Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2022 | |
Document and Entity Information | |
Document Type | S-1/A |
Entity Registrant Name | QUOIN PHARMACEUTICALS LTD. |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Central Index Key | 0001671502 |
Amendment Flag | true |
Amendment Description | AMENDMENT NO. 1 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 5,249,832 | $ 7,482,773 |
Investments | 9,911,200 | |
Prepaid expenses | 496,686 | 1,015,474 |
Total current assets | 15,657,718 | 8,498,247 |
Intangible assets, net | 730,572 | 808,604 |
Deferred loan costs | 50,000 | 50,000 |
Other Assets | 50,000 | |
Total assets | 16,438,290 | 9,356,851 |
Current liabilities: | ||
Accounts payable | 280,698 | 923,239 |
Accrued expenses | 1,569,920 | 1,685,409 |
Accrued license acquisition | 250,000 | |
Accrued interest and financing expense | 1,146,251 | 743,840 |
Due to officers - short term | 600,000 | 600,000 |
Warrant liability | 373,599 | |
Total current liabilities | 3,596,869 | 4,576,087 |
Due to officers - long term | 3,673,733 | 4,123,732 |
Total liabilities | 7,270,602 | 8,699,819 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Treasury Stock, 2,641,693 ordinary shares | (2,932,000) | (2,932,000) |
Additional paid in capital | 47,615,475 | 31,659,017 |
Accumulated deficit | (35,515,787) | (28,069,985) |
Total shareholders' equity | 9,167,688 | 657,032 |
Total liabilities and shareholders' equity | $ 16,438,290 | $ 9,356,851 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | 12 Months Ended | |||||||||||
Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2021 | Jun. 30, 2022 | Mar. 31, 2022 | Oct. 29, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Ordinary shares, par value | $ 0 | $ 0 | $ 0 | $ 0 | ||||||||
Ordinary shares, authorized | 50,000,000,000 | 12,000,000,000 | 12,000,000,000 | 12,000,000,000 | ||||||||
Ordinary shares, shares issued | 24,233,024,799 | 3,354,650,799 | 3,354,650,799 | 1,201,460,800 | ||||||||
Ordinary shares, shares outstanding | 24,233,024,799 | 3,354,650,799 | 3,354,650,799 | 1,201,460,800 | ||||||||
Treasury Stock, ordinary shares | 2,641,693 | 2,641,693 | 2,641,693 | |||||||||
ADS | ||||||||||||
Ordinary shares, shares issued | 4,846,605 | 670,930 | 670,930 | 670,930 | ||||||||
Ordinary shares, shares outstanding | 4,846,605 | 670,930 | 670,930 | 1,013,031 | 670,931 | 670,930 | 240,292 | 240,292 | 240,292 | 240,292 | 240,292 | 240,292 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses | ||||
General and administrative | $ 1,582,059 | $ 1,042,783 | $ 5,112,002 | $ 2,525,366 |
Research and development | 745,506 | 259,996 | 2,059,769 | 556,064 |
Total operating expenses | 2,327,565 | 1,302,779 | 7,171,771 | 3,081,430 |
Other (income) and expenses | ||||
Forgiveness of accounts payable | (416,000) | |||
Fair value adjustment to convertible notes payable | 1,250,000 | |||
Change in fair value of warrant liability | (146,808) | (77,237) | 4,522,844 | |
Financing expense | 275,000 | |||
Unrealized loss | 3,053 | 3,053 | ||
Interest income | (15,132) | (15,132) | ||
Interest and financing expense | 714,081 | 248,165 | 714,081 | 516,276 |
Total other expense (income) | 702,002 | 101,357 | 208,765 | 6,564,120 |
Net loss | (3,029,567) | (1,404,136) | (7,380,536) | (9,645,550) |
Deemed dividend on warrant modification | (65,266) | (65,266) | ||
Net loss attributable to shareholders | $ (3,094,833) | $ (1,404,136) | $ (7,445,802) | $ (9,645,550) |
ADS | ||||
Loss per ADS | ||||
Basic | $ (0.94) | $ (5.84) | $ (4.65) | $ (40.14) |
Fully-diluted | $ (0.94) | $ (5.84) | $ (4.65) | $ (40.14) |
Weighted average number of ADS's outstanding | ||||
Basic | 3,291,806 | 240,292 | 1,601,396 | 240,292 |
Fully-diluted | 3,291,806 | 240,292 | 1,601,396 | 240,292 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) | Ordinary Shares | Treasury Stock | Additional paid in Capital | Accumulated Deficit | ADS | Total |
Balance at beginning of year at Dec. 31, 2018 | $ 100 | $ (2,951,632) | $ (2,951,532) | |||
Balance at beginning of year (in shares) at Dec. 31, 2018 | 1,201,460,800 | 240,292 | ||||
Net loss | (1,560,401) | (1,560,401) | ||||
Balance at end of year at Dec. 31, 2019 | 100 | (4,512,033) | (4,511,933) | |||
Balance at ending of year (in shares) at Dec. 31, 2019 | 1,201,460,800 | 240,292 | ||||
Net loss | (2,095,364) | (2,095,364) | ||||
Balance at end of year at Dec. 31, 2020 | 100 | (6,607,397) | $ (6,607,297) | |||
Balance at ending of year (in shares) at Dec. 31, 2020 | 1,201,460,800 | 240,292 | 1,201,460,800 | |||
Net loss | (3,903,871) | $ (3,903,871) | ||||
Balance at end of year at Mar. 31, 2021 | 100 | (10,511,268) | (10,511,168) | |||
Balance at ending of year (in shares) at Mar. 31, 2021 | 1,201,460,800 | 240,292 | ||||
Balance at beginning of year at Dec. 31, 2020 | 100 | (6,607,397) | $ (6,607,297) | |||
Balance at beginning of year (in shares) at Dec. 31, 2020 | 1,201,460,800 | 240,292 | 1,201,460,800 | |||
Net loss | $ (9,645,550) | |||||
Balance at end of year at Sep. 30, 2021 | 100 | (16,252,947) | (16,252,847) | |||
Balance at ending of year (in shares) at Sep. 30, 2021 | 1,201,460,800 | 240,292 | ||||
Balance at beginning of year at Dec. 31, 2020 | 100 | (6,607,397) | $ (6,607,297) | |||
Balance at beginning of year (in shares) at Dec. 31, 2020 | 1,201,460,800 | 240,292 | 1,201,460,800 | |||
Net loss | (21,462,588) | $ (21,462,588) | ||||
Issuance of ADS and Pre-Funded Warrants, net | 17,000,000 | 17,000,000 | ||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 1,710,500,800 | 342,100 | ||||
Conversion of "2020 Notes" into ordinary shares | 1,213,313 | 1,213,313 | ||||
Conversion of "2020 Notes" into ordinary shares (in shares) | 25,913,600 | 5,183 | ||||
Costs associated with sale of equity securities | (1,897,126) | (1,897,126) | ||||
Merger recapitalization of Cellect | $ (2,932,000) | 2,932,000 | ||||
Merger recapitalization of Cellect (in shares) | 416,775,599 | 83,355 | ||||
Reclassification of warrant liability upon issuance of Exchange warrant | 12,410,730 | 12,410,730 | ||||
Balance at end of year at Dec. 31, 2021 | (2,932,000) | 31,659,017 | (28,069,985) | $ 657,032 | ||
Balance at ending of year (in shares) at Dec. 31, 2021 | 3,354,650,799 | 670,930 | 3,354,650,799 | |||
Balance at beginning of year at Mar. 31, 2021 | 100 | (10,511,268) | $ (10,511,168) | |||
Balance at beginning of year (in shares) at Mar. 31, 2021 | 1,201,460,800 | 240,292 | ||||
Net loss | (4,337,543) | (4,337,543) | ||||
Balance at end of year at Jun. 30, 2021 | 100 | (14,848,811) | (14,848,711) | |||
Balance at ending of year (in shares) at Jun. 30, 2021 | 1,201,460,800 | 240,292 | ||||
Net loss | (1,404,136) | (1,404,136) | ||||
Balance at end of year at Sep. 30, 2021 | 100 | (16,252,947) | (16,252,847) | |||
Balance at ending of year (in shares) at Sep. 30, 2021 | 1,201,460,800 | 240,292 | ||||
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 | 3,354,650,799 | 670,930 | 3,354,650,799 | |||
Net loss | (1,682,802) | $ (1,682,802) | ||||
Cashless exercise of warrants (in shares) | 3,200 | 1 | ||||
Reclassification of warrant liability upon issuance of Exchange warrant | 296,362 | 296,362 | ||||
Balance at end of year at Mar. 31, 2022 | (2,932,000) | 31,955,379 | (29,752,787) | (729,408) | ||
Balance at ending of year (in shares) at Mar. 31, 2022 | 3,354,653,999 | 670,931 | ||||
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 | 3,354,650,799 | 670,930 | 3,354,650,799 | |||
Net loss | $ (7,380,536) | |||||
Settlement of accrued expenses (In shares) | 44,187 | |||||
Balance at end of year at Sep. 30, 2022 | (2,932,000) | 47,615,475 | (35,515,787) | $ 9,167,688 | ||
Balance at ending of year (in shares) at Sep. 30, 2022 | 24,233,024,799 | 4,846,605 | 24,233,024,799 | |||
Balance at beginning of year at Mar. 31, 2022 | (2,932,000) | 31,955,379 | (29,752,787) | $ (729,408) | ||
Balance at beginning of year (in shares) at Mar. 31, 2022 | 3,354,653,999 | 670,931 | ||||
Net loss | (2,668,167) | (2,668,167) | ||||
Stock based compensation | 229,441 | 229,441 | ||||
Cashless exercise of warrants (in shares) | 1,710,500,800 | 342,100 | ||||
Balance at end of year at Jun. 30, 2022 | (2,932,000) | 32,184,820 | (32,420,954) | (3,168,134) | ||
Balance at ending of year (in shares) at Jun. 30, 2022 | 5,065,154,799 | 1,013,031 | ||||
Net loss | (3,029,567) | (3,029,567) | ||||
Stock based compensation | 267,283 | 267,283 | ||||
Issuance of ADS and Pre-Funded Warrants, net | 14,904,569 | 14,904,569 | ||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 16,800,000,000 | 3,360,000 | ||||
Cashless exercise of warrants (in shares) | 2,146,935,000 | 429,387 | ||||
Settlement of accrued expenses | 193,537 | 193,537 | ||||
Settlement of accrued expenses (In shares) | 220,935,000 | 44,187 | ||||
Deemed dividend on warrant modification | 65,266 | (65,266) | ||||
Balance at end of year at Sep. 30, 2022 | $ (2,932,000) | $ 47,615,475 | $ (35,515,787) | $ 9,167,688 | ||
Balance at ending of year (in shares) at Sep. 30, 2022 | 24,233,024,799 | 4,846,605 | 24,233,024,799 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows provided by (used in) operating activities | ||
Net loss | $ (7,380,536) | $ (9,645,550) |
Fair value adjustment to convertible notes payable | 1,250,000 | |
Change in fair value of warrant liability | (77,237) | 4,522,844 |
Stock based compensation expense | 496,724 | |
Forgiveness of accounts payable | (416,000) | |
Financing expense | 275,000 | |
Amortization of intangibles | 78,032 | 78,032 |
Increase in accrued interest and financing expense | 402,411 | 516,276 |
Unrealized gain on investments | (12,079) | |
Changes in assets and liabilities: | ||
Increase (decrease) in accounts payable and accrued expenses | (148,493) | 462,117 |
Decrease in prepaid expenses | (518,788) | |
Net cash used in operating activities | (6,538,390) | (2,541,281) |
Cash flows used in investing activities | ||
Purchase of investments | (9,899,121) | |
Payment for license acquisition | (250,000) | (375,000) |
Net cash used in investing activities | (10,149,121) | (375,000) |
Cash flows provided by financing activities: | ||
Payments of offering costs | (164,578) | |
Payments of deferred loan costs | (50,000) | |
Increase in other assets | 139,285 | |
Payment of amounts due to officers | (449,999) | (154,466) |
Proceeds from issuance of "Bridge Notes", net | 3,475,000 | |
Proceeds from sale of equity securities, net | 14,904,569 | |
Net cash provided by financing activities | 14,454,570 | 3,245,241 |
Net change in cash | (2,232,941) | 328,960 |
Cash - beginning of period | 7,482,773 | 323,832 |
Cash - end of period | 5,249,832 | $ 652,792 |
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 | 491,601 | |
Settlement of accrued expenses | $ 193,537 |
ORGANIZATION AND BUSINESS
ORGANIZATION AND BUSINESS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
ORGANIZATION AND BUSINESS | ||
ORGANIZATION AND BUSINESS | NOTE 1 – ORGANIZATION AND BUSINESS Quoin Pharmaceuticals Ltd. (“Quoin Ltd.,” or the “Company”), formerly known as Cellect Biotechnology Ltd. (“Cellect”), is the holding company for Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin Inc.”). On October 28, 2021, Cellect completed the business combination with Quoin Inc., in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of March 24, 2021 (the “Merger Agreement”), by and among Cellect, Quoin Inc. and CellMSC, Inc., a Delaware corporation and wholly-owned subsidiary of Cellect (“Merger Sub”), pursuant to which Merger Sub merged with and into 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.” Because Quoin Inc. was the accounting acquirer, its historical financial statements became the Company’s historical financial statements and such assets and liabilities continued to be recorded at their historical carrying values. The impact of the recapitalization has been retroactively applied to all periods presented. Effective August 1, 2022, the ratio of American Depositary Shares (“ADSs”) evidencing ordinary shares changed from 1 ADS representing four hundred (400) ordinary shares to 1 ADS representing five thousand (5,000) ordinary shares, which resulted in a one for 12.5 reverse split of the issued and outstanding ADSs (the “Ratio Change”). All ADSs and related option and warrant information presented in these financial statements and accompanying footnotes has been retroactively adjusted to reflect the reduced number of ADSs resulting from the Ratio Change. Quoin Inc. was incorporated in Delaware on March 5, 2018. Quoin Inc. is a specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. The first lead product is QRX003, a once daily, topical lotion comprised of a broad-spectrum serine protease inhibitor, formulated with the proprietary Invisicare® technology, to treat Netherton Syndrome (NS). QRX003, is currently in clinical development in the United States under an open IND application with the U.S. Food and Drug Administration (“FDA”). The ongoing study is a randomized, double blinded assessment of two different doses of QRX003 versus a placebo vehicle in NS patients. The Company commenced opening of clinical sites in July 2022. In addition, the Company intends to pursue the clinical development of QRX003 in additional rare dermatological diseases, including Peeling Skin Syndrome, SAM Syndrome and Palmoplantar Keratoderma. To date, no products have been commercialized and revenue has not been generated. | NOTE 1 – ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION Quoin Pharmaceuticals Ltd. (“Quoin Ltd.”or the “Company”or”we,” “us,” “our”), formerly known as Cellect Biotechnology Ltd. (“Cellect”), is the holding company for Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin Inc.”). On October 28, 2021, Cellect completed the business combination with Quoin Inc., in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of March 24, 2021 (the “Merger Agreement”), by and among Cellect, Quoin Inc. and CellMSC, Inc., a Delaware corporation and wholly-owned subsidiary of Cellect (“Merger Sub”), pursuant to which Merger Sub merged with and into 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 has accounted for the transaction as a reverse recapitalization with Quoin Inc. as the accounting acquirer. Because Quoin Inc. is the accounting acquirer, its historical financial statements became the Company’s historical financial statements and such assets and liabilities continued to be recorded at their historical carrying values. The impact of the recapitalization has been retroactively applied to all periods presented. All equity related disclosures are presented in American Depositary Shares (“ADSs”), unless the context indicates otherwise. One ADS represents 5,000 ordinary shares of the Company. Quoin Inc. was incorporated in Delaware on March 5, 2018. Quoin Inc. is a specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. The first lead product is QRX003, a once daily, topical lotion comprised of a broad-spectrum serine protease inhibitor, formulated with the proprietary Invisicare® technology, to treat Netherton Syndrome (NS). In addition, the Company. intends to pursue the clinical development of QRX003 in additional rare dermatological diseases, including Peeling Skin Syndrome, SAM Syndrome and Palmoplantar Keratoderma. To date, no products have been commercialized and revenue has not been generated. The majority of the operating expenses since inception have been associated with completing due diligence on various technologies, asset technology acquisitions, negotiating and finalizing potential funding agreements, costs related to the Merger and building the pipeline of preclinical product candidates. The founders of Quoin Inc. funded all related expenditures through September 2020. On October 28, 2021, Cellect sold the entire share capital of its subsidiary, Cellect Biotherapeutics Ltd., which essentially included all of Cellect’s then existing net assets, to EnCellX Inc. (“EnCellX”), a newly formed U.S. privately held company based in San Diego, CA (the “Share Transfer”), pursuant to an Amended and Restated Share Transfer Agreement. Quoin Ltd. has no interests in EnCellX subsequent to the closing of the Merger. See Note 12. On October 28, 2021, the Company completed the private placement transaction with an investor (the Investor”) for an aggregate purchase price of approximately $17.0 million (comprised of the set off of approximately $5 million of senior secured notes issued in connection with the bridge loan that the Investor previously made to Quoin Inc. and approximately $12 million in cash from the Investor (the “Primary Financing”). See Note 5. Immediately after the closing of the Merger, there were approximately 670,930 ADSs issued and outstanding |
LIQUIDITY RISKS AND OTHER UNCER
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
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 $35.5 million at September 30, 2022. The Company has historically funded its operations through debt and equity financings. On August 9, 2022, the Company completed an offering (the “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 an ordinary warrant, for aggregate gross proceeds of $16.8 million, resulting in net proceeds of approximately $14.9 million (see Note 14). As a result of the completion of the Offering, the Company believes that it has sufficient resources to effect its business plan for at least one year from the issuance of these unaudited condensed consolidated financial statements. Additional financing will still be required to complete the research and development of the Company’s therapeutic targets and its other operating requirements until it achieves commercial profitability, if ever. Such financing may not be available at acceptable terms, if at all. If the Company is unable to obtain additional funding when it becomes necessary, the development of its product candidates will be impacted and the Company would likely be forced to delay, reduce, or terminate some or all of its development programs, all of which could have a material adverse effect on the Company’s business, 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 single-source suppliers which include the supplier of the active pharmaceutical ingredient (API), as well as the contract manufacturer of the drug substance for the expected clinical development. Coronavirus (“COVID-19”) created a global pandemic, which commenced in 2020. The Company’s operations, to date, have not been dramatically affected by COVID-19. However, the extent of any future impact on the Company’s operational and financial performance will depend on the possibility of a resurgence and resulting severity with respect to the Company’s access to API and drug product for clinical testing, as well as the Company’s ability to safely and efficiently conduct planned clinical trials. Nasdaq Listing On April 22, 2022, the Company received a letter from the Listing Qualifications staff (the “Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying the Company that it is no longer in compliance with Nasdaq Listing Rule 5550(b)(1) requiring minimum stockholders’ equity of at least $2.5 million for continued listing on The Nasdaq Capital Market. Based on the Company’s Form 6-K, dated August 10, 2022, the Staff has determined that the Company complies with the minimum stockholder’s equity requirement, and the Company evidences continued compliance with these financial statements for the quarter ended September 30, 2022. On June 10, 2022, the Company received a letter from the Staff 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). Since then, the Staff has determined that the closing bid price of the Company’s ADSs has been at $1.00 per ADS or greater, and the Company has regained compliance with the minimum bid price requirement. There can be no assurance that the Company will be able to maintain compliance with Nasdaq’s minimum stockholders’ equity requirement or minimum bid-price requirement for continued listing. If the Company’s ADSs are delisted from Nasdaq, it will have material negative impacts on the actual and potential liquidity of the Company’s securities, as well as material negative impacts on the Company’s ability to raise future capital. | NOTE 2 - LIQUIDITY RISKS AND UNCERTAINTIES AND GOING CONCERN The Company has incurred net losses every year since inception and had an accumulated deficit of approximately $28.1 million at December 31, 2021. The Company funded its operations through the issuance of the 2020 Notes (as defined below) and the Bridge Financing (as defined below) prior to the Merger and the Primary Financing completed on October 28, 2021, whereby the Company received funding of approximately $12 million ($10.1 million after offering costs) at the closing of the Merger. The Company expected to receive additional funding through the mandatory exercise provision of the Series C Warrant issued to the Investor in March 2022 which would have resulted in proceeds of approximately $9.5 million. In the event the requirements of the mandatory exercise provision of such warrant were not met (see Note 5), the Company received a written commitment from the Investor to provide funding equal to the $9.5 million expected upon exercise of the Series C Warrant, at prevailing market rates. However, on July 14, 2022, the Company and Altium entered into an agreement, pursuant to which the parties agreed to, among other things, cancel the Series C Warrant and a portion of the Series A Warrant previously issued to Altium (see Note 17). Following the cancellation of the Series C Warrant on July 14, 2022, the Company no longer expects to receive such proceeds from Altium, and the Company does not have sufficient resources to implement its business plan for at least one year from the issuance of these consolidated financial statements. This raises substantial doubt about the Company’s ability to continue as a going concern. Additional financing will be required to complete the research and development of the Company’s therapeutic targets and its other operating requirements, which may not be available at acceptable terms, if at all. The Company has filed a registration statement on Form F-1 related to an offering of its securities on a “reasonable best efforts” basis, however there is no assurance of the successful consummation of such offering. The Company is also in the process of discussing a line of credit with a bank which has not yet been closed as of the financial statement filing date and is likely to be conditional on additional equity funding. If the Company is unable to obtain the 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. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements of the Company as of September 30, 2022 and for the three and nine months then ended. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the operating results for the year or any other period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures as of December 31, 2021 and for the year then ended which are included in the Company’s Annual Report on Form 20- F, filed with the SEC on April 14, 2022, as updated in the Company’s Form 6-K furnished to the SEC on August 11, 2022. The Company operates in one segment. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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. Reclassification: Certain 2021 amounts were reclassified to conform to the current year presentation. The amount reclassified included the short term portion from long term portion due to officers. 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 balance sheets as of September 30, 2022. Investments: Investments as of September 30, 2022 consist of U.S. Treasury Bills, which are classified as trading securities, totaling $ 9.9 million. 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 mature within the subsequent six months from the date of purchase. As of September 30, 2022, 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 the Company considers that could trigger an impairment review include the following: ● Significant changes in the manner of the Company’s use of the acquired assets or the strategy for the Company’s overall business, ● Significant underperformance relative to expected historical or projected development milestones, ● Significant negative regulatory or economic trends, and ● Significant technological changes which could render the platform technology obsolete. The Company recognizes impairment when the sum of the expected undiscounted future cash flows is less than the carrying amount of the asset. Impairment losses, if any, are measured as the excess of the carrying amount of the asset over its estimated fair value. During the three and nine months ended September 30, 2022 and 2021, 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 expense in future periods as the related services are rendered. 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 to employees, non-employees and directors is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company’s expected stock volatility is based on the historical data regarding the volatility of a publicly traded set of peer companies, since it has limited history of trading as a public company. The Company utilizes the simplified method to estimate the expected term. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield was assumed to be zero as the Company has not paid and dividends since its inception and does not anticipate paying dividends in the foreseeable future. Fair value of financial instruments: The Company considers its cash, investments, accounts payable, and accrued expenses to meet the definition of financial instruments. The carrying amounts of the remaining 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 (“ASC Topic 820”). ASC Topic 820 defines fair value, establishes a framework and gives guidance regarding the methods used for measuring fair value, and expands disclosures about fair value measurements. Earnings (loss) per share: The Company reports loss per share in accordance with ASC 260-10, Earnings Per Share, which provides for calculation of “basic” and “diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss available to common shareholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per share gives effect to ordinary shares equivalents; however, potential common shares are excluded if their effect is anti-dilutive. For the three and nine months ended September 30, 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding options and warrants to purchase 309,114 ADSs and 3,368,820 ADSs, respectively. For the three and nine months ended September 30, 2021, the 5,183 ADS’s issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the 40,247 ADSs issuable upon conversion of the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. | 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, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. 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 selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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: 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 U.S. Food and Drug Administration (“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 single-source suppliers which include the supplier of the active pharmaceutical ingredient (API) as well as the contract manufacturer of the drug substance for the expected clinical development. A novel strain of coronavirus (“COVID-19”) created a global pandemic, which commenced in 2020. The Company’s operations, to date, have not been dramatically affected by COVID-19. However, the extent of any future impact on the Company’s operational and financial performance will depend on the possibility of a resurgence and resulting severity of COVID-19 with respect to the Company’s access to API and drug substance, the potential disruption in global freight networks, as well as our ability to safely and efficiently conduct planned clinical trials. 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. 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 years ended December 31, 2021, 2020 and 2019, there were no impairment indicators which required an impairment loss measurement. Deferred Offering Costs: Deferred offering costs are expenses directly related to the Primary Financing. These costs consisted of legal, accounting, printing, and filing fees that the Company capitalized which were offset against the proceeds upon completion of the Primary Financing. 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 expense 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, 2021 and 2020, 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. Fair value of financial instruments: The Company considers its cash, accounts payable, accrued expenses and the convertible and bridge notes payable to meet the definition of financial instruments. The convertible and bridge notes payable are recorded at fair value, see Notes 4, 5 and 6. The warrants are recorded at fair value, see Notes 4, 5 and 6. The carrying amounts of the remaining 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, 2021, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 143,028 ADS or 715,137,600 Ordinary Shares and warrants to purchase 1,257,722 ADS or 6,288,605,600 Ordinary Shares issuable pursuant to Primary Financing. For the year ended December 31, 2020, the number of shares issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. New accounting pronouncements: The Company has evaluated all recent accounting pronouncements and believes that none of them will have a material effect on the Company’s financial position, results of operations or cash flows except as discussed below. Debt with Conversion and Other Options and Derivatives and Hedging The FASB recently issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity Earnings Per Share Earnings Per Share In May 2021, the FASB issued ASU 2021-04, Earnings Per Share Compensation-Stock Compensation Derivatives and Hedging-Contracts in Entity’s Own Equity Recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. |
CONVERTIBLE NOTES AND WARRANTS
CONVERTIBLE NOTES AND WARRANTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
CONVERTIBLE NOTES AND WARRANTS | ||
CONVERTIBLE NOTES AND WARRANTS | NOTE 4 – CONVERTIBLE NOTES AND WARRANTS On October 2, 2020, Quoin Inc. commenced an offering of promissory notes (the “2020 Notes” or “Convertible Notes Payable”) and warrants. Based upon the terms agreed to in March 2021 in the Primary Financing (see Note 5), the 2020 Notes were mandatorily convertible into 5,183 ADSs in the Primary Financing, subject to adjustment. The holders of the 2020 Notes (the “2020 Noteholders”) also received warrants exercisable at any time after the issuance date for 29,388 ADSs at an initial exercise price of $49.75 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 an Exchange Warrant as 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 three and nine months ended September 30, 2022. The ADSs issued to the 2020 Noteholders did not account for accrued interest which was estimated to be approximately $744,000 at December 31, 2021, and included in accrued interest and financing expense in the accompanying consolidated balance sheet. Approximately $312,000 was paid to two of the five 2020 Noteholders during the nine months ended September 30, 2022. Based on the terms of the cash settlement with these two 2020 Noteholders, the Company’s estimate of the liability to the remaining three 2020 Noteholders was increased to $1,146,000 as of September 30, 2022. The Company expects to settle the remaining liability in 2022 or early 2023. | NOTE 4 – CONVERTIBLE NOTES PAYABLE On October 2, 2020, Quoin Inc. commenced an offering of promissory notes (the “2020 Notes” or “Convertible Notes Payable”) and warrants. The 2020 Notes were issued at a 25% original issue discount and bear interest at a rate of 20% per annum. The 2020 Notes are due one year from their respective dates of issuance. In October through December 2020, Quoin Inc. received an aggregate of approximately $910,000 pursuant to this offering, resulting in the issuance of 2020 Notes with an aggregate face value of $1,213,313 and an original issue discount of $303,333. Approximately 23% of such financing was received from parties who are related to or affiliated with members of Quoin Inc.’s board of directors. No additional funding from the 2020 Notes was received in the year ended December 31, 2021. Based upon the terms agreed to in March 2021 in the Primary Financing (see Note 5), the 2020 Notes were mandatorily convertible into 5,183 ADSs in the Primary Financing, subject to adjustment. The Company elected to account for the Convertible Notes Payable using the fair value model due to the short maturity and likely conversion at the date of the Merger. The fair value of the Convertible Notes Payable was estimated to be approximately $1.2 million at the date of issuance, resulting in a $378,000 expense recognized in the fourth quarter of 2020. There was no material change in the fair value from issuance until the conversion to equity on the Merger date. The noteholders also were entitled to receive warrants exercisable at any time after the issuance date for a number of shares of Quoin Inc.’s common stock that equates to 100% of the “as if converted” shares as if the 2020 Notes principal and interest were convertible at the lowest price any securities are sold, convertible, or exercisable into in the Primary Financing or the next round of financing (whichever is lower). The exercise price was based on a valuation equal to the next financing round and since the number of shares issuable upon the exercise of the warrants and exercise price were not knowable at the time of the financing and as of December 31, 2020 they were not recognized. After entering into the Merger Agreement in March 2021, the terms of the warrants became measurable and were exercisable for 29,388 ADSs at an initial exercise price of $49.75 per ADS. The Company determined that these warrants met the criteria to be recorded as a liability instrument. Each holder agreed to exchange its warrant for warrants on substantially the same terms as the Investor Exchange Warrants (See Note 5) with the same number of shares issuable upon the exercise of an Exchange Warrant as upon the exercise of the original warrant and the same exercise price as under the original warrant and have a contractual term of 5 years At the closing of the Merger, 5,183 ADSs were issued upon the conversion of the principle of the Convertible Notes Payable. In addition, effective as of March 13, 2022, the Company exchanged noteholders’ warrants for warrants on substantially the same terms as the Investor Exchange Warrants (See Note 5), exercisable for 29,388 ADSs, in the aggregate, at the exercise price of $49.75 per ADS. The Exchange Warrants have been determined to warrant equity classification and, as such, the fair value change through the exchange date will be included in warrant liability expense in the accompanying statement of operations. In December 2021, the Company concluded that the calculation of ADSs due to the 2020 Noteholders did not account for accrued interest due when the ADSs were issued. The Company reached cash settlements with, and plans to issue additional ADSs to, the 2020 Noteholders to account for this. The estimated amount required to settle these obligations was determined to be approximately $744,000 at December 31, 2021 and is included in accrued liabilities in the accompanying consolidated balance sheet and in interest expense in the accompanying consolidated statement of operations. Interest expense, at the stated interest rate, recognized in the year ended December 31, 2021, 2020 and 2019 was approximately $202,000, $47,000, and $0, respectively. Accrued interest and estimated settlement costs at December 31, 2021, 2020 and 2019 was approximately $744,000, $47,000, and $0, respectively, of which $697,000 was recognized in the year ended December 31, 2021. |
BRIDGE FINANCING AND PRIMARY FI
BRIDGE FINANCING AND PRIMARY FINANCING | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
BRIDGE FINANCING AND PRIMARY FINANCING | ||
BRIDGE FINANCING AND PRIMARY FINANCING | NOTE 5 – BRIDGE FINANCING AND PRIMARY FINANCING Bridge Financing In connection with the Merger Agreement and the Securities Purchase Agreement (described below), Quoin Inc. entered into a “Bridge Purchase Agreement” on March 24, 2021 with the Investor, pursuant to which the Investor agreed to purchase notes (the “Bridge Notes”) in the aggregate principal amount of up to $5,000,000 in exchange for an aggregate purchase price of up to $3,800,000 together with warrants. The Bridge Notes were purchased in three closings: (i) the first purchase of $2,000,000 on March 25, 2021 (proceeds of $1,500,000); (ii) the second purchase of $1,700,000 in April 2021 (proceeds of $1,250,000); and (iii) a third purchase of $1,300,000 in May 2021 (proceeds of $1,000,000). The Bridge Notes were issued with a 25% original issue discount, at an interest rate of 15% per annum and had a maturity date of the earliest to occur of: (i) December 25, 2021, (ii) the date on which Quoin Inc.’s equity is registered under the Exchange Act or is exchanged for equity so registered or (iii) immediately prior to the closing of the Merger. The Investor and Quoin Inc. agreed that if the Primary Financing is consummated, the Investor may, at its election, offset the purchase price related to the Primary Financing, by an amount equal to the outstanding amount under this Bridge Note, and, upon such set-off, the portion of this Bridge Note shall be deemed to have been paid in its entirety and all obligations thereunder shall be deemed to be fully satisfied. The Bridge Notes were offset against the purchase price under the Securities Purchase Agreement related to the Primary Financing and converted into 100,618 ADSs upon the closing of the Primary Financing in October 2021. Interest expense, at the stated interest rate, recognized in the three and nine months ended September 30, 2022 and 2021 was $0 and $187,000 and $0 and $334,000, respectively. Bridge Warrants Upon the funding of each Bridge Note tranches described above, the Investor received warrants (the “Bridge Warrants”) to purchase a number of shares of Quoin Inc.’s common stock equal to the aggregate principal amount of the Bridge Notes. The Bridge Warrants had a term of five years from the date all of the shares underlying the Bridge Warrants are freely tradable. Quoin Inc. issued a total of 99,074 Bridge Warrants in the year ended December 31, 2021. Following the closing date of the Merger, on each of the tenth trading day, the forty-fifth day, the ninetieth day, and the one hundred thirty-fifth day thereafter (each, a “Reset Date”), if the initial exercise price of the Bridge Warrants is greater than the arithmetic average of 85% of the three lowest weighted average prices of the post-Merger ordinary shares of the combined company during the ten trading day period immediately preceding the applicable Reset Date (the “Reset Price”), the exercise price of the Bridge Warrants will be reset to the Reset Price. Furthermore, the number of shares underlying Bridge Warrants will be adjusted such that the aggregate number of shares of common stock of Quoin Inc. issuable to the Investor reflects the Reset Price instead of the initial exercise price. Adjustments to the exercise price and number of warrant shares are available to the Investor until the second anniversary of the Registration Date, as defined in the Bridge Warrants. Upon the occurrence of a Fundamental transaction, as defined in the Bridge Warrants, the warrant holder has the right to elect a cash settlement for the value of the warrant based on the Black Scholes options pricing model. The Company determined that the warrants met the criteria to be recorded as a liability instrument through the exchange date on the closing of the Primary Financing. The fair value of warrants was determined by a MonteCarlo simulation model to be approximately $1.6 million at the date of issuance of the 39,630 warrants in connection with the first closing and $2.2 million at the date of issuance of the 59,444 warrants in connection with the second and third closing of the Bridge Notes. Upon the closing of the Primary Financing, the Bridge Warrants were exchanged for warrants to purchase 99,074 ADSs at a fixed per share exercise price of $49.75 (“Investor Exchange Warrants”), as amended, which replaced the reset provisions and modified the fundamental transaction requirements of the Bridge 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. Primary Financing 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 of 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 issued 342,100 ADSs to the Investor. Quoin Ltd. also was required to issue to the Investor, effective as of March 13, 2022, the 136th day following the consummation of the Merger (i) Series A Warrant to purchase 342,100 ADSs (the “Series A Warrant”) (ii) Series B Warrant to purchase 342,100 ADSs (the “Series B Warrant”) and (iii) Series C Warrant to purchase 191,174 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 is $49.75 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. On April 22, 2022, a registration statement for the resale of the shares underlying Investor Warrants was declared effective by the Securities and Exchange Commission. 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, which gives the Investor the sole option as elected by the Investor to receive 1.0 ADS for each warrant ADS underlying such warrant, resulting in the issuance of a total of 342,100 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 to $0.00 per ADS with respect to a total of 399,999 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 Offering (see Note 14) as the modification was done in contemplation of the 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 399,999 ADSs to Altium. The exercise price of the Noteholder Warrants was also reduced to $0.00 as of July 14, 2022 as a result of the Altium Agreement. The change in the exercise price of the Noteholder Warrants resulted in a deemed dividend of approximately $ 65,000 | NOTE 5 – BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) Bridge Financing In connection with the Merger Agreement and the Securities Purchase Agreement (described below), Quoin Inc. entered into a “Bridge Purchase Agreement” on March 24, 2021 with the Investor, pursuant to which the Investor agreed to purchase, and Quoin Inc. agreed to issue notes (the “Bridge Notes”) in the aggregate principal amount of up to $5.0 million in exchange for an aggregate purchase price of up to $3.8 million together with warrants. The Bridge Notes were purchased in three closings: (i) the first purchase of $2.0 million on March 25, 2021 (Quoin Inc. received proceeds of $1.5 million less fees of $90,000); (ii) the second purchase of $1.7 million in April 2021 (Quoin Inc. received proceeds of $1.25 million) ; and (iii) a third purchase of $1.3 million in May 2021 (Quoin Inc. received proceeds of $1.0 million less fees of $185,000). The Bridge Notes were secured by a lien on Quoin Inc.’s current and future assets, were senior to all other outstanding and future indebtedness of Quoin Inc. and included covenants limiting future indebtedness, among others. The Bridge Notes were issued with a 25% original issue discount, at an interest rate of 15% per annum and had a maturity date of the earliest to occur of: (i) December 25, 2021, (ii) the date on which Quoin Inc.’s equity is registered under the Exchange Act or is exchanged for equity so registered or (iii) immediately prior to the closing of the Merger The Investor and Quoin Inc. agreed that if the Primary Financing is consummated, the Investor may, at its election, offset the purchase price otherwise payable by Investor to Quoin Inc. pursuant to the Securities Purchase Agreement related to the Primary Financing, by an amount equal to the outstanding amount under this Bridge Note, and, upon such set-off, the portion of this Bridge Note shall be deemed to have been paid in its entirety and all obligations thereunder shall be deemed to be fully satisfied without any further obligations on, or liability to, Quoin Inc. The Company elected to account for the Bridge Notes using the fair value model due to the short maturity and likely conversion at the closing of the Merger. The cumulative fair value of the Bridge Notes was estimated to be approximately $5.0 million at the date of issuances, resulting in an increase in the fair value of approximately $1,250,000, which was recognized in the statement of operations for the year ended December 31, 2021. The fair value adjustments also included $275,000 of debt issuance costs which was also immediately recognized as a component of other expense. Management has estimated that the fair value had not significantly changed from issuance to the Merger date. See Note 6. The Bridge Notes were offset against the purchase price under the Securities Purchase Agreement related to the Primary Financing and converted into 100,618 ADSs (including shares held in escrow for the benefit of the Investor) upon the closing of the Primary Financing. The accrued interest amounting to $393,611 was paid in cash. Interest expense, at the stated interest rate, recognized in the year ended December 31, 2021 was $393,611. Warrants Upon the funding of each Bridge Note tranches described above, the Investor received warrants (the “Bridge Warrants”) to purchase a number of shares of Quoin Inc.’s common stock equal to the aggregate principal amount of the Bridge Notes. The Bridge Warrants have a term of five years from the date all of the shares underlying the Bridge Warrants are freely tradable. The Bridge Warrants also contain certain rights with regard to asset distributions and fundamental transactions. Quoin Inc. issued a total of 99,074 Bridge Warrants in the year ended December 31, 2021. Following the closing date of the Merger, on each of the tenth trading day, the forty-fifth day, the ninetieth day, and the one hundred thirty-fifth day thereafter (each, a “Reset Date”), if the initial exercise price of the Bridge Warrants is greater than the arithmetic average of 85% of the three lowest weighted average prices of the post-Merger ordinary shares of the combined company during the ten trading day period immediately preceding the applicable Reset Date (the “Reset Price”), the exercise price of the Bridge Warrants will be reset to the Reset Price. Furthermore, the number of shares underlying Bridge Warrants will be adjusted such that the aggregate number of shares of common stock issuable to the Investor reflects the Reset Price instead of the initial exercise price. Adjustments to the exercise price and number of warrant shares are available to the Investor until the second anniversary of the Registration Date, as defined in the Bridge Warrants. Upon the occurrence of a Fundamental transaction, as defined in the Bridge Warrants, the warrant holder has the right to elect a cash settlement for the value of the warrant base on the Black Scholes options pricing model. The Company determined that the warrants met the criteria to be recorded as a liability instrument through the exchange date upon the closing of the Primary Financing. The fair value of warrants was determined by a MonteCarlo simulation model to be approximately $1.6 million at the date of issuance of the 39,630 warrants in connection with the first closing and $2.2 million at the date of issuance of the 59,444 (post exchange ratio) in connection with the second and third closing of the Bridge Notes See Note 6. Upon the closing of the Primary Financing, the Bridge Warrants were exchanged for warrants to purchase 99,074 ADSs at a fixed per share exercise price of $49.75 (“Investor Exchange Warrants”), as amended, which replaced the reset provisions and modified the fundamental transaction requirements of the Bridge Warrants. The Investor Exchange Warrants and ordinary shares underlying the Investor Exchange Warrants were registered with the SEC on the Registration Statement on Form F-4. An amendment to the Investor Exchange Warrants was entered into in September 2021, which replaced the reset provisions with a fixed number of shares and exercise price. Primary Financing 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 (x) the set off of approximately $5 million of Bridge Notes, and (y) approximately $12 million in cash from the Investor) (the “Primary Financing”), and the Investor paid the Company approximately $11,504,000, which was net of $393,611 in accrued interest on the Bridge Notes. The Company incurred an additional approximate $1.4 million in costs associated with the Primary Financing, which resulted in the net proceeds of approximately $10.1 million. The Company issued 342,100 ADSs to the Investor, consisting of 66,702 delivered to the Investor on or after the Merger closing and 275,398 initially held in an escrow account for the benefit of the Investor as per the terms of the Securities Purchase Agreement. All such escrow shares were released to the Investor prior to December 31, 2021. Quoin Ltd. also was required to issue to the Investor, effective as of March 13, 2022, the 136th day following the consummation of the Merger (i) Series A Warrant to purchase 342,100 ADSs (the “Series A Warrant”) (ii) Series B Series C Series B |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
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. 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 tables present the Company’s assets and liabilities that are measured at fair value on a recurring basis by fair value hierarchy at December 31, 2021 and September 30, 2022: December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants $ — $ — $ 373,599 $ 373,599 Total Warrant Liability $ — $ — $ 373,599 $ 373,599 September 30, 2022 Level 1 Level 2 Level 3 Total US Treasury Bills $ 9,911,200 $ — $ — $ 9,911,200 Total US Treasury Bills Asset $ 9,911,200 $ — $ — $ 9,911,200 The following shows the movement of the warrant liability balance during 2021 and the nine months ended September 30, 2022. Bridge Financing 2020 Note Warrants Warrants Beginning Balance January 1, 2021 $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending balance December 31, 2021 $ — $ 373,599 Change in fair value of warrants — (77,237) Reclassification of warrant liability to an equity instrument — (296,362) Ending balance September 30, 2022 $ — $ — The Investor Exchange Warrant issued to the Investor on the Merger date was determined to be an equity-classified instrument, and accordingly the warrant liability on such date of approximately $12.4 million was reclassified to additional paid in capital. The Exchange Warrants issued to the 2020 Noteholders effective as of March 13, 2022 were determined to be an equity-classified instrument, and accordingly the warrant liability on such date of $296,362 was reclassified to additional paid in capital on that date. | 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 significant estimates used in the determining the fair value of the 2020 Notes warrants (Note 4) were as follows: 12/31/2021 (1) 12/31/2020 Stock price $ 22.75 $ 49.75 Initial exercise price $ 49.75 $ 49.75 Contractual Term 5.0 5.0 Volatility 89.2 % 98 % Discount rate 1.26 % 0.81 % (1) The warrants issued during 2020 were not exchanged for fixed term warrants until 2022, therefore the existing warrants were still considered outstanding at December 31, 2021 and classified as a liability instrument. The significant estimates used in such calculation of the fair value of the warrants issued in connection with the Bridge Financing (Note 5) were as follows: Transaction Date Merger Date March - May 2021 10/28/2021 Stock price $ 49.75 (post exchange ratio) $ 11.64 (post exchange ratio) Initial exercise price $ 49.75 (post exchange ratio) $ 49.75 (post exchange ratio) Contractual Term 5.0 5.0 Volatility 92 % 89.2 % Discount rate 0.98 % 1.18 % 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, 2021 and 2020: December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants — — $ 373,599 $ 373,599 Total Warrant Liability — — $ 373,599 $ 373,599 December 31, 2020 Level 1 Level 2 Level 3 Total 2020 Notes payable $ — $ — $ 1,213,333 $ 1,213,333 Total Liabilities $ — — $ 1,213,333 $ 1,213,333 The fair value of the convertible notes payable issued in 2020 was determined to be $1,213,333, resulting in a charge to operations of $378,333 during 2020. The fair value adjustment from December 31, 2020 to their conversion to ADSs at the Merger date was not material. The initial fair value of the Bridge Notes issued in 2021 was determined to be approximately $5,000,000, resulting in a charge to operations of $1,250,000 during 2021. The fair value adjustment from the Bridge Notes issuances to their conversion to ADSs upon the Merger date was not significant. The Bridge Notes and 2020 Notes were converted into ADSs at the Merger date. See Notes 4 and 5. The following shows the movement of the warrant liability balance during 2021. Bridge Financing 2020 Notes Warrants Warrants Beginning Balance $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in Fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending Balance $ — $ 373,599 The change in fair value of the Bridge Note warrants are included in other expense in the accompanying consolidated financial statements from the issuance date to the Merger Date. The Exchange warrants issued to the Investor on the Merger date was determined to be an equity-classified instrument, and accordingly the warrant liability on such date of $12,410,730 was reclassified to additional paid in capital on that date. |
STOCK BASED COMPENSATION
STOCK BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2022 | |
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 1,826,991,617 ordinary shares, represented by 365,398 ADSs as of September 30, 2022. 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. On April 12, 2022, the Company granted options to acquire 1,535,714,000 ordinary shares, represented by 307,142 ADSs, at $17.50 per share to management, directors and employees and 58,255 shares remained available for issuance. Such options vest over a three 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 5,744 $ 636.74 0.33 Granted 307,142 $ 17.50 Forfeited/Cancelled (3,772) $ 792.05 Outstanding at September 30, 2022 309,114 $ 19.56 9.53 Exercisable options at September 30, 2022 1,972 $ 339.80 0.08 The intrinsic value of outstanding options at September 30, 2022 was $0. Stock options granted during the nine months ended September 30, 2022 were valued using the Black-Scholes option-pricing model with the following weighted average assumptions: September 30, 2022 Expected volatility 106.0 % Risk-free interest rate 2.7 % Expected dividend yield 0.0 % Expected life of options in years 6.9 Exercise Price $ 17.50 Fair value of ADS $ 15.38 Estimated fair value of option $ 12.92 Stock based compensation expense was approximately $267,000 ($35,000 included in research and development expense and $232,000 included in general and administrative expenses) in the three months ended September 30, 2022 and approximately $497,000 ($65,000 included in research and development expense and $432,000 included in general and administrative expenses) in the nine months ended September 30, 2022. At September 30, 2022, the total unrecognized compensation expense related to non-vested options was approximately $3,472,529 and is expected to be recognized over the remaining weighted average service period of approximately 3.32 years. |
PREPAID EXPENSES
PREPAID EXPENSES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
PREPAID EXPENSES | ||
PREPAID EXPENSES | NOTE 8 – PREPAID EXPENSES Prepaid expenses are as follows: September 30, December 31, 2022 2021 Prepaid R&D costs $ 414,061 $ 329,033 Prepaid insurance 74,017 684,191 Prepaid expense 8,608 2,250 Total $ 496,686 $ 1,015,474 | NOTE 7 – PREPAID EXPENSES Prepaid expenses are as follows: December 31, 2021 2020 Prepaid R&D costs $ 329,033 $ — Prepaid insurance 684,191 — Prepaid other expenses 2,250 — Total $ 1,015,474 $ — |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
ACCRUED EXPENSES | ||
ACCRUED EXPENSES | NOTE 9 - ACCRUED EXPENSES Accrued expenses are as follows: September 30, December 31, 2022 2021 Research contract expenses (note 13) $ 381,862 $ 193,537 Payroll (note 12) 759,833 557,937 Payroll taxes (note 12) 153,552 199,582 Investor Relation firm fees (note 13) 98,000 584,000 Professional fees 115,451 144,377 Other Expenses 61,222 5,976 Total $ 1,569,920 $ 1,685,409 | NOTE 8 – ACCRUED EXPENSES Accrued expenses are as follows: December 31, 2021 2020 Professional fees $ 144,377 $ 173,095 Investor Relations fees 584,000 528,000 Payroll taxes 199,582 148,899 Payroll 557,937 — Research contract expenses 193,537 105,052 Other expenses 5,976 5,802 Total $ 1,685,409 $ 960,848 |
IN-LICENSED TECHNOLOGY
IN-LICENSED TECHNOLOGY | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
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. The terms of any royalty payments to the Seller are 4.0% of the net revenue of royalty products, as defined in the Acquisition Agreement during the ten (10) year period commencing from the date of first sale of a royalty product. If a generic product is introduced by a third party to the market, during the royalty period, the royalty fees shall be reduced from 4% to 2%. If, during the royalty period, two or more generic products are introduced, the royalty fees shall be reduced from 2% to 0%. Quoin Inc. also entered into a research and consulting agreement which committed Quoin Inc. to pay the Seller for additional research and development consulting services (See Notes 13 and 15). Skinvisible: On October 17, 2019, Quoin Inc. entered into an exclusive license agreement with Skinvisible Inc. (“Skinvisible”), pursuant to which Skinvisible granted a license to use certain patented technology for the development of products for commercial sale in the orphan rare skin disease field, and for the use of a proprietary polymer deliver system technology. This technology is currently being used in the development of QRX003. In exchange for the license, Quoin Inc. agreed to pay Skinvisible $1,000,000, as well as development and sales milestone payments and a single digit royalty on all net sales, as defined. The development milestones originally required payments upon achieving development milestones for the first Rare Skin Disease drug product developed using the licensed technology and the first two Ketamine products, as defined. On January 27, 2021, Quoin Inc. and Skinvisible entered into an amendment which modified the clinical milestone payment requirements such that $750,000 would be payable to Skinvisible upon achievement of specified clinical milestones, and $21.75 million upon regulatory approval in the U.S. and EU respectively. The license fee was originally due in two equal installments of $500,000 payable no later than December 31, 2019 and June 30, 2020, which were not paid. The agreement was subsequently amended several times to extend the payment due dates. On June 21, 2021, the parties entered into the most recent amendment which modified the payment terms and eliminated the $750,000 clinical milestone payments, reduced the milestone payment upon regulatory approval of the product containing the Skinvisible technology in either the U.S. or E.U., whichever happens first to a total of $5,000,000. | NOTE 9 – ASSET ACQUISITION AND IN-LICENSED TECHNOLOGY Polytherapeutics On March 24, 2018, Quoin Inc. entered into a securities purchase agreement (the “Acquisition Agreement”), in which it agreed to acquire all of the equity interests in Polytherapeutics, Inc. (the “Seller” or “Polytherapeutics”) for $40,833 and future royalties provided Quoin Inc. commercializes products using the technology developed by the Seller. The terms of any royalty payments to the Seller are 4.0% of the net revenue of royalty products, as defined in the Acquisition Agreement, received by Quoin Inc. during the ten (10) year period commencing from the date of first sale of a royalty product. If a generic product is introduced by a third party to the market, during the royalty period, the royalty fees shall be reduced from 4% to 2%. If, during the royalty period, two or more generic products are introduced, the royalty fees shall be reduced from 2% to 0%. The Seller had the option to repurchase the intellectual property for $100,000 if there were no products in clinical development using such technology. Quoin Inc. also entered into a research and consulting agreement which commits Quoin Inc. to pay the Seller for additional research and development consulting services (See Notes 12 and 15). Skinvisible On October 17, 2019, Quoin Inc. entered into an exclusive license agreement with Skinvisible Inc. (“Skinvisible”), pursuant to which Skinvisible granted a license to use certain patented technology for the development of products for commercial sale in the orphan rare skin disease field, and for the use of a proprietary polymer deliver system technology. This technology is currently being used in the development of QRX003. In exchange for the license, Quoin Inc. agreed to pay Skinvisible $1,000,000, as well as development and sales milestone payments and a single digit royalty on all net sales, as defined. The development milestones originally required payments upon achieving development milestones for the first Rare Skin Disease drug product developed using the licensed technology and the first two Ketamine products, as defined. Payments were originally due upon successful completions of certain clinical milestones ($7.5 million) and obtaining US and EU regulatory approval ($15 million). The sales milestones required for every licensed product commercialized by Quoin Inc. are $10 million upon achievement of $100 million in sales being achieved in the annual period; $25 million upon achievement of $250 million in sales and $50 million upon the achievement of $400 million in sales in an annual period. On January 27, 2021, Quoin Inc. and Skinvisible entered into an amendment which modified the clinical milestone payment requirements such that $750,000 would be payable to Skinvisible upon achievement of specified clinical milestones, and $21.75 million upon regulatory approval in the U.S. and EU respectively. The agreement has a termination clause that is triggered if no product has commenced clinical testing 12 months after the date of the agreement or the latest subsequent amendment. On April 19, 2021, Quoin Inc. and Skinvisible entered into another amendment which established the development deadline as December 31, 2022. Should the Company not commence clinical testing as defined by the development deadline, the license agreement will terminate immediately except in certain circumstances as specified in the agreement. The license fee was originally due in two equal installments of $500,000 payable no later than December 31, 2019 and June 30, 2020, which were not paid. The agreement was subsequently amended for payment due on July 31, 2020. On July 31, 2020, the agreement was amended to further extend the payment until September 30, 2020. On September 30, 2020, the agreement was again amended, requiring payment of the license fee only when outside financing is received, as defined in the agreement. On June 21, 2021, the parties entered into an additional amendment which modified the payment terms and required a payment of $107,500 on June 26, 2021, a payment of $250,000 within 10 days of the Primary Financing, and the remaining $250,000 upon the earlier of approval of an Investigatory New Drug application by the FDA or December 31, 2021. This amendment also eliminated the $750,000 clinical milestone payments described above and reduced the milestone payment upon regulatory approval of the product containing the Skinvisible technology in either the U.S. or E.U., whichever happens first to a total of $5,000,000. At December 31, 2021 and December 31, 2020, the license acquisition liability due was $250,000 and $875,000 respectively. In March 2022, the Company paid $50,000 against this liability. The remaining license acquisition liability has not been paid in accordance with the terms but has not impaired the Company’s rights to the technology as the Company is in the process of renegotiating this payment with Skinvisible. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
INTANGIBLE ASSETS | ||
INTANGIBLE ASSETS | NOTE 11 - INTANGIBLE ASSETS Intangible assets are as follows: September 30, December 31, 2022 2021 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (309,861) (231,829) Net book value $ 730,572 $ 808,604 The Company recorded amortization expense of approximately $78,000 for the nine months ended September 30, 2022 and 2021. The Company recorded amortization expense of approximately $26,000 for the three months ended September 30, 2022 and 2021. The annual amortization expense expected to be recorded for existing intangible assets for the years 2022 through 2026, and thereafter, is approximately $26,000, $104,000, $104,000, $104,000, $104,000, and $288,000, respectively. | NOTE 10 - INTANGIBLE ASSETS Intangible assets are as follows: December 31, 2021 2020 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (231,829) (127,785) Net book value $ 808,604 $ 912,648 The Company recorded amortization expense of approximately $104,000 $104,000 $21,000 is expected to be |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | ||
RELATED PARTY TRANSACTIONS | NOTE 12 - RELATED PARTY TRANSACTIONS Employment Agreements and Due to Officers/Founders: In March 2018, Quoin Inc. executed employment agreements with both of its officers who are also co-founders of Quoin Inc. The employment agreements for both officers/founders allow for a onetime expense that covers the salaries they would have otherwise been paid for efforts they undertook in the periods since inception. The salaries and benefits allowances provided for under the employment agreements began to accrue as the services were being provided by the officers/founders and are included in Due to Officers on the accompanying balance sheet. Since the Merger closing, the Company is approved to pay and has been repaying amounts due to officers/founders at a rate of $25,000 each per month. Amounts due to officers at September 30, 2022 and December 31, 2021 consisted of the following: September 30, December 31, 2022 2021 Salaries and other compensation $ 4,108,500 $ 4,108,500 Invoices paid on behalf of the Company 165,233 615,232 Total 4,273,733 4,723,732 Less: Short-term portion (600,000) (600,000) Long-term portion $ 3,673,733 $ 4,123,732 Expenses: Research and development expense to a related party, incurred in the three and nine months ended September 30, 2022 and 2021 was approximately $12,000 and $0 and $36,000 and $0, respectively. For the nine months ended September 30, 2021, the Company paid a consulting fee of $100,000 to a board member. | NOTE 11 – RELATED PARTY TRANSACTIONS Employment Agreements and Due to Officers/Founders In March 2018, Quoin Inc. executed employment agreements with both of its officers who are also co-founders of Quoin Inc. The employment agreements for both officers/founders allow for a onetime expense that covers the salaries they would have otherwise been paid for efforts they undertook in the periods since inception. The salaries and benefits allowances provided for under the employment agreements began to accrue as the services were being provided by the officers/founders and are included in Due to Officers on the accompanying balance sheet. Amounts due to the officers/founders consist of amounts specified in the employment agreements since inception through December 31, 2021 as well as reimbursable travel expenses and other amounts paid by them to third parties on behalf of Quoin Inc. The Company repaid $304,466, $50,000, and $0 of such amounts due to officers/founders in the year ended December 31, 2021, 2020 and 2019, respectively. Since the Merger closing, the Company has been repaying amounts due to officers/founders at a rate of $25,000 each per month (See Note 17). Amounts due to officers at December 31, 2021 and 2020 consisted of the following: December 31, 2021 2020 Salaries and allowances $ 4,108,500 $ 3,984,000 Invoices paid on behalf of the Company 615,232 904,913 Total $ 4,723,732 $ 4,888,913 During 2021, the Company incurred $108,000 of consulting expense from related parties, primarily from a related party company controlled by a member of the Board of Directors. See Note 4 for related party debt and Note 12 for employment agreements. |
RESEARCH, CONSULTING AGREEMENTS
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | ||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | NOTE 13 – RESEARCH, CONSULTING AND OTHER COMMITMENTS Research and consulting agreement: Quoin Inc. entered into a research and consulting agreement which commits it to pay the former owner of Polytherapeutics (the “Consultant” or “Seller”) to transfer the technical know-how of Polytherapeutics with respect to (i) good manufacturing practices (“GMP”), clinical and commercial manufacturing of the Company’s PolyDur polymer and (ii) formulation development of products utilizing the Company’s PharmaDur polymer. The agreement required monthly consulting payments of $20,833 beginning on July 31, 2018 and ending February 28, 2021 (the “Post-Closing Period”) for a total of $666,667 over the consulting period. Pursuant to an amendment, the Post-Closing Period was revised to terminate on December 31, 2020. Through September 30, 2022 and the financial statement issuance date, the Company has not made any payments, the Consultant has not performed any services and the Company has not incurred or accrued for any expenses. See Note 15 for Consultant’s notification of breach of contract. Other research consulting agreements: 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 September 2022 the Company issued 44,187 ADS’s to one of Axella’s principals to settle the outstanding liability in full. The Company incurred no research and development expenses in connection with these agreements, for both of the three and nine months ended September 30, 2022 and 2021, as no services were provided. In November 2020, Quoin Inc. entered into a Master Service Agreement for an initial term of three years In November 2021, the Company entered into a commitment with Queensland University of Technology for research related services associated with Netherton Syndrome of approximately $250,000 for an expected period of eighteen months. For the three and nine months ended September 30, 2022, the Company incurred research and development costs related to this agreement of approximately $35,000 and $112,000, respectively. In May 2022, the Company entered into a commitment with Queensland University of Technology for research related services associated with Scleroderma of approximately $610,000 for an expected period of eighteen months. The Company incurred research and development expenses of approximately $138,000 for the three and nine months ended September 30, 2022. As of September 30, 2022, the Company recorded prepaid research and development costs related to this agreement of approximately $85,000. 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. As of September 30, 2022, the balance of this liability is $98,000. For the three and nine months ended September 30, 2021, the Company incurred expenses of $42,000 and $42,000, respectively. For the three and nine months ended September 30, 2022, the Company incurred expenses of $42,000 and $70,000, respectively. Performance milestones and royalties: See Note 10 for asset and in-licensed technology commitments. Merger agreement commitment: In consideration for the Share Transfer disclosed in Note 1, the pre-closing Cellect shareholders received a contingent value right (“CVR”) entitling the holders to earnouts during the Payment Period (as such term is defined in the Share Transfer Agreement), comprised mainly of payments upon sale, milestone payments, license fees and exit fees realized by EnCellX. In order to secure such right, shares constituting 40% of EnCellX share capital are held in escrow. In connection with the Share Transfer, Cellect entered into a CVR Agreement with Mr. Eyal Leibovitz, in the capacity of Representative for the holders of CVRs, and Computershare Trust Company, N.A., a federally chartered trust company (the “Rights Agent”). Under the terms of the CVR Agreement, the holders of the Cellect ADSs immediately prior to the Merger had the right to receive, through their ownership of CVRs, their pro-rata share of the net Share Transfer consideration, making such holders of CVRs the indirect beneficiaries of the net payments under the Share Transfer. CVRs were recorded in a register administered by the Rights Agent but were not certificated. Since the Company will not receive any net proceeds from the CVR’s, there is no asset or liability recorded in the consolidated financial statements. | NOTE 12 – RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS Research and consulting agreement Quoin Inc. entered into a research and consulting agreement (the “Research Agreement”) which commits it to pay the former owner of Polytherapeutics (the “Consultant” or “Seller”) to transfer the technical know-how of Polytherapeutics with respect to (i) good manufacturing practices (“GMP”), clinical and commercial manufacturing of the Company’s PolyDur polymer and (ii) formulation development of products utilizing the Company’s PharmaDur polymer (See Note 9). The agreement required monthly consulting payments of $20,833 beginning on July 31, 2018 and ending February 28, 2021 (the “Post-Closing Period”) for a total of $666,667 over the consulting period. Pursuant to an amendment, the Post-Closing Period was revised to terminate on December 31, 2020. Through December 31, 2021 and the financial statement issuance date, the Company has not made any payments, the Consultant has not performed any services and the Company has not incurred or accrued for any expenses. See Note 15 for Consultant’s notification of breach of contract. Other research consulting agreements 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 under the three agreements are met. Quoin Inc. has also engaged Axella for additional services pursuant to separate work orders. Further, Quoin Inc. has two options to pay the milestones due 1) one half one-half In November 2020, Quoin Inc. entered into a Master Service Agreement for an initial term of three years with Therapeutics Inc. for managing preclinical and clinical development for new products in the field of dermatology. The agreement required the execution of individual work orders. Quoin Inc. may terminate any work order for any reason with 90 days written notice subject to costs incurred through termination and a defined termination fee, unless there is a material breach by Therapeutics Inc. The first work order was entered into in late 2020 for a clinical study at an expected estimated cost of approximately $3.5 million and expected timing through the first quarter of 2023. For the year ended December 31, 2021, the Company incurred approximately $340,000 of research and development costs related to this agreement. In November 2021, the Company entered into a commitment for research related services associated with Netherton Syndrome of approximately $250,000 for an expected period of eighteen months, of which an initial $25,000 expense was incurred in 2021. Employment agreements The employment agreements entered into by Quoin Inc. with its two founders/officers provide for a combined base salary, including monthly allowances, of $996,000 per annum, a discretionary bonus and certain allowances and benefits. In the event of termination of the two founders/officers for reason other than cause, as defined in the employment agreements, the founders shall be entitled to two years of based salary and bonus. In November 2021, the Company appointed and entered into an employment agreement with its Chief Financial Officer which provides for a base salary of $360,000 per annum, a discretionary bonus and certain allowances and benefits. In November 2021, the Board of Directors of the Company approved amendments to the employment agreements increasing base level compensation by 10% for the two founders and increasing the annual target discretionary bonus to not less than 45% of base salary for the two founders and the Chief Financial Officer. Further a transaction bonus related to the closing of the Merger and private placements aggregating approximately $324,000 was paid to the two founders in November 2021. See Note 17 describing subsequent shareholder approval of the employment agreements of the two founders/officers. Performance milestones and Royalties See Note 9 for asset and in-licensed technology commitments. Merger agreement commitment In consideration for the Share Transfer disclosed in Note 1, the pre-closing Cellect shareholders received a contingent value right (“CVR”) entitling the holders to earnouts during the Payment Period (as such term is defined in the Share Transfer Agreement), comprised mainly of payments upon sale, milestone payments, license fees and exit fees realized by EnCellX. In order to secure such right, shares constituting 40% of EnCellX share capital are held in escrow by Altshuler Shaham Trusts Ltd. In connection with the Share Transfer, Cellect entered into a CVR Agreement with Mr. Eyal Leibovitz, in the capacity of Representative for the holders of CVRs, and Computershare Trust Company, N.A., a federally chartered trust company (the “Rights Agent”). Under the terms of the CVR Agreement, the holders of the Cellect ADSs immediately prior to the Merger had the right to receive, through their ownership of CVRs, their pro-rata share of the net Share Transfer consideration, making such holders of CVRs the indirect beneficiaries of the net payments under the Share Transfer. CVRs were recorded in a register administered by the Rights Agent but were not certificated. Since the Company will not receive any net proceeds from the CVR’s, there is no asset or liability recorded in the consolidated financial statements. |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SHAREHOLDERS' EQUITY | ||
SHAREHOLDERS' EQUITY | NOTE 14 – SHAREHOLDERS’ EQUITY The Company held a Special General Meeting on February 28, 2022, at which the Company’s shareholders adopted the Amended and Restated Articles of Association of the Company. The Company held its Annual General Meeting on April 12, 2022, at which the Company’s shareholders approved an increase to the authorized share capital to 50,000,000,000 ordinary shares from 12,500,000,000, no par value. The Company held a further Annual General Meeting on November 3, 2022, at which the Company’s shareholders approved an increase to the authorized share capital to 500,000,000,000 ordinary shares from 50,000,000,000, no par value (see Note 17). These ordinary shares are not redeemable and do not have any preemptive rights. Holders of the Company’s ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders at a shareholders meeting. The board of directors shall determine and provide a record date for each shareholders meeting and all shareholders at such record date may vote. Unless stipulated differently in the Companies Law or in the articles of association, all shareholders’ resolutions shall be approved by a simple majority vote. Under Israeli law, the Company may declare and pay dividends only if, upon the determination of 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. The Bank of New York Mellon, as depositary, has registered and delivered American Depositary Shares, also referred to as ADSs. Following an ADS ratio adjustment effective August 1, 2022, each ADS represents five thousand (5,000) ordinary shares (or a right to receive five thousand (5,000) ordinary shares). Each ADS will also represent any other securities, cash or other property which may be held by the depositary. ADSs may be held either (a) directly (1) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs or (2) by having uncertificated ADSs, or (b) indirectly by holding a security entitlement in ADSs through a broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, also called DTC. On August 9, 2022 the Company completed an offering (the “Offering”) of 11,050,000,000 ordinary shares represented by 2,210,000 ADSs at a purchase price of $5.00 per ADS and pre-funded warrants (the “Pre-Funded Warrants”) to purchase 5,750,000,000 ordinary shares represented by 1,150,000 ADSs at a per pre-funded warrant price of $4.9999, with each ADS and Pre-Funded Warrant accompanied by an ordinary warrant (the “Common Warrant”), for aggregate gross proceeds of $16.8 million, resulting in net proceeds of approximately $14.9 million. Each Common Warrant has an exercise price of $5.00 per ADS and expires on the fifth anniversary of the Closing Date. On the Closing Date, the holder of Pre-Funded Warrants sold in the Offering exercised its Pre-Funded Warrants in full. In connection with the Offering, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors. The Purchase Agreement provided that for a period of 180 days following the closing of the Offering, the Company will not effect or enter into an agreement to effect a “variable rate transaction” as defined in the Purchase Agreement. Further, the Company has agreed in the Purchase Agreement not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any ADSs or ordinary shares or their equivalents, subject to certain exceptions, for a period of 90 days after the closing of the Offering. The Purchase Agreement also contained representations, warranties, indemnification and other provisions customary for transactions of this nature. Warrants The following table summarizes warrant activities during the year ended December 31, 2021 and the nine months ended September 30, 2022: Weighted ADSs Average Underlying Exercise Price Warrants Per Share Outstanding at December 31, 2021 137,282 $ 55.39 Granted 5,385,374 11.21 Terminated (232,349) 49.75 Exercised – Cashless and Pre Funded Warrants (1,921,487) — Outstanding and exercisable at September 30, 2022 3,368,820 $ 5.35 As of September 30, 2022, outstanding warrants expire in 2024 and 2027, and have an intrinsic value of $0. | NOTE 13 – SHAREHOLDERS’ EQUITY AND SHARE OWNERSHIP AND RIGHTS Quoin Inc. Quoin Inc.’s authorized capital stock consisted of 10,000 shares of common stock. On March 5, 2018, in connection with the incorporation as a Delaware corporation, Quoin Inc. issued 100 shares for a consideration of $100 split equally between the two founders and officers of Quoin Inc. In connection with the Merger transaction, the two founders exchanged their shares in Quoin Inc. for 240,292 ADSs in Quoin Ltd., which was subsequently reduced to 224,388 ADSs in May 2022 following the determination of the number of shares held in escrow allocated to certain former shareholders of Cellect. All share and per share amounts have been adjusted to reflect this recapitalization. Quoin Ltd. As of December 31, 2021, Quoin Ltd.’s authorized share capital consisted of 12,000,000,000 ordinary shares, no par value. These ordinary shares are not redeemable and do not have any preemptive rights. However, the Investor has certain approval rights in connection with the issuance of additional shares. Holders of our ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders at a shareholders meeting. Shareholders may vote at shareholders meetings either in person, by proxy or by written ballot. Israeli law does not allow public companies to adopt shareholder resolutions by means of written consent in lieu of a shareholders meeting. The board of directors shall determine and provide a record date for each shareholders meeting and all shareholders at such record date may vote. Unless stipulated differently in the Companies Law or in the articles of association, all shareholders’ resolutions shall be approved by a simple majority vote. Under Israeli law, the Company may declare and pay dividends only if, upon the determination of our board of directors, there is no reasonable concern that the distribution will prevent us 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 our existing and foreseeable obligations as they become due. The Bank of New York Mellon, as depositary, has registered and delivered American Depositary Shares, also referred to as ADSs. Post August 1, 2022 change in ADS ratio, each ADS represents (5,000) ordinary shares (or a right to receive five thousand (5,000) ordinary shares). Each ADS will also represent any other securities, cash or other property which may be held by the depositary. ADSs may be held either (a) directly (1) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs or (2) by having uncertificated ADSs, or (b) indirectly by holding a security entitlement in ADSs through a broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, also called DTC. Warrants and Options The following vested stock options and warrants were outstanding at December 31, 2021, exercisable into ADSs: ADSs Exercise Price Year of maturity Warrants held by 2020 noteholders 29,388 $ 49.75 2026 Warrants held by Investor 99,074 $ 49.75 2026 Options held by former Cellect optionholders 5,746 636.75 2022 Warrants held by former Cellect warrantholders 8,820 $ 137.50 2022-2024 Total 143,028 1) The options held by former Cellect optionholders fully vested at the closing of the Merger and expire between January and October 2022. The incremental fair value of the stock options at the closing of the Merger was not significant. The options were issued under the Cellect Ltd. Employee Shares Incentive Plan (the “2014 Plan”). The 2014 Plan was amended and restated and initial grants were made to Company officers and directors, approved at the Company Annual General Meeting held on April 12, 2022. See Note 17. The intrinsic value of the above stock options and warrants at December 31, 2021 was negligible. Effective as of March 13, 2022, the Company issued warrants to the Investor under the terms of the Primary Financing, exercisable into ADSs in the following aggregate amounts. See Note 17. ADSs Exercise Price Series A warrants (1) 533,274 $ 49.75 Series B warrants (1) 533,274 $ 49.75 Series C warrants (1) 191,174 $ 49.75 Total 1,257,722 (1) The Company expects to issue each of 191,174 additional Series A and Series B Warrants to the Investor upon exercise of the Series C Warrant, which are assumed to be exercised and, therefore, are included in the totals of the Series A and B warrants in the table above. |
CONTINGENCIES
CONTINGENCIES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
CONTINGENCIES | ||
CONTINGENCIES | NOTE 15 – 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. In February 2020, the Seller of the equity interests in Polytherapeutics and party to the Research Agreement communicated with Quoin Inc. threatening litigation for non-payment and related breach of contract and immediate payment of all monthly payments in the amount of $666,667. See Notes 10 and 13. The Consultant has not provided any services and has not complied with other technical requirements under the Research Agreement, and therefore is considered to be in breach of contract. The Company and the Consultant have had communications with respect to the duration, commencement date and payment of the consulting services, but a revised agreement has not been reached. No lawsuits have been filed as of the financial statement issuance date. Should a formal claim or lawsuit be filed, the Company believes it has meritorious defenses. | NOTE 15 - 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. In February 2020, the seller of the equity interests in Polytherapeutics and party to the Research Agreement communicated with Quoin Inc. threatening litigation for non-payment and related breach of contract and immediate payment of all monthly payments in the amount of $666,667. See Notes 9 and 12. The Consultant has not provided any services and has not complied with other technical requirements under the Research Agreement, and therefore is considered to be in breach of contract. The Company and the Consultant have had communications with respect to the duration, commencement date and payment of the consulting services, but a revised agreement has not been reached. No lawsuits have been filed as of the financial statement issuance date. Should a formal claim or lawsuit be filed, the Company believes it has meritorious defenses. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
LICENSE AGREEMENTS | ||
LICENSE AGREEMENTS | NOTE 16 – LICENSE AGREEMENTS In November and December 2021, the Company entered into three license and supply agreements, whereby the Company is entitled to a royalty or other proceeds from the specified product revenues in select non-US markets from the licensee, if and when the underlying products are approved and commercialized. During nine months ended September 30, 2022, the Company entered into six license and supply agreements, whereby the Company will receive a royalty or other proceeds from the specified product revenues in select non-US markets from the licensor, if and when the underlying products are approved and commercialized. No royalty revenues have been received through September 30, 2022 under any of these agreements. | NOTE 16 – LICENSE AGREEMENTS In November and December 2021, the Company entered into three license and supply agreements, whereby the Company is entitled to a royalty or other proceeds from the specified product revenues in select non-US markets from the licensee, if and when the underlying products are approved and commercialized. No royalty revenues were received in 2021. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SUBSEQUENT EVENTS | ||
SUBSEQUENT EVENTS | NOTE 17 - SUBSEQUENT EVENTS On November 3, 2022, the Company held its Annual General Meeting of Shareholders, at which the Company’s shareholders approved an increase to the authorized share capital to 500,000,000,000 ordinary shares from 50,000,000,000, no par value. | NOTE 17 - SUBSEQUENT EVENTS In March 2022, the Company paid an aggregate of $311,670 to two out of five 2020 noteholders in settlement of the amounts included in accrued interest payable at the closing of the Merger. See Note 4. In the first quarter of 2022, the Company entered into four license and supply agreements, whereby the Company will receive a royalty or other proceeds from the specified product revenues in select non-US markets from the licensor, if and when the underlying products are approved and commercialized. Effective as of March 13, 2022, the Company issued warrants to purchase ADSs as follows: ● Exchanged the existing warrants of 2020 noteholders (Note 4) for warrants on substantially the same terms as the Investor Exchange Warrant (See Note 5), exercisable for 29,388 ADSs, in the aggregate, at the exercise price of $49.75 per ADS. The exercise price was reduced to $0.00 as of July 14, 2022 as a result of the Altium Agreement described below. ● Issued Series A Warrant, Series B Warrant and Series C Warrant to purchase 342,100 ADSs, 342,100 ADSs and 191,174 ADSs, respectively, at the exercise price of $49.75 per ADS, based on the terms of the Primary Financing. These warrants were amended as of July 14, 2022 under the Altium Agreement described below. The Company held a Special General Meeting on February 28, 2022, at which the Company’s shareholders adopted the Amended and Restated Articles of Association of the Company. Amended and Restated Equity Incentive Plan and Annual Meeting of Shareholders In March 2022, our board of directors 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 our outstanding ordinary shares on a fully-diluted basis, or 1,826,991,616 ordinary shares, represented by 365,398 ADSs as of March 31, 2022. The board of directors further approved the award of options to our officers and directors to purchase, in the aggregate, 316,571 ADSs under the Amended Plan, and annual discretionary bonuses for officers of $472,500 in aggregate. We held our Annual General Meeting on April 12, 2022, at which our shareholders approved, among other items, the following: ● The increase in authorized share capital from 12.5 billion to 50 billion ordinary shares. ● Modification of the annual compensation of the two founders to a combined base salary of $990,000 and to increase the annual discretionary bonus to not less than 45% of the annual base salary. ● Repayment of amounts due to the two founders at a rate of $25,000 each per month. ● The grant of an option to purchase up to 85,714 ADSs to each of the two founders under the Amended Plan, at an exercise price per ADS of $17.50 , to vest over a four-year period. ● The grant of an option to purchase 12,857 ADSs to each of the five non-employee director under the Amended Plan at an exercise price per ADS of $17.50 , to vest over a three-year period, and (as an annual grant for 2022) an option to an officer to purchase 71,429 ADSs at an exercise price per ADS of $17.50 , to vest over a four-year period. ADS Ratio Change On July 12, 2022, our Board of Directors approved the change in the ratio of ADS evidencing ordinary shares from 1 ADS representing four hundred (400) ordinary shares to 1 ADS representing five thousand (5,000) ordinary shares, which will result in a one for 12.5 reverse split of the issued and outstanding ADSs (the “Ratio Change”). The Ratio Change was effective August 1, 2022. All ADS and related option and warrant information presented in these financial statements and accompanying footnotes has been retroactively adjusted to reflect the reduced number of ADSs resulting from the Ratio Change. Nasdaq Listing On April 22, 2022, we received a letter from the Listing Qualifications staff of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that we are no longer in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2.5 million. In addition, as of April 21, 2022, we did not meet the alternative continued listing requirements based on market value of listed securities or net income from continuing operations. In accordance with Nasdaq Rule 5810(c)(2)(A), within 45 calendar days of receiving this notice, we submitted a plan to regain compliance to Nasdaq. This plan was accepted, and Nasdaq has granted us an extension until October 19, 2022 to evidence compliance. On June 10, 2022, we received a letter from The Nasdaq Listing Qualifications staff notifying us 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 we did not meet the minimum bid price requirements set forth in Nasdaq Rule 5550(a)(2). Pursuant to Nasdaq Rule 5810(c)(3)(A), we have a period of one hundred eighty (180) calendar days, or until December 7, 2022 (the “Compliance Period”), to regain compliance with Nasdaq’s minimum bid price requirement. If at any time during the Compliance Period, the closing bid price per ADS is at least $1.00 for a minimum of ten (10) consecutive business days, Nasdaq will provide us a written confirmation of compliance and the matter will be closed. In the event we do not regain compliance by December 7, 2022, we may be eligible for an additional 180 calendar day grace period. To qualify, we will be required to meet the continued listing requirement for market value of publicly held ADSs and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period. Although there is no assurance, we expect that the offering that is being registered on the registration statement on Form F-1, which includes these financial statements and accompanying notes, will enable us to regain compliance with Nasdaq’s minimum stockholders’ equity requirement and the Ratio Change will help us to regain compliance with the minimum bid-price requirement for continued listing on The Nasdaq Capital Market. Although Nasdaq notification letters described above have no immediate effect on our listing on The Nasdaq Capital Market, and we are working on implementing plans to regain compliance with Nasdaq listing standards, there can be no assurance that we will be able to regain compliance with Nasdaq’s minimum stockholders’ equity requirement or minimum bid-price requirement for continued listing. If our ADSs are delisted from Nasdaq, it will have material negative impacts on the actual and potential liquidity of our securities, as well as material negative impacts on our ability to raise future capital. Agreements with Altium Growth Fund, LP and Altium Warrant Exercises During the second quarter of 2022, Altium exercised the Series B Warrant in full pursuant to the alternate cashless exercise right of such warrant, under which Altium had an option to receive 1 ADS for each ADS underlying the warrant being exercised in such cashless exercise, resulting in the issuance of a total of 342,100 ADSs to Altium. On July 14, 2022, we, 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, among other things, reduce the exercise price to $0.00 per ADS with respect to a total of 399,999 ADSs, (ii) cancel the Series C Warrant and a 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. As of August 2, 2022, Altium exercised all of its warrants outstanding and we issued a total of 399,999 ADSs to Altium. The exercise price of the 2020 noteholder warrants was reduced to $0.00 as of July 14, 2022 as a result of the Altium Agreement described below. As of August 2, 2022, 23,040 noteholder warrants had been exercised. As a result of the Altium and noteholder warrant exercises and the Altium Agreement, the warrants outstanding as of August 2, 2022 are set out below, exercisable into ADS: Exercise Year of ADSs Price maturity Warrants held by 2020 noteholders 6,348 $ 0 2027 Warrants held by former Cellect warrant holders 8,820 $ 137.5 2024 Total 15,168 |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Basis of Presentation: | Basis of Presentation: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements of the Company as of September 30, 2022 and for the three and nine months then ended. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the operating results for the year or any other period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures as of December 31, 2021 and for the year then ended which are included in the Company’s Annual Report on Form 20- F, filed with the SEC on April 14, 2022, as updated in the Company’s Form 6-K furnished to the SEC on August 11, 2022. The Company operates in one segment. | 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, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. |
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 selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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. | 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 selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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: |
Reclassification: | Reclassification: Certain 2021 amounts were reclassified to conform to the current year presentation. The amount reclassified included the short term portion from long term portion due to officers. | |
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. | 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 balance sheets as of September 30, 2022. | |
Investments | Investments: Investments as of September 30, 2022 consist of U.S. Treasury Bills, which are classified as trading securities, totaling $ 9.9 million. 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 mature within the subsequent six months from the date of purchase. As of September 30, 2022, 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 the Company considers that could trigger an impairment review include the following: ● Significant changes in the manner of the Company’s use of the acquired assets or the strategy for the Company’s overall business, ● Significant underperformance relative to expected historical or projected development milestones, ● Significant negative regulatory or economic trends, and ● Significant technological changes which could render the platform technology obsolete. The Company recognizes impairment when the sum of the expected undiscounted future cash flows is less than the carrying amount of the asset. Impairment losses, if any, are measured as the excess of the carrying amount of the asset over its estimated fair value. During the three and nine months ended September 30, 2022 and 2021, there were no impairment indicators which required an impairment loss measurement. | 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 years ended December 31, 2021, 2020 and 2019, 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 expense in future periods as the related services are rendered. | 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 expense in future periods as the related services are rendered. |
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 to employees, non-employees and directors is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company’s expected stock volatility is based on the historical data regarding the volatility of a publicly traded set of peer companies, since it has limited history of trading as a public company. The Company utilizes the simplified method to estimate the expected term. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield was assumed to be zero as the Company has not paid and dividends since its inception and does not anticipate paying dividends in the foreseeable future. | |
Fair value of financial instruments: | Fair value of financial instruments: The Company considers its cash, investments, accounts payable, and accrued expenses to meet the definition of financial instruments. The carrying amounts of the remaining 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 (“ASC Topic 820”). ASC Topic 820 defines fair value, establishes a framework and gives guidance regarding the methods used for measuring fair value, and expands disclosures about fair value measurements. | Fair value of financial instruments: The Company considers its cash, accounts payable, accrued expenses and the convertible and bridge notes payable to meet the definition of financial instruments. The convertible and bridge notes payable are recorded at fair value, see Notes 4, 5 and 6. The warrants are recorded at fair value, see Notes 4, 5 and 6. The carrying amounts of the remaining 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, which provides for calculation of “basic” and “diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss available to common shareholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per share gives effect to ordinary shares equivalents; however, potential common shares are excluded if their effect is anti-dilutive. For the three and nine months ended September 30, 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding options and warrants to purchase 309,114 ADSs and 3,368,820 ADSs, respectively. For the three and nine months ended September 30, 2021, the 5,183 ADS’s issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the 40,247 ADSs issuable upon conversion of the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. | 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, 2021, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 143,028 ADS or 715,137,600 Ordinary Shares and warrants to purchase 1,257,722 ADS or 6,288,605,600 Ordinary Shares issuable pursuant to Primary Financing. For the year ended December 31, 2020, the number of shares issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | ||
Schedule of assets and liabilities measured at fair value on a recurring basis | December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants $ — $ — $ 373,599 $ 373,599 Total Warrant Liability $ — $ — $ 373,599 $ 373,599 September 30, 2022 Level 1 Level 2 Level 3 Total US Treasury Bills $ 9,911,200 $ — $ — $ 9,911,200 Total US Treasury Bills Asset $ 9,911,200 $ — $ — $ 9,911,200 | December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants — — $ 373,599 $ 373,599 Total Warrant Liability — — $ 373,599 $ 373,599 December 31, 2020 Level 1 Level 2 Level 3 Total 2020 Notes payable $ — $ — $ 1,213,333 $ 1,213,333 Total Liabilities $ — — $ 1,213,333 $ 1,213,333 |
Schedule of movement in warrant liability balance | Bridge Financing 2020 Note Warrants Warrants Beginning Balance January 1, 2021 $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending balance December 31, 2021 $ — $ 373,599 Change in fair value of warrants — (77,237) Reclassification of warrant liability to an equity instrument — (296,362) Ending balance September 30, 2022 $ — $ — | Bridge Financing 2020 Notes Warrants Warrants Beginning Balance $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in Fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending Balance $ — $ 373,599 |
STOCK BASED COMPENSATION (Table
STOCK BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
STOCK BASED COMPENSATION | |
Summary of stock-based activities | Weighted Weighted Average Average ADS Underlying Exercise Contractual Options Price Terms Outstanding at December 31, 2021 5,744 $ 636.74 0.33 Granted 307,142 $ 17.50 Forfeited/Cancelled (3,772) $ 792.05 Outstanding at September 30, 2022 309,114 $ 19.56 9.53 Exercisable options at September 30, 2022 1,972 $ 339.80 0.08 |
Summary of weighted average assumptions of stock options granted valued using the Black-Scholes option-pricing model | September 30, 2022 Expected volatility 106.0 % Risk-free interest rate 2.7 % Expected dividend yield 0.0 % Expected life of options in years 6.9 Exercise Price $ 17.50 Fair value of ADS $ 15.38 Estimated fair value of option $ 12.92 |
PREPAID EXPENSES (Tables)
PREPAID EXPENSES (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
PREPAID EXPENSES | ||
Schedule of prepaid expenses | September 30, December 31, 2022 2021 Prepaid R&D costs $ 414,061 $ 329,033 Prepaid insurance 74,017 684,191 Prepaid expense 8,608 2,250 Total $ 496,686 $ 1,015,474 | December 31, 2021 2020 Prepaid R&D costs $ 329,033 $ — Prepaid insurance 684,191 — Prepaid other expenses 2,250 — Total $ 1,015,474 $ — |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
ACCRUED EXPENSES | ||
Schedule of accrued expenses | September 30, December 31, 2022 2021 Research contract expenses (note 13) $ 381,862 $ 193,537 Payroll (note 12) 759,833 557,937 Payroll taxes (note 12) 153,552 199,582 Investor Relation firm fees (note 13) 98,000 584,000 Professional fees 115,451 144,377 Other Expenses 61,222 5,976 Total $ 1,569,920 $ 1,685,409 | December 31, 2021 2020 Professional fees $ 144,377 $ 173,095 Investor Relations fees 584,000 528,000 Payroll taxes 199,582 148,899 Payroll 557,937 — Research contract expenses 193,537 105,052 Other expenses 5,976 5,802 Total $ 1,685,409 $ 960,848 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
INTANGIBLE ASSETS | ||
Schedule of intangible assets | September 30, December 31, 2022 2021 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (309,861) (231,829) Net book value $ 730,572 $ 808,604 | December 31, 2021 2020 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (231,829) (127,785) Net book value $ 808,604 $ 912,648 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | ||
Schedule of amounts due to offices | September 30, December 31, 2022 2021 Salaries and other compensation $ 4,108,500 $ 4,108,500 Invoices paid on behalf of the Company 165,233 615,232 Total 4,273,733 4,723,732 Less: Short-term portion (600,000) (600,000) Long-term portion $ 3,673,733 $ 4,123,732 | December 31, 2021 2020 Salaries and allowances $ 4,108,500 $ 3,984,000 Invoices paid on behalf of the Company 615,232 904,913 Total $ 4,723,732 $ 4,888,913 |
SHAREHOLDERS' EQUITY (Tables)
SHAREHOLDERS' EQUITY (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SHAREHOLDERS' EQUITY | ||
Schedule of stock options and warrants outstanding | The following vested stock options and warrants were outstanding at December 31, 2021, exercisable into ADSs: ADSs Exercise Price Year of maturity Warrants held by 2020 noteholders 29,388 $ 49.75 2026 Warrants held by Investor 99,074 $ 49.75 2026 Options held by former Cellect optionholders 5,746 636.75 2022 Warrants held by former Cellect warrantholders 8,820 $ 137.50 2022-2024 Total 143,028 1) The options held by former Cellect optionholders fully vested at the closing of the Merger and expire between January and October 2022. The incremental fair value of the stock options at the closing of the Merger was not significant. The options were issued under the Cellect Ltd. Employee Shares Incentive Plan (the “2014 Plan”). The 2014 Plan was amended and restated and initial grants were made to Company officers and directors, approved at the Company Annual General Meeting held on April 12, 2022. See Note 17. ADSs Exercise Price Series A warrants (1) 533,274 $ 49.75 Series B warrants (1) 533,274 $ 49.75 Series C warrants (1) 191,174 $ 49.75 Total 1,257,722 (1) The Company expects to issue each of 191,174 additional Series A and Series B Warrants to the Investor upon exercise of the Series C Warrant, which are assumed to be exercised and, therefore, are included in the totals of the Series A and B warrants in the table above. Exercise Year of ADSs Price maturity Warrants held by 2020 noteholders 6,348 $ 0 2027 Warrants held by former Cellect warrant holders 8,820 $ 137.5 2024 Total 15,168 | |
Summary of warrant activities | Weighted ADSs Average Underlying Exercise Price Warrants Per Share Outstanding at December 31, 2021 137,282 $ 55.39 Granted 5,385,374 11.21 Terminated (232,349) 49.75 Exercised – Cashless and Pre Funded Warrants (1,921,487) — Outstanding and exercisable at September 30, 2022 3,368,820 $ 5.35 |
ORGANIZATION AND BUSINESS (Deta
ORGANIZATION AND BUSINESS (Details) - shares | Aug. 01, 2022 | Oct. 29, 2021 |
Sale of stock | ||
Shares owned (as a percent) | 12.50% | 88% |
Minimum | ||
Sale of stock | ||
Number of shares represented for one ADS | (400) | |
Maximum | ||
Sale of stock | ||
Number of shares represented for one ADS | (5,000) |
LIQUIDITY RISKS AND OTHER UNC_2
LIQUIDITY RISKS AND OTHER UNCERTAINTIES (Details) - USD ($) | Aug. 10, 2022 | Sep. 30, 2022 | Aug. 09, 2022 | Jun. 10, 2022 | Dec. 31, 2021 | Oct. 28, 2021 | Dec. 31, 2020 |
Substantial Doubt About Going Concern Line Items | |||||||
Accumulated deficit | $ 35,500,000 | $ 28,100,000 | |||||
Deferred Offering Costs | $ 141,338 | ||||||
Threshold number of consecutive business days for calculating closing bid price per ads | 30 days | ||||||
ADS | |||||||
Substantial Doubt About Going Concern Line Items | |||||||
Minimum Stockholders' equity required for continued listing on The Nasdaq Capital Market | $ 2,500,000 | ||||||
Minimum closing bid price required per ADS. | $ 1 | $ 1 | |||||
2020 Notes | |||||||
Substantial Doubt About Going Concern Line Items | |||||||
Proceeds received | $ 16,800,000 | $ 12,000,000 | |||||
Deferred Offering Costs | $ 14,900,000 | $ 10,100,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Basis of Presentation (Details) | 9 Months Ended |
Sep. 30, 2022 segment | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Number of operating segment | 1 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Long-lived assets & Income taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||
Intangible assets, useful life | 10 years | 10 years | |||||
Impairment loss measurement | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Uncertain tax positions | $ 0 | $ 0 | |||||
U.S. Treasury Bills | $ 9,900,000 | $ 9,900,000 | |||||
Maturity term | 6 months |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings per share (Details) - shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Outstanding warrants | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 3,368,820 | 3,368,820 | 715,137,600 | ||
Outstanding warrants | ADS | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 309,114 | 309,114 | 143,028 | ||
Warrants | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 40,247 | 40,247 | 6,288,605,600 | ||
Warrants | ADS | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 5,183 | 5,183 | 1,257,722 |
CONVERTIBLE NOTES AND WARRANTS
CONVERTIBLE NOTES AND WARRANTS - 2020 Notes (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | Sep. 30, 2022 | |
Debt Instrument [Line Items] | ||||
Fair value of convertible notes | $ 1,213,313 | |||
Contractual term | 5 years | |||
Expected accrued interest | $ 312,000 | |||
Convertible Notes Warrants, Common Stock | ||||
Debt Instrument [Line Items] | ||||
Fair value of convertible notes | $ 1,200,000 | |||
Shares warrants may purchase | 29,388 | 29,388 | 744,000 | |
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||
Contractual term | 5 years | |||
Financing received from related party (as a percent) | 23% | |||
Increase in fair value of convertible notes payable | $ 378,000 | |||
2020 Notes | ||||
Debt Instrument [Line Items] | ||||
Shares issued upon conversion | 5,183 | |||
Shares warrants may purchase | 29,388 | 65,000 | ||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||
2020 Notes | Convertible Notes Warrants, Common Stock | ||||
Debt Instrument [Line Items] | ||||
Shares issued upon conversion | 5,183 | |||
Equivalent percentage of warrants received | 100% | |||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | $ 0 | ||
Convertible notes payable | 1,213,313 | |||
Original issue discount | $ 303,333 | |||
Additional funding received from convertible notes | $ 0 |
CONVERTIBLE NOTES AND WARRANT_2
CONVERTIBLE NOTES AND WARRANTS - Interest Expense (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) item | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | |
Debt Instrument [Line Items] | |||||||
Accrued interest | $ 743,840 | $ 47,041 | |||||
Total number of notes holders | item | 5 | ||||||
Number of notes holders who received consideration | item | 2 | ||||||
Number of remaining noteholders | item | 3 | ||||||
Interest expense | $ 0 | $ 0 | $ 187,000 | $ 334,000 | |||
2020 Notes | |||||||
Debt Instrument [Line Items] | |||||||
Other expense | 697,000 | ||||||
Accrued interest | $ 1,146,000 | $ 1,146,000 | 744,000 | 47,000 | $ 0 | ||
Interest expense | $ 202,000 | $ 47,000 | $ 0 |
BRIDGE FINANCING AND PRIMARY _2
BRIDGE FINANCING AND PRIMARY FINANCING - Bridge Financing (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Mar. 24, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Aug. 09, 2022 | |
Debt Instrument [Line Items] | |||||||
Interest paid | $ 393,611 | ||||||
Interest expense | $ 0 | $ 0 | $ 187,000 | $ 334,000 | |||
Bridge Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, face amount | $ 5,000,000 | $ 5,000,000 | |||||
Debt instrument, aggregate purchase price | $ 3,800,000 | ||||||
Debt instrument, par, discount percentage (as a percent) | 25% | ||||||
Debt instrument, interest rate, stated percentage (as a percent) | 15% | ||||||
Long-term debt, fair value | $ 100,618 | 5,000,000 | |||||
Debt issuance costs | $ 275,000 | ||||||
Bridge Notes, First Closing, March 25, 2021 | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, face amount | 2,000,000 | ||||||
Debt instrument, aggregate purchase price | 2,000,000 | ||||||
Proceeds from convertible debt | 1,500,000 | ||||||
Payments of debt issuance costs | 90,000 | ||||||
Bridge Notes, Second Purchase, April 2021 | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, face amount | 1,700,000 | ||||||
Debt instrument, aggregate purchase price | 1,700,000 | ||||||
Proceeds from convertible debt | 1,250,000 | ||||||
Bridge Notes, Third Purchase, May 2021 | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, face amount | 1,300,000 | ||||||
Debt instrument, aggregate purchase price | 1,300,000 | ||||||
Proceeds from convertible debt | 1,000,000 | ||||||
Payments of debt issuance costs | $ 185,000 | ||||||
Convertible notes payable | |||||||
Debt Instrument [Line Items] | |||||||
Debt conversion, converted instrument, shares issued | 100,618 | ||||||
Interest paid | $ 393,611 | ||||||
Interest expense | $ 393,611 |
BRIDGE FINANCING AND PRIMARY _3
BRIDGE FINANCING AND PRIMARY FINANCING - General Information (Details) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 | Oct. 28, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 |
Class of Warrant or Right [Line Items] | ||||||
Warrants, term | 5 years | |||||
Bridge Warrants, Common Stock | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, term | 5 years | 5 years | ||||
Warrants, number of securities called by warrants (in shares) | 99,074 | |||||
Warrants, exercise price of the three lowest weighted-average prices of post-merger ordinary shares, threshold, percentage (as a percent) | 85% | 85% | ||||
Bridge Warrants, Common Stock, First Closing | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 39,630 | 39,630 | ||||
Warrant liability | $ 1.6 | |||||
Bridge Warrants, Common Stock, Second and Third Closings | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 59,444 | 59,444 | ||||
Warrant liability | $ 2.2 |
BRIDGE FINANCING AND PRIMARY _4
BRIDGE FINANCING AND PRIMARY FINANCING - Exchange Warrants (Details) - Exchange Warrants, American Depositary Shares - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Class of Warrant or Right [Line Items] | ||
Warrants, number of securities called by warrants (in shares) | 99,074 | 99,074 |
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | $ 49.75 |
BRIDGE FINANCING AND PRIMARY _5
BRIDGE FINANCING AND PRIMARY FINANCING - Investor Warrants (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Jul. 14, 2022 | Mar. 13, 2022 | Oct. 28, 2021 | Mar. 24, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Aug. 09, 2022 | Aug. 02, 2022 | Apr. 02, 2022 | |
Class of Warrant or Right [Line Items] | ||||||||||||
Proceeds from sale of common stock, net | $ 11,504,000 | |||||||||||
Payment of stock issuance cost | 1,400,000 | |||||||||||
Net proceeds | 10,100,000 | $ 14,904,569 | $ 10,102,874 | |||||||||
Warrants, issued, period after purchase agreement closing | 136 days | |||||||||||
Investor warrants maturity term | 5 years | |||||||||||
Number of warrants outstanding | 399,999 | |||||||||||
Change in fair value of warrant liability | $ 491,000 | $ (146,808) | (77,237) | $ 4,522,844 | $ 12,784,329 | |||||||
Deemed Dividend on Warrant Modification | $ 65,266 | $ 65,266 | ||||||||||
Altium Agreement | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 0 | |||||||||||
Bridge Notes | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Aggregate purchase price | 12,000,000 | |||||||||||
Debt Instrument, Face Amount | $ 5,000,000 | $ 5,000,000 | ||||||||||
ADS | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants, number of securities called by warrants (in shares) | 342,100 | |||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 0 | $ 0 | $ 0 | |||||||||
Number of ADS received for a warrant | 1 | |||||||||||
Number of warrants outstanding | 143,028 | |||||||||||
Sale of equity securities, including conversion of "Bridge Notes" (in shares) | 3,360,000 | 342,100 | ||||||||||
ADS | Altium | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Number of warrants outstanding | 399,999 | |||||||||||
ADS | Altium Agreement | Altium | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 0 | |||||||||||
ADS | Bridge Notes | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Sale of equity securities, including conversion of "Bridge Notes" (in shares) | 29,388 | |||||||||||
Private Placement | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Aggregate purchase price | 17,000,000 | |||||||||||
Debt Instrument, Face Amount | 12,000,000 | |||||||||||
Proceeds from sale of common stock, net of accrued interest and legal fess | $ 393,611 | |||||||||||
Sale of common stock, including conversion of Bridge Notes | 342,100 | |||||||||||
Sale of common stock, including conversion of Bridge Notes, delivered | 66,702 | |||||||||||
Sale of common stock, including conversion of Bridge Notes, held in escrow | 275,398 | |||||||||||
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) | 342,100 | 342,100 | ||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | $ 49.75 | ||||||||||
Series B Warrants, American Depositary Shares | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants, number of securities called by warrants (in shares) | 342,100 | 342,100 | ||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 3.98 | |||||||||||
Series C Warrants, American Depositary Shares [Member] | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants, number of securities called by warrants (in shares) | 191,174 | 191,174 | ||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 3.98 | |||||||||||
Series A Warrants, American Depositary Shares, Series C Warrants Exercised in Full | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants, number of securities called by warrants (in shares) | 191,174 | |||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||||||||||
Investor warrants maturity term | 5 years | |||||||||||
Series B Warrants, American Depositary Shares, Series C Warrants Exercised in Full | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants, number of securities called by warrants (in shares) | 191,174 | |||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ 3.98 | |||||||||||
Investor warrants maturity term | 2 years |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair value on a recurring basis (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Assets and liabilities measured on a recurring basis | |||
Warrant liability | $ 373,599 | ||
Convertible notes payable | $ 1,213,313 | ||
Bridge warrants | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | 5,000,000 | ||
Recurring | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | $ 9,911,200 | 373,599 | |
Convertible notes payable | 1,213,333 | ||
Recurring | US Treasury Bills | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | 9,911,200 | ||
Recurring | 2020 Notes Warrants | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | 373,599 | ||
Recurring | Level 1 | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | 9,911,200 | ||
Recurring | Level 1 | US Treasury Bills | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | $ 9,911,200 | ||
Recurring | Level 3 | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | 373,599 | ||
Convertible notes payable | $ 1,213,333 | ||
Recurring | Level 3 | 2020 Notes Warrants | |||
Assets and liabilities measured on a recurring basis | |||
Warrant liability | $ 373,599 |
FAIR VALUE OF FINANCIAL INSTR_4
FAIR VALUE OF FINANCIAL INSTRUMENTS - Change in fair value (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Change in fair value | ||||
Convertible notes payable | $ 1,213,313 | |||
Warrant liability | $ 373,599 | |||
Movement of warrant liability | ||||
Warrant liability reclassified to additional paid in capital | $ 296,362 | 12,410,730 | ||
Bridge Financing Warrants | ||||
Movement of warrant liability | ||||
Beginning Balance | 0 | $ 0 | 0 | |
Warrant value at issuance (recorded as warrant liability expense) | 3,783,079 | |||
Change in Fair value of warrants | 8,627,651 | |||
Change in fair value of warrants | 8,627,651 | |||
Reclassification of warrant liability to an equity instrument | (12,410,730) | |||
Reclassification of warrant liability to an equity instrument | (12,410,730) | |||
Ending Balance | 0 | |||
2020 Notes Warrants | ||||
Movement of warrant liability | ||||
Beginning Balance | $ 373,599 | 373,599 | 0 | |
Warrant value at issuance (recorded as warrant liability expense) | 894,113 | |||
Change in Fair value of warrants | (520,514) | |||
Change in fair value of warrants | (77,237) | (520,514) | ||
Reclassification of warrant liability to an equity instrument | (296,362) | |||
Ending Balance | $ 373,599 | |||
Warrant liability reclassified to additional paid in capital | $ 296,362 |
STOCK BASED COMPENSATION (Detai
STOCK BASED COMPENSATION (Details) - $ / shares | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Apr. 12, 2022 | Mar. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
STOCK BASED COMPENSATION | |||||
Exercised (in dollars per share) | $ 11.21 | ||||
ADS | |||||
STOCK BASED COMPENSATION | |||||
Granted | 5,385,374 | ||||
Amended and Restated Equity Incentive Plan | |||||
STOCK BASED COMPENSATION | |||||
Percentage of ordinary shares reserved for issuance | 15% | ||||
Number of ordinary shares reserved for future issuance | 1,826,991,617 | 1,826,991,617 | |||
Number of shares acquired on exercise of options granted | 1,535,714,000 | ||||
Exercised (in dollars per share) | $ 17.50 | ||||
Number of shares available for issuance | 58,255 | ||||
Granted | 0 | ||||
Amended and Restated Equity Incentive Plan | Minimum | |||||
STOCK BASED COMPENSATION | |||||
Vesting period | 3 years | ||||
Amended and Restated Equity Incentive Plan | ADS | |||||
STOCK BASED COMPENSATION | |||||
Number of ordinary shares reserved for future issuance | 365,398 | 365,398 | |||
Exercised (in dollars per share) | $ 17.50 | ||||
Vesting period | 4 years | ||||
Granted | 307,142 | 307,142 |
STOCK BASED COMPENSATION - Opti
STOCK BASED COMPENSATION - Option activity (Details) - $ / shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Apr. 12, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Weighted Average Exercise Price | ||||
Balance at the beginning (in dollars per share) | $ 55.39 | |||
Granted (in dollars per share) | $ 11.21 | |||
Forfeited/Cancelled (in dollars per share) | $ 49.75 | |||
Balance at the end (in dollars per share) | $ 5.35 | $ 5.35 | ||
ADS | ||||
ADS Underlying Options | ||||
Outstanding at beginning (in shares) | 137,282 | |||
Granted (in shares) | 5,385,374 | |||
Forfeited/Cancelled (in shares) | (232,349) | |||
Outstanding at ending (in shares) | 3,368,820 | 3,368,820 | ||
Amended Plan | ||||
ADS Underlying Options | ||||
Granted (in shares) | 0 | |||
Weighted Average Exercise Price | ||||
Balance at the beginning (in dollars per share) | $ 636.74 | |||
Granted (in dollars per share) | 17.50 | |||
Forfeited/Cancelled (in dollars per share) | 792.05 | |||
Balance at the end (in dollars per share) | $ 19.56 | 19.56 | $ 636.74 | |
Exercisable options (in dollars per share) | $ 339.80 | $ 339.80 | ||
Weighted Average Contractual Terms | ||||
Contractual term (in years) | 9 years 6 months 10 days | 3 months 29 days | ||
Exercisable options (in years) | 29 days | |||
Amended Plan | ADS | ||||
ADS Underlying Options | ||||
Outstanding at beginning (in shares) | 5,744 | |||
Granted (in shares) | 307,142 | 307,142 | ||
Forfeited/Cancelled (in shares) | (3,772) | |||
Outstanding at ending (in shares) | 309,114 | 309,114 | 5,744 | |
Exercisable options (in shares) | 1,972 | 1,972 | ||
Weighted Average Exercise Price | ||||
Granted (in dollars per share) | $ 17.50 |
STOCK BASED COMPENSATION - Weig
STOCK BASED COMPENSATION - Weighted average assumptions (Details) | 9 Months Ended |
Sep. 30, 2022 $ / shares | |
STOCK BASED COMPENSATION | |
Expected volatility | 106% |
Risk-free interest rate | 2.70% |
Expected dividend yield | 0% |
Expected life of options in years | 6 years 10 months 24 days |
Exercise Price | $ 17.50 |
Fair value of ADS | 15.38 |
Estimated fair value of option | $ 12.92 |
STOCK BASED COMPENSATION - Stoc
STOCK BASED COMPENSATION - Stock based compensation expense (Details) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | |
Stock-Based Compensation Expense | ||
Intrinsic value of outstanding options | $ 0 | $ 0 |
Stock-based compensation expense | 267,000 | 497,000 |
Unrecognized stock compensation expense | 3,472,529 | $ 3,472,529 |
Unrecognized stock compensation expense expected to be recognized over the remaining weighted average service period | 3 years 3 months 25 days | |
Research and development | ||
Stock-Based Compensation Expense | ||
Stock-based compensation expense | 35,000 | $ 65,000 |
General and administrative | ||
Stock-Based Compensation Expense | ||
Stock-based compensation expense | $ 232,000 | $ 432,000 |
PREPAID EXPENSES (Details)
PREPAID EXPENSES (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
PREPAID EXPENSES | ||
Prepaid R&D costs | $ 414,061 | $ 329,033 |
Prepaid insurance | 74,017 | 684,191 |
Prepaid expense | 8,608 | 2,250 |
Total | $ 496,686 | $ 1,015,474 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
ACCRUED EXPENSES | |||
Research contract expenses | $ 381,862 | $ 193,537 | |
Payroll | 759,833 | 557,937 | |
Payroll taxes | 153,552 | 199,582 | $ 148,899 |
Investor Relation firm fees | 98,000 | 584,000 | 528,000 |
Professional fees | 115,451 | 144,377 | 173,095 |
Other Expenses | 61,222 | 5,976 | 5,802 |
Total | $ 1,569,920 | $ 1,685,409 | $ 960,848 |
IN-LICENSED TECHNOLOGY - Polyth
IN-LICENSED TECHNOLOGY - Polytherapeutics (Details) - Polytherapeutics - USD ($) | 9 Months Ended | 12 Months Ended | |
Mar. 24, 2018 | Sep. 30, 2022 | Dec. 31, 2021 | |
Asset acquisitions and in-licensed technology | |||
Purchase price agreement | $ 40,833 | ||
Royalty payments, net revenue (as a percent) | 4% | ||
Royalty payment period | 10 years | ||
Royalty payments with one generic product introduced, as a percent of net revenue | 2% | 4% | |
Royalty payments with two generic product introduced, as a percent of net revenue | 0% | 2% |
IN-LICENSED TECHNOLOGY - Skinvi
IN-LICENSED TECHNOLOGY - Skinvisible (Details) - Skinvisable - USD ($) | 1 Months Ended | ||||||||
Oct. 17, 2019 | Mar. 31, 2022 | Dec. 31, 2021 | Jul. 10, 2021 | Jun. 26, 2021 | Jan. 27, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | |
Asset acquisitions and in-licensed technology | |||||||||
Purchase price agreement | $ 1,000,000 | ||||||||
Regulatory approval milestones | $ 21,750,000 | ||||||||
Installment payments | $ 500,000 | $ 500,000 | |||||||
License acquisition liability | $ 250,000 | $ 875,000 | |||||||
Amount paid against consideration liability | $ 50,000 | ||||||||
Sales Milestone Tier One | |||||||||
Asset acquisitions and in-licensed technology | |||||||||
Sales milestones | 10,000,000 | ||||||||
Sales achievement | 100,000,000 | ||||||||
Sales Milestone Tier Two | |||||||||
Asset acquisitions and in-licensed technology | |||||||||
Sales milestones | 25,000,000 | ||||||||
Sales achievement | 250,000,000 | ||||||||
Sales Milestone Tier Three | |||||||||
Asset acquisitions and in-licensed technology | |||||||||
Sales milestones | 50,000,000 | ||||||||
Sales achievement | 400,000,000 | ||||||||
Amendment 3 | |||||||||
Asset acquisitions and in-licensed technology | |||||||||
Clinical milestone payment | 750,000 | ||||||||
Regulatory approval milestones | $ 5,000,000 | ||||||||
Amendment 5 | |||||||||
Asset acquisitions and in-licensed technology | |||||||||
First payment | $ 107,500 | ||||||||
Second payment | $ 250,000 | ||||||||
Third payment | $ 250,000 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Intangible assets | |||
Total cost | $ 1,040,433 | $ 1,040,433 | $ 1,040,433 |
Accumulated amortization | (309,861) | (231,829) | (127,785) |
Net book value | 730,572 | 808,604 | 912,648 |
Acquired technology - Polytherapeutics | |||
Intangible assets | |||
Total cost | 40,433 | 40,433 | 40,433 |
Technology license - Skinvisible | |||
Intangible assets | |||
Total cost | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 |
INTANGIBLE ASSETS - Additional
INTANGIBLE ASSETS - Additional information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
INTANGIBLE ASSETS | |||||||
Amortization of intangibles | $ 26,000 | $ 26,000 | $ 78,032 | $ 78,032 | $ 104,043 | $ 104,043 | $ 20,710 |
Expected amortization expense | |||||||
2022 | 26,000 | 26,000 | 104,000 | ||||
2023 | 104,000 | 104,000 | 104,000 | ||||
2024 | 104,000 | 104,000 | 104,000 | ||||
2025 | 104,000 | 104,000 | 104,000 | ||||
2026 | 104,000 | 104,000 | 104,000 | ||||
Thereafter | $ 288,000 | $ 288,000 | $ 288,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Oct. 28, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Related Party Transaction | ||||||||
Consulting fee | $ 100,000 | |||||||
Consulting expense | ||||||||
Related Party Transaction | ||||||||
Consulting expense from related party | $ 12,000 | $ 0 | $ 36,000 | $ 0 | $ 108,000 | |||
Officers and founders | ||||||||
Related Party Transaction | ||||||||
Payment of amounts due to officers | $ 304,466 | $ 50,000 | $ 0 | |||||
Monthly payment amounts due to related party | $ 25,000 |
RELATED PARTY TRANSACTIONS - Am
RELATED PARTY TRANSACTIONS - Amounts due to officers (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Amounts due to officers | |||
Due to officers | $ 4,273,733 | $ 4,723,732 | |
Less: Short-term portion | (600,000) | (600,000) | |
Long-term portion | 3,673,733 | 4,123,732 | |
Salaries and other compensation | |||
Amounts due to officers | |||
Due to officers | 4,108,500 | 4,108,500 | |
Invoices paid on behalf of the Company | |||
Amounts due to officers | |||
Due to officers | $ 165,233 | 615,232 | |
Officer [Member] | |||
Amounts due to officers | |||
Due to officers | 4,723,732 | $ 4,888,913 | |
Officer [Member] | Invoices paid on behalf of the Company | |||
Amounts due to officers | |||
Due to officers | 615,232 | 904,913 | |
Officer [Member] | Salaries and allowances | |||
Amounts due to officers | |||
Due to officers | $ 4,108,500 | $ 3,984,000 |
RESEARCH, CONSULTING AGREEMEN_2
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||
Jun. 30, 2022 USD ($) | Jul. 31, 2018 USD ($) | Mar. 31, 2022 USD ($) | Nov. 30, 2020 USD ($) | Jul. 31, 2018 USD ($) agreement | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) shares | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | May 31, 2022 USD ($) | Nov. 30, 2021 USD ($) | Feb. 28, 2021 USD ($) | |
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Accrued expenses | $ 1,569,920 | $ 1,569,920 | $ 1,685,409 | $ 960,848 | |||||||||||
Settlement of accrued expenses (In shares) | shares | 44,187 | ||||||||||||||
Research and development | 745,506 | $ 259,996 | $ 2,059,769 | $ 556,064 | 1,562,927 | 244,155 | $ 45,650 | ||||||||
Prepaid research and development costs | 414,061 | 414,061 | 329,033 | ||||||||||||
Gain on reduction in liability | 416,000 | ||||||||||||||
Other income | (702,002) | (101,357) | $ (208,765) | (6,564,120) | $ (15,399,738) | (425,354) | |||||||||
Percentage of share capital held in Escrow by Altshuler Shaham Trusts Ltd. | 40% | 40% | |||||||||||||
Research and consulting agreement | Polytherapeutics | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Monthly payments | $ 20,833 | ||||||||||||||
Total amount of agreement | $ 666,667 | ||||||||||||||
Research and consulting agreement | Axella Research LLC | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Total amount of agreement | $ 270,000 | $ 270,000 | |||||||||||||
Number of agreements | 3 | ||||||||||||||
Number of options to pay | 2 | 270,000 | |||||||||||||
Accrued expenses | $ 193,537 | 105,052 | 24,940 | ||||||||||||
Research and development | 0 | 0 | $ 0 | 0 | 247,000 | $ 50,000 | $ 25,000 | ||||||||
Option 1, equity payment (as a percent) | 0.50% | ||||||||||||||
Option 1, cash payment (as a percent) | 0.50% | ||||||||||||||
Option 2, cash payment discount (as a percent) | 20% | ||||||||||||||
Research and consulting agreement | Netherton Syndrome | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Research and development | 35,000 | 112,000 | |||||||||||||
Initial expenses | 25,000 | ||||||||||||||
Research and consulting agreement | Therapeutics Inc. | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Research and development | 423,000 | 88,000 | 904,000 | 232,000 | |||||||||||
Research and consulting agreement | Scleroderma | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Total amount of agreement | $ 610,000 | ||||||||||||||
Research and development | 138,000 | 138,000 | |||||||||||||
Prepaid research and development costs | 85,000 | 85,000 | |||||||||||||
Consulting agreements | Axella Research LLC | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Number of agreements | agreement | 3 | ||||||||||||||
Accrued expenses | 194,000 | ||||||||||||||
Consulting agreements | Netherton Syndrome | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Total amount of agreement | $ 250,000 | ||||||||||||||
Consulting agreements | Therapeutics Inc. | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Total amount of agreement | $ 4,400,000 | $ 3,500,000 | |||||||||||||
Research and development | 340,000 | ||||||||||||||
Initial term | 3 years | ||||||||||||||
Written termination notice period | 90 days | ||||||||||||||
Consulting agreements | Investor Relations firm | |||||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||||
Monthly payments | 14,000 | 14,000 | |||||||||||||
Accrued expenses | $ 584,000 | ||||||||||||||
Gain on reduction in liability | $ 98,000 | $ 168,000 | |||||||||||||
Other income | $ 416,000 | ||||||||||||||
Consulting fees | $ 42,000 | $ 42,000 | $ 70,000 | $ 42,000 |
SHAREHOLDERS' EQUITY (Details)
SHAREHOLDERS' EQUITY (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||
Aug. 09, 2022 USD ($) $ / shares shares | Oct. 28, 2021 | Mar. 05, 2018 shares | Sep. 30, 2022 Vote Y $ / shares shares | Jun. 30, 2022 shares | Sep. 30, 2022 Vote Y $ / shares shares | Dec. 31, 2021 Y Vote $ / shares shares | Nov. 03, 2022 $ / shares shares | Nov. 02, 2022 shares | Aug. 02, 2022 $ / shares | Aug. 01, 2022 shares | Apr. 12, 2022 $ / shares shares | Apr. 11, 2022 shares | Apr. 02, 2022 shares | Mar. 13, 2022 $ / shares | Dec. 31, 2020 $ / shares shares | |
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Ordinary shares, authorized | 50,000,000,000 | 50,000,000,000 | 12,000,000,000 | 12,000,000,000 | ||||||||||||
Ordinary shares, par value | $ / shares | $ 0 | $ 0 | $ 0 | $ 0 | ||||||||||||
Number of vote for each ordinary share | Vote | 1 | 1 | ||||||||||||||
Number of years of income that limits distribution | Y | 2 | 2 | ||||||||||||||
Maximum period between date of financial statements and distribution date | 6 months | |||||||||||||||
Threshold period for not to enter in to an agreement for variable rate transaction from the date of closing of the Offering | 180 days | |||||||||||||||
Threshold period for not to issue or proposed issuance of any ADSs or ordinary shares | 90 days | |||||||||||||||
ADS | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Number of ordinary shares for each ADS | 5,000 | |||||||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 3,360,000 | 342,100 | ||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 0 | $ 0 | $ 0 | |||||||||||||
Warrants, number of securities called by warrants (in shares) | 1 | |||||||||||||||
Offering | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 11,050,000,000 | |||||||||||||||
Offering | Pre-Funded Warrants | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 5,750,000,000 | |||||||||||||||
Offering | ADS | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Purchase price | $ / shares | $ 5 | |||||||||||||||
Offering | ADS | Pre-Funded Warrants | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Purchase price | $ / shares | $ 4.9999 | |||||||||||||||
Warrants, number of securities called by warrants (in shares) | 1,150,000 | |||||||||||||||
Gross proceeds from offering | $ | $ 16.8 | |||||||||||||||
Net proceeds from offering | $ | $ 14.9 | |||||||||||||||
Offering | ADS | Common Warrant | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 5 | |||||||||||||||
Subsequent Event | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Ordinary shares, authorized | 500,000,000,000 | 50,000,000,000 | 50,000,000,000 | 12,500,000,000 | ||||||||||||
Ordinary shares, par value | $ / shares | $ 0 | |||||||||||||||
Subsequent Event | ADS | Series B warrants | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 342,100 | |||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 49.75 | |||||||||||||||
Warrants, number of securities called by warrants (in shares) | 1 | |||||||||||||||
Quoin | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Ordinary shares, authorized | 10,000 | 12,000,000,000 | 50,000,000,000 | 12,500,000,000 | ||||||||||||
Ordinary shares, par value | $ / shares | $ 0 | |||||||||||||||
Number of vote for each ordinary share | Vote | 1 | |||||||||||||||
Number of years of income that limits distribution | Y | 2 | |||||||||||||||
Maximum period between date of financial statements and distribution date | 6 months | |||||||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 100 | |||||||||||||||
Number of founders | 2 | |||||||||||||||
Quoin | ADS | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Number of ordinary shares for each ADS | 5,000 | |||||||||||||||
Quoin | Offering | ADS | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 2,210,000 | |||||||||||||||
Quoin | Subsequent Event | ||||||||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||||||||
Ordinary shares, authorized | 500,000,000,000 | 50,000,000,000 | ||||||||||||||
Ordinary shares, par value | $ / shares | $ 0 |
SHAREHOLDERS' EQUITY - Warrants
SHAREHOLDERS' EQUITY - Warrants (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 $ / shares shares | |
Weighted Average Exercise Price Per Share | ||
Balance at the beginning (in dollars per share) | $ / shares | $ 55.39 | |
Granted (in dollars per share) | $ / shares | $ 11.21 | |
Terminated (in dollars per share) | $ / shares | $ 49.75 | |
Balance at the end (in dollars per share) | $ / shares | $ 5.35 | |
Intrinsic value of outstanding options | $ | $ 0 | |
ADS | ||
ADS Underlying Warrants | ||
Outstanding at beginning (in shares) | 137,282 | |
Granted (in shares) | 5,385,374 | |
Forfeited/Cancelled (in shares) | (232,349) | |
Exercised - Cashless and Pre Funded Warrants | (1,921,487) | |
Outstanding at ending (in shares) | 3,368,820 | |
Weighted Average Exercise Price Per Share | ||
Intrinsic value of outstanding options | $ | $ 0 |
CONTINGENCIES (Details)
CONTINGENCIES (Details) | 1 Months Ended |
Feb. 29, 2020 USD ($) | |
CONTINGENCIES | |
Possible damages sought | $ 666,667 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||
Dec. 31, 2021 agreement | Dec. 31, 2021 item | Nov. 30, 2021 agreement | Nov. 30, 2021 item | Sep. 30, 2022 USD ($) agreement | Dec. 31, 2021 USD ($) | |
LICENSE AGREEMENTS | ||||||
Number of license and supply agreements entered | 3 | 3 | 3 | 3 | 6 | |
Royalty revenues | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - $ / shares | Nov. 03, 2022 | Nov. 02, 2022 | Sep. 30, 2022 | Apr. 12, 2022 | Apr. 11, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
SUBSEQUENT EVENTS | |||||||
Ordinary shares, authorized | 50,000,000,000 | 12,000,000,000 | 12,000,000,000 | ||||
Ordinary shares, par value | $ 0 | $ 0 | $ 0 | ||||
Subsequent Event | |||||||
SUBSEQUENT EVENTS | |||||||
Ordinary shares, authorized | 500,000,000,000 | 50,000,000,000 | 50,000,000,000 | 12,500,000,000 | |||
Ordinary shares, par value | $ 0 |
Consolidated Balance Sheets_2
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash | $ 7,482,773 | $ 323,832 |
Prepaid expenses | 1,015,474 | |
Deferred offering costs | 141,338 | |
Total current assets | 8,498,247 | 465,170 |
Intangible assets, net | 808,604 | 912,648 |
Deferred loan costs | 50,000 | |
Other Assets | 50,000 | |
Total assets | 9,356,851 | 1,377,818 |
Current liabilities: | ||
Accounts payable | 923,239 | |
Accrued expenses | 1,685,409 | 960,848 |
Accrued license acquisition | 250,000 | 875,000 |
Accrued interest and amounts due under convertible notes payable | 743,840 | 47,041 |
Due to officers | 4,723,732 | 4,888,913 |
Convertible notes payable | 1,213,313 | |
Warrant liability | 373,599 | |
Total liabilities | 8,699,819 | 7,985,115 |
Commitments and contingencies | ||
Shareholders' equity (deficit): | ||
Treasury Stock, 2,641,693 ordinary shares, at cost | (2,932,000) | |
Additional paid in capital | 31,659,017 | 100 |
Accumulated deficit | (28,069,985) | (6,607,397) |
Total shareholders' equity | 657,032 | (6,607,297) |
Total liabilities and shareholders' equity | 9,356,851 | 1,377,818 |
ADS | ||
Shareholders' equity (deficit): | ||
Ordinary shares, no par value, 12,500,000,000 ordinary shares authorized - 3,354,650,799 and 1,201,460,800 (8,386,627 and 3,003,651 ADSs) ordinary shares issued and outstanding at December 31, 2021 and 2020, respectively | $ 0 | $ 0 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Parenthetical) - $ / shares | 12 Months Ended | |||||||||||
Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2021 | Jun. 30, 2022 | Mar. 31, 2022 | Oct. 29, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Ordinary shares, par value | $ 0 | $ 0 | $ 0 | $ 0 | ||||||||
Ordinary shares, shares authorized | 50,000,000,000 | 12,000,000,000 | 12,000,000,000 | 12,000,000,000 | ||||||||
Ordinary shares, shares issued | 24,233,024,799 | 3,354,650,799 | 3,354,650,799 | 1,201,460,800 | ||||||||
Ordinary shares, shares outstanding | 24,233,024,799 | 3,354,650,799 | 3,354,650,799 | 1,201,460,800 | ||||||||
Treasury Stock, ordinary shares | 2,641,693 | 2,641,693 | 2,641,693 | |||||||||
ADS | ||||||||||||
Ordinary shares, shares issued | 4,846,605 | 670,930 | 670,930 | 670,930 | ||||||||
Ordinary shares, shares outstanding | 4,846,605 | 670,930 | 670,930 | 1,013,031 | 670,931 | 670,930 | 240,292 | 240,292 | 240,292 | 240,292 | 240,292 | 240,292 |
Consolidated Statements of Op_2
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue | $ 0 | $ 0 | $ 0 |
Operating expenses | |||
General and administrative | 4,499,923 | 1,425,855 | 1,514,751 |
Research and development | 1,562,927 | 244,155 | 45,650 |
Total operating expenses | 6,062,850 | 1,670,010 | 1,560,401 |
Other expenses (income) | |||
Fair value adjustment to convertible notes payable | 1,250,000 | 378,333 | |
Warrant liability expense | 12,784,329 | ||
Financing expense | 275,000 | ||
Interest expense | 1,090,409 | 47,021 | |
Total other expense (income) | 15,399,738 | 425,354 | |
Net loss | $ (21,462,588) | $ (2,095,364) | $ (1,560,401) |
Loss per share | |||
Basic | $ (0.01) | $ (0.70) | $ (0.52) |
Fully-diluted | $ (0.01) | $ (0.70) | $ (0.52) |
Weighted average number of shares outstanding | |||
Basic | 1,579,006,444 | 1,201,460,800 | 1,201,460,800 |
Fully-diluted | 1,579,006,444 | 1,201,460,800 | 1,201,460,800 |
ADS | |||
Loss per share | |||
Basic | $ (67.96) | $ (8.72) | $ (6.49) |
Fully-diluted | $ (67.96) | $ (8.72) | $ (6.49) |
Weighted average number of shares outstanding | |||
Basic | 315,801 | 240,292 | 240,292 |
Fully-diluted | 315,801 | 240,292 | 240,292 |
Consolidated Statements of Sh_2
Consolidated Statements of Shareholders Equity (Deficit) - USD ($) | Common Stock | Treasury Stock | Additional Paid In Capital | Accumulated Deficit | ADS | Total |
Balance at beginning of year at Dec. 31, 2018 | $ 100 | $ (2,951,632) | $ (2,951,532) | |||
Balance at beginning of year (in shares) at Dec. 31, 2018 | 1,201,460,800 | 240,292 | ||||
Net loss | (1,560,401) | (1,560,401) | ||||
Balance at end of year at Dec. 31, 2019 | 100 | (4,512,033) | (4,511,933) | |||
Balance at ending of year (in shares) at Dec. 31, 2019 | 1,201,460,800 | 240,292 | ||||
Net loss | (2,095,364) | (2,095,364) | ||||
Balance at end of year at Dec. 31, 2020 | 100 | (6,607,397) | $ (6,607,297) | |||
Balance at ending of year (in shares) at Dec. 31, 2020 | 1,201,460,800 | 240,292 | 1,201,460,800 | |||
Net loss | (3,903,871) | $ (3,903,871) | ||||
Balance at end of year at Mar. 31, 2021 | 100 | (10,511,268) | (10,511,168) | |||
Balance at ending of year (in shares) at Mar. 31, 2021 | 1,201,460,800 | 240,292 | ||||
Balance at beginning of year at Dec. 31, 2020 | 100 | (6,607,397) | $ (6,607,297) | |||
Balance at beginning of year (in shares) at Dec. 31, 2020 | 1,201,460,800 | 240,292 | 1,201,460,800 | |||
Net loss | $ (9,645,550) | |||||
Balance at end of year at Sep. 30, 2021 | 100 | (16,252,947) | (16,252,847) | |||
Balance at ending of year (in shares) at Sep. 30, 2021 | 1,201,460,800 | 240,292 | ||||
Balance at beginning of year at Dec. 31, 2020 | 100 | (6,607,397) | $ (6,607,297) | |||
Balance at beginning of year (in shares) at Dec. 31, 2020 | 1,201,460,800 | 240,292 | 1,201,460,800 | |||
Net loss | (21,462,588) | $ (21,462,588) | ||||
Conversion of "2020 Notes" into ordinary shares | 1,213,313 | 1,213,313 | ||||
Conversion of "2020 Notes" into ordinary shares (in shares) | 25,913,600 | 5,183 | ||||
Sale of equity securities, including conversion of "Bridge Notes" | 17,000,000 | 17,000,000 | ||||
Sale of equity securities, including conversion of "Bridge Notes" (in shares) | 1,710,500,800 | 342,100 | ||||
Costs associated with sale of equity securities | (1,897,126) | (1,897,126) | ||||
Merger recapitalization of Cellect | $ (2,932,000) | 2,932,000 | ||||
Merger recapitalization of Cellect (in shares) | 416,775,599 | 83,355 | ||||
Reclassification of warrant liability upon issuance of Exchange warrant | 12,410,730 | 12,410,730 | ||||
Balance at end of year at Dec. 31, 2021 | (2,932,000) | 31,659,017 | (28,069,985) | $ 657,032 | ||
Balance at ending of year (in shares) at Dec. 31, 2021 | 3,354,650,799 | 670,930 | 3,354,650,799 | |||
Balance at beginning of year at Mar. 31, 2021 | 100 | (10,511,268) | $ (10,511,168) | |||
Balance at beginning of year (in shares) at Mar. 31, 2021 | 1,201,460,800 | 240,292 | ||||
Net loss | (4,337,543) | (4,337,543) | ||||
Balance at end of year at Jun. 30, 2021 | 100 | (14,848,811) | (14,848,711) | |||
Balance at ending of year (in shares) at Jun. 30, 2021 | 1,201,460,800 | 240,292 | ||||
Net loss | (1,404,136) | (1,404,136) | ||||
Balance at end of year at Sep. 30, 2021 | 100 | (16,252,947) | (16,252,847) | |||
Balance at ending of year (in shares) at Sep. 30, 2021 | 1,201,460,800 | 240,292 | ||||
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 | 3,354,650,799 | 670,930 | 3,354,650,799 | |||
Net loss | (1,682,802) | $ (1,682,802) | ||||
Reclassification of warrant liability upon issuance of Exchange warrant | 296,362 | 296,362 | ||||
Balance at end of year at Mar. 31, 2022 | (2,932,000) | 31,955,379 | (29,752,787) | (729,408) | ||
Balance at ending of year (in shares) at Mar. 31, 2022 | 3,354,653,999 | 670,931 | ||||
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 | 3,354,650,799 | 670,930 | 3,354,650,799 | |||
Net loss | $ (7,380,536) | |||||
Balance at end of year at Sep. 30, 2022 | (2,932,000) | 47,615,475 | (35,515,787) | $ 9,167,688 | ||
Balance at ending of year (in shares) at Sep. 30, 2022 | 24,233,024,799 | 4,846,605 | 24,233,024,799 | |||
Balance at beginning of year at Mar. 31, 2022 | (2,932,000) | 31,955,379 | (29,752,787) | $ (729,408) | ||
Balance at beginning of year (in shares) at Mar. 31, 2022 | 3,354,653,999 | 670,931 | ||||
Net loss | (2,668,167) | (2,668,167) | ||||
Balance at end of year at Jun. 30, 2022 | (2,932,000) | 32,184,820 | (32,420,954) | (3,168,134) | ||
Balance at ending of year (in shares) at Jun. 30, 2022 | 5,065,154,799 | 1,013,031 | ||||
Net loss | (3,029,567) | (3,029,567) | ||||
Sale of equity securities, including conversion of "Bridge Notes" | 14,904,569 | 14,904,569 | ||||
Sale of equity securities, including conversion of "Bridge Notes" (in shares) | 16,800,000,000 | 3,360,000 | ||||
Balance at end of year at Sep. 30, 2022 | $ (2,932,000) | $ 47,615,475 | $ (35,515,787) | $ 9,167,688 | ||
Balance at ending of year (in shares) at Sep. 30, 2022 | 24,233,024,799 | 4,846,605 | 24,233,024,799 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows provided by (used in) operating activities | |||
Net loss | $ (21,462,588) | $ (2,095,364) | $ (1,560,401) |
Fair value adjustment to convertible notes payable | 1,250,000 | 378,333 | |
Warrant liability expense | 12,784,329 | ||
Financing expense | 275,000 | ||
Amortization of intangibles | 104,043 | 104,043 | 20,710 |
Changes in assets and liabilities: | |||
Increase in accounts payable and accrued expenses | 1,347,801 | 227,313 | 240,833 |
Increase in accrued interest | 696,799 | 47,042 | |
Increase in prepaid expenses | (715,474) | ||
Net cash used in operating activities | (5,720,090) | (1,338,633) | (1,298,858) |
Cash flows used in investing activities | |||
Payment for license acquisition | (625,000) | (125,000) | |
Net cash used in investing activities | (625,000) | (125,000) | |
Cash flows provided by financing activities: | |||
Increase (decrease) in deferred offering costs | 141,338 | (141,338) | |
Increase in other assets | (50,000) | ||
Increase in due to officers | 139,285 | 1,068,823 | 1,298,818 |
Payments of amounts due to officers | (304,466) | (50,000) | |
Proceeds from issuance of "Bridge Notes", net | 3,475,000 | 909,980 | |
Proceeds from sale of equity securities, net | 10,102,874 | ||
Net cash provided by financing activities | 13,504,031 | 1,787,465 | 1,298,818 |
Net change in cash | 7,158,941 | 323,832 | (40) |
Cash - beginning of period | 323,832 | 40 | |
Cash - end of period | 7,482,773 | $ 323,832 | |
Supplemental information: | |||
License of acquisition payable | $ 1,000,000 | ||
Interest paid | 393,611 | ||
Exchange of "2020 Notes" for Ordinary shares | 1,213,313 | ||
Exchange of "Bridge Notes" for Ordinary shares | 5,000,000 | ||
Reclassification of warrant liability to equity upon issuance of "Exchange Warrants" | $ 12,410,730 |
ORGANIZATION, BUSINESS AND BASI
ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
ORGANIZATION AND BUSINESS | ||
ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION | NOTE 1 – ORGANIZATION AND BUSINESS Quoin Pharmaceuticals Ltd. (“Quoin Ltd.,” or the “Company”), formerly known as Cellect Biotechnology Ltd. (“Cellect”), is the holding company for Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin Inc.”). On October 28, 2021, Cellect completed the business combination with Quoin Inc., in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of March 24, 2021 (the “Merger Agreement”), by and among Cellect, Quoin Inc. and CellMSC, Inc., a Delaware corporation and wholly-owned subsidiary of Cellect (“Merger Sub”), pursuant to which Merger Sub merged with and into 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.” Because Quoin Inc. was the accounting acquirer, its historical financial statements became the Company’s historical financial statements and such assets and liabilities continued to be recorded at their historical carrying values. The impact of the recapitalization has been retroactively applied to all periods presented. Effective August 1, 2022, the ratio of American Depositary Shares (“ADSs”) evidencing ordinary shares changed from 1 ADS representing four hundred (400) ordinary shares to 1 ADS representing five thousand (5,000) ordinary shares, which resulted in a one for 12.5 reverse split of the issued and outstanding ADSs (the “Ratio Change”). All ADSs and related option and warrant information presented in these financial statements and accompanying footnotes has been retroactively adjusted to reflect the reduced number of ADSs resulting from the Ratio Change. Quoin Inc. was incorporated in Delaware on March 5, 2018. Quoin Inc. is a specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. The first lead product is QRX003, a once daily, topical lotion comprised of a broad-spectrum serine protease inhibitor, formulated with the proprietary Invisicare® technology, to treat Netherton Syndrome (NS). QRX003, is currently in clinical development in the United States under an open IND application with the U.S. Food and Drug Administration (“FDA”). The ongoing study is a randomized, double blinded assessment of two different doses of QRX003 versus a placebo vehicle in NS patients. The Company commenced opening of clinical sites in July 2022. In addition, the Company intends to pursue the clinical development of QRX003 in additional rare dermatological diseases, including Peeling Skin Syndrome, SAM Syndrome and Palmoplantar Keratoderma. To date, no products have been commercialized and revenue has not been generated. | NOTE 1 – ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION Quoin Pharmaceuticals Ltd. (“Quoin Ltd.”or the “Company”or”we,” “us,” “our”), formerly known as Cellect Biotechnology Ltd. (“Cellect”), is the holding company for Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin Inc.”). On October 28, 2021, Cellect completed the business combination with Quoin Inc., in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of March 24, 2021 (the “Merger Agreement”), by and among Cellect, Quoin Inc. and CellMSC, Inc., a Delaware corporation and wholly-owned subsidiary of Cellect (“Merger Sub”), pursuant to which Merger Sub merged with and into 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 has accounted for the transaction as a reverse recapitalization with Quoin Inc. as the accounting acquirer. Because Quoin Inc. is the accounting acquirer, its historical financial statements became the Company’s historical financial statements and such assets and liabilities continued to be recorded at their historical carrying values. The impact of the recapitalization has been retroactively applied to all periods presented. All equity related disclosures are presented in American Depositary Shares (“ADSs”), unless the context indicates otherwise. One ADS represents 5,000 ordinary shares of the Company. Quoin Inc. was incorporated in Delaware on March 5, 2018. Quoin Inc. is a specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. The first lead product is QRX003, a once daily, topical lotion comprised of a broad-spectrum serine protease inhibitor, formulated with the proprietary Invisicare® technology, to treat Netherton Syndrome (NS). In addition, the Company. intends to pursue the clinical development of QRX003 in additional rare dermatological diseases, including Peeling Skin Syndrome, SAM Syndrome and Palmoplantar Keratoderma. To date, no products have been commercialized and revenue has not been generated. The majority of the operating expenses since inception have been associated with completing due diligence on various technologies, asset technology acquisitions, negotiating and finalizing potential funding agreements, costs related to the Merger and building the pipeline of preclinical product candidates. The founders of Quoin Inc. funded all related expenditures through September 2020. On October 28, 2021, Cellect sold the entire share capital of its subsidiary, Cellect Biotherapeutics Ltd., which essentially included all of Cellect’s then existing net assets, to EnCellX Inc. (“EnCellX”), a newly formed U.S. privately held company based in San Diego, CA (the “Share Transfer”), pursuant to an Amended and Restated Share Transfer Agreement. Quoin Ltd. has no interests in EnCellX subsequent to the closing of the Merger. See Note 12. On October 28, 2021, the Company completed the private placement transaction with an investor (the Investor”) for an aggregate purchase price of approximately $17.0 million (comprised of the set off of approximately $5 million of senior secured notes issued in connection with the bridge loan that the Investor previously made to Quoin Inc. and approximately $12 million in cash from the Investor (the “Primary Financing”). See Note 5. Immediately after the closing of the Merger, there were approximately 670,930 ADSs issued and outstanding |
LIQUIDITY RISKS AND UNCERTAINTI
LIQUIDITY RISKS AND UNCERTAINTIES AND GOING CONCERN | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
LIQUIDITY RISKS AND OTHER UNCERTAINTIES | ||
LIQUIDITY RISKS AND 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 $35.5 million at September 30, 2022. The Company has historically funded its operations through debt and equity financings. On August 9, 2022, the Company completed an offering (the “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 an ordinary warrant, for aggregate gross proceeds of $16.8 million, resulting in net proceeds of approximately $14.9 million (see Note 14). As a result of the completion of the Offering, the Company believes that it has sufficient resources to effect its business plan for at least one year from the issuance of these unaudited condensed consolidated financial statements. Additional financing will still be required to complete the research and development of the Company’s therapeutic targets and its other operating requirements until it achieves commercial profitability, if ever. Such financing may not be available at acceptable terms, if at all. If the Company is unable to obtain additional funding when it becomes necessary, the development of its product candidates will be impacted and the Company would likely be forced to delay, reduce, or terminate some or all of its development programs, all of which could have a material adverse effect on the Company’s business, 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 single-source suppliers which include the supplier of the active pharmaceutical ingredient (API), as well as the contract manufacturer of the drug substance for the expected clinical development. Coronavirus (“COVID-19”) created a global pandemic, which commenced in 2020. The Company’s operations, to date, have not been dramatically affected by COVID-19. However, the extent of any future impact on the Company’s operational and financial performance will depend on the possibility of a resurgence and resulting severity with respect to the Company’s access to API and drug product for clinical testing, as well as the Company’s ability to safely and efficiently conduct planned clinical trials. Nasdaq Listing On April 22, 2022, the Company received a letter from the Listing Qualifications staff (the “Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying the Company that it is no longer in compliance with Nasdaq Listing Rule 5550(b)(1) requiring minimum stockholders’ equity of at least $2.5 million for continued listing on The Nasdaq Capital Market. Based on the Company’s Form 6-K, dated August 10, 2022, the Staff has determined that the Company complies with the minimum stockholder’s equity requirement, and the Company evidences continued compliance with these financial statements for the quarter ended September 30, 2022. On June 10, 2022, the Company received a letter from the Staff 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). Since then, the Staff has determined that the closing bid price of the Company’s ADSs has been at $1.00 per ADS or greater, and the Company has regained compliance with the minimum bid price requirement. There can be no assurance that the Company will be able to maintain compliance with Nasdaq’s minimum stockholders’ equity requirement or minimum bid-price requirement for continued listing. If the Company’s ADSs are delisted from Nasdaq, it will have material negative impacts on the actual and potential liquidity of the Company’s securities, as well as material negative impacts on the Company’s ability to raise future capital. | NOTE 2 - LIQUIDITY RISKS AND UNCERTAINTIES AND GOING CONCERN The Company has incurred net losses every year since inception and had an accumulated deficit of approximately $28.1 million at December 31, 2021. The Company funded its operations through the issuance of the 2020 Notes (as defined below) and the Bridge Financing (as defined below) prior to the Merger and the Primary Financing completed on October 28, 2021, whereby the Company received funding of approximately $12 million ($10.1 million after offering costs) at the closing of the Merger. The Company expected to receive additional funding through the mandatory exercise provision of the Series C Warrant issued to the Investor in March 2022 which would have resulted in proceeds of approximately $9.5 million. In the event the requirements of the mandatory exercise provision of such warrant were not met (see Note 5), the Company received a written commitment from the Investor to provide funding equal to the $9.5 million expected upon exercise of the Series C Warrant, at prevailing market rates. However, on July 14, 2022, the Company and Altium entered into an agreement, pursuant to which the parties agreed to, among other things, cancel the Series C Warrant and a portion of the Series A Warrant previously issued to Altium (see Note 17). Following the cancellation of the Series C Warrant on July 14, 2022, the Company no longer expects to receive such proceeds from Altium, and the Company does not have sufficient resources to implement its business plan for at least one year from the issuance of these consolidated financial statements. This raises substantial doubt about the Company’s ability to continue as a going concern. Additional financing will be required to complete the research and development of the Company’s therapeutic targets and its other operating requirements, which may not be available at acceptable terms, if at all. The Company has filed a registration statement on Form F-1 related to an offering of its securities on a “reasonable best efforts” basis, however there is no assurance of the successful consummation of such offering. The Company is also in the process of discussing a line of credit with a bank which has not yet been closed as of the financial statement filing date and is likely to be conditional on additional equity funding. If the Company is unable to obtain the 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. |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements of the Company as of September 30, 2022 and for the three and nine months then ended. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the operating results for the year or any other period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures as of December 31, 2021 and for the year then ended which are included in the Company’s Annual Report on Form 20- F, filed with the SEC on April 14, 2022, as updated in the Company’s Form 6-K furnished to the SEC on August 11, 2022. The Company operates in one segment. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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. Reclassification: Certain 2021 amounts were reclassified to conform to the current year presentation. The amount reclassified included the short term portion from long term portion due to officers. 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 balance sheets as of September 30, 2022. Investments: Investments as of September 30, 2022 consist of U.S. Treasury Bills, which are classified as trading securities, totaling $ 9.9 million. 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 mature within the subsequent six months from the date of purchase. As of September 30, 2022, 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 the Company considers that could trigger an impairment review include the following: ● Significant changes in the manner of the Company’s use of the acquired assets or the strategy for the Company’s overall business, ● Significant underperformance relative to expected historical or projected development milestones, ● Significant negative regulatory or economic trends, and ● Significant technological changes which could render the platform technology obsolete. The Company recognizes impairment when the sum of the expected undiscounted future cash flows is less than the carrying amount of the asset. Impairment losses, if any, are measured as the excess of the carrying amount of the asset over its estimated fair value. During the three and nine months ended September 30, 2022 and 2021, 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 expense in future periods as the related services are rendered. 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 to employees, non-employees and directors is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. The Company’s expected stock volatility is based on the historical data regarding the volatility of a publicly traded set of peer companies, since it has limited history of trading as a public company. The Company utilizes the simplified method to estimate the expected term. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The expected dividend yield was assumed to be zero as the Company has not paid and dividends since its inception and does not anticipate paying dividends in the foreseeable future. Fair value of financial instruments: The Company considers its cash, investments, accounts payable, and accrued expenses to meet the definition of financial instruments. The carrying amounts of the remaining 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 (“ASC Topic 820”). ASC Topic 820 defines fair value, establishes a framework and gives guidance regarding the methods used for measuring fair value, and expands disclosures about fair value measurements. Earnings (loss) per share: The Company reports loss per share in accordance with ASC 260-10, Earnings Per Share, which provides for calculation of “basic” and “diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss available to common shareholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per share gives effect to ordinary shares equivalents; however, potential common shares are excluded if their effect is anti-dilutive. For the three and nine months ended September 30, 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding options and warrants to purchase 309,114 ADSs and 3,368,820 ADSs, respectively. For the three and nine months ended September 30, 2021, the 5,183 ADS’s issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the 40,247 ADSs issuable upon conversion of the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. | 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, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. 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 selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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: 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 U.S. Food and Drug Administration (“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 single-source suppliers which include the supplier of the active pharmaceutical ingredient (API) as well as the contract manufacturer of the drug substance for the expected clinical development. A novel strain of coronavirus (“COVID-19”) created a global pandemic, which commenced in 2020. The Company’s operations, to date, have not been dramatically affected by COVID-19. However, the extent of any future impact on the Company’s operational and financial performance will depend on the possibility of a resurgence and resulting severity of COVID-19 with respect to the Company’s access to API and drug substance, the potential disruption in global freight networks, as well as our ability to safely and efficiently conduct planned clinical trials. 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. 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 years ended December 31, 2021, 2020 and 2019, there were no impairment indicators which required an impairment loss measurement. Deferred Offering Costs: Deferred offering costs are expenses directly related to the Primary Financing. These costs consisted of legal, accounting, printing, and filing fees that the Company capitalized which were offset against the proceeds upon completion of the Primary Financing. 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 expense 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, 2021 and 2020, 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. Fair value of financial instruments: The Company considers its cash, accounts payable, accrued expenses and the convertible and bridge notes payable to meet the definition of financial instruments. The convertible and bridge notes payable are recorded at fair value, see Notes 4, 5 and 6. The warrants are recorded at fair value, see Notes 4, 5 and 6. The carrying amounts of the remaining 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, 2021, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 143,028 ADS or 715,137,600 Ordinary Shares and warrants to purchase 1,257,722 ADS or 6,288,605,600 Ordinary Shares issuable pursuant to Primary Financing. For the year ended December 31, 2020, the number of shares issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. New accounting pronouncements: The Company has evaluated all recent accounting pronouncements and believes that none of them will have a material effect on the Company’s financial position, results of operations or cash flows except as discussed below. Debt with Conversion and Other Options and Derivatives and Hedging The FASB recently issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity Earnings Per Share Earnings Per Share In May 2021, the FASB issued ASU 2021-04, Earnings Per Share Compensation-Stock Compensation Derivatives and Hedging-Contracts in Entity’s Own Equity Recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. |
CONVERTIBLE NOTES PAYABLE
CONVERTIBLE NOTES PAYABLE | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
CONVERTIBLE NOTES AND WARRANTS | ||
CONVERTIBLE NOTES PAYABLE | NOTE 4 – CONVERTIBLE NOTES AND WARRANTS On October 2, 2020, Quoin Inc. commenced an offering of promissory notes (the “2020 Notes” or “Convertible Notes Payable”) and warrants. Based upon the terms agreed to in March 2021 in the Primary Financing (see Note 5), the 2020 Notes were mandatorily convertible into 5,183 ADSs in the Primary Financing, subject to adjustment. The holders of the 2020 Notes (the “2020 Noteholders”) also received warrants exercisable at any time after the issuance date for 29,388 ADSs at an initial exercise price of $49.75 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 an Exchange Warrant as 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 three and nine months ended September 30, 2022. The ADSs issued to the 2020 Noteholders did not account for accrued interest which was estimated to be approximately $744,000 at December 31, 2021, and included in accrued interest and financing expense in the accompanying consolidated balance sheet. Approximately $312,000 was paid to two of the five 2020 Noteholders during the nine months ended September 30, 2022. Based on the terms of the cash settlement with these two 2020 Noteholders, the Company’s estimate of the liability to the remaining three 2020 Noteholders was increased to $1,146,000 as of September 30, 2022. The Company expects to settle the remaining liability in 2022 or early 2023. | NOTE 4 – CONVERTIBLE NOTES PAYABLE On October 2, 2020, Quoin Inc. commenced an offering of promissory notes (the “2020 Notes” or “Convertible Notes Payable”) and warrants. The 2020 Notes were issued at a 25% original issue discount and bear interest at a rate of 20% per annum. The 2020 Notes are due one year from their respective dates of issuance. In October through December 2020, Quoin Inc. received an aggregate of approximately $910,000 pursuant to this offering, resulting in the issuance of 2020 Notes with an aggregate face value of $1,213,313 and an original issue discount of $303,333. Approximately 23% of such financing was received from parties who are related to or affiliated with members of Quoin Inc.’s board of directors. No additional funding from the 2020 Notes was received in the year ended December 31, 2021. Based upon the terms agreed to in March 2021 in the Primary Financing (see Note 5), the 2020 Notes were mandatorily convertible into 5,183 ADSs in the Primary Financing, subject to adjustment. The Company elected to account for the Convertible Notes Payable using the fair value model due to the short maturity and likely conversion at the date of the Merger. The fair value of the Convertible Notes Payable was estimated to be approximately $1.2 million at the date of issuance, resulting in a $378,000 expense recognized in the fourth quarter of 2020. There was no material change in the fair value from issuance until the conversion to equity on the Merger date. The noteholders also were entitled to receive warrants exercisable at any time after the issuance date for a number of shares of Quoin Inc.’s common stock that equates to 100% of the “as if converted” shares as if the 2020 Notes principal and interest were convertible at the lowest price any securities are sold, convertible, or exercisable into in the Primary Financing or the next round of financing (whichever is lower). The exercise price was based on a valuation equal to the next financing round and since the number of shares issuable upon the exercise of the warrants and exercise price were not knowable at the time of the financing and as of December 31, 2020 they were not recognized. After entering into the Merger Agreement in March 2021, the terms of the warrants became measurable and were exercisable for 29,388 ADSs at an initial exercise price of $49.75 per ADS. The Company determined that these warrants met the criteria to be recorded as a liability instrument. Each holder agreed to exchange its warrant for warrants on substantially the same terms as the Investor Exchange Warrants (See Note 5) with the same number of shares issuable upon the exercise of an Exchange Warrant as upon the exercise of the original warrant and the same exercise price as under the original warrant and have a contractual term of 5 years At the closing of the Merger, 5,183 ADSs were issued upon the conversion of the principle of the Convertible Notes Payable. In addition, effective as of March 13, 2022, the Company exchanged noteholders’ warrants for warrants on substantially the same terms as the Investor Exchange Warrants (See Note 5), exercisable for 29,388 ADSs, in the aggregate, at the exercise price of $49.75 per ADS. The Exchange Warrants have been determined to warrant equity classification and, as such, the fair value change through the exchange date will be included in warrant liability expense in the accompanying statement of operations. In December 2021, the Company concluded that the calculation of ADSs due to the 2020 Noteholders did not account for accrued interest due when the ADSs were issued. The Company reached cash settlements with, and plans to issue additional ADSs to, the 2020 Noteholders to account for this. The estimated amount required to settle these obligations was determined to be approximately $744,000 at December 31, 2021 and is included in accrued liabilities in the accompanying consolidated balance sheet and in interest expense in the accompanying consolidated statement of operations. Interest expense, at the stated interest rate, recognized in the year ended December 31, 2021, 2020 and 2019 was approximately $202,000, $47,000, and $0, respectively. Accrued interest and estimated settlement costs at December 31, 2021, 2020 and 2019 was approximately $744,000, $47,000, and $0, respectively, of which $697,000 was recognized in the year ended December 31, 2021. |
BRIDGE FINANCING AND SECURITIES
BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
BRIDGE FINANCING AND PRIMARY FINANCING | ||
BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) | NOTE 5 – BRIDGE FINANCING AND PRIMARY FINANCING Bridge Financing In connection with the Merger Agreement and the Securities Purchase Agreement (described below), Quoin Inc. entered into a “Bridge Purchase Agreement” on March 24, 2021 with the Investor, pursuant to which the Investor agreed to purchase notes (the “Bridge Notes”) in the aggregate principal amount of up to $5,000,000 in exchange for an aggregate purchase price of up to $3,800,000 together with warrants. The Bridge Notes were purchased in three closings: (i) the first purchase of $2,000,000 on March 25, 2021 (proceeds of $1,500,000); (ii) the second purchase of $1,700,000 in April 2021 (proceeds of $1,250,000); and (iii) a third purchase of $1,300,000 in May 2021 (proceeds of $1,000,000). The Bridge Notes were issued with a 25% original issue discount, at an interest rate of 15% per annum and had a maturity date of the earliest to occur of: (i) December 25, 2021, (ii) the date on which Quoin Inc.’s equity is registered under the Exchange Act or is exchanged for equity so registered or (iii) immediately prior to the closing of the Merger. The Investor and Quoin Inc. agreed that if the Primary Financing is consummated, the Investor may, at its election, offset the purchase price related to the Primary Financing, by an amount equal to the outstanding amount under this Bridge Note, and, upon such set-off, the portion of this Bridge Note shall be deemed to have been paid in its entirety and all obligations thereunder shall be deemed to be fully satisfied. The Bridge Notes were offset against the purchase price under the Securities Purchase Agreement related to the Primary Financing and converted into 100,618 ADSs upon the closing of the Primary Financing in October 2021. Interest expense, at the stated interest rate, recognized in the three and nine months ended September 30, 2022 and 2021 was $0 and $187,000 and $0 and $334,000, respectively. Bridge Warrants Upon the funding of each Bridge Note tranches described above, the Investor received warrants (the “Bridge Warrants”) to purchase a number of shares of Quoin Inc.’s common stock equal to the aggregate principal amount of the Bridge Notes. The Bridge Warrants had a term of five years from the date all of the shares underlying the Bridge Warrants are freely tradable. Quoin Inc. issued a total of 99,074 Bridge Warrants in the year ended December 31, 2021. Following the closing date of the Merger, on each of the tenth trading day, the forty-fifth day, the ninetieth day, and the one hundred thirty-fifth day thereafter (each, a “Reset Date”), if the initial exercise price of the Bridge Warrants is greater than the arithmetic average of 85% of the three lowest weighted average prices of the post-Merger ordinary shares of the combined company during the ten trading day period immediately preceding the applicable Reset Date (the “Reset Price”), the exercise price of the Bridge Warrants will be reset to the Reset Price. Furthermore, the number of shares underlying Bridge Warrants will be adjusted such that the aggregate number of shares of common stock of Quoin Inc. issuable to the Investor reflects the Reset Price instead of the initial exercise price. Adjustments to the exercise price and number of warrant shares are available to the Investor until the second anniversary of the Registration Date, as defined in the Bridge Warrants. Upon the occurrence of a Fundamental transaction, as defined in the Bridge Warrants, the warrant holder has the right to elect a cash settlement for the value of the warrant based on the Black Scholes options pricing model. The Company determined that the warrants met the criteria to be recorded as a liability instrument through the exchange date on the closing of the Primary Financing. The fair value of warrants was determined by a MonteCarlo simulation model to be approximately $1.6 million at the date of issuance of the 39,630 warrants in connection with the first closing and $2.2 million at the date of issuance of the 59,444 warrants in connection with the second and third closing of the Bridge Notes. Upon the closing of the Primary Financing, the Bridge Warrants were exchanged for warrants to purchase 99,074 ADSs at a fixed per share exercise price of $49.75 (“Investor Exchange Warrants”), as amended, which replaced the reset provisions and modified the fundamental transaction requirements of the Bridge 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. Primary Financing 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 of 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 issued 342,100 ADSs to the Investor. Quoin Ltd. also was required to issue to the Investor, effective as of March 13, 2022, the 136th day following the consummation of the Merger (i) Series A Warrant to purchase 342,100 ADSs (the “Series A Warrant”) (ii) Series B Warrant to purchase 342,100 ADSs (the “Series B Warrant”) and (iii) Series C Warrant to purchase 191,174 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 is $49.75 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. On April 22, 2022, a registration statement for the resale of the shares underlying Investor Warrants was declared effective by the Securities and Exchange Commission. 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, which gives the Investor the sole option as elected by the Investor to receive 1.0 ADS for each warrant ADS underlying such warrant, resulting in the issuance of a total of 342,100 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 to $0.00 per ADS with respect to a total of 399,999 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 Offering (see Note 14) as the modification was done in contemplation of the 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 399,999 ADSs to Altium. The exercise price of the Noteholder Warrants was also reduced to $0.00 as of July 14, 2022 as a result of the Altium Agreement. The change in the exercise price of the Noteholder Warrants resulted in a deemed dividend of approximately $ 65,000 | NOTE 5 – BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) Bridge Financing In connection with the Merger Agreement and the Securities Purchase Agreement (described below), Quoin Inc. entered into a “Bridge Purchase Agreement” on March 24, 2021 with the Investor, pursuant to which the Investor agreed to purchase, and Quoin Inc. agreed to issue notes (the “Bridge Notes”) in the aggregate principal amount of up to $5.0 million in exchange for an aggregate purchase price of up to $3.8 million together with warrants. The Bridge Notes were purchased in three closings: (i) the first purchase of $2.0 million on March 25, 2021 (Quoin Inc. received proceeds of $1.5 million less fees of $90,000); (ii) the second purchase of $1.7 million in April 2021 (Quoin Inc. received proceeds of $1.25 million) ; and (iii) a third purchase of $1.3 million in May 2021 (Quoin Inc. received proceeds of $1.0 million less fees of $185,000). The Bridge Notes were secured by a lien on Quoin Inc.’s current and future assets, were senior to all other outstanding and future indebtedness of Quoin Inc. and included covenants limiting future indebtedness, among others. The Bridge Notes were issued with a 25% original issue discount, at an interest rate of 15% per annum and had a maturity date of the earliest to occur of: (i) December 25, 2021, (ii) the date on which Quoin Inc.’s equity is registered under the Exchange Act or is exchanged for equity so registered or (iii) immediately prior to the closing of the Merger The Investor and Quoin Inc. agreed that if the Primary Financing is consummated, the Investor may, at its election, offset the purchase price otherwise payable by Investor to Quoin Inc. pursuant to the Securities Purchase Agreement related to the Primary Financing, by an amount equal to the outstanding amount under this Bridge Note, and, upon such set-off, the portion of this Bridge Note shall be deemed to have been paid in its entirety and all obligations thereunder shall be deemed to be fully satisfied without any further obligations on, or liability to, Quoin Inc. The Company elected to account for the Bridge Notes using the fair value model due to the short maturity and likely conversion at the closing of the Merger. The cumulative fair value of the Bridge Notes was estimated to be approximately $5.0 million at the date of issuances, resulting in an increase in the fair value of approximately $1,250,000, which was recognized in the statement of operations for the year ended December 31, 2021. The fair value adjustments also included $275,000 of debt issuance costs which was also immediately recognized as a component of other expense. Management has estimated that the fair value had not significantly changed from issuance to the Merger date. See Note 6. The Bridge Notes were offset against the purchase price under the Securities Purchase Agreement related to the Primary Financing and converted into 100,618 ADSs (including shares held in escrow for the benefit of the Investor) upon the closing of the Primary Financing. The accrued interest amounting to $393,611 was paid in cash. Interest expense, at the stated interest rate, recognized in the year ended December 31, 2021 was $393,611. Warrants Upon the funding of each Bridge Note tranches described above, the Investor received warrants (the “Bridge Warrants”) to purchase a number of shares of Quoin Inc.’s common stock equal to the aggregate principal amount of the Bridge Notes. The Bridge Warrants have a term of five years from the date all of the shares underlying the Bridge Warrants are freely tradable. The Bridge Warrants also contain certain rights with regard to asset distributions and fundamental transactions. Quoin Inc. issued a total of 99,074 Bridge Warrants in the year ended December 31, 2021. Following the closing date of the Merger, on each of the tenth trading day, the forty-fifth day, the ninetieth day, and the one hundred thirty-fifth day thereafter (each, a “Reset Date”), if the initial exercise price of the Bridge Warrants is greater than the arithmetic average of 85% of the three lowest weighted average prices of the post-Merger ordinary shares of the combined company during the ten trading day period immediately preceding the applicable Reset Date (the “Reset Price”), the exercise price of the Bridge Warrants will be reset to the Reset Price. Furthermore, the number of shares underlying Bridge Warrants will be adjusted such that the aggregate number of shares of common stock issuable to the Investor reflects the Reset Price instead of the initial exercise price. Adjustments to the exercise price and number of warrant shares are available to the Investor until the second anniversary of the Registration Date, as defined in the Bridge Warrants. Upon the occurrence of a Fundamental transaction, as defined in the Bridge Warrants, the warrant holder has the right to elect a cash settlement for the value of the warrant base on the Black Scholes options pricing model. The Company determined that the warrants met the criteria to be recorded as a liability instrument through the exchange date upon the closing of the Primary Financing. The fair value of warrants was determined by a MonteCarlo simulation model to be approximately $1.6 million at the date of issuance of the 39,630 warrants in connection with the first closing and $2.2 million at the date of issuance of the 59,444 (post exchange ratio) in connection with the second and third closing of the Bridge Notes See Note 6. Upon the closing of the Primary Financing, the Bridge Warrants were exchanged for warrants to purchase 99,074 ADSs at a fixed per share exercise price of $49.75 (“Investor Exchange Warrants”), as amended, which replaced the reset provisions and modified the fundamental transaction requirements of the Bridge Warrants. The Investor Exchange Warrants and ordinary shares underlying the Investor Exchange Warrants were registered with the SEC on the Registration Statement on Form F-4. An amendment to the Investor Exchange Warrants was entered into in September 2021, which replaced the reset provisions with a fixed number of shares and exercise price. Primary Financing 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 (x) the set off of approximately $5 million of Bridge Notes, and (y) approximately $12 million in cash from the Investor) (the “Primary Financing”), and the Investor paid the Company approximately $11,504,000, which was net of $393,611 in accrued interest on the Bridge Notes. The Company incurred an additional approximate $1.4 million in costs associated with the Primary Financing, which resulted in the net proceeds of approximately $10.1 million. The Company issued 342,100 ADSs to the Investor, consisting of 66,702 delivered to the Investor on or after the Merger closing and 275,398 initially held in an escrow account for the benefit of the Investor as per the terms of the Securities Purchase Agreement. All such escrow shares were released to the Investor prior to December 31, 2021. Quoin Ltd. also was required to issue to the Investor, effective as of March 13, 2022, the 136th day following the consummation of the Merger (i) Series A Warrant to purchase 342,100 ADSs (the “Series A Warrant”) (ii) Series B Series C Series B |
FAIR VALUE OF FINANCIAL INSTR_5
FAIR VALUE OF FINANCIAL INSTRUMENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
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. 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 tables present the Company’s assets and liabilities that are measured at fair value on a recurring basis by fair value hierarchy at December 31, 2021 and September 30, 2022: December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants $ — $ — $ 373,599 $ 373,599 Total Warrant Liability $ — $ — $ 373,599 $ 373,599 September 30, 2022 Level 1 Level 2 Level 3 Total US Treasury Bills $ 9,911,200 $ — $ — $ 9,911,200 Total US Treasury Bills Asset $ 9,911,200 $ — $ — $ 9,911,200 The following shows the movement of the warrant liability balance during 2021 and the nine months ended September 30, 2022. Bridge Financing 2020 Note Warrants Warrants Beginning Balance January 1, 2021 $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending balance December 31, 2021 $ — $ 373,599 Change in fair value of warrants — (77,237) Reclassification of warrant liability to an equity instrument — (296,362) Ending balance September 30, 2022 $ — $ — The Investor Exchange Warrant issued to the Investor on the Merger date was determined to be an equity-classified instrument, and accordingly the warrant liability on such date of approximately $12.4 million was reclassified to additional paid in capital. The Exchange Warrants issued to the 2020 Noteholders effective as of March 13, 2022 were determined to be an equity-classified instrument, and accordingly the warrant liability on such date of $296,362 was reclassified to additional paid in capital on that date. | 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 significant estimates used in the determining the fair value of the 2020 Notes warrants (Note 4) were as follows: 12/31/2021 (1) 12/31/2020 Stock price $ 22.75 $ 49.75 Initial exercise price $ 49.75 $ 49.75 Contractual Term 5.0 5.0 Volatility 89.2 % 98 % Discount rate 1.26 % 0.81 % (1) The warrants issued during 2020 were not exchanged for fixed term warrants until 2022, therefore the existing warrants were still considered outstanding at December 31, 2021 and classified as a liability instrument. The significant estimates used in such calculation of the fair value of the warrants issued in connection with the Bridge Financing (Note 5) were as follows: Transaction Date Merger Date March - May 2021 10/28/2021 Stock price $ 49.75 (post exchange ratio) $ 11.64 (post exchange ratio) Initial exercise price $ 49.75 (post exchange ratio) $ 49.75 (post exchange ratio) Contractual Term 5.0 5.0 Volatility 92 % 89.2 % Discount rate 0.98 % 1.18 % 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, 2021 and 2020: December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants — — $ 373,599 $ 373,599 Total Warrant Liability — — $ 373,599 $ 373,599 December 31, 2020 Level 1 Level 2 Level 3 Total 2020 Notes payable $ — $ — $ 1,213,333 $ 1,213,333 Total Liabilities $ — — $ 1,213,333 $ 1,213,333 The fair value of the convertible notes payable issued in 2020 was determined to be $1,213,333, resulting in a charge to operations of $378,333 during 2020. The fair value adjustment from December 31, 2020 to their conversion to ADSs at the Merger date was not material. The initial fair value of the Bridge Notes issued in 2021 was determined to be approximately $5,000,000, resulting in a charge to operations of $1,250,000 during 2021. The fair value adjustment from the Bridge Notes issuances to their conversion to ADSs upon the Merger date was not significant. The Bridge Notes and 2020 Notes were converted into ADSs at the Merger date. See Notes 4 and 5. The following shows the movement of the warrant liability balance during 2021. Bridge Financing 2020 Notes Warrants Warrants Beginning Balance $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in Fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending Balance $ — $ 373,599 The change in fair value of the Bridge Note warrants are included in other expense in the accompanying consolidated financial statements from the issuance date to the Merger Date. The Exchange warrants issued to the Investor on the Merger date was determined to be an equity-classified instrument, and accordingly the warrant liability on such date of $12,410,730 was reclassified to additional paid in capital on that date. |
PREPAID EXPENSES_2
PREPAID EXPENSES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
PREPAID EXPENSES | ||
PREPAID EXPENSES | NOTE 8 – PREPAID EXPENSES Prepaid expenses are as follows: September 30, December 31, 2022 2021 Prepaid R&D costs $ 414,061 $ 329,033 Prepaid insurance 74,017 684,191 Prepaid expense 8,608 2,250 Total $ 496,686 $ 1,015,474 | NOTE 7 – PREPAID EXPENSES Prepaid expenses are as follows: December 31, 2021 2020 Prepaid R&D costs $ 329,033 $ — Prepaid insurance 684,191 — Prepaid other expenses 2,250 — Total $ 1,015,474 $ — |
ACCRUED EXPENSES_2
ACCRUED EXPENSES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
ACCRUED EXPENSES | ||
ACCRUED EXPENSES | NOTE 9 - ACCRUED EXPENSES Accrued expenses are as follows: September 30, December 31, 2022 2021 Research contract expenses (note 13) $ 381,862 $ 193,537 Payroll (note 12) 759,833 557,937 Payroll taxes (note 12) 153,552 199,582 Investor Relation firm fees (note 13) 98,000 584,000 Professional fees 115,451 144,377 Other Expenses 61,222 5,976 Total $ 1,569,920 $ 1,685,409 | NOTE 8 – ACCRUED EXPENSES Accrued expenses are as follows: December 31, 2021 2020 Professional fees $ 144,377 $ 173,095 Investor Relations fees 584,000 528,000 Payroll taxes 199,582 148,899 Payroll 557,937 — Research contract expenses 193,537 105,052 Other expenses 5,976 5,802 Total $ 1,685,409 $ 960,848 |
ASSET ACQUISITION AND IN-LICENS
ASSET ACQUISITION AND IN-LICENSED TECHNOLOGY | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
IN-LICENSED TECHNOLOGY | ||
ASSET ACQUISITION AND 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. The terms of any royalty payments to the Seller are 4.0% of the net revenue of royalty products, as defined in the Acquisition Agreement during the ten (10) year period commencing from the date of first sale of a royalty product. If a generic product is introduced by a third party to the market, during the royalty period, the royalty fees shall be reduced from 4% to 2%. If, during the royalty period, two or more generic products are introduced, the royalty fees shall be reduced from 2% to 0%. Quoin Inc. also entered into a research and consulting agreement which committed Quoin Inc. to pay the Seller for additional research and development consulting services (See Notes 13 and 15). Skinvisible: On October 17, 2019, Quoin Inc. entered into an exclusive license agreement with Skinvisible Inc. (“Skinvisible”), pursuant to which Skinvisible granted a license to use certain patented technology for the development of products for commercial sale in the orphan rare skin disease field, and for the use of a proprietary polymer deliver system technology. This technology is currently being used in the development of QRX003. In exchange for the license, Quoin Inc. agreed to pay Skinvisible $1,000,000, as well as development and sales milestone payments and a single digit royalty on all net sales, as defined. The development milestones originally required payments upon achieving development milestones for the first Rare Skin Disease drug product developed using the licensed technology and the first two Ketamine products, as defined. On January 27, 2021, Quoin Inc. and Skinvisible entered into an amendment which modified the clinical milestone payment requirements such that $750,000 would be payable to Skinvisible upon achievement of specified clinical milestones, and $21.75 million upon regulatory approval in the U.S. and EU respectively. The license fee was originally due in two equal installments of $500,000 payable no later than December 31, 2019 and June 30, 2020, which were not paid. The agreement was subsequently amended several times to extend the payment due dates. On June 21, 2021, the parties entered into the most recent amendment which modified the payment terms and eliminated the $750,000 clinical milestone payments, reduced the milestone payment upon regulatory approval of the product containing the Skinvisible technology in either the U.S. or E.U., whichever happens first to a total of $5,000,000. | NOTE 9 – ASSET ACQUISITION AND IN-LICENSED TECHNOLOGY Polytherapeutics On March 24, 2018, Quoin Inc. entered into a securities purchase agreement (the “Acquisition Agreement”), in which it agreed to acquire all of the equity interests in Polytherapeutics, Inc. (the “Seller” or “Polytherapeutics”) for $40,833 and future royalties provided Quoin Inc. commercializes products using the technology developed by the Seller. The terms of any royalty payments to the Seller are 4.0% of the net revenue of royalty products, as defined in the Acquisition Agreement, received by Quoin Inc. during the ten (10) year period commencing from the date of first sale of a royalty product. If a generic product is introduced by a third party to the market, during the royalty period, the royalty fees shall be reduced from 4% to 2%. If, during the royalty period, two or more generic products are introduced, the royalty fees shall be reduced from 2% to 0%. The Seller had the option to repurchase the intellectual property for $100,000 if there were no products in clinical development using such technology. Quoin Inc. also entered into a research and consulting agreement which commits Quoin Inc. to pay the Seller for additional research and development consulting services (See Notes 12 and 15). Skinvisible On October 17, 2019, Quoin Inc. entered into an exclusive license agreement with Skinvisible Inc. (“Skinvisible”), pursuant to which Skinvisible granted a license to use certain patented technology for the development of products for commercial sale in the orphan rare skin disease field, and for the use of a proprietary polymer deliver system technology. This technology is currently being used in the development of QRX003. In exchange for the license, Quoin Inc. agreed to pay Skinvisible $1,000,000, as well as development and sales milestone payments and a single digit royalty on all net sales, as defined. The development milestones originally required payments upon achieving development milestones for the first Rare Skin Disease drug product developed using the licensed technology and the first two Ketamine products, as defined. Payments were originally due upon successful completions of certain clinical milestones ($7.5 million) and obtaining US and EU regulatory approval ($15 million). The sales milestones required for every licensed product commercialized by Quoin Inc. are $10 million upon achievement of $100 million in sales being achieved in the annual period; $25 million upon achievement of $250 million in sales and $50 million upon the achievement of $400 million in sales in an annual period. On January 27, 2021, Quoin Inc. and Skinvisible entered into an amendment which modified the clinical milestone payment requirements such that $750,000 would be payable to Skinvisible upon achievement of specified clinical milestones, and $21.75 million upon regulatory approval in the U.S. and EU respectively. The agreement has a termination clause that is triggered if no product has commenced clinical testing 12 months after the date of the agreement or the latest subsequent amendment. On April 19, 2021, Quoin Inc. and Skinvisible entered into another amendment which established the development deadline as December 31, 2022. Should the Company not commence clinical testing as defined by the development deadline, the license agreement will terminate immediately except in certain circumstances as specified in the agreement. The license fee was originally due in two equal installments of $500,000 payable no later than December 31, 2019 and June 30, 2020, which were not paid. The agreement was subsequently amended for payment due on July 31, 2020. On July 31, 2020, the agreement was amended to further extend the payment until September 30, 2020. On September 30, 2020, the agreement was again amended, requiring payment of the license fee only when outside financing is received, as defined in the agreement. On June 21, 2021, the parties entered into an additional amendment which modified the payment terms and required a payment of $107,500 on June 26, 2021, a payment of $250,000 within 10 days of the Primary Financing, and the remaining $250,000 upon the earlier of approval of an Investigatory New Drug application by the FDA or December 31, 2021. This amendment also eliminated the $750,000 clinical milestone payments described above and reduced the milestone payment upon regulatory approval of the product containing the Skinvisible technology in either the U.S. or E.U., whichever happens first to a total of $5,000,000. At December 31, 2021 and December 31, 2020, the license acquisition liability due was $250,000 and $875,000 respectively. In March 2022, the Company paid $50,000 against this liability. The remaining license acquisition liability has not been paid in accordance with the terms but has not impaired the Company’s rights to the technology as the Company is in the process of renegotiating this payment with Skinvisible. |
INTANGIBLE ASSETS_2
INTANGIBLE ASSETS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
INTANGIBLE ASSETS | ||
INTANGIBLE ASSETS | NOTE 11 - INTANGIBLE ASSETS Intangible assets are as follows: September 30, December 31, 2022 2021 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (309,861) (231,829) Net book value $ 730,572 $ 808,604 The Company recorded amortization expense of approximately $78,000 for the nine months ended September 30, 2022 and 2021. The Company recorded amortization expense of approximately $26,000 for the three months ended September 30, 2022 and 2021. The annual amortization expense expected to be recorded for existing intangible assets for the years 2022 through 2026, and thereafter, is approximately $26,000, $104,000, $104,000, $104,000, $104,000, and $288,000, respectively. | NOTE 10 - INTANGIBLE ASSETS Intangible assets are as follows: December 31, 2021 2020 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (231,829) (127,785) Net book value $ 808,604 $ 912,648 The Company recorded amortization expense of approximately $104,000 $104,000 $21,000 is expected to be |
RELATED PARTY TRANSACTIONS_2
RELATED PARTY TRANSACTIONS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | ||
RELATED PARTY TRANSACTIONS | NOTE 12 - RELATED PARTY TRANSACTIONS Employment Agreements and Due to Officers/Founders: In March 2018, Quoin Inc. executed employment agreements with both of its officers who are also co-founders of Quoin Inc. The employment agreements for both officers/founders allow for a onetime expense that covers the salaries they would have otherwise been paid for efforts they undertook in the periods since inception. The salaries and benefits allowances provided for under the employment agreements began to accrue as the services were being provided by the officers/founders and are included in Due to Officers on the accompanying balance sheet. Since the Merger closing, the Company is approved to pay and has been repaying amounts due to officers/founders at a rate of $25,000 each per month. Amounts due to officers at September 30, 2022 and December 31, 2021 consisted of the following: September 30, December 31, 2022 2021 Salaries and other compensation $ 4,108,500 $ 4,108,500 Invoices paid on behalf of the Company 165,233 615,232 Total 4,273,733 4,723,732 Less: Short-term portion (600,000) (600,000) Long-term portion $ 3,673,733 $ 4,123,732 Expenses: Research and development expense to a related party, incurred in the three and nine months ended September 30, 2022 and 2021 was approximately $12,000 and $0 and $36,000 and $0, respectively. For the nine months ended September 30, 2021, the Company paid a consulting fee of $100,000 to a board member. | NOTE 11 – RELATED PARTY TRANSACTIONS Employment Agreements and Due to Officers/Founders In March 2018, Quoin Inc. executed employment agreements with both of its officers who are also co-founders of Quoin Inc. The employment agreements for both officers/founders allow for a onetime expense that covers the salaries they would have otherwise been paid for efforts they undertook in the periods since inception. The salaries and benefits allowances provided for under the employment agreements began to accrue as the services were being provided by the officers/founders and are included in Due to Officers on the accompanying balance sheet. Amounts due to the officers/founders consist of amounts specified in the employment agreements since inception through December 31, 2021 as well as reimbursable travel expenses and other amounts paid by them to third parties on behalf of Quoin Inc. The Company repaid $304,466, $50,000, and $0 of such amounts due to officers/founders in the year ended December 31, 2021, 2020 and 2019, respectively. Since the Merger closing, the Company has been repaying amounts due to officers/founders at a rate of $25,000 each per month (See Note 17). Amounts due to officers at December 31, 2021 and 2020 consisted of the following: December 31, 2021 2020 Salaries and allowances $ 4,108,500 $ 3,984,000 Invoices paid on behalf of the Company 615,232 904,913 Total $ 4,723,732 $ 4,888,913 During 2021, the Company incurred $108,000 of consulting expense from related parties, primarily from a related party company controlled by a member of the Board of Directors. See Note 4 for related party debt and Note 12 for employment agreements. |
RESEARCH, CONSULTING AGREEMEN_3
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | ||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | NOTE 13 – RESEARCH, CONSULTING AND OTHER COMMITMENTS Research and consulting agreement: Quoin Inc. entered into a research and consulting agreement which commits it to pay the former owner of Polytherapeutics (the “Consultant” or “Seller”) to transfer the technical know-how of Polytherapeutics with respect to (i) good manufacturing practices (“GMP”), clinical and commercial manufacturing of the Company’s PolyDur polymer and (ii) formulation development of products utilizing the Company’s PharmaDur polymer. The agreement required monthly consulting payments of $20,833 beginning on July 31, 2018 and ending February 28, 2021 (the “Post-Closing Period”) for a total of $666,667 over the consulting period. Pursuant to an amendment, the Post-Closing Period was revised to terminate on December 31, 2020. Through September 30, 2022 and the financial statement issuance date, the Company has not made any payments, the Consultant has not performed any services and the Company has not incurred or accrued for any expenses. See Note 15 for Consultant’s notification of breach of contract. Other research consulting agreements: 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 September 2022 the Company issued 44,187 ADS’s to one of Axella’s principals to settle the outstanding liability in full. The Company incurred no research and development expenses in connection with these agreements, for both of the three and nine months ended September 30, 2022 and 2021, as no services were provided. In November 2020, Quoin Inc. entered into a Master Service Agreement for an initial term of three years In November 2021, the Company entered into a commitment with Queensland University of Technology for research related services associated with Netherton Syndrome of approximately $250,000 for an expected period of eighteen months. For the three and nine months ended September 30, 2022, the Company incurred research and development costs related to this agreement of approximately $35,000 and $112,000, respectively. In May 2022, the Company entered into a commitment with Queensland University of Technology for research related services associated with Scleroderma of approximately $610,000 for an expected period of eighteen months. The Company incurred research and development expenses of approximately $138,000 for the three and nine months ended September 30, 2022. As of September 30, 2022, the Company recorded prepaid research and development costs related to this agreement of approximately $85,000. 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. As of September 30, 2022, the balance of this liability is $98,000. For the three and nine months ended September 30, 2021, the Company incurred expenses of $42,000 and $42,000, respectively. For the three and nine months ended September 30, 2022, the Company incurred expenses of $42,000 and $70,000, respectively. Performance milestones and royalties: See Note 10 for asset and in-licensed technology commitments. Merger agreement commitment: In consideration for the Share Transfer disclosed in Note 1, the pre-closing Cellect shareholders received a contingent value right (“CVR”) entitling the holders to earnouts during the Payment Period (as such term is defined in the Share Transfer Agreement), comprised mainly of payments upon sale, milestone payments, license fees and exit fees realized by EnCellX. In order to secure such right, shares constituting 40% of EnCellX share capital are held in escrow. In connection with the Share Transfer, Cellect entered into a CVR Agreement with Mr. Eyal Leibovitz, in the capacity of Representative for the holders of CVRs, and Computershare Trust Company, N.A., a federally chartered trust company (the “Rights Agent”). Under the terms of the CVR Agreement, the holders of the Cellect ADSs immediately prior to the Merger had the right to receive, through their ownership of CVRs, their pro-rata share of the net Share Transfer consideration, making such holders of CVRs the indirect beneficiaries of the net payments under the Share Transfer. CVRs were recorded in a register administered by the Rights Agent but were not certificated. Since the Company will not receive any net proceeds from the CVR’s, there is no asset or liability recorded in the consolidated financial statements. | NOTE 12 – RESEARCH, CONSULTING AGREEMENTS AND COMMITMENTS Research and consulting agreement Quoin Inc. entered into a research and consulting agreement (the “Research Agreement”) which commits it to pay the former owner of Polytherapeutics (the “Consultant” or “Seller”) to transfer the technical know-how of Polytherapeutics with respect to (i) good manufacturing practices (“GMP”), clinical and commercial manufacturing of the Company’s PolyDur polymer and (ii) formulation development of products utilizing the Company’s PharmaDur polymer (See Note 9). The agreement required monthly consulting payments of $20,833 beginning on July 31, 2018 and ending February 28, 2021 (the “Post-Closing Period”) for a total of $666,667 over the consulting period. Pursuant to an amendment, the Post-Closing Period was revised to terminate on December 31, 2020. Through December 31, 2021 and the financial statement issuance date, the Company has not made any payments, the Consultant has not performed any services and the Company has not incurred or accrued for any expenses. See Note 15 for Consultant’s notification of breach of contract. Other research consulting agreements 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 under the three agreements are met. Quoin Inc. has also engaged Axella for additional services pursuant to separate work orders. Further, Quoin Inc. has two options to pay the milestones due 1) one half one-half In November 2020, Quoin Inc. entered into a Master Service Agreement for an initial term of three years with Therapeutics Inc. for managing preclinical and clinical development for new products in the field of dermatology. The agreement required the execution of individual work orders. Quoin Inc. may terminate any work order for any reason with 90 days written notice subject to costs incurred through termination and a defined termination fee, unless there is a material breach by Therapeutics Inc. The first work order was entered into in late 2020 for a clinical study at an expected estimated cost of approximately $3.5 million and expected timing through the first quarter of 2023. For the year ended December 31, 2021, the Company incurred approximately $340,000 of research and development costs related to this agreement. In November 2021, the Company entered into a commitment for research related services associated with Netherton Syndrome of approximately $250,000 for an expected period of eighteen months, of which an initial $25,000 expense was incurred in 2021. Employment agreements The employment agreements entered into by Quoin Inc. with its two founders/officers provide for a combined base salary, including monthly allowances, of $996,000 per annum, a discretionary bonus and certain allowances and benefits. In the event of termination of the two founders/officers for reason other than cause, as defined in the employment agreements, the founders shall be entitled to two years of based salary and bonus. In November 2021, the Company appointed and entered into an employment agreement with its Chief Financial Officer which provides for a base salary of $360,000 per annum, a discretionary bonus and certain allowances and benefits. In November 2021, the Board of Directors of the Company approved amendments to the employment agreements increasing base level compensation by 10% for the two founders and increasing the annual target discretionary bonus to not less than 45% of base salary for the two founders and the Chief Financial Officer. Further a transaction bonus related to the closing of the Merger and private placements aggregating approximately $324,000 was paid to the two founders in November 2021. See Note 17 describing subsequent shareholder approval of the employment agreements of the two founders/officers. Performance milestones and Royalties See Note 9 for asset and in-licensed technology commitments. Merger agreement commitment In consideration for the Share Transfer disclosed in Note 1, the pre-closing Cellect shareholders received a contingent value right (“CVR”) entitling the holders to earnouts during the Payment Period (as such term is defined in the Share Transfer Agreement), comprised mainly of payments upon sale, milestone payments, license fees and exit fees realized by EnCellX. In order to secure such right, shares constituting 40% of EnCellX share capital are held in escrow by Altshuler Shaham Trusts Ltd. In connection with the Share Transfer, Cellect entered into a CVR Agreement with Mr. Eyal Leibovitz, in the capacity of Representative for the holders of CVRs, and Computershare Trust Company, N.A., a federally chartered trust company (the “Rights Agent”). Under the terms of the CVR Agreement, the holders of the Cellect ADSs immediately prior to the Merger had the right to receive, through their ownership of CVRs, their pro-rata share of the net Share Transfer consideration, making such holders of CVRs the indirect beneficiaries of the net payments under the Share Transfer. CVRs were recorded in a register administered by the Rights Agent but were not certificated. Since the Company will not receive any net proceeds from the CVR’s, there is no asset or liability recorded in the consolidated financial statements. |
SHAREHOLDERS' EQUITY AND SHARE
SHAREHOLDERS' EQUITY AND SHARE OWNERSHIP AND RIGHTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SHAREHOLDERS' EQUITY | ||
SHAREHOLDERS' EQUITY AND SHARE OWNERSHIP AND RIGHTS | NOTE 14 – SHAREHOLDERS’ EQUITY The Company held a Special General Meeting on February 28, 2022, at which the Company’s shareholders adopted the Amended and Restated Articles of Association of the Company. The Company held its Annual General Meeting on April 12, 2022, at which the Company’s shareholders approved an increase to the authorized share capital to 50,000,000,000 ordinary shares from 12,500,000,000, no par value. The Company held a further Annual General Meeting on November 3, 2022, at which the Company’s shareholders approved an increase to the authorized share capital to 500,000,000,000 ordinary shares from 50,000,000,000, no par value (see Note 17). These ordinary shares are not redeemable and do not have any preemptive rights. Holders of the Company’s ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders at a shareholders meeting. The board of directors shall determine and provide a record date for each shareholders meeting and all shareholders at such record date may vote. Unless stipulated differently in the Companies Law or in the articles of association, all shareholders’ resolutions shall be approved by a simple majority vote. Under Israeli law, the Company may declare and pay dividends only if, upon the determination of 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. The Bank of New York Mellon, as depositary, has registered and delivered American Depositary Shares, also referred to as ADSs. Following an ADS ratio adjustment effective August 1, 2022, each ADS represents five thousand (5,000) ordinary shares (or a right to receive five thousand (5,000) ordinary shares). Each ADS will also represent any other securities, cash or other property which may be held by the depositary. ADSs may be held either (a) directly (1) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs or (2) by having uncertificated ADSs, or (b) indirectly by holding a security entitlement in ADSs through a broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, also called DTC. On August 9, 2022 the Company completed an offering (the “Offering”) of 11,050,000,000 ordinary shares represented by 2,210,000 ADSs at a purchase price of $5.00 per ADS and pre-funded warrants (the “Pre-Funded Warrants”) to purchase 5,750,000,000 ordinary shares represented by 1,150,000 ADSs at a per pre-funded warrant price of $4.9999, with each ADS and Pre-Funded Warrant accompanied by an ordinary warrant (the “Common Warrant”), for aggregate gross proceeds of $16.8 million, resulting in net proceeds of approximately $14.9 million. Each Common Warrant has an exercise price of $5.00 per ADS and expires on the fifth anniversary of the Closing Date. On the Closing Date, the holder of Pre-Funded Warrants sold in the Offering exercised its Pre-Funded Warrants in full. In connection with the Offering, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors. The Purchase Agreement provided that for a period of 180 days following the closing of the Offering, the Company will not effect or enter into an agreement to effect a “variable rate transaction” as defined in the Purchase Agreement. Further, the Company has agreed in the Purchase Agreement not to issue, enter into any agreement to issue or announce the issuance or proposed issuance of any ADSs or ordinary shares or their equivalents, subject to certain exceptions, for a period of 90 days after the closing of the Offering. The Purchase Agreement also contained representations, warranties, indemnification and other provisions customary for transactions of this nature. Warrants The following table summarizes warrant activities during the year ended December 31, 2021 and the nine months ended September 30, 2022: Weighted ADSs Average Underlying Exercise Price Warrants Per Share Outstanding at December 31, 2021 137,282 $ 55.39 Granted 5,385,374 11.21 Terminated (232,349) 49.75 Exercised – Cashless and Pre Funded Warrants (1,921,487) — Outstanding and exercisable at September 30, 2022 3,368,820 $ 5.35 As of September 30, 2022, outstanding warrants expire in 2024 and 2027, and have an intrinsic value of $0. | NOTE 13 – SHAREHOLDERS’ EQUITY AND SHARE OWNERSHIP AND RIGHTS Quoin Inc. Quoin Inc.’s authorized capital stock consisted of 10,000 shares of common stock. On March 5, 2018, in connection with the incorporation as a Delaware corporation, Quoin Inc. issued 100 shares for a consideration of $100 split equally between the two founders and officers of Quoin Inc. In connection with the Merger transaction, the two founders exchanged their shares in Quoin Inc. for 240,292 ADSs in Quoin Ltd., which was subsequently reduced to 224,388 ADSs in May 2022 following the determination of the number of shares held in escrow allocated to certain former shareholders of Cellect. All share and per share amounts have been adjusted to reflect this recapitalization. Quoin Ltd. As of December 31, 2021, Quoin Ltd.’s authorized share capital consisted of 12,000,000,000 ordinary shares, no par value. These ordinary shares are not redeemable and do not have any preemptive rights. However, the Investor has certain approval rights in connection with the issuance of additional shares. Holders of our ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders at a shareholders meeting. Shareholders may vote at shareholders meetings either in person, by proxy or by written ballot. Israeli law does not allow public companies to adopt shareholder resolutions by means of written consent in lieu of a shareholders meeting. The board of directors shall determine and provide a record date for each shareholders meeting and all shareholders at such record date may vote. Unless stipulated differently in the Companies Law or in the articles of association, all shareholders’ resolutions shall be approved by a simple majority vote. Under Israeli law, the Company may declare and pay dividends only if, upon the determination of our board of directors, there is no reasonable concern that the distribution will prevent us 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 our existing and foreseeable obligations as they become due. The Bank of New York Mellon, as depositary, has registered and delivered American Depositary Shares, also referred to as ADSs. Post August 1, 2022 change in ADS ratio, each ADS represents (5,000) ordinary shares (or a right to receive five thousand (5,000) ordinary shares). Each ADS will also represent any other securities, cash or other property which may be held by the depositary. ADSs may be held either (a) directly (1) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs or (2) by having uncertificated ADSs, or (b) indirectly by holding a security entitlement in ADSs through a broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, also called DTC. Warrants and Options The following vested stock options and warrants were outstanding at December 31, 2021, exercisable into ADSs: ADSs Exercise Price Year of maturity Warrants held by 2020 noteholders 29,388 $ 49.75 2026 Warrants held by Investor 99,074 $ 49.75 2026 Options held by former Cellect optionholders 5,746 636.75 2022 Warrants held by former Cellect warrantholders 8,820 $ 137.50 2022-2024 Total 143,028 1) The options held by former Cellect optionholders fully vested at the closing of the Merger and expire between January and October 2022. The incremental fair value of the stock options at the closing of the Merger was not significant. The options were issued under the Cellect Ltd. Employee Shares Incentive Plan (the “2014 Plan”). The 2014 Plan was amended and restated and initial grants were made to Company officers and directors, approved at the Company Annual General Meeting held on April 12, 2022. See Note 17. The intrinsic value of the above stock options and warrants at December 31, 2021 was negligible. Effective as of March 13, 2022, the Company issued warrants to the Investor under the terms of the Primary Financing, exercisable into ADSs in the following aggregate amounts. See Note 17. ADSs Exercise Price Series A warrants (1) 533,274 $ 49.75 Series B warrants (1) 533,274 $ 49.75 Series C warrants (1) 191,174 $ 49.75 Total 1,257,722 (1) The Company expects to issue each of 191,174 additional Series A and Series B Warrants to the Investor upon exercise of the Series C Warrant, which are assumed to be exercised and, therefore, are included in the totals of the Series A and B warrants in the table above. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES | |
INCOME TAXES | NOTE 14 – INCOME TAXES The Company’s deferred tax assets relate primarily to its net operating loss carryforwards and other balance sheet basis differences. The Company maintains a valuation allowance to fully offset the gross deferred tax asset because it is not more likely than not that the Company will realize future benefits associated with these deferred tax assets at December 31, 2021 and 2020. The valuation allowance increased by approximately $2,178,000 and $515,000 for the years ended December 31, 2021 and 2020, respectively. Significant components of the Company’s deferred tax assets are as follows: December 31, 2021 2020 Deferred tax assets: Net operating losses carryforward $ 1,945,000 $ 355,000 Due to officers 1,411,000 1,467,000 Accrued expenses and other 212,000 44,000 R&D credit carryforward 102,000 — Debt related attributes 375,000 — Total deferred tax assets 4,045,000 1,866,000 Valuation allowance (4,045,000) (1,866,000) Deferred tax asset, net of valuation allowance $ — $ — At December 31, 2021 and 2020, the Company had U.S. federal and state income tax net operating loss (“NOL”) carryforward of approximately $6,482,000 and $1,180,000, respectively, that may be used to offset future taxable income. 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. At December 31, 2021, the Company had approximately $102,000 The income tax benefit for the years ended December 31, 2021 and 2020 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 fair value adjustments and other permanent items, which resulted in an effective tax rate of zero for both years. On March 27, 2020, the United States enacted the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”). The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, some of the more significant provisions which are expected to impact the Company’s financial statements include removal of certain limitations on utilization of net operating losses, increasing the loss carryback period for certain losses to five years, and increasing the ability to deduct interest expense, as well as amending certain provisions of the previously enacted Tax Cuts and Jobs Act. The Company has concluded that the CARES Act did not have a material impact on its financial position, results of operations, or cash flows. On December 27, 2020, the United States enacted the Consolidated Appropriations Act which extended many of the benefits of the CARES Act that were scheduled to expire. The Company evaluated the impact of the Consolidated Appropriations Act on its consolidated financial statements and related disclosures and concluded that the impact is immaterial. |
CONTINGENCIES_2
CONTINGENCIES | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
CONTINGENCIES | ||
CONTINGENCIES | NOTE 15 – 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. In February 2020, the Seller of the equity interests in Polytherapeutics and party to the Research Agreement communicated with Quoin Inc. threatening litigation for non-payment and related breach of contract and immediate payment of all monthly payments in the amount of $666,667. See Notes 10 and 13. The Consultant has not provided any services and has not complied with other technical requirements under the Research Agreement, and therefore is considered to be in breach of contract. The Company and the Consultant have had communications with respect to the duration, commencement date and payment of the consulting services, but a revised agreement has not been reached. No lawsuits have been filed as of the financial statement issuance date. Should a formal claim or lawsuit be filed, the Company believes it has meritorious defenses. | NOTE 15 - 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. In February 2020, the seller of the equity interests in Polytherapeutics and party to the Research Agreement communicated with Quoin Inc. threatening litigation for non-payment and related breach of contract and immediate payment of all monthly payments in the amount of $666,667. See Notes 9 and 12. The Consultant has not provided any services and has not complied with other technical requirements under the Research Agreement, and therefore is considered to be in breach of contract. The Company and the Consultant have had communications with respect to the duration, commencement date and payment of the consulting services, but a revised agreement has not been reached. No lawsuits have been filed as of the financial statement issuance date. Should a formal claim or lawsuit be filed, the Company believes it has meritorious defenses. |
LICENSE AGREEMENTS_2
LICENSE AGREEMENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
LICENSE AGREEMENTS | ||
LICENSE AGREEMENTS | NOTE 16 – LICENSE AGREEMENTS In November and December 2021, the Company entered into three license and supply agreements, whereby the Company is entitled to a royalty or other proceeds from the specified product revenues in select non-US markets from the licensee, if and when the underlying products are approved and commercialized. During nine months ended September 30, 2022, the Company entered into six license and supply agreements, whereby the Company will receive a royalty or other proceeds from the specified product revenues in select non-US markets from the licensor, if and when the underlying products are approved and commercialized. No royalty revenues have been received through September 30, 2022 under any of these agreements. | NOTE 16 – LICENSE AGREEMENTS In November and December 2021, the Company entered into three license and supply agreements, whereby the Company is entitled to a royalty or other proceeds from the specified product revenues in select non-US markets from the licensee, if and when the underlying products are approved and commercialized. No royalty revenues were received in 2021. |
SUBSEQUENT EVENTS_2
SUBSEQUENT EVENTS | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SUBSEQUENT EVENTS | ||
SUBSEQUENT EVENTS | NOTE 17 - SUBSEQUENT EVENTS On November 3, 2022, the Company held its Annual General Meeting of Shareholders, at which the Company’s shareholders approved an increase to the authorized share capital to 500,000,000,000 ordinary shares from 50,000,000,000, no par value. | NOTE 17 - SUBSEQUENT EVENTS In March 2022, the Company paid an aggregate of $311,670 to two out of five 2020 noteholders in settlement of the amounts included in accrued interest payable at the closing of the Merger. See Note 4. In the first quarter of 2022, the Company entered into four license and supply agreements, whereby the Company will receive a royalty or other proceeds from the specified product revenues in select non-US markets from the licensor, if and when the underlying products are approved and commercialized. Effective as of March 13, 2022, the Company issued warrants to purchase ADSs as follows: ● Exchanged the existing warrants of 2020 noteholders (Note 4) for warrants on substantially the same terms as the Investor Exchange Warrant (See Note 5), exercisable for 29,388 ADSs, in the aggregate, at the exercise price of $49.75 per ADS. The exercise price was reduced to $0.00 as of July 14, 2022 as a result of the Altium Agreement described below. ● Issued Series A Warrant, Series B Warrant and Series C Warrant to purchase 342,100 ADSs, 342,100 ADSs and 191,174 ADSs, respectively, at the exercise price of $49.75 per ADS, based on the terms of the Primary Financing. These warrants were amended as of July 14, 2022 under the Altium Agreement described below. The Company held a Special General Meeting on February 28, 2022, at which the Company’s shareholders adopted the Amended and Restated Articles of Association of the Company. Amended and Restated Equity Incentive Plan and Annual Meeting of Shareholders In March 2022, our board of directors 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 our outstanding ordinary shares on a fully-diluted basis, or 1,826,991,616 ordinary shares, represented by 365,398 ADSs as of March 31, 2022. The board of directors further approved the award of options to our officers and directors to purchase, in the aggregate, 316,571 ADSs under the Amended Plan, and annual discretionary bonuses for officers of $472,500 in aggregate. We held our Annual General Meeting on April 12, 2022, at which our shareholders approved, among other items, the following: ● The increase in authorized share capital from 12.5 billion to 50 billion ordinary shares. ● Modification of the annual compensation of the two founders to a combined base salary of $990,000 and to increase the annual discretionary bonus to not less than 45% of the annual base salary. ● Repayment of amounts due to the two founders at a rate of $25,000 each per month. ● The grant of an option to purchase up to 85,714 ADSs to each of the two founders under the Amended Plan, at an exercise price per ADS of $17.50 , to vest over a four-year period. ● The grant of an option to purchase 12,857 ADSs to each of the five non-employee director under the Amended Plan at an exercise price per ADS of $17.50 , to vest over a three-year period, and (as an annual grant for 2022) an option to an officer to purchase 71,429 ADSs at an exercise price per ADS of $17.50 , to vest over a four-year period. ADS Ratio Change On July 12, 2022, our Board of Directors approved the change in the ratio of ADS evidencing ordinary shares from 1 ADS representing four hundred (400) ordinary shares to 1 ADS representing five thousand (5,000) ordinary shares, which will result in a one for 12.5 reverse split of the issued and outstanding ADSs (the “Ratio Change”). The Ratio Change was effective August 1, 2022. All ADS and related option and warrant information presented in these financial statements and accompanying footnotes has been retroactively adjusted to reflect the reduced number of ADSs resulting from the Ratio Change. Nasdaq Listing On April 22, 2022, we received a letter from the Listing Qualifications staff of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that we are no longer in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Rule 5550(b)(1) requires listed companies to maintain stockholders’ equity of at least $2.5 million. In addition, as of April 21, 2022, we did not meet the alternative continued listing requirements based on market value of listed securities or net income from continuing operations. In accordance with Nasdaq Rule 5810(c)(2)(A), within 45 calendar days of receiving this notice, we submitted a plan to regain compliance to Nasdaq. This plan was accepted, and Nasdaq has granted us an extension until October 19, 2022 to evidence compliance. On June 10, 2022, we received a letter from The Nasdaq Listing Qualifications staff notifying us 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 we did not meet the minimum bid price requirements set forth in Nasdaq Rule 5550(a)(2). Pursuant to Nasdaq Rule 5810(c)(3)(A), we have a period of one hundred eighty (180) calendar days, or until December 7, 2022 (the “Compliance Period”), to regain compliance with Nasdaq’s minimum bid price requirement. If at any time during the Compliance Period, the closing bid price per ADS is at least $1.00 for a minimum of ten (10) consecutive business days, Nasdaq will provide us a written confirmation of compliance and the matter will be closed. In the event we do not regain compliance by December 7, 2022, we may be eligible for an additional 180 calendar day grace period. To qualify, we will be required to meet the continued listing requirement for market value of publicly held ADSs and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period. Although there is no assurance, we expect that the offering that is being registered on the registration statement on Form F-1, which includes these financial statements and accompanying notes, will enable us to regain compliance with Nasdaq’s minimum stockholders’ equity requirement and the Ratio Change will help us to regain compliance with the minimum bid-price requirement for continued listing on The Nasdaq Capital Market. Although Nasdaq notification letters described above have no immediate effect on our listing on The Nasdaq Capital Market, and we are working on implementing plans to regain compliance with Nasdaq listing standards, there can be no assurance that we will be able to regain compliance with Nasdaq’s minimum stockholders’ equity requirement or minimum bid-price requirement for continued listing. If our ADSs are delisted from Nasdaq, it will have material negative impacts on the actual and potential liquidity of our securities, as well as material negative impacts on our ability to raise future capital. Agreements with Altium Growth Fund, LP and Altium Warrant Exercises During the second quarter of 2022, Altium exercised the Series B Warrant in full pursuant to the alternate cashless exercise right of such warrant, under which Altium had an option to receive 1 ADS for each ADS underlying the warrant being exercised in such cashless exercise, resulting in the issuance of a total of 342,100 ADSs to Altium. On July 14, 2022, we, 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, among other things, reduce the exercise price to $0.00 per ADS with respect to a total of 399,999 ADSs, (ii) cancel the Series C Warrant and a 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. As of August 2, 2022, Altium exercised all of its warrants outstanding and we issued a total of 399,999 ADSs to Altium. The exercise price of the 2020 noteholder warrants was reduced to $0.00 as of July 14, 2022 as a result of the Altium Agreement described below. As of August 2, 2022, 23,040 noteholder warrants had been exercised. As a result of the Altium and noteholder warrant exercises and the Altium Agreement, the warrants outstanding as of August 2, 2022 are set out below, exercisable into ADS: Exercise Year of ADSs Price maturity Warrants held by 2020 noteholders 6,348 $ 0 2027 Warrants held by former Cellect warrant holders 8,820 $ 137.5 2024 Total 15,168 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Basis of Presentation | Basis of Presentation: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed consolidated financial statements of the Company as of September 30, 2022 and for the three and nine months then ended. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the operating results for the year or any other period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures as of December 31, 2021 and for the year then ended which are included in the Company’s Annual Report on Form 20- F, filed with the SEC on April 14, 2022, as updated in the Company’s Form 6-K furnished to the SEC on August 11, 2022. The Company operates in one segment. | 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, reflecting the operations of Quoin Inc. since inception and include the accounts of Quoin Ltd. since the date of the Merger. |
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 selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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. | 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 selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. In addition, other factors may affect estimates, 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: |
Other risks and uncertainties | 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 U.S. Food and Drug Administration (“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 single-source suppliers which include the supplier of the active pharmaceutical ingredient (API) as well as the contract manufacturer of the drug substance for the expected clinical development. A novel strain of coronavirus (“COVID-19”) created a global pandemic, which commenced in 2020. The Company’s operations, to date, have not been dramatically affected by COVID-19. However, the extent of any future impact on the Company’s operational and financial performance will depend on the possibility of a resurgence and resulting severity of COVID-19 with respect to the Company’s access to API and drug substance, the potential disruption in global freight networks, as well as our ability to safely and efficiently conduct planned clinical trials. | |
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. | 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. |
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 the Company considers that could trigger an impairment review include the following: ● Significant changes in the manner of the Company’s use of the acquired assets or the strategy for the Company’s overall business, ● Significant underperformance relative to expected historical or projected development milestones, ● Significant negative regulatory or economic trends, and ● Significant technological changes which could render the platform technology obsolete. The Company recognizes impairment when the sum of the expected undiscounted future cash flows is less than the carrying amount of the asset. Impairment losses, if any, are measured as the excess of the carrying amount of the asset over its estimated fair value. During the three and nine months ended September 30, 2022 and 2021, there were no impairment indicators which required an impairment loss measurement. | 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 years ended December 31, 2021, 2020 and 2019, there were no impairment indicators which required an impairment loss measurement. |
Deferred Offering Costs | Deferred Offering Costs: Deferred offering costs are expenses directly related to the Primary Financing. These costs consisted of legal, accounting, printing, and filing fees that the Company capitalized which were offset against the proceeds upon completion of the Primary Financing. | |
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 expense in future periods as the related services are rendered. | 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 expense 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, 2021 and 2020, 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. | |
Fair value of financial instruments | Fair value of financial instruments: The Company considers its cash, investments, accounts payable, and accrued expenses to meet the definition of financial instruments. The carrying amounts of the remaining 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 (“ASC Topic 820”). ASC Topic 820 defines fair value, establishes a framework and gives guidance regarding the methods used for measuring fair value, and expands disclosures about fair value measurements. | Fair value of financial instruments: The Company considers its cash, accounts payable, accrued expenses and the convertible and bridge notes payable to meet the definition of financial instruments. The convertible and bridge notes payable are recorded at fair value, see Notes 4, 5 and 6. The warrants are recorded at fair value, see Notes 4, 5 and 6. The carrying amounts of the remaining 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, which provides for calculation of “basic” and “diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss available to common shareholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per share gives effect to ordinary shares equivalents; however, potential common shares are excluded if their effect is anti-dilutive. For the three and nine months ended September 30, 2022, the number of shares excluded from the diluted net earnings (loss) per share included outstanding options and warrants to purchase 309,114 ADSs and 3,368,820 ADSs, respectively. For the three and nine months ended September 30, 2021, the 5,183 ADS’s issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the 40,247 ADSs issuable upon conversion of the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. | 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, 2021, the number of shares excluded from the diluted net earnings (loss) per share included outstanding warrants to purchase 143,028 ADS or 715,137,600 Ordinary Shares and warrants to purchase 1,257,722 ADS or 6,288,605,600 Ordinary Shares issuable pursuant to Primary Financing. For the year ended December 31, 2020, the number of shares issuable upon the conversion of both the Convertible Notes Payable (as defined below) and the Bridge Notes (as defined below) as well as the warrants issued in connection with both of these convertible instruments are not included in the denominator since their inclusion would be anti-dilutive. |
New accounting pronouncements | New accounting pronouncements: The Company has evaluated all recent accounting pronouncements and believes that none of them will have a material effect on the Company’s financial position, results of operations or cash flows except as discussed below. Debt with Conversion and Other Options and Derivatives and Hedging The FASB recently issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity Earnings Per Share Earnings Per Share In May 2021, the FASB issued ASU 2021-04, Earnings Per Share Compensation-Stock Compensation Derivatives and Hedging-Contracts in Entity’s Own Equity Recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. |
FAIR VALUE OF FINANCIAL INSTR_6
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Schedule of assets and liabilities measured at fair value on a recurring basis | December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants $ — $ — $ 373,599 $ 373,599 Total Warrant Liability $ — $ — $ 373,599 $ 373,599 September 30, 2022 Level 1 Level 2 Level 3 Total US Treasury Bills $ 9,911,200 $ — $ — $ 9,911,200 Total US Treasury Bills Asset $ 9,911,200 $ — $ — $ 9,911,200 | December 31, 2021 Level 1 Level 2 Level 3 Total 2020 Notes warrants — — $ 373,599 $ 373,599 Total Warrant Liability — — $ 373,599 $ 373,599 December 31, 2020 Level 1 Level 2 Level 3 Total 2020 Notes payable $ — $ — $ 1,213,333 $ 1,213,333 Total Liabilities $ — — $ 1,213,333 $ 1,213,333 |
Schedule of movement in warrant liability balance | Bridge Financing 2020 Note Warrants Warrants Beginning Balance January 1, 2021 $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending balance December 31, 2021 $ — $ 373,599 Change in fair value of warrants — (77,237) Reclassification of warrant liability to an equity instrument — (296,362) Ending balance September 30, 2022 $ — $ — | Bridge Financing 2020 Notes Warrants Warrants Beginning Balance $ — $ — Warrant value at issuance (recorded as warrant liability expense) 3,783,079 894,113 Change in Fair value of warrants 8,627,651 (520,514) Reclassification of warrant liability to an equity instrument (12,410,730) — Ending Balance $ — $ 373,599 |
2020 Notes Warrants | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Schedule of significant estimates used in the determining the fair value of warrants | 12/31/2021 (1) 12/31/2020 Stock price $ 22.75 $ 49.75 Initial exercise price $ 49.75 $ 49.75 Contractual Term 5.0 5.0 Volatility 89.2 % 98 % Discount rate 1.26 % 0.81 % (1) The warrants issued during 2020 were not exchanged for fixed term warrants until 2022, therefore the existing warrants were still considered outstanding at December 31, 2021 and classified as a liability instrument. | |
Bridge Financing Warrants | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Schedule of significant estimates used in the determining the fair value of warrants | Transaction Date Merger Date March - May 2021 10/28/2021 Stock price $ 49.75 (post exchange ratio) $ 11.64 (post exchange ratio) Initial exercise price $ 49.75 (post exchange ratio) $ 49.75 (post exchange ratio) Contractual Term 5.0 5.0 Volatility 92 % 89.2 % Discount rate 0.98 % 1.18 % |
PREPAID EXPENSES (Tables)_2
PREPAID EXPENSES (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
PREPAID EXPENSES | ||
Schedule of Prepaid expenses | September 30, December 31, 2022 2021 Prepaid R&D costs $ 414,061 $ 329,033 Prepaid insurance 74,017 684,191 Prepaid expense 8,608 2,250 Total $ 496,686 $ 1,015,474 | December 31, 2021 2020 Prepaid R&D costs $ 329,033 $ — Prepaid insurance 684,191 — Prepaid other expenses 2,250 — Total $ 1,015,474 $ — |
ACCRUED EXPENSES (Tables)_2
ACCRUED EXPENSES (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
ACCRUED EXPENSES | ||
Schedule of accrued expenses | September 30, December 31, 2022 2021 Research contract expenses (note 13) $ 381,862 $ 193,537 Payroll (note 12) 759,833 557,937 Payroll taxes (note 12) 153,552 199,582 Investor Relation firm fees (note 13) 98,000 584,000 Professional fees 115,451 144,377 Other Expenses 61,222 5,976 Total $ 1,569,920 $ 1,685,409 | December 31, 2021 2020 Professional fees $ 144,377 $ 173,095 Investor Relations fees 584,000 528,000 Payroll taxes 199,582 148,899 Payroll 557,937 — Research contract expenses 193,537 105,052 Other expenses 5,976 5,802 Total $ 1,685,409 $ 960,848 |
INTANGIBLE ASSETS (Tables)_2
INTANGIBLE ASSETS (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
INTANGIBLE ASSETS | ||
Schedule of intangible assets | September 30, December 31, 2022 2021 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (309,861) (231,829) Net book value $ 730,572 $ 808,604 | December 31, 2021 2020 Acquired technology – Polytherapeutics $ 40,433 $ 40,433 Technology license – Skinvisible 1,000,000 1,000,000 Total cost 1,040,433 1,040,433 Accumulated amortization (231,829) (127,785) Net book value $ 808,604 $ 912,648 |
RELATED PARTY TRANSACTIONS (T_2
RELATED PARTY TRANSACTIONS (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | ||
Amounts due to offices | September 30, December 31, 2022 2021 Salaries and other compensation $ 4,108,500 $ 4,108,500 Invoices paid on behalf of the Company 165,233 615,232 Total 4,273,733 4,723,732 Less: Short-term portion (600,000) (600,000) Long-term portion $ 3,673,733 $ 4,123,732 | December 31, 2021 2020 Salaries and allowances $ 4,108,500 $ 3,984,000 Invoices paid on behalf of the Company 615,232 904,913 Total $ 4,723,732 $ 4,888,913 |
SHAREHOLDERS' EQUITY AND SHAR_2
SHAREHOLDERS' EQUITY AND SHARE OWNERSHIP AND RIGHTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SHAREHOLDERS' EQUITY | |
Schedule of stock options and warrants outstanding | The following vested stock options and warrants were outstanding at December 31, 2021, exercisable into ADSs: ADSs Exercise Price Year of maturity Warrants held by 2020 noteholders 29,388 $ 49.75 2026 Warrants held by Investor 99,074 $ 49.75 2026 Options held by former Cellect optionholders 5,746 636.75 2022 Warrants held by former Cellect warrantholders 8,820 $ 137.50 2022-2024 Total 143,028 1) The options held by former Cellect optionholders fully vested at the closing of the Merger and expire between January and October 2022. The incremental fair value of the stock options at the closing of the Merger was not significant. The options were issued under the Cellect Ltd. Employee Shares Incentive Plan (the “2014 Plan”). The 2014 Plan was amended and restated and initial grants were made to Company officers and directors, approved at the Company Annual General Meeting held on April 12, 2022. See Note 17. ADSs Exercise Price Series A warrants (1) 533,274 $ 49.75 Series B warrants (1) 533,274 $ 49.75 Series C warrants (1) 191,174 $ 49.75 Total 1,257,722 (1) The Company expects to issue each of 191,174 additional Series A and Series B Warrants to the Investor upon exercise of the Series C Warrant, which are assumed to be exercised and, therefore, are included in the totals of the Series A and B warrants in the table above. Exercise Year of ADSs Price maturity Warrants held by 2020 noteholders 6,348 $ 0 2027 Warrants held by former Cellect warrant holders 8,820 $ 137.5 2024 Total 15,168 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INCOME TAXES | |
Schedule of deferred tax assets | December 31, 2021 2020 Deferred tax assets: Net operating losses carryforward $ 1,945,000 $ 355,000 Due to officers 1,411,000 1,467,000 Accrued expenses and other 212,000 44,000 R&D credit carryforward 102,000 — Debt related attributes 375,000 — Total deferred tax assets 4,045,000 1,866,000 Valuation allowance (4,045,000) (1,866,000) Deferred tax asset, net of valuation allowance $ — $ — |
SUBSEQUENT EVENTS (Tables)
SUBSEQUENT EVENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SUBSEQUENT EVENTS | |
Schedule of warrants outstanding | The following vested stock options and warrants were outstanding at December 31, 2021, exercisable into ADSs: ADSs Exercise Price Year of maturity Warrants held by 2020 noteholders 29,388 $ 49.75 2026 Warrants held by Investor 99,074 $ 49.75 2026 Options held by former Cellect optionholders 5,746 636.75 2022 Warrants held by former Cellect warrantholders 8,820 $ 137.50 2022-2024 Total 143,028 1) The options held by former Cellect optionholders fully vested at the closing of the Merger and expire between January and October 2022. The incremental fair value of the stock options at the closing of the Merger was not significant. The options were issued under the Cellect Ltd. Employee Shares Incentive Plan (the “2014 Plan”). The 2014 Plan was amended and restated and initial grants were made to Company officers and directors, approved at the Company Annual General Meeting held on April 12, 2022. See Note 17. ADSs Exercise Price Series A warrants (1) 533,274 $ 49.75 Series B warrants (1) 533,274 $ 49.75 Series C warrants (1) 191,174 $ 49.75 Total 1,257,722 (1) The Company expects to issue each of 191,174 additional Series A and Series B Warrants to the Investor upon exercise of the Series C Warrant, which are assumed to be exercised and, therefore, are included in the totals of the Series A and B warrants in the table above. Exercise Year of ADSs Price maturity Warrants held by 2020 noteholders 6,348 $ 0 2027 Warrants held by former Cellect warrant holders 8,820 $ 137.5 2024 Total 15,168 |
ORGANIZATION, BUSINESS AND BA_2
ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION (Details) - USD ($) | Aug. 01, 2022 | Oct. 29, 2021 | Oct. 28, 2021 | Sep. 30, 2022 | Aug. 09, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Mar. 24, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Sale of stock | |||||||||||||||
Ordinary shares, shares issued | 24,233,024,799 | 3,354,650,799 | 1,201,460,800 | ||||||||||||
Ordinary shares, shares outstanding | 24,233,024,799 | 3,354,650,799 | 1,201,460,800 | ||||||||||||
Shares owned (as a percent) | 12.50% | 88% | |||||||||||||
Bridge Notes | |||||||||||||||
Sale of stock | |||||||||||||||
Aggregate purchase price | $ 12,000,000 | ||||||||||||||
Debt instrument, face amount | $ 5,000,000 | $ 5,000,000 | |||||||||||||
Cellect shareholders immediately prior to the merger | |||||||||||||||
Sale of stock | |||||||||||||||
Shares owned (as a percent) | 12% | ||||||||||||||
Private Placement | |||||||||||||||
Sale of stock | |||||||||||||||
Aggregate purchase price | 17,000,000 | ||||||||||||||
Debt instrument, face amount | 12,000,000 | ||||||||||||||
Private Placement | Bridge Notes | |||||||||||||||
Sale of stock | |||||||||||||||
Aggregate purchase price | $ 5,000,000 | ||||||||||||||
ADS | |||||||||||||||
Sale of stock | |||||||||||||||
Number of shares represented for one ADS | 5,000 | ||||||||||||||
Ordinary shares, shares issued | 670,930 | 4,846,605 | 670,930 | ||||||||||||
Ordinary shares, shares outstanding | 670,930 | 4,846,605 | 1,013,031 | 670,931 | 670,930 | 240,292 | 240,292 | 240,292 | 240,292 | 240,292 | 240,292 |
LIQUIDITY RISKS AND UNCERTAIN_2
LIQUIDITY RISKS AND UNCERTAINTIES AND GOING CONCERN (Details) - USD ($) | 12 Months Ended | ||||
Oct. 28, 2021 | Dec. 31, 2021 | Sep. 30, 2022 | Aug. 09, 2022 | Dec. 31, 2020 | |
Substantial Doubt About Going Concern Line Items | |||||
Accumulated deficit | $ 28,100,000 | $ 35,500,000 | |||
Proceeds from exercised warrants | $ 9,500,000 | ||||
Deferred Offering Costs | $ 141,338 | ||||
Warrant exercises | 9,500,000 | ||||
Investors | |||||
Substantial Doubt About Going Concern Line Items | |||||
Warrant exercises | $ 9,500,000 | ||||
2020 Notes | |||||
Substantial Doubt About Going Concern Line Items | |||||
Proceeds received | 12,000,000 | $ 16,800,000 | |||
Proceeds received net of offering costs | 10,100,000 | ||||
Deferred Offering Costs | $ 10,100,000 | $ 14,900,000 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Long-lived assets & Income taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||
Intangible assets, useful life | 10 years | 10 years | |||||
Impairment loss measurement | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Uncertain tax positions | $ 0 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings per share (Details) - shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Outstanding warrants | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 3,368,820 | 3,368,820 | 715,137,600 | ||
Outstanding warrants | ADS | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 309,114 | 309,114 | 143,028 | ||
Warrants | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 40,247 | 40,247 | 6,288,605,600 | ||
Warrants | ADS | |||||
Antidilutive securities excluded from diluted computation | |||||
Antidilutive securities | 5,183 | 5,183 | 1,257,722 |
CONVERTIBLE NOTES PAYABLE - 202
CONVERTIBLE NOTES PAYABLE - 2020 Notes (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2022 | Oct. 02, 2020 | |
Debt Instrument [Line Items] | |||||||
Proceeds notes payable | $ 3,475,000 | $ 3,475,000 | $ 909,980 | ||||
Fair value of convertible notes | $ 1,213,313 | 1,213,313 | |||||
Contractual term | 5 years | ||||||
Warrant liability at date of issuance | $ 373,599 | ||||||
Convertible Notes Warrants, Common Stock | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds notes payable | $ 910,000 | ||||||
Financing received from related party (as a percent) | 23% | ||||||
Fair value of convertible notes | $ 1,200,000 | $ 1,200,000 | |||||
Increase in fair value of convertible notes payable | $ 378,000 | ||||||
Shares warrants may purchase | 29,388 | 29,388 | 744,000 | 29,388 | |||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | ||||||
Contractual term | 5 years | ||||||
2020 Notes | |||||||
Debt Instrument [Line Items] | |||||||
Shares issued upon conversion | 5,183 | ||||||
Shares warrants may purchase | 29,388 | 65,000 | |||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | ||||||
2020 Notes | Convertible Notes Warrants, Common Stock | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, par, discount percentage (as a percent) | 25% | ||||||
Debt instrument, interest rate, stated percentage (as a percent) | 20% | ||||||
Convertible notes payable | $ 1,213,313 | $ 1,213,313 | |||||
Original issue discount | $ 303,333 | $ 303,333 | |||||
Additional funding received from convertible notes | $ 0 | ||||||
Shares issued upon conversion | 5,183 | ||||||
Equivalent percentage of warrants received | 100% | ||||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | $ 0 |
CONVERTIBLE NOTES PAYABLE - Int
CONVERTIBLE NOTES PAYABLE - Interest Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | |||||||
Interest expense | $ 0 | $ 0 | $ 187,000 | $ 334,000 | |||
Accrued interest and amounts due under convertible notes payable | $ 743,840 | $ 47,041 | |||||
2020 Notes | |||||||
Debt Instrument [Line Items] | |||||||
Interest expense | 202,000 | 47,000 | $ 0 | ||||
Other expense | 697,000 | ||||||
Accrued interest and amounts due under convertible notes payable | $ 1,146,000 | $ 1,146,000 | $ 744,000 | $ 47,000 | $ 0 |
BRIDGE FINANCING AND SECURITI_2
BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) - Bridge Financing (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Mar. 24, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 09, 2022 | |
Debt Instrument [Line Items] | ||||||||
Fair value adjustment to convertible notes payable | $ (1,250,000) | $ (1,250,000) | $ (378,333) | |||||
Interest paid | 393,611 | |||||||
Interest expense | $ 0 | $ 0 | $ 187,000 | $ 334,000 | ||||
Bridge Notes | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | $ 5,000,000 | $ 5,000,000 | ||||||
Debt instrument, aggregate purchase price | $ 3,800,000 | |||||||
Debt instrument, par, discount percentage (as a percent) | 25% | |||||||
Debt instrument, interest rate, stated percentage (as a percent) | 15% | |||||||
Long-term debt, fair value | $ 100,618 | 5,000,000 | ||||||
Fair value adjustment to convertible notes payable | 1,250,000 | |||||||
Debt issuance costs | $ 275,000 | |||||||
Bridge Notes, First Closing, March 25, 2021 | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | 2,000,000 | |||||||
Debt instrument, aggregate purchase price | 2,000,000 | |||||||
Proceeds from convertible debt | 1,500,000 | |||||||
Payments of debt issuance costs | 90,000 | |||||||
Bridge Notes, Second Purchase, April 2021 | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | 1,700,000 | |||||||
Debt instrument, aggregate purchase price | 1,700,000 | |||||||
Proceeds from convertible debt | 1,250,000 | |||||||
Bridge Notes, Third Purchase, May 2021 | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | 1,300,000 | |||||||
Debt instrument, aggregate purchase price | 1,300,000 | |||||||
Proceeds from convertible debt | 1,000,000 | |||||||
Payments of debt issuance costs | $ 185,000 | |||||||
Convertible notes payable | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt conversion, converted instrument, shares issued | 100,618 | |||||||
Interest paid | $ 393,611 | |||||||
Interest expense | $ 393,611 |
BRIDGE FINANCING AND SECURITI_3
BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) - Bridge Warrants - General Information (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Oct. 28, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 |
Class of Warrant or Right [Line Items] | ||||||
Warrants, term | 5 years | |||||
Warrant liability | $ 373,599 | |||||
Bridge Warrants, Common Stock | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, term | 5 years | 5 years | ||||
Warrants, number of securities called by warrants (in shares) | 99,074 | |||||
Warrants, exercise price of the three lowest weighted-average prices of post-merger ordinary shares, threshold, percentage (as a percent) | 85% | 85% | ||||
Bridge Warrants, Common Stock, First Closing | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 39,630 | 39,630 | ||||
Warrant liability | $ 1,600,000 | |||||
Bridge Warrants, Common Stock, Second and Third Closings | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 59,444 | 59,444 | ||||
Warrant liability | $ 2,200,000 |
BRIDGE FINANCING AND SECURITI_4
BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) - Exchange Warrants (Details) - Exchange Warrants, American Depositary Shares - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Class of Warrant or Right [Line Items] | ||
Warrants, number of securities called by warrants (in shares) | 99,074 | 99,074 |
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | $ 49.75 |
BRIDGE FINANCING AND SECURITI_5
BRIDGE FINANCING AND SECURITIES PURCHASE AGREEMENT (Primary Financing) - Investor Warrants (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||||
Mar. 13, 2022 | Oct. 28, 2021 | Mar. 24, 2021 | Sep. 30, 2022 | Dec. 31, 2021 | Aug. 09, 2022 | |
Class of Warrant or Right [Line Items] | ||||||
Proceeds from sale of common stock, net | $ 11,504,000 | |||||
Payment of stock issuance cost | 1,400,000 | |||||
Net proceeds | 10,100,000 | $ 14,904,569 | $ 10,102,874 | |||
Warrants, issued, period after purchase agreement closing | 136 days | |||||
Investor warrants maturity term | 5 years | |||||
Bridge Notes | ||||||
Class of Warrant or Right [Line Items] | ||||||
Aggregate purchase price | 12,000,000 | |||||
Debt Instrument, Face Amount | $ 5,000,000 | $ 5,000,000 | ||||
Private Placement | ||||||
Class of Warrant or Right [Line Items] | ||||||
Aggregate purchase price | 17,000,000 | |||||
Debt Instrument, Face Amount | 12,000,000 | |||||
Proceeds from sale of common stock, net of accrued interest and legal fess | $ 393,611 | |||||
Sale of common stock, including conversion of Bridge Notes | 342,100 | |||||
Sale of common stock, including conversion of Bridge Notes, delivered | 66,702 | |||||
Sale of common stock, including conversion of Bridge Notes, held in escrow | 275,398 | |||||
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) | 342,100 | 342,100 | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | $ 49.75 | ||||
Series B Warrants, American Depositary Shares | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 342,100 | 342,100 | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 3.98 | |||||
Series C Warrants, American Depositary Shares [Member] | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 191,174 | 191,174 | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 3.98 | |||||
Series A Warrants, American Depositary Shares, Series C Warrants Exercised in Full | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 191,174 | |||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||||
Investor warrants maturity term | 5 years | |||||
Series B Warrants, American Depositary Shares, Series C Warrants Exercised in Full | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants, number of securities called by warrants (in shares) | 191,174 | |||||
Warrants, exercise price of warrants (in dollars per share) | $ 3.98 | |||||
Investor warrants maturity term | 2 years |
FAIR VALUE OF FINANCIAL INSTR_7
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) | Dec. 31, 2021 Y $ / shares | Oct. 28, 2021 Y $ / shares | May 31, 2021 $ / shares Y | Dec. 31, 2020 $ / shares Y |
Stock price | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Measurement input | 22.75 | 11.64 | 49.75 | 49.75 |
Initial exercise price | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Measurement input | 49.75 | 49.75 | 49.75 | 49.75 |
Contractual Term | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Measurement input | Y | 5 | 5 | 5 | 5 |
Volatility | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Measurement input | 89.2 | 89.2 | 92 | 98 |
Discount rate | ||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||
Measurement input | 1.26 | 1.18 | 0.98 | 0.81 |
FAIR VALUE OF FINANCIAL INSTR_8
FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair value on a recurring basis (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2022 | |
Assets and liabilities measured on a recurring basis | ||||
Warrant liability | $ 373,599 | |||
Convertible notes payable | $ 1,213,313 | |||
Total liabilities | $ (1,250,000) | (1,250,000) | (378,333) | |
Bridge warrants | ||||
Assets and liabilities measured on a recurring basis | ||||
Warrant liability | 5,000,000 | |||
Recurring | ||||
Assets and liabilities measured on a recurring basis | ||||
Warrant liability | 373,599 | $ 9,911,200 | ||
Convertible notes payable | 1,213,333 | |||
Total liabilities | 1,213,333 | |||
Recurring | 2020 Notes Warrants | ||||
Assets and liabilities measured on a recurring basis | ||||
Warrant liability | 373,599 | |||
Recurring | Level 1 | ||||
Assets and liabilities measured on a recurring basis | ||||
Warrant liability | $ 9,911,200 | |||
Recurring | Level 3 | ||||
Assets and liabilities measured on a recurring basis | ||||
Warrant liability | 373,599 | |||
Convertible notes payable | 1,213,333 | |||
Total liabilities | $ 1,213,333 | |||
Recurring | Level 3 | 2020 Notes Warrants | ||||
Assets and liabilities measured on a recurring basis | ||||
Warrant liability | $ 373,599 |
FAIR VALUE OF FINANCIAL INSTR_9
FAIR VALUE OF FINANCIAL INSTRUMENTS - Change in fair value (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Change in fair value | |||
Convertible notes payable | $ 1,213,313 | ||
Warrant liability | $ 373,599 | ||
Fair value adjustment to convertible notes payable | $ 1,250,000 | 1,250,000 | 378,333 |
Bridge Financing Warrants | |||
Movement of warrant liability | |||
Beginning Balance | 0 | 0 | |
Warrant value at issuance (recorded as warrant liability expense) | 3,783,079 | ||
Change in Fair value of warrants | 8,627,651 | ||
Reclassification of warrant liability to an equity instrument | (12,410,730) | ||
Ending Balance | 0 | 0 | |
2020 Notes Warrants | |||
Movement of warrant liability | |||
Beginning Balance | $ 0 | 0 | |
Warrant value at issuance (recorded as warrant liability expense) | 894,113 | ||
Change in Fair value of warrants | (520,514) | ||
Ending Balance | $ 373,599 | $ 0 |
PREPAID EXPENSES (Details)_2
PREPAID EXPENSES (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
PREPAID EXPENSES | ||
Prepaid R&D costs | $ 414,061 | $ 329,033 |
Prepaid insurance | 74,017 | 684,191 |
Prepaid other expenses | 8,608 | 2,250 |
Total | $ 496,686 | $ 1,015,474 |
ACCRUED EXPENSES (Details)_2
ACCRUED EXPENSES (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
ACCRUED EXPENSES | |||
Professional fees | $ 115,451 | $ 144,377 | $ 173,095 |
Investor Relations fees | 98,000 | 584,000 | 528,000 |
Payroll taxes | 153,552 | 199,582 | 148,899 |
Payroll | 759,833 | 557,937 | |
Research contract expenses | 193,537 | 105,052 | |
Other expenses | 61,222 | 5,976 | 5,802 |
Total | $ 1,569,920 | $ 1,685,409 | $ 960,848 |
ASSET ACQUISITION AND IN-LICE_2
ASSET ACQUISITION AND IN-LICENSED TECHNOLOGY - Polytherapeutics (Details) - Polytherapeutics - USD ($) | 12 Months Ended | |||
Mar. 24, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2021 | |
Asset acquisitions and in-licensed technology | ||||
Purchase price agreement | $ 40,833 | |||
Royalty payments, as a percent of net revenue | 4% | |||
Royalty payment period | 10 years | |||
Royalty payments with one generic product introduced, as a percent of net revenue | 2% | 4% | ||
Royalty payments with two generic product introduced, as a percent of net revenue | 0% | 2% | ||
Intellectual property repurchase price | $ 100,000 |
ASSET ACQUISITION AND IN-LICE_3
ASSET ACQUISITION AND IN-LICENSED TECHNOLOGY - Skinvisible (Details) - Skinvisable - USD ($) | 1 Months Ended | |||||||
Oct. 17, 2019 | Mar. 31, 2022 | Dec. 31, 2021 | Jul. 10, 2021 | Jun. 26, 2021 | Jan. 27, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Asset acquisitions and in-licensed technology | ||||||||
Purchase price agreement | $ 1,000,000 | |||||||
Clinical milestones | $ 7,500,000 | |||||||
Regulatory approval milestones | 15,000,000 | $ 21,750,000 | ||||||
Installment payments | $ 500,000 | |||||||
License acquisition liability | 250,000 | $ 875,000 | ||||||
Amount paid against consideration liability | $ 50,000 | |||||||
Sales Milestone Tier One | ||||||||
Asset acquisitions and in-licensed technology | ||||||||
Sales milestones | 10,000,000 | |||||||
Sales achievement | 100,000,000 | |||||||
Sales Milestone Tier Two | ||||||||
Asset acquisitions and in-licensed technology | ||||||||
Sales milestones | 25,000,000 | |||||||
Sales achievement | 250,000,000 | |||||||
Sales Milestone Tier Three | ||||||||
Asset acquisitions and in-licensed technology | ||||||||
Sales milestones | 50,000,000 | |||||||
Sales achievement | 400,000,000 | |||||||
Amendment 3 | ||||||||
Asset acquisitions and in-licensed technology | ||||||||
Clinical milestones | 750,000 | |||||||
Regulatory approval milestones | $ 5,000,000 | |||||||
Amendment 5 | ||||||||
Asset acquisitions and in-licensed technology | ||||||||
First payment | $ 107,500 | |||||||
Second payment | $ 250,000 | |||||||
Third payment | $ 250,000 |
INTANGIBLE ASSETS (Details)_2
INTANGIBLE ASSETS (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Intangible assets | |||
Total cost | $ 1,040,433 | $ 1,040,433 | $ 1,040,433 |
Accumulated amortization | (309,861) | (231,829) | (127,785) |
Net book value | 730,572 | 808,604 | 912,648 |
Acquired technology - Polytherapeutics | |||
Intangible assets | |||
Total cost | 40,433 | 40,433 | 40,433 |
Technology license - Skinvisible | |||
Intangible assets | |||
Total cost | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 |
INTANGIBLE ASSETS (Details)_2_3
INTANGIBLE ASSETS (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
INTANGIBLE ASSETS | |||||||
Amortization of intangibles | $ 26,000 | $ 26,000 | $ 78,032 | $ 78,032 | $ 104,043 | $ 104,043 | $ 20,710 |
Expected amortization expense | |||||||
2022 | 26,000 | 26,000 | 104,000 | ||||
2023 | 104,000 | 104,000 | 104,000 | ||||
2024 | 104,000 | 104,000 | 104,000 | ||||
2025 | 104,000 | 104,000 | 104,000 | ||||
2026 | 104,000 | 104,000 | 104,000 | ||||
Thereafter | $ 288,000 | $ 288,000 | $ 288,000 |
RELATED PARTY TRANSACTIONS - Na
RELATED PARTY TRANSACTIONS - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Oct. 28, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Consulting expense | ||||||||
Related Party Transaction [Line Items] | ||||||||
Consulting expense from related party | $ 12,000 | $ 0 | $ 36,000 | $ 0 | $ 108,000 | |||
Officers and founders | ||||||||
Related Party Transaction [Line Items] | ||||||||
Payment of amounts due to officers | $ 304,466 | $ 50,000 | $ 0 | |||||
Monthly payment amounts due to related party | $ 25,000 |
RELATED PARTY TRANSACTIONS - _2
RELATED PARTY TRANSACTIONS - Amounts due to officers (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Related Party Transaction [Line Items] | |||
Due to officers | $ 4,273,733 | $ 4,723,732 | |
Invoices paid on behalf of the Company | |||
Related Party Transaction [Line Items] | |||
Due to officers | $ 165,233 | 615,232 | |
Officer [Member] | |||
Related Party Transaction [Line Items] | |||
Due to officers | 4,723,732 | $ 4,888,913 | |
Officer [Member] | Salaries and allowances | |||
Related Party Transaction [Line Items] | |||
Due to officers | 4,108,500 | 3,984,000 | |
Officer [Member] | Invoices paid on behalf of the Company | |||
Related Party Transaction [Line Items] | |||
Due to officers | $ 615,232 | $ 904,913 |
RESEARCH, CONSULTING AGREEMEN_4
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS - Research (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Jul. 31, 2018 USD ($) | Nov. 30, 2020 USD ($) | Jul. 31, 2018 USD ($) agreement | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | Jun. 30, 2022 USD ($) | Nov. 30, 2021 USD ($) | Feb. 28, 2021 USD ($) | |
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Research and development | $ 745,506 | $ 259,996 | $ 2,059,769 | $ 556,064 | $ 1,562,927 | $ 244,155 | $ 45,650 | ||||||
Accrued expenses | 1,569,920 | 1,569,920 | 1,685,409 | 960,848 | |||||||||
Research and consulting agreement | Polytherapeutics | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Monthly payments | $ 20,833 | ||||||||||||
Total amount of agreement | $ 666,667 | ||||||||||||
Research and consulting agreement | Axella Research LLC | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Total amount of agreement | $ 270,000 | $ 270,000 | |||||||||||
Number of agreements | 3 | ||||||||||||
Number of options to pay | 2 | 270,000 | |||||||||||
Option 1, equity payment (as a percent) | 0.50% | ||||||||||||
Option 1, cash payment (as a percent) | 0.50% | ||||||||||||
Option 2, cash payment discount (as a percent) | 20% | ||||||||||||
Research and development | 0 | 0 | 0 | 0 | 247,000 | 50,000 | 25,000 | ||||||
Accrued expenses | 193,537 | $ 105,052 | $ 24,940 | ||||||||||
Research and consulting agreement | Netherton Syndrome | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Research and development | 35,000 | 112,000 | |||||||||||
Initial expenses | 25,000 | ||||||||||||
Research and consulting agreement | Therapeutics Inc. | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Research and development | 423,000 | $ 88,000 | 904,000 | $ 232,000 | |||||||||
Consulting agreements | Axella Research LLC | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Number of agreements | agreement | 3 | ||||||||||||
Accrued expenses | 194,000 | ||||||||||||
Consulting agreements | Investor Relations firm | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Monthly payments | $ 14,000 | $ 14,000 | |||||||||||
Accrued expenses | 584,000 | ||||||||||||
Consulting agreements | Netherton Syndrome | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Total amount of agreement | $ 250,000 | ||||||||||||
Consulting agreements | Therapeutics Inc. | |||||||||||||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||||||||||||
Total amount of agreement | $ 3,500,000 | $ 4,400,000 | |||||||||||
Research and development | $ 340,000 | ||||||||||||
Initial term | 3 years | ||||||||||||
Written termination notice period | 90 days |
RESEARCH, CONSULTING AGREEMEN_5
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS - Employment agreements (Details) - Employment Contracts [Member] | 1 Months Ended | 12 Months Ended | |
Nov. 30, 2021 USD ($) item | Dec. 31, 2021 Y | Mar. 31, 2018 USD ($) | |
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||
Number founders under employment agreement | 2 | 2 | |
Two Founders | |||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||
Combine salary and benefits | $ 996,000 | ||
Number of years of salary and bonus equivalent for termination | Y | 2 | ||
Percentage of increase in base level compensation | 10% | ||
Annual target discretionary bonus (in percent) | 45% | ||
Amount of transaction bonus related to merger and private placement paid | $ 324,000 | ||
Chief Financial Officer | |||
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | |||
Transaction bonus | $ 360,000 |
RESEARCH, CONSULTING AGREEMEN_6
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS - Merger agreement commitment (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
RESEARCH, CONSULTING AGREEMENTS AND OTHER COMMITMENTS | ||
Percentage of share capital held in Escrow by Altshuler Shaham Trusts Ltd. | 40% | 40% |
SHAREHOLDERS' EQUITY AND SHAR_3
SHAREHOLDERS' EQUITY AND SHARE OWNERSHIP AND RIGHTS - Share Capital (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Oct. 28, 2021 shares | Mar. 05, 2018 USD ($) shares | May 31, 2022 shares | Sep. 30, 2022 USD ($) Vote Y shares | Sep. 30, 2022 Vote Y shares | Dec. 31, 2021 USD ($) Y Vote shares | Aug. 01, 2022 shares | Apr. 12, 2022 shares | Apr. 11, 2022 shares | Dec. 31, 2020 shares | |
SHARE OWNERSHIP AND RIGHTS | ||||||||||
Ordinary shares, shares authorized | 50,000,000,000 | 50,000,000,000 | 12,000,000,000 | 12,000,000,000 | ||||||
Issuance of ADS and Pre-Funded Warrants, net | $ | $ 14,904,569 | $ 17,000,000 | ||||||||
Number of vote for each ordinary share | Vote | 1 | 1 | ||||||||
Number of years of income that limits distribution | Y | 2 | 2 | ||||||||
Maximum period between date of financial statements and distribution date | 6 months | |||||||||
ADS | ||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 3,360,000 | 342,100 | ||||||||
Shares issued upon conversion | 5,183 | |||||||||
Number of ordinary shares for each ADS | 5,000 | |||||||||
Quoin | ||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||
Ordinary shares, shares authorized | 10,000 | 12,000,000,000 | 50,000,000,000 | 12,500,000,000 | ||||||
Issuance of ADS and Pre-Funded Warrants, net (in shares) | 100 | |||||||||
Issuance of ADS and Pre-Funded Warrants, net | $ | $ 100 | |||||||||
Number of founders | 2 | |||||||||
Number of vote for each ordinary share | Vote | 1 | |||||||||
Number of years of income that limits distribution | Y | 2 | |||||||||
Maximum period between date of financial statements and distribution date | 6 months | |||||||||
Quoin | ADS | ||||||||||
SHARE OWNERSHIP AND RIGHTS | ||||||||||
Shares issued upon conversion | 240,292 | 224,388 | ||||||||
Number of ordinary shares for each ADS | 5,000 |
SHAREHOLDERS' EQUITY AND SHAR_4
SHAREHOLDERS' EQUITY AND SHARE OWNERSHIP AND RIGHTS - Warrants and Options (Details) - $ / shares | Sep. 30, 2022 | Aug. 02, 2022 | Jul. 14, 2022 | Dec. 31, 2021 |
Equity | ||||
Outstanding warrants | 399,999 | |||
ADS | ||||
Equity | ||||
Outstanding warrants | 143,028 | |||
Warrants, exercise price of warrants (in dollars per share) | $ 0 | $ 0 | ||
Number issuable warrants | 1,257,722 | |||
Warrants | 2020 note holders | ||||
Equity | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||
Warrants | 2020 note holders | ADS | ||||
Equity | ||||
Outstanding warrants | 29,388 | |||
Warrants | Investor | ||||
Equity | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||
Warrants | Investor | ADS | ||||
Equity | ||||
Outstanding warrants | 99,074 | |||
Warrants | Cellect warrantholders | ||||
Equity | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 137.50 | |||
Warrants | Cellect warrantholders | ADS | ||||
Equity | ||||
Outstanding warrants | 8,820 | |||
Series A warrants held by Investor | ||||
Equity | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||
Series A warrants held by Investor | ADS | ||||
Equity | ||||
Number issuable warrants | 533,274 | |||
Series B warrants | ||||
Equity | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||
Series B warrants | ADS | ||||
Equity | ||||
Number issuable warrants | 533,274 | |||
Series C warrants | ||||
Equity | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 49.75 | |||
Series C warrants | ADS | ||||
Equity | ||||
Number issuable warrants | 191,174 | |||
Options | Cellect optionholders | ||||
Equity | ||||
Warrants, exercise price of warrants (in dollars per share) | $ 636.75 | |||
Options | Cellect optionholders | ADS | ||||
Equity | ||||
Outstanding warrants | 5,746 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
INCOME TAXES | ||
Increase in valuation allowance | $ 2,178,000 | $ 515,000 |
Net operating loss carryforward | $ 6,482,000 | $ 1,180,000 |
Federal income tax rate | 21% | 21% |
Deferred tax assets: | ||
Net operating losses carryforward | $ 1,945,000 | $ 355,000 |
Due to officers | 1,411,000 | 1,467,000 |
Accrued expenses and other | 212,000 | 44,000 |
R&D credit carryforward | 102,000 | |
Debt related attributes | 375,000 | |
Total deferred tax assets | 4,045,000 | 1,866,000 |
Valuation allowance | $ (4,045,000) | $ (1,866,000) |
CONTINGENCIES (Details)_2
CONTINGENCIES (Details) | 1 Months Ended |
Feb. 29, 2020 USD ($) | |
CONTINGENCIES | |
Possible damages sought | $ 666,667 |
LICENSE AGREEMENTS (Details)_2
LICENSE AGREEMENTS (Details) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||
Dec. 31, 2021 agreement | Dec. 31, 2021 item | Nov. 30, 2021 agreement | Nov. 30, 2021 item | Sep. 30, 2022 USD ($) agreement | Dec. 31, 2021 USD ($) | |
LICENSE AGREEMENTS | ||||||
Number of license and supply agreements entered | 3 | 3 | 3 | 3 | 6 | |
Royalty revenues | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details)_2
SUBSEQUENT EVENTS (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||||||||
Jul. 12, 2022 shares | Jul. 11, 2022 shares | Apr. 12, 2022 USD ($) director $ / shares shares | Mar. 31, 2022 USD ($) item shares | Dec. 31, 2021 agreement $ / shares shares | Dec. 31, 2021 item $ / shares shares | Nov. 30, 2021 agreement | Nov. 30, 2021 item | Sep. 30, 2022 $ / shares shares | Jun. 30, 2022 shares | Mar. 31, 2022 item shares | Sep. 30, 2022 agreement $ / shares shares | Dec. 31, 2021 $ / shares shares | Nov. 03, 2022 shares | Nov. 02, 2022 shares | Aug. 02, 2022 $ / shares shares | Jul. 29, 2022 $ / shares | Jul. 14, 2022 $ / shares shares | Apr. 11, 2022 shares | Apr. 02, 2022 shares | Mar. 14, 2022 $ / shares | Mar. 13, 2022 $ / shares shares | Dec. 31, 2020 shares | |
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of license and supply agreements entered | 3 | 3 | 3 | 3 | 6 | ||||||||||||||||||
Ordinary shares, shares authorized | 12,000,000,000 | 12,000,000,000 | 50,000,000,000 | 50,000,000,000 | 12,000,000,000 | 12,000,000,000 | |||||||||||||||||
Exercised (in dollars per share) | $ / shares | $ 11.21 | ||||||||||||||||||||||
Class of Warrant or Right, Outstanding | 399,999 | ||||||||||||||||||||||
Altium Agreement | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 0 | ||||||||||||||||||||||
Amended Plan | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of ordinary shares reserved for future issuance | 1,826,991,617 | 1,826,991,617 | |||||||||||||||||||||
Exercised (in dollars per share) | $ / shares | $ 17.50 | ||||||||||||||||||||||
Amended Plan | Minimum | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Vesting period | 3 years | ||||||||||||||||||||||
ADS | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 342,100 | ||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 0 | $ 0 | $ 0 | ||||||||||||||||||||
Stock Issued During Period, Shares, New Issues | 3,360,000 | 342,100 | |||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | ||||||||||||||||||||||
Class of Warrant or Right, Outstanding | 143,028 | 143,028 | 143,028 | ||||||||||||||||||||
ADS | Amended Plan | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of ordinary shares reserved for future issuance | 365,398 | 365,398 | |||||||||||||||||||||
Exercised (in dollars per share) | $ / shares | $ 17.50 | ||||||||||||||||||||||
Vesting period | 4 years | ||||||||||||||||||||||
2020 Notes | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 29,388 | 29,388 | 65,000 | 65,000 | 29,388 | ||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 49.75 | $ 49.75 | $ 49.75 | ||||||||||||||||||||
Subsequent Event | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of license and supply agreements entered | item | 4 | ||||||||||||||||||||||
Number of ADSs acquirable for options | 71,429 | ||||||||||||||||||||||
Annual discretionary bonuses | $ | $ 472,500 | ||||||||||||||||||||||
Ordinary shares, shares authorized | 50,000,000,000 | 500,000,000,000 | 50,000,000,000 | 12,500,000,000 | |||||||||||||||||||
Combined base salary of two founders | $ | $ 990,000 | ||||||||||||||||||||||
Exercised (in dollars per share) | $ / shares | $ 17.50 | ||||||||||||||||||||||
Vesting period | 4 years | ||||||||||||||||||||||
Amount of repayments per each month to two founders | $ | $ 25,000 | ||||||||||||||||||||||
Number of non-employee directors | director | 5 | ||||||||||||||||||||||
Subsequent Event | Altium Agreement | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 0 | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 23,040 | ||||||||||||||||||||||
Subsequent Event | Minimum | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Percentage of annual discretionary bonus on annual base salary | 45% | ||||||||||||||||||||||
Subsequent Event | Amended Plan | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of ordinary shares reserved for future issuance (in percentage) | 15% | ||||||||||||||||||||||
Number of ordinary shares reserved for future issuance | 1,826,991,616 | 1,826,991,616 | |||||||||||||||||||||
Number of ADSs represented by ordinary shares | 365,398 | 365,398 | |||||||||||||||||||||
Number of shares purchased for award | 316,571 | ||||||||||||||||||||||
Subsequent Event | Amended Plan | Two Founders | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of ADSs acquirable for options | 85,714 | ||||||||||||||||||||||
Exercised (in dollars per share) | $ / shares | $ 17.50 | ||||||||||||||||||||||
Vesting period | 4 years | ||||||||||||||||||||||
Subsequent Event | Amended Plan | Directors | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of ADSs acquirable for options | 12,857 | ||||||||||||||||||||||
Exercised (in dollars per share) | $ / shares | $ 17.50 | ||||||||||||||||||||||
Vesting period | 3 years | ||||||||||||||||||||||
Subsequent Event | ADS | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Number of shares represented for one ADS | 5,000 | 400 | |||||||||||||||||||||
Ratio Change | 12.5 | ||||||||||||||||||||||
Subsequent Event | ADS | Altium Agreement | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Class of Warrant or Right, Outstanding | 15,168 | ||||||||||||||||||||||
Subsequent Event | Series A warrants held by Investor | ADS | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 342,100 | ||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 49.75 | ||||||||||||||||||||||
Subsequent Event | Series B warrants | ADS | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 342,100 | ||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 49.75 | ||||||||||||||||||||||
Stock Issued During Period, Shares, New Issues | 342,100 | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | ||||||||||||||||||||||
Subsequent Event | Series C warrants | ADS | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 191,174 | ||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 49.75 | ||||||||||||||||||||||
Subsequent Event | Series A Warrant and Investor Exchange Warrants | ADS | Altium Agreement | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 399,999 | ||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 0 | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 399,999 | ||||||||||||||||||||||
Subsequent Event | Warrants held by 2020 noteholders | ADS | Altium Agreement | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 0 | ||||||||||||||||||||||
Class of Warrant or Right, Outstanding | 6,348 | ||||||||||||||||||||||
Subsequent Event | Warrants held by former Cellect warrant holders | ADS | Altium Agreement | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 137.5 | ||||||||||||||||||||||
Class of Warrant or Right, Outstanding | 8,820 | ||||||||||||||||||||||
Subsequent Event | 2020 Notes | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Aggregate payment for notes payables settlement | $ | $ 311,670 | ||||||||||||||||||||||
Number of note payables settled | item | 2 | ||||||||||||||||||||||
Number of notes payables | item | 5 | 5 | |||||||||||||||||||||
Subsequent Event | 2020 Notes | Exchange warrant held by Investor | ADS | |||||||||||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||||||||||
Warrants, number of securities called by warrants (in shares) | 29,388 | ||||||||||||||||||||||
Warrants, exercise price of warrants (in dollars per share) | $ / shares | $ 0 | $ 49.75 |