Uveal Melanoma · registered primary completion 2027-01-15 · NCT05987332
Cash of $829M against operating outflow of $53M per quarter gives roughly 15.7 quarters of runway, clearing the registered primary completion 1.6 quarters out by 14.1 quarters.
96,489,484 shares outstanding against 107,744,653 if every outstanding option, warrant and convertible were exercised. In that case 10.5% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
2 approved products already carry Uveal Melanoma on label, including KIMMTRAK, Hepzato Kit. Approval would enter an occupied market.
Registered design for NCT05987332: randomized, open-label, 420 participants (estimated). Primary outcome: Phase 2a: To determine the optimal dose of IDE196 + Crizotinib combination for Phase 2B and Phase 3 by evaluating the following:. 2 further primary outcome(s) registered.
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.
13 distinct molecules in 10 active company-sponsored trials; IDE196 accounts for 2 of them at Phase 1/Phase 2/Phase 3.
Programs receiving under $250k of research spend in the quarter: Year Ended December.