Dravet Syndrome · registered primary completion 2027-03-01 · NCT06872125
Cash of $293M against operating outflow of $47M per quarter gives roughly 6.2 quarters of runway, clearing the registered primary completion 2.0 quarters out by 4.2 quarters.
64,526,242 shares outstanding against 78,216,578 if every outstanding option, warrant and convertible were exercised. In that case 17.5% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
3 approved products already carry Dravet Syndrome on label, including Diacomit, Epidiolex, Fintepla. Approval would enter an occupied market.
Registered design for NCT06872125: randomized, quadruple-masked, 170 participants (estimated). Primary outcome: Measurement of Seizure Change.
Designations disclosed: Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review Voucher. These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.
2 distinct molecules in 2 active company-sponsored trials; zorevunersen accounts for 1 of them at Phase 3.