A Pivotal Year Ahead for Quoin Pharmaceuticals

Company celebrates key milestones and charts path from clinical-stage to commercial.

Since commencing trading on Nasdaq in October 2021, Quoin Pharmaceuticals ( Nasdaq: QNRX ) has rapidly established itself as a company with a clearly defined commercial approach to growth and an eye on multiple avenues for success.

The company’s lead product candidate, QRX003, is a potential treatment for Netherton Syndrome (NS), a rare and devastating genetic disease with no approved treatment and no cure. NS is extremely debilitating and sometimes fatal.

Quoin initiated its first clinical study in June 2022 following receipt of the first-ever Investigational New Drug application (IND) approval from the FDA for a potential treatment for NS. This was followed by the announcement of the initiation of a second clinical trial in October the same year. Quoin is the only pharmaceutical company actively conducting two clinical studies in Netherton patients under an open IND.

With a promising pipeline, a clear pathway to regulatory approval and a strategy approach to commercialization, Quoin now seems poised to deliver value for both investors and patients.

We took a look at Quoin’s milestone achievements in 2022 and what investors can expect to see in the coming year.

Foundations for success

 With a strong focus on establishing its own commercial infrastructure, Quoin has successfully established a distribution network spanning 60 countries around the world. By Q1 2022, the company had inked exclusive licensing and distribution agreements for its lead candidate, QRX003, in the Middle East, North Africa, Australasia, and the Commonwealth of Independent States (CIS), key Latin America markets, Israel and 21 Central and Eastern European countries.

The company believes these agreements will facilitate a global launch of its lead product once it is approved. This direct path to commercialization is a remarkable achievement for a small company and highly emblematic of the company’s relentless focus on making its products available to every patient, everywhere.

An expanding pipeline

 As it advances its own product portfolio, Quoin is constantly evaluating potential opportunities to add to its growing pipeline. In 2022, the company entered into two research agreements with the Queensland University of Technology (QUT) in Australia for the development of potential treatments for NS, and for scleroderma, which is a rare autoimmune disease affecting the skin and connective tissue and for which there is no approved treatment or cure.

In addition to its focus on NS and scleroderma, Quoin is targeting treatments for other rare disorders including Peeling Skin Syndrome, Palmoplantar Keratoderma, SAM Syndrome and Epidermolysis Bullosa, giving the company a diverse pipeline of future commercial opportunities. As part of its strategy for growth, Quoin has publicly stated that one of its key goals for 2023 is the addition of new products into this pipeline.

A clinical-stage company

 Quoin’s lead product candidate, QRX003 for NS, is now in two separate clinical trials under an open U.S. IND application. The company has five US-based clinical sites open and actively recruiting patients for both studies.

The first trial is a randomized, double blinded, vehicle-controlled study assessing two different doses of QRX003 topical lotion versus a vehicle lotion in NS patients. The company announced the dosing of the first patient in December 2022 and recruitment has continued since then. Quoin’s second study is assessing QRX003 topical lotion in NS patients who are currently receiving treatment including systemic therapy for symptomatic relief. This second study is being conducted at the same clinical sites and by the same clinical investigators as the first study, leading to significant efficiencies and overall cost reductions.

A clear pathway to approval

In response to the company’s pre-IND and IND submissions, the FDA has provided constructive feedback to Quoin. The company believes it has a clearly defined pathway to regulatory approval, which it expects to seek in the US by the end of 2024. Similarly, the European Medicines Agency has provided Quoin with Scientific Advice for the clinical and regulatory development of QRX003 in Europe, enabling the company to meet the requirements for approval in both jurisdictions via a single program.

Quoin is actively working with its regulatory consultants to pursue a path to Conditional Marketing Approval (CMA) in Europe, which is available to new treatments for diseases where there are no approved treatments and a clearly defined unmet medical need. The granting of a CMA for QRX003 in Europe would allow the company to market the product there in advance of full, formal regulatory approval, potentially accelerating Quoin’s transition from a clinical stage company to a commercial one.

Delivering long term value for investors

With the advancement of QRX003 through clinical development, Quoin is positioned to deliver the first  approved treatment for NS and has laid the groundwork for the product to be launched effectively globally. QRX003 is described as a ‘whole body, whole life’ product which means that it would be applied to the entire surface of a patient’s skin, once daily, for life. This represents a long-term marketing opportunity and a substantial value-add for the company’s investors.

QRX003 potentially qualifies for Rare Pediatric Drug Designation which, upon approval, would result in the company receiving a freely tradable Priority Review Voucher. The market for these vouchers remains strong and Quoin could potentially receive a non-dilutive cash influx in the region of $100-$120 million, upon its sale.

A commercial approach

Quoin’s mission is clear: the company is firmly committed to making its products available to every patient, everywhere. Over the past 24 months, Quoin and its global distribution partners have worked together to identify where its target patient populations are located, where they are being treated and who is treating them.

The company has established ties with leading KOLs and crucially with the advocacy foundations across the globe that actively support patients and their families. These efforts have led to the establishment of a very high awareness level among patients and treating physicians of both Quoin and its product pipeline.

A transformational 2023

 What can investors expect to see from Quoin in 2023? The company started the year in a strong financial position and further augmented this by completing a raise of an additional $7 million in February 2023, extending its cash runway to late 2024, which is beyond a number of key inflection points for the company.

During the year, Quoin is expecting to achieve a number of potentially transformative milestones, including releasing topline clinical data from its ongoing clinical trials in NS whilst making additional progress with its other pipeline products.

2023 is poised to be a transformational year for Quoin as the company continues along the path of transition into a commercial stage enterprise.