Viral Hepatitis · registered primary completion 2026-12-01 · NCT07128550
Registered design for NCT07128550: randomized, open-label, 150 participants (estimated). Primary outcome: HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24. 1 further primary outcome(s) registered.
Cash of $529M against operating outflow of $88M per quarter gives roughly 6.0 quarters of runway, clearing the registered primary completion 1.1 quarters out by 4.9 quarters.
169,215,958 shares outstanding against 179,589,293 if every outstanding option, warrant and convertible were exercised. In that case 5.8% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
Designations disclosed: Breakthrough Therapy, Fast Track, Orphan Drug, PRIME (EU). These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.
7 distinct molecules in 7 active company-sponsored trials; Tobevibart accounts for 3 of them at Phase 2/Phase 3.