Humacyte, Inc. (HUMA) Earnings Call Transcript & Summary

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.