Quoin Pharmaceuticals Provides Corporate Update and Announces Fourth Quarter and 2023 Financial Results
March 13 2024 - 4:05PM
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.
- 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 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 |
|
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 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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