Full Press Release Details
Quoin Pharmaceuticals Announces Second Quarter
2025 Financial Results and Corporate Update
6 Month Clinical Data Reported for Ongoing Pediatric Netherton Syndrome Study
Clears Second Pivotal Study of QRX003 for Netherton Syndrome
Positive Data Announced from Peeling Skin Syndrome Pediatric Study
Drug Designation Granted by European Medicines Agency for QRX003
Pediatric Disease Designation Awarded by U.S. FDA
NOW Campaign Expanded with New Patient and Expert Video Releases
ASHBURN, Va., August 7, 2025
(GLOBE NEWSWIRE) - Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) ("Quoin" or the "Company"), a late clinical-stage
specialty pharmaceutical company focused on rare and orphan diseases provided a corporate update today on its clinical progress and advocacy
initiatives and announced its financial results for the second quarter ended June 30, 2025.
"Second quarter of 2025 was one
of the most impactful in Quoin's history, marked by meaningful progress on multiple fronts," said Dr. Michael Myers,
Chief Executive Officer of Quoin Pharmaceuticals. "We continue to be encouraged by the positive and durable clinical improvements
observed in our ongoing investigator-led pediatric Netherton Syndrome study. In addition, with the reporting of impressive Peeling Skin
Syndrome data during the quarter, we are beginning to see the versatility of QRX003 as a potentially safe and effective treatment for
a variety of rare skin diseases. We look forward to initiating additional studies in other indications in the coming months. From a regulatory
standpoint, receiving Orphan Drug Designation in Europe and Rare Pediatric Disease Designation in the United States are important milestones
for the Company which we believe will help accelerate the development of QRX003 and bring it to the patients who urgently need it. Additionally,
our NETHERTON NOW campaign continues to elevate awareness of the profound need for effective treatment options, reaching
millions of people with education, advocacy, and powerful stories that highlight the faces of patients living with this disease, their
family members who care for them and the clinicians who provide treatment for them each day without an FDA-approved therapy. With our
late-stage trials advancing and global engagement expanding, we remain fully focused on delivering the first approved therapy for Netherton
Corporate Highlights
Quoin continued to advance its lead clinical asset, QRX003, into pivotal
trials for Netherton Syndrome, a devastating and life-threatening genetic skin disorder with no approved therapies. The Company also made
important regulatory, clinical, and advocacy progress in the second quarter of 2025:
Quoin Pharmaceuticals announced positive clinical data from its ongoing
Investigator Pediatric Netherton Syndrome study. After six months of treatment with QRX003, significant improvements were observed in
the patient's skin condition, reduced itch, and no adverse events were reported.
released the second episode in its Living with Netherton video series, part of its broader NETHERTON NOW awareness campaign, highlighting
the daily challenges faced by patients and families living with Netherton Syndrome.
clinical data were announced from an investigator-led Pediatric Peeling Skin Syndrome (PSS) study. After 12 weeks of treatment with QRX003,
patients showed improvement in disease severity, skin condition, and quality of life metrics, with no adverse events reported.
received Orphan Drug Designation from the European Medicines Agency for QRX003, granting 10 years of market exclusivity in Europe upon
approval. This designation offers benefits like scientific advice on study protocols and fee reductions.
was announced for the initiation of a second pivotal clinical study (CL-QRX003-002) for QRX003, targeting Netherton Syndrome. The study
will include 12-15 subjects, with recruitment expected to conclude by the end of Q1 2026 and an NDA filing anticipated later in
FDA granted Rare Pediatric Disease Designation to QRX003 for the treatment of Netherton Syndrome, enabling potential Priority Review
Voucher eligibility upon marketing approval.
launched a new installment in its NETHERTON NOW campaign, featuring Professor Jemima Mellerio, a world-renowned expert in genetic
skin diseases. The video emphasized the severe burden of Netherton Syndrome in pediatric patients.
Financial Highlights
Quoin had approximately $7.8 million in cash, cash equivalents, and
marketable securities as of June 30, 2025. The Company believes this capital will support operations into the first quarter of 2026.
For the three and six months ended June 30, 2025, Quoin reported
a net loss of approximately $3.7 million and $7.5 million, respectively, compared to a net loss of approximately $2.0 million and $4.3
million, respectively, for the same periods in 2024. The increase in net loss was primarily due to an increase in research and development
expenditure in the three and six months ended June 30, 2025 of approximately $2.1 million and $4.4 million, respectively, compared
to $0.6 million and $1.5 million, respectively, for the same periods in 2024.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late 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, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations,
Angiofibroma and others. For more information, visit www.quoinpharma.com or LinkedIn for updates.
Cautionary Note Regarding Forward
The Company cautions that statements in this press release that are not descriptions 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,"
"hope," "plan," "potential," "anticipate," "look forward," "believe,"
"may," 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: continuing to be encouraged by the positive and durable clinical improvements observed in the Company's
ongoing investigator-led pediatric Netherton Syndrome study, beginning to see the versatility of QRX003 as a potentially safe and effective
treatment for a variety of rare skin diseases, initiating additional studies in other indications in the coming months, receiving Orphan
Drug Designation in Europe and Rare Pediatric Disease Designation in the United States helping to accelerate the development of QRX003
and bring it to the patients who urgently need it, the NETHERTON NOW campaign continuing to elevate awareness of the profound need for
effective treatment options, remaining fully focused on delivering the first approved therapy for Netherton Syndrome, concluding recruitment
of 12-15 subjects by the end of Q1 2026 for a second pivotal clinical study for QRX003, targeting Netherton Syndrome, filing an
NDA later in 2026, the Company's capital supporting its operations into the first quarter of 2026,and Quoin's products in
development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome,
Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, , Microcystic Lymphatic Malformations, Venous Malformations,
Angiofibroma and 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 including,
but not limited to, the Company's ability to deliver a safe and effective treatment for Netherton Syndrome; the Company's
ability to pursue its regulatory strategy; the Company's ability to obtain regulatory approvals for commercialization of product
candidates or to comply with ongoing regulatory requirements; the Company's ability to complete clinical trials on time and achieve
desired results and benefits as expected, the Company experiencing unanticipated or higher than
expected clinical trial costs;; and other factors discussed in the Company's Annual Report on Form 10-K for the year
ended December 31, 2024 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. 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:
Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
QUOIN PHARMACEUTICALS, LTD.
Consolidated Balance Sheets
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,668,492 | $ | 3,623,343 | ||||
| Investments | 6,121,830 | 10,433,535 | ||||||
| Prepaid expenses and other current assets | 688,933 | 869,126 | ||||||
| Total current assets | 8,479,255 | 14,926,004 | ||||||
| Prepaid expenses - long term | - | 300,000 | ||||||
| Intangible assets, net | 433,334 | 483,334 | ||||||
| Total assets | $ | 8,912,589 | $ | 15,709,338 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 873,684 | $ | 905,704 | ||||
| Accrued expenses | 1,717,564 | 1,528,977 | ||||||
| Accrued interest and financing expense | 1,146,251 | 1,146,251 | ||||||
| Due to officers - short term | 600,000 | 600,000 | ||||||
| Total current liabilities | 4,337,499 | 4,180,932 | ||||||
| Due to officers - long term | 2,023,733 | 2,323,733 | ||||||
| Total liabilities | $ | 6,361,232 | $ | 6,504,665 | ||||
| Commitments and contingencies | ||||||||
| Shareholders' equity: | ||||||||
| Ordinary shares, no par value per share, 100,000,000 authorized at March 31, 2025 and December 31, 2024, respectively - 20,585,830 (588,166 ADS's) ordinary shares issued and outstanding at June 30, 2025 and 8,948,164 (255,661 ADS's) ordinary shares issued and outstanding at December 31, 2024 | $ | - | $ | - | ||||
| Additional paid in capital | 65,225,266 | 64,370,465 | ||||||
| Accumulated deficit | (62,673,909 | ) | (55,165,792 | ) | ||||
| Total shareholders' equity | 2,551,357 | 9,204,673 | ||||||
| Total liabilities and shareholders' equity | $ | 8,912,589 | $ | 15,709,338 |
QUOIN PHARMACEUTICALS, LTD.
Consolidated Statements of Operations (Unaudited)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ | 1,742,594 | $ | 1,549,615 | $ | 3,325,632 | $ | 3,122,601 | ||||||||
| Research and development | 2,050,585 | 587,503 | 4,424,724 | 1,472,801 | ||||||||||||
| Total operating expenses | 3,793,179 | 2,137,118 | 7,750,356 | 4,595,402 | ||||||||||||
| Other (income) and expenses | ||||||||||||||||
| Unrealized loss | 6,004 | 2,177 | 5,878 | 8,686 | ||||||||||||
| Realized and accrued interest income | (103,245 | ) | (165,262 | ) | (248,117 | ) | (302,775 | ) | ||||||||
| Total other income | (97,241 | ) | (163,085 | ) | (242,239 | ) | (294,089 | ) | ||||||||
| Net loss | $ | (3,695,938 | ) | $ | (1,974,033 | ) | $ | (7,508,117 | ) | $ | (4,301,313 | ) | ||||
| Loss per ADS | ||||||||||||||||
| Basic | $ | (6.28 | ) | $ | (13.68 | ) | $ | (12.79 | ) | $ | (42.09 | ) | ||||
| Fully-diluted | $ | (6.28 | ) | $ | (13.68 | ) | $ | (12.79 | ) | $ | (42.09 | ) | ||||
| Weighted average number of ADS's outstanding | ||||||||||||||||
| Basic | 588,166 | 144,278 | 587,253 | 102,186 | ||||||||||||
| Fully-diluted | 588,166 | 144,278 | 587,253 | 102,186 |