below), during March to May 2021 Quoin Inc. issued three tranches of bridge notes (the “Bridge Notes”) in the aggregate principal amount of $5.0 million. The Bridge notes had a maturity date of the earliest to occur of: (i) December 25, 2021, (ii) the date on which the Company’s equity was registered under the Exchange Act or is exchanged for equity so registered or (iii) immediately prior to the closing of the Merger. The Bridge Notes were offset against the purchase price under the Securities Purchase Agreement related to the Primary Financing and converted into 8,385 ADSs upon the closing of the Primary Financing in October 2021. The Bridge Notes were issued with warrants to purchase a number of shares of Quoin Inc.’s common stock equal to the aggregate principal amount of the Bridge Notes. Upon the closing of the financing in October 2021, the warrants were exchanged for warrants to purchase 8,256 ADSs at a fixed per share exercise price of $597 with a five year maturity (“Investor Exchange Warrants”). On July 14, 2022, the Company and the Investor entered into an agreement amending the terms of the Investor Exchange Warrants. See below, “Agreements with Altium Growth Fund, LP and Warrant Exercises”. On October 28, 2021, the Company completed the private placement transaction with the Investor for an aggregate purchase price of approximately $17.0 million (comprised of the set off from approximately $5.0 million of Bridge Notes, and approximately $12.0 million in cash) (the “Primary Financing”), which resulted in the net proceeds of approximately $10.1 million. The Company also issued to the Investor, effective as of March 13, 2022 (i) Series A Warrant to purchase 28,508 ADSs (the “Series A Warrant”) (ii) Series B Warrant to purchase 28,508 ADSs (the “Series B Warrant”) and (iii) Series C Warrant to purchase 15,931 ADSs (“Series C Warrant” and, together with the Series A Warrant and Series B Warrant, the “Investor Warrants”). The exercise price for the Investor Warrants was $597 per ADS, with Series A Warrant having a five-year maturity, and Series B Warrant and Series C Warrant having a two-year maturity. The Company had the right to require the mandatory exercise of the Series C Warrant, subject to an effective registration statement being in place for the resale of the shares underlying such warrants and the satisfaction of equity market conditions, as defined in the Series C Warrant. In the period from April 22, 2022 to June 30, 2022, the Investor exercised the Series B Warrant in full pursuant to the alternate cashless exercise rights of such warrant, resulting in the issuance of a total of 28,508 ADSs to the Investor. The market related conditions to require the mandatory exercise of the Series C Warrant were not met during the period up to July 14, 2022. Agreements with Altium Growth Fund, LP and Warrant Exercises On July 14, 2022, the Company, Quoin Inc. and Altium entered into an agreement (the “Altium Agreement”), pursuant to which the parties agreed to, among other things, (i) amend certain terms of the Series A Warrant and Investor Exchange Warrants previously issued to Altium to reduce the exercise price from $597 to $0.00 per ADS with respect to a total of 33,333 ADSs, (ii) cancel the Series C Warrant and the remaining portion of the Series A Warrant previously issued to Altium, and (iii) terminate the Purchase Agreements, pursuant to which the warrants were previously issued to Altium. The incremental fair value of the modified warrants was approximately $491,000, which was accounted for as an offering expense as part of the 2022 Offering (see Note 14) as the modification was done in contemplation of such offering. As of August 2, 2022, Altium exercised all of its outstanding warrants to purchase ADSs at $0.00 per ADS exercise price and the Company issued a total of 33,333 ADSs to Altium. The exercise price of the Noteholder Warrants (See Note 4) was also reduced from $597 to $0.00 as of July 14, 2022 as a result of the Altium Agreement. |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2023 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | NOTE 6 - 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 December 31, 2023 and 2022: December 31, 2023 Level 1 Level 2 Level 3 Total US Treasury Bills $ 8,293,663 $ — $ — $ 8,293,663 Total US Treasury Bills Asset $ 8,293,663 $ — $ — $ 8,293,663 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 The following shows the movement of the warrant liability balance during the year ended December 31,2022, there was no movement in the year ended December 31, 2023. 2020 Note Warrants Beginning Balance January 1, 2022 $ 373,599 Change in Fair value of warrants (77,237) Reclassification of warrant liability to an equity instrument (296,362) Ending Balance December 31, 2022 $ — Warrants issued to the 2020 Noteholders were classified as a liability on issuance. The original warrants were exchanged for the Noteholder Warrants effective as of March 13, 2022, which were determined to be an equity-classified instrument, and accordingly the warrant liability on such date of $296,362 was reclassified to additional paid in capital on that date. |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
STOCK BASED COMPENSATION | |
STOCK BASED COMPENSATION | NOTE 7 – 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 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 106,532 ordinary shares, represented by 106,532 ADSs as of December 31, 2022, and 319,397 ordinary shares represented by 319,397 ADSs as of December 31, 2023. Under the Amended Plan, the Company may grant options to its directors, officers, employees, consultants, advisers and service providers. The Amended Plan was approved by the shareholders at the Company’s Annual General Meeting of Shareholders held on April 12, 2022. As of the year ended December 31, 2023, 41,386 shares remained available for issuance. 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, 2021 479 $ 7,640.88 0.33 Granted 25,595 210.00 — Forfeited/Cancelled (479) 7,640.00 — Outstanding at December 31, 2022 25,595 $ 210.00 9.28 Granted 252,416 6.62 — Forfeited/Cancelled — — — Outstanding at December 31, 2023 278,011 $ 25.34 9.68 Exercisable options at December 31, 2023 7,382 $ 210.00 8.38 The intrinsic value of outstanding options at December 31, 2023 was $0. Stock options granted during the year ended December 31, 2023 were valued using the Black-Scholes option-pricing model with the following weighted average assumptions: December 31, December 31, 2023 2022 Expected volatility 110.6 % 106.0 % Risk-free interest rate 4.8 % 2.7 % Expected dividend yield 0.0 % 0.0 % Expected life of options in years 6.4 6.9 Exercise Price $ 6.62 $ 210.00 Fair value of common stock $ 4.31 $ 184.56 Estimate fair value of option $ 3.60 $ 155.04 Stock based compensation expense was approximately $1.09 million ($152,000 included in research and development expense and $942,000 included in general and administrative expenses) in the year ended December 31, 2023. Stock based compensation expense was approximately $764,000 ($100,000 included in research and development expense and $664,000 included in general and administrative expenses) in the year ended December 31, 2022. At December 31, 2023, the total unrecognized compensation expense related to non-vested options was approximately $3.0 million and is expected to be recognized over the remaining weighted average service period of approximately 3.7 years. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | NOTE 8 – PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets are as follows: December 31, December 31, 2023 2022 Prepaid R&D costs $ 447,979 $ 383,390 Prepaid insurance 401,972 508,084 Prepaid expense 8,500 8,500 Deferred offering costs (note 18) 32,583 — Total $ 891,034 $ 899,974 Less: Short-term portion (591,034) (516,584) Long-term portion $ 300,000 $ 383,390 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | NOTE 9 – ACCRUED EXPENSES Accrued expenses are as follows: December 31, December 31, 2023 2022 Research contract expenses (note 13) $ 358,287 $ 105,071 Payroll (note 12) 804,156 788,169 Payroll taxes (note 12) 93,989 159,593 Professional fees 50,534 44,278 Other expenses 1,740 78,594 Total $ 1,308,706 $ 1,175,705 |
IN-LICENSED TECHNOLOGY
IN-LICENSED TECHNOLOGY | 12 Months Ended |
Dec. 31, 2023 | |
IN-LICENSED TECHNOLOGY | |
IN-LICENSED TECHNOLOGY | NOTE 10 –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. There were no royalty obligations due at December 31, 2023 and December 31, 2022. As of December 31, 2023 the Company determined that the Polytherapeutics asset was no longer of use and reduced the carrying value to zero, see Note 11. 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 an 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. There were no milestone or royalty obligations due at December 31, 2023 and December 31, 2022. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
INTANGIBLE ASSETS | |
INTANGIBLE ASSETS | NOTE 11 - INTANGIBLE ASSETS Intangible assets are as follows: December 31, December 31, 2023 2022 Acquired technology – Polytherapeutics $ — $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,000,000 1,040,433 Accumulated amortization (416,666) (335,872) Net book value $ 583,334 $ 704,561 The Company recorded amortization expense of approximately $104,000 and $104,000 in the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 the Company determined that the Polytherapeutics asset was no longer of use and reduced the carrying value to zero, which resulted in an impairment expense of approximately $18,000 recorded in research and development expenses in the year ended December 31, 2023. The annual amortization expense expected to be recorded for existing intangible assets for the years 2024 through 2027, and thereafter, is approximately $100,000 , $100,000 , $100,000 , 100,000 and $183,000 , respectively. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2023 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 12 – RELATED PARTY TRANSACTIONS 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 the above-described non-interest-bearing indebtedness. The Company repaid $300,000 and $300,000 of such indebtedness to Dr. Myers and $300,000 and $300,000 to Ms. Carter in the year ending December 31, 2023 and 2022, respectively. As of December 31, 2023, approximately $1,959,000 and $1,565,000 of such indebtedness was outstanding to Dr. Myers and Ms. Carter, respectively. Amounts due to officers at December 31, 2023 and 2022 consisted of the following: December 31, December 31, 2023 2022 Salaries and other compensation $ 3,523,733 $ 4,108,500 Invoices paid on behalf of the Company — 15,232 Total $ 3,523,733 $ 4,123,732 Less: Short-term portion (600,000) (600,000) Long-term portion $ 2,923,733 $ 3,523,733 Expenses: Research and development expense of $12,000 and $48,000 were paid during the years ended December 31, 2023 and 2022, respectively, to Dr. Myers’ son, who had been consulting for the Company on matters from time to time. As of March 31, 2023, Dr. Myers’ son no longer provided 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 | 12 Months Ended |
Dec. 31, 2023 | |
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | |
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | NOTE 13 – RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS Research and consulting agreement In November 2020, Quoin Inc. entered into a Master Service Agreement with Therapeutics Inc. for the management of the preclinical and clinical development of QRX003 for Netherton Syndrome. The initial term of the agreement was three years with automatic one year extensions, and 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. An additional work order was entered into in December 2022 for a second QRX003 clinical study at an expected estimated cost of approximately $830,000 . In the years ended December 31, 2023 and 2022, the Company incurred a research and development expense under these agreements of approximately $1.5 million and $1.2 million respectively. During the year ended December 31, 2023, the Company received a credit of approximately $278,000 applied to prior expenses incurred during the period of March 2023 to July 2023. In November 2021, the Company entered into a research agreement with Queensland University of Technology (QUT) for a pre-clinical research program for the development of a product to treat Netherton Syndrome of approximately $250,000. In May 2022, the Company entered into a second research agreement with QUT for the development of a product to treat Scleroderma of approximately $610,000. Each agreement remains in place until the completion of the research program, which in each case was initially anticipated to be 18 months from execution. For the years December 31, 2023 and 2022, the Company incurred research and development costs related to these agreements of approximately $361,000 and $353,000 respectively. 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, which was included in accrued expenses in the accompanying balance sheet. 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. For the years ended December 31, 2023 and 2022, the Company incurred expenses of $0 and $112,000, respectively. As of December 31, 2023 and December 31, 2022 the Company has $-0- and $56,000 in accrued balances, respectively. Performance milestones and Royalties See Note 10 for asset and in-licensed technology commitments. |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2023 | |
SHAREHOLDERS' EQUITY | |
SHAREHOLDERS' EQUITY | NOTE 14 – SHAREHOLDERS’ EQUITY Historical authorized shares amounts in this Note 14 were not retroactively adjusted to reflect the number of ordinary shares and ADSs resulting from the ordinary share reverse split and ADS ratio changes discussed herein. On April 12, 2022, the Company held a Special General Meeting, at which the Company’s shareholders approved, among other items, to increase the Company’s registered share capital from 12,500,000,000 ordinary shares (without any nominal value) to 50,000,000,000 ordinary shares (without any nominal value). 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. Subsequent thereto, on November 3, 2022, the Company held its Annual General Meeting, at which the Company’s shareholders approved, among other items, an increase in the registered share capital of the Company from 50,000,000,000 ordinary shares without any nominal value each to 500,000,000,000 ordinary shares (without any nominal value). On or about July 18, 2023, the Company changed the ratio of ADSs evidencing ordinary shares from one ADS representing five thousand ( 5,000 ) ordinary shares to one ADS representing sixty thousand ( 60,000 ) ordinary shares (the “Ratio Change”). The Ratio Change resulted in a one for twelve split of issued and outstanding ADSs, however it had no effect on the Ordinary Shares. On October 26, 2023, the Company held its Annual General Meeting (“2023 Meeting”), at which the Company’s shareholders approved, among other items, an increase in the Company’s registered share capital from 500,000,000,000 ordinary shares, no par value, to 6,000,000,000,000 ordinary shares, no par value. Moreover, at the 2023 Meeting, the Company’s shareholders approved a reverse share split (“Reverse Split”) of the Company’s ordinary shares on a date to be determined by the Board, at a ratio of 1-for-60,000. On November 5, 2023, the Board approved November 8, 2023 as the effective date of the Reverse Split. Effective as of November 8, 2023, the number of authorized ordinary shares through the Reverse Split was reduced to 100,000,000 ordinary shares, combining every 60,000 outstanding ordinary shares into one ordinary share, with each ADS representing one ordinary share. Each holder of a Company’s ordinary share has one vote for each ordinary share held on all matters submitted to a vote of shareholders at each 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. In November 2023 the company retired 45 ordinary shares of treasury stock. Under Israeli law, the Company may declare and pay dividends only if, upon the determination of our board of directors, there is no reasonable concern that the distribution will prevent the Company from being able to meet the terms of our 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 our 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 our 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. On August 9, 2022, the Company completed the 2022 Offering of 184,167 ordinary shares represented by 184,167 ADSs at a purchase price of $60.00 per ADS and pre-funded warrants (the “2022 Pre-Funded Warrants”) to purchase 93,833 ordinary shares represented by 93,833 ADSs at a per pre-funded warrant price of $59.998, with each ADS and 2022 Pre-Funded Warrant accompanied by an ordinary warrant (the “2022 Common Warrant”), for aggregate gross proceeds of $16.8 million, resulting in net proceeds of approximately $14.9 million. Each 2022 Common Warrant had an exercise price of $60.00 per ADS and was to expire on the fifth anniversary of the Closing Date. On the Closing Date, the holder of 2022 Pre-Funded Warrants sold in the 2022 Offering exercised its Pre-Funded Warrants in full. The 2022 Common Warrant exercise price and expiration date were subsequently amended for investors who participated in both the 2022 Offering and 2023 Offering (Note 5). Quoin Inc. entered into three consulting agreements with Axella Research LLC (“Axella”) to provide regulatory and pre- clinical/clinical services to the Company with respect to QRX003 and QRX004. The combined fees of the three agreements are approximately $270,000, payable as milestones were met. The Company incurred accrued expenses of approximately $194,000 in relation to Axella consulting agreements as of December 31, 2021. In August 2022 the Company issued 3,682 ADSs to one of Axella’s principals to settle the outstanding liability in full. The Company has no ongoing relationship with Axella Research and no further services will be provided. On February 24, 2023 (the “2023 Closing Date”), the Company completed an offering (the “2023 Offering”) of 412,500 ordinary shares represented by 412,500 ADSs at a purchase price of $12.00 per ADS and a pre-funded warrant (the “Pre-Funded Warrant”) to purchase 170,833 ordinary shares represented by 170,833 ADSs at a per pre-funded warrant price of $11.9988, with each ADS and Pre-Funded Warrant accompanied by an ordinary warrant (the “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 Common Warrant has an exercise price of $12.00 per ADS and expires on the fifth anniversary of the 2023 Closing Date. On the 2023 Closing Date, the holder of the Pre-Funded Warrant exercised its Pre-Funded Warrants in full. In connection with the 2023 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 2022 Offering and 2023 Offering. The Warrant Amendments amended certain terms of the Warrants issued in the 2022 Offering to such 2022 Purchasers. Specifically, the Warrant Amendments reduced the exercise price of Warrants to purchase 236,670 ADSs out of the total 280,000 issued in the 2022 Offering from $60.00 to $13.20 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 2023 Offering. Warrants The following table summarizes warrant activities during the year ended December 31, 2022 and the year ended December 31, 2023: Weighted ADSs Average Underlying Exercise Price Warrants Per ADS Outstanding at December 31, 2021 11,440 $ 664.68 * Granted Common Warrants 448,779 134.52 ** Terminated (19,362) 597.00 * Exercised - Cashless and Pre Funded Warrants (160,122) — Outstanding at December 31, 2022 280,735 $ 64.20 ** Granted Common Warrants 583,346 12.00 Granted Pre-Funded Warrants 170,833 — Exercised Pre-Funded Warrants (170,833) — Outstanding and exercisable at December 31, 2023 864,081 $ 16.13 As of December 31, 2023, outstanding warrants expire in 2024 and 2027, and have an intrinsic value of $0. * Note that the exercise price of certain warrants was reduced from $597 to $0 on July 14, 2022 and to refer to Note 5 ** Note that the exercise price of certain warrants were reduced from $60.00 to $13.20 per ADS for Common Warrants issued in the 2022 Offering to investors who participated in both the Company’s 2022 Offering and 2023 Offering, see above. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
INCOME TAXES | NOTE 15 – INCOME TAXES Significant components of the Company’s deferred tax assets and liabilities at December 31, 2023 and December 31, 2022 are as follows: (table in thousands) 2023 2022 Net operating losses $ 4,276 $ 3,334 Accrued Expenses and Other 175 189 R&D Credit Carryforward 321 76 Stock Compensation 289 178 R&D Capitalization 1,104 581 Intangibles 51 34 Total gross deferred tax assets/(liabilities) $ 6,216 $ 4,392 Less valuation allowance (6,216) (4,392) Net deferred tax assets/(liabilities) $ — $ — The income tax benefit for the years ended December 31, 2023 and December 31, 2022 differed from the amounts computed by applying the U.S. federal income tax rate of 21% to loss before tax benefit as a result of nondeductible expenses, tax credits generated, utilization of net operating loss carryforwards, and increases in the Company’s valuation allowance. (table in thousands) 2023 2022 Federal Statutory Rate $ (1,824) $ (1,970) Permanent Differences 167 153 Research and Development (195) (76) State Income Tax 79 388 Change in Valuation Allowance 1,824 347 Deferred True Up (51) 1,158 Effective Tax $ — $ — A valuation allowance is required to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of the available evidence, both positive and negative, the Company determined that valuation allowances of $6,216,000 and $4,392,000 at December 31, 2023 and December 31, 2022 were necessary to reduce the deferred tax assets to the amount that will more likely than not be realized. At December 31, 2023 and 2022, the Company had gross U.S. Federal income tax net operating loss (“NOL”) carryforward of approximately $17,891,000 and $12,951,000, respectively that may be used to offset future taxable income. The NOL was generated after 2017 and can be carried forward indefinitely under the Tax Cuts and Jobs Act. The company also had gross $17,892,000 of state net operating losses that will begin to expire in 2038. At December 31, 2023, the Company had approximately $321,000 of federal Research and Development (R&D) tax credit carry-forwards. If not utilized, the federal R&D credits will begin to expire in 2042. The Internal Revenue Code (the “IRC”) contains limitations on the use of net operating loss carryforwards after the occurrence of a substantial ownership change as defined by IRC Section 382. The Company has not performed a detailed analysis, however utilization of such net operating loss carryforwards will likely be significantly limited due to the shares issued in the Primary Financing and the Merger. The income tax benefit for the years ended December 31, 2023 and 2022 differed from the amounts computed by applying the US federal income tax rate of 21% primarily because of the increase in the valuation allowance and the tax impact of other permanent items, which resulted in an effective tax rate of zero for both years. The Tax Cuts and Jobs Act of 2017 (TCJA) has modified the IRC 174 expenses related to research and development for the tax years beginning after December 31, 2021. Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize over five years for U.S. activities and 15 years for non-U.S. activities using a mid-year convention. Therefore, the capitalization of research and development costs in accordance with IRC 174 resulted in a gross deferred tax asset of $4,617,000. |
CONTINGENCIES
CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
CONTINGENCIES | |
CONTINGENCIES | NOTE 16 - 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 | 12 Months Ended |
Dec. 31, 2023 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | NOTE 17 – LICENSE AGREEMENTS As of December 31, 2023 and December 31, 2022, the Company had nine and eight commercial license and supply agreements outstanding, whereby the Company will receive a royalty or other proceeds from the specified product revenues from the licensor, if and when the underlying products are approved and commercialized or sold via compassionate use or early access programs. No revenues have been received through December 31, 2023 from any of these agreements. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2023 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 18 - SUBSEQUENT EVENTS Alumni Equity Line and Purchase Agreement On January 25, 2024, the Company entered into a purchase agreement (the “Alumni Purchase Agreement”) with Alumni Capital LP (“Alumni”). Pursuant to the Alumni Purchase Agreement, the Company has the right to sell to Alumni up to $8,000,000 (the “Commitment Amount”) of newly issued ordinary shares that are represented by ADS, subject to certain conditions and limitations, from time to time during the term of the Alumni Purchase Agreement. The Company has agreed to issue purchase notices for an aggregate of at least $4,000,000 of the Commitment Amount pursuant to the Alumni Purchase Agreement. If shareholder approval of the issuance of ADSs under the Purchase Agreement is not obtained by April 30, 2024, the Company may terminate the Alumni Purchase Agreement by written notice to Alumni and neither party shall have any obligation or liability to the other party. There is no upper limit on the price per share that Alumni could be obligated to pay for the ADSs under the Alumni Purchase Agreement; provided, however at no time can the purchase price be below a floor price of $1.00 per share (subject to adjustment as provided in the Alumni Purchase Agreement). As consideration for Alumni’s irrevocable commitment to purchase ADSs under the Alumni Purchase Agreement, the Company agreed to issue to Alumni, at the times set forth in the Alumni Purchase Agreement a number of ADSs with a value at the time of issuance not to exceed $240,000 in the aggregate (the “Commitment Securities”). The Company may pay cash in lieu of issuing all or any portion of the Commitment Securities. In connection with the 2024 Offering, the Company agreed not to sell any ADSs to Alumni under the Alumni Purchase Agreement for a period of 180 days from the closing date of the 2024 Offering. Public Offering On March 7, 2024, (the “2024 Closing Date”) the Company completed an offering (the “2024 Offering”) of the following securities (i) 811,250 ordinary shares represented by ADSs, (ii) 4,062,500 Series D warrants (the “Series D Warrants”) to purchase 4,062,500 ordinary shares represented by ADSs, (iii) 4,062,500 Series E warrants (the “Series E Warrants” and together with the Series D Warrants, the “2024 Warrants”) to purchase 4,062,500 ordinary shares represented by ADSs, and (iv) 3,251,250 pre-funded warrants (the “2024 Pre-Funded Warrants”) to purchase 3,251,250 ordinary shares represented by ADSs for aggregate gross proceeds of approximately $6.5 million, resulting in net proceeds of approximately $5.6 million, after deducting the placement agent’s fees and offering expenses paid by us. Each ADS (or 2024 Pre-Funded Warrant to purchase one ADS in lieu thereof) was sold together with a Series D Warrant to purchase one ADS and a Series E Warrant to purchase one ADS. The ADSs and accompanying 2024 Warrants were sold at a combined public offering price of $1.60 and the 2024 Pre-Funded Warrants and accompanying 2024 Warrants were sold at a combined public offering price of $1.5999, which is equal to the combined purchase price per ADS and accompanying 2024 Warrants, minus the exercise price of each 2024 Pre-Funded Warrant of $0.0001.The Series D and Series E warrants have an exercise price of $1.60 per share, are exercisable immediately following the 2024 Closing Date and expire in two years and five years, respectively, from the closing of the 2024 Offering. In connection with the 2024 Offering, the Company entered into a Securities Purchase Agreement (the “2024 Purchase Agreement”) dated March 4, 2024, with certain institutional investors signatory thereto, pursuant to which the Company agreed to issue and sell to such investors, certain of the ADSs, 2024 Pre-Funded Warrants and 2024 Warrants sold in the 2024 Offering. Pursuant to the terms of the 2024 Purchase Agreement, the Company agreed, subject to certain exceptions, (i) to not enter into variable rate financings for a period of 180 days following the closing of the 2024 Offering, and (ii) to not enter into any equity financings for 90 days from closing of the 2024 Offering. On March 7, 2024, the Company also entered into privately negotiated agreements with the holders of certain existing outstanding warrants to purchase up to 638,834 ADSs (the “Prior Warrants”) to, among other things, reduce the exercise price of such Prior Warrants to $1.60 and to extend the current expiration date of the Prior Warrants until March 7, 2029. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation: | Basis of Presentation: The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”), which have been consistently applied. All intercompany accounts and transactions have been eliminated in consolidation. Effective July 18, 2023, the ratio of American Depositary Shares (“ADSs”) evidencing ordinary shares changed from 1 ADS representing five thousand ( 5,000 ) ordinary shares to 1 ADS representing sixty thousand ( 60,000 ) ordinary shares, which resulted in a 1 for 12 reverse split of the issued and outstanding ADSs. Effective November 8, 2023, the Company completed a 1 for 60,000 reverse split of the ordinary shares which resulted in the ratio of ADSs evidencing ordinary shares to be changed from 1 ADS representing sixty thousand ( 60,000 ) ordinary shares to 1 ADS representing one ( 1 ) ordinary share. All ordinary share, ADSs and related option and warrant information presented in these financial statements and accompanying footnotes has been retroactively adjusted to reflect the number of ordinary shares and ADSs resulting from the aforementioned ordinary share reverse split and ADS ratio changes. |
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: settlement of debt or other obligations, stock-based compensation, 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). 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 consolidated balance sheets as of December 31, 2023 and December 31, 2022, respectively. |
Investments: | Investments: Investments as of December 31, 2023 and 2022 consist of U.S. Treasury Bills, which are classified as trading securities, totaling $8.3 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. All of the Company’s U.S. Treasury Bills held on December 31, 2023 have maturities within four months from the balance sheet date. As of December 31, 2023, the carrying value of the Company’s U.S. Treasury Bills approximates their fair value due to their short-term maturities. |
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 our use of the acquired assets or the strategy for our 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 year ended December 31, 2023 there was one impairment indicator which required an impairment loss measurement (see Note 11). During the year ended December 31, 2022, 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 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 December 31, 2023 and 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. Since the Company has a limited history of trading as a public company, the Company’s expected stock volatility is based on a weighting of its historical volatility along with a group of a publicly traded set of peer companies. 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 year ended December 31, 2023, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 864,081 ADS and outstanding stock options to purchase 278,011 ADS. For the year ended December 31, 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 280,735 ADS and outstanding stock options to purchase 25,595 ADS. The inclusion of these warrants and stock options for both 2023 and 2022 in the denominator would be anti-dilutive. |
Recent Accounting Pronouncements: | Recent Accounting Pronouncements: In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
Schedule of assets and liabilities measured at fair value on a recurring basis | December 31, 2023 Level 1 Level 2 Level 3 Total US Treasury Bills $ 8,293,663 $ — $ — $ 8,293,663 Total US Treasury Bills Asset $ 8,293,663 $ — $ — $ 8,293,663 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 |
Schedule of movement of the warrant liability | 2020 Note Warrants Beginning Balance January 1, 2022 $ 373,599 Change in Fair value of warrants (77,237) Reclassification of warrant liability to an equity instrument (296,362) Ending Balance December 31, 2022 $ — |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 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, 2021 479 $ 7,640.88 0.33 Granted 25,595 210.00 — Forfeited/Cancelled (479) 7,640.00 — Outstanding at December 31, 2022 25,595 $ 210.00 9.28 Granted 252,416 6.62 — Forfeited/Cancelled — — — Outstanding at December 31, 2023 278,011 $ 25.34 9.68 Exercisable options at December 31, 2023 7,382 $ 210.00 8.38 |
Summary of weighted average assumptions of stock options granted valued using the Black-Scholes option-pricing model | December 31, December 31, 2023 2022 Expected volatility 110.6 % 106.0 % Risk-free interest rate 4.8 % 2.7 % Expected dividend yield 0.0 % 0.0 % Expected life of options in years 6.4 6.9 Exercise Price $ 6.62 $ 210.00 Fair value of common stock $ 4.31 $ 184.56 Estimate fair value of option $ 3.60 $ 155.04 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
Schedule of prepaid expenses and other current assets | December 31, December 31, 2023 2022 Prepaid R&D costs $ 447,979 $ 383,390 Prepaid insurance 401,972 508,084 Prepaid expense 8,500 8,500 Deferred offering costs (note 18) 32,583 — Total $ 891,034 $ 899,974 Less: Short-term portion (591,034) (516,584) Long-term portion $ 300,000 $ 383,390 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
ACCRUED EXPENSES | |
Schedule of Accrued Expenses | December 31, December 31, 2023 2022 Research contract expenses (note 13) $ 358,287 $ 105,071 Payroll (note 12) 804,156 788,169 Payroll taxes (note 12) 93,989 159,593 Professional fees 50,534 44,278 Other expenses 1,740 78,594 Total $ 1,308,706 $ 1,175,705 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
INTANGIBLE ASSETS | |
Schedule of intangible assets | December 31, December 31, 2023 2022 Acquired technology – Polytherapeutics $ — $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,000,000 1,040,433 Accumulated amortization (416,666) (335,872) Net book value $ 583,334 $ 704,561 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
RELATED PARTY TRANSACTIONS | |
Schedule of amounts due to officers | December 31, December 31, 2023 2022 Salaries and other compensation $ 3,523,733 $ 4,108,500 Invoices paid on behalf of the Company — 15,232 Total $ 3,523,733 $ 4,123,732 Less: Short-term portion (600,000) (600,000) Long-term portion $ 2,923,733 $ 3,523,733 |
SHAREHOLDERS' EQUITY (Tables)
SHAREHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
SHAREHOLDERS' EQUITY | |
Schedule of warrant activities | Weighted ADSs Average Underlying Exercise Price Warrants Per ADS Outstanding at December 31, 2021 11,440 $ 664.68 * Granted Common Warrants 448,779 134.52 ** Terminated (19,362) 597.00 * Exercised - Cashless and Pre Funded Warrants (160,122) — Outstanding at December 31, 2022 280,735 $ 64.20 ** Granted Common Warrants 583,346 12.00 Granted Pre-Funded Warrants 170,833 — Exercised Pre-Funded Warrants (170,833) — Outstanding and exercisable at December 31, 2023 864,081 $ 16.13 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
Schedule of deferred tax assets and liabilities | (table in thousands) 2023 2022 Net operating losses $ 4,276 $ 3,334 Accrued Expenses and Other 175 189 R&D Credit Carryforward 321 76 Stock Compensation 289 178 R&D Capitalization 1,104 581 Intangibles 51 34 Total gross deferred tax assets/(liabilities) $ 6,216 $ 4,392 Less valuation allowance (6,216) (4,392) Net deferred tax assets/(liabilities) $ — $ — |
Schedule of reconciliation between effective tax and tax computed by applying the U.S. federal income tax rate | (table in thousands) 2023 2022 Federal Statutory Rate $ (1,824) $ (1,970) Permanent Differences 167 153 Research and Development (195) (76) State Income Tax 79 388 Change in Valuation Allowance 1,824 347 Deferred True Up (51) 1,158 Effective Tax $ — $ — |
LIQUIDITY RISKS AND OTHER UNC_2
LIQUIDITY RISKS AND OTHER UNCERTAINTIES (Details) - USD ($) | Mar. 07, 2024 | Aug. 01, 2023 | Apr. 05, 2023 | Feb. 24, 2023 | Dec. 31, 2023 | Dec. 31, 2022 |
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | ||||||
Accumulated deficit | $ 46,200,000 | |||||
Cash balance | 2,401,198 | $ 2,860,628 | ||||
Investments | $ 8,293,663 | $ 9,992,900 | ||||
Aggregate gross proceeds | $ 7,000,000 | |||||
Subsequent Event | ||||||
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | ||||||
Aggregate gross proceeds | $ 6,500,000 | |||||
ADS | ||||||
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | ||||||
Minimum closing bid price required per ADS | $ 1 | $ 1 | ||||
Threshold number of consecutive business days for calculating closing bid price per ads | 10 days | 30 days |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) $ in Millions | 12 Months Ended | ||||||
Nov. 08, 2023 shares | Oct. 26, 2023 shares | Jul. 18, 2023 shares | Aug. 01, 2022 shares | Dec. 31, 2023 USD ($) | Oct. 25, 2023 shares | Dec. 31, 2022 USD ($) shares | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||
Number of shares represented for one ADS | 60,000 | ||||||
Shares owned (as a percent) | 0.083% | 12.50% | |||||
Reverse stock split | 1.67 | ||||||
Number of ordinary shares for ADS | 60,000 | 500,000,000,000 | 6,000,000,000,000 | ||||
U.S. Treasury Bills | $ | $ 8.3 | $ 10 | |||||
Maturity term | 4 months | ||||||
Minimum | |||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||
Number of shares represented for one ADS | 5,000 | ||||||
ADS | |||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||
Reverse stock split | 1 | ||||||
Number of ordinary shares for ADS | 1 | 60,000 | 400 | 5,000 | |||
ADS | Minimum | |||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||
Number of ordinary shares for ADS | 5,000 | ||||||
ADS | Maximum | |||||||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||
Number of ordinary shares for ADS | 60,000 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Long-lived assets & Income taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Intangible assets, useful life | 10 years | |
Impairment loss measurement | $ 1 | $ 0 |
Unrecognized Tax Benefits | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings (loss) per share (Details) - ADS - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee Stock Option | ||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Antidilutive securities | 278,011 | 25,595 |
Outstanding warrants | ||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Antidilutive securities | 864,081 | 280,735 |
ACCRUED INTEREST AND FINANCIN_2
ACCRUED INTEREST AND FINANCING EXPENSE - 2020 Notes (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2023 | Jul. 14, 2022 | Oct. 02, 2020 | |
ACCRUED INTEREST AND FINANCING EXPENSE | ||||||
Deemed Dividend On Warrant Modification | $ 65,266 | |||||
Convertible Notes Warrants, Common Stock | ||||||
ACCRUED INTEREST AND FINANCING EXPENSE | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,449 | |||||
Deemed Dividend On Warrant Modification | $ 65,000 | |||||
Warrants, exercise price of warrants (in dollars per share) | $ 0 | $ 597 | ||||
Warrants, term | 5 years | |||||
Convertible notes 2020 | Convertible Notes Warrants, Common Stock | ||||||
ACCRUED INTEREST AND FINANCING EXPENSE | ||||||
Shares issued upon conversion | 2,449 | 432 | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 0 |
ACCRUED INTEREST AND FINANCIN_3
ACCRUED INTEREST AND FINANCING EXPENSE (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) item | Dec. 31, 2022 USD ($) item | |
ACCRUED INTEREST AND FINANCING EXPENSE | ||
Accrued interest and financing expense | $ | $ 1,146,251 | $ 1,146,251 |
Convertible notes 2020 | ||
ACCRUED INTEREST AND FINANCING EXPENSE | ||
Accrued interest and financing expense | $ | $ 1,146,000 | $ 1,146,000 |
Total number of notes holders | item | 5 | |
Number of notes holders who received consideration | item | 2 | |
Number of remaining noteholders | item | 3 | 3 |
Interest expense | $ | $ 0 |
FINANCING - Bridge Financing (D
FINANCING - Bridge Financing (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Oct. 31, 2021 | Oct. 28, 2021 | Mar. 24, 2021 | |
Debt Instrument [Line Items] | |||
Debt instrument, face amount | $ 12 | ||
Bridge Notes | |||
Debt Instrument [Line Items] | |||
Debt instrument, face amount | $ 5 | ||
Convertible Debt | |||
Debt Instrument [Line Items] | |||
Debt conversion, converted instrument, shares issued | 8,385 |
FINANCING - Investor Warrants (
FINANCING - Investor Warrants (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Jul. 14, 2022 | Mar. 13, 2022 | Oct. 28, 2021 | Oct. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Feb. 24, 2023 | Aug. 02, 2022 | Jul. 13, 2022 | Jun. 30, 2022 | |
Class of Warrant or Right [Line Items] | ||||||||||
Net proceeds | $ 5,849,266 | $ 14,877,332 | ||||||||
Number of warrants outstanding | 33,333 | |||||||||
Change in fair value of warrant liability | $ 491,000 | (77,237) | ||||||||
Deemed dividend on warrant modification | $ 65,266 | |||||||||
Altium Agreement | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 597 | |||||||||
ADS | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants, number of securities called by warrants (in shares) | 280,000 | 28,508 | ||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 0 | $ 60 | $ 0 | |||||||
ADS | Altium | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Number of warrants outstanding | 33,333 | |||||||||
ADS | Altium Agreement | Altium | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 0 | $ 597 | ||||||||
Private Placement | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Aggregate purchase price | $ 17,000,000 | |||||||||
Net proceeds | 10,100,000 | |||||||||
Private Placement | Bridge Notes | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Aggregate purchase price | $ 5,000,000 | |||||||||
Series A Warrants, American Depositary Shares | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants, number of securities called by warrants (in shares) | 28,508 | |||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 597 | |||||||||
Investor warrants maturity term | 5 years | |||||||||
Series B Warrants, American Depositary Shares | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants, number of securities called by warrants (in shares) | 28,508 | |||||||||
Series C Warrants, American Depositary Shares | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants, number of securities called by warrants (in shares) | 15,931 | |||||||||
Series B Warrants and Series C Warrants, American Depositary Shares | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Investor warrants maturity term | 2 years | |||||||||
Investor Exchange Warrants American Depositary Shares | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Warrants, number of securities called by warrants (in shares) | 8,256 | |||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 597 | |||||||||
Investor warrants maturity term | 5 years |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair value on a recurring basis (Details) - Recurring - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
FAIR VALUE OF FINANCIAL INSTRUMENTS | ||
Warrant liability | $ 8,293,663 | $ 9,992,900 |
US Treasury Bills | ||
FAIR VALUE OF FINANCIAL INSTRUMENTS | ||
Warrant liability | 8,293,663 | 9,992,900 |
Level 1 | ||
FAIR VALUE OF FINANCIAL INSTRUMENTS | ||
Warrant liability | 8,293,663 | 9,992,900 |
Level 1 | US Treasury Bills | ||
FAIR VALUE OF FINANCIAL INSTRUMENTS | ||
Warrant liability | $ 8,293,663 | $ 9,992,900 |
FAIR VALUE OF FINANCIAL INSTR_4
FAIR VALUE OF FINANCIAL INSTRUMENTS - Change in fair value (Details) - USD ($) | 12 Months Ended | |
Mar. 13, 2022 | Dec. 31, 2022 | |
Movement of warrant liability | ||
Warrant liability reclassified to additional paid in capital | $ 296,362 | |
2020 Notes Warrants | ||
Movement of warrant liability | ||
Beginning Balance | 373,599 | |
Change in Fair value of warrants | (77,237) | |
Reclassification of warrant liability to an equity instrument | $ (296,362) | |
Warrant liability reclassified to additional paid in capital | $ 296,362 |
STOCK BASED COMPENSATION (Detai
STOCK BASED COMPENSATION (Details) - Amended plan - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2023 | |
STOCK BASED COMPENSATION | ||
Percentage of ordinary shares reserved for issuance | 15% | |
Number of ordinary shares reserved for future issuance | 106,532 | 319,397 |
Number of shares available for issuance | 41,386 | |
ADS | ||
STOCK BASED COMPENSATION | ||
Number of ordinary shares reserved for future issuance | 106,532 | 319,397 |
STOCK BASED COMPENSATION - Opti
STOCK BASED COMPENSATION - Option activity (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted Average Exercise Price | |||
Outstanding at beginning of the period | $ 64.20 | $ 664.68 | |
Forfeited/Cancelled (in dollars per share) | 597 | ||
Outstanding at the end of the period | $ 16.13 | $ 64.20 | $ 664.68 |
ADS | |||
ADS Underlying Options | |||
Number of options outstanding at beginning of period | 280,735 | 11,440 | |
Forfeited/Cancelled (in shares) | (19,362) | ||
Number of Options outstanding at end of period | 864,081 | 280,735 | 11,440 |
Amended plan | ADS | |||
ADS Underlying Options | |||
Number of options outstanding at beginning of period | 25,595 | 479 | |
Granted | 252,416 | 25,595 | |
Forfeited/Cancelled (in shares) | (479) | ||
Number of Options outstanding at end of period | 278,011 | 25,595 | 479 |
Exercisable options (in shares) | 7,382 | ||
Weighted Average Exercise Price | |||
Outstanding at beginning of the period | $ 210 | $ 7,640.88 | |
Granted | 6.62 | 210 | |
Forfeited/Cancelled (in dollars per share) | 7,640 | ||
Outstanding at the end of the period | 25.34 | $ 210 | $ 7,640.88 |
Exercisable options (in dollars per share) | $ 210 | ||
Weighted Average Contractual Terms | |||
Contractual term (in years) | 9 years 8 months 4 days | 9 years 3 months 10 days | 3 months 29 days |
Exercisable options (in years) | 8 years 4 months 17 days |
STOCK BASED COMPENSATION - Weig
STOCK BASED COMPENSATION - Weighted average assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
STOCK BASED COMPENSATION | ||
Expected volatility | 110.60% | 106% |
Risk-free interest rate | 4.80% | 2.70% |
Expected dividend yield | 0% | 0% |
Expected life of options in years | 6 years 4 months 24 days | 6 years 10 months 24 days |
Exercise Price | $ 6.62 | $ 210 |
Fair value of ADS | 4.31 | 184.56 |
Estimated fair value of option | $ 3.60 | $ 155.04 |
STOCK BASED COMPENSATION - Stoc
STOCK BASED COMPENSATION - Stock based compensation expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
STOCK BASED COMPENSATION | ||
Intrinsic value of outstanding options | $ 0 | |
Stock-based compensation expense | 1,090,000 | $ 764,000 |
Unrecognized stock compensation expense | $ 3 | |
Unrecognized stock compensation expense expected to be recognized over the remaining weighted average service period | 3 years 8 months 12 days | |
Research and Development Expense | ||
STOCK BASED COMPENSATION | ||
Stock-based compensation expense | $ 152,000 | 100,000 |
General and Administrative Expense | ||
STOCK BASED COMPENSATION | ||
Stock-based compensation expense | $ 942,000 | $ 664,000 |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||
Prepaid R&D costs | $ 447,979 | $ 383,390 |
Prepaid insurance | 401,972 | 508,084 |
Prepaid expense | 8,500 | 8,500 |
Deferred offering costs | 32,583 | |
Total | 891,034 | 899,974 |
Less: Short-term portion | (591,034) | (516,584) |
Long-term portion | $ 300,000 | $ 383,390 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
ACCRUED EXPENSES | ||
Research contract expenses | $ 358,287 | $ 105,071 |
Payroll | 804,156 | 788,169 |
Payroll taxes | 93,989 | 159,593 |
Professional fees | 50,534 | 44,278 |
Other expenses | 1,740 | 78,594 |
Total | $ 1,308,706 | $ 1,175,705 |
IN-LICENSED TECHNOLOGY - Polyth
IN-LICENSED TECHNOLOGY - Polytherapeutics (Details) | Mar. 24, 2018 USD ($) |
Polytherapeutics | |
IN-LICENSED TECHNOLOGY | |
Purchase price agreement | $ 40,833 |
IN-LICENSED TECHNOLOGY - Skinvi
IN-LICENSED TECHNOLOGY - Skinvisible (Details) - Skinvisible Licensing agreement $ in Millions | 1 Months Ended |
Oct. 31, 2019 USD ($) | |
IN-LICENSED TECHNOLOGY | |
License Fee | $ 1 |
Percentage of revenues to be paid | 25% |
Amount of payment to be made | $ 5 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
INTANGIBLE ASSETS | ||
Total cost | $ 1,000,000 | $ 1,040,433 |
Accumulated amortization | (416,666) | (335,872) |
Net book value | 583,334 | 704,561 |
Acquired technology - Polytherapeutics | ||
INTANGIBLE ASSETS | ||
Total cost | 40,433 | |
Technology license - Skinvisible | ||
INTANGIBLE ASSETS | ||
Total cost | $ 1,000,000 | $ 1,000,000 |
INTANGIBLE ASSETS - Additional
INTANGIBLE ASSETS - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
INTANGIBLE ASSETS | ||
Amortization of intangibles | $ 103,706 | $ 104,043 |
Expected amortization expense | ||
Impairment expense | $ 18,000 | |
Impairment, intangible asset, finite-lived, statement of income or comprehensive income [extensible enumeration] | Research and development | |
2024 | $ 100,000 | |
2025 | 100,000 | |
2026 | 100,000 | |
2027 | 100,000 | |
Thereafter | $ 183,000 |
RELATED PARTY TRANSACTIONS - Na
RELATED PARTY TRANSACTIONS - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
RELATED PARTY TRANSACTIONS | ||
Non-bearing interest indebtedness | $ 600,000 | $ 599,999 |
Outstanding indebtedness | $ 600,000 | $ 600,000 |
Other Liability, Related Party, Type [Extensible Enumeration] | srt:OfficerMember | srt:OfficerMember |
Operating cost and expenses | $ 9,378,504 | $ 9,257,704 |
Research and development | ||
RELATED PARTY TRANSACTIONS | ||
Operating cost and expenses | 12,000 | 48,000 |
Dr. Myers | ||
RELATED PARTY TRANSACTIONS | ||
Non-bearing interest indebtedness | $ 300,000 | 300,000 |
Other Liability, Related Party, Type [Extensible Enumeration] | us-gaap:RelatedPartyMember | |
Outstanding indebtedness | $ 1,959,000 | |
Monthly payment amount | 25,000 | |
Ms. Carter | ||
RELATED PARTY TRANSACTIONS | ||
Non-bearing interest indebtedness | $ 300,000 | $ 300,000 |
Other Liability, Related Party, Type [Extensible Enumeration] | us-gaap:RelatedPartyMember | |
Outstanding indebtedness | $ 1,565,000 | |
Monthly payment amount | $ 25,000 |
RELATED PARTY TRANSACTIONS - Am
RELATED PARTY TRANSACTIONS - Amounts due to officers (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
RELATED PARTY TRANSACTIONS | ||
Total | $ 3,523,733 | $ 4,123,732 |
Other Liability, Related Party, Type [Extensible Enumeration] | srt:OfficerMember | srt:OfficerMember |
Less: Short-term portion | $ (600,000) | $ (600,000) |
Other Liability, Current, Related Party, Type [Extensible Enumeration] | srt:OfficerMember | srt:OfficerMember |
Long-term portion | $ 2,923,733 | $ 3,523,733 |
Other Liability, Noncurrent, Related Party, Type [Extensible Enumeration] | srt:OfficerMember | srt:OfficerMember |
Salaries and other compensation | ||
RELATED PARTY TRANSACTIONS | ||
Total | $ 3,523,733 | $ 4,108,500 |
Other Liability, Related Party, Type [Extensible Enumeration] | srt:OfficerMember | srt:OfficerMember |
Invoices paid on behalf of the Company | ||
RELATED PARTY TRANSACTIONS | ||
Total | $ 15,232 | |
Other Liability, Related Party, Type [Extensible Enumeration] | srt:OfficerMember | srt:OfficerMember |
RESEARCH, CONSULTING AGREEMEN_2
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Aug. 31, 2022 | Mar. 31, 2022 | Nov. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | May 31, 2022 | Dec. 31, 2021 | Nov. 30, 2021 | Jul. 31, 2018 | |
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | ||||||||||
Research and development | $ 3,307,987 | $ 2,672,836 | ||||||||
Accrued expenses | 1,308,706 | 1,175,705 | ||||||||
Other income | 691,931 | (123,792) | ||||||||
Gain on reduction in liability | 416,000 | |||||||||
Settlement of accrued expenses (in shares) | 3,682 | |||||||||
Research and consulting agreement | Axella Research LLC | ||||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | ||||||||||
Total amount of agreement | $ 270,000 | |||||||||
Research and consulting agreement | Therapeutics Inc. | ||||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | ||||||||||
Credit of prior expenses incurred | 278,000 | |||||||||
Research and development | 1,200,000 | 1,500,000 | ||||||||
Research and consulting agreement | Scleroderma | ||||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | ||||||||||
Total amount of agreement | $ 610,000 | |||||||||
Research and development | 361,000 | 353,000 | ||||||||
Consulting agreements | Axella Research LLC | ||||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | ||||||||||
Accrued expenses | $ 194,000 | |||||||||
Consulting agreements | Investor Relations firm | ||||||||||
RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS | ||||||||||
Monthly payments | 14,000 | |||||||||
Accrued expenses | 0 | 56,000 | $ 584,000 | |||||||
Other income | $ 416,000 | |||||||||
Gain on reduction in liability | $ 168,000 | |||||||||
Consulting fees | $ 0 | 112,000 | ||||||||
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 | $ 830,000 | $ 4,400,000 |
SHAREHOLDERS' EQUITY - Share Ca
SHAREHOLDERS' EQUITY - Share Capital (Details) | 1 Months Ended | 12 Months Ended | ||||||||||||||||
Nov. 08, 2023 shares | Oct. 26, 2023 $ / shares shares | Jul. 18, 2023 shares | Feb. 24, 2023 USD ($) $ / shares shares | Aug. 09, 2022 USD ($) $ / shares shares | Aug. 01, 2022 shares | Nov. 30, 2023 shares | Aug. 31, 2022 shares | Dec. 31, 2023 USD ($) Y $ / shares shares | Oct. 25, 2023 $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Nov. 03, 2022 shares | Nov. 02, 2022 shares | Aug. 02, 2022 $ / shares | Jul. 14, 2022 $ / shares | Jun. 30, 2022 shares | Apr. 12, 2022 shares | Apr. 11, 2022 shares | |
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Ordinary shares, shares authorized | 100,000,000 | 100,000,000 | 8,333,334 | |||||||||||||||
Ordinary shares, shares outstanding | 987,220 | 403,887 | ||||||||||||||||
Ordinary shares, par value | $ / shares | $ 0 | $ 0 | $ 0 | $ 0 | ||||||||||||||
Number of years of income that limits distribution | Y | 2 | |||||||||||||||||
Maximum period between date of financial statements and distribution date | 6 months | |||||||||||||||||
Accrued expenses | $ | $ 1,308,706 | $ 1,175,705 | ||||||||||||||||
Settlement of accrued expenses (in shares) | 3,682 | |||||||||||||||||
Aggregate gross proceeds | $ | $ 7,000,000 | |||||||||||||||||
Net Proceeds from Issuance Offering | $ | 5,800,000 | |||||||||||||||||
Ordinary share of treasury stock | 45 | |||||||||||||||||
Number of ordinary shares for ADS | 60,000 | 500,000,000,000 | 6,000,000,000,000 | |||||||||||||||
Shares owned (as a percent) | 0.083% | 12.50% | ||||||||||||||||
Reverse stock split | 1.67 | |||||||||||||||||
Quoin Pharmaceuticals Inc | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Ordinary shares, shares authorized | 50,000,000,000 | 500,000,000,000 | 12,500,000,000 | 50,000,000,000 | ||||||||||||||
Warrant Amendments | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Incremental fair value | $ | $ 238,000 | |||||||||||||||||
Minimum [Member] | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 60 | $ 0 | ||||||||||||||||
Maximum [Member] | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | 13.20 | 597 | ||||||||||||||||
Public offering | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 184,167 | |||||||||||||||||
Public offering | Pre-Funded Warrants | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 93,833 | |||||||||||||||||
ADS | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Ordinary shares, shares outstanding | 60,000 | 987,220 | 403,887 | |||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 60 | $ 0 | $ 0 | |||||||||||||||
Shares warrants may purchase | 280,000 | 28,508 | ||||||||||||||||
Number of ordinary shares for ADS | 1 | 60,000 | 400 | 5,000 | ||||||||||||||
Reverse stock split | 1 | |||||||||||||||||
ADS | Warrant Amendments | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 13.20 | |||||||||||||||||
Shares warrants may purchase | 236,670 | |||||||||||||||||
ADS | Minimum [Member] | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Number of ordinary shares for ADS | 5,000 | |||||||||||||||||
ADS | Maximum [Member] | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Number of ordinary shares for ADS | 60,000 | |||||||||||||||||
ADS | Public offering | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Purchase price | $ / shares | $ 60 | |||||||||||||||||
ADS | Public offering | Quoin Pharmaceuticals Inc | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 184,167 | |||||||||||||||||
ADS | Public offering | Pre-Funded Warrants | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Purchase price | $ / shares | $ 59.998 | |||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 93,833 | |||||||||||||||||
Gross proceeds from offering | $ | $ 16,800,000 | |||||||||||||||||
Net proceeds from offering | $ | $ 14,900,000 | |||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 60 | |||||||||||||||||
ADS | Public offering | Common Warrants | ||||||||||||||||||
SHAREHOLDERS' EQUITY | ||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 12 |
SHAREHOLDERS' EQUITY - Warrants
SHAREHOLDERS' EQUITY - Warrants (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Weighted Average Exercise Price Per Share | ||
Outstanding at beginning of the period | $ 64.20 | $ 664.68 |
Terminated (in dollars per share) | 597 | |
Outstanding at the end of the period | $ 16.13 | 64.20 |
Intrinsic value of outstanding options | $ 0 | |
Common Warrants | ||
Weighted Average Exercise Price Per Share | ||
Granted | $ 12 | $ 134.52 |
ADS | ||
ADSs Underlying Warrants | ||
Number of options outstanding at beginning of period | 280,735 | 11,440 |
Terminated (in shares) | (19,362) | |
Number of Options outstanding at end of period | 864,081 | 280,735 |
Weighted Average Exercise Price Per Share | ||
Intrinsic value of outstanding options | $ 0 | |
ADS | Common Warrants | ||
ADSs Underlying Warrants | ||
Granted | 583,346 | 448,779 |
ADS | Pre-Funded Warrants | ||
ADSs Underlying Warrants | ||
Granted | 170,833 | |
StockIssuedDuringPeriodSharesStockOptionsExercised | (170,833) | (160,122) |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
INCOME TAXES | ||
Increase in valuation allowance | $ 6,216,000 | $ 4,392,000 |
Federal income tax rate | 21% | 21% |
Effective tax rate | 0% | 0% |
Gross deferred tax asset | $ 4,617,000 | |
Deferred tax assets: | ||
Net operating losses | 4,276,000 | $ 3,334,000 |
Accrued Expenses and Other | 175,000 | 189,000 |
R&D Credit Carryforward | 321,000 | 76,000 |
Stock Compensation | 289,000 | 178,000 |
R&D Capitalization | 1,104,000 | 581,000 |
Intangibles | 51,000 | 34,000 |
Total gross deferred tax assets/(liabilities) | 6,216,000 | 4,392,000 |
Less valuation allowance | (6,216,000) | (4,392,000) |
Federal | ||
INCOME TAXES | ||
Net operating loss carryforward | 17,891,000 | $ 12,951,000 |
Federal | Research and Development (R&D) tax credit | ||
INCOME TAXES | ||
Tax credit carry-forwards | 321,000 | |
State | ||
INCOME TAXES | ||
Net operating loss carryforward | $ 17,892,000 |
INCOME TAXES - Company's valuat
INCOME TAXES - Company's valuation allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
INCOME TAXES | ||
Federal Statutory Rate | $ (1,824) | $ (1,970) |
Permanent Differences | 167 | 153 |
Research and Development | (195) | (76) |
State Income Tax | 79 | 388 |
Change in Valuation Allowance | 1,824 | 347 |
Deferred True Up | $ (51) | $ 1,158 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) agreement | Dec. 31, 2022 agreement | |
LICENSE AGREEMENTS | ||
Number of license and supply agreements entered | agreement | 9 | 8 |
Royalty revenues | $ | $ 0 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) | Mar. 07, 2024 | Jan. 25, 2024 | Feb. 24, 2023 | Aug. 02, 2022 | Jul. 14, 2022 | Jun. 30, 2022 |
SUBSEQUENT EVENTS | ||||||
Aggregate gross proceeds | $ 7,000,000 | |||||
Net Proceeds from Issuance Offering | $ 5,800,000 | |||||
February Pre Funded Warrant | ||||||
SUBSEQUENT EVENTS | ||||||
Shares warrants may purchase | 170,833 | |||||
February Offering | ||||||
SUBSEQUENT EVENTS | ||||||
Number of shares issued for warrants | 412,500 | |||||
ADS | ||||||
SUBSEQUENT EVENTS | ||||||
Shares warrants may purchase | 280,000 | 28,508 | ||||
Exercise price of warrants | $ 60 | $ 0 | $ 0 | |||
ADS | February Pre Funded Warrant | ||||||
SUBSEQUENT EVENTS | ||||||
Shares warrants may purchase | 170,833 | |||||
Warrant price | $ 11.9988 | |||||
ADS | February Offering | ||||||
SUBSEQUENT EVENTS | ||||||
Number of shares issued for warrants | 412,500 | |||||
Shares Issued, Price Per Share | $ 12 | |||||
Subsequent Event | ||||||
SUBSEQUENT EVENTS | ||||||
Aggregate gross proceeds | $ 6,500,000 | |||||
Subsequent Event | Alumni Purchase Agreement | ||||||
SUBSEQUENT EVENTS | ||||||
Commitment amount | $ 8,000,000 | |||||
Minimum commitment amount | $ 4,000,000 | |||||
Floor price | $ 1 | |||||
Maximum commitment securities value | $ 240,000 | |||||
Purchase agreement period | 180 days | |||||
Subsequent Event | Prior Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Shares warrants may purchase | 638,834 | |||||
Exercise price of warrants | $ 1.60 | |||||
Subsequent Event | Public Offering 2024 | ||||||
SUBSEQUENT EVENTS | ||||||
Aggregate gross proceeds | $ 6,500,000 | |||||
Net proceeds from offering | $ 5,600,000 | |||||
Threshold period for not to enter into an agreement to effect a variable rate transaction, after the closing date of the Offering | 180 days | |||||
Threshold period for not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any ADSs, ordinary shares or ordinary share equivalents, after the closing date of the Offering | 90 days | |||||
Subsequent Event | Public Offering 2024 | 2024 Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Combined public offering price | $ 1.5999 | |||||
Exercise price of warrants | $ 1.60 | |||||
Warrant maturity term | 5 years | |||||
Subsequent Event | Public Offering 2024 | Series D Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Warrants issued (in shares) | 4,062,500 | |||||
Number of ordinary shares for each ADS | 1 | |||||
Subsequent Event | Public Offering 2024 | Series E Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Warrants issued (in shares) | 4,062,500 | |||||
Number of ordinary shares for each ADS | 1 | |||||
Subsequent Event | Public Offering 2024 | 2024 Pre-Funded Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Warrants issued (in shares) | 3,251,250 | |||||
Number of ordinary shares for each ADS | 1 | |||||
Combined public offering price | $ 1.60 | |||||
Exercise price of warrants | $ 0.0001 | |||||
Warrant maturity term | 2 years | |||||
Subsequent Event | ADS | Public Offering 2024 | ||||||
SUBSEQUENT EVENTS | ||||||
Number of shares issued for warrants | 811,250 | |||||
Subsequent Event | ADS | Public Offering 2024 | Series D Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Shares warrants may purchase | 4,062,500 | |||||
Subsequent Event | ADS | Public Offering 2024 | Series E Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Shares warrants may purchase | 4,062,500 | |||||
Subsequent Event | ADS | Public Offering 2024 | 2024 Pre-Funded Warrants | ||||||
SUBSEQUENT EVENTS | ||||||
Shares warrants may purchase | 3,251,250 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (8,686,573) | $ (9,381,496) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |