---
schema_version: "secwatch.filing_event.v1"
accession: "0001818382-24-000153"
form_type: "8-K"
ticker: "HUMA"
cik: "0001818382"
company_name: "Humacyte, Inc."
filed_at: "2024-08-13T23:59:59+00:00"
generated_at: "2026-05-31T09:47:09.718181+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA delays ATEV trauma BLA review beyond PDUFA date; Q2 net loss $56.7M

## Summary
- FDA notified Humacyte on Aug 9 that additional time needed to complete ATEV BLA review; PDUFA date was Aug 10; no revised action date yet.
- Q2 net loss $56.7M vs $22.7M YoY, driven by $27.2M non-cash earnout remeasurement and higher R&D costs.
- ATEV V007 Phase 3 trial in hemodialysis showed superior functional patency vs autogenous fistula at 6 and 12 months (p=0.0071).
- Cash $93.6M at June 30, 2024; H1 net cash provided $13.1M from $43M public offering and $20M Oberland draw.
- R&D expense $23.8M (+16% YoY); G&A $5.7M (-8% YoY); no revenue reported.

## SEC filing metadata
- accession: 0001818382-24-000153
- form_type: 8-K
- ticker: HUMA
- cik: 0001818382
- company_name: Humacyte, Inc.
- filed_at: 2024-08-13T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818382/000181838224000153/0001818382-24-000153-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818382/000181838224000153/huma-20240809.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001818382-24-000153
- JSON: https://secwatch.observer/filing/0001818382-24-000153.json
- Plain text: https://secwatch.observer/filing/0001818382-24-000153.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.