Good morning, and thanks for joining us to have a conversation with Laura Niklason, Founder, President, and CEO of Humacyte, and Dale Sander, Chief Financial Officer of Humacyte. Humacyte is a commercial-stage biotechnology platform company developing universally implantable bioengineered human tissues at commercial scale. The company's platform produces off-the-shelf acellular tissue engineered vessels, or ATEVs, that require no immunosuppression and remodel into the patient's own tissue. Symvess was approved by the FDA in December 2024 for extremity arterial injury and with the company building a new commercial leadership team, has launched the product. in June of this year, the V012 phase III interim analysis in women on dialysis met its primary endpoint with 91 more catheter-free days than AV fistula. Humacyte now expects to file that BLA dialysis access in November of 2026. Behind all this sits PAD, a first-in-human CABG study of the coronary vessel. It is also looking into BioVascular Pancreas as well. To discuss the company's pipeline, commercial rebuild, and the regulatory path, let's get started with Laura and Dale. Thank you very much, Laura and Dale. Glad that you both are here, and appreciate you accepting our invitation to talk to our audience today. Laura, for those folks who are really new to the story, you know Humacyte has one approved product now in vascular trauma, and a supplemental BLA on the way, are targeted in November. How should investors think about this long-term strategy? Is trauma to be considered as a beachhead that funds a much larger dialysis and also the cardiovascular franchise? Or should we think of them as three different or independent businesses? Well, thanks for that, RK, and it's great to be here. It's been a great meeting. You know I would say that the answer to your question is sort of a little bit of both in the sense that for our first approved indication for Symvess, which is our 40 cm long by 6 mm diameter vessel. For that vessel and for the dialysis indication, it's the same product. In terms of our filing in dialysis, which we're very excited about because our clinical data's extremely strong, that will be a supplemental BLA because all of the manufacturing for the product is the same. We're providing new information to the FDA in the form of three phase III clinical trials, all of which have shown consistent results, in outcomes, particularly in women, which is a really underserved population in the enormous dialysis market. When you were asking about a beachhead, I really do believe that the vascular injury indication, which we got a year and a half ago, really is a beachhead for dialysis. Because dialysis access is typically performed by all the same surgeons and in the same hospitals as vascular injury repair is performed. There are some subtle differences and non-overlaps, but most of all, vascular injury will really be a beachhead. In every hospital where we have our vessel on the shelf for vascular injury repair, once we do get approval in dialysis access, which I hope, I anticipate will be sometime middle of next year, 2027, then if it's on the shelf, we'll be able to send a letter notifying the hospital of the approval, and physicians will be able to pull the product and use it on label. All of the initial startup activities that we've had to do in our first indication won't be true here. Very good. Let's start talking about the commercial products, Symvess. In the second quarter, Symvess sales was about $0.4 million, which was certainly lower than the consensus expectation of $1.1 million. Jim Mercadante attributed the shortfall to the ongoing commercial rebuild. What specifically was not working in the original launch model, and what does the rebuild actually look like today? Right. Thank you for that. Jim Mercadante, who's our new Chief Commercial Officer, he came on April 1st, right at the beginning of Q2 of this year. When he joined us, we also had Todd Rasmussen join as our Chief Surgical Officer. He's a vascular surgeon with the Mayo Clinic and also provides a lot of peer-to-peer support as far as our commercial launch of Symvess. What I would say was probably not working with launch 1.0 was that we had many members of the commercial team really did not have the deep relationships with vascular surgeons that are really needed to launch a first-in-class product that is completely new to a market that hasn't seen a new conduit in 40 years. The revamp that Jim has done is not only himself, but also bringing in other very senior people from such heavyweights as Medtronic. We've had a number of very successful salespeople leave very good jobs and come and work for Humacyte because we've got these great commercial leaders in place, and their reputation precedes them. We anticipate that with the more experienced and deeper relationships with hospitals and surgeons, that we'll penetrate the market better. In addition, I think how we talked about Symvess to surgeons and hospitals is changing, and we're really pointing out the value of the vessel for patients and for hospitals and surgeons. For example, we have programs in place now where if one of our vessels becomes infected early in the postoperative course, and if it's clear that it was not just a surgical error. Then we replace that product at no charge to the hospital. That's really kind of a bold move, but it really reflects how confident we are in the properties of our product. That level of confidence when expressed by the sponsor goes a long way when you're talking to surgeons and hospitals. You have also said that the new national structure opens access to roughly about 1,000 additional hospitals, and that at least 20 major U.S. health systems, each spanning 5- 50 hospitals, are actually in the process of adopting Symvess in the second half of this year. Can you walk us through what adoption means at each of these steps, especially like the VACs shelf stocking, and also the first use, and in general, how long does that cycle take? The last part of your question, in general, how long does that cycle take? That's probably the hardest part of the question to answer, because in some cases we've seen very accelerated uptake, and in some cases, it can take months. With respect to the first part of your question, which dealt with national accounts, that was another, I think, thing that Jim, when he came on, built out a national accounts force, which really seeks to engage larger groups of hospitals like HCA and Ascension and what have you. Really engage them in a contracting process, which is not the same as the VAC process. The contracting process is really critical, especially for these larger systems, because without being on contract, even if you do have VAC approval, it's very hard to get the product on the shelf. Dealing with the contracting is a huge area of focus for us with these larger systems.You know I think that contracting, which takes time, I think is going to progress over the third quarter and fourth quarter. I think we'll really start to see the impacts of that in the fourth quarter of this year, and then starting in the first quarter of next year. Moving on to dialysis access. In the V012 interim analysis of the first 80 patients, 80 patients averaged 220 catheter days versus 129 for the fistula, which is a 91-day difference. Why was catheter-free days the right primary endpoint and how do nephrologists and payers actually translate these three extra months into value? Yeah. The three months of catheter-free days on average in women that we had just in the first year is just the beginning of the benefit of our vessel, Symvess, as compared to fistula. What our clinical data have shown in the V007 trial, which is another trial that compared our vessel to fistula, and the results of which were just published in The Lancet a few weeks ago. What that trial showed and what the ongoing V012 trial just in women is continuing to show, is that we have an advantage in catheter-free days in year one, and this extends into year two. The two year data, for example, in the V007 study have already shown across all patients a five to six month benefit in terms of catheter-free days. What does that mean? In terms of nephrologist goals, in the care of dialysis patients, one of the metrics that nephrologists and dialysis centers are measured against is how many patients are dialyzing via catheter. CMS will actually penalize dialysis centers if they have too many patients on catheter. In addition, the cost to the system are substantial. Literature shows that if a patient is dialyzing on a catheter for a full year, on average, they'll cost insurers and Medicare about $30,000 more per year, every year than a patient who's dialyzing with a fistula. The math becomes pretty simple. If you save six months of catheter exposure time, that's easily a $15,000 savings just on the cost of hospitalization and infection. The economics actually become very attractive for payers in addition to providing better outcomes for patients and hitting goals for nephrologists. Okay. In your August 24 release, you also confirmed the November filing supported by V012, plus also the earlier studies, V007 and V006. And you are seeking for a broader label, beyond the women at elevated risk, including certain at-risk men. What in the data actually can you point to that supports this broader population? Did the FDA signal on that, or did you have any discussions with the FDA for that broader population? So we have had no specific discussions with the FDA on the intended label and population. But you are right, RK, when we file, we anticipate filing for the dialysis indication in November, and if we get an accelerated review timeline, we would expect a PDUFA date sometime in May of 2027. That all depends, of course, on decisions by the FDA and their timelines. As far as our target indication, we are anticipating targeting that our vessel would be indicated for hemodialysis access in patients who are at high risk of fistula non-maturation. Examples of those patient subsets might be women and men with certain risk factors, such as diabetes or obesity. The data to support outcomes in men really comes largely from the V007 study, where we directly compared our vessel to fistula in both men and women. What we found and what we published a few weeks ago in The Lancet is that men with certain risk factors, such as diabetes and obesity did more poorly with fistula and did better with our vessel. We have data from the V007 study in men. We also have supporting data for durability and safety outcomes in the V006 study, which did not compare our vessel to fistula but compared it to PTFE. The total number of patient years of data that we are going in with this supplemental BLA is over 1,000 patient years of exposure, which is a tremendous amount of data. Again, we believe these data sets are consistent across the studies, particularly for women, and we think it is going to be a strong package. Okay. In the U.S., 60% of the permanent access are actually fistulas and roughly 40% of which fail to mature. Even successful fistulas take three to six months to become usable. If approved, where does the ATEV get used first? Is it as a fistula alternative, or is it after first access failure? You know I think that's going to be an interesting discussion with the FDA and with surgeons. A case can be made. Of course, again, we are not approved for the dialysis indication, but I believe our data says that a case can be made that if you're particularly a high-risk woman, a woman who might have diabetes and/or obesity, we know that those women are at very high risk of fistula non-maturation. And a very large fraction of those women remain on catheter for a long period of time. So it might be a suitable case to be made that in those particularly high-risk patients, Symvess might be first line for dialysis access in a new incident patient. In some other patients where the surgeon feels that a fistula has a reasonable chance of maturing, if it happens that in that patient it does not mature, then certainly our vessel, according to our targeted indication, would be an outstanding choice for those patients. Okay. Moving on to cardiovascular. The FDA has accepted the IND for coronary tissue engineered vessel, and you plan to initiate a phase II-A study in CABG. So with the 3.5 mm inner diameter in a high-pressure environment versus the 6 mm ATEV, what have been the changes, and what would you need to see in the first patients to call it a success? Well, we're very excited, RK, and thank you for bringing this up because this is the first prospective study of a new conduit in coronary artery bypass that's ever been done in the U.S., to the best of my knowledge, or certainly in the last 30- 40 years. So the way the phase II-A trial is designed, and as was agreed with the FDA, is that the primary endpoint is patency at two months. We will follow these patients for three years, but the primary endpoint is patency and avoidance of thrombosis at two months, as documented by imaging. And the reason for that is because the mechanical properties of the smaller caliber vessel are actually outstanding, that the vessel is very strong. But at a smaller diameter, what clinicians will worry about is the risk of thrombosis. In our study, we're providing good anti-clotting medicine, anti-platelet medicines to really reduce the risk of thrombosis. Typically if a conduit-driven thrombosis is going to occur, it will tend to occur early. That's why the FDA signed off on this two month primary endpoint. We're really looking at patency over these initial time points. The way the trial will go is that we're going to enroll the first three patients in a staggered manner every two months and then send those results to the FDA, and then we hope and anticipate get clearance to enroll the rest of the study. Okay. Saphenous vein grafts are used in about 80%-90% of the CABG procedures, but we know that within a year, 10%-25% of them fail. Is the realistic target for the ATEV the patients who really lack a usable vein? Do you eventually intend to go head-to-head with the vein patency on patency? Well, I think it's hard for us to predict at this early phase what a pivotal study would look like. Certainly, you're correct in that there are at least 200,000 coronary artery bypass operations that are done each year in the U.S. If there were more patients who had high-quality, suitable vein, more of those operations would probably occur. Assuming that our patency levels were comparable to those of vein, then I would expect patients who lack suitable vein, either because it's been harvested or because the vein is diseased or too small or poor quality, those patients might be suitable for using our vessel for coronary bypass. I think that the head-to-head studies and the long-term comparability to vein is something that we would certainly aim for. I think that we have a scientific basis to believe that we may be comparable to vein in the long term, but we have to do the studies and prove it out. Okay. Dale, you ended the second quarter with $80 million in cash after doing a secondary offering. Also did a restructuring in May, which is expected to deliver about $14 million in net savings for the year. With all this, what sort of a runway does a current cash position provide? Thanks, RK. The combination of the financing and the cost-cutting that we had done by refocusing some of our R&D efforts gives us runway well into the second half of 2027. That is past some very key milestones for the company. Laura has also already described the fact that we expect quarter-over-quarter sales to continue to grow with our initial launch of Symvess in vascular trauma. With the dialysis area, we have a whole series of key milestones coming up. The filing of the supplemental BLA in November, our expected acceptance by the FDA of that BLA in January, and then approval, dependent upon if we get granted a priority review, as early as May or June next year. That combined, we believe, with the results of CABG, which we will initiate that trial sometime in 2026. With the two month follow-up, we should start getting results early in the first half of 2027, and we think there will be a great deal of excitement about the CABG initiation of that trial as well as the results. The financing does take us past a number of key milestones. Laura, in closing, of all the catalysts that Dale just talked about, which ones do you think the market is not paying proper attention to? Well, I don't think the market is paying proper attention to anything that we're doing because I think we're incredibly undervalued. But I do think that the market is perhaps undervaluing the dialysis opportunity. There has not been a new conduit for use in dialysis access in decades. Women in particular are terribly underserved. More than 200,000 women are on hemodialysis in the U.S. right now. Half of them are forced to rely on plastic, either plastic catheters or plastic grafts in their arms because fistulas don't work. So this is an enormous and underserved market that we've known about for decades, and I believe that our vessel may finally be able to address this. And I think there's going to be a lot of enthusiasm among surgeons and nephrologists and frankly, also amongst patients. Thank you. Thank you for being here. And good luck. I know it's a great next 12 months for you folks. Yes. Thank you very much. Thank you.