Acute Myeloid Leukemia (AML) · registered primary completion 2031-11-01 · NCT07007312
8 approved products already carry Acute Myeloid Leukemia (AML) on label, including Idamycin PFS, RYDAPT, Daurismo, VANFLYTA. Approval would enter an occupied market.
Registered design for NCT07007312: randomized, quadruple-masked, 1300 participants (estimated). Primary outcome: Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS). 3 further primary outcome(s) registered.
Cash of $519M against operating outflow of $76M per quarter gives roughly 6.8 quarters of runway; the registered primary completion is 20.7 quarters out.
88,960,619 shares outstanding against 110,627,619 if every outstanding option, warrant and convertible were exercised. In that case 19.6% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
Designations disclosed: Breakthrough Therapy, Fast Track, Orphan Drug. These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.
15 distinct molecules in 6 active company-sponsored trials; Ziftomenib accounts for 5 of them at Phase 1/Phase 2/Phase 3.