Quoin Pharmaceuticals, Ltd.

What they do

Quoin is a late-stage clinical specialty pharmaceutical company focused on developing and commercializing treatments for rare and orphan diseases. Its lead product, QRX003, is a topical lotion in pivotal clinical testing for Netherton Syndrome and is also being developed for Peeling Skin Syndrome. The company is also developing QRX009, a topical rapamycin formulation, for multiple rare indications. Quoin has not generated any revenue and has no products approved for commercial sale.

Revenue drivers

• QRX003 (Netherton Syndrome) — Lead product candidate; no revenue yet as it is in clinical development; potential revenue depends on regulatory approval and commercialization.
• QRX003 (Peeling Skin Syndrome) — Additional indication under development; no revenue yet.
• QRX009 (topical rapamycin) — Preclinical/early-stage development for multiple rare diseases; no revenue yet.
• Commercial partnerships — Nine partnerships for QRX003 covering 61 countries outside core territories (U.S., Western Europe, Japan); potential future royalty or distribution revenue, but none recorded.

Recent performance

For the year ended December 31, 2025, Quoin reported a net loss of $15.8 million and operating cash flow of -$13.5 million. In the first quarter of 2026, the company had cash and equivalents of $3.1 million, total assets of $15.7 million, and total liabilities of $6.9 million as of March 31, 2026. Historical losses: 2022 net loss $9.4M, 2023 $8.7M, 2024 $9.0M. The company has not generated any revenue to date.

Strategy

Quoin plans to complete late-stage clinical testing of QRX003 for Netherton Syndrome and file for marketing approval in the U.S., Europe, Japan, and other territories with existing commercial agreements. It intends to establish its own sales infrastructure in the U.S., Europe, and Japan, while using distribution partners in other regions. The company also plans to continue development of QRX003 for Peeling Skin Syndrome and related diseases, and initiate clinical testing of QRX009 topical rapamycin in selected indications. Additionally, it seeks business development opportunities such as partnerships and licensing to expand its pipeline.

Risks

• No revenue and limited cash — Quoin has no approved products and only $3.1 million in cash as of March 31, 2026, which may be insufficient to fund operations without additional financing.
• Clinical and regulatory uncertainty — QRX003 is still in clinical trials and has not received marketing approval; failure of trials or regulatory delays could halt development.
• Dependence on additional funding — The company states it will need further funding through equity or debt offerings, warrants, or collaborations, and may not be able to secure it on favorable terms.
• Competition and market acceptance — Other companies are developing treatments for Netherton Syndrome, and even if approved, QRX003 may face competition or limited patient uptake.

Outlook

Management expects to complete Phase 3 patient recruitment for QRX003 in Netherton Syndrome by the end of 2026, with a potential NDA filing in 2027. Regulatory designations include U.S. FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations, and MHLW confirmation of ODD and fast track in Japan. The company also plans to submit an IND for QRX009 by Q3 2026 and initiate investigator-led studies in Pachyonychia Congenita, Gorlin Syndrome, and Tuberous Sclerosis Complex.