Advancing the lead candidate QTORIN™ 3.9% rapamycin anhydrous gel through regulatory channels, following positive Phase 3 SELVA trial results (which met its primary endpoint with a mean mLM-IGA improvement of +2.13, p<0.001). This includes preparing the Section 505(b)(2) NDA submission planned for the second half of 2026.

Expected impact: Establishes QTORIN™ rapamycin as the first FDA-approved targeted therapy and standard of care for microcystic LMs, addressing an estimated population of over 30,000 diagnosed patients in the U.S.

Expanding the clinical development of QTORIN™ rapamycin into cutaneous VMs, following positive Phase 2 TOIVA study results (where 73% of patients demonstrated improvement on the CVM-IGA at week 12). Plans include initiating a Phase 3 pivotal study.

Expected impact: Addresses a large underserved market of over 75,000 diagnosed patients in the U.S. with no current FDA-approved therapies.

Developing QTORIN™ pitavastatin as a potential first-in-class, pathogenesis-directed topical therapy for disseminated superficial actinic porokeratosis (DSAP), targeting the mevalonate pathway locally.

Expected impact: Targets a premalignant genetic skin disease affecting over 50,000 diagnosed patients in the U.S. with no FDA-approved treatments.