ASHBURN, Va., Nov. 10, 2022 (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 third quarter, ended September 30, 2022.
Quoin CEO, Dr. Michael Myers, commented, “We are extremely pleased with Quoin’s clinical and operational progress over the third quarter as the company continues to execute on its business plan. We believe that our recent successful public offering underpins confidence in the company’s strategic direction and provides Quoin with sufficient capital beyond a number of key inflection points.
Our ongoing clinical study for QRX003 in Netherton Syndrome continues to progress, with a majority of clinical sites now fully open and the remaining sites on target to open in the fourth quarter of 2022. During the quarter, we also established a website to facilitate patient awareness and participation in the study. Patient recruitment is actively underway, and we anticipate dosing to commence promptly.
We were excited to announce our plans to initiate a second clinical trial in Netherton Syndrome patients which we believe further establishes the company’s leadership position in this disease state. This second study will investigate the safety and efficacy of QRX003 in Netherton Syndrome patients currently receiving off-label systemic therapy, primarily biologic therapy. This trial is expected to run concurrently with our ongoing clinical trial and will recruit patients who currently do not qualify for the ongoing trial.
During the quarter, we entered into our eighth international partnership agreement for QRX003. This latest partnership is with Endo Ventures Ltd, a subsidiary of Endo International Plc. Under the terms of the agreement, Endo Ventures has the exclusive right, which was sublicensed to its affiliate, Paladin Labs Inc., to commercialize QRX003 in Canada upon regulatory approval. With this latest agreement Quoin now has partnerships in place for QRX003 that cover 60 countries. We are continuing to work closely with our partners in those 60 countries to explore potential opportunities for the advancement of QRX003 into local Compassionate Use or Early Access Programs to facilitate the local availability of the product to Netherton Syndrome patients, in advance of formal regulatory approval.
Both of our research programs with Queensland University of Technology continue to make progress and we are targeting the initiation of clinical testing in 2023,” concluded Dr. Myers.
Recent Highlights
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 20-F filed with the SEC on April 14, 2022, and in other filings the Company has made and may make with the SEC in the future. 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, contact:
Investor Relations
PCG Advisory
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341
Quoin Pharmaceuticals Ltd. Consolidated Balance Sheets
September 30, | December 31, | |||||||||||
2022 | 2021 | |||||||||||
(Unaudited) | (Audited) | |||||||||||
ASSETS | ||||||||||||
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 | ||||||||||
Total assets | $ | 16,438,290 | $ | 9,356,851 | ||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||||
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: | ||||||||||||
Ordinary shares, no par value per share, 50,000,000,000 ordinary shares | $ | – | $ | – | ||||||||
authorized – 24,233,024,799 (4,846,605 ADS’s) | ||||||||||||
ordinary shares issued and outstanding at September 30, 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 | 47,615,475 | 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 | ||||||||
Quoin Pharmaceuticals Ltd. Consolidated Statements of Operations (Unaudited)
Nine months ended September 30, | Three months ended September 30, | ||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||
Operating expenses | |||||||||||||||||||
General and administrative | $ | 5,112,002 | $ | 2,525,366 | $ | 1,582,059 | $ | 1,042,783 | |||||||||||
Research and development | 2,059,769 | 556,064 | 745,506 | 259,996 | |||||||||||||||
Total operating expenses | 7,171,771 | 3,081,430 | 2,327,565 | 1,302,779 | |||||||||||||||
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 | (77,237 | ) | 4,522,844 | – | (146,808 | ) | |||||||||||||
Financing expense | – | 275,000 | – | – | |||||||||||||||
Unrealized loss | 3,053 | – | 3,053 | – | |||||||||||||||
Interest income | (15,132 | ) | – | (15,132 | ) | – | |||||||||||||
Interest and financing expense | 714,081 | 516,276 | 714,081 | 248,165 | |||||||||||||||
Total other expense | 208,765 | 6,564,120 | 702,002 | 101,357 | |||||||||||||||
Net loss | $ | (7,380,536 | ) | $ | (9,645,550 | ) | $ | (3,029,567 | ) | $ | (1,404,136 | ) | |||||||
Deemed dividend on warrant modification | (65,266 | ) | – | (65,266 | ) | – | |||||||||||||
Net loss attributable to shareholders | $ | (7,445,802 | ) | $ | (9,645,550 | ) | $ | (3,094,833 | ) | $ | (1,404,136 | ) | |||||||
Loss per ADS | |||||||||||||||||||
Loss per ADS | |||||||||||||||||||
Basic | $ | (4.65 | ) | $ | (40.14 | ) | $ | (0.94 | ) | $ | (5.84 | ) | |||||||
Fully-diluted | $ | (4.65 | ) | $ | (40.14 | ) | $ | (0.94 | ) | $ | (5.84 | ) | |||||||
Weighted average number of ADS’s outstanding | |||||||||||||||||||
Basic | 1,601,396 | 240,292 | 3,291,806 | 240,292 | |||||||||||||||
Fully-diluted | 1,601,396 | 240,292 | 3,291,806 | 240,292 |
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