SKVI — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• On January 27, 2026 Quoin Pharmaceuticals Announced 1. USA - Quoin Pharmaceuticals Announces “FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome”. Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditio…

• On March 25, 2026 Quoin Pharmaceuticals Ltd. provided a clinical and regulatory update from its recent constructive Type C meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome (NS):

• § FDA indicated that a single Phase 3 study may be sufficient to support marketing approval for QRX003 for Netherton Syndrome, which is an alternative to the traditional expectation for two Phase 3 studies in NS patients originally proposed by the Company.

• § FDA expressed openness to an alternative innovative clinical trial design such as a randomized withdrawal or a randomized delayed start for a pivotal Phase 3 study. Such trial design would likely not include a traditional upfront vehicle or placebo control.

• § Based on the feedback from the meeting, Quoin is implementing FDA recommendations consistent with the meeting outcomes, ensuring its readiness to advance toward registrational Phase 3 development. Quoin will submit clinical data from the ongoing Phase 2 and pediatric investigator studies and plans…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Our revenue, which we combine from product sales, royalties on patent licenses and license fees (product development fees), was $5,000 for the three months ended September 30, 2025 as compared with $5,000 for the same period ended September 30, 2024. Our revenue, which we combine from product sales,…

• Operating expenses decreased to $111,057 for the three months ended September 30, 2025, from $129,969 for the same period ended September 30, 2024. Operating expenses decreased to $397,146 for the nine months ended September 30, 2025, from $405,846 for the same period ended September 30, 2024.

• We had other expense of $144,188 for the three months ended September 30, 2025, as compared with other expenses of $161,635 for the three months ended September 30, 2024. We had other expense of $423,531 for the nine months ended September 30, 2025, as compared with other expenses of $489,579 for th…

• Our other expense for the three and nine months ended September 30, 2025 consisted mainly of interest expense netted against other income related to the sale of polymer. Our other expense for the three and nine months ended September 30, 2024 consisted mainly of interest expense, netted against a ga…

• We recorded a net loss of $250,245 for the three months ended September 30, 2025, as compared with a net loss of $286,604 for the three months ended September 30, 2024. We recorded a net loss of $805,677 for the nine months ended September 30, 2025, as compared with a net loss of $880,425 for the ni…