Form 8-K

8-K — Quoin Pharmaceuticals, Ltd.

Accession: 0001104659-26-070501

Filed: 2026-06-04

Period: 2026-06-04

CIK: 0001671502

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2616916d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2616916d1_ex99-1.htm)

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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 ¨

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.

(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 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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2616916d1_ex99-1.htm · Sequence: 2

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

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