Cellect(QNRX) - 2025 Q2 - Quarterly Results

Introduction Company Overview Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, announcing its Q2 2025 financial results and corporate updates - Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases[1] CEO Statement CEO Dr. Michael Myers highlighted Q2 2025 as impactful, citing positive clinical improvements in the pediatric Netherton Syndrome study, impressive Peeling Skin Syndrome data, and the versatility of QRX003. Key regulatory milestones included Orphan Drug Designation in Europe and Rare Pediatric Disease Designation in the US, expected to accelerate QRX003 development. The NETHERTON NOW campaign continues to raise awareness - CEO Dr. Michael Myers stated Q2 2025 was impactful with meaningful progress on multiple fronts, including positive and durable clinical improvements in the ongoing investigator-led pediatric Netherton Syndrome study[2] - Impressive Peeling Skin Syndrome data reported, demonstrating QRX003's versatility as a potentially safe and effective treatment for various rare skin diseases[2] - Received Orphan Drug Designation in Europe and Rare Pediatric Disease Designation in the United States, expected to help accelerate QRX003 development[2] - The NETHERTON NOW campaign continues to elevate awareness for effective Netherton Syndrome treatment options[2] Corporate Highlights Key Achievements in Q2 2025 Quoin Pharmaceuticals made significant progress in Q2 2025, advancing its lead clinical asset QRX003 into pivotal trials for Netherton Syndrome. Key achievements include positive clinical data for Netherton and Peeling Skin Syndromes, FDA clearance for a second pivotal Netherton study, and important regulatory designations in both Europe and the US - Advanced lead clinical asset, QRX003, into pivotal trials for Netherton Syndrome, a devastating and life-threatening genetic skin disorder with no approved therapies[3] - Reported positive 6-month clinical data for ongoing pediatric Netherton Syndrome study and initial positive data from Peeling Skin Syndrome pediatric study[3] - FDA cleared a second pivotal study of QRX003 for Netherton Syndrome[3] - Granted Orphan Drug Designation by European Medicines Agency and Rare Pediatric Disease Designation by U.S. FDA for QRX003[3] Detailed Clinical and Regulatory Milestones Q2 2025 saw several specific milestones for QRX003, including positive clinical data for Netherton and Peeling Skin Syndromes, FDA clearance for a second pivotal Netherton study, and key regulatory designations from both the EMA and FDA, alongside continued expansion of the NETHERTON NOW awareness campaign Netherton Syndrome Program Updates Positive 6-month clinical data from an investigator-led pediatric Netherton Syndrome study showed significant improvements in skin condition and reduced itch with no adverse events. The FDA also cleared a second pivotal clinical study (CL-QRX003-002) for Netherton Syndrome, with recruitment expected to conclude by Q1 2026 and an NDA filing anticipated later in 2026 - Positive clinical data from ongoing Investigator Pediatric Netherton Syndrome study reported on April 2, 2025, showing significant improvements in patient's skin condition and reduced itch after six months of QRX003 treatment, with no adverse events[4] - FDA clearance announced on May 22, 2025, for the initiation of a second pivotal clinical study (CL-QRX003-002) for QRX003, targeting Netherton Syndrome[8] - The second pivotal 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[8] Peeling Skin Syndrome Program Updates Initial positive clinical data from an investigator-led Pediatric Peeling Skin Syndrome (PSS) study demonstrated improvements in disease severity, skin condition, and quality of life metrics after 12 weeks of QRX003 treatment, with no adverse events - Positive clinical data announced on May 14, 2025, from an investigator-led Pediatric Peeling Skin Syndrome (PSS) study[6] - 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[6] Regulatory Designations QRX003 received Orphan Drug Designation from the European Medicines Agency, granting 10 years of market exclusivity in Europe upon approval, along with scientific advice and fee reductions. The FDA also granted Rare Pediatric Disease Designation for QRX003 for Netherton Syndrome, potentially enabling Priority Review Voucher eligibility - On May 20, 2025, the Company received Orphan Drug Designation from the European Medicines Agency for QRX003, granting 10 years of market exclusivity in Europe upon approval and offering benefits like scientific advice on study protocols and fee reductions[7] - On June 24, 2025, the FDA granted Rare Pediatric Disease Designation to QRX003 for the treatment of Netherton Syndrome, enabling potential Priority Review Voucher eligibility upon marketing approval[9] Advocacy Initiatives Quoin continued to expand its NETHERTON NOW awareness campaign, releasing new episodes in its 'Living with Netherton' video series to highlight patient challenges and featuring expert insights on the severe burden of Netherton Syndrome in pediatric patients - On April 10, 2025, Quoin 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[5] - On June 26, 2025, Quoin launched a new installment in its NETHERTON NOW campaign, featuring Professor Jemima Mellerio, a world-renowned expert, emphasizing the severe burden of Netherton Syndrome in pediatric patients[10] Financial Highlights Cash Position As of June 30, 2025, Quoin Pharmaceuticals held approximately $7.8 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into Q1 2026 - Cash, cash equivalents, and marketable securities as of June 30, 2025: approximately $7.8 million[11] - The Company believes this capital will support operations into the first quarter of 2026[11] Net Loss Quoin reported an increased net loss for Q2 2025 and the six months ended June 30, 2025, primarily driven by a significant increase in research and development expenditures compared to the same periods in 2024 Net Loss and R&D Expenditure Comparison | Period | Net Loss (2025) | Net Loss (2024) | R&D Expenditure (2025) | R&D Expenditure (2024) | Change in Net Loss (YoY) | Change in R&D (YoY) | | :------------------- | :---------------- | :---------------- | :----------------------- | :----------------------- | :----------------------- | :-------------------- | | Three months ended June 30 | ~$3.7 million | ~$2.0 million | ~$2.1 million | ~$0.6 million | Increased by ~$1.7 million | Increased by ~$1.5 million | | Six months ended June 30 | ~$7.5 million | ~$4.3 million | ~$4.4 million | ~$1.5 million | Increased by ~$3.2 million | Increased by ~$2.9 million | - Net loss for the three months ended June 30, 2025, increased to approximately $3.7 million from $2.0 million in the prior year, primarily due to a rise in R&D expenditure from $0.6 million to $2.1 million[12][17] - Net loss for the six months ended June 30, 2025, increased to approximately $7.5 million from $4.3 million in the prior year, primarily due to a rise in R&D expenditure from $1.5 million to $4.4 million[12][17] About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company dedicated to developing and commercializing therapies for rare and orphan diseases. Its pipeline includes four products targeting a broad range of indications such as Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, and others - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases[13] - 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, and Angiofibroma[13] Cautionary Note Regarding Forward Looking Statements This section advises that statements not based on historical facts are forward-looking and subject to risks and uncertainties, meaning actual results may differ materially. It lists various forward-looking statements made in the press release and highlights potential risks, including the ability to deliver safe treatments, obtain regulatory approvals, complete trials, and manage costs. The company disclaims any obligation to update these statements - 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, and actual results may differ materially due to risks and uncertainties[14] - Forward-looking statements include expectations regarding clinical improvements, QRX003 versatility, initiation of new studies, acceleration of development due to designations, campaign awareness, delivering the first approved Netherton Syndrome therapy, recruitment timelines, NDA filing, capital sufficiency, and product pipeline potential[14] - Risks and uncertainties include the Company's ability to deliver a safe and effective treatment, pursue its regulatory strategy, obtain regulatory approvals, complete clinical trials on time, achieve desired results, and manage unanticipated or higher than expected clinical trial costs[14] Financial Statements Consolidated Balance Sheets As of June 30, 2025, Quoin's total assets decreased significantly to $8.91 million from $15.71 million at December 31, 2024, primarily due to reductions in cash, cash equivalents, and investments. Total liabilities slightly decreased, while total shareholders' equity saw a substantial reduction from $9.20 million to $2.55 million, largely due to an increased accumulated deficit Consolidated Balance Sheet Highlights | Item | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :-------------- | :---------------- | :------------------- | | Cash and cash equivalents | $1,668,492 | $3,623,343 | -$1,954,851 | | Investments | $6,121,830 | $10,433,535 | -$4,311,705 | | Total current assets | $8,479,255 | $14,926,004 | -$6,446,749 | | Total assets | $8,912,589 | $15,709,338 | -$6,796,749 | | Total current liabilities | $4,337,499 | $4,180,932 | +$156,567 | | Total liabilities | $6,361,232 | $6,504,665 | -$143,433 | | Total shareholders' equity | $2,551,357 | $9,204,673 | -$6,653,316 | | Accumulated deficit | $(62,673,909) | $(55,165,792) | -$7,508,117 | Consolidated Statements of Operations For the three and six months ended June 30, 2025, Quoin reported increased net losses compared to the prior year, primarily driven by a substantial rise in research and development expenses. Basic and fully-diluted loss per ADS also decreased significantly year-over-year for both periods, despite the increased net loss, due to a higher weighted average number of ADS's outstanding Consolidated Statements of Operations Highlights | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | 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 | | 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) | | Weighted average ADS's outstanding (Basic) | 588,166 | 144,278 | 587,253 | 102,186 | - Net loss for the three months ended June 30, 2025, increased to approximately $3.7 million from $2.0 million in the prior year, primarily due to a rise in R&D expenditure from $0.6 million to $2.1 million[12][17] - Net loss for the six months ended June 30, 2025, increased to approximately $7.5 million from $4.3 million in the prior year, primarily due to a rise in R&D expenditure from $1.5 million to $4.4 million[12][17] Contact Information This section provides contact details for Quoin Pharmaceuticals Ltd., including the CEO, Dr. Michael Myers, and for investor relations through PCG Advisory, Jeff Ramson - Contact for Quoin Pharmaceuticals Ltd.: Michael Myers, Ph.D., CEO (mmyers@quoinpharma.com)[15] - Investor Contact: PCG Advisory, Jeff Ramson (jramson@pcgadvisory.com, (646) 863-6341)[15]