Quoin Pharmaceuticals QNRX

Quoin Pharmaceuticals Ltd is a late stage clinical specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases lacking approved treatments. Its lead candidate QRX003 is a topical lotion under investigation for Netherton Syndrome a rare hereditary skin disorder caused by SPINK5 mutations and is also being evaluated for Peeling Skin Syndrome and related ichthyosis conditions. The company is advancing QRX008 a small molecule inhibitor of VLA 4 obtained through an option from a research agreement with Queensland University of Technology for scleroderma a rare autoimmune disease with no approved therapy. Quoin Pharmaceuticals Ltd further supports QRX009 comprising novel topical rapamycin sirolimus formulations developed under a research agreement with University College Cork for orphan indications such as microcystic lymphatic malformations venous malformations Gorlin syndrome epidermolysis bullosa and pachyonychia congenita. The firm has six clinical sites in the United States and is opening additional sites in the United Kingdom Spain France and the Netherlands while conducting investigator initiated studies in Ireland Austria the Netherlands and New Zealand. It has nine commercial partnerships covering sixty one countries outside its core territories of the United States Western Europe and Japan extending reach into Canada Australia New Zealand the Middle East China Taiwan Hong Kong Singapore Israel Central and Eastern Europe Turkey and several Latin American nations. Its mission is to bring proprietary drug products to patients with high unmet medical need prioritizing diseases where no approved treatment currently exists.

We have no revenue as no product is commercialized. Future revenue depends on approval and sale of QRX003 for Netherton Syndrome via our US Europe Japan sales force or distribution partners in our nine commercial territories. If approved we expect revenue from product sales driven by chronic use in a patient population of about 6,000 to 8,000 in the US and Europe with possible expansion to indications like Peeling Skin Syndrome. We may also earn revenue from licensing or milestone payments for QRX008 and QRX009 if options are exercised. The company pursues partnering licensing mergers acquisitions or other deals to grow its pipeline and add income. Until a product reaches market funding comes from private placements equity financings and research.

Quoin Pharmaceuticals Ltd operates in a niche area focused on rare diseases where competition is limited but includes firms with similar therapies. Company is only organization known to actively administer study drug in multiple Netherton Syndrome trials under an open IND with the US FDA. It holds Orphan Drug Designation from the EMA and FDA for QRX003 Rare Pediatric Disease and Fast Track designations which may confer market exclusivity and tax credits on approval. It has pursued Breakthrough Medicine Designation from the Saudi FDA and seeks Orphan Drug Designation from the Japanese Ministry of Health Labour and Welfare. These factors with limited patient base treatable by few specialists support its aim to secure a defensible spot in the rare disease therapeutics market.

The company's primary customers are patients with rare genetic skin diseases such as those with Netherton Syndrome and Peeling Skin Syndrome who need new therapies to address severe skin barrier dysfunction chronic itching and infections. Physicians mainly board certified dermatologists in major urban centres form another key customer group because they prescribe the medicine and oversee treatment. Caregivers and families of affected individuals also influence treatment decisions and are important for education and support. Quoin Pharmaceuticals Ltd will serve these customers via a direct sales force in the United States Europe and Japan and rely on its nine commercial partners to distribute QRX003 in the sixty one countries where it has agreements.