earnings
confidence high
sentiment neutral
materiality 0.70
Humacyte Q1 net loss $37M; secures second RMAT for HAV in vascular trauma, plans BLA filing in 2023
Humacyte, Inc.
2023-Q1 EPS reported
-$0.36
- Net loss of $37.0M in Q1 2023 vs $19.8M in Q1 2022; cash & investments $131.7M at March 31, 2023.
- Received second FDA RMAT designation for HAV in urgent arterial repair after extremity vascular trauma.
- Completed enrollment in Phase 3 hemodialysis access trial (240 patients); top-line results expected in 2024.
- Plans to file BLA with FDA later in 2023 for HAV in vascular trauma; V005 trial enrolled 66 patients.
- Subsequent to Q1, secured up to $160M funding arrangement with Oberland Capital to fund operations past potential approval.