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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):
November 11, 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 November 11,
2025, Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the target
loading concentrations for its two topical rapamycin delivery technologies have been successfully achieved. 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 November 11,
2025, the Company announced that the target loading concentrations for its two topical rapamycin delivery technologies have been successfully
achieved. Specifically, a rapamycin loading concentration of 4% w/w has been achieved for the Company’s proprietary topical formulation,
while an even higher rapamycin concentration of 5% w/w has been formulated in a proprietary dermal patch system. The Company plans to
move forward with the manufacture of clinical trial and stability batches from at least one of the delivery technologies this quarter
with a view to commencing clinical testing in the first half of 2026. The initial clinical indications that have been identified by the
Company as targets include Microcystic Lymphatic Malformations and Venous Malformations among others. For each of these initial targets,
there are currently no FDA approved treatments or cures.
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: clinical trial and
stability batch manufacturing commencing in Q4 2025 and commencing clinical testing in 1H 2026 in a number of indications including microcystic
lymphatic malformations and venous malformations 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 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 November 11,
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: November 12, 2025 |
QUOIN PHARMACEUTICALS LTD. |
| |
|
| |
By: |
/s/ Michael Myers |
| |
Name: |
Dr. Michael Myers |
| |
Title: |
Chief Executive Officer |
