Humacyte, Inc. Q4 FY2023 earnings call

• Humacyte submitted its BLA for the HAV in the vascular trauma indication to the FDA in December 2023, supported by positive trial results and real-world evidence from Ukraine.
• FDA accepted the BLA in February 2024, granted priority review, and set a PDUFA goal date of August 10, 2024.
• Made progress in other programs: completion of enrollment in Phase III trial in dialysis access, presentation/publication of results in peripheral arterial disease, and preclinical results for small caliber HAV in juvenile heart model.
• Conducted mock inspections with ex-FDA inspectors to prepare for upcoming FDA manufacturing inspections.
• Manufacturing platform is modular and flexible, allowing production of different vessel diameters and lengths.

Revenue was $0 for the fourth quarter of 2023 and the year ended December 31, 2023. Research and development expenses were $20.2 million for the fourth quarter of 2023 (compared to $15 million in Q4 2022) and $76.6 million for the year ended December 31, 2023 (compared to $63.3 million in 2022). General and administrative expenses were $6 million for Q4 2023 (compared to $5.8 million in Q4 2022) and $23.5 million for the year ended December 31, 2023 (compared to $22.9 million in 2022). Net loss was $25.1 million for Q4 2023 (compared to $3.7 million in Q4 2022) and $110.8 million for the year ended December 31, 2023 (compared to $12 million in 2022).

• Anticipate topline results from the V007 trial in dialysis access in the third quarter of 2024.
• Cash and cash equivalents of $80.4 million as of December 31, 2023, with additional cash from public offering and revenue purchase agreement, providing adequate funds for operations through commercialization.
• Expect increased commercialization expenses in the second half of 2024 with the addition of a sales force, but some R&D expenses will wind down.

• Potential challenges during FDA manufacturing inspections, though Humacyte has conducted mock inspections and is prepared.
• Uncertainty in reimbursement and NTAP application timelines and outcomes.

Q: About commercial preparation and pricing of HAV.

A: HAV is priced higher than current standard of care but expected to have favorable health economic impact reducing complications, pricing to be determined at launch.

Q: About manufacturing and FDA inspections.

A: Conducted mock inspections with ex-FDA inspectors, feel prepared for upcoming inspection, manufacturing processes are well characterized.

Q: About preclinical study and platform flexibility.

A: Manufacturing platform is modular, can produce different vessel diameters/lengths without changing machinery.

Q: About dialysis access trial and leveraging trauma data.

A: V007 trial results expected in Q3 2024, trauma data can be leveraged for safety but efficacy focus on dialysis data.

Q: About NTAP cycle and dialysis trial.

A: Earliest NTAP application in October 2024, decision in a couple of quarters, V007 trial is a superiority trial comparing HAV to Fistula