Humacyte, Inc. Q2 FY2025 earnings call

• Commercial launch of Symvess: Continued expansion of VAC approvals, 13 organizations completed VAC process with 82 civilian hospitals eligible, ECAT listing approval from DLA with first sale to military facility, encountered headwinds in April-May but saw acceleration in June-July.
• ATEV program: V007 Phase III trial results presented at SVS Annual Meeting, enrolled 242 patients with positive outcomes, V012 Phase III trial ongoing with 100 patients enrolled, plan to submit supplemental BLA in second half of 2026.
• Cost reduction plan: Implemented workforce reduction, deferred hires, reduced operating expenses, estimated net savings of $3.8 million in 2025 and up to $38 million in 2026.

For the second quarter of 2025, revenue was $0.3 million, with $0.1 million related to U.S. sales of Symvess and $0.2 million from a research collaboration. For the 6 months ended June 30, 2025, revenue was $0.8 million, with $0.2 million from U.S. sales of Symvess and $0.6 million from the research collaboration. Cost of goods sold was $0.2 million for the second quarter of 2025 and $0.4 million for the 6 months ended June 30, 2025. Research and development expenses were $22.0 million for the second quarter of 2025 compared to $23.8 million for the second quarter of 2024. Selling, general and administrative expenses were $7.8 million for the second quarter of 2025 compared to $5.7 million for the second quarter of 2024. Net loss was $37.7 million for the second quarter of 2025 compared to a net loss of $56.7 million for the second quarter of 2024, and net income was $1.5 million for the 6 months ended June 30, 2025, compared to a net loss of $88.6 million for the 6 months ended June 30, 2024.

• Plan to complete V012 Phase III trial and submit supplemental BLA for ATEV in dialysis by second half of 2026.
• Estimated net savings of $3.8 million in 2025 and up to $38 million in 2026 due to cost reduction plan.

• Unsubstantiated public attacks caused headwinds in April-May.
• CMS declined NTAP approval for Symvess, impact on private payers uncertain.
• Tough economy making commercial launch of new products more challenging.

Q: Maybe just to start on some of the dynamics commercially, Laura. If you think about second quarter volume versus what's taken place in July and you noted that uptick, has anything changed in your view that you think you can identify in July that now becomes kind of more part of your commercial strategy in terms of launching Symvess?

A: A lot of it is just passage of time. Part of the uptick in hospitals eligible to purchase Symvess was due to hospital systems approving the product in their VAC process. Also, decreased price of Symvess from $29,500 to $24,250 which increased ease for VAC committees.

Q: Yes. You -- actually, that was my next question around pricing strategy, just looking at kind of the unit volumes versus the revenue. And is that now something that you're making standard across all facilities? I guess, how do we think about kind of your pricing strategy over time? And if this is kind of the new price point that we should think about going forward?

A: I think this is the new price point that we should think about. This was a price point that we put into place on July 1. This was a price point that we put into place on July 1. So that certainly correspond -- that had some overlap with the uptick in sales. I don't think that was the entire thing, though, but -- because we clearly had centers that were buying before the decrease in price. But the decrease in price will now be standard for the next year. And then just as with any other medical products, we will consider annual price increases on a yearly basis.

Q: I wanted to just ask -- I know you talked about some of the headwinds in -- early in the year from substantiated attacks by detractors. And I was just wanted to review just the accrual of real-world evidence and any registry data that would build over the coming quarters, years that would significantly [bury] any detractor noise?

A: Well, I think -- so as we've mentioned to the market, we do have some post approval commitments with the FDA to essentially create a registry of trauma patients and follow at least 100 patients for a year. We're still working on that protocol with the FDA. So that registry hasn't officially kicked off yet, but we're still -- we are on time. We're meeting our time lines and our milestones for that. But I actually think that the real-world evidence is going to continue to accrue in different hospitals that are using the product. Multiple hospitals have reordered the product, and there are people who are using it with a tremendous amount of success. So I think that, that word of mouth, but also publications from real-world use of the product will definitely help to solidify our commercial position.

Q: The first question is, looking back at the first quarter press release, you were stating 45 hospitals had initiated the VAC process. So how many of those have actually ordered at this point? And also, any insight into what the time line is in general for getting through the VAC to the ordering process itself?

A: It is a mix of hospitals that we started early and then hospitals that we've approached more recently that a mix of them that have worked through the process to then have the approval to then be able to sell into. But as we stated in the press release, we've had 12 hospitals to date order Symvess, and then a number of them actually already having reordered. So our success rate with VAC is strong. As I mentioned before, in Q2, some of the public attacks did slow us down with value analysis committees, and that's where I was mentioning that in kind of from my commercial experience, you could think of 3 to 6 months to get through a value analysis committee and then obviously contracting on the back end. We view that as 6 to 9-plus months now, one in general because of the economy, but then also some of the attacks on us. But as I also mentioned, we have a full sales funnel and not all of them take the upper end and not all of them in the lower end. So if you have a full funnel, you always have something coming through on the back end to -- with approval and then be able to sell into. But that's something that we've accounted for and as I mentioned, believe that we're turning the corner on.

Q: The second question is regarding the negative decision by the CMS. So what sort of an impact, if any, would it have on the private payers' reimbursement decisions?

A: Yes, Laura, I can jump in on that one, too, and feel free. As Laura had mentioned, obviously, a disappointment for us, newness. I think we can kind of all agree that our product new and a one-of-one type. But we were denied. That was disappointing. There are pathways that we think you can refile. That's something that we will look at and consider. But when it rolls to -- and again, private payers are the ones that pay the majority of these vascular trauma repair type of procedures in these patients. We believe that our product is new, but more importantly, how private payers view in essence, being able to pay for a product and writing procedures behind that is really based on your clinical and health economic data. And so not only of what we've gathered, but published peer reviewed, both on the clinical side and following these patients over time and our budget impact model that is also published of reducing costly complications like infections and amputations versus products that are used today that private insurers will see this as a strong value proposition and work with them to get them to incrementally pay for our product.

Q: I was wondering if we could get an update on the coronary artery bypass graft program.

A: Yes, absolutely. We have a paper that's been accepted for publication about our primate results in coronary artery bypass that we expect to publish in the near future, and we'll put out a press release with that when that happens. We're also making excellent headway on our IND filing with the FDA. So we're in the process of pulling that filing together, and we expect to have that in -- later in 2025 as we've messaged to the market previously. After we submit the IND, we anticipate that the FDA will spend some time looking at it. We're a first-in-class product, and we're going into the human coronary system. So we expect that there will be some review time. But once they approve that, and I certainly anticipate that they will, then we would start our clinical trial sometime in 2026. So everything is on track with what we've messaged to the market previously.