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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 20, 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 October 20, 2026,
Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing the publication of a peer-reviewed
manuscript titled “An Investigational Mechanism-Informed Therapy for Netherton Syndrome: Introduction to QRX003 and a Pediatric
Compassionate-Use Case Report” in Dermatology and Therapy.. 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 is furnished and 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, 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 20, 2026,
the Company announced the publication of a peer-reviewed manuscript titled “An Investigational Mechanism-Informed Therapy for Netherton
Syndrome: Introduction to QRX003 and a Pediatric Compassionate-Use Case Report” in Dermatology and Therapy. The peer-reviewed paper
introduces QRX003, the Company’s investigational topical serine protease inhibitor lotion, and describes its mechanism of action
in Netherton Syndrome. It also presents a case report from Professor Alan Irvine, consultant dermatologist at Children’s Health
Ireland and professor of dermatology at Trinity College Dublin, describing his positive clinical experience treating a pediatric patient
with QRX003 under Quoin’s Pediatric Compassionate Use Program
The case report describes
a pediatric patient with genetically confirmed Netherton Syndrome treated with once-daily, whole-body application of QRX003 on a compassionate-use
basis, added to the patient’s existing treatment plan. After six weeks, the patient’s Investigator’s Global Assessment
(IGA) score improved from 4 (severe) at baseline to 1 (almost clear), and itch, as measured by the Worst Itch Numeric Rating Scale (WI-NRS),
was reduced from 5 to 1. By eight months, IGA was 0 (clear) and WI-NRS was 0 (no itch). Over 21 months of treatment, the patient remained
mostly at IGA 0, with occasional episodes recorded at IGA 1. During the treatment period, the patient discontinued previously required
medications, including antihistamines, glucocorticoids and antivirals, has not required antibiotics since whole-body application began,
and is experiencing no sleep disturbances related to Netherton Syndrome. No adverse events considered treatment-related were reported
by the family or treating physician. The case represents the first use of QRX003 in a pediatric patient and the longest continuous exposure
to QRX003 to date.
The authors note that
these single-patient observations are consistent with a possible treatment-associated effect, and that ongoing clinical trials will further
evaluate the safety and efficacy of QRX003.
Separately, in August
Quoin reported positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in Netherton Syndrome. In
the interim analysis of the first six participants to complete 12 weeks of treatment, four of six (66.7%) achieved the primary endpoint
of a 1-grade or greater improvement in Investigator Global Assessment (p=0.0087 vs. a pre-specified alpha of 0.0215). Quoin expects to
complete recruitment of all 20 participants in CL-QRX003-004 by the end of 2026 and report topline data in the second quarter of 2027.
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 October 20, 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: October 20, 2026 |
QUOIN PHARMACEUTICALS LTD. |
| |
|
| |
By: |
/s/ Michael Myers |
| |
Name: |
Dr. Michael Myers |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Quoin Pharmaceuticals
Announces Publication of Peer-Reviewed Paper on QRX003 for Netherton Syndrome in Dermatology and Therapy
– Peer-Reviewed
Paper Introducing QRX003 and Its Mechanism of Action in Netherton Syndrome Now Published
– Case
Report Details 21 Months of Compassionate Use Treatment in a Pediatric Patient
– Patient’s
Skin Improved from Severe to Clear with Complete Elimination of Pruritus (itch)
– After
21 Months of Treatment with QRX003, Patient’s Skin Remains Fully Clear and Pruritus Free
– No Adverse
Events have Been Reported for the Patient
– Full
Recruitment in Ongoing Phase 2/3 Netherton Syndrome Study Expected to Complete by End of 2026, with Topline Data Expected in Q2 2027
ASHBURN, Va., October 20,
2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage
specialty pharmaceutical company focused on rare and orphan diseases, today announced the publication of a peer-reviewed manuscript titled
“An Investigational Mechanism-Informed Therapy for Netherton Syndrome: Introduction to QRX003 and a Pediatric Compassionate-Use
Case Report” in Dermatology and Therapy. The paper was published online on October 13, 2026, is open access, and is available
at: https://doi.org/10.1007/s13555-026-01948-y
The peer-reviewed
paper introduces QRX003, the Company’s investigational topical serine protease inhibitor lotion, and describes its mechanism of
action in Netherton Syndrome. It also presents a case report from Professor Alan Irvine, consultant dermatologist at Children’s
Health Ireland and professor of dermatology at Trinity College Dublin, describing his positive clinical experience treating a pediatric
patient with QRX003 under Quoin’s Pediatric Compassionate Use Program.
The case report
describes a pediatric patient with genetically confirmed Netherton Syndrome treated with once-daily, whole-body application of QRX003
on a compassionate-use basis, added to the patient’s existing treatment plan. After six weeks, the patient’s Investigator’s
Global Assessment (IGA) score improved from 4 (severe) at baseline to 1 (almost clear), and itch, as measured by the Worst Itch Numeric
Rating Scale (WI-NRS), was reduced from 5 to 1. By eight months, IGA was 0 (clear) and WI-NRS was 0 (no itch). Over 21 months of treatment,
the patient remained mostly at IGA 0, with occasional episodes recorded at IGA 1. During the treatment period, the patient discontinued
previously required medications, including antihistamines, glucocorticoids and antivirals, has not required antibiotics since whole-body
application began, and is experiencing no sleep disturbances related to Netherton Syndrome. No adverse events considered treatment-related
were reported by the family or treating physician. The case represents the first use of QRX003 in a pediatric patient and the longest
continuous exposure to QRX003 to date.
The authors note
that these single-patient observations are consistent with a possible treatment-associated effect, and that ongoing clinical trials will
further evaluate the safety and efficacy of QRX003.
Separately, in
August Quoin reported positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in Netherton Syndrome.
In the interim analysis of the first six participants to complete 12 weeks of treatment, four of six (66.7%) achieved the primary endpoint
of a 1-grade or greater improvement in Investigator Global Assessment (p=0.0087 vs. a pre-specified alpha of 0.0215). Quoin expects to
complete recruitment of all 20 participants in CL-QRX003-004 by the end of 2026 and report topline data in the second quarter of 2027.
“Publication
of this paper makes the scientific rationale behind QRX003, and Professor Irvine’s clinical experience with it, available to the
broader dermatology and Netherton communities. Netherton Syndrome remains unfamiliar to many physicians, and peer-reviewed evidence such
as this plays an important role in building awareness of the disease and of new approaches to treating it,” said Dr. Michael Myers,
Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals. “We are grateful to the patient and family for allowing this experience
to be shared. This case report adds to a growing body of clinical evidence for QRX003, from our pediatric compassionate use program to
the positive interim results from our ongoing Phase 2/3 study. We look forward to completing recruitment in that study by the end of
this year.”
About Netherton Syndrome
Netherton Syndrome
is a rare, serious genetic skin disease caused by mutations in the SPINK5 gene. The condition is characterized by impaired skin barrier
function, persistent inflammation, and increased serine protease activity in the skin. There are currently no approved therapies in the
United States indicated specifically for Netherton Syndrome.
About QRX003
QRX003 is an investigational
topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has
been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug
Designation in the European Union and Japan. QRX003 lotion (4%) is currently being evaluated in whole-body clinical trials in patients
with Netherton Syndrome, including the Phase 2/3 study CL-QRX003-004.
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 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.
This press release contains forward-looking statements. 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: ongoing clinical trials further evaluating the safety and efficacy of QRX003; the timing of completing participant
recruitment and reporting topline data for the Company’s ongoing Phase 2/3 Netherton Syndrome study; publication of the aforementioned
paper making the scientific rationale and clinical experience associated with QRX003 available to the broader dermatology and Netherton
communities; and the role of peer-reviewed evidence in building awareness of Netherton Syndrome and its treatment; 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.
Dr. Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
