Investment Highlights - The company is focused on a rare and orphan disease product pipeline[9] - The company is on track for First Netherton Syndrome Treatment Approval in 2026[9] - The global Netherton commercial opportunity is in excess of $1 billion[9] Product Pipeline - QRX003 is in pivotal clinical studies for Netherton Syndrome[12] - Clinical trial has been initiated for QRX003 for Peeling Skin Syndrome[12] - Clinical testing for QRX003 for Palmoplantar Keratoderma is expected to commence in the second half of 2025[12] Netherton Syndrome (NS) and QRX003 - Netherton Syndrome affects 6,000 – 8,000 newborns in the US and Europe combined, with up to 30,000 in Quoin Partnered Territories[21] - QRX003 is a topical lotion to be applied twice-daily to whole body surface[26] - Pilot study data showed marked improvements across all measured clinical endpoints with QRX003[31] - Pediatric whole body data showed that one patient experienced zero nightly sleep disturbances for the first time in her life after treatment with QRX003[40] Additional Rare Skin Disorders - Clinical testing in PPK to commence in 2025[50] - First Subject Peeling Skin Data showed the M-IASI decreased from 36 to 12 after 12 weeks[52]

New episode spotlights the severe burden of Netherton Syndrome in infants and children, reinforcing the need for effective pediatric treatmentsASHBURN, Va., June 26, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced the release of a new episode in its NETHERTON NOW video series. The episode features Professor Jemima Mellerio, a recognized authority in derma ...

Core Viewpoint - Quoin Pharmaceuticals has received Rare Pediatric Disease Designation from the FDA for its lead asset QRX003, aimed at treating Netherton Syndrome, a rare genetic disorder affecting children [1][3][4] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes four products targeting various conditions [5] Regulatory Designations - The FDA's Rare Pediatric Disease Designation for QRX003 highlights its potential as a therapeutic candidate for an underserved pediatric population, following the Orphan Drug Designation granted by the EMA in May 2025 [2][3] Clinical Development - The company is focused on completing pivotal clinical studies for QRX003 and advancing it towards a New Drug Application (NDA) as the first potential treatment for Netherton Syndrome [3][5] Disease Background - Netherton Syndrome is a rare genetic disorder affecting approximately 1 in 200,000 newborns, with symptoms that can lead to severe skin inflammation and a mortality rate in infancy estimated at 10 to 20 percent [4]

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 Viewpoint - Quoin Pharmaceuticals has received Orphan Drug Designation in Europe for its lead product QRX003, which is in late-stage clinical trials for treating Netherton Syndrome, providing the company with significant regulatory advantages and potential market exclusivity [1][2][3] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes four products targeting various conditions [4] Product Development - QRX003 is designed as a topical, non-systemic treatment for Netherton Syndrome, a severe disease with no current approved therapies, and is currently undergoing multiple late-stage clinical trials [3][4] - The product has shown promising clinical results, including significant skin healing and reduction of severe chronic pruritus in pediatric studies, indicating its potential efficacy as a broad-spectrum kallikrein inhibitor [3] Regulatory Milestones - The Orphan Drug Designation provides Quoin with benefits such as scientific advice on study protocols, fee reductions, and access to EU grants, and if approved, QRX003 will receive 10 years of market exclusivity in Europe [2][3]

Financial Performance - Quoin 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, reflecting an increase in losses of about 65.2% year-over-year[11] - The net loss for the period was $3.81 million, compared to a net loss of $2.32 million in the previous year, indicating an increase in losses of approximately 64.1%[19] - Basic loss per ADS was $6.50, compared to $3.87 for the same period last year, reflecting a significant increase in loss per share[19] - Total revenue for the three months ended March 31, 2025, was $3.95 million, compared to $3.57 million for the same period in 2024, representing a growth of approximately 10.6%[19] - Operating expenses for the period were $3.95 million, with general and administrative expenses at $1.58 million and research and development expenses at $2.37 million[19] - Quoin's total assets decreased from approximately $15.7 million as of December 31, 2024, to approximately $12.96 million as of March 31, 2025[18] - Total liabilities increased from approximately $6.5 million at the end of 2024 to approximately $7.03 million by March 31, 2025[18] - The company reported a significant increase in accumulated deficit, rising to approximately $58.98 million as of March 31, 2025, compared to $55.17 million at the end of 2024[18] - The weighted average number of ADS outstanding was 586,331, compared to 609,094 in the previous year, showing a decrease in outstanding shares[19] Clinical Progress - The company achieved significant clinical progress with QRX003, showing almost complete skin healing and elimination of pruritus in patients, allowing for the discontinuation of multiple prior medications[2] - The interim results from the pediatric Investigator Study indicated improvement from "Severe" to "Mild" on the Investigator's Global Assessment after six weeks of treatment[4] - A newly FDA-cleared study will evaluate whole-body application of QRX003 in up to 12 patients, aiming to generate extensive clinical data for Netherton Syndrome[12] Intellectual Property and Initiatives - Quoin expanded its patent portfolio with new filings for novel formulations targeting several rare skin diseases, potentially extending intellectual property protection through 2045[9] - The company launched the NETHERTON NOW awareness initiative to support and engage with the Netherton community and advocacy groups[6] Cash and Financial Outlook - As of March 31, 2025, Quoin had approximately $11.6 million in cash, cash equivalents, and marketable securities, which is expected to support operations into Q1 2026[10]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to __________ Commission file number: 001-37846 QUOIN PHARMACEUTICALS LTD. (Exact name of registrant as specified in its charter) ...

Episode Highlights a Truly Remarkable Patient Story Spanning 79 Years Video features 79-year-old Norma Coles, believed to be among the earliest individuals ever evaluated for Netherton Syndrome and is available on the company's NETHERTON NOW website ASHBURN, Va., April 10, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) ("Quoin" or the "Company"), a late clinical-stage specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare ...

Core Insights - Quoin Pharmaceuticals has released the second episode of its "Living with Netherton" video series, featuring a 79-year-old patient, Norma Coles, who has lived with Netherton Syndrome for decades, highlighting the need for awareness and treatment [1][2][4] - The company aims to raise awareness and improve education regarding Netherton Syndrome, which currently has no FDA-approved treatment, emphasizing the urgency for effective therapeutic options [2][5] Company Overview - Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases [1][7] - The company is committed to addressing unmet medical needs and has a pipeline that includes four products targeting various rare conditions, including Netherton Syndrome [7] Product Development - Quoin's lead product candidate, QRX003, is currently undergoing evaluation in four clinical trials for the treatment of Netherton Syndrome, with initial data showing improvements in skin healing and quality of life [5][6] - QRX003 is a topical lotion designed to normalize skin-shedding processes and strengthen the skin barrier, addressing the underlying issues of Netherton Syndrome [6] Campaign and Advocacy - The NETHERTON NOW campaign is central to Quoin's efforts to raise awareness and support for individuals affected by Netherton Syndrome, sharing real patient experiences to foster understanding [4][5] - The company emphasizes the importance of patient stories, like that of Norma Coles, to illustrate the challenges faced by those living with this rare genetic disorder [2][5]

Continued Clear Visual Evidence of Almost Completely Healed Skin After 6 weeks TreatmentHigh Durability of Treatment Effect of QRX003 with Continuous Daily Dosing Patient Continues Not to Require Previously Necessary MedicationsWith Patient's Pruritus Almost Completely Eliminated, Patient Continues to Experience Zero Nightly Sleep Disturbance No Adverse Events Reported from 6 Weeks of Whole Body Treatment with QRX003Approval Received to Initiate Whole Body Testing of a Second Pediatric Patient ASHBURN, Va., ...