Humacyte, Inc. Q3 FY2025 earnings call

• Commercial Launch of Symvess: 25 hospitals/health care systems completed VAC process, 92 civilian hospitals eligible to purchase Symvess; 45 VAC committees reviewing Symvess. Product sales increased to $703,000 in Q3 2025 from $100,000 in prior quarter. Obtained ECAT approval, enabling sales to military facilities. Strong publications support Symvess, including studies on vascular trauma outcomes.
• Dialysis Access Program: Positive 2-year results from V007 Phase III trial presented at Kidney Week 2025. Plan to complete interim analysis of V012 Phase III trial (women on hemodialysis) by April 2026 and submit supplemental BLA for dialysis access in H2 2026.
• CTEV Program: Positive preclinical study results published. On track to advance CTEV into first-in-human study in CABG in 2026, with IND filed with FDA.
• Intellectual Property: Grant of new U.S. patent covering bioengineered esophagus, expanding tubular prosthesis patent family.

The company's main product segment is Symvess. In the third quarter ended September 30, 2025, product sales of Symvess improved to $703,000, a significant increase from the $100,000 reported last quarter. For the 9 months ended September 30, 2025, revenue related to U.S. sales of Symvess was $0.9 million. The revenue from Symvess contributed to the overall financial results for the period.

• Plan to complete interim analysis of V012 Phase III trial (women on hemodialysis) by April 2026.
• Intend to submit supplemental BLA for dialysis access in the second half of 2026, including data from V012 and V007 studies.
• On track to advance CTEV into first-in-human study in coronary artery bypass grafting (CABG) in 2026, with IND filed with FDA.

• Price sensitivity in the market as hospitals are more budget-conscious post-COVID, which could impact adoption.
• Potential delays in FDA approvals for dialysis access and CTEV programs.
• CMS decision that Symvess in trauma is not novel, leading to decision not to resubmit for NTAP in trauma, which could affect market access to some extent.

Q: In Q2, mentioned 12 of 45 hospitals initiated VAC process and now 16 started ordering. How many of those that have started ordering have begun reorder process? And have you disclosed that data?

A: We have not disclosed that data previously, but I believe the majority have reordered.

Q: Now that you have new data from trial for 007, how does that change your view for potential of Symvess in dialysis?

A: The very strong results in duration of usability in high unmet need subgroups going out to 2 years is very strong data. Shows continued sustained benefit in high-need subgroups versus current care, which will be strong support for supplemental BLA application in dialysis access.

Q: Out of units purchased, how many have been used versus initial stocking orders at hospitals?

A: Initial stocking orders range from 1 to 3 units. Hospitals reorder when they fall below par level. Surgeons are happy with product, easy to handle in OR. Presentations on vessel function to be online next week at VEITH meeting.

Q: Benefits seen from price reduction for Symvess, accelerated adoption or decreased time for VAC approvals?

A: Yes, price sensitivity is important. Hospitals are moving through VAC process quicker. Some hospitals that didn't consider at original price point are now reinstituting VAC process due to price discussions.

Q: Cost savings initiatives, still feeling comfortable with level or changes expected?

A: Seeing cost savings already. R&D expenses dropped from $22 million in Q2 to $17 million in Q3. SG&A costs pretty flat. Expect to achieve full $50 million in cost savings targeted.

Q: Impact of strong supportive evidence for Symvess in vascular trauma on process and real-world outcomes tracking?

A: Publications helpful in bringing surgeons on board. There's a post-approval study with FDA for trauma as first-in-class product, to kick off in first half of 2026, data expected 6-12 months after.

Q: Transitioning sales force for dialysis, how done?

A: Initial launch in trauma with small sales force, looking to strategically add more reps. Vascular surgeons performing trauma also do dialysis access, so visibility with same cohort. Aim to add additional sales force if V012 results positive and BLA filed in H2 2026.

Q: Reconsidering NTAP submission for trauma?

A: Opted not to resubmit for NTAP in trauma. CMS decision that conduit not novel led to this. Price reductions helped drive market activity.

Q: Reorders and expansion beyond initial implanting physicians?

A: Seen usage beyond initial champion in some hospitals. With VAC approval for hospital systems, still doing contract negotiations with individual hospitals in covered chains.

Q: Initiating and maintaining value proposal to VAC committees and what resonates?

A: Published Budget Impact Model in March showing cost savings even at initial price point. With price reduction, economic argument stronger. Some hospitals still pushback on initial acquisition price, but majority of VAC submissions successful.

Q: Cash burn, new cash use expectations and runway?

A: Quarter-over-quarter expenses reduced. Expect SG&A somewhat constant, R&D reductions continuing. Cash on hand exceeds 12 months from today, takes past interim results of V012, BLA filing in dialysis, and commencement of human testing in CABG.