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Quoin Pharmaceuticals, Ltd.
Quoin Pharmaceuticals Ltd. is a clinical stage specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products that treat rare and orphan diseases for which there are currently no approved treatments. Quoin’s lead product, QRX003, is a once daily, topical lotion to treat Netherton Syndrome, a rare hereditary skin disease. Clinical testing of QRX003 is currently being tested in two clinical studies under an open IND in Netherton patients.
Nasdaq: QNRX
IR Website: https://investors.quoinpharma.com/
Headquarters: Ashburn, Virginia
Last updated: 1/10/23
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Summary
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Quoin Pharmaceuticals, Ltd., a clinical stage specialty pharmaceutical company, focuses on the development of therapeutic products for rare and orphan diseases. It offers QRX003, a potential therapy for the treatment of Netherton Syndrome; QRX004, a topical lotion for the treatment recessive dystrophic epidermolysis bullosa; and QRX008, a recently in-licensed product candidate for the treatment of scleroderma a devastating rare disease for which there is currently no available treatment or cure.
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Investor Presentation
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Business Description
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Quoin is an emerging specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products that treat rare and orphan diseases for which there are currently no approved treatments. Quoin’s lead product, QRX003, is a once daily, topical lotion to treat Netherton Syndrome, a rare hereditary skin disease. In addition, the company intends to pursue the clinical development of QRX003 in other orphan dermatological indications, including Peeling Skin Syndrome, SAM Syndrome and Palmoplantar Keratoderma. Clinical testing of QRX003 is currently underway in two studies under an open IND. Quoin’s second lead product, QRX004, is being developed as a potential treatment for Dystrophic Epidermolysis Bullosa. A further product, QRX008, is under development for scleroderma, a devastating rare disease for which there is currently no approved treatment or cure. Quoin intends to The company will establish a sales infrastructure to commercialize its products in both US and Europe and seek to enter into strategic licensing partnerships for all other territories. Currently, eight such partnerships have been established covering 60 countries.
Highlights
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Experienced Management Team with proven track record of success
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Focused Rare and Orphan Disease product pipeline
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Rare Pediatric Designation opportunity for lead products
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Targeting US/EU Approvals in 2024, 2025 and 2026.
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Company will establish sales infrastructure for both US and EU markets
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Differentiated polymer delivery technology with Strong IP Position
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Strong KOL support from leading experts
Lead Product
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QRX003 is a once-daily topical lotion being developed for the treatment of Netherton Syndrome, a rare hereditary skin disease for which there is currently no approved treatment or cure.
The active ingredient in QRX003 is a competitive broad-spectrum serine protease inhibitor whose mechanism of action is to target the serine proteases present in the skin, called Kallikreins, which are responsible for the process of skin shedding. As a result of the genetic mutation that causes Netherton Syndrome, these Kallikreins go unregulated and become hyperactive resulting in the uncontrolled desquamation that leads to the highly defective skin barrier in Netherton patients. When applied daily to the skin, QRX003 acts to regulate the activity of these Kallikreins leading to a more normalized skin shedding process and the formation of a stronger and more effective skin barrier.
Core Technology Highlights
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Patented polymer delivery system
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Provides immediate barrier protection on skin
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Withstands frequent washing, allowing once daily application
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Unique polymer combination both moisturizes and protects skin
Market Opportunity
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An estimated 6,000-7,000 individuals in the US and Europe combined are believed to have Netherton Syndrome, with a birth incidence of approximately 1:200,000. QRX003 has the potential to become the first approved treatment for Netherton Syndrome to reach the market both in the U.S. and Europe and may therefore likely be used in a large proportion of patients. It is intended that QRX003 will be applied once daily to the patient’s whole body for the remainder of their life thus providing a long-term opportunity for the product. Outside of Europe, there are additional attractive market opportunities in Canada, Australia, the Middle East and South East Asia.
Quoin’s management believes the rare and orphan disease space represents an attractive commercial opportunity for several reasons. The overall success rate for obtaining regulatory approval for orphan drugs is estimated to be 26% compared to just 11% for all other indications. Worldwide orphan drug sales are forecast to grow at a compound annual growth rate (CAGR) of 12.3% from 2019-2024, essentially double the forecast for the non-orphan drug market. By 2024, orphan drug sales are expected to reach $242 billion and capture one-fifth of total worldwide sales. Furthermore, the mean drug price of the top 100 US orphan drugs was almost 4.5 times greater than the non-orphan drug price in 2018 and the small patient populations coupled with the lack of other treatment options greatly enhance the likelihood of insurance coverage and reimbursement.
Quoin intends to self-commercialize QRX003, and other rare disease products the company may develop, in both the US and Europe. Because of the very low number of patients and the fact that diagnosis and treatment is generally provided by a relatively small number of board-certified dermatologists in major urban areas, this concentration of care will enable us to market QRX003 with a small, dedicated salesforce to target those patients and caregivers. Outside of the U.S and in Europe, Quoin intends to establish marketing partnerships for QRX003 in Canada, Australia, the Middle East and Asia. Currently eight such partnerships have been established covering Australia, New Zealand, the Middle East, China, Taiwan, Hong Kong, Latin America as well as Central and Eastern Europe and Turkey.
Netherton Syndrome and Its Unmet Needs
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Netherton Syndrome (NS) – a rare, hereditary skin disorder – is an autosomal recessive genetic disease caused by a mutation in the SPINK5 gene (serine protease inhibitor, Kazal Type 5). The SPINK5 gene, when behaving normally, encodes a protein, called Lympho- Epithelial Kazal Type Related Inhibitor or LEKTI, that serves to regulate the activity of certain proteases (enzymes that digest proteins) in the skin. These enzymes are called Kallikreins and consist of the KLK5, KLK7 and KLK14 proteases. For patients with NS, the LEKTI protein is absent due to the mutation of the SPINK5 gene. This results in the Kallikreins being completely unregulated, leading to excessive skin shedding and the highly porous and defective skin barrier that NS patients have.
Unmet Medical Needs in Netherton Syndrome
Currently, there is no cure for Netherton Syndrome nor are there any approved therapeutic treatments. What is available, such as skin moisturizers, are currently limited to providing symptomatic relief. Due to the highly compromised skin, even the selection of an appropriate moisturizer can be challenging. For example, moisturizers typically used for skin barrier repair, such as those containing lanolin and petrolatum, can cause further skin damage to NS patients due to friction or high shear forces upon application or removal. Topical steroids may have harmful rather than helpful effects and can further reduce the thickness of the skin barrier. Incidences of Cushing’s Syndrome have also been reported from the use of topical steroids. Other standard topical treatments, such as calcineurin inhibitors, can lead to dangerously high systemic blood levels due to the defective skin barrier. There is a critical need for a new and effective treatment for NS.
SEC Filings
Management Overview
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Dr. Michael Myers
Chief Executive Officer and Director.
Dr. Myers has more than 30 years of industry experience in the drug delivery and specialty pharmaceutical sectors. He has served CEO of Innocoll, Inc. and was responsible for taking that company public in 2014. He has also served as president of the drug delivery division of West Pharmaceutical Services, president of pharmaceutical operations for Fuisz Technologies (Biovail) and has held executive positions in Flamel Technologies and Elan Corporation. Dr. Myers earned his Ph.D. in Chemistry from the University College Cork. Dr. Myers serves on the Board of Directors of Sonoran Biosciences.
Denise Carter
Chief Operating Officer and Director
Ms. Denise Carter has over 30 years of experience in the drug delivery and specialty pharmaceutical industries. Prior to Quoin, Ms. Carter was executive vice president of business development and corporate affairs at Innocoll, Inc., vice president of business development of the drug delivery division of West Pharmaceuticals, and she has held executive positions at Eurand and Fuisz Technologies (Biovail.) Ms. Carter earned her MBA from Wharton School of Business, University of Pennsylvania and a B.S in Chemistry from the College of William and Mary. Ms. Carter serves on the Board of Wellesley Pharmaceuticals.
Gordon Dunn
Chief Financial Officer
Gordon joined Quoin in November of 2021. He brings over 30 years of finance experience and has served as CFO of both private and publicly traded companies. In addition, Mr. Dunn has deep experience in investment banking and private equity. Over the last five years he has served as Chief Financial Officer for several private companies, most recently with Qured, a UK based healthcare provider, from 2020 to 2021. Mr Dunn also served as CFO of Innocoll Inc. from 2012-2016. Prior to joining Innocoll, Mr. Dunn had 20 years’ experience in investment banking and private equity, including over ten years managing the private equity funds of NewSmith Capital, and nine years at Merrill Lynch where he served as co-head of the European Private Equity Group and Director of Equity Capital Markets. Mr. Dunn received a B.A. from Stanford University and a J.D. from New York University School of Law.
Risks & Disclosures
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This communication is neither an offer to sell nor a solicitation of an offer to buy, nor a recommendation of any securities of the company mentioned herein.
Quoin Pharmaceuticals Inc. (the “Company”) and its counsel have reviewed the content of this page as well as the accompanying presentation (“Company Presentation”) displayed on this page. To the best of its knowledge, the Company does not believe this content to be misleading or inaccurate in any material respect, nor does it believe there are any material omissions with respect to such content. The Company does not believe the contents of the page or the Company Presentation to contain any non-public material information.
Information and opinions presented in the Company Presentation are provided by the Company, and b2i digital makes no representation as to their accuracy or completeness. The information contained on this page is not intended to constitute any form of advice, and the information provided is not intended to provide a sufficient basis on which to make an investment decision. It is not investment research, nor does it constitute a research recommendation, as it does not constitute substantive research or analysis. This information is not to be relied upon in substitution for the exercise of independent judgment.
Information, opinions and estimates contained on this page or in the Company Presentation reflect judgments by the Company as of the original date of publication by the Company and are subject to change without notice. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied is made regarding future performance.
A complete description of the risks and uncertainties relating to the Company and its securities can be found in the company's filings with the U.S. Securities and Exchange Commission available for free at www.sec.gov.
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