Jan. 13 at 2:08 PM
$KOD MESI data expected in February, followed by Phase 3 readout in March. The confidence comes from the study design itself, it’s built on lessons learned from the prior failure, keeping what worked, fixing what didn’t, and adding additional endpoints. This doesn’t feel like a random shot on goal.
BLA planned for mid 2026, which aligns with the fact that manufacturing is already validated. Ursus has been running batches in 2025, covering biopolymer, conjugates, and antibody production, which significantly de-risks the regulatory path.
Overall, this wasn’t a hype deck, it was a comprehensive, execution focused presentation. Management is clearly operating as if success is the base case, not a hope. High risk biotech, yes, but the setup going into Q1/Q2 looks unusually strong.
