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

Humacyte, Inc.

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.

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