Metastatic Melanoma · registered primary completion 2028-03-01 · NCT05727904
Cash of $298M against operating outflow of $85M per quarter gives roughly 3.5 quarters of runway — the registered primary completion is 6.1 quarters out. On these figures the company raises capital before the readout.
8 approved products already carry Metastatic Melanoma on label, including Mekinist, KEYTRUDA QLEX, YERVOY, BRAFTOVI. Approval would enter an occupied market.
Registered design for NCT05727904: randomized, open-label, 670 participants (estimated). Primary outcome: Objective Response Rate and Progression Free Survival.
452,971,432 shares outstanding against 485,702,308 if every outstanding option, warrant and convertible were exercised. In that case 6.7% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
Share count up 25% year over year to 452,971,432 as of 2026-07-29.
Designations disclosed: RMAT, Breakthrough Therapy, Fast Track, Orphan Drug. These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.
6 distinct molecules in 9 active company-sponsored trials; Lifileucel plus Pembrolizumab accounts for 1 of them at Phase 3.