Good afternoon. I'm Josh Jennings from the TD Cowen Medical Devices team. We are excited to have Humacyte executives participating in the 45th annual TD Cowen Healthcare Conference up here in Boston. I'm going to hand it over to Laura Niklason, the founder and CEO of Humacyte, to take us through some slides, and then we'll open it up for some Q&A at the end. Laura, thanks so much for participating in our conference this year, and it's great to see you. Thank you, Josh. It's always great to be at the Cowen Conference. I'm excited because this is the first talk I've been able to give at a conference where we not only have FDA approval, but we've also announced commercial launch. It is a very exciting time for our company. For those who don't know about the technology, Humacyte is really a world leader in creating what I like to say are spare parts for patients. We have a unique and proprietary platform technology that allows us to use human cells to make universally implantable human tissues. In our case, our first several products are our blood vessels. These blood vessels are available off the shelf. Importantly, they don't require any immunosuppression. In fact, we've treated more than 600 patients with our blood vessels over more than a decade, and we've never had a bout of rejection. In addition, after implantation, our initially acellular tissues repopulate with cells from the patient over time, making them a living tissue. As I just mentioned, we just announced commercial launch last week. The FDA approved our engineered vessel, which is trade name Symvess, in late December of last year. We have very large addressable markets that we're looking at for this vessel. The first market that we've gained approval in is in treating traumatic injury, but we have a series of other markets that we think we can address, and I'll talk about some of that today. Importantly, we have commercial scale manufacturing in place. In fact, our commercial scale manufacturing has been up and running for several years, and we're located in the US, in North Carolina. We also have multiple important partnerships, including with Fresenius Medical Care, who's very interested in what I think will be our second indication in dialysis access, as well as the Defense Department, who's very interested in our first indication in trauma. At a very high level, this is how the platform works. We start off with a bank of human cells that we have cryopreserved that are proprietary and that we've developed. We expand those cells in the laboratory, and then we seed them onto degradable scaffolds that are the size and the shape of the tissue that we want to grow. In this case, our engineered vessels are 42 centimeters long and 6 millimeters in diameter. In fact, I think Dale Sander, our CFO, has an example of one of our vessels, and if you like, he can pass it around so you can see it, like active show and tell. Anyway, after the cells are seeded onto the scaffold, the bioreactor bag that Dale's passing around now is filled with culture medium, and the cells grow for about two months. During that time, the cells secrete extracellular matrix, and the polymer underneath the cells is dissolving. After two months, we have an engineered human tissue that we've grown from scratch, and it contains just cells and matrix proteins. In a final step, we wash the cells out of the tissue, and that's what makes it non-immunogenic, and that's what gives it a shelf life. It can sit in the refrigerator for up to 18 months and be at the hospital in the OR right there when the surgeon needs it. This is just an example of what I mentioned earlier, which is how our engineered blood vessel repopulates with cells over time. I will not spend a lot of time on this slide, but I will say that this is a tissue section taken from a patient who was on hemodialysis using our vessel as a dialysis access, and we obtained a small biopsy of the vessel at around month nine. As you can see from the cross-section image here, the wall of the vessel, which we call ATEV, which is the generic name for our vessel, the wall of the vessel is filled with spindle-shaped, red-colored cells, which are actually vascular smooth muscle cells, which came from the patient and migrated into the tissue over time, turning it into a living artery. As I mentioned, we are FDA approved for Symvess in the indication of extremity vascular trauma. Our indication statement reads that Symvess is an acellular tissue engineered vessel. That's where we get ATEV from. That's indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed and when autologous vein graft, in other words, vein from the own patient's leg, is not feasible. What is the value proposition that Symvess brings to the vascular trauma market, both civilian and military? The reality is that prior to the availability of Symvess, when a patient presented to the emergency room with some horrific injury that destroyed a blood vessel in an extremity, the surgeon, once the patient gets to the OR, really has three options. He can spend an extra hour harvesting vein from the patient and further injuring the patient and then moving that vein over to fix the artery. If he thinks he does not have time for that, or if the patient is too injured to do that, then he can take a plastic graft off the shelf and use that graft to repair the injured blood vessel. As you might imagine, if you put a plastic graft into a contaminated wound, the frequency of infection is pretty high. Failing those two options, if the surgeon thinks that neither of those will work, he'll take the limb. The problem there is that there's really no conduit that's immediately available that doesn't require injuring the patient and that can also have a low infection rate. I would say there was no product available until the approval of Symvess just a few weeks ago. Here's the data that formed the basis of our BLA approval by the FDA. I'd like to point you to, let's see if this cursor works. No, it doesn't work. If I can point you to the right-hand column in blue, what you can see is the patency outcomes and the infection rate and the amputation outcomes for patients, both civilian and military, who were treated with Symvess with Humacyte's vessel. Compared on the right-hand side in the gray column to our external comparator group, which was the outcomes of patients who were treated, similar patients, but who were treated with synthetic grafts. What you can see is that our patency values are substantially above those that are reported for synthetic grafts. Our infection rate is about one ninth of what was reported for synthetic grafts. Probably most importantly, our amputation rate is much lower. With synthetic grafts, if you got treated with a plastic graft after a vascular extremity injury, the literature would say that you have a one in four chance of losing the limb. In our studies, we saw only a one in 20 chance of losing the limb. That is a five times reduction in your likelihood of going on to amputation, which is obviously important for hospitals and patients and surgeons. When I talk to surgeons about this, they often ask, you do better than synthetic grafts, that's great, but how do you do in comparison to autologous vein? In other words, vein that's harvested from the patient. We haven't done a head-to-head study on that, but we have done a retrospective comparison where we've gone to a large vascular trauma database called the PREVIT database. We did some propensity score matching where we looked at our patients who were treated with Symvess, and then we found two matching patients who were very similar in the trauma database, in the PREVIT database, who had been treated with vein. When we look at their outcomes in terms of patency, the vein patency is actually a little bit better than it is for Symvess. If you look at the amputation rate, our amputation rate in our studies was 7.5%, and the amputation rate with vein was 8.2%. The infection rate for both Symvess and for vein in these patients was very low, and the mortality was identical. As you can see, even in patients where vein is not feasible, what our retrospective post-hoc study shows is that if a surgeon uses Symvess, you know he can feel confident that the outcomes may not be that different from those that might have been occurring if he had been able to use vein. If we talk about the commercial launch of the product, which we're very excited about, when we talk about the total addressable market in vascular trauma, we like to say that there's probably, from looking at hospital databases and discharge databases, there's probably about 26,000 cases per year in the US where there's a significant vascular traumatic injury that requires a surgical repair. This is a mixture of injuries that occur in the community, like car accidents and gunshot wounds, but it's also iatrogenic injuries. These are injuries that are caused by surgeons in the hospital, sometimes on purpose, like when they're taking a tumor out, and sometimes not on purpose, like when the orthopedic surgeon is operating on your knee and accidentally lacerates your artery. If you add up all of these cases, it's about 26,000. If you look generally at how they're treated, this is again from the PREVIT database, what you can see is that about a quarter of these in the orange part of the pie chart there are treated with either synthetic grafts or what we call other grafts, meaning cryopreserved vein, bovine grafts, other sorts of things. Whereas about three quarters of these types of injuries are treated with vein. Vein is considered the gold standard here. It's also important to note that for patients who are treated with vein, some of these patients are treated in the setting of having a very short ischemia time. In other words, there's a short time from the time of their injury to the time of their repair, like an hour or two. Some of these patients who are treated with vein are actually treated in the setting of a long ischemia time. Patients who have a car accident and take a while to get to the hospital, sometimes it's four or five hours before the surgeon can be in the operating room repairing their limb. In that case, in those patients who do use vein and where the surgeon spends an extra hour, that can actually increase the risk of amputation and necrosis and gangrene and other types of stuff. We actually believe in terms of the market that we will ultimately capture over several years of commercialization in trauma, we believe that we will capture the vast majority of that 26%, that one quarter of patients who are treated with synthetics. We also believe that we'll capture a fraction of the vein market, particularly patients where it's been a long time since their injury and surgeons need to move quickly and have a conduit that's immediately available. If we think about reimbursement and how the vessel is paid for, in the setting of trauma, all of those hospitalizations operate under a DRG, diagnostic related groups, or a fixed price basis. What this means is that the hospital purchases our product and there's no separate reimbursement. In order to work with hospitals and to work through the value analysis committee, it's necessary for us to show not only improved clinical outcomes, which I believe our data show, but also a compelling budget impact model, which talks about the total cost to the hospital that they incur every time they take care of these patients. This budget impact model is actually going to be published in the next week or two. The publication is imminent. At a price point of $29,500, what we're able to show is that if Symvess is used as compared to the 26% of patients who are currently treated with synthetics or bovine grafts or cryovein, actually the hospital probably saves money, primarily because of the reduced rate of amputations and the reduced rate of infections that will occur in patients who are treated with Symvess as opposed to these other grafts. In addition, the total cost of treating the patient as compared to the cost of using vein for a patient who's had a long ischemia time is actually not that different. If you're almost on par in terms of costs, then other factors begin to weigh in, such as surgeon preference, time pressure, desire to get out of the operating room with a badly injured patient. We're also very excited to be working on a new technology add-on payment of reimbursement or NTAP from CMS. Even before we got approval, we submitted an application for an NTAP to CMS last fall, and we had our town hall meeting in December. We've gone back and forth with them and answered some questions. We believe we have a strong case for getting an NTAP payment because there's really two important criteria for getting an NTAP. One is that the technology is new and we clearly qualify. Two, that the technology provides an important clinical benefit above and beyond what's currently available. I believe that we check both those boxes and that we have a strong case for getting NTAP reimbursement. We should hear that decision in August. If we do get that reimbursement, it would begin to kick in in October of this year. It would provide up to 65% of a reimbursement to the hospitals when they use our vessel in the treatment of trauma. Going beyond the trauma indication, I'd like to talk about other indications that we're excited about in the pipeline for Symvess or ATEV as the generic name. In dialysis access, which is a chronic and very challenging medical problem, we believe that there are aspects of the ATEV that really make it ideally suited to treat patients who need access for hemodialysis. One is that the diameter of our vessel is actually ideally suited. It's 6 millimeters in diameter, and so it doesn't have to mature or dilate or grow after implantation. In fact, after implantation, after about four weeks of healing, the vessel is usually usable for dialysis. In addition, we've done several clinical trials which have shown a very low infection rate for our vessel, despite the fact that it gets punctured with needles three times a week for dialysis access. Thirdly, we've seen that it's durable. Because of this and because of our connection with Fresenius Medical Care, we've been very interested in understanding how well our vessel performs relative to what is currently the gold standard now in dialysis access, which is the autogenous fistula. We recently reported about six months ago the top line results on a prospective randomized head-to-head phase three trial, comparing our vessel, the ATEV, to the gold standard, which is autogenous fistula. This was a US-based trial in about 242 patients where we looked at patency and usability for dialysis during the first year. Just very briefly, these are the top line results on that trial where, as you can see, the functional patency at month six and the secondary patency at month 12 for our vessel, the ATEV, were both greater than those observed for AVF, which is autogenous fistula. The P-value there was 0.007, so it was a very convincing result. In addition, the number of months that the vessel was usable for dialysis across all patients was better for ATEV than for AVF. We were very encouraged by these results. We also wanted to understand at a more fundamental level, in the whole dialysis community, what are the patients who really struggle with arteriovenous access and who are the patients who could benefit most from our vessel? Because again, at a $29,000 price point, we believe that we're going to have to show enormous clinical value as well as potentially savings to the system in order to get broad market adoption. This is a Kaplan-Meier curve of the functionality of our vessel, the ATEV in red, and then compared to autogenous fistula in blue. What this KM curve is showing is the results for two subgroups. One is women, all women, and the other is men with diabetes and obesity. If you add those two subgroups together, it's actually more than half the market, so it's not a teeny tiny subgroup. As you can see, the separation in these Kaplan-Meier curves is enormous, and it extends out to two years. What's also sort of sobering about this curve is the fact that you can see that in women and in men with diabetes and obesity, the success rate of the fistula operation is only about 50% because that blue KM curve sits right around the 50% line, which means it's like flipping a coin. Every time you do a fistula operation in these patients, chances are one in two times it's going to fail. When it fails, what happens is the patient winds up staying on a catheter and having to survive repeated infections, sometimes sepsis, sometimes hospitalization. This causes a lot of morbidity for the patient, and it's also expensive to the system. We believe that the ATEV in the dialysis population really has the potential to get patients who really struggle with fistula maturation, to get those patients a reliable surgical access and get them off catheter and keep them out of the hospital. Importantly, if we look at the safety results for patients overall, but I would say even more importantly for this subgroup of women and men who have diabetes and obesity, what we can see is that if we look at the number of complications or the number of interventions that are required to keep the vessel working, if we look at it in terms of events per patient year, we can see that actually the event rate for the ATEV is very similar for the intervention and event rate for fistula. The number of interventions that are required to keep the access going is pretty similar. Importantly, though, if we look at important safety events like rupture, in fact, there were two ruptures reported with fistulas, and there were none reported with our vessel. The amount of surgical intervention and removal was also less for our vessel. We believe that the efficacy results, which are very strong in this subgroup, combined with really encouraging safety results, means that this is a good population for us to go after in this very important market. After discussions with the FDA about a supplemental BLA filing, we have decided to go after this general subgroup. Before we file a supplemental BLA, which we are hoping to do later in 2026, our plan is to complete a currently ongoing phase three trial, which we are doing just in women, which compares our vessel, the ATEV, to women who are receiving a fistula for hemodialysis. This is a small trial. The total enrollment is only about 150 patients, and we're doing an interim analysis at 80 patients. We expect to hit this interim enrollment number in the next couple of months and expect to get interim data in the middle of next year. If those data are positive, then our plan would be to file a supplemental BLA in this target subgroup because we believe we'll show both outstanding function and outstanding efficacy compared to the gold standard and also outstanding safety. More to come. I think that while the trauma market is very exciting for Humacyte, I believe that the second follow-on market for the same vessel in dialysis access could be even more exciting. With that, I will finish. Thank you very much. The ASP that we've announced is $29,500. The cost of harvesting a vein, you don't have to buy a vein. There is the cost of operating room time, and it can take up to an hour to harvest and prepare a vein. There's also costs associated with wound infections at the vein harvest site. We believe, more importantly, in trauma, the costs of using vein in a patient who's had a long ischemia time can be greater than just the OR time because if you add that extra hour to somebody who's had an ischemic limb for four hours and then you make it five hours, the chances that that patient goes on to amputation, which is very expensive, get higher and higher. We believe that the total cost of care that gets factored into the cost that the hospital bears in the DRG, you have to think about not just the acquisition cost of the vessel, but also all of the complications that I believe we avoid. Does that make sense? Yeah, thanks for that. As far as the TAM and the AV access market, when we've talked about the addressable market for dialysis, we've always thought that we would aim for about 20% or 25% of the market. That's how we've guided analysts for a long time. I actually think we may be able to aim for a bigger chunk of the market. In answer to your question, the total number of dialysis patients in the US right now on hemodialysis is a little under 500,000. If you look at the total number of surgical access procedures that are done every year to maintain access, it's about 150,000 or so. If you assume that half of those are in our target population, which is women and obese diabetic men, then let's say that's 75,000 cases per year. That's a lot of cases. I think that is the right way to think about it. In fact, we had some leadership from Fresenius visiting Humacyte just last week to talk about some of these clinical results because we think they're exciting. Fresenius obviously thinks they're exciting too because Fresenius wants their patients to do better and wants to get them off catheter. What's important from the standpoint of Fresenius's mind view, in addition, obviously, they want their patients to do better and have better surgical access. From a reimbursement standpoint, up until about a year ago, CMS used to reimburse dialysis clinics based on how many fistulas they had because they were trying to push as many patients getting fistula as possible. About a year ago, that reimbursement paradigm changed. Now the thinking is get patients off catheter because it's abundantly clear that catheters are bad for the system and bad for patients. Now CMS has changed the reimbursement so that the more catheters a center has, the more of a ding they take on their reimbursement. We believe that the incentives are going to be aligned because we believe we can improve dialysis access in these target populations while also helping Fresenius meet its goals of minimizing catheter exposure. Sure, yeah. The VEETH meeting was very exciting. We had actually expected to have already been approved by the time of the VEETH meeting, which was in November of last year. As it turns out, the FDA dragged their feet a little bit, and we got approval after the VEETH. Even pre-approval, there was a tremendous amount of buzz. We gave several presentations, and there was a lot of traffic at our booth. I think that's really because if you look in vascular surgery writ large, there hasn't been a new conduit that conducts blood introduced for the last 30 or 40 years. All of the innovation in vascular surgery has been stents and syringes and catheters and this and that, and not to diminish catheters and stents, but there's been no fundamental new conduit to enter this space in decades. We've been presenting at the podium for years, and there's a fair bit of surgeon awareness about this. Now that we have approval, there is a lot of excitement, and there's a lot of sort of boostering from local surgeons at a lot of these trauma centers. Even though we just announced a commercial launch last week, what I can tell you is that we're already through more than 21 VACs, which means that there's only 200 level one trauma centers in the US. We've already introduced our materials into more than 20 of them. We also already have two VAC approvals, which in my mind is sort of the land speed record. I would say, Josh, to your question, as far as guiding the market on what type of sales we expect during this year, the reality is that most VAC processes require three to six months. Since we got our approval only a few weeks ago and we just had our commercial launch last week, we really expect that for the first one or two quarters, sales are going to be pretty low. We're not going to have a lot of sales. We really think the sales will be backhanded in the second half of the year. We will continue to inform the market about our progress with VACs, our track record with how many approve it and how many do not approve it, et cetera, et cetera. We think there are lots of surrogate markers where we're going to show progress in our commercialization effort. We do think that sales are going to be loaded in the back half of the year. I think having it in the peer-reviewed literature will be helpful. Although I will say our commercial team has these VAC packs, right, which is all of our clinical data and also our entire budget impact model. They even have sort of an interactive version of the budget impact model where these centers can input their own complication rates and their own numbers of patients treated per year and can directly calculate the impact of Symvess on their bottom line. We have actually had pretty good traction with the VACs. Although you're right, I mean, a peer-reviewed publication would give us even more momentum. I think it might even help more, frankly, with surgeons because surgeons are so—it's not just the hospital administrators. Surgeons are also conditioned to think about costs.