Form 8-K

8-K — Quoin Pharmaceuticals, Ltd.

Accession: 0001104659-26-097094

Filed: 2026-08-14

Period: 2026-08-14

CIK: 0001671502

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2623115d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2623115d1_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):

August 14, 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 August 14, 2026 Quoin Pharmaceuticals

Ltd. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy

of the press release is furnished with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

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 August 14,

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: August 14, 2026

QUOIN PHARMACEUTICALS LTD.

By:

/s/ Sally Lawlor

Name:

Sally Lawlor

Title:

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2623115d1_ex99-1.htm · Sequence: 2

Exhibit

99.1

Quoin

Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2026 Financial Results

–

Receives FDA Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome

–

Reports Positive Clinical Update from Ongoing Pediatric Compassionate Use Program in Netherton Syndrome

–

Receives U.S. Notice of Allowance for a Patent Covering a Combination Treatment for Netherton Syndrome

–

Submits First-Ever IND for Peeling Skin Syndrome; FDA Clearance Received Subsequent to Quarter End, Enabling First Company-Sponsored

Phase 2/3 Study to Initiate in 2H 2026

–

Advances QRX009 Topical Rapamycin Platform Toward Clinical Testing in a number of indications

ASHBURN, Va., August 14, 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 progress for the second quarter

ended June 30, 2026.

“The

second quarter was a highly productive period across both of our delivery technology platforms,” said Dr. Michael Myers, Chief

Executive Officer and Co-Founder of Quoin Pharmaceuticals. “Our Ichthyosis focused platform, QRX003 continued to advance toward

pivotal development in Netherton Syndrome while expanding into additional rare dermatologic indications, highlighted by FDA clearance

of the first-ever formal clinical study for a potential Peeling Skin Syndrome therapy. At the same time, our topical rapamycin platform,

QRX009, remains on track to enter the clinic in a number of indications which have no or limited approved treatments. With QRX003 approaching

Phase 3 and QRX009 advancing toward clinical testing, we believe Quoin has built one of the broadest development pipelines focused exclusively

on rare dermatologic diseases.”

QRX003

(QYLEKI™) – Netherton Syndrome

QYLEKI™

Brand Name Conditionally Approved by FDA. On June 23, 2026, the FDA conditionally approved QYLEKI™ as the proposed

brand name for QRX003 for Netherton Syndrome. QRX003 holds Orphan Drug Designation in the United States, the European Union, and Japan,

along with Fast Track and Rare Pediatric Disease Designations from the FDA.

Positive

Pediatric Compassionate Use Program Update. On June 16, 2026, Quoin reported a positive clinical update from its ongoing

Pediatric Compassionate Use Program.

U.S.

Patent Notice of Allowance Received for Netherton Syndrome Program. On June 30, 2026, the U.S. Patent and Trademark Office

issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, “Combination Treatment for Netherton Syndrome.”

The allowed claims cover a method of treating Netherton Syndrome using a topical serine protease inhibitor together with an anti-inflammatory

agent, including in patients carrying SPINK5 mutations, and add to the Company’s U.S. intellectual property position for QRX003.

QRX003

– Peeling Skin Syndrome

First-Ever

IND for Peeling Skin Syndrome Submitted and Cleared. On June 2, 2026, Quoin submitted the first-ever IND to the FDA for

Peeling Skin Syndrome (PSS), the second indication for QRX003. Subsequent to quarter end, on July 9, 2026, the FDA cleared

the IND and expressed no safety concerns regarding study design or duration of dosing. The planned Phase 2/3 study, the first ever company-sponsored

formal clinical study for the disease, is expected to enroll pediatric and adult patients in the United States and Europe and to initiate

in the second half of 2026. There is currently no approved treatment for PSS.

QRX009

– Topical Rapamycin Platform

QRX009

Advancing Toward Clinical Testing. Quoin continues to advance its proprietary topical rapamycin platform toward clinical testing.

Investigator-led studies are planned across several indications, including Pachyonychia Congenita, Gorlin Syndrome, and Tuberous Sclerosis

Complex, and the Company plans to submit an IND to the FDA for an additional indication before the end of 2026.

Financial

Highlights

Quoin

had approximately $10.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026. The Company believes its

current cash position will fund operations into 2027.

Net

loss for the quarter ended June 30, 2026, was approximately $5.4 million, compared to approximately $3.7 million for the quarter

ended June 30, 2025. Net loss for the six months ended June 30, 2026, was approximately $10.4million, compared to approximately

$7.5 million for the six months ended June 30, 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 June 30, 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, 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.

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: FDA clearance enabling first company-sponsored Phase 2/3 study to initiate in 2H 2026,

continuing to advance QRX003 toward pivotal development in Netherton Syndrome while expanding into additional rare dermatologic indications;

QRX009 remaining on track to enter the clinic in a number of indications which have no or limited approved treatments QRX003 approaching

Phase 3 and QRX009 advancing toward clinical testing, planned Phase 2/3 study for Peeling Skin Syndrome being expected to enroll pediatric

and adult patients in the United States and Europe and to initiate in the second half of 2026, Quoin continuing to advance its proprietary

topical rapamycin platform toward clinical testing; Investigator-led studies being planned across several indications, including Pachyonychia

Congenita, Gorlin Syndrome, and Tuberous Sclerosis Complex, the Company submitting an IND to the FDA for an additional indication before

the end of 2026, the Company’s current cash position funding operations into 2027, and Quoin’s products in development collectively

having 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,

Angiofibroma 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

June 30,

December 31,

2026

2025

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$ 3,845,606

$ 3,818,096

Investments

6,954,476

14,927,165

Prepaid expenses and other current assets

836,146

1,261,974

Total current assets

11,636,228

20,007,235

Intangible assets, net

333,334

383,334

Total assets

$ 11,969,562

$ 20,390,569

LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:

Accounts payable

$ 3,109,517

$ 1,262,222

Accrued expenses

1,757,390

2,538,457

Accrued interest and financing expense

1,146,251

Due to officers - short term

600,000

Total current liabilities

6,613,158

5,546,930

Due to officers - long term

1,423,733

1,723,733

Total liabilities

$ 8,036,891

$ 7,270,663

Commitments and contingencies

Shareholders' equity:

Ordinary shares, no par value

per share, 5,000,000,000 authorized at June 30, 2026 and December 31, 2025, respectively - 70,294,615 (2,008,418 ADS's)

ordinary shares issued and outstanding at June 30, 2026 and 52,441,360 (1,498,325 ADS's) ordinary shares issued and outstanding

at December 31, 2025

$ -

Accumulated other comprehensive loss

(582 )

(613 )

Additional paid in capital

85,272,477

84,090,966

Accumulated deficit

(81,339,224 )

(70,970,447 )

Total shareholders' equity

3,932,671

13,119,906

Total liabilities and shareholders' equity

$ 11,969,562

$ 20,390,569

QUOIN PHARMACEUTICALS, LTD.

Consolidated Statement of Operations & Other

Comprehensive Loss (Unaudited)

Three months ended

June 30,

Six months ended June

30,

2026

2025

2026

2025

Operating expenses

General and administrative

$ 1,846,406

$ 1,742,594

$ 3,543,854

$ 3,325,632

Research and development

3,627,168

2,050,585

7,060,930

4,424,724

Total operating expenses

5,473,574

3,793,179

10,604,784

7,750,356

Other (income) and expenses

Unrealized (gain) loss

(1,585 )

6,004

11,715

5,878

Realized and accrued interest income

(100,947 )

(103,245 )

(247,722 )

(248,117 )

Total other income

(102,532 )

(97,241 )

(236,007 )

(242,239 )

Net loss

$ (5,371,042 )

$ (3,695,938 )

$ (10,368,777 )

$ (7,508,117 )

Other comprehensive loss

Foreign currency translation

(423 )

Comprehensive loss

$ (5,371,465 )

$ (3,695,938 )

$ (10,368,746 )

$ (7,508,117 )

Loss per ADS

Basic

$ (1.90 )

$ (6.28 )

$ (3.66 )

$ (12.79 )

Fully-diluted

$ (1.90 )

$ (6.28 )

$ (3.66 )

$ (12.79 )

Weighted average number of ADS's outstanding

Basic

2,832,915

588,166

2,831,948

587,253

Fully-diluted

2,832,915

588,166

2,831,948

587,253

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