Humacyte Stock

Good morning, ladies and gentlemen, and welcome to Humacyte's second quarter 2026 earnings conference call. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over.

Thank you, operator. Before we begin 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.

Forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the 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; Jim Mercadante, Chief Commercial 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 second quarter and recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with the [ Symbest ] commercial launch. And Dale Sander will review the company's financial results for the quarter ended June 30, 2026. With that, I'll now turn the call over to Dr. Niklason. Laura?

Thank you, Tom. Good morning, everyone, and thank you all for joining us for our second quarter financial results and business update call. During today's call, I'll review progress across our development programs for the quarter and recent weeks, and then I'll turn the call over to Jim Mercadante for a review of our commercial progress for our [ Symbest ] launch in the vascular injury indication. As you know, Jim was appointed as our Chief Commercial Officer in April and is a seasoned commercial executive with a track record of successful leadership across medical devices, diagnostics, and healthcare technology. We're pleased to have him with us on today's call.

After Jim's update, Dale will review our financial results for the quarter and six months ending June 30. As a reminder, our goals for 2026 include the advancing of the U.S. and global commercial launch of [ Symbest ], completion of our V012 Phase 3 pivotal trial of our ATEV in dialysis access, and 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. I'm happy to report that our second quarter and recent weeks were a transformative period for Humacyte across all of these fronts.

With that, let's begin. In June, we presented breakthrough top-line interim results from our V012 Phase 3 trial in female dialysis patients at the Vascular Annual Meeting in Boston. Results from this trial exceeded our expectations, showing that our acellular tissue engineered vessel outperformed autologous fistula, which is the current standard of care. In a pre-specified interim analysis of the first 80 patients from the study, women who received the ATEV achieved 91 more catheter-free days than those receiving AV fistula. This difference was highly statistically significant with a p-value of 0.0007, thereby meeting the primary efficacy endpoint of the study and consistent with our expectations for ATEV in hemodialysis.

Infections of catheters and surgical access wounds were also less common. There were 6 infections per 100 patient-years with ATEV as compared to 23 infections per 100 patient-years for patients receiving the AV fistula. We believe these data from our V012 study are a breakthrough for women who have historically been left behind by the fistula procedure, leaving many women being forced to rely on infection-prone plastic catheters and grafts. Combined with results from the V007 Phase 3 trial that we reported previously, we believe that the ATEV could represent a major advance in hemodialysis, the largest advance in decades.

As I stated earlier, we plan to submit a Supplemental Biologics License Application, or sBLA, to the FDA in the second half of this year. And to help prepare for that planned commercialization in dialysis access, we have appointed Robert Kossman, M.D., and Prabir Roy-Chaudhury, M.D., Ph.D., as advisors to Humacyte. Dr. Kossman previously served as Executive Vice President and the Chief Medical Officer for Fresenius Medical Care North America. Dr. Roy-Chaudhury is the immediate past president of the American Society of Nephrology and is co-director of the UNC Kidney Center. Both Robert and Prabir are contributing to our health economic reimbursement and market access strategies. They will also provide peer-to-peer scientific support and medical education as we prepare for the planned hemodialysis access launch.

Turning to our pipeline, we recently announced that the FDA has accepted our Investigational New Drug Application, or IND, for a first-in-human clinical study of CTEV in coronary artery bypass grafting, or CABG. As you'll recall, the CTEV is a smaller diameter version of the ATEV, which was bioengineered to be suitable for CABG surgery. CTEV has been tested in large animals for more than 5 years, and these results have supported the FDA's approval of our IND study. There have been no new off-the-shelf conduits that have been prospectively tested in CABG in the U.S. in at least the last 40 years, and our preclinical results suggest that CTEV may be a promising off-the-shelf alternative to saphenous vein grafts.

To support this Phase 2a study, we completed the first large-scale manufacturing lot of CTEVs in our commercial-scale production facilities, and we plan to initiate the Phase 2a study of CTEV in CABG patients during the current quarter. And with that, I'll now turn it over to Jim for an update on our progress with the global [ Symbest ] commercialization.

Thank you, Laura, and good morning, everyone. It is a pleasure to be speaking with you all. Our second quarter was focused on rebuilding our commercial effort for [ Symbest ] designed to drive product adoption by hospitals, expand product usage, and to strengthen the site for sustained growth. To that end, we have remodeled our commercial team to ensure that all members have relevant long-term relationships in the vascular surgery space. We've also refined our introductory pricing incentive programs, professional education, and Value Analysis Committee engagement to better drive [ Symbest ] adoption. These initiatives are designed to create a scalable engine that converts interest in our first-in-class product into approvals, utilization, and sustained revenue growth.

As we move into the second half of 2026, results are beginning to materialize with influential hospitals adopting [ Symbest ] and utilization is increasing. Surgeon feedback on patient use cases has been excellent, and we look forward to assisting these physicians as they share their success stories with their colleagues. Elsewhere on the commercial front, our Marketing Authorization Application for approval of [ Symbest ] for arterial injury repair was accepted for review by the Israel Ministry of Health in April of 2026. The Ministry set a 180-day working period for the MAA through the existing FDA approval of [ Symbest ] in extremity vascular injury.

Last quarter, the fiscal 2026 U.S. Department of Defense Appropriations Act included dedicated funding to support the evaluation and cooperation of biological vascular repair for the warfighter suffering traumatic vascular injuries. We are continuing to work with leaders in the military and Pentagon to assure appropriate access to [ Symbest ] for American service personnel. During our second quarter, we also strengthened our team with the appointment of Dr. Todd Rasmussen as our Chief Surgical Officer. Todd has extensive experience and expertise in vascular surgery, gained over a 28-year career in the U.S. Air Force, during which he deployed multiple times to the Iraq and Afghanistan wars.

He is a recognized leader in peripheral vascular surgery and trauma repair. At Humacyte, his focus is providing peer-to-peer scientific support, medical education, and technical insights to surgeons and other healthcare professionals. He brings experience, surgical perspective, and leadership to our educational clinical support programs and will help us align regulatory guidance with the safe, appropriate, and effective use of [ Symbest ]. With that, it is my pleasure to hand the call over to Dale for the review of our second quarter results. Dale?

Thank you, Jim. Commercial sales were $0.4 million in the second quarter of 2026, which is really a rebuilding quarter, compared to $0.1 million for the second quarter of 2025. For the six months ended June 30, 2026, commercial sales of [ Symbest ] were $0.9 million compared to $0.2 million for the six months ended June 30, 2025. There was no contract revenue in either the three or six months ended June 30, 2026, due to completion of a research collaboration project in the prior year, compared to $0.2 million and $0.6 million for the three and six months ended June 30, 2025, respectively.

Cost of goods sold were $1.2 million for the second quarter of 2026 compared to $0.2 million for the second quarter of 2025. During the second quarter of 2026, $0.2 million of cost of goods sold related to the cost of units recorded as sales revenue during the period, and the remainder were primarily comprised of a $0.7 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 reported as an expense in the period. The cost of goods sold was $3.3 million for the six months ended June 30, 2026, compared to $0.4 million for the six months ended June 30, 2025.

During the six months ended June 30, 2026, $0.5 million of cost of goods sold related to the cost of units recorded as sales revenue during the period, and the remainder was primarily comprised of a $2.3 million inventory reserve and expenses related to unused production capacity. Research and development expenses for the three and six months of 2026 were $8.1 million and $37.6 million, respectively, compared to $22.0 million and $37.4 million for the same periods in 2025. The decrease in research and development expenses during the second quarter of 2026 was primarily due to a reduction in non-commercial manufacturing runs and reduced clinical trial expenses.

Selling, general and administrative expenses were $8.0 million and $16.0 million for the three and six months ended June 30, 2026, respectively, consistent with the $7.8 million and $16.0 million recorded for the same periods in 2025. Other net income or expense was a net expense of $9.8 million and net income of $1.5 million for the three and six months ended June 30, 2026, respectively, compared to a net expense of $7.9 million for the three months ended June 30, 2025, and other net income of $54.5 million for the six months ended June 30, 2025. The increase in other net expense for the three months ended June 30, 2026, and the decrease in other net income for the six months ended June 30, 2026, compared to the prior period, resulted primarily from the non-cash remeasurement of our contingent earn-out liability and other derivative liabilities.

Net loss was $36.8 million and $54.4 million for the three and six months ended June 30, 2026, compared to a net loss of $37.7 million for the three months ended June 30, 2025, and net income of $1.5 million for the six months ended June 30, 2025. The increase in net loss for the six months ended June 30, 2026, compared to the prior year period, was primarily due to the non-cash remeasurement of the contingent earn-out liability described. We had cash, cash equivalents, and restricted cash of $80.3 million as of June 30, 2026. Total net cash provided was $29.4 million for the first six months of 2026 compared to total net cash used of $6.9 million for the first six months of 2025. The increase in total net cash provided for the six months ended June 30, 2026, resulted from higher proceeds from sales of equities and a reduction in net cash used in operations. With that, I will turn the call back to Laura.

Thank you, Dale. So we're very pleased with the progress we've made this past quarter and with the excellent progress in our pipeline programs and our reinvigorated commercial execution. With our dedicated team, we remain committed to delivering truly transformative regenerative medicine solutions that will improve patient outcomes. We believe we're positioned for growth and value generation for the balance of 2026 and beyond.

[Operator Instructions] Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Maybe to start, a question for either Laura or Jim. Around the commercial changes that you're making, maybe you could reflect on what was challenging prior to Jim coming in and taking over. What needed to be refined and what you're seeing tangibly, I think Jim you talked about picking up since you've made some of those changes. Can you share with us kind of what you're seeing from that that kind of can give us improved assurances that we could see a commercial inflection in trauma.

So yes, so Ryan, thank you for that. You know, I'll sort of answer the pre-Jim question and then I'll let Jim sort of talk about the changes that he's put in place just in the last 3, 4 months. You know, I think that our commercial uptake in vascular injury was not as rapid as we'd been hoping. And so that led us last fall actually to move our prior Chief Commercial Officer out. And then we began a search and then, you know, Jim began in April of this year. You know, what I can say is that, as a new conduit, the first new conduit to enter vascular surgery in the last 40 years, and I had said this multiple times, you know, I think that the education challenges were something that I think we underestimated as a company.

And so one of the ways we sought to address that is to bring in Rasmussen and really increase our contacts with thought leaders in the industry. But in addition, something that I think we didn't appreciate is that if you have something fundamentally new and transformative in the space, you really need a saleable, executives and leaders who have really deep, strong connections with very active practicing vascular surgeons. And while some of our people had that, a lot of our people did not. And so that made sort of breaking in with this fundamentally new product more challenging than it had to be, and I think that's one of the things that Jim saw immediately when he joined us, and I'll let him take it from here.

Thanks, Laura. I appreciate it. Great question. And I'll echo Laura's comments here. One of the key things when you're looking at a technology like this, and this is the reason why I'm here, I believe this technology is going to revolutionize open surgery for sure over time. But you have to have deep vascular surgery relationships. This is a 90% of the call point is vascular surgery for what we're trying to do here. And so the people that we're bringing in are people that have deep vascular surgery relationships and have built something from nothing. There's a difference. And those are the type of people that are used to what I call doing therapy development or new product launches. And this is a new concept and product going to vascular surgery, but it's being, I will say, well-accepted once the story is told. And it's certainly welcomed and we're already starting to see that uptick just a few months in. Hopefully that answers your question.

Yes, thank you. And if I can follow up and turn to dialysis access for a minute here and just ask, you know, we're in that window of getting the BLA submission into the agency for clearance potentially in the future. So, Laura, maybe you can just talk about kind of what you're doing to de-risk that. Give us maybe a little tenor of the conversations with the agency around submission for ATEV in dialysis access and kind of how you think about, you know, potentially bringing that to the market. If you have any thoughts on timing too, certainly those are appreciated. Thank you.

Yes, so again, we have had multiple discussions with the FDA over the years on dialysis access. And we actually have scheduled a pre-BLA meeting, which is happening in the very near future, which we're excited about, but the structure of that meeting is really not around whether to file, but around the structure of the file. Our anticipation is that we will include data from essentially all of our Phase 3 studies, and we've done three of them, as well as a number of Phase 2 studies. And so, you know, the total exposure that we have in our patient population is well over 1,000 patient-years. This is the most studied conduit ever in dialysis access. So we believe that the data that we have is not only strong, but there's a lot of it, and so we do not anticipate any pushback on filing. It's really about how we structure the file and the overall safety experience.

So that gives us a high index of confidence that this will go forward. I'll tell you our plan, we've said second half filing. Our target right now is that we'll file in November because there is a lot of data to pull together. When we file, we anticipate that we'll ask for a priority review. We anticipate that we should receive a priority review because, again, this is a supplemental BLA and we have multiple priority indications for dialysis access. If we're granted priority review, then we would see a PDUFA date sometime in May. We would expect to launch at the end of Q2 in 2027.

As far as what we're doing to prepare for the launch, there's really a tremendous focus on reimbursement and on creating the value story for insurers, both CMS and private insurers. It's a huge expenditure for Medicare and for private insurers. And as you know, there's a lot of downward price pressure on reimbursement. But our data from especially, well, from all of our Phase 3 trials really show that there are patients who get off catheter quicker and more reliably with our vessel than with any other method. And there's cost savings to be shown there. So we're putting together a budget impact, and we're also looking at Medicare claims data to really nail that argument to the wall because there are many high-risk patients who sit around on catheter for a long time and are extremely expensive to the system and cost an extra $20,000, $30,000, $40,000 per year every year. So by getting those patients off catheter with a low infection conduit, we'll be able to save the system money and also just generate better patient outcomes. So I know that's a long answer, Ryan. That's how we're thinking about it.

Yes. Thank you so much, and certainly best of luck on the submission this fall.

Our next question is from Josh Jennings with TD Cowen. Please proceed.

I was hoping to just follow up on some of the details on the rebuild of the commercial effort. And with any help just thinking about, I guess, number of reps that are pushing ATEV in the vascular trauma channel today versus prior and how that could potentially ramp up, and then also any help just thinking about introductory pricing incentives that you've called out and streamlining the VAC process. Sorry, three questions in one, but what does streamlining mean and how many processes are in play right now, how many centers could be on the adopter list by the end of this year and heading into 2027?

So, let me see if I can at least get a few of your questions here and start to answer them. So, first, what I'll say is when you look at the submission process for a VAC approval, there's several ways to go about it. We've streamlined it because we became more flexible in the process, made it a little more open so it's quicker adopted. Couple that with vascular surgery relationships, major KOLs across the U.S. that want to try the product, want to use the product. That's how it really speeds up. And the second piece to that is you need a national account strategy. And when I came in, there wasn't a national account strategy.

So we hired a very specific individual who's done this with me in the past to build out that national account strategy so you can get access to another 1,000 hospitals in the United States, which we currently didn't have. So those are some key elements in any commercialization. They have a national account strategy to streamline the VAC process, et cetera. And the creation of introductory pricing is because, you know, surgeons, what I love about surgeons in general and vascular in particular, they really want to know how it behaves in their patients and they want to try it. And you really need to create a system where it becomes easy for them to be able to try it on several patients before they start to adopt it and put it into their practice. One of the key principles is just to be easy to do business with, and we've changed our philosophy in how we're interacting with administrations of healthcare systems. I can tell you right now, we've got at least 20 major healthcare systems in the U.S. in the process of bringing it into their healthcare systems in the back half of this year. That's not to mention everything else that we're working. Hopefully that answers your question.

Yes, that helps. Thank you. And I'm sorry for loading you up with a three-level question, but just on the sales force numbers, have they been reduced? Are they stable? Are they increasing for the vascular trauma build? And then how are you thinking about the commercial strategy for the AV access indication and what's that like opens up and will Fresenius play any role in terms of helping drive the initial commercial push, at least at their vascular surgery centers?

Sure. Let me just start with the dialysis one. We have already begun preparation, no matter when we receive approval, on what that launch will look like so we're ready day one. So everything that leads up to that is, you know, if you really look at our strategy, we're using vascular injury now to get into a healthcare system. And we are seeing adoption of that. I mean, it's certainly a great product. And for the right patient, of course. And it's always about patient selection.

But that prepares us for dialysis because if you're already in the healthcare system and you're through the VAC process and already on the shelf and you have another indication, that will accelerate launch when we do launch dialysis. So that's the strategy. The strategy is we're utilizing our current indication and that's what we're selling on, also preparing for dialysis because if we have it already adopted into these healthcare systems and it's on the shelf and we launch in dialysis, that's instant access to dialysis patients. And that's what we're preparing for. Now, we're also looking at, you mentioned Fresenius. It's a great question. I will say this. Besides Fresenius, we're looking at probably 5 or 6 other strategies and particular verticals for dialysis in the U.S. So I think it's going to be much broader than just working with Fresenius, while we would love to work with Fresenius and will. But I think we have to work with some others as well as we look to launch this in a major way mid-2027, so long we have the approvals that are needed.

Our next question is from Bruce Jackson with The Benchmark Company. Please proceed.

So with the 20 new hospital systems that you're looking at right now, how many actual hospitals are associated with those systems?

They're going to range. It could be anywhere from 5 to 50. So, it just depends on the healthcare system. Right now, I can tell you that when they start to adopt and they start to expand utilization, it starts usually with a surgeon or two, and then it usually transforms itself into the entire department. We have several cases right now that we've been able to transform from what I call dabbling and using it every once in a while to weekly usage. So there's a natural progression on the adoption of this product. As I said earlier, vascular surgeons, surgeons in general, like to try it out first. They want to touch it, they want to feel it, they want to sew, and they want to see how it performs in their particular patient set.

And so, you know, it's a process that can be repeated, healthcare system to healthcare system. And as these healthcare systems adopt, they tend to share their experience with other healthcare systems and other vascular surgeons in the community. So it becomes, after a while, after you get some mass, it starts to, you know, duplicate itself naturally. Hopefully that answers your question.

It does. Thank you. And then one other question on the transition of the sales and marketing effort. Is there any change in the number of contracted hospitals or VAC approvals where there's potentially a slowdown during this quarter?

Are you asking in particular Q2 or in the back end?

Just looking at Q2, we had a certain number of contracted hospitals in the first quarter, and I think we were all sort of looking for some sort of a trend going from first quarter to second quarter. Was there any kind of pickup or break in the trend because of the transition with the sales force?

Well, I don't know if there was a hiccup or break. It was more of a, I think you heard earlier, we were literally rebuilding the entire commercial team, not only with personnel, but strategy, tactics, et cetera, across everything, sales, marketing, national accounts. And we did it pretty fast. I mean, it's pretty unheard of to do that within 3 months, but we did it and transformed the whole thing. What you'll see is you'll see those results in the back half. You didn't see them in Q2. That would have been really quick. But we started to see a minor uptick, but the uptick is really in the back half.

Our next question is from Swayampakula Ramakanth with H.C. Wainwright. Please proceed.

A couple of quick questions. I'm sorry if you've given some of this information in the opening remarks because I've missed a few minutes of it. On the supplemental BLA for the dialysis, how are you planning to use the RMAT designation that you have and also in terms of the label, can you elaborate a little bit about what you're trying to seek on the label and would you also look to see if you can get at-risk males within that label?

Hi, RK. This is Laura. Thank you for the question. Yes, so we do have the RMAT designation in dialysis access, and we will use that along with the fact that we already have approval in another indication to request priority review. So that means if we file our sBLA sometime in November, which is our current plan, then we would hope under best case to get a PDUFA date sometime in May of 2027. That would allow us best case to launch in the back end of second quarter 2027. If we do not get a priority review, then that would push our PDUFA date sometime into August. So that's kind of the bracketing of the timing that we see. Of course, as you know, the FDA doesn't always hit their PDUFA dates, but that's just what we would be expecting. As far as, gosh, what was the second half of your question, RK? I'm sorry.

Ah, yes, yes. Yes, so we are, again, the specific label language is always a subject of negotiation with the FDA. Our anticipated label is that ATEV or [ Symbest ] would be indicated for hemodialysis access in patients who are at elevated risk of fistula failure or non-maturation. And in parentheses, it might say, i.e., women and men with risk factors such as obesity and diabetes. So that is the indication language that we'll put into our application. But again, the final indication remains to be worked out with the FDA.

Yes, yes. And then regarding the Fresenius relationship, how do you forge that? Them helping on your launch especially given the third amendment that returned the worldwide rights, and also based on that, should we expect some royalty step-down thresholds, especially in the United States?

So, I'm honestly not sure what you mean about step-down thresholds, but Fresenius does have, I mean, we remain in the commercialization agreement with Fresenius, and that has a couple of clauses. One is that they have pledged to adopt this as standard of care in their dialysis access centers for patients in whom we have an indication and for whom the economic benefit makes sense. And so that's why we're doing a tremendous amount of work on the health economics of particularly getting patients off of catheters because catheters are expensive for the system for capitated patients. And they're also even expensive for dialysis centers. Dialysis centers get docked by CMS if they have too many catheter patients. So we expect that relationship with Fresenius to continue. It's also germane to point out that they get a royalty on every vessel that we sell in any indication in the U.S. So there's a lot of aligned motivations for broader adoption in the U.S. Does that get at your questions?

Yes, yes. And then the last question from me is on the CTEV study that you recently got FDA to sign off on. Anything on the timing of the study and also, how does manufacturing of that, does that impact anything with your commercial product manufacturing right now on the ATEV?

Yes, so you're right, RK, in that the vessels that we make for the CTEV studies are in the same machines, because this is a platform, in the same machines as make our commercial vessels. However, the requirements for numbers of CTEVs are very low for the next year or two. I mean, this Phase 2a study is only 10 patients. The smallest batch we can make is 100 vessels. So we may make 1 more CTEV batch next year, but it's not like it's a drain on the system at all. As far as when we expect the trial to start, we're working on getting through the IRB and finishing up that paperwork now that we have FDA sign-off on the IND. So I would expect that study to open up sometime this month.

And then it's a question of identifying the correct patients. You know, what's really important for this study is that we have the right patient and that we get outstanding outcomes. And so that's really what we're focused on. Luckily we have two surgeons who are participating in the study who have also done all of our large animal work with CTEV and are also obviously extremely experienced cardiac surgeons. So we feel like this is in good hands.

We have reached the end of our question-and-answer session. I would like to turn the conference back over to Laura for closing remarks.

Thank you very much everyone for listening to this second quarter 2026 Humacyte update and conference call. We have done a tremendous amount of rebuilding in the last 3 or 4 months especially on the commercial side and we're very pleased with the new strategy and the new team that we have in place. I believe it will be transformative for Humacyte going into the second half of this year and also for 2027 and beyond. But in addition to rebuilding the current commercial infrastructure, we've also made great progress on two future indications. So we're firing on all cylinders, and I'm very pleased that we are where we are now, and I look forward to continuing to share our quarterly updates with this group going forward. Thank you very much, everybody.

This concludes today's conference. Thank you for participating. You may now disconnect.

Good evening, and welcome to the Humacyte Virtual Investor Event. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Humacyte website following the conclusion of the event. I'd now like to turn the call over to your host, Dr. Laura Niklason, Founder, President and Chief Executive Officer of Humacyte. Please go ahead, Laura.

Hi, everyone, and thank you so much for taking the time on a Monday evening to hear our presentation on our recent clinical results, top line results from our V012 study, which was -- which evaluated Humacyte's engineered vessel, the ATEV, in comparison to autogenous fistula for dialysis access. These are our typical disclaimers. What I'd like to start off with so that we're not bearing the lead is that the V012 trial met its primary efficacy endpoint, which -- at this interim analysis, which was the measurement of how many catheter-free days patients who got our vessel, the ATEV had as compared to patients who received a fistula.

This primary -- this interim analysis was done after the first 80 enrolled patients had reached at least 1 year of follow-up. The 80th patient reached 1 year in April of this year, and we received the top line results only very recently. There were -- patients who received ATEV had 91 additional catheter-free days as compared to patients who received fistula, and this result was highly significant at a p-value of 0.007. There were also multiple secondary endpoints, efficacy endpoints that were met. And overall, we believe that the benefit/risk safety profile for ATEV is favorable, particularly for women who require access for hemodialysis, and we saw no new or unexpected safety concerns.

We expect to file a supplemental BLA application with the FDA for the indication in dialysis access later this year. So just at a very high level for those who aren't familiar with Humacyte and our platform technology, Humacyte has developed a first-in-class set of methods to take primary human cells and coach them into growing new human tissues that are functional and ready for implantation. Our engineered blood vessel, which is FDA approved a little over a year ago, the ATV is 6 millimeters in diameter and 42 centimeters in length and is available off the shelf.

These vessels are produced at commercial scale and can be stored up to 18 months in the refrigerator until needed by a surgeon and patient. We've treated more than 700 patients with these vessels and have observed that these vessels are universally implantable, and we've had no instances of immunologic rejection in any patient. In addition, we've observed that after implantation, these vessels repopulate with cells from the patient and become a living blood vessel over time. This is really category-defining innovation to create new tissues to help patients.

Humacyte has been in clinical development for a number of indications for multiple years now. As I mentioned, we have FDA approval of the ATEV in our first indication, which is treating vascular injuries. This was -- we received this approval in December of 2024 for the ATEV, which again is 6 millimeters in diameter and 42 centimeters in length. What you're going to hear about today is results from another Phase III program using our vessel for dialysis access, in particular, the V012 trial, which studied the efficacy of our vessel in women, and this was the first women-only study that's actually ever been done in dialysis access.

But looking more broadly, Humacyte also has active Phase II programs in peripheral arterial disease or PAD. And in fact, we're designing a Phase III study right now to compare our vessel to standard of care in patients with severe peripheral artery disease. In addition, Humacyte hopes to begin a Phase IIa study using a smaller version of our vessel, a 3.5-millimeter version as a coronary artery bypass conduit, and we hope to begin that trial later this year in the third quarter. And so with this now, after that sort of broad overview, I'm going to turn it over to Dr. Shamik Parikh, who's our Chief Medical Officer at Humacyte and who's -- oh, no, I'm sorry, I'm not turning it over to Shamik. That was a mistake. I'm actually turning this over to Dr. Mohamad Hussain, who is a Professor of Surgery at the Brighaman Women's Hospital, and he's going to educate you about the background of dialysis access in general and the complications that come along with this and particularly how those complications affect women.

Thank you so much. Good afternoon, everybody. I'm a vascular surgeon, and I do a lot of hemodialysis access. So this is a problem I think of frequently, and I was just looking for better solutions for our patients. So across the U.S., end-stage kidney disease or kidney failure is a big problem. There's more than 800,000 people who live with kidney failure in the U.S. Now if you look at it per year, there's over 130,000 people who develop kidney failure in the U.S. every year. And they need some sort of mechanism to clean their blood or have renal replacement therapy.

The most common way people get renal replacement therapy is hemodialysis. So through their blood, their blood is cleaned through the dialysis engine. About 85% of the people who developed kidney failure will get hemodialysis and less than 15% will get some other alternative way of renal replacement therapy, such as peritoneal dialysis, which is done through the abdomen or getting a kidney transplant even before you get renal failure is very rare, less than 5% of the time.

So it is a common problem among our patients with kidney disease. Now when we look at all types of hemodialysis options we can offer our patients, the most common is AV fistula. So this is a connection between your own artery and your own vein to facilitate dialysis or cleaning up the blood for renal replacement therapy. About 20% of the people have AV grafts, which is an alternative to fistulas, some sort of foreign material and about 20% of the people have catheters or the most temporary option. Unfortunately, although most patients get fistulas, fistulas do not work well in a lot of people. In fact, about 40% of the fistulas that we create are not being used at 1 year or fail.

So have some sort of problem. And one of the reason for this is because we're still creating fistulas like it was first described in the 1960s. So over 60 years, there has been not a ton of progress in creating and maintaining fistulas better than we do right now. So here's a graph showing you when somebody first starts hemodialysis on the far left in the U.S. 85% of the people who start dialysis, get a temporary catheter in their chest. Very few people, only 13 persons stuck with their own main or the fistula, which is the optimal access.

You would expect over a period of 3 to 6 months after that fistula has created that blue bar, the dark blue increases in almost every has a great fistula and nobody is temporary catheter. But unfortunately, if you look at the bar right at about 12 months, 1/4 of the people still have catheters and only about 36% official because of the 2 problems either fistulas are created and they don't work well or patients just find great candidates for fistulas, and that's where a lot of people still end up having catheters.

Why don't we like catheters? Well, catheters get infected. They are prosthetic foreign material sticking out of the body. And unfortunately, there's a lot of hospitalizations or infections relating to the catheter, which can then spread in the bloodstream and actually cause high rates of mortality and morbidity. The second prosthetic option, the graft option is also not optimum. A lot of patients also get graft infections, in fact, about 10% of traditional AV grafts.

Fistulas would be great if everybody is a candidate because they have a low risk of infection. Overall, this is a significant burden in the health care system. Hemodialysis catheter infections cost about $30,000 per hospitalization and over $2 billion for our health care system in general. This is because a catheter that gets infected, needs to come out, patients need to be treated with IV antibiotics, then we've been a new catheter and eventually some sort of permanent access. Synthetic grafts also have high rates of hospitalization because often these patients need surgery to remove the graft, get temporary catheter back in and then antibiotics and some sort of permanent solution down the road. This also costs over $0.5 billion per year in outpatients.

Now women, particularly are burdened with this infection prone axis. So if you look at the far left, you can see in all patients, fistula is about 50% -- 57%. But when you look at the far right and women-only synthetic grafts and catheters in particular, are present more so in women and are associated with more infections. And that's because women in general have smaller blood vessels to start off with the smaller arteries, smaller veins and they may actually not be great candidates for using their own main for fistula creation and may also not have great vessels for even a graft creation. So a lot of them will be left with catheters, which can then increase your risk of having infections relating to catheters.

So this is where the V007 and the V012 trial come in, and I'll turn it over to Dr. Shamik Parikh for discussing the results of the trial.

Thank you, Dr. Hussain. Hello, everyone. I'm Shamik Parikh, Chief Medical Officer for Humacyte and overseeing the clinical development of our product. Before going into the V012 interim results, I just wanted to take a moment to share with you the high-level results that we had for V007 that basically set the stage for the V012 study.

And in this slide, you can see that this was a larger study that was conducted in which the patients -- the subgroup of women, which was very similar in size to the interim analysis V012 showed a greater benefit, a much larger benefit for ATEV versus AVF in terms of patency, both at month 6 and month 12. And there was a longer duration of use of AVF by about 3 months between ATEV and AVF in women. And we also saw the similar differences in other patients who are considered at high risk of maturation such as males or obese and of diabetes. So all in all, the results in 007, which was an all-inclusive study of males and females indicated that a lot of the results were driven by the subgroups, especially in women.

In that same study, we had followed patients up for 2 years, and we had shown durability of ATEV. And you can see the difference in the red and the blue curve is the time when patients still need access and the increased risk of catheter use if they happen to be on AVF arm. So this were the data from 007, and that led us to the design and execution of V012 study. So in V012, we have we are head-to-head design between ATEV and AVF. It's a multicenter trial in about 25 centers in the U.S., of which about 20 centers contributed actively to enroll patients females with end-stage kidney disease on hemodialysis, they randomized 1:1. The enrollment goal was 150 and the study is designed for a 24-month follow-up.

The primary endpoint, however, is at 1 year, and the primary endpoint is catheter-free days. And the protocol -- in the protocol, we had specified that once 80 patients complete 1 year of follow-up, we'll do an interim analysis to see if very superiority in catheter-free days. And that's the results that we are now presenting to you for this interim analysis of 80 patients at 1 year. So looking at these patients, there's very similar distribution of the characteristics that might impact maturation rates such as elderly patients, very equally distributed, obese patients were equally distributed and patients with diabetes were also equally distributed between the 2 treatment arms.

We also have taken into account the fact if somebody gets a forearm procedure or an upper arm procedure or if somebody might be a candidate for 1-stage AVF or 2-stage AVF ahead of randomization just to make sure that there is equal distribution of such patients in the 2 treatment arms. It's also important to note that investigators did look at the anatomy of patients and made sure that patients would be candidate for either an AVF or ATEV so that they can be enrolled into the trial.

As Dr. Niklason presented, the primary endpoint of our study was met at this interim analysis. We had a statistically significant increase in catheter-free days of approximately 3 months. In the ATEV arm , the average duration of catheter-free days was 221 days which essentially means this is the time during which ATEV was working for functional dialysis. And in AVF, it was 130 days, this established the superiority of ATEV over AVF for catheter-free days at the 1-year time point.

This slide shows you the rate of maturation between the 2 treatment arms. Again, ATEV had a superior maturation, patients in ATEV showing red matured faster and they mature at a higher rate, closer to 90%. While in AVF, there was approximately 60% maturation rate with 40% failure rate. And again, you can see the amount of time it takes to mature for AVF. And the separation between the curves is when these patients would be relying on catheters for their AVF access.

An important safety endpoint that we had highlighted was to look at infections. If you look at the infection rates over 100 patient years, there were 17 less dialysis excess infections for ATEV use of 1 year versus AVF. There were 2 events of infection in the ATEV group, both where dialysis catheter and then there were 9 events in AVF, 3 of which were AVF related infections and others were mostly catheter-related infections. And if you look at the difference in rates, as I mentioned earlier, this would translate to 6 events but 100 patient years for 8 versus 23 events per 100 patient years for AVF for a difference of 17 infection events, less on the ATEV arm versus AVF.

Besides the primary endpoint, we had a bunch of secondary endpoints that we analyzed and here are the results of the secondary end points. We were looking at catheter-free days in the first 6 months. And you can see virtually most of the is opt in here in terms of catheter-free days for ATEV versus AVF arm. For a p-value of 0.0009. The 12-month functional patency, this was a it predefined hemodialysis threshold that the patients had to reach to get functional patency. Again, there was a significant difference between the 2 arms of 250 days versus 150 days. very significant p-value.

We have looked at secondary patency at 6 months, ATEV, which was very consistent with what we have seen in previous studies was at 88% versus 65% for AVF, again, a significant p-value. And the last one was 12-month secondary patency where ATEV was at 78%, again, consistent with the other studies we have done in the past. AVF was 62%. This one was a p-value of 0.16 in part because of only 40 patients being available for analysis. So those are the secondary endpoints that we had predetermined in the trial and that we tested and the they all showed benefit in favor of ATEV.

I want to take a moment talking about safety in this study. And this is ATEV versus AVF with percentage of subjects reporting safety events the total number of events that were reported. And then because there is such a big difference in duration of use of 3 months, the third column is events adjusted to patient years of use for that period of time. If you look at all AEs that were reported, you can see 235 events in ATEV versus 287. The rate difference is about 8.9% versus 18 in the AVF arm.

So less treatment emergent adverse events in the ATEV arm. Serious adverse events tells the same story, 46 versus 75 events, 1.73 versus 4.77. There were some events that we had prespecified that are of interest because of associated with AV access. There were 0 infections, as I mentioned before, with ATEV per se. There were 3 related infections in the AVF group. Thrombosis was 20% versus 8% with a rate of 0.75 to 0.51. This is significantly less than what we had seen in the V007. But importantly, also, the thrombosis treatment rate, our successful resolution rate was 75% in the ATEV arm versus 38% in the AVF arm.

Stenosis occurred at a rate of 1.62 in our study, while it was 2.29 in AVF. So adjusted for duration of use, it was less stenosis in the ATEV group. And then rest of the things, clinically [Sinfonia] syndrome, steady access ruptures, which were 0 in both arms. iatrogenic injury was 1 in ATEV and none in AVF and then AE leading to abandonment, as you can see, was somewhat higher in the AVF group versus ATEV. So very balanced, very favorable safety profile to go along with a favorable efficacy profile in this study.

So in summary, -- ATEV met its primary endpoint by demonstrating superior catheter-free days compared to AVF, which is the current standard of care, as Dr. Hussain explained there were approximately 3 more months on average, 3 more months of catheter-free days compared to AVF in the ATEV group. ATEV patients incurred 17 fewer dialysis access infection that AVF for every 100 patient years of use. There was clear and consistent advantages or ATEV in multiple secondary end points and overall, our benefit risk safety profile of ATEV is favorable with no new or unexpected safety concerns identified.

As we had prespecified in the protocol, if we established an interim analysis, which we have, we terminate the further enrollment in this study, which we have -- we will continue to follow up the patients who are already enrolled in the study, and we plan to file our supplemental BLA with the FDA during the second half of this year. And we are looking for a target indication in adult patients with end-stage kidney disease were at an increased risk of AV fistula maturation failure. Thank you, and I would like to turn it back to you, Dr. Hussain, for your perspectives as a VO12 investigator.

Thank you so much. So very exciting and interesting results and potentially a new avenue for our patients who are high risk for access complications. So -- so I'll talk about these 3 things and sort of try to put the results in context of clinical experience. I've had the privilege of being the highest enroller in both this trial and the previous V007 trial and have had an opportunity to really use the ATEV quite a bit in these patients. And also have had observers come and sort of see us use it and teach others to use it.

And I think the most common comment I get when for somebody starts using it is how much it feels like a real vessel and how much is souls like a real vessel. And I think that's really one of the nice thing as a surgeon to think about having an option, which is -- that really mimics a human body's vein or artery. So I think that's been a very nice to handle, and it's been easy to use. And I think a very nice experience for the surgeon to be able to utilize for the patients.

These results are very exciting. And a couple of nuanced outcomes I'd like to bring out is that as a surgeon, we really think about infections in these patients and graft infections. And these patients who had the ATEV had significantly lower catheter time and significantly lower number of overall infections because of 2 reasons. One, because of having less catheter contact time, which leads to lower infection. But also what really I found interesting was that risk of infection was 0 in the access itself in the ATEV group, but 8% in the fistula group.

So you may ask, well, why did 8% of the fistula group get infections? Well, because most likely, these patients who are having the fistulas that weren't maturing being revised with grafts or having 2-stage accesses. We had a fistula that didn't quite develop, so then having a second stage graft made out of other foreign material leading to more infections. So I think sort of those 2 advantages having less catheter time and less exposure to graft material and getting the ATEV right away seems like really beneficial for this cohort.

And this was a high-risk cohort. As you saw from the slides, 50% were obese and 50% had diabetes, which are really high risk for infection. So I think that was very interesting to see for our patients. Looking ahead, I think this could have a large role in a lot of our patients. Certainly, this trial was done in women, and I think women, in particular, could really benefit because of the things I discussed in terms of having smaller blood vessels to start off with.

In fact, 24 hours after the press release, I was already planting this in a patient of mine who I had told before that this is a very nice option for her because being a woman on immunosuppressive therapy, she could have an alternative conduit to a vein that was borderline, not great, will likely not mature, mainly the second stage surgery, but this certainly presents a lower risk option for her, and I was able to implant that for her shortly after the results. And I foresee that patients who have borderline veins, both men and women or patients who need 2-stage surgery and are going to have a long catheter time of several months.

You can see in this case, in the trial, it was about 5 months for patients who had fistulas. So we have patients who we anticipate will have catheter time of several months because they need multiple surgeries to get a fistula usable. I think this could very well be in the algorithms and potentially change future guidelines as a therapeutic option for these patients. So these are my initial thoughts, and it's a very exciting time for this potential option for our patients. And I will turn it back over to Tara and happy to take any questions.

Great. Thank you, Dr. Hussain, yes. [Operator Instructions] So please hold for a brief moment. Great. So our first question comes from Bruce Jackson at Benchmark.

First, on the definition of the diabetic patients, what was the objective measure for that?

So you want to take it?

Yes, yes. That was patients who had a history of a documented history of type 2 diabetes.

Documented history of type 2 diabetes. Was it like an A1C level or insulin use. What was the exact criteria?

No, we didn't use A1c criteria because you could have patients who are very well controlled on diabetes whose A1s would be perfectly normal. So these are patients who have a history of type 2 diabetes documented, just like you would have a history of hypertension. And yes, a minimal A1c was not needed to participate. They had to have history of diabetes. I think there was an exclusion for severely uncontrolled diabetes patients simply because they may not be stable in the study, but that was about it, Bruce.

Okay. And then a quick follow-up. The -- so the label, hopefully, is going to be people at -- with increased risk for graft failure. Is that something that's generally recognized in terms of the criteria? And how do you think the data from the study supports that?

I'll answer it, but I would also like for Dr. Hussain to add his perspective on how commonly it is known about patients at risk of maturation failure. So one, this is a very well-published area in the literature of patients of risk factors for maturation failure. And as I sort of indicated, women, obesity, diabetes and in some cases, elderly have been identified as strong predictors of maturation failure. In this study, we have women, and we have obese and diabetes and elderly patients in our other studies that we'll be pulling together and presenting to the FDA to show the evidence that ATEV works consistently well in these patients and AVF not so much.

Congratulations on the study results.

So our next question comes from Izzy McMahon at BTIG.

Just to start, I was hoping to follow up on that last point that Bruce was just making and maybe think about it about from the practicality standpoint of the off-the-shelf availability of the ATEV. So I was curious how the AVF maturation failure or delay in results in patients and having them default back to catheters impacts where you see the ATEV playing and the ability to use it off the shelf and how it will impact your workflows going forward?

Yes. Great question. I'm happy to sort of think about it from a clinician standpoint. So I think there's 2 scenarios. One is the creation of the new access, which is more of an elective procedure where you have time and if you don't have it on shelf, you can ensure you get the appropriate conduit that you're planning on using. And that's a decision one can make in clinic or in hospital or any other setting that one sees a patient that they think is an appropriate candidate for this type of conduit.

The other scenario is the urgent situation. So you may have a patient who has an infected access and it needs to be revised pretty quickly. And in that scenario, I think as a surgeon, I would also consider this and we'll actually very much like to have it on the shelf so that one could just utilize it in a more urgent scenario to maintain the continuity of the access of a patient that may be infected, may have ruptured or may have sort of other issues that come up.

I appreciate that. And then just one follow-up. Based on the data from the V007 trial, I think we would expect to see similar outcomes for patients extended into year 2 for this V012 study. I was curious, Dr. Hussain, in your clinical experience, does the benefit of avoiding a catheter compound over time as patients become more stable on a durable access? And what do you think this could mean for longer-term outcomes?

Yes. Thank you for the question. Yes, I think these are very promising 1-year results, and we'd love to see how things pan out over 2 years. I think it's very promising that the patients are staying off catheters that the risk of infections will be lower. And if they're not getting suboptimal vein accesses or that may have to be revised by conduits that get infected at a higher rate, then I do anticipate that the risk of infection will be lower long term.

And the nice thing about this is it does integrate really well with the human tissues. And we know that there is a delayed risk of infection with prosthetic conduits because of repeated cannulation 3 times a week every week when they go to dialysis. But when you have a conduit like this made out of human cells that integrates with all the tissues and then you would anticipate that the risk of these delayed infections is also lower, but we're very much looking forward to the results.

Great. Our next question comes from RK at H.C. Wainwright.

Thank you very much for hosting this session. So a couple of quick questions for Dr. Hussain. Given that this is a women only and U.S. only 80-patient interim analysis that you are looking at, how confident are you that this effect can be generalized both to men and women and also to a broader real-world dialysis patient population?

Yes. Thank you for the question. So I think the way I look at this, this is just the next edition of the CLEAR data that we have. I was part of the V007 trial, which was all comers, men and women. And that was also positive with patients who received ATEV, met the primary endpoint and had better durable accesses. The subgroup analysis of course, showed the women and the high-risk subgroup of diabetic evidence. Now we have Level A evidence in women, which, again, we don't have in the [indiscernible] space.

So I'm just very excited. We have -- I'm also a clinical trialist and I get excited about Level A evidence. So I think this certainly elevates the evidence that we have. And I think certainly compared to what observational confounded data that we have, this is much more clean and certainly, I will feel a lot more comfortable for applying that data in the high-risk patient cohort, which includes the women and certain men without the appropriate conduit options available and fistula options available.

I have one more question for you, Doctor. So as we know, some of this patient population are candidates for transplant. And how meaningful is the immunogenicity advantage that you discussed in the data? Does the implantation with the ATV preserve and actually improve the eligibility of these patients for transplants better than having grafts or fistulas?

Yes, good question. I'll let the Humacyte team talk about specifically the immunogenicity part. But I think from a clinician standpoint, patients who are not candidates for or are not great candidates for transplant are as follows. Of course, they have active infections, sepsis, which we hope this would have a lower risk for or if they get dysfunctional accesses that are high flow aneurysmal and the patients get heart failure, and that's really hard to come back from the transplant side.

So some of the fistulas, for example, we create -- become very high flow because they become aneurysmal and they cause pulmonary hypertension and heart flow. From the ultrasound data that we've seen from -- and the steel data that you saw today, the rate of steel was very low in the women who received day which indicates to me that this conduit is not dilating. It's not becoming anurysmal, which hopefully means better for the patient's heart and better for the transplant candidacy. So that's how I look at the patient and the access when we think about transplant candidates from a cardiopulmonary standpoint, which can be affected by the access. I'll let the Humacyte team talk about the immunosuppression part as well.

Yes. Yes. So unlike when putting in a PTFE graft, which is essentially plastic, the body does develop antibodies to it, and we have plasma reactive antibodies to it. Humacyte graft or Symvess does not have that issue. It's human cells. And it has shown 0 immune rejection or signs of clinical immunogenicity in terms of clinical reactions in over 1,200 patient years to date. So the more the antibodies, the greater is the chance of rejection in dialysis. So there is an advantage versus especially PTFE in terms of less immunogenicity with ATEV. And the second is about infections and less infection rate versus PTFE as was commented on before.

Our next question comes from Allison Bratzel at Piper Sandler.

Just actually 2 questions for the company on the regulatory path. So first, could you just talk to your FDA interactions that you've had on plans to file based on V007 and the V012 interim data? And just how will data from V006 be considered in the review? And then the second question is just based on your FDA interactions, does the agency need to see 24-month data from V012 to make an approval decision? Or just what was FDA feedback on the ability to file just on the 12-month versus 24-month data?

Yes. Great questions. We had a discussion with the FDA once 007 was over, and they were open to us filing with 007 data. But at the time, we had 12 ongoing, and we wanted to wait for results of 12 study, especially the interim analysis was around the corner. And so we have had ongoing dialogue with FDA. They are aware that we are very interested in filing a BLA. We have actually sent a letter to the FDA or it will be going in the next 24 hours, informing them that we have hit our primary endpoint for the interim analysis and that we will be engaging in a discussion with them on how the BLA would look like and what data would look like.

So that's the discussion we would have planned with the FDA. Regarding your point about how we're going to use the data from V007 and V006, V006 gives us 5-year durability data because we did continue that study for 5 years in ATEV patients. And we are going to look at the women's subset and patients at high risk of maturation failure like obesity and diabetes from that group and show to the FDA the durability of our product over 5 years.

We're going to use the 2 years data from V007, which we briefly showed earlier in the presentation today. And with that, we're going to show the 1-year analysis of this V012 study. It's up to the FDA. I mean they can always request more data, but we will also have ongoing data that we will share with the FDA during the file review. So there is something called day 120 safety update, which allows us another opportunity to give them a more recent look of the data, which will also have more follow-up data in week 12 of the first 80 patients.

So I think we have a strong package, if you will, clinical package. I think we are the most tested product ever in AV access before being approved, quite honestly. And I think we feel confident of the clinical -- both the clinical package, the clinical arguments and the benefit risk of our product versus the other competitors we had in our trial. So I hope that answers your question.

Great. Thank you for the questions, Allison. So this concludes our Q&A session for today. I'll turn it back to Laura for some quick closing remarks before we wrap up.

Well, again, I want to really thank the audience and the analysts for providing thoughtful and insightful questions. This is an exciting time for Humacyte. And I agree with Dr. Parikh. This is the most studied conduit in dialysis access prior to approval ever. And we have a lot of Level A evidence, very high-quality evidence, which we will compile into the FDA file that we submit later this year. We also expect additional publications to be forthcoming later this year to really fill out the clinical story.

So my goal is to provide better hemodialysis access for kidney patients who are a very ill population with a lot of comorbidities, and they suffer a lot of hospitalizations and complications, particularly referable to their access. And my hope is that we will be able to decrease some of that patient morbidity and misery by providing a functional access that has few complications and low infections and that works well, particularly for our most vulnerable dialysis patients. And with that, we'll close it up. Thank you so much.

Good morning, ladies and gentlemen, and welcome to the Humacyte First Quarter 2026 Earnings Conference Call. [Operator Instructions] 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 and 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 onetime 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, which is -- 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.

[Operator Instructions] First question is from the line of Matt Miksic with Barclays.

So I wanted to ask about the commercial efforts that you're putting in place to sort of drive greater adoption in the, I guess, 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. And 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. And 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.

We've -- I think 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 have -- 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.

So we think we've really targeted the correct team. And now we have to change the way we engage with surgeons. And 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. I mean we're certainly working. We've still got, I think, 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. And we're certainly not happy with the number of hospitals where we are on the shelf. But what's become clear is that just getting it on the shelf, but then not providing additional surgeon support and education and sort of letting them see the value of the product for its approved indications, not just now but in the future. 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.

And 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 how -- what you've taken from that or how investors should expect the eventual introduction into the dialysis indication to be -- or 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. And in many cases, not all, but in many cases, our product was able to reconstruct their vasculature. And so 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 dealing with -- or 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 on Wednesday mornings or what have you. And so the awareness of the product translates directly over there. In fact, 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 because the -- particularly the problem of dialysis access in women, which 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, but -- and you don't want to put a catheter in. Those are really recalcitrant difficult problems that dialysis surgeons are really hoping to get a better answer for.

So 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. Well, we're talking about 30 or more sites. And so it's a little bit to sort of have a blanket. It's a little difficult to have a blanket response, but I'll try. In most of the sites that are using, in the last quarter, what we've seen is examples of -- because as with any new technology or device, typically, there's one surgeon that's using at the site 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, 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 confidence, growing confidence at these individual hospitals.

But I think what we're also seeing is that we have product on the shelf in some institutions. But I think because of insufficient support, the product isn't getting pulled. And so that's really sort of a missed opportunity for us that I think our behavior as a 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.

Yes. Thank you. That's a good set of questions. So again, I just want to preface with the fact that I never know what the FDA is going to do. I would never sit here and tell you what I think the FDA is going to do. I can only tell you what I anticipate and what I hope will happen. So 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, if we have a clear superiority over standard of care, which is fistula, then it's probably not even ethical to continue the study.

So if we hit our endpoint, the study stops. At which point, we will analyze data on all of the patients that have been enrolled and followed up. And that will be the lead -- the V012 study will be the lead clinical file that will go into the BLA. But the BLA will be supplemented with our prior V007 study, which also compared our vessel to fistula in catheter-dependent patients. Only the V007 study was in both men and women. And so these -- if both studies are positive since the last study was positive, then these are 2 positive prospective randomized head-to-head studies done in the United States that would show superiority of Symvess or our ATEV to the standard of care.

So even with all of the FDA turmoil, which continues day after day, still the most conservative stance by the Center for Biologics has been that they like to see 2 prospective randomized head-to-head trials showing similar outcomes, which I believe if our outcomes in V012 are positive, I think that's what we'll have. In addition, the -- because it's the same product as what is already approved in trauma, there are parts of the BLA application like the manufacturing pieces and the preclinical and the safety and toxicity and what have you, all of that is essentially the same from 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, say, I'm making this up, I'm making this up. But if we were to submit in November, then they would have 2 months to accept the file, which would put us in January. We would ask for -- because we have an RMAT designation, we would ask for an accelerated review, which would be a 6-month review, which would put us in July of 2027. We may or may not get 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. I mean, clearly, there's a severance period, which comes in. And obviously, when you take these measures, for example, in May, there's costs that have already been incurred. But for the second half of 2026, you could expect that the $14.3 million in savings that's estimated 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 thanks for that, Josh. So in terms of the Fresenius contribution, they have certainly -- we've certainly worked with multiple Fresenius sites because some of the key data in this clinical trial is how dialysis patients are doing, whether or not they have a -- they're dependent on catheter or whether the dialysis center is able to take the catheter out. And so we've had to partner pretty closely with a lot of Fresenius centers where a lot of our patients are being treated to collect that data. And so they've certainly been part of this process. I would not say they're part of the BLA filing. That's really held entirely by Humacyte, but they've certainly been supportive partners in gathering the data for this indication.

As far as recent discussions with the FDA, we have not had recent discussions -- on dialysis access, we had discussions with them regarding our plan for executing on the V012 trial. And if that was positive, we let them know that we would plan to file a supplemental BLA. But we had that meeting about 12, 18 months ago. Certainly, we are looking at preparing an application for a pre-BLA meeting should these results be positive. At the pre-BLA meeting, we would then really lay out our top line results and our strategy for filing, and we get a little bit more clarity there.

I will say that despite all of the turnover at the FDA, which continues, as we know, the clinical review team in the Center for Biologics, which has reviewed our trauma application and which also will review our dialysis application has remained relatively intact. We had a meeting with the -- 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 do believe there will be some continuity there, which is good for us.

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? Appreciate you taking the time.

Yes. So we have -- our Executive VP of Strategy, who used to work in federal government for 20 years in procurement has really been spearheading this effort. This is a collaborative effort between Humacyte, the Department of Defense and several surgeons at different military treatment facilities or MTFs. It's difficult for me to give precise timing. 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. But as with the FDA, it's very difficult for me to sit here and predict 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?

Dale, do you want to take that?

Yes, absolutely. So clearly, the reacquisition of our ex-U.S. rights due to the -- as a result of the amendment of 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. So that's just an area that for a variety of reasons, in part due to the current conflict and in part due to some longer-term interest we've had from that region. We continue to push that forward extensively.

As you infer, we also have the ability now to pursue European or other major region ex U.S. partners, including Japan or Europe and 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. And 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. And 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, thank you for that, although I'm still getting used to the whole StoneX thing. So -- but forgive me, anyway, yes, absolutely. So as you mentioned and as we are well aware, CMS has instituted a payment system whereby dialysis clinics who maintain large numbers of patients on catheters actually suffer in terms of their reimbursement. And so dialysis centers for reasons of patient care, but now also for reasons of reimbursement, are eager to get patients off of catheter.

And for women in particular, as we know, if you look at the USRDS, nearly 1 in 3 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. And so this is a hard number to get unstuck because there have been no other alternatives, particularly for women in decades. So we believe that, that is going to be the sweet spot for patient care and patient outcomes and also for reimbursement for dialysis centers. If we can target women who are remaining on catheter and suffering all those complications and all that 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. And patients who are on catheter who then get a fistula, but the fistula fails, the cost of that patient in the first year is $45,000 because of all the return trips to the operating room and rehospitalization. So remaining on catheter is expensive. Trying to get off catheter and failing is even more expensive. So we believe that Symvess may offer an alternative that will reliably work in women that won't fail to mature and that will have a low infection rate. And so that, I think, could represent a real benefit for this population.

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

Well, I'd like to thank the analysts for their thoughtful and insightful questions this morning and also to the audience for listening to us. We've had -- we have had a tremendous number of developments and Humacyte, I would say, is firing on all cylinders to both expand our current commercial footprint in the U.S. and worldwide, but also to take advantage of the huge number of opportunities that this platform technology is affording us.

I am impressed and grateful to the people at Humacyte who have been so incredibly productive and have accomplished so much over these past several years. And I'm very excited about what the rest of 2026 is going to bring. And 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.

Good morning, and welcome to the Humacyte Virtual Webinar. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Humacyte website following the conclusion of the event.

I'd like to turn the call over to Dr. Laura E. Niklason, Founder, President and Chief Executive Officer of Humacyte. Please go ahead, Laura.

Thank you, Tara, and welcome, everyone, to Humacyte's virtual webinar describing the current unmet needs in dialysis access for patients who have kidney failure. As many of you know, we have been engaged in a Phase III program looking at the safety and the efficacy of Humacyte's Acellular Tissue Engineered Vessel or ATEV, in its function as an access for hemodialysis and specifically comparing this access to patients who receive the current gold standard, which is fistula. Next slide, please.

These are just our disclaimers. Next slide. As you'll see from this program, you're going to hear from 2 important key opinion leaders discussing about the current unmet medical need and the current shortcomings of hemodialysis access and how Humacyte's ATEV may be able to benefit some patients.

The first speaker will be Dr. Prabir Roy-Chaudhury, who is the Co-Director of the UNC Kidney Center and who is an eminent Professor of Nephrology at University of North Carolina. Importantly, Dr. Roy-Chaudhury is also the immediate past President of the American Society of Nephrology and has a broad view on the current challenges that are presented to many dialysis patients in the United States.

After that, you'll hear from Dr. Mohamad Hussain. He's an associate professor, I believe, at the Brigham Women's Hospital in Boston, and he is a Vascular and an Endovascular Surgeon and has participated in several of Humacyte's clinical trials studying the safety and efficacy of ATEV compared to fistula in patients with kidney failure.

After the presentation from these 2 speakers, you'll then hear from our Chief Medical Officer, Dr. Shamik Parikh, who will give you a little preview of the current Phase III trial that we're running comparing the ATEV to fistula, particularly in women who suffer kidney failure and who are on hemodialysis. After that, we'll have time for questions. And with that, I'm going to turn it over to Dr. Roy-Chaudhury.

Great. Thanks so much. So I'm going to start off by saying that I'm a nephrologist, as Laura said, which means that for the last 25 years of my professional life, I have taken care of patients on hemodialysis.

My charge, as I see it over the next 10 to 15 minutes is to speak to you about the why, why we need the ATEV, why we need to do better as a kidney community and why I believe that the ATEV could actually make a difference in the quality of lives of hemodialysis patients.

So with that, let's talk a little bit about vascular access. There are 3 -- so we have 550,000 patients currently in the United States who are on dialysis. And if you're on dialysis, I should say, hemodialysis, you need to have some form of dialysis vascular access, so that the nurses and the physicians get access to the blood purified in the machine and pumped back in.

So the vascular access is truly lifeline for these 0.5 million-plus patients on hemodialysis. But it is also unfortunately, Achilles' heel of hemodialysis. And this slide tells you why, 3 main forms of dialysis vascular access, the arteriovenous fistula, the tunneled dialysis catheter and then synthetic grafts.

The gold standard, although it isn't really a gold standard at the moment, is the arteriovenous fistula. Commonly, in 2025, if you place 100 or if Dr. Hussain, I should say, 100 new arteriovenous fistulae in dialysis patients, about 45 of them actually function without a problem.

Dr. Roy-Chaudhury, I'm so sorry to interrupt. But at least for me, the audio is a little choppy. I'm wondering if you can go off camera and that we help the bandwidth.

Okay. My apologies. How about now? Is that better?

It's better.

My apologies. Okay. So if we were saying that if Dr. Hussain puts in 100 arteriovenous fistulae, nearly about 40 will actually function without a problem, which I think is actually concerning in 2025 for a vascular access procedure.

And remember, gold standard, although it's actually been unchanged, if you will, for the last 50 years. Now the problem that happens when a fistula doesn't mature, is that in our current process of care, 80% of new hemodialysis patients actually start with a tunneled dialysis catheter and we then place fistula, which means that it's going -- that if the fistula does mature quickly or which means fistula fails, you're going to have a long time you're going to have a long time of contact -- pardon -- with your catheter.

You're going to have a prolonged catheter contact time. And to me, that is one of the worst things that can happen in the world because if you have a prolonged catheter contact time, you have the complications of catheters, infection, thrombosis, central vein stenosis, but most importantly, I would say, infection, infection, infection, which results in ICU admissions, hospitalizations and a huge increase in cost, which is why, particularly in older patients, if you dialyze them for a year with a dialysis catheter, the cost is almost $100,000 a year.

If you can dialyze that same patient through fistula, then that is down to about $120,000 in older patients. So huge savings. And these savings, again, in my mind, particularly through the work that we've done in the American Society of Nephrology, could actually be very, very important in global payment systems, such as the comprehensive kidney care contracting models and other such patients, where you reduce upfront initial costs, you're actually -- you are going to end up with a significant cost savings.

So let's move on a little bit more in detail. Who are the people who actually end up with a catheter and who are the people who actually have complications? So this is data from the United States renal data.

And what it shows is that if you treat 100 patients starting dialysis with a tunneled dialysis catheter, and remember, I said earlier that if you have 100 patients starting dialysis, 80 of them will start with a catheter. So this is the vast majority of patients start with a catheter -- sorry, I beg your pardon, so which means that the vast majority of patients starting with hemodialysis catheter.

So even out at 6 months, if you're a male, 50% of patients still have a catheter. But if you are a woman, that is actually a lot more. You have 54% and that number continues to be high as you go down to 9 and to 12 months.

So the next question, of course is, why do women have an increased incidence of catheters? And the answer comes back to the fact that women are the phenotype where your arteriovenous fistula is actually not sufficient to mature well. And the reason for that is that these fistulae, these connections between the arteries and veins actually fail because you have arteries and smaller women, of course, do have smaller arteries and smaller veins compared to men.

So if you think a bit further, what I've spoken about till now are the people or the patients who want hemodialysis. Out of 100 patients who've been on dialysis for a long period of time, you have more women in a catheter about 30% as compared to 24%.

So both for incident hemodialysis patients and for prevalent hemodialysis patients, you have more women on catheters, you have fewer women with a fistula, which is the goal standard of preventing complications and for reducing infections.

And then finally, if I go on to my penultimate slide, I believe, I just want to, as a physician say that catheters are in a way evil. I think catheters are often described as the white tube of death. I just want to emphasize that, yes, you can say that they cause infection, thrombosis and central venous access dysfunction.

You can say that they costs a lot of money. But I would say that most importantly, catheters destroy the quality of life of our patients. So in summary, what I want to emphasize is that 80% of our dialysis patients start with a catheter.

When arteriovenous fistula are placed, it takes many months for the fistula to work. And the people, the patients who suffer the brunt more than anything else of failed fistulae or fistulae that failed mature are actually women, which results, as you can see on this slide, in a higher morbidity and all the in terms of infection, stenosis and thrombosis that I spoke about.

And that's why I'm so excited the potential of the ATEV to be placed in women instead of an AV fistula, so that we can target all of these complications and problems. I want to end just as I started, [indiscernible] clinical nephrologist.

And this is a patient story that is absolutely true. It was about 15 years ago, I do a lot of transplant work. And I remember seeing this 28-year-old black female, [indiscernible] tall and she came with her husband. They had just got married. She had end-stage kidney disease and she had a catheter in place.

And as a transplant nephrologist, I remember spending a lot talking to her that we can give you a normal life if we can get you to a transplant. You can work, you can have children. She was very positive about it because she had a living donor. But what I had not taken into consideration at that point in time is that she had a tunneled dialysis catheter and that she was a woman.

And that combination changed everything for the worst. The next time I saw her the Vascular Access Clinic, she was paraplegic, so she couldn't move her lower extremities and she was in a wheel chair. And what had happened was that she had, had a fistula placed, it didn't work. She had a prolonged duration of catheter exposure.

The catheter got infected. The bacteria from that infection seeded her heart valve and she had an embolus that went off to her spine that resulted in spinal cord compression. And the tragedy is that my 25 years experience as a nephrologist, these problems [indiscernible] the same.

And I'm going to end really -- I really hope that we can do better. And I do believe, depending on the results, of course, but I'm excited about Mohamad's presentation and Shamik's presentation that the aim is to actually allow us to improve our patients' quality of life at a reduced cost by reducing catheter time.

So with that, thank you for your attention, and I will hand over to you, Mohamad.

Good morning, everybody. Thank you so much. It's really a pleasure being here, and thank you, Dr. Roy-Chaudhury for setting that up so nicely. So I'm a vascular surgeon at the Brigham and Women's Hospital and Harvard Medical School in Boston.

I've had good experience using the ATEV as we've been participating in Humacyte's randomized controlled trials because like Dr. Chaudhury said, we feel that there's a big unmet need for these patients. So today, I'll specifically be talking to you about results from the V007 randomized controlled trial focusing on the female subgroup.

So as we heard, AV fistulas are generally the preferred initial access for hemodialysis according to our national guidelines. But there's a big problem. These fistulas do not mature well, especially for women with small blood vessels. ATEV is a promising alternative vascular access, as we've heard about, and it has shown durability and low infection risk, which is very important to me as a surgeon as well as for our patients.

So the analysis I'm presenting to you today is a 2-year outcome analysis from the V007 randomized controlled trial that compared ATEV with autologous AV fistulas in hemodialysis patients in the subgroup of women who are enrolled in this trial.

So here is the study design. This was a prospective multicenter randomized controlled trial across 31 centers in the U.S. with broad representation. 242 patients were enrolled in the trial. All of these patients had end-stage kidney disease. They were on hemodialysis with a tunnel catheter, and they were eligible for both an AV fistula creation or an AV graft creation.

And they were randomized 1:1 to receive either the ATEV or AV fistula. And all of these patients were followed for 2 years. The key inclusion criteria were as follows. So these were adults with ESKD on dialysis who were eligible for either AV fistula or AV graft and were expected to live longer than 2 years.

And the key exclusion criteria were that patients who were candidates for the perfect optimal fistula in the hand of distal 4 arm were excluded, which is not very women.

Patients with uncontrolled diabetes were also excluded. And importantly, patients who would need a 2-stage access were also excluded. And let me put that in context. Many patients, if they have small blood vessels, we often need to do 2 surgeries to give them a usable fistula, which could take several more months to mature and get ready for use.

Often, these are women and these particular high-risk subgroups were excluded who would otherwise get a fistula.

Here are the key primary endpoints. The primary endpoints was a combination of functional patency at 6 months, which was defined as 2 needle cannulation in the dialysis unit for 4 weeks and secondary patency at 12 months, which is a measure of durability.

Key secondary outcomes included duration of usability of the access over 1 year and 2 years as well as interventions over the first 2 years and safety outcomes included infection and other adverse events. This was a subgroup of patients in the overall trial. You can see mean age was around 57 to 60 in both groups and about 1/3 were over the age of 65, female subgroup, which we will focus on in the next slides, was about 30% in both groups.

About 40% were obese in the ATEV group and 35% were obese in the AV fistula group. 2/3 of the patients were diabetic, which is in line with our expectations. And you can see patients already had the catheters in for 3 to 4 months by the time they even enrolled in the study.

Here's the primary outcome in the overall trial, so all patients. You can see the trial was positive with functional patency 81% in ATEV and only 66% in AV fistula and secondary patency, 67% in ATEV and 62% in AV fistula.

And this is a number I'd like for you to remember the secondary patency as we move on to the women subgroup. Overall, the p-value was 0.009 with a joint relative patency of 1.17 in favor of ATEV over AV fistula for all patients in the trial.

But this benefit of ATEV was really amplified in the women subgroup. So you can see the functional patency women was 89% for the ATEV group and 54% in the AV fistula group. And the secondary patency was also now dramatically different, 81% in the ATEV group and 48% in the AV fistula group with a p-value of less than 0.0001 or joint relative patency of 1.65 or 65% improvement in outcomes in the female subgroup with ATEV compared with AV fistulas.

There was a larger ATEV benefit for females with respect to usability of the access over the first 2 years. So you can see the first bar graph represents all randomized patients. Purple is AV fistula and dark blue is ATEV. You can see AV fistula was used about 12 months of the first 2 years, whereas ATEV was used about 13 months from the first 2 years. But the difference was significant when you look at that female subgroup.

So in the female subgroup, because of high-risk anatomy and patients, AV fistula was only used about 10 months, whereas ATEV was used about 15 months with a p-value of 0.0137, a significant difference. Patients who received the ATEV also matured earlier at a higher rate. So the first graph on the left shows median time to maturation.

And you can see in all randomized patients, fistulas take about 3 to 4 months to mature, which is in line with our expectations, whereas ATEV can be used much quicker between 5 to 6 weeks. And again, the difference is amplified in the female subgroup. Females, it takes much longer for their fistulas to mature and the trial took about 4.5 months, whereas ATEV recipients, the access was usable within 5 to 6 weeks.

The maturation rate was also higher in the ATEV group. All randomized patients, about 69% used their fistula that matured, whereas this number was 84% in the ATEV group. And when you look at the female subgroup, again, the difference is amplified with only 55% of females who received fistulas had their fistula matured, whereas the ATEV was 94%.

Here's a look at the safety outcomes over 24 months, and there's a lot of numbers here, but I'll break this down for you. One of the most important things to me as a surgeon and again, for the patients is infection, especially when it comes to testing new tech conduits and new technology in patients.

And importantly, graft infections were 0 in the ATEV group and 0 in the AV fistula group, which is very reassuring and very exciting that this infection rate is very low, similar to AV fistulas in the ATEV group.

The rates of thrombosis, stenosis and pseudoaneurysm were higher with ATEV as they generally are with non-autogenous conduits. Aneurysms and Steal Syndromes were very low in both groups, either 0 or 1. And the second very important thing, again, to me as a surgeon and for patients is the rate of rupture when testing these conduits in patients. And the rate of rupture was 0 in the ATEV group.

And this is important because you can imagine these patients have their access cannulated with 2 needles 3 times a week. for years. So it was very reassuring to see despite all that cannulation and ayogenic trauma that we purposely caused, there were 0 rates of rupture in the ATEV group. AV fistula, there was only 1 rupture.

Now of the thrombosis that did occur in the ATEV group, the vast majority were successfully treated. You can see 83% of females who had a thrombotic event was successfully treated with standard vascular techniques.

So in summary, in this clinical trial, ATEV outperformed AV fistula in patients who were female and had ESKD. There was superior 6-month functional patency, which is usability as well as durability, which is 12-month secondary patency. In addition, we observed longer duration of successful dialysis over the first 2 years in the female patients who received ATEV.

When we look at the safety profile in the trial, there were no infections in the ATEV and AV fistula group. There were fewer maturation and surgical revision procedures required with ATEV compared with AV fistula, but higher rates of thrombosis and stenosis with ATEV, which were successfully treated with most endovascular or open surgical techniques.

The key takeaways for ATEV in this trial, it demonstrated meaningful improvements in usability and durability. The access use was faster and more reliable, particularly in the high-risk groups such as females. And there was anticipated decreased prolonged exposure to catheter dependence. Thank you. And I'll turn it over to Dr. Parikh for his slides.

Thank you, Dr. Hussain. Thank you, Dr. Prabir Roy-Chaudhury. I'm going to talk to you a little bit about our V012 study. This is a Phase III study, and I'll introduce this study to you.

As you have heard from our experts, the reason for doing this study should be quite clear. And it is our way of calling to action and shifting the paradigm by testing if deploying the right access, in this case, the ATEV for the first time in the right patient, in this case, women, helps them in terms of a durable AV access and decreasing catheter exposure.

We want to see if this helps shift the fistula first ideology to a more individualized life plan for choosing the correct AV access for the right patient. And in this study, we directly will be testing the catheter dependence because we believe that women are, as you have heard, at a higher risk of catheter dependence, and this is a fixable problem.

So V012 study is ATEV versus AVF in women with end-stage kidney disease. It is a prospective randomized multicenter study with over 25 centers within the United States enrolling patients. It's a 1:1 randomization. The clinical trial started in 2023.

The goal was to randomize 150 patients, of which we have randomized 126 patients. The key inclusion criteria was women with end-stage kidney disease requiring hemodialysis on a dialysis catheter and requiring an AV access and then being randomized to either ATEV or AVF. This is an inclusive study. We are allowing patients who might be candidates for even 2-stage AVF to enroll and the study is stratified based on whether they get an upper arm access or a 4-arm access and also based on whether it's a 1-stage or 2-stage AVF patient in the opinion of the investigator to balance the 2 treatment arms.

The endpoints we are directly testing is the freedom from catheter over 12 months, catheter-free days over a 12-month period, which is a way of testing the durability of the AV access that they get. The primary safety endpoint would be infections through 12 months post implant. And we have a number of secondary endpoints for efficacy and safety, including testing the patency and durability as well as other safety endpoints that Dr. Hussain just went over in the V007 study.

This is a protocol that we have discussed in great detail with the FDA. And the protocol is designed with an interim analysis when the first 80 patients complete 1 year of treatment, we are able to pause and analyze the data. We have reached that milestone recently where the first 80 patients have completed 1 year of analysis.

Our clinical research organization is now cleaning the data. We'll be sending this data -- once cleaned, we'll be sending it to the independent adjudication committee who will adjudicate for our key endpoints like catheter-free days, patency, infections and abandonment of the access.

We currently expect results in the second week of June, and we do have plans to present the results at the SVS meeting. This is the Vascular Access meeting in Boston this year on June 11 at a Women's Forum section.

So if we have results earlier, we'll be announcing them earlier, of course, but we do plan on presenting the results at this SVS session. I think with that, I would like to end the formal presentation and would like to see if there are any questions from the audience. Thank you so much.

[Operator Instructions] So our first question comes from Matt Miksic at Barclays.

Can you hear me now?

Yes, we can.

Great. I appreciate the update. Wondering if maybe you could talk about -- to both of you or all 3 of you, I guess, what do you think the process looks like for the clinical community and for centers to start to uptake these new devices and new approach for AV fistulas, assuming, obviously, data comes through, the product is available, what does that process look like? If you could lay that out for us?

Dr. Hussain or Dr. Prabir Roy-Chaudhury?

Yes. I can speak to the surgeons part and then maybe others can comment on sort of the process part. I think from a surgeon's point of view, there's not much difference in terms of -- we are already used to creating accesses with prosthetic conduit.

So the technical aspects of the ATEV really are not that unique to a surgeon's usual skill. Usually, an initial conversation to go over any nuances or questions I found and have had a chance to speak with other surgeons in the trial is adequate for them to be comfortable using the access and describing it to their patients.

I think there might be some additional nuances from the patient or the DOS unit point of view. Maybe Dr. Roy-Chaudhury have some comments on that.

Yes. No. Thank you, Mohamad. I just want to make sure that you can hear me and see me because I know there were some problems with my audio.

Yes.

You sound much better.

Okay. I'm sorry. All right. So yes. So from a nephrologist and I would say, larger kidney community point of view, the most important thing clinically is trying to get rid of the catheters.

And both Mohamad and I sort of spoke about at a morbidity level, at a mortality level and at a quality of life level, the huge impact that prolonged catheter contact time has on our patients. Now that vision or that mission has really, I think, translated into our organizational system.

So every month as a medical director, you get a print out of the percentage of your patients that are on a fistula on a graft and a catheter. And the one that we focus on is the catheter, and we focus on that. We focus on trying to reduce the numbers of catheters.

And we focus on that because of all the negatives that we've spoken about, but we also focus on that because catheter prevalence is a metric that is increasingly being linked to payment, both in prevalent patients and also in incident patients.

So to me, what excited me most about Mohamad's presentation and about what Shamik said was that the endpoints that the study is looking at are catheter-free days. And I just cannot emphasize how important that is to the kidney community in terms of quality of life, complications and payment. Shamik, do you want to -- or Laura, do you want to talk?

Yes. I just want to add one thing. We've already seen the analysis of the V007 study. Dr. Hussain presented it. That's one clinical trial in women subgroup. This would be the second clinical trial that we are doing exclusively in women.

So we do anticipate that the 2 clinical trials, we will -- showing good results should have an impact on clinical guidelines because it's very much data-driven. And so we do expect guidelines, which are already talking about individualized access options to look for different access options and to choose the right access option for the right patients. So that's another thing that we should be able to achieve, I hope.

Great. Could I ask just one follow-up, if I could, on just the -- it's great -- the metric that you've described is important. And obviously, the clinical benefit is exciting for these patients.

Is there anything from a purchasing or a cost adoption that you anticipate will meet some resistance? Or do you think that the benefit to the center in terms of improving outcomes, improving metrics is a sufficient motivation to begin adoption generally?

I think Dale or Laura probably is going to respond to this.

Yes, I can speak to this a little bit, but then I'd ask Dr. Roy-Chaudhury to also chip in. So certainly, for patients who are at high risk to be stuck on a catheter to remain on catheter for 6 or 12 or 18 months, we know that the costs associated with caring for those patients on an annual basis can be $200,000, $30,000, $40,000, $50,000 more than if the catheter were removed.

So just from a very simplistic cost analysis, the cost of keeping the catheter in even during the first year well exceeds the cost of placing an ATEV. So I think what these studies are designed to show is that for particular high-risk patients, women who have a very -- who, in some cases, have a very low chance of having their fistula mature, there are better clinical outcomes, but also savings to the system. Dr. Roy-Chaudhury may be able to speak about newer payment models that are being implemented now by Medicare.

Yes. Yes. No, thank you, Laura. Thank you, Shamik. So I'm going to start off by emphasizing one of the things that Shamik said, which is that the kidney community really is excited about moving towards a more individualized and more precision medicine-based approach to vascular access, and that's what our guidelines say.

I also want to say that the kidney community as a whole is moving because of the huge costs of care is moving towards a more global payment system. And one of the things that I personally, and I'm wearing my American Society of Nephrology hat here, I'm excited about is that the person who pretty much wrote the kidney executive order, Abe Sutton, is currently the Director of CMMI and the Deputy Administrator for CMS as a whole. And many organizations in the kidney space, including the American Society of Nephrology, and you can blame them actually for the bad connection because I'm sitting in their office in D.C., have really worked hard and have created connections and pathways to move towards a system where we reduce complications in patients.

And again, as Laura said, if you have a global payment system where you get a certain amount of money for taking care of, let's say, 5,000 dialysis patients. And if you can spend x amount of dollars upstream, ATEV, in order to save 3x dollars downstream, preventing the angioplasties when your fistula fails, preventing the ICU admissions, preventing all the things that happen to my patient, right?

That woman went through a $1 million admission between the time that I saw her with a catheter and when I saw her about 3 months later in the vascular access clinic. So I really do believe we're moving towards that sort of payment system.

And remember, end-stage kidney disease patients comprise 1% of the Medicare population, but they use up 7% of Medicare resources. And just recently, for the first time, and we're very proud of that, 4 people from the kidney community, including somebody from ASN testified before the Chairman of the House Ways and Means Committee. And that, I think, is a congressional testimony just about 2 weeks ago that I think is really important for the community.

Our next question comes from Izzy McMahon at BTIG.

So I just wanted to start out, as we think longer term about adoption of the ATEV in these populations, do you think it will primarily be within these high-risk populations that were highlighted today? Or could we see broader applicability across the dialysis population?

Could I take that, Laura and Shamik?

Yes, go ahead.

So absolutely, good question. We are always looking for new therapies that can initially target a high-risk population. But as the kidney community gets more experience with these new devices.

And in a way, it's not so new, as Mohamad said. This is like a graph that has been used for many, many years. I am very positive about this sort of device, in particular, sort of moving out into other patients.

And I think a key issue is going to be both the ease of placing the device and then how -- and then the ease of cannulation. And I don't see that any of those are different from normal standard of care. And I just want to emphasize again what Mohamad said in that there were very few infections.

And I think that, that's really key when compared to other therapies, so when compared to the standard of care, which is a graft. So I am really positive actually about the potential of this happening.

Yes. Let me just add a couple of points to this. As Dr. Hussain showed, ATEV worked well in across the patients. 07 was all comers, males and females. The mean duration use was actually slightly more in ATEV versus AVF in all patients.

A lot of significance came from the women's side and women represent 45% of the population. And then we look at other high-risk categories. We look at obese males or diabetic males or even elderly patients. Together, this comprises more than 2/3 of all patients who get dialysis. So the so-called high-risk group is the majority of dialysis population.

Yes. And if I could add one other thing, and maybe this is more of a philosophical or personal point. And that is that in many different areas, we are moving not only towards sort of individualization of care, but also trying to see whether women are different.

And to me, one of the things that is exciting is that this would really be the first intervention in the vascular access dialysis area that's actually targeting a very large minority of patients where there is actually a biological rationale for doing so, which is small arteries, small veins, poor fistula maturation, increased incidence of catheters.

And then at a disparity health equity level, there are -- there is a lot of evidence about the fact that women get short changed in that they are not assessed for fistulae rightly or wrongly.

and an intervention like this, I think, could actually have a big -- make a big difference in vulnerable populations, not just women, but women in deprived areas, in [indiscernible] areas, other situations.

No. I think it's a great question, and I'll add one more thought. We're only talking about access creation. But from a surgical perspective, there's a lot of patients who have dysfunctional accesses, whether fistulas or grafts. And they're high risk because maybe they've had a previous infection or a focal infection. maybe they are large and they have diabetes and all those risk factors.

So there is a whole population that the surgeon when they get comfortable using this vessel would definitely, I know I would, utilize this for revision or revising accesses that are dysfunctional. So I think that will be a natural progression of an additional area that surgeons would consider using this vessel.

That's all really helpful. And actually, Dr. Hussain, if I could follow up with you for one question here. You specifically called out the advantages of ATEV for the earlier usability relative to AVF. I was curious in your practice, how meaningful is the faster time accumulation in terms of both the quality of clinical outcomes, but also quality of life for the patients? And does this play a major factor in your decision-making on what to use for these patients?

Yes, that's a fantastic question. So I think we obviously want to minimize catheter time because of all the things we discussed with the catheter issues. But also, there's an element of what the patient wants.

We focus on the ESKD life plan, which is guiding our therapy that lines with patients' needs and wants. And there are patients who come to us and say, I want this thing out as quickly as possible.

And even though they may have a vein and he said, we can create a fistula, I'll take 2 surgeries in a few months, they'll be like, no, I just want this out. And in those particular patients, I think using a vessel that matures faster and usable quicker definitely is in line with their ESKD life plan.

So I do think the timing does play a large part. It's not the only factor, but it does play a large part in our conversations with the patients to see what's meaningful to them and what we achieve their best outcome consistent with their goals.

Our next question comes from RK at H.C. Wainwright.

Thank you, doctors, for spending the hour with us this morning and helping us understand the ATEV. I'm trying to -- I'm focusing just on a couple of slides from Dr. Hussain's presentation on the V007 study.

So if you're looking into the slide that talks about the safety outcomes over 24 months in the females, I know you called out the infections and rupture. But then when I look at this, there is stenosis and thrombosis also, which shows up at a higher number compared to the AVF.

My question is, was there anything specific about these patients, either smoking or some other therapies that they're on that's causing this increased number? And also, would you characterize that certain patients may not be real candidates for ATEV, especially when you have these issues?

Thank you. That's a great question. And maybe Shamik, you want to chime in after too. I think I'll answer it with 2 points.

One is, yes, it's a great question. Are there specific factors that are contributing to access thrombosis? And my initial response is the sample size was too low in the subgroup and probably with the larger V012 and combining the data, one could do some subgroup analysis to try to pick up any specific signals to see if there's any particular things that are unique to this population.

My second point would be that we know this thrombosis and stenosis is a common issue with any non-autologous access in a patient, whether it's PTFE that we've been around or other conduits. The most common area of stenosis happens at the venous connection. So the connection between the conduit and the vein, not with the artery, but the vein.

And that's because there's a change in high pressure to low pressure and there's more sheer stress and turbulent flow, and that's a common area of stenosis, which leads to thrombosis and leads to often intervention. So that is a problem that is present just like it has been present in other accesses.

But it was reassuring to see with standard minimally invasive techniques, which usually involves the day procedures where we do endovascular thrombectomy that the access is revived and the patients can carry on with their use.

So I don't think -- there's -- certainly, this has not solved the problem, which is present in non-vein conduits. But it's reassuring to see that even though the problem is present, it can be treated successfully with standard maneuvers. And sort of final point, are there particular patients that would not be candidates.

So there was a requirement to get in a trial that you have to get antiplatelet therapy. So if there are patients who are not candidates for any antiplatelet therapy because of certain medical history or contraindications, which we know reduces the rate of stenosis and thrombosis. I think those -- that particular population, which is probably not that much, is one to consider not implanting it.

I think the only thing I would add is that the V007 study went on for about 6 years and 4 of those years overlapped with COVID. And there was a major disruption, especially in hemodialysis access care during that period of time.

And simple things like antiplatelet treatment or even the training that we have been given to the staff was disrupted at that time for ATEV like not using balloon catheters and things. Those are not the issues we have in V012.

So it would be interesting to see how that incidence pans out in V012 study. And I think the results will help us understand better what is the difference between the 2 treatments when it comes to thrombosis and stenosis.

Yes. And if I could just very quickly add, I would say that in general, in the kidney community, getting rid of a catheter and preventing ICU admissions, multiple other complications in general terms, the need for an intervention, which, as Mohamad said, is almost always successful.

If I may, I can ask a quick second question. Just the following slide where you have shown, Dr. Hussain, that about 83% of these females when they experienced a thrombosis were taken care of successfully. So I'm thinking about the other 17%, which did not go through successfully.

So what is -- are there additional things that you as in the physician community can do so that you can increase this number so that you get more of these females back to using the ATEV?

I think that's a good question. And again, I think the sample sizes were low. So there's only very few patients in which it was not successful. But I think the key things to think about are as surgeons get more comfortable implanting it, surgeons get more comfortable, picking the right patient, making sure they're an antiplatelet therapy.

And I think also acknowledging that even if you're not successful in 17% with thrombectomy, there might be another option that was offered and maybe it was leveraged. For example, you can create now a new access around the vein that's developed and the artery that's developed with ATEV being there for several months.

So I think there's a lot to learn, and I think there is an opportunity to, yes, get that number from 83% hopefully to 100% at some point. That's what we want to do, to do better for our patients. But I think those things will learn as we get the new data from the women trial.

Our next question comes from Bruce Jackson at Benchmark.

I'd like to know a little bit more about how you think about the decision to use the ATEV. So do you feel there are clear patient selection criteria? Are they similar to the criteria for the clinical trial?

Do they -- do you need to have guidelines in order for physicians to start using the ATEV? And then where does it fit in the sequelae of like which different treatments you select? Could it potentially be the first thing you select? Dr. Hussain mentioned this about the timing could be a factor. So that's kind of generally what I'm trying to get my arms around here. Any one of you can start with that question, that would be great.

Sure. I'm happy to take that first. So I currently have a patient scheduled next week, which will be out of the clinical trial, but I'm doing an ATEV because she is a high-risk patient. She had an infection in the contralateral arm for a non-ATEV conduit that needed explantation.

And now she needs a new access in the other arm. And I'll be planting an ATEV because being a woman, already had a history of infection on the other side. So I think as a surgeon, when you start off, you really want to include people that were included in the trial because you want to see if you can produce consistent results with the trial.

So I would -- patients would not include if you had that perfect snuff box vein in the hand and that type of vein might do really well, especially in a patient who's a male and nondiabetic. But if I do have a patient like the one I described to you next week, a woman diabetic and has a high-risk features, I would definitely consider an ATEV because it performs well.

And I think surgeons, we would want to be consistent with the inclusion criteria for the trial starting off. But at the same time, people will use it for accesses that are dysfunctional and may need some revision and maybe it's a little -- have had an infection in the past, a large arm. So maturation will take a while.

So I think it will be a combination of using that objective inclusion criteria and a bit of clinical judgment to see the new and the revision access cases that I think will particularly benefit from this vessel.

Yes. I would just add, it's important to be holistic. It's important to look at the whole patient. And I think all of the things that Dr. Hussain spoke about come into play.

I do think that as there is more and more experience, the earlier question was about expanding indications potentially. But I think as we get more and more experience with the ATEV, I think we're going to find more patients who could benefit from them.

Okay. And then if I could do one more follow-up question. Dr. Roy-Chaudhury shared some data from the U.S. renal data system -- database. There's a subpopulation in there with grafts, 21%, I believe.

And I just wanted to know what kind of grafts are you using today? And how would you approach that particular subpopulation if you have the ATV available?

Yes. So the grafts that are generally being used today are standard PTFE grafts. We've used the same grafts, I think, for the last 40 years.

And what I am particularly looking forward to is data that shows that if you use the ATEV in a female population who almost by definition, are at high risk for problems with all sorts of vascular access, fistulae and grafts, if we find that the ATEV performs well, I think that is -- I think that's hard data that to me would be very, very important.

Great. Our next question comes from Charles Wallace at H.C. Wainwright .

So when comparing the V007 and the V012 study, the study populations are a little bit different and maybe potentially there's room for the ATEV gap to widen.

So I just wanted to maybe get a better understanding on how you think the benefit will be for the number of catheter days between the ATEV and the AV fistula patients compared from the V012 study to the V007 study.

No, I think it's a very good question. And I can go over one nuance that's important to me. So as I mentioned, in the V007 study, 2-stage fistulas were excluded. So many patients, they need 2 surgeries, one to prepare the vein, do a little connection.

And then a second surgery, usually about 2 to 3 months after when the vein has developed, matured and to bring it closer to the skin, either because it's too deep or it's not accessible because it's a basilic vein that's developed away and deep in the arm. So those patients were excluded from the first trial.

The second trial, the V012 is more pragmatic in that those are fistula patients. So those patients are included. And I think it's a more representation of the real world, like some high-risk patients will need 6 months and 2 surgeries to get the fistula usable.

So I think you'll be a more direct comparison between what's actually happening in the real world in women versus ATEV. And we don't know the results yet, but my anticipation is that the time to using an AV fistula in the control arm would be longer in the control arm in V012, but that's my hypothesis, and we'll see.

Yes. I think I would only add that V012 is a very inclusive study for women. In one way, it's study for women, but it's quite inclusive compared to V007.

And the thinking was, well, of course, it's good to have a big gap from a product perspective, but the thinking was more to see to conduct a very balanced clinical trial, which was in all its facets discussed with the FDA, and they were quite conservative in a number of instructions they provided, which we incorporated.

So our goal was to make sure that this truly represents the clinical population, especially in women and be inclusive and we'll look at both maturation time and eventual success rate as 2 big factors that can perhaps help differentiate and lower catheter dependence on ATEV versus AVF.

So it looks like that concludes our Q&A session. I'll turn it back over to Laura for quick closing remarks.

Well, I just want to give a huge shout out to our speakers and Dr. Parikh for really describing the landscape in kidney care, especially for women, patients with kidney failure who rely on hemodialysis in order to survive. This is a very complex population.

And it's a population that has seen very little genuine innovation, as our speakers said, for decades. So I personally am very excited to see the results that we've already generated in the Phase III trial. And I'm really excited to see what's going to come in June. So I appreciate all of your attention, and I appreciate all of the participants, and I wish you a nice day.

Good morning, ladies and gentlemen, and welcome to Humacyte Fourth Quarter and Full Year 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

Thank you, operator. Before we proceed with the call, I'd 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 in this call is contained in our periodic reports filed with the SEC.

Forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise these 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-K, which after filing may be accessed from the Investors 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 Development Officer. Dr. Niklason will provide a summary of the company's progress for the fourth quarter and in recent weeks, and Dale will review the financial results for the quarter and year ended December 31, 2025. I will now turn the call over to Dr. Niklason. Laura?

Thank you, Tom. Good morning, everyone, and thank you for joining us for our 2025 fourth quarter and year financial results and business update call. I'm pleased to report that our fourth quarter and recent weeks have been a productive period for Humacyte with continued execution of our commercial program for Symvess and the advancement of other bioengineered vessel programs. During today's call, I'll review progress across our commercial and development programs. Before turning the call over to Dale for a review of our financial results for the year. I'll begin with the commercial launch of Symvess. We continue to execute our U.S. market launch of Symvess.

And in parallel, we've taken major steps to expand the commercialization of the product into international markets. To date, there are a total of 27 VAC approvals for Symvess in the U.S. And furthermore, an additional 43 VAC committees are currently conducting their review process. Our rate of success with VAC submissions is roughly 70%, which is a good success rate. To date, 27 hospitals have ordered Symvess, with the majority of these hospitals placing reorders. Fourth quarter product sales were $0.4 million for the year -- for the quarter and $1.4 million for the year. We're pleased that the U.S. Defense Department has dedicated funding for evaluation and incorporation of new biologic vascular repair technologies. In appropriating the funding, the lawmakers demonstrated that they recognize and understand the need for human-derived bioengineered blood vessels to save life and limb in 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 wherever and whenever they need it. We look forward to working with leaders in our military and in the DoD to ensure that the American service personnel will have access to this groundbreaking technology. Internationally, interest in Symvess has been highlighted by 2 recent announcements. Earlier this month, we received a $1.475 million purchase commitment that will facilitate the clinical evaluation and outreach program in hospitals within the Kingdom of Saudi Arabia. The planned clinical evaluation program is going to be conducted in parallel with ongoing negotiations with a Kingdom-based entity for establishment of a joint venture and a license to commercialize Symvess within country.

Also in March, we submitted a marketing authorization application, or MAA, with the Israeli Ministry of Health for Symvess for arterial trauma repair. In response to surgeon requests, we're also pursuing a mechanism for making Symvess available in Israel on a hospital-by-hospital basis even in advance of MAA approval. Commercial adoption of Symvess was further supported by publication of several important papers, including long-term safety data from our V005 Phase II/III trial in the Journal of Vascular Surgery cases at Innovations and Techniques. These data were also presented last January by Dr. Michael Curi of the New Jersey Medical School at the Annual Winter Meeting of the Vascular and Endovascular Surgery Society.

Among those treated in the V005 study were 54 patients who underwent extremity vascular repair with Symvess, for whom treatment with autologous vein, which is the standard of care was not feasible. Within this patient population, once early complications from the traumatic injuries resolved, the rates of conduit infection, limb salvage and patient survival plateaued and remained relatively constant through the 3 years of follow-up.

Symvess maintained an infection free rate of 92.9% from months 3 to 36 with no infections after day 37. Limb salvage rates were 87.3% at 12 months and 82.5% at 24 months despite a severely injured trauma cohort. Long-term mechanical durability was also demonstrated during the V005 study with Symvess diameters maintained constant over 3 years of follow-up. And importantly, no deaths or amputations or mechanical failures were attributed to Symvess in this high-risk trauma population. There were no evidence of spontaneous ruptures or structural failures in any patient throughout the follow-up period. These outcomes point to the potential of Symvess to provide meaningful benefits for patients who are facing life or limb-threatening injury where autologous reconstruction is not an option.

In addition, durability data in the military trauma setting was highlighted in an October 2025 publication in Oxford Academics Military Medicine, which describes positive long-term results from a humanitarian program using Symvess to treat wartime vascular injuries in Ukraine. The publication reported on 17 trauma patients with wartime extremity injuries, who were treated with Symvess, and were followed for up to 18 months. These wartime patients were observed to have a high Symvess patency rate of 87.1% and also 100% limb salvage, showing the durability of Symvess in treatment of real-world combat injuries. Also in October, a new study comparing the clinical outcomes of Symvess to autologous vein in the treatment of extremity arterial trauma was published in the American Association for the Surgery of Trauma or the AAST, trauma surgery and open care -- and acute care open journal.

This study showed that in comparison to trauma registry pre-existing patients who were treated with autologous vein, the patients who were treated with Symvess experienced similar short-term outcomes for patency and limb salvage and infection. In fact, there were no significant differences for any of these outcomes between patients who were treated with Symvess and the prior registry patients who had been treated with autologous vein. I'll now turn to our program, which is our next priority, which is dialysis access. As we reported last quarter, positive 2-year results from the V007 Phase III trial of the ATEV in dialysis patients were presented at the American Society of Nephrology's Kidney Week.

The ATEV demonstrated superior duration of use over 24 months compared to the gold standard autogenous fistula, particularly in high need subgroups having historically poor outcomes with AV fistula procedures. In particular, women who received ATEV for dialysis access had approximately 6 additional months of usability of the access as compared to fistula. This is a dramatic and significantly longer duration of ATEV use over 2 years in female patients.

And this observation could greatly reduce the reliance on catheters for dialysis access for these patients. Catheters are a major cause of complications, morbidity and cost for dialysis patients, especially women in the U.S. were nearly 30% rely on catheters for dialysis. The complications from dialysis catheters result in excess costs of tens of thousands of dollars per year per patient. Indeed, the catheter use nationwide in the U.S. has been rising for both men and women since 2019. Women and men with obesity and diabetes make up more than half of the dialysis access market and are historically underserved by fistulas, which often fail to mature or become usable in these patients. It's been known for decades that women suffer lower rates of fistula maturation than men as evidenced by the fact that only 50% of women dialyzed with a fistula nationwide compared to more than 60% of men.

However, a chronic lack of better access options has limited progress for these high-risk and expensive patients. We believe that the efficacy and safety results in these high unmet need groups, combined with the approximately 50% failure rate of fistulas makes women and high-risk men a potentially important population for treatment with ATEV. We're nearing an exciting milestone, and we are currently working to complete a prespecified interim analysis of our ongoing V12 Phase III trial that is being conducted in women specifically. The V12 trial compares the ATEV to fistula for hemodialysis access in female patients. A total of 116 patients have been enrolled to date in the trial. The planned interim analysis will be conducted when the first 80 patients reach 1 year of follow-up and the top line interim results will be reported by early June 2026.

Subject to these interim results, our plan is to submit a supplemental BLA in the second half of 2026, which will include data from V012 and the V007 Phase III pivotal study to add dialysis, which is a major market as an indication for the ATEV. And finally, I'll briefly discuss one of our earlier stage programs that we're also very excited about. Our coronary tissue engineered vessel, or CTEV, for use in coronary artery bypass grafting. Positive results of a preclinical study evaluating the CTEV as a coronary artery bypass graft in a nonhuman primate model were published in September of 2025. In that study, the CTEV was observed to sustain blood flow recellularized with the animal cells and remodel to bring the diameter of the CTEV in line with the animals native coronary artery.

We're on track with our plan to advance CTEV into first-in-human use in coronary artery bypass grafting later in 2026. We submitted an investigational new drug application to the FDA for this indication late last year in the fourth quarter. To support this planned study, we initiated the first large-scale manufacturing of CTEV in our commercial scale manufacturing facility. We plan to commence the first-in-human Phase I/II study in coronary artery bypass in the second half of 2026 upon completion of manufacturing and clearance by the FDA. And with this, I'll turn it over to Dale.

Thank you, Laura. There was $0.5 million in revenue for the 3 months ended December 31, 2025, of which $0.4 million related to U.S. sales of 25 Symvess units. The remaining revenue resulted from a research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications. Revenue for the year ended December 31, 2025, was $2.0 million, of which $1.4 million related to U.S. sales of 61 Symvess units and the remainder resulted from the research collaboration. There was no revenue for either the 3 months or the year ended December 31, 2024. Cost of goods sold were $9.1 million and $9.7 million for the 3 months and the year ended December 31, 2025, respectively. Cost of sales for both periods included a reserve of $8.9 million to reduce inventory to its net realizable value as a consistent sales history has not yet been established, and we were required under financial accounting standards to essentially reduce inventory to the level equivalent to our 2025 historic sales.

Cost of sales also included overhead related to unused production capacity, which was recorded as an expense in the period incurred. There were no cost of goods sold for either the 3 months or the year ended December 31, 2024. Research and development expenses were $14.6 million for the 3 months ended December 31, 2025, compared to $20.7 million for the 3 months ended December 31, 2024, and were $69.3 million for the year ended December 31, 2025, compared to $88.6 million for the year ended December 31, 2024. The decrease reflects in part the transition from development activities to commercial operations following the FDA approval of Symvess in December 2024 including the current year allocation of manufacturing cost to inventory and cost of sales to offset in prior years were included within research and development expenses.

In addition, during 2025 clinical study costs decreased due to the completion or winding down of certain clinical programs, including the V005 study in trauma. Selling, general and administrative expenses were $7.6 million for the 3 months ended December 31, 2025 compared to $7.4 million for the 3 months ended December 31, 2024 and were $31.2 million for the year ended December 31, 2025, compared to $25.8 million for the year ended December 31, 2024. The increase in 2025 expenses compared to the prior year periods resulted primarily from the U.S. commercial launch of Symvess in the vascular trauma indication, including increased personnel expenses. Other net income for the 3 months ended December 31, 2025, was net income of $6.0 million compared to $7.1 million for the 3 months ended December 31, 2024, and other net income was $67.3 million for the year ended December 31, 2025, compared to other net expenses of $34.3 million for the year ended December 31, 2024.

The increase in other net income for the year ended December 31, 2025, primarily resulted from $98.2 million in noncash gains consisting of a $59.5 million fair market remeasurement of our contingent earn-out liability and a $38.8 million fair market remeasurement of derivative liabilities partially offset by a $22.3 million loss on extinguishment of debt. Net loss was $24.8 million for the 3 months ended December 31, 2025 compared to a net loss of $20.9 million for the 3 months ended December 31, 2024, and net loss was $40.8 million for the year ended December 31, 2025 compared to a net loss of $148.7 million for the year ended December 31, 2024. The increase in net loss for the 3 months ended December 31, 2025, primarily resulted from the inventory reserve, partially offset by a decrease in operating expenses. The decrease in net loss for the year ended December 31, 2025, resulted primarily from the increase in other net income and the decrease in operating expenses, partially offset by the inventory reserves.

We had cash and cash equivalents of $50.5 million as of December 31, 2025. Subsequent to December 31, 2025, we raised an additional $18.4 million in net proceeds from the registered direct offering of common stock and net proceeds of $4.6 million from the sale of common stock through our aftermarket facility. In December 2025, we entered into a credit facility with a fund of the Avenue Capital Group, providing up to $77.5 million in new financing. The credit agreement, which has a term of 4 years, includes an initial tranche of $40 million, which was fully funded at close and an additional 2 tranches of up to an aggregate of $37.5 million available to Humacyte, subject to the satisfaction of certain revenue regulatory and liquidity conditions. Proceeds from the initial $40 million tranche were used primarily to retire our existing debt facility.

Total net cash used was $44.4 million for the year ended December 31, 2025 compared to total net cash provided of $14.5 million for the year ended December 31, 2024. The increase in net cash used in 2025 resulted primarily from the 2025 debt extinguishment and an additional debt draw during 2024 that did not occur in 2025. With that, I will turn the call back over to Laura.

Thank you, Dale. And I think, as you can see, we've had a very busy and productive 2025 as well as early 2026. We are continuing to execute on our commercial activities, and we are continuing to expand into international markets. And also expand our pipeline, both clinically and preclinically. I think at this point, operator, we can take questions.

[Operator Instructions] Our first question is from Ryan Zimmerman with BTIG.

Certainly, a lot different directions to go on the questions here. But I guess I want to stick with trauma just because it is kind of the present day topic in terms of commercialization. So just, one, how are sites responding to the new pricing of Symvess. And then the second question, again, I appreciate that you're looking forward to dialysis access. But what do you expect? And what are your thoughts on the year ahead within trauma adoption? And any forward commentary? I know, again, it's still early to guide, but any forward commentary is appreciated.

Yes. It is too early to guide, Ryan. Thank you very much. But we have seen a positive response to the new price point of $17,000. This puts us in a price range that is not that different from other products that are used by vascular and aortic surgeons. Certainly some aortic stents and other reconstruction devices certainly can be upwards of $20,000. So this price point is $17,000 puts us in a good range. And in my personal communications with surgeons and also those of the surgical sales force. That's been a uniform commentary. So the result there has been a higher rate of VAC approvals, a higher percentage. So we're up above 70% now. And also, we're getting more usage and more repeat usage because surgeons are less hesitant to pull the product because it's "expensive." The time lines as far as VAC committees continue to be what they have been fairly long, 6 to 9 months, which is followed by contracting.

What I didn't mention is that we are beginning to engage with group purchasing organizations, GPOs, and working to get on contract with larger GPOs that cover many hospitals. If you get on contract with GPOs, then that doesn't eliminate the VAC process but it eliminates the subsequent contracting process that we've heretofore been doing with individual hospitals.

We also are working with several IDNs. We have VAC approvals and several integrated delivery networks or IDNs. So while we can't really guide for 2026, I do think that the price difference has made an important impact. The publication of long-term data has made an important impact and showing that our outcomes are similar to vein has also made an important impact with surgeons. So we're just going to continue growing.

Understood, Laura. And then as we look ahead to dialysis access, I think a lot of people will be focused on the interim top line results in 2Q. But once you get past that, maybe just talk to us about kind of the submission for BLA, for dialysis access. What do you -- what's on your list to check off? How are you de-risking that now? And as you think about kind of what you need to do to submit and subsequently get a clearance for dialysis access in the second half of this year?

Sure. Well, we've actually already got a team focused on this with a time line for all the document submissions. Again, what's helpful for us here is that the clinical data will be different in dialysis, but all of the preclinical and the toxicity in the CMC data will all be the same. It's already been submitted and reviewed and approved by the agency. We've had some submissions to update the CMC, but all of those have gone through. And we really have no sort of standing queries with the agency right now. So it will really be about the clinical package. So after we get the top line results, which based on V007, we anticipate will be positive. I don't know the results, but based on V007, if they're similar to the V007, they'll be positive. Then we will schedule a pre-BLA meeting with the agency and advise them as to the structure of the clinical data content in the BLA. We will also -- we have a priority designation in AV access. So we'll also ask for a 6-month review cycle once the BLA has been accepted by the agency and that usually takes about 2 months.

Our next question is from Jason Kolbert with D. Boral Capital.

Congratulations on all the progress. Laura, could you talk us through a little bit about how important the sales cycle is? And where I'm asking the question is it's in relation to SG&A. And what I'm wondering is if you were to spend -- put more resources and more aggressively built the sales force, will that more aggressively ramp the sales numbers? And where would you focus those efforts, what percentage would be domestic? What percentage would be international?

Right. So we're focusing in both places. And I would say we're looking at adding to the sales team, and I've communicated this to the market before. We're looking at adding to the sales team domestically. We already have added some medical affairs people. We're looking at adding salespeople to extend our reach to more metropolitan areas. But in addition, the Israeli and the Saudi commercialization efforts, we see those more as partnered. We have a putative partner for commercialization in Israel and also one in Saudi. I can't share names right now, but we have putative partners who are very excited about the product and the technology and getting it in country. So we would imagine that in terms of sort of additional G&A hires, there would probably be more educational hires, medical affairs hires, that would be deployed in those countries that we would support and provide but we anticipate that a lot of the sales would be -- sales personnel would be provided by our distributors in country.

Got you. That makes a lot of sense. And the other part of the question is once you're in an institution, they're kind of going through the learning curve, how long does it take for them to be really users and adopters. I mean, that process is at a year -- is it 18 months? Is it 6 months? From your experience, what are you seeing like at a given institution that you're really focused on?

Yes. Well, we've only been on the market for a year. So -- and in a lot of these places, we've been on the shelf for less than 6 months because of the VAC cycle. So it's hard for me to answer that question. But what I can say is that once it's on the shelf and pulled by a surgeon, they will tend to use it, watch the first patient for a little while, a month or two, and then they begin pulling it again. So it's just like any other new medical device or implantable technology, surgeons -- a new surgeon will typically want to watch the first patient and then reuse and that's what we've been seeing. We've really had no blowback as far as how the vessel is being used. I can tell you it's being used in extraordinarily difficult cases where things are challenging. And I can tell you that from reports I've heard from surgeons, we are absolutely saving limb and life. There is no question.

Yes, I think that's the title of my next note. Thank you so much. Look forward to more updates.

Our next question is from Ali Bratzel with Piper Sandler.

This is Peter Spanogiannopoulos on for Ali Bratzel from Piper Sandler. On the commercial front for Symvess, you noted that 27 hospitals have ordered to date with the majority reordering. Could you break down what proportion of Q4 sales came from newly onboarded accounts versus reorders? And within those reordering hospitals, are you seeing utilization expand beyond the initial champion surgeon to other trauma surgeons.

I'm sorry, I don't have the level of granularity to accurately answer the first part of your question, although we could come back to you, folks from our commercial team could come back to you for the answer with that. As far as growth to other surgeons beyond the initial sort of champion, we're definitely seeing that in some of our busier centers. And it's definitely a word-of-mouth type thing as it is with all new devices. In some centers, we have 3 and 4 surgeons using -- in the majority of centers, we probably still just have one surgeon using, but that's changing every week, every month.

Our next question is from Matt Miksic with Barclays.

Congrats Laura and Dale again on the really impressive progress on the clinical front and with some of the developments around sort of defense-oriented and Middle Eastern contracts. That's great. So on that front, I was wondering if you could talk a little bit about how some of those contracts we should expect to kind of fall into the revenue flow as soon as the sort of like lumpy orders or gradual orders or contracts to order and sort of we can see on revenues? How would you describe it?

The way we're working with, in particular, our Saudi partners, our commercialization partners over there. The initial orders will be chunky. So the $1.475 million order will be realized as a single order. The goal is to get quite a bit of product in-country and distributed to multiple leading academic medical centers in Saudi Arabia so that multiple surgeons can be trained and really understand the utility of the vessel. There's a tremendous amount of trauma in Saudi Arabia. It has more car accidents than any other country in the world. And in addition to that, there's also a large PAD market. So there's a tremendous opportunity for Symvess in Saudi.

And so the strategy with our partner is that in parallel with submitting for full approval with the Saudi FDA, we're also initiating this physician trialing period, not a clinical trial per se but a trial period. After approval, we would imagine further chunky orders because some medical acquisitions come from individual hospitals certainly in Saudi, but some also come directly from the Ministry of Health, and those can be larger chunky orders. And I don't know exactly how that's going to look at.

That's fair. That's very helpful. And then on VAC on sort of the hospital, where you are with VAC approvals and the 43 hospitals in kind of review process or accounts and review process. Are we getting to a point where I know you have a certain set of target hospitals in the U.S. from focusing on vascular trauma. Do you feel like we're getting to a plateau or maybe the opposite in terms of the pricing and the continued experience in clinical data starting to feel more like increasing momentum? How would you describe the -- where we are in that list of whatever, 100, 120 centers?

Yes. Thank you for that. No, it feels -- again, it feels it's lumpy for sure, but it feels like it's accelerating. We're getting more sort of spontaneous inbound calls from surgeons even before they have it on the shelf if they have VAC approval or even before they have VAC approval. The word is getting out in the surgical community. I mean some surgeons post on social media on their use of the vessel and they go back and forth with each other on their experiences. And so there's a lot of sort of organic word of mouth that's happening across medical centers, and that's driving enthusiasm for the product. So we're -- in terms of level 1 and level 2 trauma centers, I think that I don't know the exact number, but it's probably around 50 level 1 and level 2 trauma centers where we have VAC approvals. There's a total of 200 level 1s and 300 or 400 level 2s. So I still think that we're just I don't want to say we're scraping the surface, but we're still at the beginning. And the rate -- the excitement about the product and the rate of usage, I feel is increasing.

Our next question is from Swayampakula Ramakanth from H.C. Wainwright.

Laura and Dale, this is RK from H.C. Wainwright. A couple of quick questions from me. Regarding the DoD procurement that you're expecting, since I believe this particular funding got initiated sometime in February, early February. And as we know the budget here ends in September, do you have any insight into when some of this procurement could happen? Or do you think this could bleed into 2027 budget year or for 2027, is it a completely new application all over again?

Yes. No. So it's -- so I'll do my best to answer your question, RK. So we anticipate that this funding will be spent in calendar 2026. It may bleed over into fiscal 2027. But the funding is really designed to both procure Symvess, probably more than half of the funding is for military procurement. And then the balance, we've drafted a plan working with some leading surgeons in military treatment facilities in the U.S. who are currently soldiers in the military. And we've designed a plan where a little bit more than half of the funding is -- will be utilized for procurement and the balance will be utilized for training. So there's roughly 40 vascular surgeons in the U.S. military. And probably 4 or 5 of them have used Symvess in their patients. But that leaves a large number who still could remain to be trained in addition to trauma surgeons. So our -- we really designed this not just as procurement but also training and we're hoping to execute all of that during calendar 2026.

In addition, we are working with some of our congressional delegation looking at perhaps a larger procurement for the next fiscal year in the budget, but that's still a work in progress.

Regarding the VAC approvals, between Q3 announcement and now 2 additional VAC approvals came on board. I'm just trying to understand a couple of things. One, is the VAC approval time? Is the time got extended because of some of the holidays and stuff. And also, what's the conversion? Is the conversion getting better between VAC approval and procurement of the product itself?

So I do think -- I'm not exactly sure why the VAC approval slowed down. I don't think it represents anything fundamental. I think it was probably more to do with holidays and meeting cycles during the holidays, VACs tend to meet less often, and they often have a backlog of cases. So I don't see this as fundamental at all. The low number of additional approvals. In terms of the conversion from VAC approval to getting product on the shelf, I do think that the lower price point has really increased the rate of -- the speed of that. It's much easier to get on the shelf and negotiate the contract and get on the shelf after the VAC approval at the current price point.

So that -- in addition to improving the success rate in VAC, which is over 70% all told, it's also, I think, speeding getting product on the shelf. At the higher price point in the very early times, our VAC approval rate was less than 50%. So this has had a meaning -- the price shift has had a meaningful input in our ability to get product into hospitals.

One last question, if I may. Regarding the Saudi Arabia, opportunity. Do you -- can you maintain the $17,000 price point there? Or do you have to -- I mean, negotiate a price over in Saudi Arabia, and given the demand or the expected market over there, which is higher than here in the United States. Do you have to kind of come up with a certain formula for the pricing?

Yes. So we have not begun negotiating pricing with the Ministry of Health yet in Saudi. So I think it's a little too early for me to answer your question explicitly. I would say that our expected pricing is probably somewhat above the current U.S. pricing because of just the additional logistics of getting product in country going through the approval process, doing the distribution process. Right now, we do our own distribution. So we're going to have to be paying a distributor so I think that there will -- it certainly will not be less than $17,000. There will be some additional real-world costs that will be additive there. I don't want to know what the final number will be. But again, I strongly believe that our continued excellent data in trauma and the published data that we've seen in Phase II trials in PAD will mean that this is an important addition to the Saudi medical armamentarium. I mean amputation in Saudi is a big problem. Between trauma and PAD and diabetes, it's a big problem. So I think we can do a lot of good in-country.

Our final question is from Josh Jennings with TD Cowen.

It's John on for Josh. Certainly helpful commentary on the VAC approval process and response to pricing. Just revisiting the 4Q in your commentary on 2026, I certainly appreciate that it's too early to provide formal guidance or you're likely not to, but just any color you could provide on what may have caused the shortfall between Street expectations. And again, I think for the puts and takes around some of the revenue components in the year ahead, but do you feel the Street is accurately modeling directionally what the year will look like? And I just had 1 quick follow-up.

Yes. So again, it's hard for me to comment on what the Street is saying without giving projections, and so as you know, it's a little bit of a tight rope. But also, as you know, different analysts have come out with a broad range of expectations. The higher ones, I think, are probably not in line with reality. I think that like we -- if there's an analyst that says we're going to sell $30 million next year, I think that's probably not true. So I think our growth is going to be more gradual than that. But I think that we all -- the analysts learned a lot, and I think we learned a lot in this first year of commercial launch. We learned a lot about how to approach VACs better, how to approach the pricing better, how to approach surgeons better. So we are a much more effective commercial team now than we were 12 months ago. And some of those learnings are just hard to predict. I mean, that's probably not a satisfactory answer, but that's what I got.

No, that's very helpful. And then just following up on that, cash on the quarter came in essentially right in line with the pre-announcement, but just as you go through this commercialization process, do you see an opportunity to maybe reduce your cash burn rate? Probably too early to talk about maybe a steady-state growth profile, but what does cash burn look like in the quarters ahead?

Yes. Again, we're not going to give guidance on burn, but certainly, we're looking very closely at burn. We -- as you know, we did a reduction in force last year around May and that saved us a total of $50 million in projected burn for 2025 and for this year 2026. We're continuing to look at spend very, very closely. We understand that the biotech financing market has been challenging, and we understand that the growth ramp for sales is something that we're going to have to continue to work on. So we're definitely looking at the spend side.

In addition to that, we're also looking at business development opportunities. We've had a great deal of interest in our platform from preclinical to clinical. I think that's evidenced by the interest we're seeing internationally just for Symvess, but we're also seeing a great deal of interest on our other pipeline programs, which is why we made the announcement yesterday about adding a business development executive and that's to help field the inquiries and just we're getting across our platform in terms of licensing and partnering opportunities, which can help with nondilutive funding.

We have reached the end of our question-and-answer session. I would like to turn the conference back over to Laura for closing remarks.

Thank you, operator, and thank you for the analysts and all of the attendees on this call. Humacyte is continuing just an incredible journey. I am so proud to have brought this first-in-class unbelievably effective product into the surgical market. It is a thunder clap in vascular surgery. We are changing the way vascular surgery is practiced right now and we're going to continue to do so. And this is a very exciting time, and I'm very proud of our employees, and I'm very proud of our sales force, and we're just going to keep pushing ahead. So thank you very much for your time.

Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.

All right. Well, we are a couple of minutes into our time here. So we're going to have to talk fast, Laura.

Okay.

I am very pleased to have with us here at our conference Humacyte. Laura Niklason, Dr. Laura Niklason, Founder, President and Chief Executive Officer; and Dale Sander, CFO. So thank you for coming.

Just a quick snippet of history. I've told you before, I think we've met a long time ago in very early stages and I was fascinated by the technology and a lot of things happened from that meeting to like launching in the last year or 2. I feel like I've missed the hard part and showed up for the good part, the fun part, maybe. So but it's been fun to see this develop over the years. So with that sort of prelude, the launch last year into vascular trauma and the cadence being vascular trauma dialysis and CABG, I guess, around figures. There were some excitement out of that, success, obviously, clinical success of the product, but also some learnings and some course corrections during the year. So maybe just catch us up to what you've learned, what you've changed and how you're entering 2026.

Yes. So thank you, Matt, for the opportunity to do this. So 2025 was the first year you launch a first-in-class product into the market. There's always a lot of learnings. So what I would say we learned is that the process -- especially going through the VAC committees, the value analysis committees, takes a little bit more time than we had initially envisioned. So that's a learning. And I think that's a post COVID thing where hospitals and hospital systems are just a little bit more spend conscious than they were previously. I would say that we've also learned that our clinical and our health economic arguments, they carry the day. And so we have greater, I think, than a 70% VAC approval rating. So more than 70% of the time, they say, yes, it just takes time. So that's one learning that we had.

Another learning is that we did have to adjust the price. So our current ASP depending on the hospital and the specific indication, but it's around $17,000 to $20,000. Being under that $20,000 price point, we found has really helped with getting through the administrative processes and the hospitals and hospital systems. So that's the second learning. I would say the third learning is that we've really increased our focus on education both of surgeons and of hospitals because this is a first-in-class product, and there hasn't been a new vascular conduit introduced into the market in 30 or 40 years. So that means every single surgeon we talk to has never used a new conduit ever during his career.

So there's training and just sort of teaching and intellectual understanding. And so we've been growing our medical science liaison team, and we're looking at bringing on some senior surgical talent as well, which we're very excited about. And then I would say that lastly, what we have seen in terms of when the product is used is that it's used in patients who are very sick and who don't have a lot of options or who have no options. And surgeons by and large are having a good experience and surgeons who use it, use it again. And I am quite sure that we are saving life and limb. I'm quite sure.

That's excellent. So that's -- and just on the economics part on the pricing, the returns are clear, the cost of adverse events and reoperations and those costs are clear. I would say you're not the first company that's with the resources you have experts in bioengineered tissue implants, but maybe not fully staffed in the department of what are the health economics and what will CMS and hospitals exactly be willing to pay, especially not having another commercial product in the market with which you can -- as a conduit we're interacting with hospitals or any experience. So yes, it was an adjustment. But no, it was not. That's surprising that there's got to be something.

Yes. No, there's got to be something. And I think we've weathered that. And I think the team has come out, if anything, smarter and stronger, both our sales team and our medical education folks and we can feel the momentum. The sales people can feel the momentum. We're talking to GPOs now. I mean it's -- yes, it's exciting.

And to support that, you have a pretty strong set of cadence of clinical evidence. So maybe talk a little bit about what came through last year that you found was significant and that clinicians are responding to and maybe VAC committees -- and what's on deck for this year?

Right. So as far as publications in '25 that support sort of the trauma indication and the data there, we had multiple publications come out. The first was a value impact -- budget impact model that came out about a year ago in the Journal of Medical Economics, which showed that even at our higher price point, we still saved money for the trauma center by avoiding amputations and infections. We have some other papers, some data retrospective comparison papers that came out. We had a paper that came out that said in the trauma indication in vascular injury our outcomes, outcomes with our vessel in patients who don't have vein available for patient survival, amputation, infection what have you, our outcomes are actually pretty comparable to vein. They're not significantly different from similar patients who were treated with vein.

So to be the fallback for situations who don't have vein and to have outcomes that are similar to vein that's a great story to be able to tell surgeons. I would say in terms of data upcoming, as you mentioned and as I'm sure you know, we have a Phase III data -- Phase III trial that read out in dialysis access comparing our vessel to the gold standard, which is fistula that trial read out 1- and 2-year data were positive, and we're actually we're in the process of publishing that now. But we have a second trial in women looking again at our vessel compared to fistula and dialysis access. And we're going to get an interim read on that trial in just a couple of months. And if that's positive, then we expect to file a supplemental BLA later this year in dialysis.

Okay. And that will be, I guess, maybe the major catalyst for driving your commercial efforts in renal dialysis. But maybe talk a little bit about why the cohort of women, not that women aren't always important, but why is this particularly important for adoption and driving interest?

Well, as I mentioned, there hasn't been -- fundamentally, there hasn't been a new conduit introduced to vascular surgery or trauma surgery or dialysis in 30 to 40 years. And it's been known for decades that while the gold standard in dialysis access is fistula, if you're a man like Dale here with fairly large veins or you, that option works pretty well, but it's been known for decades that for women, it works poorly, and it fails almost half the time. And the reason nobody has addressed this is because there hasn't been another conduit option to solve the problem. So we think that's an important clinical message, and it's an important value message because, again, our value proposition is providing dialysis access for patients who have a hard time with fistula maturation. But by doing so, we also get the catheter out of the patient. And that saves dollars, it saves hospitalizations, it saves morbidity and mortality.

Okay, right. So maybe drawing an analogy to like medical devices have a history of starting in difficult-to-treat patients, these might be the difficult to treat anatomies of fistula. And maybe also talk a little bit about the difference in the commercial efforts in sort of vascular trauma and going hospital to hospital and network to network and working through that committees to what we should expect to be the process for hemodialysis centers in the U.S.

Dale, do you want to take that?

Yes, absolutely. So there's a lot of synergy in parallels. The vascular surgeons that we target in our trauma commercial launch in many cases, the same vascular surgeons that will be implanting either performing a fistula procedure or as an alternative implanting our product Symvess as an alternative to provide access and dialysis. So we are already educating the same population in many ways that we'll be targeting in dialysis. Differences with dialysis, it's an outpatient market. So for most patients won't be the DRG reimbursement methodology that we see in trauma. They'll be CMS reimbursed. We've started those discussions with CMS already. And the value proposition in terms of getting patients, particularly in these key subgroups like women off of catheters early, which is critical to reducing cost. We believe we'll be able to make a very strong argument that use of our product in these important subgroups will actually save the payer money in this instance, CMS.

Got it. And so in the time line for CMS, what does that look like for ahead of commercialization?

Well, as Dale said, we're actively engaging CMS right now. There are some discussions with them about the data that we have in hand and the health economic arguments that we have in hand now. Those discussions are going to continue through this year for sure. We're actually approaching CMS at exactly the right time in that we have data coming very soon, and we already have an approved indication. And so they have sort of intellectual platform from which to like view the product and then understand its potential impact. So again, if we file the supplemental BLA late in 2026, best case, we get approval mid-2027. We are anticipating that our engagement with CMS right now really helps the reimbursement, which we're aiming for a pass-through reimbursement at ASP plus 6%, that's the goal. We're hoping that, that reimbursement matches up with the approval date.

Okay. All right. And then the relationship -- our investment and relationship with Fresenius also kind of plays a role maybe describe, I guess, the largest owner of...

Yes. We greatly appreciate our relationship with Fresenius. Fresenius is the largest provider of renal care services in the world. And so we're certainly proud to have them as our #1 shareholder. They've been certainly supportive of the activities we've undertaken. And I think they, like us, believe that innovation in patient care in dialysis is critical, and we can provide that for important subgroups with our product Symvess.

Okay. And any -- sometimes these investments are arm's length. Sometimes they have a strategic or go-to-market element. What would you describe this one?

Yes, Fresenius is more than a shareholder. It's also a collaborator of ours. So within the United States, we have retained the rights to distribute Symvess. Outside the United States, particularly in Europe, Fresenius holds the right to distribute our vascular product Symvess in the first 3 indications, which are trauma, dialysis and PAD.

Okay. And then within the U.S., I guess, when you're discussing like uptake and contract negotiations, with these centers, Fresenius own centers essentially you're discussing them with Fresenius? Or is it going to be like a sort of call it a hunting license sometimes to go like you have freedom to roam in our centers, but it's up to them to work out how they're going to use your product.

Well, I think we're going to have to work out the details on that. I mean, obviously, Fresenius like us, would want to understand the outcomes, the clinical outcomes in the second study. We're also working alongside them and with them to really nail down what the cost savings -- the total cost of care savings might be in these patient population. My guess is that the strength of those 2 arguments might dictate how -- whether it's just a hunting license or whether it's a mandate or somewhere in the middle and we'll just have to see. But certainly, as Dale said, we appreciate Fresenius' input and collaboration and frankly, the data that they have at their fingertips in terms of clinical outcomes and cost of care is unrivaled anywhere in the world. And that really helps us formulate our arguments for the market and for CMS, et cetera.

And then that brings us to CABG, coronary artery, smaller conduit sort of slightly different dimensional design, but same technology. And that, I have to say, when we first met and whatever that was 10 years ago, it felt like, boy, that's like a medical device analyst, we know about CABG, right? We know about coronary indications and operations, so that sounds exciting. But it's really just kind of getting started. So maybe talk about the time line for that.

Right. So we have -- we've developed because, again, Humacyte's platform is a platform. We can make tissues in different shapes and sizes, and we don't have to redo all of our production machines to do that. We have to change the size and the shape of the plastic bags we work with. But it's a pretty easy lift. So yes, so we've tested a smaller caliber version of our vessel in large animals for a number of years for heart bypass and we've published some of that data. And we filed an IND late last year, and we're still trading data back and forth with the FDA.

But we anticipate that when we've sent them all the data that they're looking for, that we'll be able to start a Phase I/II trial in patients for heart bypass probably in the third quarter of this year. One of my favorite phrases on this is as in vascular surgery, where there hasn't been a new conduit in 30 to 40 years, I believe it's true, Matt, and maybe you can correct me, but I believe it's true that there hasn't -- since coronary artery bypass started in the 1960s, there hasn't been a prospective trial in heart bypass with a conduit ever.

Yes, I think that's right.

Not in the U.S. This work has always been done overseas because the data package was never strong enough to make it in the U.S. And so I'm very proud of that. I mean that really speaks to the quality of Humacyte's data and our platform and the regulatory oversight. And so yes, so this is very exciting.

Yes. No, I think so, too. And I would -- in the time that we have here, the short time in this session, there's no way I could do justice to sort of the platform that you put together, but it is kind of impressive the way these -- the way it works and as much as I understand it, not being tissue scientist. Maybe talk a little bit about -- and this is a little bigger picture, but I think it's exciting. As you mentioned, you can make lots of shapes and sizes. We're still kind of getting through vascular trauma. We're on the verge of dialysis and then coronary bypass. But what applications that you see for this tissue engineering platform?

Well, we're -- as Dale mentioned and as you may recall, we've done several Phase II trials in peripheral artery disease. We've treated probably more than 100 patients. Typically, we're treating patients who don't have vein of their own for revascularization and who have severe ischemia. They're facing potential limb loss. Our outcomes, which have been published at the Phase II level are pretty promising. Our rate of limb retention is pretty high. Again, not quite as good as vein, but pretty close, which is really saying something for patients who don't have vein.

So we've been in the process of trying to design a Phase III study partnering with the FDA on those discussions. And that continues to be sort of an active mental exercise that we're doing. Right now, in terms of our resources, we're focused on trauma, commercial execution. We're focused on dialysis, and we're focused on coronary. So in terms of monetary capital resources, we're not deploying a lot on PAD right now, but that's clearly the next place we go.

Okay. And then maybe in the time that we have left here, just the model, maybe talk a little bit about how we sort of see a lot of small medical device companies, which oftentimes are a better new version of an existing competitive product and there's a fair amount of investments, say, in the middle of the P&L to execute on that opportunity, which can take a long time to turn a corner. What's the shape of Humacyte over the next few years as the top line starts to grow, how much in that in sort of SG&A, training, field resources? Or does this become accounts are opened, accounts understand the value. They order and stock the product and they use the product, and there may be a little bit more leverage. I'm leading you with the question, but maybe describe the shape of the P&L.

Yes. I think each of the markets is a little different, but R&D costs have been winding down because we've -- 1.5 years ago, we had 3 Phase III trials underway, and now we have one that is -- we believe, is about to wind down when we have the interim analysis in the second quarter in dialysis. So certainly, clinical trial costs are coming down. We expect sales to continue to ramp in trauma. Now trauma is not the largest of the markets we're targeting, but it's still a meaningful market and one where there's a high unmet need and it's also an attractive market for the first launch because it's so concentrated. There's only about 200 Level 1 trauma centers in the United States. And so we've been able to reach it with a sales force of about 12 field reps currently, we believe to get adequate coverage of the market.

Beyond that, we think dialysis will be certainly very additive to revenues. It's a market that even by targeting meaningful subsets is probably at least 3x the size of the trauma market. So we think that will be very additive to revenue. There'll be somewhat of an expansion of the commercial team to bring on dialysis. But as I mentioned, in many instances, we're targeting the same surgeons that we're currently targeting in trauma, and we also believe that the relationship with Fresenius will help with them being our largest customer that will help when we launch in dialysis at least for that segment of the market, although we'll clearly be marketing to the entire dialysis market within the United States. So we expect R&D costs to continue to ramp down for some period of time, sales to increase SG&A to increase somewhat as we bring on dialysis in the second half of 2027.

Okay. Well, with that, we're at time. So we should probably call it. Thanks so much for joining us.

Thank you.

Thank you, Matt.

Good morning. We're getting towards the end of the morning, but -- or actually middle of the morning, sorry. I'm Josh Jennings from the TD Cowen Medical Research Medical Devices Research team, and we are excited to have executives from Humacyte in our midst, in our presence, multiyear participant.

Thank you guys for supporting the conference and especially this year, it's the -- we have CEO, President and Founder, Dr. Laura Niklason; and CFO, Dale Sanders, is here as well. But I'm going to hand it over to Laura to run through the Humacyte story and get us up to speed on an exciting regenerative medicine technology. Laura, thanks so much for coming again this year.

Thank you, Josh. Really appreciate the opportunity. I know this is a 30-minute slot. I'm going to try to keep this to 20 or 25 minutes in case there are questions. But there's a lot of really exciting stuff that has happened in the last year and that's upcoming in the next year. I'm really excited to talk about that.

So for those who are not familiar with the Humacyte story, this is an engineered tissue platform where we use normal human cells to create functional implantable human tissues at commercial scale. The way that we grow these tissues allows us to produce them so that when they're implanted into a patient, even though they come from a cell bank, they do not require any immunosuppression. In fact, we've treated more than 700 patients during clinical and commercial phases over more than a decade, and we've never seen a bout of immune rejection.

So we believe these tissues are really universally implantable. But in addition, after the tissues are implanted and they're functioning as blood vessels, what also happens is cells from the patient repopulate those tissues and turn it into a living artery over time. And that's an aspect of the technology that really provides durability and some other important features that provide value for the product.

So we got our first FDA approval for our first engineered blood vessel, which is 40 centimeters long and 6 millimeters in diameter. We got that approval late in 2024, had a market launch in the first quarter of 2025. So we've been on the market now for roughly a year. Our manufacturing platform is in-house. We do all of our own manufacturing. I'd like to say that we're a vertically integrated biotechnology company that gives us a tremendous amount of control and quality control and stability on the process and the product. And we have multiple partnerships, which have been very important, including a major partnership with Fresenius Medical Care, the largest provider of dialysis services as well as the Department of Defense.

So fundamentally, this is what the technology looks like. And again, the diagram that I show here is really applicable to growing tissues of multiple shapes and sizes. And as you'll see, we're making blood vessels of multiple dimensions for clinical study. But essentially, as I mentioned, we start with a working cell stock. These are human cells that we've extensively screened, and we seed them onto a degradable polymer scaffold.

And it's really the size and the shape of that scaffold that dictates the ultimate size and the shape of the tissue that we grow. After the cells are put on to the scaffold, then there's a growth process where the cells proliferate over 2 months and they secrete extracellular matrix proteins. And then while that happens, the scaffold dissolves. So after 2 months, we have an engineered human artery that's the size and the shape that the dimensions that we set, and it consists of cells and the matrix proteins that they made like collagen, but there's really no polymer left.

And then in a final step, we drain -- in each culture bag has an artery. We drain the culture medium out of the bag, and we replace it with decellularization solutions. Over a period of 5 days, we wash the cells out of the tissue, wash all the DNA away. And that means that we've got a mechanically robust human tissue that doesn't have cells and doesn't have DNA and so doesn't get rejected. But it can function as an artery from the time it's implanted. So I'm going to focus today on just a couple of indications. We have clinical and preclinical stage work in multiple large markets, as you can see here.

What I'm going to focus on primarily is some of our data in trauma, which -- or vascular injury, which is our first FDA-approved indication and also what we hope will be our second FDA indication, which is using the same vessel for hemodialysis access in patients with kidney failure. Lastly, I'm going to focus on a smaller caliber version of the vessel that we hope to study in an early phase trial late next year in coronary artery bypass grafting or CABG. So here's the approval for our vessel in trauma. As you can see, this is an off-the-shelf non-immunogenic product that's just removed from the refrigerator and can be available for use by the surgeon within minutes.

It's truly an off-the-shelf product. And it's indicated for patients with vascular injury when urgent revascularization is needed and when vein is not obtainable. So sorry for the GORE photos. I actually cut down the number of GORI photos in this presentation. But the value proposition for our vessel, which the approved name is Symvess, the value proposition for Symvess in trauma is really as follows. If a patient, either a civilian or a war fighter presents with an acute injury to an artery such that blood flow is cut off to the limb, typically, that patient will get worked up for a few hours in the emergency room.

And by the time the patient gets to the operating room, the surgeon has to restore blood flow in this contaminated wound bed. He can either spend an hour taking a vein out of the leg. That causes additional injury, but it's a preferred method because vein has a very low infection rate. If you take a vein and if you put it into this contaminated wound, the chances are good, it's not going to get infected. In contrast, though, if the surgeon feels like he doesn't have time, then he'll -- prior to our approval, he had to reach up on the shelf and take down a plastic graft made out of Teflon.

And those grafts are really prone to infection and they often fail. And alternatively, the surgeon could just amputate the limb. So the value proposition for our vessel in acute injury, vascular injury is really the fact that we have a low infection rate. We're very durable, but we're also immediately available for the surgeon. So given that we're in war time, I thought I would show one war time photo. So the conflict with Iran in the Middle East has certainly changed some thinking of some of the players that we work with as far as where the product should be going.

But I will say that part of our -- part of the data package that supported approval by the FDA was a civilian data package of treatment of trauma patients in the U.S. and Israel, but we also had a wart time data package where we collected data on patients who we treated under a humanitarian program in wart time Ukraine in 2022 and 2023. And this is just some of the data from those war time experiences where you can see, by and large, patients had incredibly contaminated and really devastating wounds, typically blast injuries, not so much bullets, more blast injuries.

And this is one -- an example of one patient who had a terrible blast injury that was nearly fatal. He got his leg revascularized with our vessel, which did not become infected despite the terribly contaminated nature of the wound. And then this patient walked out of the hospital a couple of months later. So this is a finding that we -- this type of finding we've seen over and over in both clinical and military settings. So just at a very high level because I don't want to spend too much time in detail here, but essentially, this is the data package that supported approval of our BLA in vascular injury about a year ago. The way the approval worked is that we looked at outcomes for our vessel in trauma patients to include patency, which is blood flow, infection rate, amputation rate, et cetera.

And then we compared those outcomes to published outcomes for use of plastic grafts like made out of Teflon, the published outcomes from those grafts. And as you can see, for patency or how many vessels had blood flow in them, outcomes with Symvess were generally better than outcomes with synthetic grafts. The infection rate for our vessel was only 0.9%. It was about 1/9 of the infection rate of plastic grafts, which again does not surprise us, really all of our clinical data supports a very low infection rate. And because the blood flow rate was better and because the infection rate was lower, the amputation rate was a lot lower.

So there was only about a 4% overall amputation rate in patients who were treated with our vessel as compared to almost a 1 in 4 amputation rate in patients who have been treated with synthetics historically. So this was really the value proposition, the efficacy data that supported approval in treating vascular injury in the U.S. And again, this frequent focus on low infection rate that we've seen in trauma, but we've also seen in dialysis, which is the next thing I'm going to talk about. And in other indications is really the fact that our vessel, even though it's decellularized when it goes in and has no cells when it's implanted, it becomes cellular over time. It becomes a living vessel over time. And an illustration of this is shown here.

This is a sample from a patient, a dialysis patient who had our vessel in place for about 9 months. And then we wound up getting a small biopsy of that vessel and looking at it under the microscope. And what we can see here is that the wall -- here, it's ATEV, acellular tissue engineered vessel. The wall of the ATEV is shown here, the lumen of the vessel is down here and the outside of the vessel is up here. As you can see, there's a lot of spindle-shaped cells, red cells that are taking up most of the wall of the vessel. I can tell you that if we had done this stain on this vessel before it went into the patient 9 months ago, you would see no red staining here.

So all of these cells have come from the patient. And in fact, what we've seen is that this happens over and over. We've looked at about 30 or 40 specimens, happens every time. And even small capillaries form in the wall of this vessel and really turn it into a living artery. And because it becomes living, it has a resistance to infection and a durability that's very similar to our own tissues. So this is some long-term data that we just recently published. The short-term data that gained us approval were published about 1.5 years ago. And the long-term data going out to 3 years were just published a few months ago.

And as you can see, the outcomes in terms of potency, but also in terms of limb salvage and infection-free rate were outstanding. So actually, the infection-free rate isn't shown here, but it remained at like 98% limb salvage remained very stable. And this is patency values going out to 3 years. As you can see, there was some loss of patency over time. But that patency loss in these patients was not associated with any limb loss. And this was probably gradual decrease of blood flow in the conduit, but without any clinical manifestations.

And then lastly, again, we are approved in patients -- in trauma, we're approved in patients who do not have vein as an alternative for treating their wounds. But as soon as we got on the market, surgeons began to ask us, well, how would those patients have done if they had vein? How would that have turned out? And so we were able to answer that question sort of by doing a retrospective comparison. We looked at the outcomes of patients treated with our vessel, Symvess, and then we compared those outcomes to very similar patients who were already in a vascular trauma database called the PROOVIT database.

And this database contains data from more than 5,000 patients. And so we did this propensity matching and we matched up patient characteristics and artery and gender and age and all those things. And the patients in the PROOVIT database, though, all got vein as a treatment, which is the gold standard. And as you can see, if we compare patency, the patency was a little bit lower than our -- for our vessel than for vein. But if you look at rates of amputation, if you look at infection and if you look at death from all causes and interventions, they were pretty similar.

And there was no significant p-values for any of these outcomes, meaning that if you have a patient who does not have vein available as a gold standard of care, these data suggest that if you use our Symvess instead, that actually the outcomes are going to be pretty similar to what you would have gotten if you had -- if the gold standard had been available. As far as the commercial launch in this product, not the clinical -- the outstanding clinical data is fantastic, it's necessary, but it's not sufficient. And so we've also published budget impact models in the Journal of Medical Economics, and we have some follow-on papers as well, showing that because patients who are treated with our vessel as compared to patients -- trauma patients who are treated with plastic grafts or xenografts or other types of grafts, because patients treated with our vessel have a much lower rate of expensive complications, particularly infection and amputation.

Even though our vessel is expensive to acquire, our cost right now is between $17,000 and $20,000. So even though it's more expensive to acquire than some other conduits, the low cost of complications such as infection and amputation mean that the total cost to the hospital are actually lower for our vessel than for most other options that surgeons have in the operating room. So these data have been very important for us in terms of going through value analysis committees and getting the product on the shelf in Level 1 and Level 2 trauma centers. So I'm just going to go on to the next indication for the same vessel that's already approved. This is an indication that we're currently studying at Phase III using our vessel for hemodialysis access.

So as you can see, for those of you who don't think about dialysis all day long, when patients have kidney failure and they have to go to the dialysis center 3 times a week to get their blood cleaned, what has to happen is nurses have to be able to stick 2 needles into the patient and 1 patient -- 1 needle draws blood out at 0.5 liter per minute and runs it through a machine and then returns it to the patient through the other needle. In order to do that, surgeons typically need to sell sort of an artificial blood vessel in the arm right underneath the skin, which is large and which nurses can hit with needles so that they can dialyze the patient.

The gold standard for creating this sort of artificial blood vessel is what's called a fistula, which is where the surgeon goes into the arm and sows an artery and a vein directly together. That's the gold standard because it has a very low infection rate and because it's durable if it works. The problem is 40% or 50% of the time when a surgeon does this operation, it fails. And the fistula never becomes a usable functional thing that patients can use for dialysis. If a fistula operation is done, but if it never works, then patients are stuck on temporary catheters, which should be temporary, but sometimes they are practically permanent because surgeons are never able to get a fistula to work.

And so patients are stuck with a catheter in their neck that leads to many complications, including sepsis and hospitalization. So Humacyte has -- because of our low infection rate and because of the durability of our conduit and the biologic nature of our conduit, we believe for some time that we would present a real benefit, a real value proposition for surgeons and for patients who are on hemodialysis. So the first part of supporting that value proposition is a Phase III study that we've completed, and we've announced results on and it's actually in the process of being published right now.

This was a prospective randomized head-to-head trial of our vessel, the ATEV versus the gold standard of care, which is fistula in 240 patients in the U.S. Patients were randomized in the operating room. So there was really very little chance for bias on the part of the surgeon. And what we found is when we looked at function at 6 months and 12 months, when we looked at these co-primary endpoints across all patients in this study, what we found was that our vessel had substantially better function at 6 months compared to fistula and also at 12 months compared to fistula with an impressive p-value.

So this was a very exciting outcome for us because it showed for the first time that our conduit was better than the gold standard in dialysis access, which has actually kind of never been shown before. But when we dug out in the data, what we saw something that was really interesting, and that was that there were certain subsets of dialysis patients where fistulas tend to fail even more frequently and where our vessel tended to do even a little better. And the most important subset was women, which is almost half of the dialysis population. So if we look at female patients and if we follow them out over 2 years, this is 24 months. This is a Kaplan-Meier curve showing patency or blood flow through the conduit for our vessel, which is shown in red and then for fistula or AVF, which is shown in blue.

And as you can see, and as I mentioned earlier, when the fistula operation is done in women, nearly half the time, the thing never works. And what that means is that the whole time this thing is not working, typically, these women are sitting around with catheters in their neck, getting infections and getting hospitalized and creating a lot of morbidity and also a lot of expense. So the ability to get women, in particular, off of catheters, that ability is really shown by the difference in these 2 plots, which is pretty significant. So when we saw this in the first trial, we decided that we really wanted to confirm this in a second study, and that's what we're doing right now.

So we have what we call the V012 trial, which is the first only dialysis trial ever to be done just in women. And it's a prospective head-to-head randomized trial comparing, again, our vessel to the gold standard, which is fistula. And the way this trial is designed is that there's a prespecified interim analysis after the first 80 patients have reached 1 year. We're actually coming up on that analysis right now. Our 80th patient will have their 12-month follow-up in April. So we are hoping by late May, maybe early June, but hopefully, late May, we will have results on this interim analysis.

If this is positive, then that will be 2 independent indications that for nearly half of the dialysis population, our vessel substantially beats the gold standard, which to us is very exciting. And we would then -- if we hit that endpoint, we would plan to file for a secondary indication in dialysis with the FDA later in '26. I'll just spend a couple of minutes on the pipeline because, again, this is a platform. We can make tissues of different shapes and sizes. And I'm very excited about the ability to make smaller diameter tissues that can be used as a heart bypass. So this is just a diagram of what happens when a surgeon does a bypass of blocked arteries in the heart. Essentially, he'll use the internal memory artery or the thoracic -- left internal thoracic artery graph, which is shown here. But more commonly, surgeons will take vein out of the leg, saphenous vein, and then they'll show it pass to bypass blockages. So they'll show it to the aorta and then they'll show it downstream to the coronary artery past the blockage. And the way, by doing this, they're able to provide blood flow to the downstream parts of the heart and really remove the effects of the main artery blockage. So this is a very commonly performed surgical procedure. There's about 200,000 cases done in the U.S. every year.

Even beyond that, there are many cases wherein patients who need a bypass actually can't have one because their vein is either diseased, has varicosities, has been stripped already for other surgery indications or they're just too high risk for vein harvest. For these patients, they're effectively not able to undergo bypass. And even for patients who do get vein harvested for bypass, the success rate with vein is actually not that great. 20% or 30% of them fail in the first year. And so we became very interested in whether or not our smaller caliber version of our technology, could be useful in heart bypass.

So this is just an enormous photo showing the difference between our approved product here and then the product that's going to be under study, we hope, in patients later on this year. We've studied the smaller caliber version in large animals to include baboons, nonhuman primates. And this is just some of the publications on that work. This was recently published -- well, it was presented at the American Heart and then was recently published in the Journal of American College of Cardiology. But essentially, this looked at 6-month results of coronary artery bypasses done with our vessel in large nonhuman primates. And what you can see here, this is kind of one of the coolest parts of the study, which when cardiac surgeons and when cardiologists see this, it makes them sort of very interested.

This is -- these are 3 CAT scans, 3-dimensional CT scans that are taken of animal that got our vessel at 1 month, 3 months and 6 months. And in these images, the heart is inside here. You can't see the heart. What you see in these images is the aorta, which is the large artery coming up here and then the 3 main coronary arteries in the animal, the right coronary artery in the left and the left circumflex. The yellow arrow in each case points to our vessel. So our vessel is a human sized vessel made for an adult human that's 3.5 millimeters.

Unfortunately, these male baboons are only about 60, 65 pounds. So they're about as big as a first grader. So our vessel is oversized for them. So in order to [indiscernible] in, we have to actually show in a pretty short segment from the aorta right to the right coronary artery. But as you can see, it's oversized. Our vessel is oversized at 1 month. But then by 6 months, it's been remodeled down to the same diameter as the native artery.

And this happened every single time. And we've also seen a similar phenomenon happen in patients who've gotten our arteries to treat blockages in the legs or in the upper extremities, where over time, cells from the patient, as I showed earlier, they remodel and they repopulate the vessel, but they remodel it so beautifully that I've had multiple radiologists say to us, I can't find the vessel, where is it?

And that never happens with a plastic graft. So our vessel really becomes very biologically incorporated, and this is very exciting. This has never been shown in coronary artery bypass before. So we've embarked on commercial-grade manufacturing of these vessels, and we're still trading data with the FDA, but we hope to be in our first trial in patients with coronary artery bypass graft sometime in the third quarter of this year.

So as far as milestones, we hit all of the major milestones that we said that we were going to do in 2025. And we've got ongoing milestones in 2026 that I think are going to be very exciting. We're going to continue our commercial launch and look for quarter-over-quarter sales growth. We're going to read out our Phase III in dialysis, which is very exciting. And if that's positive, we'll file a BLA in dialysis. We'll also have, I hope, starting our early phase trial in coronary artery bypass.

And this will be the first prospective trial done in the U.S. of a new coronary conduit ever. So for the clinical community and for the surgical community, I believe this is going to be a thunder clap. This is going to be very important. And then we've got other stuff going on in the pipeline as well that I haven't even talked about. But I appreciate your time. I've got a couple of minutes for questions, if there are any. Thank you.

We have one from the audience. Thank you.

Discuss the secondary patency in [indiscernible]

What's going on there?

And is that just -- is it good for the first months than the time [indiscernible].

Yes, it depends on the patient population.

Can you just repeating the question for any...

I'm sorry. I'm sorry. Yes. So the question is regarding the secondary patency in dialysis and what that data means for total efficacy for patients. So you're right, the difference in usability or efficacy at 6 months was greater than it was at 12 months. So the benefit of our vessel in all comers shrank down going from 6 to 12 months. What I can tell you is that looking at subsets of the data, what we saw is that women and men with risk factors for fistula and nonmaturation, like if they have obesity and diabetes, those high-risk patients, women and high-risk men, the profile that we had over time looked like this. In relatively healthy men, the loss of patency was more significant. And actually, what I'm saying to people is if you're a relatively healthy man on dialysis, you should get a fistula, go with God.

But if you're in part of that 55% of patients who have a lot of trouble with fistula maturation, our data state pretty clearly that you're going to do better with us. And the infection rates are similar, the intervention rates are similar. I mean it's in these high-risk groups, there's real durable benefit.

In the [indiscernible] you saw that the vessel remodel [indiscernible]

It does not. It does not. So vascular diameter is maintained in dialysis. It's also maintained in PAD. We see -- and we've published long-term data going out to 6 years in dialysis, 5 years in dialysis, 6 years in PAD that shows that the diameter is relatively well maintained. I believe that what's happening in the coronary system is because of the big size mismatch. The cells that repopulate the vessel are sort of programmed to see a smaller diameter in a different blood flow rate and they grow in until they sort of hit their equilibrium.

Do you ever see any vessel remodel through the bigger size?

We have not seen remodeling to a bigger size unless you talk about patients who've been using the vessel for dialysis. So we have patients who've had the vessel in for 5 or 10 years and getting punctured with large bore needles 3 times a week. In some of those patients, there will be a gradual dilatation, not an aneurysm formation, but our long-term data shows that our vessels go from like 6 millimeters up to about 7 or 8 millimeters.

Why is that [indiscernible] better than anything...

I don't know that it is. I don't know that it's not.

[indiscernible] Not much difference in all [indiscernible]

Oh, you mean for -- no, that's in trauma. So the question is, why isn't our vessel better than vein?

Usually a vein, I mean usually a vein in place in artery which has much higher pressures [indiscernible] you have [indiscernible] engineers [indiscernible] more resilience and...

We do engineer to be tougher and more resilient.

[indiscernible]

It is -- so it is better in the fact that it's...

[indiscernible]

So our mechanics, our mechanical durability is superior and the tendency to develop inflammation and intimal hyperplasia is superior. What is inferior is the fact that veins have an interlining on the inner surface of endothelial cells, which inherently blocks blood clotting. Our published data show that our vessels develop an endothelium, but it takes time. It takes -- they have a head start on the early patency data, they have a head start. But in terms of durability and resistance to infection, we're the same. And the small differences in patency in trauma between our vessel and vein actually don't translate into loss of limb or other complications.

You can improve the technology to [indiscernible]

We spent about 15 years working on that.

How does the price compare to [indiscernible] procedure versus your product?

Right. So it's -- so that's a loaded question because price in terms of what the hospital total charges for the hospital will vary with indication. So in trauma, the way hospitals are reimbursed is with a DRG or just a fixed number based on how injured the patient is. And then the hospital has to care for all the complications of that patient with that one fixed dollar amount.

So in answer to your question, though, our vessel, it takes about an extra hour of operating room time to harvest vein, which is actually thousands of dollars for an acute trauma OR. So -- and our vessel costs about $17,000, so it's more expensive than that. It's also more expensive than plastic as far as the acquisition cost because plastic is about $1,000 or $2,000. But the fiscal benefit to the hospital comes from the fact that they're saving not only OR time, but compared to plastic, they're also saving infections and amputations, which they also have to -- those all occur in the first hospitalization and the hospital has to foot the bill for those. So that's -- it's really the economic -- I mean, the clinical data are strong, but it's really the economic argument that means that our VAC success rate is pretty high.

Excellent. Well, I think we've hit the buzzer here for this time. Thank you, Laura, for the presentation for taking the questions. And again, thank you for participating in our conference this year.

Good morning, ladies and gentlemen, and welcome to the Humacyte's Third Quarter Results Conference Call. [Operator Instructions] 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.

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 the 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 third quarter and recent weeks, and Dale will review the company's financial results for the quarter ended September 30, 2025.

I will now turn the call over to Dr. Niklason. Laura?

Thank you, Tom. Good morning, everyone, and thank you for joining us for our third quarter 2025 financial results and business update call. I'm pleased to report that our third quarter was a productive period for Humacyte and continued execution of our commercial launch with Symvess and also with advancement of our other bioengineered vessel programs. During today's call, I'll review progress across our commercial and development programs before turning the call over to Dale for a review of his financial -- of our financial results for the third quarter.

Beginning with our commercial launch of Symvess, we're pleased by the traction we continue to gain in our interactions with surgeons and hospitals. To date, 25 hospitals and/or health care systems have completed the Value Analysis Committee, or VAC process and have approved the purchase of Symvess. Since these VAC approvals include multi-hospital networks, approvals obtained thus far represent 92 civilian hospitals now eligible to purchase Symvess. An additional 45 VAC committees at hospitals or health systems are currently conducting reviews of Symvess. Along with the progress in VAC reviews and approvals in the third quarter, product sales improved to $703,000, a significant increase over the $100,000 that we reported last quarter.

Our active engagement with surgeons and clinicians continues to grow, and we're observing an increased number of hospitals placing orders and reordering Symvess. This active physician engagement is complemented by our steady drumbeat of strong publications that support Symvess and our technology platform.

As you know, in July, we announced that Symvess had been awarded the Electronic Catalog, or ECAT listing approval from the U.S. Defense Logistics Agency, which provides the Department of Defense and other federal agencies with access to manufacturers and distributors' products. ECAT approval make Symvess available to health care professionals treating military service members, veterans and other patients receiving care at military treatment facilities and the U.S. Department of Veterans Affairs Hospitals. Since obtaining ECAT approval, we recorded our first commercial sale to U.S. military facilities. And we have great interest in improving medical options available to health care professionals who are treating military personnel and their families, and we look forward to advancing our discussions with additional DoD-affiliated hospitals.

Our commercial rollout of Symvess was supported by the recent publication of 3 studies demonstrating the potential of this product in vascular trauma. First, the publication entitled Bioengineered Human Blood Vessels To Treat Hospital-acquired Vascular Complications was published recently in the Journal of Vascular Surgery. This publication describes the outcomes of using Symvess in the treatment of arterial injuries that are sustained in the process of medical care rather than injuries that are sustained in the community. Complications of surgery and vascular procedures, including iatrogenic injuries, planned oncologic tumor resections and what have you, are increasingly common in modern medical care and comprise up to 30% of patients requiring vascular injury repairs. Harvesting of autologous vein to address these consequences and complications produces additional injury for the patient and suitable vein may not always be accessible. This publication describes the outcomes of patients with hospital-acquired iatrogenic injuries or complications of vascular surgery procedures, which was a subgroup of our V005 pivotal Phase II/III clinical study that we conducted in the U.S. and Israel. At the end of an average follow-up of 23.3 months, 92% of the patients retained secondary patency or had blood flow in the conduit. None of the patients suffered an amputation, and there were 0 infections of Symvess.

Patients experiencing hospital-acquired vascular complications represent an important subset of vascular trauma patients, and it's gratifying to see that the outcomes in this study show that Symvess can provide limb salvage and durable potency.

Another publication in the Oxford Academic Journal Military Medicine described positive long-term results from our humanitarian program using Symvess to treat wartime vascular injuries in Ukraine. This publication reported on 17 patients suffering combat-related extremity vascular trauma from gunshot wounds, blasts and shrapnel. Up to 18 months -- after up to 18 months of follow-up, physicians observed 0 deaths, 0 infections and 0 amputations in these treated patients in Ukraine. Furthermore, Symvess had a high potency of 87.1% and no instances of immunologic rejection. These outcomes demonstrate the long-term durability of Symvess in the treatment of real-world combat injuries.

And finally, the Trauma Surgery and Acute Care Open Journal published results of a new study comparing clinical outcomes of Symvess to those resulting from autologous vein in the treatment of extremity arterial trauma. This analysis leveraged data from 2 clinical trials, Humacyte's Phase II/III V005 study and the humanitarian V017 study in Ukraine and match Symvess patients in those trials to patients who had suffered similar injuries and who were previously treated with vein. The matching patients who were previously treated with vein were obtained from the PROspective Observational Vascular Injury treatment, or PROOVIT registry, which is the world's largest vascular trauma database. The comparison between Symvess and vein outcomes found that patients who were treated with Symvess had statistically similar outcomes to patients from the PROOVIT registry who received autologous vein. Secondary patency for Symvess versus the autologous vein group was 91% versus 97.7%. The amputation rate was 7.5% versus 8.2%. The conduit infection rate was 1.5% versus 0%, and the death rate was 4.5% for both groups, respectively. There were no significant differences that were noted between the 2 groups for any of these outcomes that were assessed.

The use of autologous vein to repair an injured blood vessel is the current standard of care because it offers excellent long-term patency and low infection rate. However, in many cases, suitable autologous vein may not be available due to extreme limb damage, prior surgeries or poor vein quality. Even when available, harvesting the vein is a time-consuming procedure and may not be an option for patients with severe traumatic injuries. We believe that the results of this study underscore Symvess' potential as a much needed effective and life-saving alternative as a treatment for patients where autologous vein is not feasible. We're very pleased with these study results. And as Symvess is increasingly adopted by surgeons, we're confident that we will continue to see the benefits of this product validated by further research. In addition, we have another publication of the long-term results of Symvess in vascular trauma in a civilian setting that will be forthcoming soon.

I'll turn now to the program that is our next priority, which is dialysis access. Positive 2-year results from the V007 Phase III trial of the ATEV in dialysis patients were presented last weekend at the American Society of Nephrology's Kidney Week 2025, which is the premier nephrology meeting. The ATEV demonstrated superior duration of use over 24 months as compared to autogenous fistula in high-need subgroups that have historically poor outcomes with AV fistula procedures. The significantly longer duration of ATEV use over 2 years in patients with this high unmet need could greatly reduce reliance on catheters for dialysis access, which are a major cause of complications, morbidity and costs for dialysis patients. Women and men with diabetes and obesity make up more than half of the dialysis access market and are historically underserved by the current standard of care. It's been known for decades that women, in particular, suffer low rates of fistula maturation, lower rates of fistula maturation than do men, but a lack of better alternatives has limited progress for these patients. We believe that the efficacy and safety results in this subgroup, combined with the approximately 50% failure rate of fistulas in this subgroup, makes women and high-risk men an important population for Humacyte to target. We look forward to publication of the results from the V007 Phase III trial in a major peer-reviewed medical journal.

Before we file a supplemental BLA for the ATV and dialysis access, our plan is to complete a prespecified interim analysis of the currently ongoing trial, which is the V012 Phase III trial, which is being conducted in women on hemodialysis. The V012 trial compares the ATEV to women receiving fistula for hemodialysis access. A total of 109 patients have been enrolled to date in the V012 Phase III clinical trial, and an interim analysis is planned when the first 80 patients reach 1 year of follow-up, meaning that the interim analysis results should be available around April of 2026. Subject to those interim results, our plan is to submit a supplemental BLA in the second half of 2026, including data from V012, which is ongoing and the V007 Phase III pivotal study in order to add dialysis access as an indication for the ATEV.

Finally, I'll briefly discuss one of our earlier-stage programs that we're also very excited about, our coronary tissue engineered vessel, or CTEV, for use in coronary artery bypass grafting, or CABG. Positive results of a preclinical study evaluating the CTEV as a coronary artery bypass graft in a nonhuman primate model were published in September of 2025 in JACC Basic Translational Science, which is a specialist journal launched by the Journal of the American College of Cardiology. In this study, the CTEV was observed to sustain blood flow, recellularize with the animals host cells and remodel to bring the diameter of the CTEV in line with an animal's native coronary artery. We are on track with our plan to advance CTEV into first-in-human study in CABG in 2026. We have filed an IND with the FDA for the CABG indication. And if successful, the CTEV would be the first novel conduit to be tested in CABG in the U.S. in decades.

Before turning the call over to Dale, I'll mention last the expansion of our intellectual property estate and the grant of a new U.S. patent covering the composition of a bioengineered esophagus. This new patent provides protection into 2041 for key structural and mechanical attributes for an esophageal replacement, including size, strength and methods of production. Our tubular prosthesis patent family now encompasses granted claims for the composition and methods for engineered trachea, engineered urinary conduits and engineered esophagus. So our third quarter has been very productive for Humacyte as we've continued to grow our commercial launch and continue to publish strong supportive data for our vessel Symvess in multiple indications. We also look forward to continuing to share our progress going forward.

And with that, I'll now turn the call over to Dale for a review of our financial results and other business developments.

Thank you, Laura, and good morning, everyone. Revenue for the 3 months ended September 30, 2025, was $0.8 million, of which $0.7 million related to U.S. sales of Symvess. The remaining $0.1 million resulted from a research collaboration with a large medical technology company. Revenue for the 9 months ended September 30, 2025, was $1.6 million, of which $0.9 million related to U.S. sales of Symvess and $0.6 million resulted from the research collaboration. There was no revenue either for the 3 or 9 months ended September 30, 2024.

Cost of goods sold were $0.3 million and $0.6 million for the 3 and 9 months ended September 30, 2025, respectively, which includes overhead related to unused production capacity that was recorded as an expense in the applicable periods. There was no cost of goods sold for either the 3 or 9 months ended September 30, 2024.

Research and development expenses were $17.3 million for the 3 months ended September 30, 2025, compared to $22.9 million for the prior year period and were $54.7 million for the 9 months ended September 30, 2025, compared to $67.9 million for the same period in 2024. The decrease in research and development expenses for the third quarter of 2025 compared to 2024, primarily related to the capitalization of material and overhead costs associated with the commercial manufacturing of Symvess and cost reductions implemented during the quarter ended June 30, 2025. The decrease in research and development expenses for the 9 months ended September 30, 2025, compared to 2024 resulted primarily from decreased material costs as the company began capitalizing expenditures for inventory following the commercial launch of Symvess, combined with the winding down of certain clinical trial programs, partially offset by higher noncommercial production runs.

Selling, general and administrative expenses were $7.6 million for the 3 months ended September 30, 2025, compared to $7.3 million for the prior year period and were $23.6 million for the 9 months ended September 30, 2025, compared to $18.4 million for the same period in 2024. The increase in 2025 expenses compared to the prior year periods resulted primarily from the U.S. commercial launch of Symvess in the vascular trauma indication, including increased personnel expenses.

Other net income for the 3 months ended September 30, 2025, was $6.9 million compared to net expense of $9.0 million for the prior year period. And other net income was $61.3 million for the 9 months ended September 30, 2025, compared to other net expense of $41.5 million for the same period in 2024. The increase in other net income for the 3 and 9 months ended September 30, 2025, compared to the prior year periods resulted primarily from the noncash remeasurement of the contingent earn-out liability associated with the company's August 2021 merger with Alpha Healthcare Acquisition Corp.

Net loss was $17.5 million for the 3 months ended September 30, 2025, compared to a net loss of $39.2 million for the prior year period and net loss was $16.0 million for the 9 months ended September 30, 2025, compared to a net loss of $127.8 million for the same period in 2024. The decrease in net loss for the 3 and 9 months ended September 30, 2025, compared to the prior year periods was primarily due to noncash remeasurement of the contingent earn-out liability described previously, combined with current period decreases in operating expenses and a decrease in loss from operations.

We had cash, cash equivalents and restricted cash of $19.8 million as of September 30, 2025. In addition, subsequent to September 30, 2025, we completed the sale of common stock and warrants that added an additional net proceeds to our cash position of approximately $56.5 million. As will further be discussed in the 10-Q to be filed later today, we believe that gives us cash runway exceeding 12 months from today's date. Total net cash used in operating expenses was $78.9 million for the first 9 months of 2025 compared to cash -- net cash used of $71.5 million for the first 9 months of 2024. The increase in net cash used for operating activities during the first 9 months of 2025 compared to the prior year resulted primarily from the buildup of inventory associated with the commercial launch of inventory, partially offset by our reduced loss from operations.

With that, I'll turn the call over to Laura.

Thank you, Dale. With our strong commercial execution, our promising pipeline programs and our dedicated team, we remain committed to delivering truly transformative regenerative medicine solutions to improve patient outcomes. We believe that we are positioned for growth and value generation in the remainder of 2025 and beyond.

Thank you all for joining us today. Operator, we're now ready to take questions.

[Operator Instructions] Our first question comes from the line of Matt Miksic with Barclays.

This is Sneha on for Matt Miksic. We wanted to ask -- one of the first questions we just kind of wanted to ask was, in Q2, you mentioned that 12 of the 45 hospitals had initiated the VAC process and now you said that 16 had started ordering. How many of those that have started ordering have begun the reorder process? And have you disclosed that data?

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

Okay. And then just as a quick follow-up. Now that you have this new data from the trial for 007, how does that change your view for the potential for Symvess in dialysis?

Well, we believe that the very strong results in duration of usability in these subgroups of patients with a high unmet need going out to 2 years is very, very strong data. Most studies in dialysis access have follow-up time periods of a year. So showing continued sustained benefit in these high-need subgroups going out to 2 years versus the gold standard of current care, we believe is very important. And we believe it will be a strong support when we eventually file our supplemental BLA application in dialysis access. And again, these subgroups are not small. It's -- if you combine all women with men having these risk factors, it's more than half of the dialysis population.

Our next question comes from the line of Ryan Zimmerman with BTIG.

Laura, this is Izzy on for Ryan. Congrats on all the progress this quarter. Just to start out on the launch that you -- the progress with the launch so far. Out of the units that you've been purchased, I was curious what is -- or how many of those have been used versus what are initial stocking orders at these hospitals?

It's very hard to answer that question succinctly. What I can tell you and what we've messaged to the market before is that, initial stocking orders range from 1 to 3 units. There are a couple of hospitals who are ordering on an as-needed basis, although that's less common. Typically, what we're starting to see with usage and repeat usage is that, as hospitals use the vessel and then they come down to their par, then they will reorder when they hit their -- when they fall below their par level, whether that's 1 or 2 or 3 units.

So we have been -- again, we've been getting good feedback from surgeons as far as how happy they are using the product. Surgeons tell us that it's easy to handle and that they're pleased with its function in the OR.

I would also say, although you didn't ask this question, that we have several presentations on the function of our vessel that are being presented at the VEITH meeting, which is the large annual vascular surgery meeting in New York every year. Those presentations are going to be coming online next week.

That's helpful, Laura. And I believe last quarter, you called out the fact that the price has come down for Symvess. I was curious what benefits you've seen from that, if it's accelerated any of the adoption or if it even decreased the time it's taking for these hospitals to get through their VAC approvals.

Yes and yes. Yes. The market is price sensitive now. That's certainly true. As we've discussed before, in the post-COVID era, hospitals are looking much more closely at budgets. And so, the price sensitivity is something that we found to be important. With this lower price point, what we've seen is that, hospitals are moving through the VAC process quicker. There are some hospitals and groups of hospitals that did not consider us at our original price point. But with further discussions on price, they've now reinstituted the VAC process, and so that has reopened other doors. And the VAC process tends to be moving a little bit more quickly. So this is still a process that takes time. And once the VAC approvals are obtained, then there's a 1- or 2- or 3-month contracting process that happens with each hospital. So there is a time factor here, but we've definitely seen an acceleration, both of VAC submissions and also an acceleration to time for approval.

That's helpful. And if I could squeeze in just one more for Dale. I believe you guys have called out some cost savings initiatives that have been put in place for '25 and '26 for about $50 million in total savings. I was curious if you're still feeling comfortable with this level or if we should expect any changes as we start to think about next year. Congrats again on the progress.

Thanks, Izzy. And no, absolutely, we are seeing those savings. Obviously, as part of the kind of the formal GAAP reporting out of our financial results, we compare to the prior year. But if you just compare our expense levels to last quarter, we're seeing those drops already. Research and development in the second quarter was $22 million. We've dropped that to $17 million, so almost $5 million reduction in R&D there. SG&A costs were pretty flat, maybe $200,000 down. So our operating expenses quarter-over-quarter were reduced by about $5 million. So we are already experiencing those cost reductions and expect those to continue out and achieve that full $50 million in cost savings that we targeted when we announced our second quarter results.

Our next question comes from the line of Josh Jennings with TD Cowen.

I was hoping that just -- you guys have generated some strong supportive evidence for Symvess in the vascular trauma indication. And it sounds like this question has already been answered, but how impactful has that been just in terms of getting that processes started and then moving through the process?

And just remind us, if you would, just how real-world outcomes are going to be tracked? Is there a post-approval registry study, and I think it will take some time for that to formulate. But when could we see any results from any registry -- real-world registry outcomes?

Yes, Josh, those are good questions. Thank you. So the steady drumbeat of publications that have been coming out and frankly, are going to continue, has certainly been helpful in terms of providing additional assurance to surgeons as we speak to them at hospitals. Our initial endpoint for the V005 and V017 studies was at 30 days. And so, having these long-term outcomes that are now out in the public domain that we can share has been very powerful in terms of bringing surgeons on board. So -- and again, we're going to continue to lean into that.

And your second question, I'm sorry.

Just about the real-world outcomes and how those are being tracked and what's the process there and...

Sure. So there is a post-approval study that we've agreed to with the FDA as part of our FDA approval in trauma since we're a first-in-class product. So this will be a follow-up registry study in 100 trauma patients following at least 100 patients for at least a year. We have not kicked that trial off. In fact, we're continuing discussions about the specifics of the trial design with the FDA. The FDA has been a little bit slower in part because of the shutdown and some other changes. And so, we're still working through that. But we expect to kick off this post-marketing study sometime in the first half of 2026. And we expect data to come out from that 6 or 12 months after that. It certainly won't be a full data set, but there will be some information forthcoming. But frankly, I think that there will be more information forthcoming just from individual surgeon publications and reports on their experience, whether it's case reports or short series. And some of that, we're even going to see at the VEITH next week.

Excellent. And I wanted to ask about Symvess in the AV access indication. Congratulations on the 2 results presented at ASN. In terms of the BLA process and this interim analysis, I mean, should we be thinking that if the interim analysis for the first 80 patients in V012 kind of those results mirror the 1 and 2 results in females from V007 that the package will be robust enough for the FDA to consider approval?

Yes, we believe so. I mean, the way we would approach this is that the LEAD study would be the study in women, the prospective head-to-head randomized study versus fistula in women. If we met our endpoint at the interim analysis, this would be a very strong indication of superiority of our vessel compared to the gold standard fistula in dialysis. So we would then lead with that publication and the V007 data, which includes data from all comers, as you know, but which has an important subgroup analysis in women and high-risk men, we anticipate that would be supporting data. So this would then be 2 prospective studies, basically, of course, pending the results of the V012 analysis, of course. But in that situation, we would have 2 prospective randomized studies supporting the same message in these patient subgroups.

Our next question comes from the line of Jason Kolbert with D. Boral Capital.

Congrats on all the progress in transitioning to being a commercial entity. I'd like to just ask you a little bit about what's involved in transitioning the sales force as you start looking towards hemodialysis and essentially the work you're doing now kind of creating the awareness in the marketplace, how do you transition that into the commercial opportunity for dialysis?

Thank you, Jason. That's a great question. So as your team probably knows, we've done the initial launch in trauma with a fairly small sales force, about 12 agents who are out in the field in different territories that are essentially high-value territories with large metropolitan areas and a lot of trauma centers. We are looking -- as we've messaged to the market, we're looking at strategically adding a small number of additional sales representatives in other geographies right now. We're in the process of doing that. But again, as we've mentioned, there's only about 3,000 vascular surgeons in the United States. And it's -- as we continue our sales efforts during 2025 and then through 2026, we anticipate having touch points with a large fraction of these surgeons. The vascular surgeons who perform trauma operations are the same surgeons who also perform dialysis access operations. And so, the visibility with this surgeon cohort, we think is going to be tremendously supported by our trauma efforts in 2025 and 2026.

That said, if the results in V012 are positive and if we file the supplemental BLA in the second half of 2026, we would aim for approval sometime in early 2027. And by that time, we would probably bring on an additional sales force. This would not be a huge sales force, and we haven't given specific numbers, but there might be -- I'm making this up. There might be another 10 or 20 reps because we would be targeting the same surgeons, but we would be targeting additional call points because dialysis access is primarily an outpatient procedure. It's the same surgeons, but it's slightly different facilities.

Yes, that makes a lot of sense. Can you talk also a little bit just because I'm fascinated by it, work you're doing towards the virtual -- well, the actual replacement of esophagus, trachea and the urinary conduit, how did those programs proceed? And how aware are you of all the prior data done by companies like Harvard Apparatus almost a decade ago?

Yes. So these other indications are indications that Humacyte has sought intellectual properties on and obtained intellectual property. I would say we do not have active preclinical programs advancing those indications right now. Frankly, we're going to up-prioritize that as our revenues increase and as our cash position improves. But right now, we're not doing active studies there. But, of course, from my long-standing work in this field, I'm very aware of the Harvard Apparatus outcomes and some of the problems that have occurred with esophagus and with airway replacements, very aware of those. Those are clinically challenging environments. And some of the earlier failures of other technologies, I believe, were driven by, frankly, a failure to consider the proper design criteria for the implant. I would hope that as we continue to develop these products in the future that we would make better conduits. We would have -- meet better design criteria, but we'll have to see.

Our next question comes from the line of Bruce Jackson with The Benchmark Company.

I wanted to follow-up on the NTAP submission. Have you reconsidered the strategy? And is there a plan to resubmit it?

Yes, Bruce, thank you for that. We've considered this carefully, and we've actually opted not to resubmit for the NTAP in trauma. The decision by CMS that our conduit in trauma is not novel was obviously very surprising for us as we messaged to the market last quarter. And in reviewing sort of their thinking that the CMS took a very reductionist approach to this and said, because we are a conduit that conducts blood, we are not novel because there are other conduits that conduct blood. We decided that it was probably not a good use of our resources to go back at that again. Instead, as you know, we have had some price reductions actually from around the time of the NTAP decision. And the reduction in price has helped to drive activity in the market. So we don't really see the -- we don't see it as a good use of effort to reapproach NTAP at this time.

Bruce, another consideration is that, out of the vascular trauma patients, only about 4% are covered by Medicare. So that was another consideration.

The other question I had was around the -- just some anecdotal information about the reorders and the marketing efforts. So in the multi-hospital approvals that you've gotten, have you seen additional hospitals ordered the product? And in the hospitals where you are selling right now, oftentimes, there's a single surgeon who is your champion who does the initial implants. Have you seen any expansion beyond your initial implanting physicians?

We have. We have in a couple of the hospitals, I don't want to name them specifically, but in a couple of trauma hospitals we have seen usage beyond our initial champion. As it is with any new surgical product, as you know, there's typically a lead champion who will use and reuse. And then as his colleagues see those outcomes, they will continue to adopt. So we have seen that in several hospitals.

As far as the hospital systems, when we get a VAC approval for a hospital system, there's still individual contracting that we must do with each individual hospital. So while having a blanket VAC approval helps with an important step in that process, we are undergoing contract negotiations right now in multiple hospitals that are covered by some of these chains that we've gotten approvals in, if that makes sense.

Yes, that does.

Our next question comes from the line of RK with H.C. Wainwright.

Laura and Dale, congratulations. A couple of questions from me. The first one being, how do you initiate your conversations and maintain your conversations on value proposal to the folks on the VAC committees? And what are the things that resonate with them, especially when you had to still dislodge the autologous vein grafts? That's question number one.

And the second question, Dale, it looks like there's some good operational excellence being done here. So you reduced your cash burn. Is this the new, I mean, cash use expectations from here onwards? And also with the $76 million in the bank now, how long of a runway are you going to have? And does that include the BLA submission for the dialysis indication?

So I'll take the first question with regard to the value proposition to VACs and hospitals. As you know, RK, or you may remember, we published a Budget Impact Model in March of this year in the Journal of Medical Economics. That Budget Impact Model contemplated our initial list price of $29,500. And in that model, we showed that by virtue of decreasing amputations and conduit infection relative to plastic grafts, but also relative to other types of grafts like CryoVein and xenograft, because we decreased those complication costs, we actually came in cheaper even at our initial $29,500 price point. With the reduction in price point, that economic argument becomes even stronger. And so, when we lay that out to VACs, it is compelling.

What we see, though, is that, some hospitals are -- there are -- because of changes in Medicaid, I will say that there are some hospitals who are -- despite the compelling Budget Impact Model, occasionally, hospitals will still look at just the initial acquisition price and say, even if it's going to save us money in the longer term, I have to think about what I'm spending today. And so, there is still -- in some hospitals, there is still some pushback. But the majority of cases -- in the majority of our VAC submissions, those are now going through successfully. I think because these arguments around decreased cost of amputation, decreased cost of infection are really driving home, especially at our new price point.

Yes. Regarding spend levels, I mean, obviously, quarter-over-quarter, we've reduced expenses quite a bit. I think both operating expenses and loss from operations have come down by about $5 million. Going out, I think we expect SG&A to be somewhat constant. I think we'll continue to see some reductions in the R&D area. As will be further disclosed in our 10-Q filed probably later today, we expect that the cash on hand, based on how we expect to operate, takes us beyond 12 months from where we are today.

And in terms of what milestones that means as part of your later question, we believe that takes us past having the interim results from our V012 study in dialysis. And based upon those results, taking us past the BLA filing in dialysis and also taking us past the commencement of human testing in a cardiac bypass graft surgery. So it takes us past some -- and there'll be a lot else happening in the company also, but it certainly is sufficient to take us past some very key milestones.

Ladies and gentlemen, we've come to the end of our time allowed for questions. I'll turn the floor back to Dr. Niklason for any final comments.

Thank you very much. We really appreciate the time that our investors and our analysts have taken to catch up with us on our call this quarter. We've continued to execute on the goals that we've said we would execute on. We've continued to expand our commercial launch, and we're continuing to get traction in the clinical marketplace as surgeons continue to use our vessel in trauma. So we're very excited with our progress, and we look forward to catching up with you again next quarter.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.