Humacyte, Inc. Q1 FY2025 earnings call

• Symvess commercial launch began in late February 2025, with first shipments to three Level 1 trauma centers. 45 hospitals are in the VAC approval process, and 5 have approved Symvess. - Military market efforts include working on listing Symvess in ECAT for military hospitals. - V007 Phase 3 trial in dialysis showed superior patency, and V012 Phase 3 trial in dialysis has reached a major enrollment milestone. Plan to file a supplemental BLA for dialysis ATEV in 2026. - Plan to file an IND with the FDA in 2025 for small-diameter ATEV in coronary artery bypass grafting. - Addressed unfounded negative press regarding Symvess, emphasizing clinical results and science-based facts. - Extended cash runway via March 2025 financing and cost reductions, including workforce reductions and operating expense cuts.

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 compared to $21.3 million in the first quarter of 2024, primarily due to decreased material costs and reduced clinical study costs. General and administrative expenses were $8.1 million compared to $5.3 million in the prior year, driven by the Symvess commercial launch. Other net income was $62.3 million in Q1 2025 vs. a net expense of $5.3 million in Q1 2024. Net income was $39.1 million in Q1 2025 vs. a net loss of $31.9 million in Q1 2024. Cash, cash equivalents, and restricted cash totaled $113.2 million at March 31, 2025.

• Sales of Symvess are expected to be second half loaded in 2025. - Plan to file a supplemental BLA for the ATEV in dialysis in 2026. - Intends to file an IND with the FDA in 2025 to enable first-in-human clinical testing of the small-diameter ATEV in coronary artery bypass grafting.

• Unfounded negative press regarding Symvess and Humacyte, which has been addressed but remains a potential risk. - Economic environment affecting VAC reviews at hospitals. - Procurement hurdles for military markets, though progress is being made with ECAT listing and DoD procurement partner assistance.

Q: Can you share the experience of the three sites that purchased Symvess, including how you're servicing those cases?

A: We've performed the first implant at one site, with sales reps sometimes present at the OR. Sales executives are conducting hands-on training in hospitals. The New York Times article caused some pushback but is receding as clinical facts become clearer.

Q: How are the V012 and V007 trials in dialysis progressing?

A: V007 showed superior patency, and V012 has reached a major enrollment milestone with 84 patients enrolled. An interim analysis is planned for April 2026. The partnership with Fresenius is strong, aligning with Fresenius' objectives regarding patient costs and reimbursement.

Q: Is the VAC questioning consistent across the 45 hospitals added since Analyst Day?

A: The dialogue and talk track are pretty similar. Clinical data published in JAMA Surgery in November is strong, and leveraging the budget impact model helps. The proposed NTAP ruling is being responded to, with a mid-June deadline.

Q: Can you provide insight into surgeon adoption patterns for Symvess?

A: It starts with early adopter surgeons, with a mix of vascular and trauma surgeons. There's anecdotal evidence of a vascular surgeon having a great experience and looking forward to using the product again. Pipeline for BioVascular Pancreas includes primate implants and lab experiments, with preclinical results expected later this year.