Biliary Tract Cancer · registered primary completion 2026-12-01 · NCT05506943
Cash of $180M against operating outflow of $21M per quarter gives roughly 8.5 quarters of runway, clearing the registered primary completion 1.1 quarters out by 7.4 quarters.
180,087,915 shares outstanding against 205,387,915 if every outstanding option, warrant and convertible were exercised. In that case 12.3% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
6,710,000 pre-funded warrant shares outstanding at a nominal exercise price — economically issued equity.
Share count up 30% year over year to 180,087,915 as of 2026-07-28.
4 approved products already carry Biliary Tract Cancer on label, including KEYTRUDA QLEX, IMFINZI, KEYTRUDA, ZIIHERA. Approval would enter an occupied market.
Registered design for NCT05506943: randomized, single-masked, 168 participants (actual). Primary outcome: Best Overall Response.
Designations disclosed: Breakthrough Therapy, Fast Track, Orphan Drug. These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.
4 distinct molecules in 4 active company-sponsored trials; CTX-009 accounts for 1 of them at Phase 2/Phase 3.