Humacyte, Inc. Q3 FY2024 earnings call

• Vascular Trauma: FDA review of ATEV BLA in vascular trauma ongoing, PDUFA date delayed. Commercial team training for US launch, NTAP application submitted to CMS. Long-term results from Ukraine humanitarian program featured. • Dialysis Access: V007 Phase 3 trial results positive at Kidney Week, showing superior function/patency in subgroups like women, obese, diabetic patients. RMAT designation for ATEV in PAD. • BVP: US Patent Office allowed patent covering design/composition. Non-human primate studies show islet survival. • Financials: No revenue for Q3 2024 or prior periods. R&D, G&A, and net loss details provided.

No specific product segments with revenue breakdowns provided. Financials discussed include R&D expenses of $22.9 million for Q3 2024, general and administrative expenses of $7.3 million for Q3 2024, other net expense of $9.0 million for Q3 2024, and net loss of $39.2 million for Q3 2024.

• Confidence in approvability of ATEV in vascular trauma based on interactions with FDA. • Preparing for commercial launch of ATEV in vascular trauma upon FDA approval. • VO12 trial in dialysis access making progress in enrollment. • PAD trial design considerations, noting it may be a large market but funding needed.

• Forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from expectations. Factors detailed in periodic reports filed with SEC.

Q: Ryan Zimmerman asked about FDA discussions post-PDUFA delay, nature of interactions, and prioritization of efforts between vascular trauma and AV access.

A: Laura Niklason stated FDA interactions since PDUFA date have been minimal, with occasional 'pinging'. Prioritization involves conservatively sized sales team for vascular trauma, minimal spend on AV access commercial efforts.

Q: Josh Jennings inquired about AV access BLA, Fresenius agreement, revision opportunities, and PAD trial timelines.

A: Laura Niklason discussed need for continued discussions with Fresenius, revision opportunities varying by practice, and PAD trial design considerations with funding needed.

Q: Kristen Kluska asked about AV access trial endpoints, community enthusiasm, and supplemental BLA pathway.

A: Laura Niklason explained co-primary endpoints in V007, community enthusiasm increasing with results, and plans for meeting with FDA to discuss supplemental BLA.

Q: Bruce Jackson inquired about CABG program and BVP.

A: Laura Niklason discussed CABG program needing third animal model testing and BVP program progress with islet survival in primates.

Q: Vernon Bernardino asked about BVP progress and early results in primates.

A: Laura Niklason provided updates on BVP islet dosing studies and future results to be awaited.