Humacyte, Inc. Q4 FY2024 earnings call

• FDA approved Symvess for extremity vascular trauma; commercial launch ongoing with 34 hospitals initiating VAC, 3 approvals, first shipments made. • BVP Impact Model published showing cost reductions with Symvess; NTAP application submitted to CMS. • New patent for Symvess manufacturing system. • ATEV program in dialysis access: V007 Phase 3 met co-primary endpoints, V012 Phase 3 enrolling female patients. • Small diameter ATEV for CABG: IND filing planned based on preclinical study results.

No detailed product segment financial performance with absolute revenue and contribution % provided. R&D expenses for Q4 2024 were $20.7M, G&A expenses $7.4M. Full year 2024 R&D expenses $88.6M, G&A $25.8M.

• No specific guidance on VAC approvals but expect majority of VAC to agree; 2025 sales projected between $7M-$13M, mostly in H2. • Supplemental BLA for ATEV in 2026, sales in 2027. • R&D expenses to ramp down due to trial wind down and manufacturing costs moving to COGS.

• Uncertainty in VAC process timing. • Uncertainty in FDA review timing for BLA supplements. • Cash position impact on proceeding with PAD trial.

Q: Josh Jennings asked about characteristics of hospitals that approved Symvess and 2025 launch goals.

A: Laura Niklason said VAC approval speeds include surgeon champions and literature awareness; no specific guidance but rate of VAC initiation suggests majority may agree.

Q: Ryan Zimmerman asked about V012 trial interim analysis and BLA supplement timing.

A: Laura Niklason said V012 trial has endpoint of catheter-free days, expecting positive interim results; supplemental BLA in 2026.

Q: Anne asked about PAD program timeline and investment.

A: Laura Niklason said continuing to design Phase 3 trial, evaluating cash position for timing.

Q: Vernon Bernardino asked about sales team education, BLA review time, and small diameter ATEV cost.

A: Laura Niklason said sales team educated on product; BLA review time uncertain; smaller diameter ATEV production cost less.

Q: Bruce Jackson asked about biovascular pancreas project.

A: Laura Niklason said continuing primate work, showing islets survive months, tweaking design for maximal effect.