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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):
October 21, 2025
| 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 October 21, 2025,
Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the U.S. Food and
Drug Administration (the “FDA”) has granted Orphan Drug Designation to the Company’s lead product candidate, QRX003,
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.
On October 21, 2025,
the Company announced that the FDA has granted Orphan Drug Designation to the Company’s lead product candidate, QRX003, for the
treatment of Netherton Syndrome. The designation follows previously granted Orphan Drug Designation by the European Medicines Agency (the
“EMA”) in May 2025.
The FDA’s Orphan
Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that
affect fewer than 200,000 people in the United States. This designation provides certain benefits, including tax credits for qualified
clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved. QRX003 is on track
to potentially become the first approved treatment for Netherton Syndrome.
QRX003 lotion (4%) is
being evaluated in two late-stage whole body pivotal clinical trials for Netherton Syndrome. Enrollment in both pivotal studies is expected
to be completed in the first quarter of 2026, top-line data is anticipated in the second half of 2026, and a new drug application (“NDA”)
submission is planned later in the year.
Cautionary Note
Regarding Forward Looking Statements
The Company cautions
that statements in this Report 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: QRX003 being on
track to potentially become the first approved treatment for Netherton Syndrome, the progress of the Company’s clinical trials,
and the timing of trial results and regulatory submissions. 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 timing of the Company’s clinical studies may be delayed 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.
Item 9.01. Financial
Statements and Exhibits.
(d) Exhibits.
The following exhibits
are filed or furnished, as applicable, with this Report:
|
Exhibit
Number |
|
Description |
| |
|
|
| 99.1 |
|
Press Release
of the Company, dated October 21, 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: October 21, 2025 |
QUOIN PHARMACEUTICALS LTD. |
| |
|
| |
By: |
/s/ Michael Myers |
| |
Name: |
Dr. Michael Myers |
| |
Title: |
Chief Executive Officer |
