QNRX

EX-99.1

2 tm2613938d1_ex99-1.htm

EXHIBIT 99.1

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 regulat

EX-99.1

2 tm269662d1_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Quoin Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial Results

– Closes Private Placement Financing of Up to $104.5 Million

– Secures Orphan Drug Designations for QRX003 for Netherton Syndrome (NS) in the U.S. and Europe

– Advances Proposed Expedited Regulatory Approval Pathways in Japan and Saudi Arabia and Secures Fast Track Designation in the U.S. for QRX003 for NS Subsequent to the End of Q4

– Reports Continued Clinical Progress for QRX003 in Netherton Syndrome Clinical Studies including Data Supporting Longer Term Durable Treatment Effect and Safety Profile

–Pediatric NS Study Expanded to 7 Children Now Actively Treated with QRX003, Largest Cohort of This Age Group Ever Studied

– Ongoing Clinical Data Continues to Support Development of QRX003 as a Treatment for Peeling Skin Syndrome with Study Being Expanded to 6 subjects

– Proprietary Rapamycin Topical Platforms Achieve Target Loadings; Clinical Studies Planned in 2H 2026

– NETHERTON NOW Awareness Campaign Surpasses 2 Million Video Views and 24 Million Global Impressions

ASHBURN, Va., March 26, 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 fourth quarter and full-year 2025 progress for the period ended December 31, 2025.

“2025 was a defining year for Quoin as we transitioned from clinical stage to a company actively preparing for commercial readiness,” said Michael Myers, Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals. “We strengthened our balance sheet with a significant financing, secured key regulatory designations across our core territories, and continued to advance the clinical development of QRX003 supported by encouraging long-term efficacy data demonstrating durable treatment effect with no reported safety concerns. With Orphan Drug Designations in place in the United States and Europe, and confirmation of eligibility for Orphan Drug Designation and Fast Track review in Japan, QRX003 is now aligned with expedited regulatory pathways in our key target markets. In the United States, QRX003 was also awarded Rare Pediatric Disease Designation by the U.S. Food and Drug Administration (FDA) for Netherton Syndrome, which, if approved, could result in the receipt of a freely tradable Priority Review Voucher, with a potential value to Quoin of $150-$200 million in non-dilutive cash. Based on positive initial clinical data from our ongoing Peeling Skin Syndrome study, we are increasing the size of this study to 6 subjects, and we are planning to submit an Investigational New Drug application to the FDA in the second half of this year. In addition, we are planning to initiate clinical testing of QRX003 in Ichthyosis and SAM syndrome potentially putting the product on track for approval for four rare genetic diseases where there are currently no approved treatments. Finally, we are moving forward with our topical rapamycin program. We are targeting initiating clinical testing in at least one indication in the second half of this year and we believe our optimized delivery technologies may offer competitive advantages over more conventional topical formulations of rapamycin. All in all, we are excited at what 2026 could bring for our company and the patient populations we serve. We have begun the year with strong forward momentum with a platform poised to succeed on multiple fronts.”

Recent Accomplishments

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 as early as the second half of 2026.

On January 27, 2026, Quoin submitted an application to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking Orphan Drug Designation for QRX003. The MHLW confirmed that QRX003 qualifies for both Orphan Drug Designation and Fast Track review in Japan.

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 U.S. Food and Drug Administration (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 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.

Fourth Quarter and F

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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 6, 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 2.02 Results of Operations and Financial Condition.

On November 6, 2025 Quoin Pharmaceuticals Ltd. (the “Company”) announced its third quarter 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 November 6, 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 6, 2025

QUOIN PHARMACEUTICALS LTD.

By: /s/ Sally Lawlor

Name: Sally Lawlor

Title: Chief Financial Officer