Systemic Sclerosis · registered primary completion 2028-07-01 · NCT06154252
Cash of $225M against operating outflow of $47M per quarter gives roughly 4.8 quarters of runway — the registered primary completion is 7.4 quarters out. On these figures the company raises capital before the readout.
Management has concluded there is substantial doubt about the company's ability to continue as a going concern.
5 approved products already carry Systemic Sclerosis on label, including ACTEMRA, Nintedanib, Nintedanib Capsules, 100 mg and 150 mg, nintedanib. Approval would enter an occupied market.
169,545,445 shares outstanding against 235,183,675 if every outstanding option, warrant and convertible were exercised. In that case 27.9% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
50,000,000 pre-funded warrant shares outstanding at a nominal exercise price — economically issued equity.
Share count up 85% year over year to 169,545,445 as of 2026-08-07.
Registered design for NCT06154252: non-randomized, open-label, 74 participants (estimated). Primary outcome: Phase 1/2: Incidence and severity of adverse events (AEs). 2 further primary outcome(s) registered.
Designations disclosed: RMAT, Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review Voucher, PRIME (EU). These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.
2 distinct molecules in 5 active company-sponsored trials; CABA-201 accounts for 8 of them at Phase 1/Phase 2/Phase 3.