Development Roadmap

Path to Approval & Beyond

Clear milestones driving value creation through clinical proof-of-concept and regulatory advancement.
SERIES B TARGET
$75M
Triggered by Phase I/II data
2025

Foundation & IND

ACTIVE
Series A Close IND Package Filed First Patient In GMP Batch Release
2026

Phase I/II Expansion

PLANNED
Cohort B Complete Cohort C Initiate Interim Safety RMAT Filing
2027

Pivotal Data & Series B

KEY INFLECTION
Topline Data Series B ($75M) EU Trial Partnerships
2028–29

Registration & Launch

TARGET
Pivotal Complete BLA Filing FDA Approval Commercial Launch