Company Description
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. According to multiple company disclosures, Quoin concentrates on severe, underserved dermatologic and vascular conditions where there are no approved treatments or cures for many indications.
Business focus and therapeutic areas
Quoin describes itself as a company dedicated to addressing unmet medical needs for patients, their families, communities and care teams. Its disclosed pipeline consists of several products in development that collectively have the potential to target a broad number of rare and orphan indications. Across its press releases and SEC filings, the company consistently highlights the following target diseases:
- Netherton Syndrome
- Peeling Skin Syndrome
- SAM Syndrome
- Palmoplantar Keratoderma
- Scleroderma
- Microcystic Lymphatic Malformations
- Venous Malformations
- Angiofibroma
Quoin characterizes Netherton Syndrome as a devastating and life-threatening genetic skin disorder with no approved therapies. It also notes that for initial topical rapamycin targets such as microcystic lymphatic malformations and venous malformations, there are currently no U.S. Food and Drug Administration (FDA) approved treatments or cures.
Lead program: QRX003 for Netherton Syndrome
The company’s lead clinical asset is QRX003, a topical lotion formulated with a proprietary delivery technology. Quoin states that QRX003 contains a broad-spectrum serine protease inhibitor whose mechanism of action is intended to perform the function of a specific protein called LEKTI. In Netherton Syndrome, the absence of LEKTI leads to excessive skin shedding and a highly porous, compromised skin barrier. QRX003 is designed to promote a more normalized skin-shedding process and support formation of a stronger and more effective skin barrier.
QRX003 lotion (4%) is being evaluated in two late-stage, whole-body pivotal clinical trials for Netherton Syndrome. Company communications indicate that these pivotal studies are intended to support a potential new drug application (NDA) for QRX003. In addition to pivotal trials, Quoin has reported positive data from an investigator-led pediatric Netherton Syndrome study, including durable improvements in skin condition, pruritus scores and sleep disturbance, with no adverse events reported over extended treatment in the described subject.
Regulatory designations and incentives
Quoin reports that QRX003 has received several important regulatory designations. The U.S. FDA has granted Orphan Drug Designation for QRX003 in Netherton Syndrome, following an earlier Orphan Drug Designation from the European Medicines Agency (EMA). The company also discloses that QRX003 has been granted Rare Pediatric Disease Designation by the FDA for Netherton Syndrome. These designations provide potential benefits such as market exclusivity periods, tax credits for qualified clinical testing, fee reductions and possible eligibility for a Priority Review Voucher upon marketing approval.
Broader pipeline and topical technologies
Beyond Netherton Syndrome, Quoin is advancing development programs in Peeling Skin Syndrome and other rare dermatologic conditions. The company has reported initial positive data from an investigator-led pediatric Peeling Skin Syndrome study, where patients showed improvements in disease severity, skin condition and quality-of-life metrics, with no adverse events reported over the described treatment period.
Quoin is also developing topical rapamycin delivery technologies. In a recent update, the company announced that it had achieved target loading concentrations for two proprietary topical rapamycin systems: a 4% weight/weight rapamycin loading in a topical formulation and a 5% weight/weight loading in a dermal patch system. Quoin states that it plans to manufacture clinical trial and stability batches from at least one of these technologies and to pursue clinical testing in indications such as microcystic lymphatic malformations and venous malformations, for which it notes there are currently no FDA approved treatments or cures.
Patient advocacy and awareness initiatives
In parallel with its clinical programs, Quoin has launched and expanded the NETHERTON NOW awareness campaign. The company’s news releases describe a series of video episodes featuring patients, families, advocates and clinical experts discussing the physical, emotional and social impact of living with Netherton Syndrome. Quoin reports that this campaign has generated significant viewership and impressions, and it presents the initiative as part of its effort to amplify the voices of those affected by the disease and to highlight the need for effective treatments.
Corporate and capital markets profile
Quoin Pharmaceuticals Ltd. is incorporated in the State of Israel and reports that its American Depositary Shares (ADSs), each representing thirty-five ordinary shares with no par value, trade on The Nasdaq Stock Market LLC under the symbol QNRX. The company has characterized itself in SEC filings and press releases as a late clinical-stage specialty pharmaceutical company rather than a commercial-stage entity.
Quoin has used private placement financings and warrant structures to fund operations and research and development. In a detailed Form 8-K, the company described a securities purchase agreement with institutional and accredited investors involving ADSs, pre-funded warrants and multiple series of warrants (Series H, I, J and K) with exercise terms tied to key regulatory and clinical milestones for QRX003, including pivotal trial outcomes and potential FDA approval. The company has indicated that proceeds from such financings are intended for general corporate purposes, including completion of clinical development of QRX003, advancement of programs in Peeling Skin Syndrome and topical rapamycin, working capital, possible future acquisitions and capital expenditures.
Governance and equity incentive structures
Quoin’s SEC filings describe an active corporate governance and compensation framework. Shareholders have approved a 2025 Equity Incentive Plan and a new compensation policy for executive officers and directors. The company’s board and compensation committee have adopted forms of stock option award agreements under the 2025 Equity Incentive Plan, outlining exercise price payment methods and treatment of vested and unvested awards upon various types of employment termination, including death, disability, termination for cause and other separations.
The company has also reported amendments to its non-employee director compensation program, including changes to annual retainers and the option for directors to receive a portion of compensation in the form of options to purchase ADSs. In addition, Quoin has disclosed lock-up agreements executed by directors and officers in connection with financing transactions, as well as shareholder approval to increase authorized ordinary share capital.
Clinical-stage risk profile
Across its press releases and SEC reports, Quoin includes cautionary notes regarding forward-looking statements. The company highlights risks and uncertainties related to delivering a safe and effective treatment for Netherton Syndrome, pursuing its regulatory strategy, obtaining regulatory approvals, completing clinical trials on time, achieving desired clinical outcomes, managing clinical trial costs and securing sufficient capital. These disclosures emphasize that, as a late clinical-stage company without approved products, Quoin’s prospects depend on the success of its development programs and regulatory interactions.
Summary
According to its own disclosures, Quoin Pharmaceuticals Ltd. is focused on the development and potential commercialization of topical therapies for rare and orphan diseases, particularly severe genetic skin disorders and vascular malformations. Its lead candidate, QRX003, targets Netherton Syndrome and has received Orphan Drug and Rare Pediatric Disease designations. Additional programs in Peeling Skin Syndrome and topical rapamycin-based treatments broaden the company’s rare disease focus. For investors and observers, QNRX represents exposure to a clinical-stage, rare-disease–oriented specialty pharmaceutical company whose value is closely tied to clinical trial results, regulatory milestones and ongoing financing activities.