Humacyte, Inc. Q1 FY2025 earnings call

• Commercial launch of Symvess: Commenced in late February 2025, with first shipments to three Level 1 trauma centers. 45 hospitals are evaluating Symvess via VAC, 5 have approved purchase. Publication of budget impact model in Journal of Medical Economics shows economic value. Working on military market listing in ECAT.
• ATEV in dialysis: V007 Phase 3 trial met primary endpoints, V012 Phase 3 trial has 84 enrolled, interim analysis planned for April 2026, plan to submit supplemental BLA in 2026.
• Small-diameter ATEV: Plan to file IND with FDA for first-in-human testing in coronary artery bypass grafting, moving closer to human clinical studies.

In the first quarter of 2025, Humacyte had $517,000 in revenue. Of this, $147,000 related to the initial U.S. commercial launch of Symvess in trauma, and the remaining $370,000 resulted from a research collaboration. Cost of goods sold was $147,000. Research and development expenses were $15.4 million, general and administrative expenses were $8.1 million. Other net income was $62.3 million, and net income was $39.1 million. Cash, cash equivalents, and restricted cash at March 31, 2025, were $113.2 million.

• Expect most Symvess sales in the second half of 2025 based on VAC ramp. Still comfortable with previous guidance despite economic environment. Net savings estimated at $13.8 million in 2025 and up to $38 million in 2026 relative to original forecast.

• Economic environment may affect VAC reviews and sales uptake. Potential issues with clinical trial adherence in dialysis patients' care and handling of the conduit. Unfounded negative press earlier that needed to be addressed with science-based facts.

Q: Ryan Zimmerman asked about the experience with the three purchased Symvess sites, how cases are serviced, and uptake of Symvess this year.

A: Laura Niklason and BJ Scheessele responded, discussing implant experience, VAC conversion rates, and the impact of publications and economic models.

Q: Josh Jennings inquired about 2025 revenue estimates and V012 trial learnings.

A: Laura and Dale stated they remain comfortable with guidance and discussed V012 trial focus on patient care and Fresenius partnership.

Q: Kristen Kluska asked about VAC questioning consistency since Analyst Day.

A: Laura and BJ noted similar dialogue, strong clinical data, and importance of budget impact model.

Q: Bruce Jackson asked about surgeon adoption patterns and pipeline updates.

A: Dale and BJ shared anecdotes on surgeon adoption and ongoing work on BioVascular Pancreas preclinical results