8-K
Quoin Pharmaceuticals, Ltd. (QNRX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 7, 2025
| QUOIN PHARMACEUTICALS LTD. | ||
|---|---|---|
| (Translation of registrant’s name into English) | ||
| State of Israel | 001-37846 | 92-2593104 |
| --- | --- | --- |
| (State or other jurisdiction<br><br>of incorporation) | (Commission File Number) | (I.R.S. Employer<br><br>Identification No.) |
| 42127 Pleasant Forest Court<br><br> <br>Ashburn, VA | 20148-7349 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code:
(703) 980-4182
| Not applicable |
|---|
| (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | TradingSymbol(s) | Name of each exchange on which registered |
|---|---|---|
| American Depositary Shares, each representing Thirty-five (35) Ordinary Shares, no par value per share | QNRX | The Nasdaq Stock Market LLC |
| Ordinary Shares, no par value per share* | N/A | |
| * | Not for trading, but only in connection with the registration of the American Depositary Shares pursuant<br>to requirements of the Securities and Exchange Commission. | |
| --- | --- |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 Results of Operations and FinancialCondition.
On August 7, 2025 Quoin Pharmaceuticals Ltd. (the “Company”) announced its second quarter financial results. A copy of the Company’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.
The information set forth and incorporated by reference in this Item 2.02 shall not be deemed to be “filed” with the Securities and Exchange Commission for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and the Company does not incorporate it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit<br><br>No. | Description |
|---|---|
| 99.1 | Press Release, dated August 7, 2025 |
| 104 | Cover Page Interactive Data file (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| Date: August 7, 2025 | QUOIN PHARMACEUTICALS LTD. | |
|---|---|---|
| By: | /s/ Michael Myers | |
| Name: | Dr. Michael Myers | |
| Title: | Chief Executive Officer |
Exhibit 99.1
Quoin Pharmaceuticals Announces Second Quarter2025 Financial Results and Corporate Update
Positive6 Month Clinical Data Reported for Ongoing Pediatric Netherton Syndrome Study
FDAClears Second Pivotal Study of QRX003 for Netherton Syndrome
InitialPositive Data Announced from Peeling Skin Syndrome Pediatric Study
OrphanDrug Designation Granted by European Medicines Agency for QRX003
RarePediatric Disease Designation Awarded by U.S. FDA
NETHERTONNOW 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 Syndrome."
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:
April 2, 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.
April 10, 2025
Quoin 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.
May 14, 2025
Positive 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.
May 20, 2025
The Company 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.
May 22, 2025
FDA clearance 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 2026.
June 24, 2025
The FDA granted Rare Pediatric Disease Designation to QRX003 for the treatment of Netherton Syndrome, enabling potential Priority Review Voucher eligibility upon marketing approval.
June 26, 2025
Quoin 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
Cash Position:
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.
Net Loss:
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 ForwardLooking Statements
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:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Contact:
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
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<br> months ended June 30, | Six<br> 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<br> 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 |