Form 8-K

8-K — Quoin Pharmaceuticals, Ltd.

Accession: 0001104659-26-057140

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001671502

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2613938d1_8k.htm (Primary)

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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):

May 7, 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 2.02 Results of Operations and Financial

Condition.

On May 7, 2026 Quoin

Pharmaceuticals Ltd. (the “Company”) announced its first quarter 2026 financial results. A copy of the Company’s press

release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

The information set forth and incorporated by reference in this Item

2.02 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, and the Company

does not incorporate it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release, dated May 7, 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: May 7, 2026

QUOIN PHARMACEUTICALS LTD.

By:

/s/ Sally Lawler

Name:

Sally Lawler

Title:

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2613938d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Quoin Pharmaceuticals Provides Corporate Update and Reports First

Quarter 2026 Financial Results

– Filed Breakthrough Medicine Designation Application with

Saudi FDA for QRX003 in Netherton Syndrome

– Submitted Application to Japanese MHLW for Orphan Drug Designation

(ODD) for QRX003; MHLW Confirmed QRX003 Qualifies for Both Orphan Drug Designation and Fast Track Review

– U.S. FDA Granted Fast Track Designation to QRX003 lotion

(4%) for the treatment of Netherton Syndrome, Complementing Previously Granted Orphan Drug and Rare Pediatric Disease Designations

– Constructive Type C Meeting with FDA: Single Phase 3 Study

May Be Sufficient to Support U.S. Marketing Approval; FDA Open to Trial Design Without Traditional Vehicle or Placebo Control

– Rare Pediatric Disease Priority Review Voucher Program Extended

by Congress Through September 30, 2029

– On Track to Complete Phase 3 Patient Recruitment by End

of 2026, with Potential NDA Filing in 2027 for QRX003 as the First Approved Treatment for Netherton Syndrome

ASHBURN, Va., May 7, 2026 (GLOBE NEWSWIRE) — Quoin Pharmaceuticals

Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on

rare and orphan diseases, today announced recent corporate achievements and provided an update on its first quarter 2026 progress for

the period ended March 31, 2026.

“The first quarter of 2026 delivered meaningful regulatory progress

on a number of fronts for QRX003 for Netherton Syndrome,” said Dr. Michael Myers, Chief Executive Officer and Co-Founder of

Quoin Pharmaceuticals. “In the United States, we were granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).

In addition, we had a constructive Type C meeting with FDA where the agency indicated that a single Phase 3 study may be sufficient to

support marketing approval, with expressed openness to an alternative study design for Phase 3 that would likely not include a traditional

upfront vehicle or placebo control. In Japan, we submitted our Orphan Drug Designation application following confirmation from MHLW that

QRX003 qualifies for both ODD and Fast Track review. In Saudi Arabia, we filed for Breakthrough Medicine Designation, which could expedite

the path to patient access, if granted. We also remain on track to complete Phase 3 recruitment this year and potentially file for NDA

approval in 2027. On top of this, we have made substantial progress this year with our QRX009 topical rapamycin platform. Through engagement

with KOLs and advocacy foundations, we are now in a position to initiate clinical testing in a number of indications later this year including

investigator studies for Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex. We are also planning to submit an Investigational

New Drug (IND) Application to the FDA for QRX009 for an additional indication by Q3 of this year. We believe the combination of our QRX003

platform for Netherton Syndrome and related diseases combined with our QRX009 topical rapamycin platform represents an intriguing value

proposition for investors and we look forward to sharing more information on both throughout this year."

First Quarter 2026 Highlights

Regulatory Progress for QRX003 in Netherton Syndrome:

On January 20, 2026,

Quoin filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003. If granted,

the designation could enable accelerated regulatory review and availability in Saudi Arabia. Quoin has an established distribution partnership

with Genpharm for QRX003 in Saudi Arabia and other MENA countries.

On January 27, 2026,

Quoin submitted an application to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking Orphan Drug Designation for QRX003. MHLW

confirmed that QRX003 qualifies for both Orphan Drug Designation and Fast Track review in Japan. The Company has also initiated the establishment

of a Japanese subsidiary to facilitate self-commercialization of QRX003 in Japan, if approved.

On February 3, 2026,

the U.S. Rare Pediatric Disease Priority Review Voucher (PRV) program was extended by Congress through September 30, 2029 as part

of the Give Kids a Chance Reauthorization Act. QRX003 previously received Rare Pediatric Disease Designation from the FDA in June 2025.

Upon approval of QRX003, Quoin would be eligible to receive a Priority Review Voucher, which if awarded may be used to obtain priority

review for another product or sold or transferred.

On March 11, 2026,

the U.S. FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome. Fast Track status enables

more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated

Approval and Priority Review, if relevant criteria are met.

On March 25, 2026,

Quoin provided a clinical and regulatory update from its constructive Type C meeting with the FDA for QRX003 in Netherton Syndrome. The

FDA indicated that a single Phase 3 study may be sufficient to support marketing approval in the U.S. and expressed openness to an alternative

study design, such as a randomized withdrawal or randomized delayed start, that would likely not include a traditional upfront vehicle

or placebo control. Quoin will submit clinical data from the ongoing Phase 2 and pediatric investigator studies and plans to request

a meeting to discuss this data with the FDA prior to initiating the Phase 3 pivotal program to gain alignment on the design of the program.

Quoin remains on track to complete patient recruitment into its Phase 3 program by the end of 2026 and to potentially file for FDA approval

for QRX003 as the first treatment for Netherton Syndrome in 2027.

On April 28, 2026,

Quoin provided a clinical and regulatory update for its QRX009 topical rapamycin development program, announcing the planned initiation

of an investigator-led clinical study in Pachyonychia Congenita led by Professor Edel O’Toole, Queen Mary University of London

as well as additional investigator-led studies in Gorlin Syndrome and Tuberous Sclerosis Complex. In addition, Quoin is targeting to

submit an IND to the FDA for QRX009 for an additional indication in Q3 of 2026.

Clinical Development:

QRX003 lotion (4%) continues to be evaluated in late-stage whole-body

clinical trials for the treatment of Netherton Syndrome, with topline data anticipated in the second half of 2026. The ongoing pediatric

investigator-led study has been expanded to six children actively being treated with QRX003 in Ireland, Austria, the Netherlands, and

New Zealand, representing the largest pediatric cohort of this age group ever studied in Netherton Syndrome.

Pipeline Programs:

Additional QRX003 Indications: Quoin continues to advance its Peeling

Skin Syndrome (PSS) program, with the ongoing investigator-led study being expanded to six subjects. The Company plans to submit an IND

to the FDA for PSS in Q2 of 2026.

QRX009 Development: Quoin also continues to advance its proprietary

topical rapamycin platforms, which have achieved target loadings of 4% and 5% for the topical lotion and dermal patch, respectively. Investigator-led

clinical studies are being planned for a number of indications including Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis

Complex and the Company is planning to submit an IND to the FDA for QRX009 for an additional indication before the end of Q3 of this year.

Awareness and Advocacy:

On February 26, 2026,

in recognition of Rare Disease Day 2026, Quoin highlighted continued momentum of its NETHERTON NOW awareness campaign, which has reached

nearly 2 million video views and more than 24 million impressions globally since launch.

Financial Highlights

Quoin had approximately $14 million in cash, cash equivalents and marketable

securities as of March 31, 2026. The Company believes its current cash position will fund operations into 2027.

Net loss for the quarter ended March 31, 2026, was approximately

$5 million compared to approximately $3.8 million for the quarter ended March 31, 2025.

Investors are encouraged to read the Company's Quarterly Report on

Form 10-Q when filed with the Securities and Exchange Commission, which will contain additional details about Quoin's financial results

as of and for the period ended March 31, 2026.

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, PC, GS, TSC, 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: a single Phase 3 study being sufficient to support US marketing approval

of QRX003 for Netherton Syndrome; the FDA being open to a trial design that would likely not include a traditional upfront vehicle or

placebo control; a Breakthrough Medicine Designation expediting the path to patient access in Saudi Arabia; being in a position to initiate

clinical testing for QRX009 in a number of indications later this year, including investigator studies for Pachyonychia Congenita, Gorlin

Syndrome and Tuberous Sclerosis Complex; plans to submit an IND Application to the FDA for an additional indication by the Q3 of this

year; the combination of the Company’s QRX003 platform for Netherton Syndrome and related diseases combined with its QRX009 topical

rapamycin platform representing an intriguing value proposition for investors; sharing more information on both throughout this year;

establishing a Japanese subsidiary to facilitate self-commercialization of QRX003 in Japan, if approved; submitting clinical data from

the Company’s ongoing Phase 2 and pediatric investigator studies; requesting a meeting with the FDA to discuss the data prior to

initiating the Phase 3 pivotal program to gain alignment on the design of the program; remaining on track to complete patient recruitment

into the Company’s Phase 3 program by the end of 2026; filing for FDA approval for QRX003 as the first treatment for Netherton Syndrome

in 2027; continuing to evaluate QRX003 lotion in late-stage whole-body clinical trials for the treatment of Netherton Syndrome, with topline

data anticipated in the second half of 2026; continuing to advance the Company’s PSS program; plans to submit an IND Application

to the FDA for PSS in the Q2 2026; the Company’s current cash position funding operations into 2027; 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, PC, GS, TSC, 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

-Tables to follow-

QUOIN PHARMACEUTICALS, LTD.

Consolidated Balance Sheets

March 31,

December 31,

2026

2025

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$ 3,124,522

$ 3,818,096

Investments

10,918,778

14,927,165

Prepaid expenses and other current assets

1,291,256

1,261,974

Total current assets

15,334,556

20,007,235

Intangible assets, net

358,334

383,334

Total assets

$ 15,692,890

$ 20,390,569

LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:

Accounts payable

$ 1,776,231

$ 1,262,222

Accrued expenses

1,823,544

2,538,457

Accrued interest and financing expense

1,146,251

Due to officers - short term

600,000

Total current liabilities

5,346,026

5,546,930

Due to officers - long term

1,573,733

1,723,733

Total liabilities

$ 6,919,759

$ 7,270,663

Commitments and contingencies

Shareholders' equity:

Ordinary shares, no par value per share, 5,000,000,000 authorized at March 31, 2026 and December 31, 2025, respectively - 68,642,195 (1,961,206 ADS's) ordinary shares issued and outstanding at March 31, 2026 and 52,441,360 (1,498,325 ADS's) ordinary shares issued and outstanding at December 31, 2025

$ -

Accumulated other comprehensive loss

(159 )

(613 )

Additional paid in capital

84,741,473

84,090,966

Accumulated deficit

(75,968,183 )

(70,970,447 )

Total shareholders' equity

8,773,131

13,119,906

Total liabilities and shareholders' equity

$ 15,692,890

$ 20,390,569

QUOIN PHARMACEUTICALS, LTD.

Consolidated Statement of Operations & Other Comprehensive Loss (Unaudited)

Three months ended March 31,

2026

2025

Operating expenses

General and administrative

$ 1,697,448

$ 1,583,038

Research and development

3,433,763

2,374,139

Total operating expenses

5,131,211

3,957,177

Other (income) and expenses

Unrealized gain (loss)

13,300

(126 )

Realized and accrued interest income

(146,775 )

(144,872 )

Total other income

(133,475 )

(144,998 )

Net loss

$ (4,997,736 )

$ (3,812,179 )

Deemed dividend on warrant modification

Net loss

$ (4,997,736 )

$ (3,812,179 )

Other comprehensive loss

Foreign currency translation

454

Comprehensive loss

$ (4,997,282 )

$ (3,812,179 )

Loss per ADS

Basic

$ (1.77 )

$ (6.50 )

Fully-diluted

$ (1.77 )

$ (6.50 )

Weighted average number of ADS's outstanding

Basic

2,830,970

586,331

Fully-diluted

2,830,970

586,331

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dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration