Cellect(QNRX) - 2025 Q4 - Annual Results

Financial Performance - The net loss for the quarter ended December 31, 2025, was approximately $4.3 million, compared to approximately $2.3 million for the same quarter in 2024; the net loss for the full year was approximately $15.8 million, compared to approximately $9.0 million in 2024 [16]. - Total operating expenses for the three months ended December 31, 2025, were $16,290,716, a significant increase from $9,528,465 in the same period of 2024, representing a 70% year-over-year increase [22]. - Research and development expenses rose to $9,802,807 for the year ended December 31, 2025, compared to $3,602,632 in 2024, marking a 172% increase [22]. - The net loss for the three months ended December 31, 2025, was $15,804,655, compared to a net loss of $8,962,472 in the same period of 2024, indicating a 76% increase in losses [22]. - Loss per ADS for the year ended December 31, 2025, was $14.80, compared to $68.02 for the year ended December 31, 2024 [22]. - Comprehensive loss for the three months ended December 31, 2025, was $15,805,268, compared to $8,962,472 in the same period of 2024, reflecting a 76% increase [22]. - General and administrative expenses for the three months ended December 31, 2025, were $6,487,909, up from $5,925,833 in 2024, a 9% increase [22]. - Total other income for the three months ended December 31, 2025, was $(486,061), compared to $(565,993) in the same period of 2024, showing a decrease in other expenses [22]. - Unrealized gains for the year ended December 31, 2025, were $(3,980), compared to $(7,502) in 2024, indicating a slight improvement [22]. - Foreign currency translation loss for the year ended December 31, 2025, was $(613), with no loss reported in 2024 [22]. Funding and Financial Position - Quoin Pharmaceuticals closed a private placement financing raising up to $104.5 million in gross proceeds, including $16.5 million at closing and up to $88.0 million upon potential exercise of accompanying warrants [7]. - 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 [15]. Product Development and Regulatory Affairs - The U.S. FDA granted Orphan Drug Designation to QRX003 for Netherton Syndrome, providing potential benefits such as market exclusivity and tax credits for clinical testing [8]. - Quoin plans to submit an Investigational New Drug application to the FDA for QRX003 in the second half of 2026, targeting multiple rare genetic diseases [2]. - Quoin expanded its pediatric study of QRX003 to 7 children, the largest cohort of this age group ever studied, demonstrating sustained skin healing and no adverse events [9]. - The company achieved target loadings of 4% and 5% for its proprietary topical rapamycin platforms, with clinical studies planned for the second half of 2026 [14]. - Quoin anticipates reporting topline data from two whole-body clinical trials for Netherton Syndrome in the second half of 2026 [12]. - The U.S. Rare Pediatric Disease Priority Review Voucher program was extended through September 30, 2029, potentially providing Quoin with a voucher valued at $150-$200 million upon approval of QRX003 [5]. Marketing and Outreach - The NETHERTON NOW awareness campaign surpassed 2 million video views and 24 million global impressions, highlighting the company's outreach efforts [6].