Humacyte, Inc. Q1 FY2024 earnings call

• HAV Program in Vascular Trauma: FDA accepted BLA in Feb 2024, granted Priority Review, PDUFA date set for Aug 10, 2024; pre-licensing inspection of manufacturing facilities completed. Commercial readiness activities include budget impact model completion, medical affairs team building awareness, payer discussions, and working on ICD-10 code for HAV implantation.
• Dialysis Access: Partnership with Fresenius leveraged to analyze dialysis access complications; V007 Phase III trial on track for Q3 2024 results; V012 study initiated for women receiving HAV for dialysis access.
• Diabetes: BioVascular Pancreas preclinical results show insulin-producing cells survived 3 months in nonhuman primates; human stem cell-derived islets arrest diabetes in rodent models, results to be presented at ADA meeting.
• Cardiac Bypass: Small diameter HAV preclinical 6-month studies in nonhuman primates show remodeling, results to be presented at Tissue Engineering and Regenerative Medicine Conference.
• Financials: Strengthened balance sheet with $43M equity raise in Feb 2024 and $20M funding from Oberland Capital.

As of March 31, 2024, Humacyte had cash and cash equivalents of $115.5 million. Total net cash provided was $35.1 million for the first quarter of 2024 compared to net cash used of $20.2 million for the same period in 2023. Research and development expenses were $21.3 million in Q1 2024 vs. $17.3 million in Q1 2023, driven by expanded initiatives. General and administrative expenses were $5.3 million in Q1 2024 vs. $5.2 million in Q1 2023. Net loss was $31.9 million in Q1 2024 vs. $37.0 million in Q1 2023, primarily due to noncash remeasurement of contingent earnout liability. The company's HAV program in vascular trauma saw FDA acceptance of BLA in Feb 2024 with Priority Review and PDUFA date Aug 10, 2024; dialysis access, diabetes, and cardiac bypass programs had ongoing trials and preclinical progress.

• Anticipated PDUFA date for HAV in vascular trauma is Aug 10, 2024.
• Results from V007 Phase III trial in dialysis access expected in Q3 2024.
• Preclinical results from diabetes and cardiac bypass programs to be presented at upcoming medical meetings.

• Uncertainty around regulatory approval timelines and requirements for HAV and other pipeline programs.
• Dependence on successful clinical trial outcomes for dialysis access, diabetes, and cardiac bypass programs.
• Market adoption challenges including payer negotiations and timely ICD-10 code approval for HAV implantation.

Q: Ryan Zimmerman asks about FDA facility inspection and SG&A costs for commercialization.

A: Heather Prichard states the FDA pre-license inspection of manufacturing facility was successful and they remain confident in approval; Dale Sander mentions SG&A expenses are in line with prior quarter, sales force ramp-up will be closer to approval with a small sales team for vascular trauma.

Q: Kristen Kluska asks about AV access data presentation and subset analyses.

A: Laura Niklason mentions leveraging Fresenius database on dialysis access complications, will present V07 data through lens of all patients and demographic subsets, including women, diabetics, and obese patients.

Q: Bruce Jackson asks about FDA interaction and BLA progress.

A: Laura Niklason states FDA interactions have been smooth with clarifying questions addressed, mid-cycle meeting completed, and on-track with Priority Review timeline.

Q: Joshua Jennings asks about commercialization steps and manufacturing capacity.

A: Dale Sander talks about typical launch timeline including approval, packaging changes, and soft/full launch; Heather Prichard mentions manufacturing capacity is ready with LUNA system and can scale up to 40,000 HAVs per year.

Q: Ryan Zimmerman asks about ICD-10 code timing.

A: Laura Niklason states CMS application for ICD-10 code submitted in Dec 2023, public forum meeting in Mar 2024, CMS recommendation in public domain, expected to have code before approval, and plan to apply for NTAP with CMS after approval.