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Quoin Pharmaceuticals Ltd. reported second quarter 2026 results and multiple clinical and regulatory milestones across its rare dermatology pipeline. QRX003 for Netherton Syndrome received FDA conditional approval of the proposed brand name QYLEKI™, continued in pivotal-path development, and is supported by a new U.S. Notice of Allowance covering a combination treatment patent. The company also submitted the first-ever IND for Peeling Skin Syndrome, which the FDA subsequently cleared, enabling a planned Phase 2/3 study in pediatric and adult patients in the United States and Europe in the second half of 2026. Quoin’s topical rapamycin platform QRX009 is advancing toward clinical testing with planned investigator-led studies in several additional indications.
Quoin held approximately $10.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026 and expects this to fund operations into 2027. Net loss for the quarter was about $5.4 million, compared with $3.7 million in the prior-year quarter, driven mainly by higher research and development spending.
Quoin Pharmaceuticals Ltd. is a late-stage clinical specialty pharma company focused on rare dermatologic diseases. Its lead candidate, QRX003, is in pivotal registrational development for Netherton Syndrome, with U.S. and European clinical sites open and eight pediatric patients treated under a compassionate use program.
Regulatory progress includes Japan Orphan Drug Designation for QRX003 in Netherton Syndrome, FDA Fast Track Designation, conditional FDA brand-name approval (QYLEKI), and FDA clearance of an IND to start a Phase 2 study of QRX003 in Peeling Skin Syndrome. The QRX009 topical rapamycin program is advancing via multiple investigator-led studies.
For the quarter ended June 30, 2026, Quoin recorded a net loss of $5.37 million (six‑month loss $10.37 million). Total assets were $12.0 million, including $3.85 million in cash and equivalents and $6.95 million in investments; shareholders’ equity was $3.93 million and the accumulated deficit reached $81.3 million. Management discloses substantial doubt about continuing as a going concern without additional financing.
Quoin Pharmaceuticals Ltd. will hold its 2026 Annual General Meeting on August 20, 2026 at 12:00 p.m. US Eastern Time at Blank Rome LLP in Philadelphia. Shareholders of record on July 15, 2026, holding 70,294,615 ordinary shares (represented by 2,008,418 ADSs, each equal to 35 shares), are entitled to vote.
Shareholders will vote on five proposals: electing seven directors; an advisory “say‑on‑pay” for named executive officers; changes to non‑employee director compensation; changes to 401(k) matching (including U.S. executives); and appointment of CBIZ CPAs P.C. as auditor. A quorum requires 33⅓% of voting power. Proposals 1‑4 are treated as non‑routine for broker voting; Proposal 5 is expected to be routine. The board recommends voting FOR all proposals.
Quoin Pharmaceuticals Ltd. is soliciting proxies for its 2026 Annual General Meeting to be held on August 20, 2026 at 12:00 p.m. ET in Philadelphia. Shareholders of record as of July 15, 2026 may vote. The Board recommends that shareholders vote FOR seven director nominees and for Proposals 2–5, which include a non-binding advisory vote on executive compensation, changes to director compensation, amendments to 401(k) matching contributions, and appointment of CBIZ CPAs P.C. as independent auditors. The proxy materials and the Annual Report on Form 10-K for the year ended December 31, 2025 are being distributed beginning on or about July [•], 2026.
Quoin Pharmaceuticals announced that the U.S. Food and Drug Administration has conditionally approved QYLEKI™ as the proposed brand name for QRX003, its investigational lotion for treating the rare skin disorder Netherton Syndrome. Final approval of the brand name would come only with FDA marketing approval of QRX003.
QRX003 (QYLEKI 4% lotion) is in Phase 2 whole-body clinical trials, with a pivotal Phase 3 study expected to start in the second half of 2026 and a potential New Drug Application filing anticipated in 2027. The product has Orphan Drug Designation in the U.S., European Union, and Japan, and has also received Fast Track and Rare Pediatric Disease designations from the FDA, in an area where there is currently no approved treatment.
Quoin Pharmaceuticals reports that Japan’s Ministry of Health, Labour and Welfare has granted Orphan Drug Designation to QRX003 lotion (4%) for treating Netherton Syndrome, a rare genetic skin disorder with no approved treatments.
The Japanese designation covers diseases affecting fewer than 50,000 patients and provides prioritized consultation, reduced fees, tax incentives, priority review, and up to 10 years of market exclusivity upon approval.
QRX003 already holds Orphan Drug, Pediatric Rare Disease, and Fast Track designations from the U.S. FDA and Orphan Drug status from the European Medicines Agency. The drug is in Phase 2 trials, with a pivotal Phase 3 study expected in the second half of 2026 and potential NDA filing in 2027.
Quoin Pharmaceuticals Ltd. Schedule 13G: a group led by Millennium affiliates and Israel A. Englander reports shared beneficial ownership of 3,850,385 ordinary shares, representing 5.5% of the class, per cover-page disclosures. The filers executed a Joint Filing Agreement dated June 1, 2026. The filing notes CUSIP 74907L409 and that each American Depositary Share represents thirty-five Ordinary Shares.
Quoin Pharmaceuticals Ltd. updates its resale prospectus supplement to reflect a substitution in the Selling Shareholders table and the transfer of warrants tied to ADSs. The registration covers 10,045,455 American Depositary Shares (ADSs) representing 351,590,925 ordinary shares.
The supplement substitutes SILV Fund Ltd. for Point72 Associates, LLC for a transferred block of warrants to purchase 909,090 ADSs; the prospectus remains otherwise unchanged. The ADSs trade on Nasdaq under the symbol QNRX.
Quoin Pharmaceuticals, Ltd. Schedule 13G/A amendment reports beneficial ownership positions held or controlled by ADAR1-related entities and an individual, tied to American Depositary Shares (each representing 35 Ordinary Shares).
The filing states shared dispositive power of 102,846 and 102,883 Depositary Shares for named filers and cites 1,961,206 Depositary Shares outstanding as of March 31, 2026.