Humacyte, Inc. Q2 FY2024 earnings call

• Vascular trauma: FDA needs additional time to review BLA for ATEV in vascular trauma; ATEV met primary endpoint in V007 Phase 3 trial for hemodialysis access and received third RMAT designation; ongoing commercial preparation with new ICD-10 codes and sales hire.
• Dialysis access: V007 Phase 3 trial of ATEV for hemodialysis showed positive results with higher functional and secondary patency vs standard of care, though more adverse events reported.
• PAD: ATEV results in PAD trials comparable to historical controls, granted third RMAT designation, new IND cleared.
• Diabetes: BioVascular Pancreas preclinical study results positive; ATEV preclinical studies in coronary artery bypass grafting show promising remodeling.
• Board: Added two seasoned experts.

For the second quarter of 2024, research and development expenses were $23.8 million compared to $20.5 million in the second quarter of 2023. For the six months ended June 30, 2024, research and development expenses were $45.0 million versus $37.8 million in the same period of 2023. General and administrative expenses for the second quarter of 2024 were $5.7 million compared to $6.2 million in 2023, and for the six months ended June 30, 2024, they were $11.1 million versus $11.4 million in 2023. Other net expense for the second quarter of 2024 was $27.2 million compared to net income of $4.0 million in 2023, and for the six months ended June 30, 2024, it was $32.5 million versus $10.4 million in 2023. Net loss for the second quarter of 2024 was $56.7 million compared to $22.7 million in 2023, and for the six months ended June 30, 2024, it was $88.6 million versus $59.7 million in 2023.

Confident in ATEV's approvability in vascular trauma and continuing to prepare for commercialization if approved; committed to advancing pipeline programs showing encouraging results.

Uncertainty from FDA needing more time to review BLA for vascular trauma; potential impact on timelines; cash burn and financial management considerations during interim period.

Q: Ryan Zimmerman asked about FDA communication on new clearance date and impact on AV access BLA submission timing.

A: Laura Niklason said FDA didn't provide new date or insight, but AV access BLA filing remains on track for 2025.

Q: Josh Jennings inquired about higher adverse events in ATEV dialysis study.

A: Laura Niklason clarified it's on dialysis, adverse events mostly minor with no new safety signals.

Q: Allison Bratzel asked about FDA review areas for vascular trauma BLA and adverse event measurement in dialysis.

A: Laura Niklason said FDA didn't specify review areas, adverse events in dialysis measured over entire study.

Q: Kristen Kluska asked about subgroup analysis in dialysis access and manufacturing/clinical site inspections in vascular trauma.

A: Laura Niklason explained subgroup analysis on problematic patient demographics, inspections went well with standard follow-up items.

Q: Bruce Jackson asked about new technology add-on payment application.

A: Laura Niklason said plan to file NTAP application in October 2024 regardless of FDA approval delay.