Quoin Pharmaceuticals Ltd. (QNRX) filings document a State of Israel registrant whose Nasdaq-listed American Depositary Shares each represent 35 ordinary shares. Recent 8-K reports record quarterly and annual financial results, Regulation FD disclosures and material events tied to the company's rare-disease drug-development programs.
The filing record includes disclosures about QRX003 regulatory designations for Netherton Syndrome, QRX009 topical rapamycin delivery technologies, capital-structure matters and board compensation arrangements. These reports also identify the ADS and ordinary-share structure and exchange listing for QNRX securities.
Quoin Pharmaceuticals Ltd. reported a wider first quarter 2026 net loss while highlighting major regulatory progress for its rare-disease pipeline. Net loss was about $5.0 million for the quarter ended March 31, 2026, compared with roughly $3.8 million a year earlier. Cash, cash equivalents and investments totaled approximately $14 million at March 31, 2026, which the company believes will fund operations into 2027.
Regulatory momentum centered on lead candidate QRX003 for Netherton Syndrome. The U.S. FDA granted Fast Track Designation, and a Type C meeting indicated a single Phase 3 study may support U.S. approval, potentially without a traditional placebo or vehicle control. Quoin filed for Breakthrough Medicine Designation in Saudi Arabia and submitted an Orphan Drug Designation application in Japan, where authorities confirmed QRX003 qualifies for both Orphan Drug and Fast Track review. Quoin aims to complete Phase 3 recruitment by the end of 2026 and potentially file an NDA in 2027.
The company also advanced its QRX009 topical rapamycin platform, planning investigator-led studies in Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, and targeting an additional U.S. IND filing in the third quarter of 2026.
Quoin Pharmaceuticals Ltd. reported a larger quarterly loss as it advances late-stage programs for rare skin diseases and faces a going concern warning. For the three months ended March 31, 2026, net loss widened to $4.99 million from $3.81 million a year earlier.
Research and development spending rose to $3.43 million, driven mainly by QRX003 clinical studies and early work on QRX009. General and administrative expenses were $1.70 million. Quoin ended the quarter with $3.12 million in cash and $10.92 million in U.S. Treasury investments, and an accumulated deficit of about $76.0 million.
Management concluded there is substantial doubt about the company’s ability to continue as a going concern for at least one year without new funding. The company continues pivotal preparations for QRX003 in Netherton Syndrome and development of QRX009, while holding nine commercial license and supply agreements that have not yet generated revenue.
Aberdeen Group plc reports beneficial ownership of 75,000 American Depositary Shares (ADS) of Quoin Pharmaceuticals, Ltd., representing 4.16% of the ADS class. Each ADS represents 35 ordinary shares.
The filing lists Aberdeen Group plc as the parent, with abrdn Inc. holding shared voting and dispositive power over the 75,000 ADS on behalf of underlying clients. Signatures are dated 04/29/2026.
Quoin Pharmaceuticals, Ltd. reported a Form 4 filing by Stonepine Capital Management, LLC, identified as a ten percent owner of QNRX. The summarized data shows no reported purchases, sales, exercises, gifts, or other share transactions in this filing.
Quoin Pharmaceuticals Ltd. is a late-stage clinical specialty pharma company focused on rare genetic skin diseases, led by QRX003 for Netherton Syndrome. The therapy is in multiple Phase 2 studies under an open FDA IND and has shown meaningful itch and skin-score improvements in very small patient groups, including a pediatric case rated clear after 12 months.
QRX003 holds Orphan Drug, Rare Pediatric Disease and Fast Track designations from the FDA, plus Orphan status in Europe, and the company has applied for Saudi Breakthrough Medicine and Japanese Orphan Drug designations. A recent FDA Type C meeting indicated a single Phase 3 trial may support U.S. approval.
Quoin has no approved products or revenue and reported an accumulated deficit of about $71.0 million as of December 31, 2025, with cash and cash equivalents of $3.8 million and investments of $14.9 million. Management and auditors note substantial doubt about its ability to continue as a going concern without additional capital.
Quoin Pharmaceuticals reported fourth quarter and full-year 2025 results alongside a substantial corporate and regulatory update. For the year ended December 31, 2025, net loss was approximately $15.8 million compared to $9.0 million in 2024, reflecting higher research and development and general and administrative spending. Net loss for the quarter ended December 31, 2025 was about $4.3 million versus $2.3 million a year earlier. Quoin held roughly $18.7 million in cash, cash equivalents and marketable securities at year-end and believes this will fund operations into 2027.
Strategically, Quoin closed a private placement financing of up to $104.5 million in October 2025, including $16.5 million at closing and up to $88.0 million from potential warrant exercises. The company secured Orphan Drug Designations for lead candidate QRX003 for Netherton Syndrome in the U.S. and Europe and obtained U.S. Fast Track Designation in March 2026. A recent Type C meeting indicated that a single Phase 3 trial may support U.S. approval, with Phase 3 initiation and full enrollment targeted for 2026 and a potential NDA filing in 2027. Quoin is also expanding studies in Peeling Skin Syndrome and advancing topical rapamycin programs with proof-of-concept trials planned for the second half of 2026.
Quoin Pharmaceuticals Ltd. filed a report describing that the U.S. Food and Drug Administration has granted Fast Track Designation to its investigational QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disease with no approved therapies.
The company explains that Fast Track status is intended to speed development and review of drugs for serious conditions with unmet medical need. QRX003 is already in two late-stage whole-body clinical trials and has previously received Orphan Drug and Pediatric Rare Disease designations in the U.S., as well as Orphan Drug Designation in Europe.
Quoin Pharmaceuticals, Ltd. reported Schedule 13G ownership disclosures for certain ADAR1-related parties. The filing shows ADAR1 Capital Management, LLC and Daniel Schneeberger each beneficially hold 58,230 American Depositary Shares (ADS), representing 6.9% of the class as of December 31, 2025. The filing states ADAR1 Capital Management GP, LLC beneficially holds 50,226 ADS (6.0%). These figures are reported based on 838,976 ADS outstanding as of November 3, 2025 as disclosed in the company prospectus. The disclosure also notes excluded amounts of ADS underlying warrants that are subject to a 4.99% beneficial ownership limitation.
Quoin Pharmaceuticals shareholder Woodline Partners has disclosed a significant passive stake in the company. Woodline Partners LP, an investment adviser, reports beneficial ownership of 2,785,370 Ordinary Shares of Quoin, representing 9.5% of the class, with sole voting and dispositive power over all reported shares.
The position is held through Woodline Master Fund LP via American Depositary Shares, each representing thirty-five Ordinary Shares. The percentage ownership is based on 29,364,180 Ordinary Shares outstanding as of November 3, 2025. Woodline certifies the holdings are in the ordinary course of business and not for the purpose of influencing control of Quoin Pharmaceuticals.
A group of investment entities associated with Israel A. Englander, including Integrated Core Strategies (US) LLC and Millennium Management LLC, reports beneficial ownership of 2,618,595 Quoin Pharmaceuticals ordinary shares, representing 4.6% of the class as of December 31, 2025.
The group reports only shared voting and dispositive power over these shares and no sole power. They state they have ceased to be beneficial owners of more than 5% of the outstanding ordinary shares and certify that the holdings are not for the purpose of influencing control of Quoin Pharmaceuticals.