Humacyte, Inc. Q4 FY2024 earnings call

• FDA approval of Symvess for extremity vascular trauma, a first-in-class product with 20+ years of R&D.
• Commercial launch of Symvess: 34 hospitals in VAC process, 3 hospitals approved purchase, first shipments made to Level 1 trauma centers.
• NTAP application for Symvess submitted to CMS, with potential reimbursement starting Oct 1, 2025 if successful.
• New patent issued covering Symvess manufacturing system, protecting until 2040.
• ATEV program: V007 Phase 3 trial met co-primary endpoints, V012 Phase 3 trial enrolling female patients with interim analysis near, plan to submit supplemental BLA in second half of 2026.
• Small diameter ATEV for CABG: Plan to file IND with FDA, preclinical study in primates showed patency and recellularization.

There was no revenue for the fourth quarter of 2024, 2023, or for the years ended December 31, 2024 and 2023. Research and development expenses for the fourth quarter of 2024 were $20.7 million, with R&D expenses for the year ended December 31, 2024 at $88.6 million. General and administrative expenses for the fourth quarter of 2024 were $7.4 million, with $25.8 million for the year ended December 31, 2024. Other net income was $7.1 million for the fourth quarter of 2024. Net loss was $20.9 million for the fourth quarter of 2024 and $148.7 million for the year ended December 31, 2024. Symvess is the key product, with commercial launch underway but no revenue yet from it.

• Laura mentioned no specific guidance on VAC approvals and sales timelines, but noted majority of VAC processes likely to agree, with most sales in second half of 2025.
• ATEV dialysis sales delayed as supplemental BLA now planned for second half of 2026, meaning sales won't hit until 2027.
• R&D expense guidance: Ramping down due to wind-down of trauma trials and manufacturing costs shifting to inventory/cost of sales.

• Controversial article published, with surgeons feeling it was biased; potential impact on VAC approvals and surgeon support.
• Uncertainty around FDA review timelines for supplemental BLAs, including length of review for ATEV dialysis and other indications.

Q: Josh Jennings asked about characteristics of hospitals that approved Symvess and expectations for VAC processes.

A: Laura Niklason said VAC speed depends on VAC commitment or surgeon champions; 34 hospitals in process, with various scenarios driving approvals.

Q: Josh Jennings asked about 2025 launch goals and ATEV sales timing.

A: Laura Niklason said no specific guidance but majority of VACs likely to agree, with sales mostly in second half; ATEV dialysis sales delayed to 2027 due to supplemental BLA timing.

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

A: Laura Niklason said V012 trial near 80 patient interim enrollment, endpoint is catheter-free days; plan to submit supplemental BLA in second half of 2026.

Q: Anne asked about PAD program timeline and investment.

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

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

A: Laura Niklason said sales force educated on product and label, FDA review time uncertain, small diameter ATEV production cost less due to smaller bags and same equipment.

Q: Bruce Jackson asked about biovascular pancreas project.

A: Laura Niklason said continuing primate work, islets surviving months and producing insulin in diabetic primates, tweaking design for maximal effect.