earnings
confidence high
sentiment neutral
materiality 0.65
Humacyte Q3 net loss $39.2M; ATEV BLA review ongoing with no new timeline
Humacyte, Inc.
2024-Q3 EPS reported
-$1.10
- Net loss $39.2M (Q3 2024) vs $26.0M (Q3 2023) driven by non-cash contingent earnout remeasurement.
- Cash $71M at Sep 30; received $29.6M net from Oct registered direct offering.
- FDA BLA for ATEV in vascular trauma still under review; no new PDUFA date provided.
- V007 Phase 3 AV access data presented at ASN Kidney Week: ATEV superior patency vs fistula in key subgroups.
- Submitted NTAP reimbursement application to CMS for FY2026 cycle (Oct 2025 effective date if approved).