Humacyte, Inc. Q1 FY2026 Earnings Call

Good morning, ladies and gentlemen, and welcome to the Humacyte First Quarter 2026 Earnings Conference Call. As a reminder, this conference call is being recorded. I'll now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead, Tom.

Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise forward-looking statements, except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after filing may be accessed from the Investor page of the Humacyte website. Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Niklason will provide a summary of the company's progress for the first quarter and in recent weeks, and Dale will review the company's financial results for the quarter ended March 31, 2026. I will now turn the call over to Dr. Niklason. Laura?

Thank you, Tom, and good morning, everyone, and thank you for joining us for our first quarter financial results and business update call for 2026. To remind this audience, Humacyte's key corporate goals for this year include advancing the U.S. and global commercial launch of Symvess, completion of the V012 Phase III pivotal trial of our ATEV in dialysis access, the planned filing of a supplemental BLA with the FDA in the dialysis indication and the commencement of a human study of our coronary tissue engineered vessel or CTEV in coronary artery bypass grafting. During today's call, I'll review progress across those commercial and developmental programs before turning the call over to Dale for a review of our financial results for the quarter. During our first quarter and in recent weeks, we continue to make progress in our U.S. market launch of Symvess as well as expand commercialization into international markets. First quarter sales of Symvess were $0.5 million in 2026 as compared to $0.1 million in the first quarter of 2025. While we've seen expansion in the commercial uptake of Symvess, we also recognize that more rapid product uptake and sales growth is necessary and is warranted based on Symvess' tremendous potential. To that end, we recently announced substantial new hires in senior commercial and clinical leadership positions. Industry veteran, James Mercadante has been brought in as our new Chief Commercial Officer, while Dr. Todd Rasmussen has been brought in as our Chief Surgical Officer. Jim is an accomplished medtech commercial leader with an extensive track record of field-specific success in vascular and cardiothoracic surgery markets. Dr. Rasmussen is one of the trailblazers of modern vascular surgery, particularly vascular trauma and peripheral artery disease, and he will be instrumental in guiding our education strategy for Symvess going forward. We're also adding commercial talent that will more thoroughly cover important U.S. markets and will engage directly with large integrated delivery networks or IDNs. We look forward to working with this new revamped and restructured commercial and clinical leadership team to accelerate and expand patient access to Symvess in the U.S. and globally. In parallel with our U.S. launch of Symvess, we're also taking steps to expand the commercialization into international markets. In March, we submitted a marketing authorization application, or MAA, with the Israeli Ministry of Health for Symvess for arterial injury repair. In April, our MAA was accepted for review by the Israel Ministry of Health. The Ministry of Health has set a 180 working-day review period for our MAA. International interest has also been highlighted by the $1.475 million purchase commitment that we announced for the Kingdom of Saudi Arabia. This funding will facilitate clinical evaluation and outreach programs in hospitals within the Kingdom. The planned clinical evaluation will be conducted in parallel with ongoing negotiations with a Kingdom-based entity for establishment of a joint venture and license to commercialize Symvess within country. Also, as previously announced, the U.S. Department of Defense has dedicated funding for evaluation and incorporation of new biologic vascular repair technologies. In appropriating this funding, lawmakers demonstrated that they recognize the need for human-derived bioengineered vessels to save life and limb on the battlefield. We believe this historic first-of-its-kind federal investment will help ensure that our soldiers continue to have access to cutting-edge treatments and state-of-the-art care whenever and wherever they need it. We look forward to working with leaders in our military and at our military health facilities to ensure that the American service personnel will have access to this groundbreaking technology. Also, in May of 2026, Humacyte implemented a restructuring of its workforce to reduce total headcount by 45 employees or roughly 25%. We did this by trimming some current staff and by deferring some planned hires for this year. Other operating expenses were also trimmed, and this was enabled by the successful completion of multiple technical and clinical projects at Humacyte over the past year. These spending reductions were done thoughtfully, and Humacyte has retained personnel, resources and initiatives to meet its key corporate goals and milestones. These key corporate goals include, as mentioned earlier, advancing the U.S. and global commercial launch of Symvess, completion of the V012 Phase III trial in dialysis, the planned filing of our supplemental BLA in dialysis in the U.S. and the commencement of a first-in-human study of CTEV in CABG. With this reorganization, we've grown the support for the commercial mission by taking advantage of prior successes in the technical sphere that have allowed Humacyte to reduce run costs while maintaining our laser focus on medical education, sales and marketing. As a result of the restructuring, Humacyte estimates that we'll incur aggregate charges representing a one-time cash expenditure for severance and other employee termination benefits of approximately $0.8 million, of which the majority is expected to be incurred during the second quarter of 2026. We further estimate a savings for the remainder of 2026 of approximately $14.3 million, which is net of the severance and benefits. I'll turn now to the program that's our next priority, which is dialysis access, which will reach an exciting milestone later this quarter. Further illustrating the platform nature of Humacyte's technology, we're nearing the presentation of top line interim results for our Phase III trial in dialysis access. These results should be ready for presentation by June 11, 2026, at the Vascular Annual Meeting in Boston. Thus far, a total of 120 patients have been enrolled to date in the V012 Phase III clinical trial, which is designed to assess the efficacy and safety of the ATEV in dialysis access in comparison to AV fistulas in female patients. We're currently working to complete a prespecified interim analysis of our ongoing V012 trial, which is being conducted in women. These top line interim results are expected to be available for reporting around June 11, as I mentioned, in Boston. Subject to the results, our plan is to submit a supplemental BLA in the second half of 2026 to add dialysis as an indication for Humacyte's ATEV. The compelling unmet needs for hemodialysis access among female and other underserved patients were also highlighted in a key opinion leader event that we hosted on April 28 featuring Dr. Prabir Roy-Chaudhury of the University of North Carolina and Dr. Mohamad Hussain of the Brigham and Women's Hospital at Harvard Medical School. This was a very well-attended event, which we believe speaks to the interest in alternatives to the current treatments for access in hemodialysis patients. Next, I'll briefly discuss one of the pipeline programs that we're also very excited about. Our coronary tissue engineered vessel or CTEV, for use in coronary artery bypass grafting or CABG. We are on track to commence our Phase I/II trial of CTEV in CABG in the second half of 2026. In support of Humacyte's first-in-human study in CABG, we submitted an investigational new drug application, or IND, to the FDA late in 2025. Also for this study, we initiated the first large-scale manufacturing lot of CTEV in our commercial production facility, and this production is now nearing completion. Our CTEV vessels have a diameter of 3.5 millimeters, which is suitable for the coronary circulation and which is smaller than the FDA-approved 6-millimeter vessels that are being used in the limbs. We plan to commence the CABG study in the second half of 2026 upon completion of manufacturing and clearance by the FDA. I'll now turn this over to Dale for a review of our financial results for the first quarter.

Thank you, Laura, and good morning, everyone. Commercial sales of Symvess were $0.5 million or 29 units in the first quarter of 2026 compared to $0.1 million or 5 units in the first quarter of 2025. Contract revenue from a research collaboration with a large medical technology company was $2,000 in the first quarter of 2026 compared to $0.4 million in the first quarter of 2025; this decrease related to the completion of this phase of the collaboration. Cost of goods sold were $2 million for the first quarter of 2026 compared to $0.1 million for the first quarter of 2025. For the first quarter of 2026, $0.2 million of the cost of goods sold related to cost of units recorded as sales revenue during the quarter, and the remainder was primarily comprised of a $1.6 million inventory reserve recorded to reduce certain inventory balances to their estimated net realizable value as well as overhead related to unused production capacity, which was recorded as an expense in the period. Research and development expenses for the first quarter of 2026 were $19.5 million compared to $15.4 million for the first quarter of 2025. The increase related to $4.3 million in material costs, primarily from noncommercial manufacturing runs associated with CTEV production as well as process improvement designed to improve future cost of goods sold. General and administrative expenses for the first quarter of 2026 were $7.9 million, consistent with the $8.1 million incurred in the first quarter of 2025. Other net income was $11.3 million for the first quarter of 2026 compared to $62.3 million for the first quarter of 2025. The decrease in 2026 of other net income compared to the prior year resulted primarily due to a decrease in noncash income from the remeasurement of the contingent earn-out liability. Net loss was $17.6 million for the first quarter of 2026 compared to net income of $39.1 million for the first quarter of 2025. The increase in 2026 net loss compared to the prior year period was primarily due to the decrease in noncash income from the remeasurement of the contingent earn-out liability I described earlier. We had cash, cash equivalents and restricted cash of $48.9 million as of March 31, 2026. Net cash used was $2.0 million for the first 3 months of 2026 compared to net cash provided of $17.9 million for the first 3 months of 2025. The increase in net cash used for the first quarter of 2026 resulted from $47.0 million in net proceeds from a public offering completed in March 2025, partially offset by $23.3 million in net proceeds from sales of shares during 2026. With that, I'll turn the call back to Laura.

Thank you, Dale. With our outstanding and augmented commercial and medical team, our strong commercial execution, our very promising pipeline programs and our dedicated employees at Humacyte, we remain committed to delivering truly transformational regenerative medicine solutions that will improve patient outcomes and lives. We believe we are positioned for growth and value generation for 2026 and beyond. Thank you all for joining us today. Operator, we're ready to take questions.

First question is from the line of Matt Miksic with Barclays. Thank you, Dale. With our outstanding and augmented commercial and medical team, our strong commercial execution, our very promising pipeline programs and our dedicated employees at Humacyte, we remain committed to delivering truly transformational regenerative medicine solutions that will improve patient outcomes and lives. We believe we are positioned for growth and value generation for 2026 and beyond. Thank you all for joining us today. Operator, we're ready to take questions.

So I wanted to ask about the commercial efforts that you're putting in place to sort of drive greater adoption in the U.S. market for trauma away from some of the government contracts that you've established, which are great. But what can you tell us about the sort of the pace that we should expect the trajectory of revenues that we might see from those efforts? And I have a follow-up.

Yes, Matt, this is Laura Niklason. Thank you so much for the question. I do think we're still a little too early to provide guidance for 2026. I personally am hoping to provide guidance by the end of the year. But we have restructured the commercial team, and we've strengthened it and grown it. The approach that we're taking to driving commercial uptake is really much more customer focused now. Our customers are primarily vascular and trauma surgeons. We are revamping how we approach the customer and how we educate them about Humacyte and about the products, but also about our platform and potential future indications. One learning that we've taken away over the last year is that we have to provide better education on the technology, which we've been doing. But we also have to view the new technology from the surgeon's perspective and help show them the ways in which the technology can help their patients now, but also in future as we gain additional indications. So we've really revamped the team with a very experienced medical device sales team that has worked for decades in high-end vascular and aortic devices and procedures. We think we've really targeted the correct team. And now we have to change the way we engage with surgeons. I believe those will result in accelerating revenues during 2026, but it's too early for us to predict the shape of that ramp.

Sure. No, that's understandable. And from your comments, it sounds like a shift or a pivot, I don't want to say away from, but the emphasis maybe this time last year was working your way through that value analysis committees and approvals and hospital contracts and establishing that sort of first use. And now it sounds from your comments, almost just to repeat what you talked about is more call point service and education to support the use or encourage the use of the device in the appropriate setting. Is that fair?

Yes, I think that is fair. We're certainly working. We've still got, I don't know how many exactly, but roughly 45 VAC applications in various funnels. So we are still working on getting on the board or getting on the shelf in hospitals. We're certainly not happy with the number of hospitals where we are on the shelf. What's become clear is that just getting it on the shelf, but then not providing additional surgeon support and education and letting them see the value of the product for its approved indications is not sufficient. I think that's something that we're really leaning into a lot more in addition to trying to expand how many hospitals where we're on the shelf. As part of the geographical expansion, we're also revamping our territories, and we're bringing on some additional salespeople with a lot of experience with integrated delivery networks. So it's leaning into both aspects. But I would say you're correct, Matt, that leaning into surgeon support and education and viewing the product and the product experience from their eyes is a critical pivot for us.

Okay. And then just one follow-up, if I could, on this process experience in Symvess and the trauma center and what you've taken from that or how investors should expect the eventual introduction into the dialysis indication to be — do you learn that's applicable? And how will that be different perhaps would be helpful color.

Yes. So what we've learned about use and uptake in trauma centers and in very difficult and infected and contaminated cases is that most surgeons are very happy with how the product works. I think we're going to have a series of case reports coming out this year of cases where surgeons thought that patients were essentially unreconstructible and had no other means to sustain life. In many cases, though not all, our product was able to reconstruct their vasculature. The word is getting around that the product works even in the most difficult circumstances. One of our goals with engaging with surgeons is to get them to think about this not just for the most difficult cases, but for more standard cases because the outcomes are so much better than many of their alternatives. As far as what we've learned in trauma and how that will apply to dialysis, certainly, many — not all, but many of the surgeons who we talk to about trauma and peripheral vasculature are also doing dialysis access. So the awareness of the product translates directly over. We have a lot of enthusiasm from surgeons who are very eager to hear about these top line results that are coming out in just a few weeks, particularly because the problem of dialysis access in women is a chronic problem that folks have never been able to solve and also the problem of infected dialysis grafts that need to be removed and where you need to restore some sort of conduit and you don't want to put a catheter in. Those are really difficult problems that dialysis surgeons are hoping to get a better answer for. I think that the fact that our vessel has done so well in some of these very challenging vascular injury reconstructions just helps inform the same surgeons about how we'll do in dialysis provided the data are positive.

Our next questions are from the line of Ryan Zimmerman with BTIG.

Laura, on the unit volume growth, you did see sequential growth this quarter from fourth quarter, which was encouraging to see on Symvess. I'm just curious of the existing users, maybe if you could talk a little bit about just the repeat usage from some of your early adopters? Are you seeing that versus maybe new account growth? And again, I know you're going through this transition commercially with how you approach the market. But I'm just curious kind of within the existing usage of Symvess, what that looks like? And then I have a couple of other questions on some other components.

Yes. We're talking about 30 or more sites, so it's difficult to give a blanket answer, but in most of the sites that were using in the last quarter, what we've seen is that typically there's one surgeon at a site using a new technology and then other surgeons start to pick it up. In the last quarter, we've seen more of that where it's not just the index surgeon at a particular site that's using it, but some of his colleagues are also starting to do cases. We've seen that at multiple of our high-use sites, which to me speaks to growing confidence at these individual hospitals. But I think we're also seeing product on the shelf in some institutions that, because of insufficient support, isn't being used. That's a missed opportunity that I think our commercial team can improve upon.

Okay. That's helpful. And then as we look ahead to AV access, I'm curious, we're going to get interim results at the meeting in June, I believe it is SVS. And so as you think about submitting for AV access, one, how similar is that to your trauma application? Is it easier because you have the trauma indication now? I guess what I — what investors would want to understand is how derisked you think clearance is for the AV access indication and what you think about in terms of the risk or potential timing when that comes to market? And then just one more on operating expenses when you're done.

Thank you. I want to preface by saying I cannot predict what the FDA will do. I can tell you what I anticipate and hope will happen. If the results are positive on the interim analysis, which we're announcing in several weeks, then by prespecification in the protocol, the trial stops because if by analyzing half the patients we have a clear superiority over standard of care, which is fistula, it may not be ethical to continue the study. If we hit our endpoint, the study stops. At that point, we will analyze data on all of the patients that have been enrolled and followed up. The V012 study will be the lead clinical file that will go into the BLA. The BLA will be supplemented with our prior V007 study, which also compared our vessel to fistula in catheter-dependent patients; V007 was in both men and women. If both studies are positive, we would then have two positive prospective randomized head-to-head trials done in the United States showing superiority of Symvess or our ATEV to the standard of care. Despite turnover at the FDA, the most conservative stance by the Center for Biologics has been that they like to see two prospective randomized head-to-head trials showing similar outcomes, which I believe, if our outcomes in V012 are positive, is what we'll have. Additionally, because it's the same product as what is already approved in trauma, parts of the BLA application like the manufacturing pieces and the preclinical and the safety and toxicity are essentially the same as what we've already filed and they've already reviewed. So it will really be a matter of reviewing the clinical data, which we expect to submit before the end of the year. If we were to submit, for example, in November, they would have two months to accept the file, which could put us in January. We would ask for an accelerated review because we have an RMAT designation, which would be a six-month review, potentially putting us in July of 2027. We may or may not receive that accelerated review.

Right. Okay. That's very helpful, Laura. And Dale, just on the reduction in operating expenses, I appreciate the savings estimates. Is that evenly spread through the remainder of the year? Or does that build towards the tail end of the year just as you wind down some of those expenses?

Yes, Ryan, it's relatively evenly spread across the remainder of 2026. Clearly, there's a severance period, which comes in. And obviously, when you take these measures, for example, in May, there are costs that have already been incurred. But for the second half of 2026, you could expect that the $14.3 million in estimated savings will be spread pretty evenly over that period.

Our next questions come from the line of Josh Jennings with TD Cowen.

I was hoping to just follow up on Ryan's question around the BLA submission. Are you able to share any recent kind of color from the FDA just on this path, the submission path? And then also, just curious if the Fresenius clinical team or regulatory team is involved in any way in terms of this BLA submission for AV access?

So in terms of the Fresenius contribution, they have certainly been involved with multiple Fresenius sites because some of the key data in this clinical trial is how dialysis patients are doing, whether or not they are catheter-dependent or whether the dialysis center is able to take the catheter out. We've had to partner closely with a lot of Fresenius centers where many of our patients are being treated to collect that data. They have been supportive partners in gathering the data for this indication, but the BLA filing itself will be held entirely by Humacyte. As far as recent discussions with the FDA, we have not had recent discussions specifically on dialysis access; we had discussions regarding our plan for executing on the V012 trial about 12 to 18 months ago. We are preparing an application for a pre-BLA meeting should the results be positive. At the pre-BLA meeting, we would lay out our top line results and our strategy for filing and get more clarity. Despite turnover at the FDA, the clinical review team in the Center for Biologics that reviewed our trauma application and will review our dialysis application has remained relatively intact. We had a meeting with that clinical team on another indication in PAD just a couple of months ago, and many of the reviewers are the same, so I believe there will be some continuity there.

And just my follow-up, I wanted to better understand the funding allocated by the Department of Defense. What are the next steps for Humacyte with the Department of Defense? And how do you see the path to potentially procurement orders and stockpiling and relative timing, if there is anything you could share there?

We have an Executive VP of Strategy who used to work in federal government for 20 years in procurement and has been spearheading this effort. This is a collaborative effort between Humacyte, the Department of Defense and several surgeons at different military treatment facilities. It's difficult to give precise timing, but we are hoping to have this purchase completed by around September. The purchase would then be involved in training surgeons and in clinical use at different MTFs. As with the FDA, it's hard to predict exact timing on DoD actions.

The next question is from the line of Peter Spanogiannopoulos with Piper Sandler.

Following the recent amendment of the Fresenius agreement, what is your current priority for international commercialization? If you could elaborate on your ex U.S. strategy, specifically regarding any plans for the European market and the steps you're taking to advance those initiatives?

Clearly, the reacquisition of our ex-U.S. rights as a result of the amendment with Fresenius creates a lot of opportunities for us. We had already initiated a number of efforts within the Middle East, and those continue and will likely expand. That's an area of focus for various reasons, including current interest from that region. We continue to push that forward extensively. As you inferred, we also have the ability to pursue European or other major region ex-U.S. partners, including Japan or Europe, and we have initiated outreach to commence those discussions.

Our next question is from the line of Bruce Jackson with StoneX.

I'd like to ask a question about the dialysis market. In particular, I'd like to ask about the CMS End-Stage Renal Disease Quality Incentive program for 2026, which provides some incentives to use fistulas or grafts instead of catheters. In particular, the long-term catheter rate is a key measure. So does this provide any kind of incentive for more rapid uptake in the dialysis market compared to trauma? And does this also dovetail with the applicability in the female population?

Yes, Bruce, absolutely. CMS has instituted a payment system whereby dialysis clinics that maintain large numbers of patients on catheters can suffer in terms of reimbursement. So dialysis centers, for reasons of patient care and reimbursement, are eager to get patients off of catheters. For women in particular, nearly one in three women dialyzes in the U.S. on a catheter. Many of these are not by choice; it's because they cannot get a fistula to mature and surgeons are unwilling to put a graft in the patient typically because of infection risk. This is a hard number to change because there have been no other alternatives for women in decades. We believe that this is the sweet spot for patient care and reimbursement for dialysis centers. If we can target women who are remaining on catheters and suffering complications and expense, we believe we can improve outcomes while decreasing costs. The cost of an average hospitalization for a catheter infection can be nearly $30,000. Patients who are on catheters who then get a fistula but the fistula fails have first-year costs around $45,000 because of return trips to the operating room and rehospitalization. Remaining on catheter is expensive; trying to get off catheter and failing is even more expensive. We believe that Symvess may offer an alternative that will reliably work in women, won't fail to mature and will have a low infection rate. That could represent a real benefit for this population.

At this time, I'll turn the floor back to management for closing remarks.

I'd like to thank the analysts for their thoughtful and insightful questions this morning and also the audience for listening to us. We have had a tremendous number of developments and Humacyte is firing on all cylinders to both expand our current commercial footprint in the U.S. and worldwide, and to take advantage of the numerous opportunities that this platform technology is affording us. I am impressed and grateful to the people at Humacyte who have been incredibly productive and have accomplished so much over these past several years. I'm very excited about what the rest of 2026 is going to bring. Thank you for your attention.

Thank you. Ladies and gentlemen, this will conclude today's conference. You may disconnect your lines at this time, and have a wonderful day.