Quoin Pharmaceuticals Provides Corporate Update and Announces Second Quarter 2022 Financial Results
August 18 2022 - 7:00AM
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 second quarter of
2022 ended June 30, 2022.
Quoin CEO, Dr. Michael Myers, said, “Quoin has
made substantial clinical and operational progress over the past
few months. Most importantly, we are proud to have initiated our
clinical study for QRX003 in Netherton Syndrome, a rare and
devastating skin disease with no approved treatment or cure. We are
also expanding our product portfolio through the signing of a
research agreement to develop a product for the potential treatment
of scleroderma with Queensland University of Technology (QUT),
further strengthening Quoin’s total commitment to the development
of safe and effective treatments for underserved rare and orphan
disease patient populations.
During the quarter, we also continued to expand
our established global network of licensing and distribution
partnerships for QRX003 to what is now eight agreements spanning 60
countries, further supporting our mission of ensuring that every
patient, everywhere, may be able to access to our products, once
approved.
Recent highlights
- In June 2022, Quoin Pharmaceuticals
Inc., a wholly owned subsidiary of the Company (“Quoin Inc.”),
secured exclusive licensing and distribution agreements with
WinHealth Investment (HK) Limited, enabling Quoin to provide
healthcare professionals and patients in Greater China, including
Hong Kong, Macau and Taiwan, with access to its products upon
receiving regulatory approval. Quoin has now established a global
network of eight marketing partnerships for QRX003 that spans 60
countries, including Greater China, the Middle East, Canada,
Australia and New Zealand, some countries in Latin America, as well
as Central and Eastern Europe and Turkey.
- In May 2022, Quoin Inc. signed a
research agreement with the Queensland University of Technology
(QUT), Australia for the development of a potential treatment for
scleroderma, a severe and sometimes fatal rare skin disease.
- In April 2022, the Company received
U.S. Food and Drug Administration (FDA) clearance to initiate
clinical testing for its Investigational New Drug (IND) application
for QRX003, the Company’s investigational product for Netherton
Syndrome.
- In July 2022, Quoin announced that
the first clinical site for its clinical study to evaluate QRX003
for the treatment of the rare genetic disease, Netherton Syndrome,
had been opened. The study is a randomized, double blinded, placebo
-controlled study being conducted under a U.S. Investigational New
Drug (IND) Application and will assess two different doses of
QRX003 topical lotion versus a placebo lotion in Netherton
patients. The test materials will be applied once daily over a
twelve-week period, to pre-designated areas of the patient’s body.
Based on discussions with the FDA, a number of different clinical
endpoints will be assessed in the study. The opening of additional
sites and patient recruitment is underway.
- In July 2022, Quoin announced that
it received constructive and comprehensive Scientific Advice from
the European Medicines Agency (EMA) regarding the clinical and
regulatory requirements for the development of QRX003 as a
potential treatment for Netherton Syndrome in Europe.
- Quoin ended the second quarter with approximately $2.7 million
in cash. Net loss for the second quarter was approximately $2.7
million. On August 9, 2022, the Company completed an upsized $16.8
million public offering of ordinary shares represented by ADSs and
warrants, with net proceeds of approximately $15.0 million.
- The Company previously announced that, on April 22, 2022, it
received a letter from the Listing Qualifications staff (the
“Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying it
that the Company was no longer in compliance with the minimum $2.5
million stockholders’ equity requirement for continued listing on
The Nasdaq Capital Market. Based on the Company’s Form 6-K, dated
August 10, 2022, the Staff has determined that the Company complies
with this requirement. The Company also previously reported that,
on June 10, 2022, the Staff notified the Company that its ADSs
failed to maintain a minimum bid price of $1.00 over the previous
30 consecutive business days as required by the Nasdaq Listing
Rules. Since then, the Staff has determined that for the 10
consecutive business days, from August 1 to August 12, 2022, the
closing bid price of the Company’s ADSs has been at $1.00 per ADS
or greater, and the Company has regained compliance with the
minimum bid price requirement.
Investors are encouraged to read the Company’s
Form 6-K when it is furnished to the Securities and Exchange
Commission (the “SEC”), which will contain additional details about
Quoin’s financial results as of, and for the three and six-month
periods ended, June 30, 2022.
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 RelationsPCG AdvisoryStephanie
Princesprince@pcgadvisory.com(646) 863-6341
Quoin Pharmaceuticals
Ltd. Consolidated Balance Sheets
(Unaudited)
|
|
June 30, |
|
|
December 31, |
|
|
2022 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash |
|
$ |
2,687,847 |
|
|
$ |
7,482,773 |
|
Prepaid expenses |
|
|
826,803 |
|
|
|
1,015,474 |
|
Total current assets |
|
|
3,514,650 |
|
|
|
8,498,247 |
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
756,583 |
|
|
|
808,604 |
|
Other assets |
|
|
50,000 |
|
|
|
50,000 |
|
Total assets |
|
$ |
4,321,233 |
|
|
$ |
9,356,851 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' DEFICIT |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
768,670 |
|
|
$ |
923,239 |
|
Accrued expenses |
|
|
1,864,794 |
|
|
|
1,685,409 |
|
Accrued license acquisition |
|
|
- |
|
|
|
250,000 |
|
Accrued interest |
|
|
432,170 |
|
|
|
743,840 |
|
Due to officers – short term |
|
|
600,000 |
|
|
|
600,000 |
|
Warrant liability |
|
|
- |
|
|
|
373,599 |
|
Total current liabilities |
|
|
3,665,634 |
|
|
|
4,576,087 |
|
Due to officers – long term |
|
|
3,823,733 |
|
|
|
4,123,732 |
|
Total liabilities |
|
$ |
7,489,367 |
|
|
$ |
8,699,819 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders' (deficit) equity: |
|
|
|
|
|
|
|
Ordinary shares, no par value per share, 50,000,000,000 ordinary
shares authorized – 5,065,154,799 (1,013,031 ADSs) |
|
$ |
- |
|
|
$ |
- |
|
ordinary shares issued and outstanding at June 30, 2022 and
3,354,650,799 (670,930 ADSs) at December 31, 2021 |
|
|
|
|
|
|
|
Treasury Stock, 2,641,693 ordinary shares |
|
|
(2,932,000 |
) |
|
|
(2,932,000 |
) |
Additional paid in capital |
|
|
32,184,820 |
|
|
|
31,659,017 |
|
Accumulated deficit |
|
|
(32,420,954 |
) |
|
|
(28,069,985 |
) |
Total shareholders' (deficit) equity |
|
|
(3,168,134 |
) |
|
|
657,032 |
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity |
|
$ |
4,321,233 |
|
|
$ |
9,356,851 |
|
QUOIN PHARMACEUTICALS LTD.
Quoin Pharmaceuticals Ltd Consolidated Statements
of Operations (Unaudited)
|
|
Three months ended June 30, |
|
|
|
|
Six months ended June 30, |
|
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
1,941,473 |
|
|
|
$ |
737,610 |
|
|
|
|
|
|
3,529,943 |
|
|
$ |
1,482,583 |
|
|
Research and development |
|
|
726,694 |
|
|
|
|
239,280 |
|
|
|
|
|
|
1,314,263 |
|
|
|
296,068 |
|
|
Total operating expenses |
|
|
2,668,167 |
|
|
|
|
976,890 |
|
|
|
|
|
|
4,844,206 |
|
|
|
$ |
1,778,651 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expenses (income) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forgiveness of trade payable |
|
|
- |
|
|
|
|
- |
|
|
|
|
|
|
(416,000 |
) |
|
|
|
- |
|
|
Fair value adjustment to convertible notes payable |
|
|
- |
|
|
|
|
750,000 |
|
|
|
|
|
|
- |
|
|
|
|
1,250,000 |
|
|
Change in fair value of warrant liability |
|
|
- |
|
|
|
|
2,223,139 |
|
|
|
|
|
|
(77,237 |
) |
|
|
|
4,669,652 |
|
|
Financing expense |
|
|
- |
|
|
|
|
185,000 |
|
|
|
|
|
|
- |
|
|
|
|
275,000 |
|
|
Interest expense |
|
|
- |
|
|
|
|
202,514 |
|
|
|
|
|
|
- |
|
|
|
|
268,111 |
|
|
Total other expense (income) |
|
|
- |
|
|
|
|
3,360,653 |
|
|
|
|
|
|
(493,237 |
) |
|
|
|
6,462,763 |
|
|
Net loss |
|
$ |
(2,668,167 |
) |
|
|
$ |
(4,337,543 |
) |
|
|
|
|
$ |
(4,350,969 |
) |
|
|
$ |
(8,241,414 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
ADS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ADS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(3.24 |
) |
|
|
$ |
(18.05 |
) |
|
|
|
|
$ |
(5.83 |
) |
|
|
$ |
(34.30 |
) |
|
Fully-diluted |
|
$ |
(3.24 |
) |
|
|
$ |
(18.05 |
) |
|
|
|
|
$ |
(5.83 |
) |
|
|
$ |
(34.30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
ADSs outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
822,877 |
|
|
|
|
240,292 |
|
|
|
|
|
|
746,903 |
|
|
|
|
240,292 |
|
|
Fully-diluted |
|
|
822,877 |
|
|
|
|
240,292 |
|
|
|
|
|
|
746,903 |
|
|
|
|
240,292 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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