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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):
June 4, 2026
| QUOIN
PHARMACEUTICALS LTD. |
| (Translation of registrant’s name into English) |
| State of Israel |
|
001-37846 |
|
92-2593104 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
|
42127 Pleasant Forest Court
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 |
|
Trading
Symbol(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
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 7.01. Regulation
FD Disclosure.
On June 4, 2026,
Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that Japan’s Ministry
of Health, Labour and Welfare (“MHLW”) has granted Orphan Drug Designation to QRX003 lotion (4%) for the treatment of Netherton
Syndrome. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”)
and is incorporated by reference herein.
The information in this
Item 7.01 and Exhibit 99.1 attached hereto are furnished and shall not be deemed to be “filed” with the Securities
and Exchange Commission (the “SEC”) 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, nor shall such information be deemed incorporated
by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific
reference in such filing.
Item 8.01. Other Events.
Announcement of Orphan
Drug Designation from Japan’s MHLW for QRX003 lotion (4%) for the Treatment of Netherton Syndrome
On March 11, 2026,
the Company announced that Japan’s MHLW has granted Orphan Drug Designation to QRX003 lotion (4%) for the treatment of Netherton
Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments.
The MHLW grants Orphan
Drug Designation to medicines intended to treat rare diseases that affect fewer than 50,000 patients in Japan and for which there is high
unmet medical need. The designation provides certain development incentives, including prioritized consultation, reduced consultation
and application fees, tax incentives, priority review of applications, and up to 10 years of market exclusivity upon approval.
Item 9.01. Financial
Statements and Exhibits.
The following exhibits
are filed or furnished, as applicable, with this Report:
Exhibit
Number |
|
Description |
| |
|
|
| 99.1 |
|
Press Release of the Company, dated June 4, 2026 |
| 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: June 4, 2026 |
QUOIN PHARMACEUTICALS LTD. |
| |
|
| |
By: |
/s/ Michael Myers |
| |
Name: |
Dr. Michael Myers |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Quoin Pharmaceuticals Announces Japan's MHLW
Grants Orphan Drug Designation for QRX003 in Netherton Syndrome
-Designation provides regulatory and development
incentives in Japan, including up to 10 years of market exclusivity upon approval-
-Follows Orphan Drug Designation, Pediatric
Rare Disease Designation, and Fast Track Designation previously granted by the U.S. FDA, and Orphan Drug Designation previously granted
by the European Medicines Agency-
-Quoin is working closely with leading Japanese
clinicians to refine clinical and regulatory pathway for approval-
ASHBURN, Va., June 4, 2026 — Quoin Pharmaceuticals Ltd.
(NASDAQ: QNRX) ("Quoin" or the "Company"), a late clinical-stage specialty pharmaceutical company focused on rare
and orphan diseases, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation to
QRX003 for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments.
The MHLW grants Orphan Drug Designation to medicines intended to treat
rare diseases that affect fewer than 50,000 patients in Japan and for which there is high unmet medical need. The designation provides
certain development incentives, including prioritized consultation, reduced consultation and application fees, tax incentives, priority
review of applications, and up to 10 years of market exclusivity upon approval.
The MHLW designation adds to the global regulatory recognition QRX003
has received for Netherton Syndrome, which includes Orphan Drug Designation, Pediatric Rare Disease Designation, and Fast Track Designation
from the U.S. Food and Drug Administration, and Orphan Drug Designation from the European Medicines Agency. Quoin has also filed an application
for Breakthrough Medicine Designation with the Saudi Food and Drug Authority.
"Receiving Orphan Drug Designation from Japan's MHLW adds an additional
important regulatory milestone for QRX003 and its potential as a safe and effective treatment for Netherton Syndrome," said Dr. Michael
Myers, CEO of Quoin Pharmaceuticals. "Japan is a strategically important market for QRX003, and, along with the US and Western Europe,
is one of three core territories in which we plan to self-commercialize QRX003 and our other pipeline products, once approved. This designation
is another important step in that strategy and complements the regulatory recognition QRX003 has received in the United States and Europe."
QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body
clinical trials in patients with Netherton Syndrome. Quoin's pivotal Phase 3 study is expected to initiate in the second half of 2026,
with potential NDA filing in 2027. Quoin is working closely with leading Japanese clinicians to refine the clinical and regulatory pathway
for approval of QRX003 for the treatment of Netherton Syndrome.
About Netherton Syndrome
Netherton Syndrome is a rare, inherited skin disorder
caused by mutations in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and a heightened risk of infections
and allergic complications. Patients often experience widespread skin redness, scaling, persistent itching, and significant impairment
in quality of life. There are currently no FDA-approved therapies for the treatment of Netherton Syndrome, and treatment options are limited
to supportive care and off-label therapies.
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
is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and
orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome
and Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations, angiofibromas 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,” “look forward to,”
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: QRX003 ‘s potential as a safe and effective treatment for Netherton Syndrome; the strategic importance of
Japan as a market for QRX003; plans to self-commercialize QRX003 and Quoin’s other pipeline products in Japan, the US and Western
Europe, once approved; initiating Quoin's pivotal Phase 3 study in the second half of 2026, with potential NDA filing in 2027; working
closely with leading Japanese clinicians to refine clinical and regulatory pathway for approval of QRX003 for the treatment of Netherton
Syndrome;; and Quoin’s belief that its products in development collectively have the potential to target a broad number of rare
and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin
Syndrome, Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations, angiofibromas 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 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; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December
31, 2025 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 Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
