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
Date of Report (Date of earliest event reported):
| (Translation of registrant’s name into English) |
| State of |
||||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
|
|
||
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including
area code: (
| Not applicable |
| (Former name or former address, if changed since last report) |
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):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| 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
growth company
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 May 8, 2023, Quoin Pharmaceuticals Ltd. (the “Company”) announced its first quarter 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 May 8, 2023 | |
| 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: May 8, 2023 | QUOIN PHARMACEUTICALS LTD. | |
| By: | /s/ Gordon Dunn | |
| Name: | Gordon Dunn | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Quoin Pharmaceuticals Provides Corporate Update and Announces First Quarter 2023 Financial Results
First patient dosed in Quoin’s single arm, open label clinical trial in Netherton Syndrome patients currently receiving off-label systemic therapy
Recruitment and dosing continue in Quoin’s ongoing double blinded, placebo-controlled study of QRX003 for Netherton Syndrome
Following successful public offering Quoin expects its cash runway will extend into 2H 2024
ASHBURN, Va., May 8, 2023 (GLOBE NEWSWIRE) -- 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 first quarter of 2023.
Quoin CEO, Dr. Michael Myers, said, “We are very pleased to announce a very positive start to 2023, which has the potential to be a transformational year for Quoin. During this past quarter, we achieved a number of important milestones for the company. Following a successful public offering, we expect to have our cash runway into the second half of 2024. We believe our strong balance sheet is a significant asset as we continue our search to expand our portfolio of rare and orphan disease drug products.”
“We were delighted to announce that with the dosing of the first patient in our second clinical trial in Netherton Syndrome, both studies are now actively recruiting and dosing patients and we anticipate releasing topline data in the second half of 2023.”
“Interest level in both studies continues to be very high from patients and clinicians.”
Corporate Highlights
| ● | In March 2023, Quoin dosed the first patient in its open label clinical trial in Netherton Syndrome patients. This trial is a single arm, open label study, investigating the safety and efficacy of Quoin’s lead candidate, QRX003, in Netherton Syndrome patients who are currently receiving off-label systemic therapy, primarily biologic therapy, and will continue to do so throughout the duration of the study. |
| ● | In February 2023, Quoin completed a public offering of securities with net proceeds of approximately $5.8 million, which Quoin expects to extend the company’s cash runway into 2H 2024. |
| ● | Quoin continues to advance two rare disease research programs with Queensland University of Technology for treatment of Scleroderma and Netherton Syndrome and expects to initiate clinical testing in Australia for at least one of these programs in 2H 2023. |
Financial Highlights
| ● | Quoin had approximately $17.0 million in cash, cash equivalents and marketable securities as of March 31, 2023. |
| ● | Net loss for the quarter ended March 31, 2023 was approximately $2.6 million compared to approximately $1.7 million for the quarter ended March 31, 2022. |
| ● | Investors are encouraged to read the Company’s Quarterly Report on Form 10-Q 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 March 31, 2023. |
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. 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, 2022 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
QUOIN PHARMACEUTICALS LTD.
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,371,854 | $ | 2,860,628 | ||||
| Investments | 13,618,026 | 9,992,900 | ||||||
| Prepaid expenses | 398,906 | 516,584 | ||||||
| Total current assets | 17,388,786 | 13,370,112 | ||||||
| Prepaid expenses - long term | 383,390 | 383,390 | ||||||
| Intangible assets, net | 678,550 | 704,561 | ||||||
| Other assets | — | — | ||||||
| Total assets | $ | 18,450,726 | $ | 14,458,063 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 281,094 | $ | 605,600 | |||||
| Accrued expenses | 2,085,205 | 1,175,705 | ||||||
| Accrued interest and financing expense | 1,146,251 | 1,146,251 | ||||||
| Due to officers – short term | 650,000 | 600,000 | ||||||
| Total current liabilities | 4,162,550 | 3,527,556 | ||||||
| Due to officers – long term | 3,373,733 | 3,523,733 | ||||||
| Total liabilities | $ | 7,536,283 | $ | 7,051,289 | ||||
| Commitments and contingencies | ||||||||
| Shareholders’ equity: | ||||||||
| Ordinary shares, no par value per share, 500,000,000,000 ordinary shares authorized – 59,233,024,799 (11,846,532 ADS’s) ordinary shares issued and outstanding at March 31, 2023 and 24,233,024,799 (4,846,605 ADS’s) at December 31, 2022 | $ | — | $ | — | ||||
| Treasury stock, 2,641,693, ordinary shares | (2,932,000 | ) | (2,932,000 | ) | ||||
| Additional paid in capital | 53,966,259 | 47,855,521 | ||||||
| Accumulated deficit | (40,119,816 | ) | (37,516,747 | ) | ||||
| Total shareholders’ equity | 10,914,443 | 7,406,774 | ||||||
| Total liabilities and shareholders’ equity | $ | 18,450,726 | $ | 14,458,063 | ||||
QUOIN PHARMACEUTICALS LTD.
Condensed Consolidated Statements of Operations (Unaudited)
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses | ||||||||
| General and administrative | $ | 1,683,817 | $ | 1,588,470 | ||||
| Research and development | 1,091,733 | 587,569 | ||||||
| Total operating expenses | 2,775,550 | 2,176,039 | ||||||
| Other (income) and expenses | ||||||||
| Forgiveness of accounts payable | — | (416,000 | ) | |||||
| Warrant liability (income) expense | — | (77,237 | ) | |||||
| Unrealized gain | (20,427 | ) | — | |||||
| Interest income | (152,054 | ) | — | |||||
| Total other expense | (172,481 | ) | (493,237 | ) | ||||
| Net loss | $ | (2,603,069 | ) | $ | (1,682,802 | ) | ||
| Loss per ADS | ||||||||
| Loss per ADS | ||||||||
| Basic | $ | (0.34 | ) | $ | (2.51 | ) | ||
| Fully-diluted | $ | (0.34 | ) | $ | (2.51 | ) | ||
| Weighted average number of ADS’s outstanding | ||||||||
| Basic | 7,646,605 | 670,930 | ||||||
| Fully-diluted | 7,646,605 | 670,930 | ||||||
Cover |
May 08, 2023 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | May 08, 2023 |
| 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 five thousand (5,000) Ordinary Shares, no par value per share |
| Trading Symbol | QNRX |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |