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
Cash Runway to be further extended by
Quoin CEO, Dr.
“We have also strengthened our balance sheet through the recently completed
Recent Corporate Highlights –
- On
March 4 th, Quoin announced FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical studies. - On
February 8 th, 2024, Quoin filedU.S. and International patent applications for a novel Netherton Syndrome combination product. - On
December 13 th, Quoin announced FDA clearance of the Clinical Optimization Plan for QRX003 for Netherton Syndrome - On
October 24 th, Quoin announced positive clinical data from the first six evaluable patients in the company’s open-label clinical trial in Netherton Syndrome patients.- 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.
- 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.
- All six subjects expressed a favorable impression of QRX003 across multiple assessed metrics.
- 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 ofDecember 31, 2023 . This does not include the proceeds from the$6.5 million public offering of common shares that the company announced onMarch 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 endedDecember 31, 2022 . Net loss for the twelve months endedDecember 31, 2023 was$8.7 million compared to$9.4 million for the twelve months endedDecember 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 endedDecember 31, 2023 .
Quoin will host a conference call and webcast at
About
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
For further information:
PCG Advisory
sprince@pcgadvisory.com
(646) 863-6341
-Tables Follow-
Consolidated Balance Sheets
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 | ||||||
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 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 | $ | - | $ | - | ||||
ordinary shares issued and outstanding at | ||||||||
(403,887 ADS's) at | ||||||||
- | (2,932,000 | ) | ||||||
-0- ordinary shares issued at | ||||||||
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 | ||||
Consolidated Statements of Operations
Years Ended | Three months ended | ||||||||||||||
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 | |||||||||||
Source:
2024 GlobeNewswire, Inc., source