Humacyte reports positive Phase 2/3 HAV trauma trial; BLA planned Q4 2023

Humacyte, Inc.

30-day secondary patency 90.2% (extremity pts) vs 81.1% synthetic graft benchmark.
Amputation rate 9.8% and infection rate 2.0%, both lower than synthetic graft rates.
BLA filing for HAV in extremity vascular trauma expected in Q4 2023.
No unexpected safety signals; results from Ukraine cohort also positive.
HAV has RMAT designation, may allow priority review and no post-approval study.

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