UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Securities registered pursuant to Section 12(b) of the Act:
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| Ordinary Shares, no par value per share* | N/A |
| * | Not for trading, but only in connection with the registration of the American Depositary Shares pursuant to requirements of the Securities and Exchange Commission. |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 Results of Operations and Financial Condition.
On March 13, 2024, Quoin Pharmaceuticals Ltd. (the “Company”) announced its fourth quarter and fiscal year 2023 financial results. A copy of the Company’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.
The information set forth and incorporated by reference in this Item 2.02 shall not be deemed to be “filed” with the Securities and Exchange Commission for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and the Company does not incorporate it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated March 13, 2024 | |
| 104 | Cover Page Interactive Data file (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| Date: March 13, 2024 | QUOIN PHARMACEUTICALS LTD. | |
| By: | /s/ Gordon Dunn | |
| Name: | Gordon Dunn | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Quoin Pharmaceuticals Provides Corporate Update and Announces Fourth Quarter and 2023 Financial Results
Company reported positive initial clinical data for QRX003 from first six evaluable subjects in ongoing open-label Netherton Syndrome study with positive benefits observed across a number of clinical endpoints
Eligibility age for enrollment into both studies has been lowered to fourteen years and older
No safety concerns have been observed to date in either ongoing clinical study
Quoin expects its cash runway will extend into the second half of 2025 following $6.5 million offering on March 5th
Cash Runway to be further extended by $8 million Equity Line of Credit arrangement signed January 25, 2024
ASHBURN, Va., March 13, 2024 -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today provides a business update and announces financial results for the quarter and year ended December 31, 2023.
Quoin CEO, Dr. Michael Myers, said, “2023 marked another year of significant progress for Quoin and for the development of QRX003 for the treatment of Netherton Syndrome. Notably, we released initial positive data from our open label clinical study, representing a first for the very underserved Netherton community. That progress has continued, and based on the strength of the initial positive clinical data, we implemented a number of important protocol changes that we believe could lead to a more streamlined development program overall.
“We have also strengthened our balance sheet through the recently completed $6.5 million capital raise and we have the capacity to further solidify our cash position via the $8.0 million equity line of credit transaction we entered into earlier this year, once shareholder approval is received. We continue to believe that Quoin is in position to deliver the first approved treatment for this terrible disease.”
Recent Corporate Highlights –
| · | On March 4th, Quoin announced FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical studies. |
| · | On February 8th, 2024, Quoin filed U.S. and International patent applications for a novel Netherton Syndrome combination product. |
| · | On December 13th, Quoin announced FDA clearance of the Clinical Optimization Plan for QRX003 for Netherton Syndrome |
| · | On October 24th, Quoin announced positive clinical data from the first six evaluable patients in the company’s open-label clinical trial in Netherton Syndrome patients. |
| o | Five of the six subjects reported that their pruritus, or itch, was either negligible or absent following treatment with QRX003, a significant improvement from prior to the study. |
| o | All six subjects exhibited improvement in the Investigator assessed skin scoring system with three subjects showing improvement at the completion of the study and the other three at various points during the study. |
| o | All six subjects expressed a favorable impression of QRX003 across multiple assessed metrics. |
| o | No safety concerns have been reported to date for any subject in either of Quoin’s studies. |
Financial Highlights
| · | Quoin had approximately $10.7 million in cash, cash equivalents and marketable securities as of December 31, 2023. This does not include the proceeds from the $6.5 million public offering of common shares that the company announced on March 5, 2024, nor the anticipated proceeds from the $8 million equity line of credit transaction which was entered into in January of this year. Implementation of this remains subject to shareholder approval. |
| · | Net loss for the quarter ended December 31, 2023 was approximately $2.0 million compared to approximately $2.0 million for the quarter ended December 31, 2022. Net loss for the twelve months ended December 31, 2023 was $8.7 million compared to $9.4 million for the twelve months ended December 31, 2022. |
| · | Investors are encouraged to read the Company’s Annual Report on Form 10-K when it is filed with the Securities and Exchange Commission (the “SEC”), which will contain additional details about Quoin’s financial results as of and for the period ended December 31, 2023. |
Quoin will host a conference call and webcast at 8:30am ET on Thursday, March 14, 2024. The call will include a discussion of fourth quarter and full year 2023 financial results and a corporate update. The live call can be accessed by dialing 1-800-603-0527 (domestic) or 1-412-317-0688 (international). The live and archived webcast of the call will also be available on the Quoin Pharmaceuticals website under the Investors section or by following this link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=ZmehVyN5
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a clinical stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
Cautionary Note Regarding Forward Looking Statements
The Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to the Company’s expected cash runway, the belief that certain protocol changes could lead to a more streamlined development program and the belief that the Company is in a position to deliver the first approved treatment for Netherton Syndrome. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 that the Company filed with the SEC. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
For further information:
PCG Advisory
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341
-Tables Follow-
QUOIN PHARMACEUTICALS, LTD.
Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,401,198 | $ | 2,860,628 | ||||
| Investments | 8,293,663 | 9,992,900 | ||||||
| Prepaid expenses and other current assets | 591,034 | 516,584 | ||||||
| Deferred offering costs | - | - | ||||||
| Total current assets | 11,285,895 | 13,370,112 | ||||||
| Prepaid expenses - long term | 300,000 | 383,390 | ||||||
| Intangible assets, net | 583,334 | 704,561 | ||||||
| Total assets | $ | 12,169,229 | $ | 14,458,063 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 526,523 | $ | 605,600 | ||||
| Accrued expenses | 1,308,706 | 1,175,705 | ||||||
| Accrued license acquisition | - | - | ||||||
| Accrued interest and financing expense | 1,146,251 | 1,146,251 | ||||||
| Due to officers - short term | 600,000 | 600,000 | ||||||
| Total current liabilities | 3,581,480 | 3,527,556 | ||||||
| Due to officers - long term | 2,923,733 | 3,523,733 | ||||||
| Total liabilities | $ | 6,505,213 | $ | 7,051,289 | ||||
| Commitments and contingencies | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, no par value per share, 100,000,000 and 8,333,334 ordinary shares authorized at December 31, 2023 and 2022, respectively - 987,220 (987,220 ADS's) | $ | - | $ | - | ||||
| ordinary shares issued and outstanding at December 31, 2023 and 403,887 | ||||||||
| (403,887 ADS's) at December 31, 2022 | ||||||||
| Treasury stock, | - | (2,932,000 | ) | |||||
| -0- ordinary shares issued at December 31, 2023 and 45 ordinary shares issued at December 31, 2022 | ||||||||
| Additional paid in capital | 51,867,336 | 47,855,521 | ||||||
| Accumulated deficit | (46,203,320 | ) | (37,516,747 | ) | ||||
| Total shareholders' equity | 5,664,016 | 7,406,774 | ||||||
| Total liabilities and shareholders' equity | $ | 12,169,229 | $ | 14,458,063 | ||||
QUOIN PHARMACEUTICALS LTD.
Consolidated Statements of Operations
| Years Ended December 31, | Three months ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Audited) | (Audited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ | 6,070,517 | $ | 6,584,868 | $ | 1,385,276 | $ | 1,472,866 | ||||||||
| Research and development | 3,307,987 | 2,672,836 | 832,391 | 613,067 | ||||||||||||
| Total operating expenses | 9,378,504 | 9,257,704 | 2,217,667 | 2,085,933 | ||||||||||||
| Other (income) and expenses | ||||||||||||||||
| Forgiveness of accounts payable | - | (416,000 | ) | - | - | |||||||||||
| Warrant liability (income) expense | - | (77,237 | ) | - | - | |||||||||||
| Unrealized loss (gain) | 2,683 | (1,307 | ) | (9,243 | ) | (4,360 | ) | |||||||||
| Realized and accrued interest income | (694,614 | ) | (95,745 | ) | (158,546 | ) | (80,613 | ) | ||||||||
| Interest and financing expense | - | 714,081 | - | - | ||||||||||||
| Total other (income) expense | (691,931 | ) | 123,792 | (167,789 | ) | (84,973 | ) | |||||||||
| Net loss | $ | (8,686,573 | ) | $ | (9,381,496 | ) | $ | (2,049,878 | ) | $ | (2,000,960 | ) | ||||
| Deemed dividend on warrant modification | - | (65,266 | ) | - | - | |||||||||||
| Net loss attributable to shareholders | $ | (8,686,573 | ) | $ | (9,446,762 | ) | $ | (2,049,878 | ) | $ | (2,000,960 | ) | ||||
| Loss per ADS | ||||||||||||||||
| Basic | $ | (9.64 | ) | $ | (46.81 | ) | $ | (2.08 | ) | $ | (4.95 | ) | ||||
| Fully-diluted | $ | (9.64 | ) | $ | (46.81 | ) | $ | (2.08 | ) | $ | (4.95 | ) | ||||
| Weighted average number of ADS's outstanding | ||||||||||||||||
| Basic | 900,919 | 201,826 | 987,220 | 403,884 | ||||||||||||
| Fully-diluted | 900,919 | 201,826 | 987,220 | 403,884 | ||||||||||||
Cover |
Mar. 13, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Mar. 13, 2024 |
| Entity File Number | 001-37846 |
| Entity Registrant Name | QUOIN PHARMACEUTICALS LTD. |
| Entity Central Index Key | 0001671502 |
| Entity Tax Identification Number | 92-2593104 |
| Entity Incorporation, State or Country Code | L3 |
| Entity Address, Address Line One | 42127 Pleasant Forest Court |
| Entity Address, City or Town | Ashburn |
| Entity Address, State or Province | VA |
| Entity Address, Postal Zip Code | 20148-7349 |
| City Area Code | 703 |
| Local Phone Number | 980-4182 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | American Depositary Shares, each representing one (1) Ordinary Share, no par value per share |
| Trading Symbol | QNRX |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |