Core Insights - Quoin Pharmaceuticals has successfully closed a private placement financing of up to $104.5 million, enhancing its financial position for future developments [7] - The company has secured Orphan Drug Designations for QRX003 for Netherton Syndrome in both the U.S. and Europe, which provides significant regulatory advantages [8] - QRX003 has received Fast Track Designation from the U.S. FDA, facilitating expedited development and review processes [10] Financial Highlights - As of December 31, 2025, Quoin had approximately $18.7 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into 2027 [16] - The net loss for the quarter ended December 31, 2025, was approximately $4.3 million, compared to $2.3 million for the same period in 2024 [17] - For the full year 2025, the net loss was approximately $15.8 million, an increase from $9.0 million in 2024 [17] Clinical Development Progress - The pediatric study for QRX003 has been expanded to include 7 children, marking the largest cohort of this age group ever studied for Netherton Syndrome [9] - Positive nine-month data from a pediatric study indicates sustained skin healing and complete elimination of pruritus with no adverse events reported [9] - The company plans to submit an Investigational New Drug application to the FDA in the second half of 2026 for QRX003 [2] Regulatory Achievements - Quoin has applied for Breakthrough Medicine Designation for QRX003 with the Saudi Food and Drug Authority, which could enable accelerated regulatory review in Saudi Arabia [3] - An application for Orphan Drug Designation for QRX003 has also been submitted to Japan's Ministry of Health, Labour and Welfare, with confirmation of eligibility for both Orphan Drug Designation and Fast Track review [4] - The U.S. Rare Pediatric Disease Priority Review Voucher program has been extended, which could provide Quoin with a potential value of $150-$200 million if QRX003 is approved [5][6] Awareness Campaign - The NETHERTON NOW awareness campaign has surpassed 2 million video views and 24 million global impressions, highlighting the company's commitment to raising awareness for Netherton Syndrome [6]

Core Viewpoint - The FDA has indicated that a single Phase 3 study may be sufficient for marketing approval of QRX003 for Netherton Syndrome, which is a shift from the company's initial plan of conducting two Phase 3 studies [1][6]. Group 1: FDA Meeting Outcomes - The FDA expressed openness to alternative clinical trial designs, such as randomized withdrawal or randomized delayed start studies, which may be more suitable for Netherton Syndrome than traditional upfront randomized controlled studies [2][6]. - Quoin Pharmaceuticals is on track to initiate its pivotal Phase 3 program and aims to complete patient recruitment by the end of 2026, with a potential NDA filing in 2027 [1][3]. Group 2: Company Commitment and Pipeline - Quoin Pharmaceuticals is focused on developing treatments for rare and orphan diseases, with a commitment to addressing unmet medical needs [4]. - The company's pipeline includes several products targeting various rare conditions, including Netherton Syndrome, Peeling Skin Syndrome, and others [4].

Core Viewpoint - Quoin Pharmaceuticals Ltd. is set to provide a corporate update and release its financial results for Q4 and the full year of 2025 on March 26, 2026, before market opening [1]. Group 1: Corporate Update - The upcoming announcement will include an operational update that highlights key achievements from the quarter, recent accomplishments, and financial highlights from 2025 [2]. Group 2: Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases [3]. - The company is dedicated to addressing unmet medical needs for patients, families, communities, and care teams [3]. - Quoin's innovative pipeline includes four products in development targeting various rare and orphan indications such as Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, microcystic lymphatic malformations, venous malformations, and angiofibromas [3].

Core Viewpoint - Quoin Pharmaceuticals Ltd. is set to provide an operational update on November 6, 2025, detailing key achievements and financial highlights for Q3 2025 [1]. Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases [2]. - The company aims to address unmet medical needs for patients and their communities [2]. - Quoin's pipeline includes four products in development targeting various rare and orphan indications such as Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, and Epidermolysis Bullosa [2].

Core Viewpoint - Quoin Pharmaceuticals Ltd. is set to release its financial results for Q2 2025 on August 7, 2025, which will include operational updates and financial highlights [1][2]. Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases [3]. - The company aims to address unmet medical needs for patients and their communities [3]. - Quoin's pipeline includes four products in development targeting various rare and orphan indications such as Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, and Epidermolysis Bullosa [3].

Core Insights - Quoin Pharmaceuticals is advancing its lead product QRX003 for Netherton Syndrome through two pivotal registrational clinical studies across the US, Europe, and the Middle East [2][3] - The company aims to file a New Drug Application (NDA) for QRX003 in the second half of 2026 and plans to self-commercialize the product in the US, Western Europe, and Japan [3] - Quoin has also reported positive initial data from a clinical study for Peeling Skin Syndrome (PSS), marking significant improvements in key clinical endpoints [4] Clinical Development - QRX003 is being tested in two studies, with over 80% of subjects' body surface area treated twice daily for 12 weeks [2] - The first study tests QRX003 as a monotherapy, while the second study combines it with off-label systemic therapy [2] - Each study is expected to recruit 12 to 16 subjects, with full recruitment targeted for early to mid Q1 2026 [2] Product Pipeline - Quoin's clinical program for QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome [3] - The company has discontinued the development of QRX007 for Netherton Syndrome and QRX004 for Epidermolysis Bullosa, focusing resources on high-potential opportunities [6][7] - The topical rapamycin program is progressing, targeting rare skin diseases, with clinical testing anticipated to begin in the first half of 2026 [5] Market Strategy - Quoin has established nine commercial partnerships to support global access to QRX003 across 61 additional countries upon approval [3] - The company is transitioning into pre-commercialization mode in anticipation of the potential approval and launch of QRX003 within the next 18 to 24 months [7]

Core Viewpoint - Quoin Pharmaceuticals has received FDA clearance to initiate a second pivotal clinical study for QRX003, targeting Netherton Syndrome, which is expected to generate comprehensive safety and efficacy data to support regulatory approval [1][3]. Group 1: Clinical Study Details - The new study, CL-QRX003-002, will involve approximately 12-15 subjects and will apply QRX003 to at least 80% of each subject's body surface area, enhancing the data collected compared to earlier studies [2][5]. - This pivotal study complements another ongoing study, CL-QRX003-003, where QRX003 is administered as monotherapy without off-label systemic therapy [2][5]. - Quoin anticipates recruiting between 24-30 subjects across 6 U.S. sites and up to 6 international sites, with recruitment expected to be completed by the end of Q1 2026 [2][5]. Group 2: Product and Market Potential - QRX003 is a topical lotion designed to downregulate the hyperactivity of kallikreins in the skin, addressing excessive skin shedding and associated symptoms in Netherton Syndrome patients [1][3]. - The combined data from both pivotal studies is expected to provide QRX003 with a broad label opportunity post-approval, allowing it to be used both as a monotherapy and in conjunction with off-label systemic treatments [5]. Group 3: Company Overview - Quoin Pharmaceuticals is a clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes products targeting various conditions such as Peeling Skin Syndrome and Epidermolysis Bullosa [4]. - The company is committed to addressing unmet medical needs for patients and their communities [4].

Core Insights - Quoin Pharmaceuticals has reported significant progress in its clinical studies for QRX003, a treatment for Netherton Syndrome, showing almost complete skin healing and elimination of pruritus in patients [2][3] - The company has expanded its patent portfolio to support its pipeline growth, including new formulations targeting various rare skin diseases [2][8] - Quoin launched the NETHERTON NOW advocacy initiative to raise awareness and support for the Netherton community [2][6] Clinical Progress - In Q1 2025, compelling data from multiple QRX003 studies indicated substantial improvement in skin conditions for both adult and pediatric patients [2][3] - A 12-week open-label study showed sustained benefits with no safety concerns for the first adult subject treated with QRX003 [3] - Pediatric subjects demonstrated significant improvement, transitioning from "Severe" to "Mild" after six weeks of treatment [4] Patent and Pipeline Development - Quoin has filed new patents for topical rapamycin formulations and novel QRX003 formulations, potentially extending intellectual property protection through 2045 [8][9] - The company is developing new programs for microcystic lymphatic malformations, venous malformations, and angiofibromas [2] Financial Overview - As of March 31, 2025, Quoin had approximately $11.6 million in cash and equivalents, expected to support operations into Q1 2026 [10] - The company reported a net loss of approximately $3.8 million for Q1 2025, compared to a net loss of approximately $2.3 million for the same period in 2024 [11][18] Future Outlook - Quoin is advancing its clinical studies of QRX003, with new FDA-cleared studies set to evaluate whole-body application in pediatric patients [12] - The upcoming studies aim to generate extensive clinical data for Netherton Syndrome, simulating real-world use of QRX003 [12]

Core Viewpoint - Quoin Pharmaceuticals Ltd. has filed a U.S. patent application for novel topical formulations aimed at treating skin diseases, including Netherton Syndrome, with its lead product QRX003 currently undergoing clinical trials [1][2]. Group 1: Product Development - QRX003 is being tested in four clinical trials for Netherton Syndrome, with three trials under an open Investigational New Drug (IND) application with the FDA [1][3]. - Initial positive clinical data has been reported from two open-label studies related to QRX003 [1]. - The company is also conducting an Investigator Clinical Study for Peeling Skin Syndrome in a pediatric patient in New Zealand [1]. Group 2: Patent Protection - The patent application aims to provide broad protection for QRX003 until 2045, covering both Netherton Syndrome and other rare skin diseases [2][7]. - The CEO emphasized the importance of securing extensive patent protection for the product and related applications [2]. Group 3: Market Position - Quoin is currently the only company actively recruiting and testing subjects in multiple clinical trials for Netherton Syndrome under an open IND [3]. - The company is committed to addressing unmet medical needs for rare and orphan diseases, with a pipeline that includes five products targeting various conditions [5].

Table of Contents As filed with the Securities and Exchange Commission on February 13, 2024 Registration No. 333-277016 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 QUOIN PHARMACEUTICALS LTD. (Exact name of Registrant as specified in its charter) State of Israel 2834 Not Applicable (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classific ...