QRX-003

ASHBURN, Va., Aug. 12, 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 the fourth episode in its NETHERTON NOW video series. This installment features Mandy Aldwin-Easton, a Netherton Syndrome patient, and a widely recognized, passionate advocate for people living with rare diseases. Mandy serves as Medical and Communications Manager and Co-founder of the UK-based Ichthyosis Support Group and is President of the European Network for Ichthyosis. In the video, Mandy shares her personal journey living with Netherton Syndrome, from delayed diagnosis, severe, chronic pain, multiple hospitalizations to the profound long-term impact this disease has had on her life. “One thing we don't talk about is how incredibly painful skin is when it doesn't work properly,” Mandy explains in the video. “Imagine millions of paper cuts all over your body. It’s just so highly unpredictable. The one thing anybody wants with a rare disease like Netherton Syndrome is hope—that better treatments are on the way.” Mandy’s story underscores the severe physical and emotional toll of the disease. Despite having a highly supportive family and medical advocacy, she has experienced extreme flare-ups, prolonged hospitalizations, and a lack of targeted treatment options throughout her entire life. As an adult, she continues to navigate the complexities of a disease that many still fail to recognize as life-threatening. “I couldn’t go out because my skin was falling off me. It was so incredibly painful that it was just unbearable to walk,” she recalls. “Even with hospital stays and treatments, no one really knew how to care for my skin.” “Mandy has long been a pillar of the ichthyosis and Netherton Syndrome communities,” said Denise Carter, Co-Founder and Chief Operating Officer of Quoin Pharmaceuticals. “Netherton Syndrome is not just a rare skin disease. It is a relentless and punishing condition marked by excruciating pain, debilitating flare-ups, recurrent infections, and emotional trauma. The toll on patients and their families is immense, not only physically and emotionally but also financially, requiring lifelong care, frequent hospitalizations, and ongoing interventions that place a heavy burden on families and healthcare systems. Beyond her personal resilience, Mandy’s unwavering advocacy has made her a powerful voice for this underserved and often overlooked population. We are honored to feature her in our NETHERTON NOW series and remain steadfast in our mission to bring awareness and hope to those living with this devastating disease.” The release of this video comes as Quoin continues to advance its lead product candidate, QRX003, in multiple pivotal clinical trials for the treatment of Netherton Syndrome. Recently reported data from ongoing studies have shown highly encouraging improvements in key clinical outcomes. “Mandy’s story reflects the extraordinary strength and perseverance of patients who have endured a lifetime of suffering without access to an approved treatment,” said Dr. Michael Myers, Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals. “As we advance QRX003 through multiple late-stage pivotal trials, voices like Mandy’s reinforce the urgency of our mission. Quoin is committed to delivering a meaningful treatment for the severely underserved Netherton Syndrome community and to driving forward research that addresses the significant unmet needs across a broader range of rare skin disorders.” The full video featuring Mandy Aldwin-Easton is available at: https://www.youtube.com/watch?v=b2RXfrx8OvM&t=45s. About QRX003 QRX003 is a topical lotion formulated with a proprietary delivery technology that contains a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to perform the function of a specific protein called LEKTI. The absence of LEKTI in Netherton patients leads to excessive skin shedding, resulting in a highly porous and compromised skin barrier. QRX003 is designed to promote a more normalized skin-shedding process and the formation of a stronger and more effective skin barrier. For more information about Quoin’s current clinical trials, visit: https://quoinpharma.com/pipeline/#trials. About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit www.quoinpharma.com or LinkedIn for updates. Cautionary Note Regarding Forward-Looking Statements The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as “expect,” “intend,” “hope,” “plan,” “potential,” “anticipate,” “look forward,” “believe,” “may,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: bringing awareness and hope to those living with Netherton Syndrome, continuing to advance QRX003 through multiple late-stage pivotal trials, delivering a meaningful treatment for the Netherton Syndrome community, driving forward research that addresses the significant unmet needs across a broader range of rare skin disorders and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, , Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome; the Company’s ability to pursue its regulatory strategy; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected, the Company experiencing unanticipated or higher than expected clinical trial costs; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. For further information, contact: Quoin Pharmaceuticals Ltd. Michael Myers, Ph.D., CEO mmyers@quoinpharma.com Investor Contact: PCG Advisory Jeff Ramson jramson@pcgadvisory.com (646) 863-6341

- Positive 6 Month Clinical Data Reported for Ongoing Pediatric Netherton Syndrome Study - FDA Clears Second Pivotal Study of QRX003 for Netherton Syndrome - Initial Positive Data Announced from Peeling Skin Syndrome Pediatric Study - Orphan Drug Designation Granted by European Medicines Agency for QRX003 - Rare Pediatric Disease Designation Awarded by U.S. FDA - NETHERTON NOW Campaign Expanded with New Patient and Expert Video Releases ASHBURN, Va., Aug. 07, 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 provided a corporate update today on its clinical progress and advocacy initiatives and announced its financial results for the second quarter ended June 30, 2025. “Second quarter of 2025 was one of the most impactful in Quoin’s history, marked by meaningful progress on multiple fronts," said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals. "We continue to be encouraged by the positive and durable clinical improvements observed in our ongoing investigator-led pediatric Netherton Syndrome study. In addition, with the reporting of impressive Peeling Skin Syndrome data during the quarter, we are beginning to see the versatility of QRX003 as a potentially safe and effective treatment for a variety of rare skin diseases. We look forward to initiating additional studies in other indications in the coming months. From a regulatory standpoint, receiving Orphan Drug Designation in Europe and Rare Pediatric Disease Designation in the United States are important milestones for the Company which we believe will help accelerate the development of QRX003 and bring it to the patients who urgently need it. Additionally, our NETHERTON NOW campaign continues to elevate awareness of the profound need for effective treatment options, reaching millions of people with education, advocacy, and powerful stories that highlight the faces of patients living with this disease, their family members who care for them and the clinicians who provide treatment for them each day without an FDA-approved therapy. With our late-stage trials advancing and global engagement expanding, we remain fully focused on delivering the first approved therapy for Netherton Syndrome." Corporate Highlights Quoin continued to advance its lead clinical asset, QRX003, into pivotal trials for Netherton Syndrome, a devastating and life-threatening genetic skin disorder with no approved therapies. The Company also made important regulatory, clinical, and advocacy progress in the second quarter of 2025: April 2, 2025Quoin Pharmaceuticals announced positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome study. After six months of treatment with QRX003, significant improvements were observed in the patient’s skin condition, reduced itch, and no adverse events were reported. April 10, 2025Quoin released the second episode in its Living with Netherton video series, part of its broader NETHERTON NOW awareness campaign, highlighting the daily challenges faced by patients and families living with Netherton Syndrome. May 14, 2025Positive clinical data were announced from an investigator-led Pediatric Peeling Skin Syndrome (PSS) study. After 12 weeks of treatment with QRX003, patients showed improvement in disease severity, skin condition, and quality of life metrics, with no adverse events reported. May 20, 2025The Company received Orphan Drug Designation from the European Medicines Agency for QRX003, granting 10 years of market exclusivity in Europe upon approval. This designation offers benefits like scientific advice on study protocols and fee reductions. May 22, 2025FDA clearance was announced for the initiation of a second pivotal clinical study (CL-QRX003-002) for QRX003, targeting Netherton Syndrome. The study will include 12–15 subjects, with recruitment expected to conclude by the end of Q1 2026 and an NDA filing anticipated later in 2026. June 24, 2025The FDA granted Rare Pediatric Disease Designation to QRX003 for the treatment of Netherton Syndrome, enabling potential Priority Review Voucher eligibility upon marketing approval. June 26, 2025Quoin launched a new installment in its NETHERTON NOW campaign, featuring Professor Jemima Mellerio, a world-renowned expert in genetic skin diseases. The video emphasized the severe burden of Netherton Syndrome in pediatric patients. Financial Highlights Cash Position: Quoin had approximately $7.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025. The Company believes this capital will support operations into the first quarter of 2026. Net Loss: For the three and six months ended June 30, 2025, Quoin reported a net loss of approximately $3.7 million and $7.5 million, respectively, compared to a net loss of approximately $2.0 million and $4.3 million, respectively, for the same periods in 2024. The increase in net loss was primarily due to an increase in research and development expenditure in the three and six months ended June 30, 2025 of approximately $2.1 million and $4.4 million, respectively, compared to $0.6 million and $1.5 million, respectively, for the same periods in 2024. About Quoin Pharmaceuticals Ltd.Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit www.quoinpharma.com or LinkedIn for updates. Cautionary Note Regarding Forward Looking StatementsThe Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as “expect,” “intend,” “hope,” “plan,” “potential,” “anticipate,” “look forward,” “believe,” “may,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: continuing to be encouraged by the positive and durable clinical improvements observed in the Company’s ongoing investigator-led pediatric Netherton Syndrome study, beginning to see the versatility of QRX003 as a potentially safe and effective treatment for a variety of rare skin diseases, initiating additional studies in other indications in the coming months, receiving Orphan Drug Designation in Europe and Rare Pediatric Disease Designation in the United States helping to accelerate the development of QRX003 and bring it to the patients who urgently need it, the NETHERTON NOW campaign continuing to elevate awareness of the profound need for effective treatment options, remaining fully focused on delivering the first approved therapy for Netherton Syndrome, concluding recruitment of 12–15 subjects by the end of Q1 2026 for a second pivotal clinical study for QRX003, targeting Netherton Syndrome, filing an NDA later in 2026, the Company’s capital supporting its operations into the first quarter of 2026,and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, , Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome; the Company’s ability to pursue its regulatory strategy; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected, the Company experiencing unanticipated or higher than expected clinical trial costs;; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. For further information, contact:Quoin Pharmaceuticals Ltd.Michael Myers, Ph.D., CEOmmyers@quoinpharma.com Investor Contact:PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com(646) 863-6341 QUOIN PHARMACEUTICALS, LTD. Consolidated Balance Sheets June 30, December 31, 2025 2024 (unaudited) ASSETS Current assets: Cash and cash equivalents$1,668,492 $3,623,343 Investments 6,121,830 10,433,535 Prepaid expenses and other current assets 688,933 869,126 Total current assets 8,479,255 14,926,004 Prepaid expenses - long term - 300,000 Intangible assets, net 433,334 483,334 Total assets$8,912,589 $15,709,338 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable$873,684 $905,704 Accrued expenses 1,717,564 1,528,977 Accrued interest and financing expense 1,146,251 1,146,251 Due to officers - short term 600,000 600,000 Total current liabilities 4,337,499 4,180,932 Due to officers - long term 2,023,733 2,323,733 Total liabilities$6,361,232 $6,504,665 Commitments and contingencies Shareholders' equity: Ordinary shares, no par value per share, 100,000,000 authorized at March 31, 2025 and December 31, 2024, respectively - 20,585,830 (588,166 ADS's) ordinary shares issued and outstanding at June 30, 2025 and 8,948,164 (255,661 ADS's) ordinary shares issued and outstanding at December 31, 2024$- $- Additional paid in capital 65,225,266 64,370,465 Accumulated deficit (62,673,909) (55,165,792) Total shareholders' equity 2,551,357 9,204,673 Total liabilities and shareholders' equity$8,912,589 $15,709,338 QUOIN PHARMACEUTICALS, LTD. Consolidated Statements of Operations (Unaudited) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Revenue - - - - (Unaudited) (Unaudited) (Unaudited) (Unaudited)Operating expenses General and administrative $1,742,594 $1,549,615 $3,325,632 $3,122,601 Research and development 2,050,585 587,503 4,424,724 1,472,801 Total operating expenses 3,793,179 2,137,118 7,750,356 4,595,402 Other (income) and expenses Unrealized loss 6,004 2,177 5,878 8,686 Realized and accrued interest income (103,245) (165,262) (248,117) (302,775) Total other income (97,241) (163,085) (242,239) (294,089)Net loss $(3,695,938) $(1,974,033) $(7,508,117) $(4,301,313) Loss per ADS Basic $(6.28) $(13.68) $(12.79) $(42.09) Fully-diluted $(6.28) $(13.68) $(12.79) $(42.09) Weighted average number of ADS's outstanding Basic 588,166 144,278 587,253 102,186 Fully-diluted 588,166 144,278 587,253 102,186