Full Press Release Details
Pharmaceuticals Provides Corporate Update and Announces Fourth Quarter And Full Year 2022 Financial Results
ASHBURN, Va., March 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 fourth quarter and full year of 2022.
Quoin CEO, Dr. Michael
Myers, said, "2022 as a whole was a year of significant progress for Quoin and the fourth quarter continued that trend of operational
execution across a number of important metrics. We were very pleased to announce the dosing of the first patient in our ongoing double
blinded, placebo controlled study in Netherton Syndrome patients. This study has continued to recruit and dose patients since then and
overall interest in participation in the study remains very high.
We were also excited
to announce in October our plans to initiate a second clinical trial in Netherton Syndrome patients which we believe further establishes
the company's leadership position related to this disease. Since then, Quoin has been cleared by the Food and Drug Administration
(FDA) to initiate this study under the Company's currently open Investigational New Drug (IND). This second study is investigating
the safety and efficacy of QRX003 in Netherton Syndrome patients currently receiving off-label systemic therapy, primarily biologic therapy.
Both of our clinical studies will be run concurrently with each other and utilize the same investigators and clinical sites, resulting
in high levels of operational synergies and cost savings. As this second trial is a single arm, open label study, Quoin will have access
to the data, which we look forward to sharing in the coming months. We believe Quoin is the only pharmaceutical company currently conducting
two clinical trials in Netherton Syndrome patients under an open IND application.
We also continued to
work closely with our 8 partners covering the 60 countries under our current commercial arrangements to determine requirements to advance
QRX003 into Compassionate Use or Early Access Programs in the various local markets, in advance of formal regulatory approval. With the
anticipated generation of clinical data this year, we are hopeful that this will provide a major step forward towards that goal.
Both of our dermatological
rare disease research programs with Queensland University of Technology for treatment of Scleroderma and Netherton Syndrome continue to
make progress under the expert scientific guidance of the program coordinators and we are working towards the initiation of clinical testing
in Australia for at least one of these programs in 2H 2023.
Finally, last month we
completed a public offering of our shares with aggregate net proceeds of approximately $6 million, which further extends our cash runway
Financial Highlights
About Quoin Pharmaceuticals
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 filings the Company has made with the SEC and the Company's Annual Report on Form 10-K for the year ended December
31, 2022 that the Company will file 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. Because such statements are subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking statements. 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,
Quoin Pharmaceuticals
Ltd. Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 2,860,628 | $ | 7,482,773 | ||||
| Investments | 9,992,900 | - | ||||||
| Prepaid expenses | 516,584 | 715,474 | ||||||
| Total current assets | 13,370,112 | 8,198,247 | ||||||
| Prepaid expenses - long term | 383,390 | 300,000 | ||||||
| Intangible assets, net | 704,561 | 808,604 | ||||||
| Other assets | - | 50,000 | ||||||
| Total assets | $ | 14,458,063 | $ | 9,356,851 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 605,600 | $ | 923,239 | |||||
| Accrued expenses | 1,175,705 | 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 | 3,527,556 | 4,576,087 | ||||||
| Due to officers - long term | 3,523,733 | 4,123,732 | ||||||
| Total liabilities | $ | 7,051,289 | $ | 8,699,819 | ||||
| Commitments and contingencies | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, no par value per share, 500,000,000,000 ordinary shares | $ | - | $ | - | ||||
| authorized - 24,233,024,799 (4,846,605 ADS's) | ||||||||
| ordinary shares issued and outstanding at December 31, 2022 and | ||||||||
| 3,354,650,799 (670,930 ADS's) at December 31, 2021 | ||||||||
| Treasury stock, 2,641,693 ordinary shares | (2,932,000 | ) | (2,932,000 | ) | ||||
| Additional paid in capital | 47,855,521 | 31,659,017 | ||||||
| Accumulated deficit | (37,516,747 | ) | (28,069,985 | ) | ||||
| Total shareholders' equity | 7,406,774 | 657,032 | ||||||
| Total liabilities and shareholders' equity | $ | 14,458,063 | $ | 9,356,851 |
Quoin Pharmaceuticals
Ltd. Consolidated Statements of Operations
| Years Ended December 31, | Three months ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Audited) | (Audited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ | 6,584,868 | $ | 4,499,923 | $ | 1,472,866 | $ | 1,974,557 | ||||||||
| Research and development | 2,672,836 | 1,562,927 | 613,067 | 1,006,863 | ||||||||||||
| Total operating expenses | 9,257,704 | 6,062,850 | 2,085,933 | 2,981,420 | ||||||||||||
| Other (income) and expenses | ||||||||||||||||
| Forgiveness of accounts payable | (416,000 | ) | - | - | - | |||||||||||
| Fair value adjustment to convertible notes payable | - | 1,250,000 | - | - | ||||||||||||
| Warrant liability (income) expense | (77,237 | ) | 12,784,329 | - | 8,261,485 | |||||||||||
| Financing expense | - | 275,000 | - | - | ||||||||||||
| Unrealized income | (1,307 | ) | - | (4,360 | ) | - | ||||||||||
| Interest income | (95,745 | ) | - | (80,613 | ) | - | ||||||||||
| Interest and financing expense | 714,081 | 1,090,409 | - | 574,133 | ||||||||||||
| Total other expense | 123,792 | 15,399,738 | (84,973 | ) | 8,835,618 | |||||||||||
| Net loss | $ | (9,381,496 | ) | $ | (21,462,588 | ) | $ | (2,000,960 | ) | $ | (11,817,038 | ) | ||||
| Deemed dividend on warrant modification | (65,266 | ) | - | - | - | |||||||||||
| Net loss attributable to shareholders | $ | (9,446,762 | ) | $ | (21,462,588 | ) | $ | (2,000,960 | ) | $ | (11,817,038 | ) | ||||
| Loss per ADS | ||||||||||||||||
| Loss per ADS | ||||||||||||||||
| Basic | $ | (3.90 | ) | $ | (67.96 | ) | $ | (0.41 | ) | $ | (21.70 | ) | ||||
| Fully-diluted | $ | (3.90 | ) | $ | (67.96 | ) | $ | (0.41 | ) | $ | (21.70 | ) | ||||
| Weighted average number of ADS's outstanding | ||||||||||||||||
| Basic | 2,421,916 | 315,801 | 4,846,605 | 544,547 | ||||||||||||
| Fully-diluted | 2,421,916 | 315,801 | 4,846,605 | 544,547 |