Humacyte, Inc. — Call Transcript 2026

Good evening. Welcome to the Humacyte Virtual Investor event. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded. 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. 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 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 burying 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 interim analysis was done after the first 80 enrolled patients had reached at least one year of follow-up. The 80th patient reached one year in April of this year. We received the top-line results only very recently. Patients who received ATEV had 91 additional catheter-free days as compared to patients who received fistula. This result was highly significant at a p-value of 0.0007. There were also multiple secondary efficacy endpoints that were met. Overall, we believe that the benefit-risk safety profile for ATEV is favorable, particularly for women who require access for hemodialysis. 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. 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 coax 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 ATEV, is six 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. We received this approval in December 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 woman-only study that's actually ever been done in dialysis access. 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 arterial disease. In addition, Humacyte hopes to begin a phase lla 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. 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. 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 an Associate Professor of Surgery at Brigham and 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 looking for better solutions for our patients. 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. 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. Through their blood, their blood is cleaned through the dialysis machine. About 85% of the people who develop 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. It is a common problem among our patients with kidney disease. When we look at all types of hemodialysis options we can offer our patients, the most common is AV fistula. This is a connection between your own artery and your own vein to facilitate dialysis or cleaning of the blood, for renal replacement therapy. About 20% of the people have AV grafts, which is an alternative to fistula, some sort of foreign material. About 20% of the people have catheters or the most temporary option. Unfortunately, although most patients get 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 one year or fail, so have some sort of problem. One of the reasons for this is because we're still creating fistulas like it was first described in the 1960s. Over 60 years, there has been not a ton of progress in creating and maintaining fistulas better than we do right now. 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% start with their own vein or their fistula, which is the optimal access. You would expect over a period of three to six months after that fistula is created, that blue bar, the dark blue, increases, and almost everybody has a great fistula, and nobody has this temporary catheter. Unfortunately, if you look at the far right, at about 12 months, a quarter of the people still have catheters, and only about 36% have fistula. Because of the two problems, either fistulas are created and they don't work well, or patients just aren't great candidates for fistulas, and that's why a lot of people still end up having catheters. Why don't we like catheters? Well, catheters get infected. They are a prosthetic foreign material sticking out of the body, and unfortunately, there's a lot of hospitalizations or infections related 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 optimal. A lot of patients also get graft infections, in fact, about 10% with traditional AV grafts. Fistulas would be great if everybody's a candidate because they have low risk of infection. Overall, this is a significant burden in the healthcare system. Hemodialysis catheter infections cost about $30,000 per hospitalization and over $2 billion for our healthcare system in general. This is because a catheter that gets infected needs to come out. Patients need to be treated with IV antibiotics, then they need 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 a temporary catheter back in, and then antibiotics and some sort of permanent solution down the road. This also costs over $0.5 Billion dollars per year in our patients. Women in particularly are burdened with this infection-prone access. If you look at the far left, you can see in all patients, fistulas is about 57%. When you look at the far right, in women only, synthetic grafts and catheters in particular are present more so in women and are associated with more infections. That's because women in general have smaller blood vessels to start off with, so smaller arteries, smaller veins. They may actually not be great candidates for using their own vein for fistula creation, and may also not have great vessels for even a graft creation. A lot of them will be left with catheters, which can then increase your risk of having infections relating to catheters. 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. 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 of V012, showed a greater benefit, a much larger benefit for ATEV versus AVF in terms of patency, both at month six and month 12. There was a longer duration of use of ATEV by about three months between ATEV and AVF in women. We also saw the similar differences in other patients who are considered at high risk of maturation, such as males who are obese and who have diabetes. All in all, the results in V007, which was an all-inclusive study of males and females, indicated that a lot of the results were driven by these subgroups, especially in women. In that same study, we had followed patients up for two years, and we had shown durability of ATEV. You can see the difference in the red and the blue curve is the time when patients still need access, and they are at increased risk of catheter use if they happen to be on AVF arm. These were the data from V007, and that led us to the design and execution of V012 study. In V012, we are a head-to-head design between ATEV and AVF. It's a multi-center trial in about 25 centers in the U.S., of which about 20 centers contributed actively to enroll patients. For females with end-stage kidney disease on hemodialysis, randomized 1-to-1. The enrollment goal was 150, and the study is designed for a 24-month follow-up. The primary endpoint, however, is at one year, and the primary endpoint is catheter-free days. In the protocol we had specified that once 80 patients complete one year of follow-up, we'll do an interim analysis to see if there is superiority in catheter-free days. That's the results that we are now presenting to you for this interim analysis of 80 patients at one year. 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, very equally distributed, and patients with diabetes were also equally distributed between the two 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 one-stage AVF or two-stage AVF ahead of randomization, just to make sure that there is equal distribution of such patients in the two 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 three 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 or AVF for catheter-free days at the one-year time point. This slide shows you the rate of maturation between the two treatment arms. Again, ATEV had a superior rate of maturation. Patients in ATEV, shown in red, matured faster, and they matured at a higher rate, closer to 90%, while in AVF, there was approximately a 60% maturation rate with 40% failure rate. Again, you can see the amount of time it takes to mature for AVF. Again, the separation between the curves is when these patients would be relying on catheters for their AV 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 access infections for ATEV use of one year versus AVF. There were two events of infection in the ATEV group, both were dialysis catheter, and then there were nine events in AVF, three of which were AVF-related infections, and the others were mostly catheter-related infections. If you look at the difference in rates, as I mentioned earlier, this would translate to six events per 100 patient-years for ATEV, 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 bunch of secondary endpoints that we analyzed. Here are the results of the secondary endpoints. We were looking at catheter-free days in the first six months, and you can see virtually most of the benefit is obtained 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 predefined hemodialysis threshold that the patients had to reach to get functional patency. Again, there was a significant difference between the two arms of 250 days versus 150 days. A very significant P value. We looked at secondary patency at six 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. The last one was 12-month secondary patency, where ATEV was at 78%, again, consistent with 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. Those are the secondary endpoints that we had predetermined in the trial and that we tested, and 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 three 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. 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 pre-specified that are of interest because of associated being with AV access. There were zero infections, as I mentioned before, with ATEV per se. There were three related infections in the AVF group. Thrombosis was 20 versus eight with a rate of 0.75 to 0.51. This is significantly less than what we had seen in V007. Importantly also, the thrombosis treatment rate or 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. Adjusted for duration of use, it was less stenosis in the ATEV group. The rest of the things, clinically significant steal syndrome, study access ruptures, which were zero in both arms. Iatrogenic injury was one 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. Very balanced, very favorable safety profile to go along with a favorable efficacy profile in this study. 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 three more months, on average, three more months of catheter-free days compared to AVF in the ATEV group. ATEV patients incurred 17 fewer dialysis access infection than AVF for every 100 patient years of use. There was clear and consistent advantages over AVF in multiple secondary endpoints. Overall, our benefit-risk safety profile of ATEV is favorable, with no new or unexpected safety concerns identified. As we had pre-specified in the protocol, if we establish superiority in 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. We plan to file our supplemental BLA with the FDA during the second half of this year, and we're looking for a target indication in adult patients with end-stage kidney disease who are at an increased risk of AV fistula maturation failure. Thank you, I would like to turn it back to you, Dr. Hussain, for your perspectives as a V012 investigator. Thank you so much. Very exciting and interesting results, potentially a new avenue for our patients who are high risk for access complications. I'll talk about these three things and sort of try to put the results in context. 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. Also have had observers come and sort of see us use it and teach others to use it, I think the most common comment I get when first somebody starts using it is how much it feels like a real vessel and how much it sews like a real vessel. I think that's really one of the nice things as a surgeon to think about having an option that really mimics a human body's vein or artery. I think that's been a very nice to handle, it's been easy to use, I think a very nice experience for the surgeon to be able to utilize for the patients. These results are very exciting. Couple of nuanced outcomes I like to bring out is that as a surgeon, we really think about infections in these patients and graft infections. These patients who had the ATEV had significantly lower catheter time and significantly lower number of overall infections because of two reasons. One, because of having less catheter contact time, which leads to lower infection. Also what really I found interesting was that risk of infection was zero in the access itself in the ATEV group, but 8% in the fistula group. You may ask, well, why did 8% of the fistula group get infections? Well, because most likely these patients were having the fistulas that weren't maturing, being revised with grafts or having 2-stage accesses. They had a fistula that didn't quite develop, having a second stage graft made out of other foreign material leading to more infections. I think sort of those two advantages, having less catheter time and less exposure to graft material and getting the ATEV right away, seems really beneficial for this cohort. This was a high-risk cohort, as you saw from the slides. 50% were obese, 50% had diabetes, which are really high risk for infection. 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, about 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, may need a stage 2 surgery. This certainly presents a lower risk option for her, and I was able to implant that for her shortly after the results. I foresee that patients who have borderline mains, both men and women, or patients who need stage 2 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 five months for patients who had fistula. If we have patients who we anticipate will have catheter time of several months because they will 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. These are my initial thoughts, and it is a very exciting time for this potential option for our patients. I will turn it back over to Tara and happy to take any questions. Great. Thank you, Dr. Hussain. Yes. At this time, we will be conducting a question and answer session with our speakers. To our analysts joining us live, please use the raise hand feature to indicate you have a question. Please hold for a brief moment. Great. Our first question comes from Bruce Jackson at Benchmark. Please go ahead, Bruce. Hi. Thank you for taking my question. First, the definition of the diabetic patients, what was the objective measure for that? Is it an A1C? Shamik, you want to take that? Yeah. That was patients who had 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 A1Cs would be perfectly normal. These are patients who have a history of type 2 diabetes documented, just like you would have a history of hypertension. Minimal A1C was not needed to participate. They had to have history of diabetes. I think there was a exclusion for severely uncontrolled diabetes patients simply because they may not be stable in the study, but that was about it, Bruce. Okay. A quick follow-up. The label hopefully is going to be people with increased risk for graft failure. Is that something that's generally recognized in terms of the criteria? How do you think the data from the study supports that? Yeah. 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. One, this is a very well-published area in the literature of patients of risk factors for maturation failure. As I sort of indicated, women, obesity, diabetes, and 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 patient 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. All right. That's it for me and congratulations on the study results. Okay. Thank you. Great. Thank you, Bruce. Our next question comes from Izzy McMahon at BTIG. Please go ahead, Izzy. Hi, everyone. Thanks for taking the questions. Just to start, I was hoping to follow up on that last point that Bruce was just making. Yeah Maybe think about it from the practicality standpoint of the ATEV. 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. Yeah. Great question. I'm happy to think about it from a clinician standpoint. I think there's two 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 end that you're planning on using. That's a decision one can make in clinic or in hospital, 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. You may have a patient who has an infected access, and it needs to be revised pretty quickly. In that scenario, I think as a surgeon, I would also consider this and would 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 have been infected, may have ruptured, or may have other issues that come up. Okay. Appreciate that. Thank you. 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 two 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? What do you think this could mean for longer-term outcomes? Thanks for taking the questions. Thank you for the question. I think these are very promising one-year results, we'd love to see how things pan out over two years. I think it's very promising that the patients are staying off catheters, that their risk of infections will be lower. If they're not getting suboptimal vein accesses or that may have to be revised by conduits that get infected at a higher rate, I do anticipate that the risk of infection would be lower long term. The nice thing about this is it does integrate really well with the human tissues. We know that there is a delayed risk of infection with prosthetic conduits because of repeated cannulation three times a week, every week when they go to dialysis. When you have a conduit like this made out of human cells that integrates with all the tissues you would anticipate that the risk of these delayed infections is also lower, would be very much looking forward to the results. Great. Thanks for the questions, Izzy. Our next question comes from RK at H.C. Wainwright. Please go ahead. Good afternoon, and thank you very much for hosting this session. Couple of quick questions for Dr. Hussain. Given that this is a women only and U.S. only 80 patient interim analysis that we 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? Yeah. Thank you for the question. I think the way I look at this is just the next addition of the clear data that we have. I was part of the V007 trial, which was all comers, men and women. That was also positive with patients who received the ATEV, met the primary endpoint and had better durable accesses. The subgroup analysis of course showed the women and the high-risk subgroup of that evidence. Now we have level A evidence in women, which again, we don't have in the AV access space. I'm just very excited we have that. I'm also a clinical trialist, and I get excited about level A evidence. 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. Certainly, I would feel a lot more comfortable as further applying that data in the high-risk patient cohort, which includes the women and certain men without the appropriate conduit options available and the fistula options available. Thank you. I have one more question for you, doctor. As we know, some of this patient population are candidates for transplant. How meaningful is the immunogenicity advantage that you had discussed in the data? Does the implantation with the ATEV preserve and actually improve the eligibility of these patients for transplants rather than having grafts or fistulas? Yeah. Good question. I'll let the Humacyte team talk about specifically immunogenicity part. 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. 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. Some of the fistulas, for example, we create become very high flow because they become aneurysmal and they cause pulmonary hypertension and heart blocks. From the ultrasound data that we've seen and the steal data that you saw today, the rate of steal was very low in the women who received data, which indicates to me that this conduit is not dilating. It's not becoming aneurysmal, which hopefully means better for the patient's heart and better for the transplant candidacy. That's how I look at the patient and the access when we think about transplant candidacy from a cardiopulmonary standpoint, which can be affected by the access. I'll let the Humacyte team talk about the immunosuppression part as well. Yeah. Unlike when putting in a PTFE graft, which is essentially plastic, the body does develop antibodies to it, and we have panel reactive antibodies to it. Humacyte graft or Symvess does not have that issue. It's human cells, and it has shown zero immune rejection or signs of clinical immunogenicity in terms of clinical reactions in over 1,200 patient years to date. The more the antibodies, the greater is the chance of rejection in dialysis. There is an advantage, versus especially PTFE, in terms of less immunogenicity, with ATEVs. The second is about infections and less infection rate versus PTFE, as was commented on before. Yeah. Thank you. Thank you all for taking my questions. Thanks, RK. Our next question comes from Allison Bratzel at Piper Sandler. Please go ahead, Allison. Hey, good afternoon, team, and thanks for taking the questions. Just actually two questions for the company on the regulatory path. 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? Just how will data from V006 be considered in the review? 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? Just what was FDA feedback on the ability to file just on the 12-month versus 24-month data? Thank you. Great questions. We had a discussion with the FDA once V007 was over, they were open to us filing with V007 data. At the time, we had V012 ongoing, we wanted to wait for results of V012 study, especially the interim analysis was around the corner. 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, it will be going in 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. 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 gives us 5-year durability data because we did continue that study for five years in ATEV patients. We are going to look at the women 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 five years. We're going to use the two years data from V007, which we briefly showed earlier in the presentation today. With that, we're going to show the one-year analysis of this V012 study. It's up to the FDA. They can always request more data, but we will also have ongoing data that we will share with the FDA during the file review. There is something called 120-day 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 V012 of these first 80 patients. I think we have a strong package, if you will, a clinical package. I think we are the most tested product ever in AV access before being approved, quite honestly. I think we feel confident of both the clinical package, the clinical arguments, and the benefit risk of our product versus the other competitors we had in our trial. I hope that answers your question. Thank you. Great. Thank you for the questions, Allison. 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. 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. 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. 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. With that, we'll close it up. Thank you so much.

Speaker 6: Good evening. Welcome to the Humacyte Virtual Investor event. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded. 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. Good evening. good evening Welcome to the Humacyte Virtual Investor event. welcome to the humacyte virtual investor event At this time, all attendees are in a listen-only mode. at this time all attendees are in a listen-only mode A question and answer session will follow the formal presentations. a question and answer session will follow the formal presentations As a reminder, this call is being recorded. as a reminder this call is being recorded A replay will be made available on the Humacyte website following the conclusion of the event. 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. 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. please go ahead laura

Speaker 4: Hi, everyone. 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 evaluated Humacyte's engineered vessel, the ATEV, in comparison to autogenous fistula for dialysis access. Hi, everyone. hi everyone 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 evaluated Humacyte's engineered vessel, the ATEV, in comparison to autogenous fistula for dialysis access. 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 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 burying 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 interim analysis was done after the first 80 enrolled patients had reached at least one year of follow-up. The 80th patient reached one year in April of this year. We received the top-line results only very recently. These are our typical disclaimers. these are our typical disclaimers What I'd like to start off with so that we're not burying 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. what i'd like to start off with so that we're not burying 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 interim analysis was done after the first 80 enrolled patients had reached at least one year of follow-up. this interim analysis was done after the first 80 enrolled patients had reached at least one year of follow-up The 80th patient reached one year in April of this year. the 80th patient reached one year in april of this year We received the top-line results only very recently. we received the top-line results only very recently Patients who received ATEV had 91 additional catheter-free days as compared to patients who received fistula. This result was highly significant at a p-value of 0.0007. There were also multiple secondary efficacy endpoints that were met. Overall, we believe that the benefit-risk safety profile for ATEV is favorable, particularly for women who require access for hemodialysis. 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. 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 coax them into growing new human tissues that are functional and ready for implantation. Patients who received ATEV had 91 additional catheter-free days as compared to patients who received fistula. patients who received atev had 91 additional catheter-free days as compared to patients who received fistula This result was highly significant at a p-value of 0.0007. this result was highly significant at a p-value of 0.0007 There were also multiple secondary efficacy endpoints that were met. there were also multiple secondary efficacy endpoints that were met Overall, we believe that the benefit-risk safety profile for ATEV is favorable, particularly for women who require access for hemodialysis. overall we believe that the benefit-risk safety profile for atev is favorable particularly for women who require access for hemodialysis We saw no new or unexpected safety concerns. 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. we expect to file a supplemental bla application with the fda for the indication in dialysis access later this year 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 coax them into growing new human tissues that are functional and ready for implantation. 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 coax 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 ATEV, is six 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. Our engineered blood vessel, which is FDA approved a little over a year ago, the ATEV, is six millimeters in diameter and 42 centimeters in length and is available off the shelf. our engineered blood vessel which is fda approved a little over a year ago the atev is six 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. 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. 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. 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. 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. 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. We received this approval in December 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 woman-only study that's actually ever been done in dialysis access. 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 arterial disease. As I mentioned, we have FDA approval of the ATEV in our first indication, which is treating vascular injuries. as i mentioned we have fda approval of the atev in our first indication which is treating vascular injuries We received this approval in December 2024 for the ATEV, which again, is 6 millimeters in diameter and 42 centimeters in length. we received this approval in december 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. 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 woman-only study that's actually ever been done in dialysis access. in particular the v012 trial which studied the efficacy of our vessel in women and this was the first woman-only study that's actually ever been done in dialysis access 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 arterial disease. 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 arterial disease In addition, Humacyte hopes to begin a phase lla 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. 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. 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 an Associate Professor of Surgery at Brigham and 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. In addition, Humacyte hopes to begin a phase lla 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. 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. 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 an Associate Professor of Surgery at Brigham and 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. in addition, humacyte hopes to begin a phase lla 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. 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. 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 an associate professor of surgery at brigham and 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

Speaker 5: 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 looking for better solutions for our patients. 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. 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. Through their blood, their blood is cleaned through the dialysis machine. 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 looking for better solutions for our patients. 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. 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. Through their blood, their blood is cleaned through the dialysis machine. 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 looking for better solutions for our patients. 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. 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. through their blood, their blood is cleaned through the dialysis machine About 85% of the people who develop 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. It is a common problem among our patients with kidney disease. About 85% of the people who develop 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. about 85% of the people who develop 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 It is a common problem among our patients with kidney disease. it is a common problem among our patients with kidney disease When we look at all types of hemodialysis options we can offer our patients, the most common is AV fistula. This is a connection between your own artery and your own vein to facilitate dialysis or cleaning of the blood, for renal replacement therapy. About 20% of the people have AV grafts, which is an alternative to fistula, some sort of foreign material. About 20% of the people have catheters or the most temporary option. When we look at all types of hemodialysis options we can offer our patients, the most common is AV fistula. when we look at all types of hemodialysis options we can offer our patients the most common is av fistula This is a connection between your own artery and your own vein to facilitate dialysis or cleaning of the blood, for renal replacement therapy. this is a connection between your own artery and your own vein to facilitate dialysis or cleaning of the blood for renal replacement therapy About 20% of the people have AV grafts, which is an alternative to fistula, some sort of foreign material. about 20% of the people have av grafts which is an alternative to fistula some sort of foreign material About 20% of the people have catheters or the most temporary option. about 20% of the people have catheters or the most temporary option Unfortunately, although most patients get 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 one year or fail, so have some sort of problem. One of the reasons for this is because we're still creating fistulas like it was first described in the 1960s. Over 60 years, there has been not a ton of progress in creating and maintaining fistulas better than we do right now. 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% start with their own vein or their fistula, which is the optimal access. Unfortunately, although most patients get fistulas do not work well in a lot of people. unfortunately although most patients get 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 one year or fail, so have some sort of problem. in fact about 40% of the fistulas that we create are not being used at one year or fail so have some sort of problem One of the reasons for this is because we're still creating fistulas like it was first described in the 1960s. one of the reasons for this is because we're still creating fistulas like it was first described in the 1960s Over 60 years, there has been not a ton of progress in creating and maintaining fistulas better than we do right now. over 60 years there has been not a ton of progress in creating and maintaining fistulas better than we do right now Here's a graph showing you when somebody first starts hemodialysis on the far left. 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. in the u.s 85% of the people who start dialysis get a temporary catheter in their chest Very few people, only 13% start with their own vein or their fistula, which is the optimal access. very few people only 13% start with their own vein or their fistula which is the optimal access You would expect over a period of three to six months after that fistula is created, that blue bar, the dark blue, increases, and almost everybody has a great fistula, and nobody has this temporary catheter. Unfortunately, if you look at the far right, at about 12 months, a quarter of the people still have catheters, and only about 36% have fistula. You would expect over a period of three to six months after that fistula is created, that blue bar, the dark blue, increases, and almost everybody has a great fistula, and nobody has this temporary catheter. you would expect over a period of three to six months after that fistula is created that blue bar the dark blue increases and almost everybody has a great fistula and nobody has this temporary catheter Unfortunately, if you look at the far right, at about 12 months, a quarter of the people still have catheters, and only about 36% have fistula. unfortunately if you look at the far right at about 12 months a quarter of the people still have catheters and only about 36% have fistula Because of the two problems, either fistulas are created and they don't work well, or patients just aren't great candidates for fistulas, and that's why a lot of people still end up having catheters. Why don't we like catheters? Well, catheters get infected. They are a prosthetic foreign material sticking out of the body, and unfortunately, there's a lot of hospitalizations or infections related to the catheter, which can then spread in the bloodstream and actually cause high rates of mortality and morbidity. Because of the two problems, either fistulas are created and they don't work well, or patients just aren't great candidates for fistulas, and that's why a lot of people still end up having catheters. because of the two problems either fistulas are created and they don't work well or patients just aren't great candidates for fistulas and that's why a lot of people still end up having catheters Why don't we like catheters? why don't we like catheters Well, catheters get infected. well catheters get infected They are a prosthetic foreign material sticking out of the body, and unfortunately, there's a lot of hospitalizations or infections related to the catheter, which can then spread in the bloodstream and actually cause high rates of mortality and morbidity. they are a prosthetic foreign material sticking out of the body and unfortunately there's a lot of hospitalizations or infections related 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 optimal. A lot of patients also get graft infections, in fact, about 10% with traditional AV grafts. Fistulas would be great if everybody's a candidate because they have low risk of infection. Overall, this is a significant burden in the healthcare system. Hemodialysis catheter infections cost about $30,000 per hospitalization and over $2 billion for our healthcare system in general. This is because a catheter that gets infected needs to come out. Patients need to be treated with IV antibiotics, then they need 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 a temporary catheter back in, and then antibiotics and some sort of permanent solution down the road. The second prosthetic option, the graft option, is also not optimal. the second prosthetic option the graft option is also not optimal A lot of patients also get graft infections, in fact, about 10% with traditional AV grafts. a lot of patients also get graft infections in fact about 10% with traditional av grafts Fistulas would be great if everybody's a candidate because they have low risk of infection. fistulas would be great if everybody's a candidate because they have low risk of infection Overall, this is a significant burden in the healthcare system. overall this is a significant burden in the healthcare system Hemodialysis catheter infections cost about $30,000 per hospitalization and over $2 billion for our healthcare system in general. hemodialysis catheter infections cost about $30,000 per hospitalization and over $2 billion for our healthcare system in general This is because a catheter that gets infected needs to come out. this is because a catheter that gets infected needs to come out Patients need to be treated with IV antibiotics, then they need a new catheter, and eventually, some sort of permanent access. patients need to be treated with iv antibiotics then they need 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 a temporary catheter back in, and then antibiotics and some sort of permanent solution down the road. synthetic grafts also have high rates of hospitalization because often these patients need surgery to remove the graft get a temporary catheter back in and then antibiotics and some sort of permanent solution down the road This also costs over $0.5 Billion dollars per year in our patients. Women in particularly are burdened with this infection-prone access. If you look at the far left, you can see in all patients, fistulas is about 57%. When you look at the far right, in women only, synthetic grafts and catheters in particular are present more so in women and are associated with more infections. That's because women in general have smaller blood vessels to start off with, so smaller arteries, smaller veins. They may actually not be great candidates for using their own vein for fistula creation, and may also not have great vessels for even a graft creation. A lot of them will be left with catheters, which can then increase your risk of having infections relating to catheters. This also costs over $0.5 Billion dollars per year in our patients. this also costs over $0.5 billion dollars per year in our patients Women in particularly are burdened with this infection-prone access. women in particularly are burdened with this infection-prone access If you look at the far left, you can see in all patients, fistulas is about 57%. if you look at the far left you can see in all patients fistulas is about 57% When you look at the far right, in women only, synthetic grafts and catheters in particular are present more so in women and are associated with more infections. when you look at the far right in women only synthetic grafts and catheters in particular are present more so in women and are associated with more infections That's because women in general have smaller blood vessels to start off with, so smaller arteries, smaller veins. that's because women in general have smaller blood vessels to start off with so smaller arteries smaller veins They may actually not be great candidates for using their own vein for fistula creation, and may also not have great vessels for even a graft creation. they may actually not be great candidates for using their own vein for fistula creation and may also not have great vessels for even a graft creation A lot of them will be left with catheters, which can then increase your risk of having infections relating to catheters. a lot of them will be left with catheters which can then increase your risk of having infections relating to catheters 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. 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. 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

Speaker 7: 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. 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 of V012, showed a greater benefit, a much larger benefit for ATEV versus AVF in terms of patency, both at month six and month 12. There was a longer duration of use of ATEV by about three months between ATEV and AVF in women. Thank you, Dr. Hussain. thank you dr hussain Hello, everyone. hello everyone I'm Shamik Parikh, Chief Medical Officer for Humacyte and overseeing the clinical development of our product. 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. 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 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 of V012, showed a greater benefit, a much larger benefit for ATEV versus AVF in terms of patency, both at month six and month 12. 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 of v012 showed a greater benefit a much larger benefit for atev versus avf in terms of patency both at month six and month 12 There was a longer duration of use of ATEV by about three months between ATEV and AVF in women. there was a longer duration of use of atev by about three months between atev and avf in women We also saw the similar differences in other patients who are considered at high risk of maturation, such as males who are obese and who have diabetes. All in all, the results in V007, which was an all-inclusive study of males and females, indicated that a lot of the results were driven by these subgroups, especially in women. In that same study, we had followed patients up for two years, and we had shown durability of ATEV. You can see the difference in the red and the blue curve is the time when patients still need access, and they are at increased risk of catheter use if they happen to be on AVF arm. These were the data from V007, and that led us to the design and execution of V012 study. We also saw the similar differences in other patients who are considered at high risk of maturation, such as males who are obese and who have diabetes. we also saw the similar differences in other patients who are considered at high risk of maturation such as males who are obese and who have diabetes All in all, the results in V007, which was an all-inclusive study of males and females, indicated that a lot of the results were driven by these subgroups, especially in women. all in all the results in v007 which was an all-inclusive study of males and females indicated that a lot of the results were driven by these subgroups especially in women In that same study, we had followed patients up for two years, and we had shown durability of ATEV. in that same study we had followed patients up for two years and we had shown durability of atev You can see the difference in the red and the blue curve is the time when patients still need access, and they are at increased risk of catheter use if they happen to be on AVF arm. you can see the difference in the red and the blue curve is the time when patients still need access and they are at increased risk of catheter use if they happen to be on avf arm These were the data from V007, and that led us to the design and execution of V012 study. these were the data from v007 and that led us to the design and execution of v012 study In V012, we are a head-to-head design between ATEV and AVF. It's a multi-center trial in about 25 centers in the U.S., of which about 20 centers contributed actively to enroll patients. For females with end-stage kidney disease on hemodialysis, randomized 1-to-1. The enrollment goal was 150, and the study is designed for a 24-month follow-up. The primary endpoint, however, is at one year, and the primary endpoint is catheter-free days. In the protocol we had specified that once 80 patients complete one year of follow-up, we'll do an interim analysis to see if there is superiority in catheter-free days. That's the results that we are now presenting to you for this interim analysis of 80 patients at one year. In V012, we are a head-to-head design between ATEV and AVF. in v012 we are a head-to-head design between atev and avf It's a multi-center trial in about 25 centers in the U.S., of which about 20 centers contributed actively to enroll patients. it's a multi-center trial in about 25 centers in the u.s of which about 20 centers contributed actively to enroll patients For females with end-stage kidney disease on hemodialysis, randomized 1-to-1. for females with end-stage kidney disease on hemodialysis randomized 1-to-1 The enrollment goal was 150, and the study is designed for a 24-month follow-up. the enrollment goal was 150 and the study is designed for a 24-month follow-up The primary endpoint, however, is at one year, and the primary endpoint is catheter-free days. the primary endpoint however is at one year and the primary endpoint is catheter-free days In the protocol we had specified that once 80 patients complete one year of follow-up, we'll do an interim analysis to see if there is superiority in catheter-free days. in the protocol we had specified that once 80 patients complete one year of follow-up we'll do an interim analysis to see if there is superiority in catheter-free days That's the results that we are now presenting to you for this interim analysis of 80 patients at one year. that's the results that we are now presenting to you for this interim analysis of 80 patients at one year 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, very equally distributed, and patients with diabetes were also equally distributed between the two treatment arms. 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, very equally distributed, and patients with diabetes were also equally distributed between the two treatment arms. 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 very equally distributed and patients with diabetes were also equally distributed between the two 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 one-stage AVF or two-stage AVF ahead of randomization, just to make sure that there is equal distribution of such patients in the two 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 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 one-stage AVF or two-stage AVF ahead of randomization, just to make sure that there is equal distribution of such patients in the two 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 one-stage avf or two-stage avf ahead of randomization just to make sure that there is equal distribution of such patients in the two 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. 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. 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 three 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 or AVF for catheter-free days at the one-year time point. This slide shows you the rate of maturation between the two treatment arms. Again, ATEV had a superior rate of maturation. Patients in ATEV, shown in red, matured faster, and they matured at a higher rate, closer to 90%, while in AVF, there was approximately a 60% maturation rate with 40% failure rate. Again, you can see the amount of time it takes to mature for AVF. We had a statistically significant increase in catheter-free days of approximately three months. we had a statistically significant increase in catheter-free days of approximately three 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. 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 or AVF for catheter-free days at the one-year time point. this established the superiority of atev or avf for catheter-free days at the one-year time point This slide shows you the rate of maturation between the two treatment arms. this slide shows you the rate of maturation between the two treatment arms Again, ATEV had a superior rate of maturation. again atev had a superior rate of maturation Patients in ATEV, shown in red, matured faster, and they matured at a higher rate, closer to 90%, while in AVF, there was approximately a 60% maturation rate with 40% failure rate. patients in atev shown in red matured faster and they matured at a higher rate closer to 90% while in avf there was approximately a 60% maturation rate with 40% failure rate Again, you can see the amount of time it takes to mature for AVF. again you can see the amount of time it takes to mature for avf Again, the separation between the curves is when these patients would be relying on catheters for their AV 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 access infections for ATEV use of one year versus AVF. There were two events of infection in the ATEV group, both were dialysis catheter, and then there were nine events in AVF, three of which were AVF-related infections, and the others were mostly catheter-related infections. If you look at the difference in rates, as I mentioned earlier, this would translate to six events per 100 patient-years for ATEV, versus 23 events per 100 patient-years for AVF, for a difference of 17 infection events, less on the ATEV arm versus AVF. Again, the separation between the curves is when these patients would be relying on catheters for their AV access. again the separation between the curves is when these patients would be relying on catheters for their av access An important safety endpoint that we had highlighted was to look at infections. 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 access infections for ATEV use of one year versus AVF. if you look at the infection rates over 100 patient-years there were 17 less dialysis access infections for atev use of one year versus avf There were two events of infection in the ATEV group, both were dialysis catheter, and then there were nine events in AVF, three of which were AVF-related infections, and the others were mostly catheter-related infections. there were two events of infection in the atev group both were dialysis catheter and then there were nine events in avf three of which were avf-related infections and the others were mostly catheter-related infections If you look at the difference in rates, as I mentioned earlier, this would translate to six events per 100 patient-years for ATEV, versus 23 events per 100 patient-years for AVF, for a difference of 17 infection events, less on the ATEV arm versus AVF. if you look at the difference in rates as i mentioned earlier this would translate to six events per 100 patient-years for atev 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 bunch of secondary endpoints that we analyzed. Here are the results of the secondary endpoints. We were looking at catheter-free days in the first six months, and you can see virtually most of the benefit is obtained 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 predefined hemodialysis threshold that the patients had to reach to get functional patency. Again, there was a significant difference between the two arms of 250 days versus 150 days. A very significant P value. We looked at secondary patency at six 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. Besides the primary endpoint, we had bunch of secondary endpoints that we analyzed. besides the primary endpoint we had bunch of secondary endpoints that we analyzed Here are the results of the secondary endpoints. here are the results of the secondary endpoints We were looking at catheter-free days in the first six months, and you can see virtually most of the benefit is obtained here in terms of catheter-free days for ATEV versus AVF arm for a P value of 0.0009. we were looking at catheter-free days in the first six months and you can see virtually most of the benefit is obtained 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 predefined hemodialysis threshold that the patients had to reach to get functional patency. the 12-month functional patency this was a predefined hemodialysis threshold that the patients had to reach to get functional patency Again, there was a significant difference between the two arms of 250 days versus 150 days. again there was a significant difference between the two arms of 250 days versus 150 days A very significant P value. a very significant p value We looked at secondary patency at six months. we looked at secondary patency at six months ATEV, which was very consistent with what we have seen in previous studies, was at 88% versus 65% for AVF. 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. again a significant p value The last one was 12-month secondary patency, where ATEV was at 78%, again, consistent with 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. Those are the secondary endpoints that we had predetermined in the trial and that we tested, and 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 three months, the third column is events adjusted to patient years of use for that period of time. The last one was 12-month secondary patency, where ATEV was at 78%, again, consistent with other studies we have done in the past. the last one was 12-month secondary patency where atev was at 78% again consistent with other studies we have done in the past AVF was 62%. avf was 62% This one was a p-value of 0.16, in part because of only 40 patients being available for analysis. this one was a p-value of 0.16 in part because of only 40 patients being available for analysis Those are the secondary endpoints that we had predetermined in the trial and that we tested, and they all showed benefit in favor of ATEV. those are the secondary endpoints that we had predetermined in the trial and that we tested and 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 three months, the third column is events adjusted to patient years of use for that period of time. 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 three 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. 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 pre-specified that are of interest because of associated being with AV access. There were zero infections, as I mentioned before, with ATEV per se. There were three related infections in the AVF group. Thrombosis was 20 versus eight with a rate of 0.75 to 0.51. This is significantly less than what we had seen in V007. Importantly also, the thrombosis treatment rate or successful resolution rate was 75% in the ATEV arm versus 38% in the AVF arm. If you look at all AEs that were reported, you can see 235 events in ATEV versus 287. 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. the rate difference is about 8.9 versus 18 in the avf arm Less treatment emergent adverse events in the ATEV arm. 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. serious adverse events tells the same story 46 versus 75 events 1.73 versus 4.77 There were some events that we had pre-specified that are of interest because of associated being with AV access. there were some events that we had pre-specified that are of interest because of associated being with av access There were zero infections, as I mentioned before, with ATEV per se. there were zero infections as i mentioned before with atev per se There were three related infections in the AVF group. there were three related infections in the avf group Thrombosis was 20 versus eight with a rate of 0.75 to 0.51. thrombosis was 20 versus eight with a rate of 0.75 to 0.51 This is significantly less than what we had seen in V007. this is significantly less than what we had seen in v007 Importantly also, the thrombosis treatment rate or successful resolution rate was 75% in the ATEV arm versus 38% in the AVF arm. importantly also the thrombosis treatment rate or 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. Adjusted for duration of use, it was less stenosis in the ATEV group. The rest of the things, clinically significant steal syndrome, study access ruptures, which were zero in both arms. Iatrogenic injury was one 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. Very balanced, very favorable safety profile to go along with a favorable efficacy profile in this study. 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 three more months, on average, three more months of catheter-free days compared to AVF in the ATEV group. Stenosis occurred at a rate of 1.62 in our study, while it was 2.29 in AVF. stenosis occurred at a rate of 1.62 in our study while it was 2.29 in avf Adjusted for duration of use, it was less stenosis in the ATEV group. adjusted for duration of use it was less stenosis in the atev group The rest of the things, clinically significant steal syndrome, study access ruptures, which were zero in both arms. the rest of the things clinically significant steal syndrome study access ruptures which were zero in both arms Iatrogenic injury was one 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. iatrogenic injury was one 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 Very balanced, very favorable safety profile to go along with a favorable efficacy profile in this study. very balanced very favorable safety profile to go along with a favorable efficacy profile in this study 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. 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 three more months, on average, three more months of catheter-free days compared to AVF in the ATEV group. there were approximately three more months on average three more months of catheter-free days compared to avf in the atev group ATEV patients incurred 17 fewer dialysis access infection than AVF for every 100 patient years of use. There was clear and consistent advantages over AVF in multiple secondary endpoints. Overall, our benefit-risk safety profile of ATEV is favorable, with no new or unexpected safety concerns identified. As we had pre-specified in the protocol, if we establish superiority in 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. We plan to file our supplemental BLA with the FDA during the second half of this year, and we're looking for a target indication in adult patients with end-stage kidney disease who are at an increased risk of AV fistula maturation failure. ATEV patients incurred 17 fewer dialysis access infection than AVF for every 100 patient years of use. atev patients incurred 17 fewer dialysis access infection than avf for every 100 patient years of use There was clear and consistent advantages over AVF in multiple secondary endpoints. there was clear and consistent advantages over avf in multiple secondary endpoints Overall, our benefit-risk safety profile of ATEV is favorable, with no new or unexpected safety concerns identified. overall our benefit-risk safety profile of atev is favorable with no new or unexpected safety concerns identified As we had pre-specified in the protocol, if we establish superiority in interim analysis, which we have, we terminate the further enrollment in this study, which we have. as we had pre-specified in the protocol if we establish superiority in 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. we will continue to follow up the patients who are already enrolled in the study We plan to file our supplemental BLA with the FDA during the second half of this year, and we're looking for a target indication in adult patients with end-stage kidney disease who are at an increased risk of AV fistula maturation failure. we plan to file our supplemental bla with the fda during the second half of this year and we're looking for a target indication in adult patients with end-stage kidney disease who are at an increased risk of av fistula maturation failure Thank you, I would like to turn it back to you, Dr. Hussain, for your perspectives as a V012 investigator. Thank you, I would like to turn it back to you, Dr. Hussain, for your perspectives as a V012 investigator. thank you i would like to turn it back to you dr hussain for your perspectives as a v012 investigator

Speaker 5: Thank you so much. Very exciting and interesting results, potentially a new avenue for our patients who are high risk for access complications. I'll talk about these three things and sort of try to put the results in context. 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. Also have had observers come and sort of see us use it and teach others to use it, I think the most common comment I get when first somebody starts using it is how much it feels like a real vessel and how much it sews like a real vessel. Thank you so much. thank you so much Very exciting and interesting results, potentially a new avenue for our patients who are high risk for access complications. very exciting and interesting results potentially a new avenue for our patients who are high risk for access complications I'll talk about these three things and sort of try to put the results in context. i'll talk about these three things and sort of try to put the results in context Clinical experience. 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. 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 Also have had observers come and sort of see us use it and teach others to use it, I think the most common comment I get when first somebody starts using it is how much it feels like a real vessel and how much it sews like a real vessel. also have had observers come and sort of see us use it and teach others to use it i think the most common comment i get when first somebody starts using it is how much it feels like a real vessel and how much it sews like a real vessel I think that's really one of the nice things as a surgeon to think about having an option that really mimics a human body's vein or artery. I think that's been a very nice to handle, it's been easy to use, I think a very nice experience for the surgeon to be able to utilize for the patients. These results are very exciting. Couple of nuanced outcomes I like to bring out is that as a surgeon, we really think about infections in these patients and graft infections. These patients who had the ATEV had significantly lower catheter time and significantly lower number of overall infections because of two reasons. One, because of having less catheter contact time, which leads to lower infection. I think that's really one of the nice things as a surgeon to think about having an option that really mimics a human body's vein or artery. i think that's really one of the nice things as a surgeon to think about having an option that really mimics a human body's vein or artery I think that's been a very nice to handle, it's been easy to use, I think a very nice experience for the surgeon to be able to utilize for the patients. i think that's been a very nice to handle it's been easy to use i think a very nice experience for the surgeon to be able to utilize for the patients These results are very exciting. these results are very exciting Couple of nuanced outcomes I like to bring out is that as a surgeon, we really think about infections in these patients and graft infections. couple of nuanced outcomes i like to bring out is that as a surgeon we really think about infections in these patients and graft infections These patients who had the ATEV had significantly lower catheter time and significantly lower number of overall infections because of two reasons. these patients who had the atev had significantly lower catheter time and significantly lower number of overall infections because of two reasons One, because of having less catheter contact time, which leads to lower infection. one because of having less catheter contact time which leads to lower infection Also what really I found interesting was that risk of infection was zero in the access itself in the ATEV group, but 8% in the fistula group. You may ask, well, why did 8% of the fistula group get infections? Well, because most likely these patients were having the fistulas that weren't maturing, being revised with grafts or having 2-stage accesses. They had a fistula that didn't quite develop, having a second stage graft made out of other foreign material leading to more infections. I think sort of those two advantages, having less catheter time and less exposure to graft material and getting the ATEV right away, seems really beneficial for this cohort. This was a high-risk cohort, as you saw from the slides. 50% were obese, 50% had diabetes, which are really high risk for infection. Also what really I found interesting was that risk of infection was zero in the access itself in the ATEV group, but 8% in the fistula group. also what really i found interesting was that risk of infection was zero in the access itself in the atev group but 8% in the fistula group You may ask, well, why did 8% of the fistula group get infections? you may ask well why did 8% of the fistula group get infections Well, because most likely these patients were having the fistulas that weren't maturing, being revised with grafts or having 2-stage accesses. well because most likely these patients were having the fistulas that weren't maturing being revised with grafts or having 2-stage accesses They had a fistula that didn't quite develop, having a second stage graft made out of other foreign material leading to more infections. they had a fistula that didn't quite develop having a second stage graft made out of other foreign material leading to more infections I think sort of those two advantages, having less catheter time and less exposure to graft material and getting the ATEV right away, seems really beneficial for this cohort. i think sort of those two advantages having less catheter time and less exposure to graft material and getting the atev right away seems really beneficial for this cohort This was a high-risk cohort, as you saw from the slides. 50% were obese, 50% had diabetes, which are really high risk for infection. this was a high-risk cohort as you saw from the slides 50% were obese 50% had diabetes which are really high risk for infection 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. I think that was very interesting to see for our patients. 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. 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. 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, about 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, may need a stage 2 surgery. This certainly presents a lower risk option for her, and I was able to implant that for her shortly after the results. In fact, about 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, may need a stage 2 surgery. in fact about 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 may need a stage 2 surgery This certainly presents a lower risk option for her, and I was able to implant that for her shortly after the results. this certainly presents a lower risk option for her and i was able to implant that for her shortly after the results I foresee that patients who have borderline mains, both men and women, or patients who need stage 2 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 five months for patients who had fistula. If we have patients who we anticipate will have catheter time of several months because they will 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. These are my initial thoughts, and it is a very exciting time for this potential option for our patients. I will turn it back over to Tara and happy to take any questions. I foresee that patients who have borderline mains, both men and women, or patients who need stage 2 surgery and are going to have a long catheter time of several months. i foresee that patients who have borderline mains both men and women or patients who need stage 2 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 five months for patients who had fistula. you can see in this case in the trial it was about five months for patients who had fistula If we have patients who we anticipate will have catheter time of several months because they will 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. if we have patients who we anticipate will have catheter time of several months because they will 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 These are my initial thoughts, and it is a very exciting time for this potential option for our patients. these are my initial thoughts and it is a very exciting time for this potential option for our patients I will turn it back over to Tara and happy to take any questions. i will turn it back over to tara and happy to take any questions

Speaker 6: Great. Thank you, Dr. Hussain. Yes. At this time, we will be conducting a question and answer session with our speakers. To our analysts joining us live, please use the raise hand feature to indicate you have a question. Please hold for a brief moment. Great. Our first question comes from Bruce Jackson at Benchmark. Please go ahead, Bruce. Great. great Thank you, Dr. Hussain. thank you dr hussain Yes. yes At this time, we will be conducting a question and answer session with our speakers. at this time we will be conducting a question and answer session with our speakers To our analysts joining us live, please use the raise hand feature to indicate you have a question. to our analysts joining us live please use the raise hand feature to indicate you have a question Please hold for a brief moment. please hold for a brief moment Great. great Our first question comes from Bruce Jackson at Benchmark. our first question comes from bruce jackson at benchmark Please go ahead, Bruce. please go ahead bruce

Speaker 2: Hi. Thank you for taking my question. First, the definition of the diabetic patients, what was the objective measure for that? Is it an A1C? Hi. hi Thank you for taking my question. thank you for taking my question First, the definition of the diabetic patients, what was the objective measure for that? first the definition of the diabetic patients what was the objective measure for that Is it an A1C? is it an a1c

Speaker 4: Shamik, you want to take that? Shamik, you want to take that? shamik you want to take that

Speaker 7: Yeah. That was patients who had a documented history of type 2 diabetes. Yeah. yeah That was patients who had a documented history of type 2 diabetes. that was patients who had a documented history of type 2 diabetes

Speaker 2: Documented history of type 2 diabetes. Was it like an A1C level or insulin use? What was the exact criteria? Documented history of type 2 diabetes. documented history of type 2 diabetes Was it like an A1C level or insulin use? was it like an a1c level or insulin use What was the exact criteria? what was the exact criteria

Speaker 7: No, we didn't use A1C criteria because you could have patients who are very well controlled on diabetes whose A1Cs would be perfectly normal. These are patients who have a history of type 2 diabetes documented, just like you would have a history of hypertension. Minimal A1C was not needed to participate. They had to have history of diabetes. I think there was a exclusion for severely uncontrolled diabetes patients simply because they may not be stable in the study, but that was about it, Bruce. No, we didn't use A1C criteria because you could have patients who are very well controlled on diabetes whose A1Cs would be perfectly normal. no we didn't use a1c criteria because you could have patients who are very well controlled on diabetes whose a1cs would be perfectly normal These are patients who have a history of type 2 diabetes documented, just like you would have a history of hypertension. these are patients who have a history of type 2 diabetes documented just like you would have a history of hypertension Minimal A1C was not needed to participate. minimal a1c was not needed to participate They had to have history of diabetes. they had to have history of diabetes I think there was a exclusion for severely uncontrolled diabetes patients simply because they may not be stable in the study, but that was about it, Bruce. i think there was a exclusion for severely uncontrolled diabetes patients simply because they may not be stable in the study but that was about it bruce

Speaker 2: Okay. A quick follow-up. The label hopefully is going to be people with increased risk for graft failure. Is that something that's generally recognized in terms of the criteria? How do you think the data from the study supports that? Okay. okay A quick follow-up. a quick follow-up The label hopefully is going to be people with increased risk for graft failure. the label hopefully is going to be people with increased risk for graft failure Is that something that's generally recognized in terms of the criteria? is that something that's generally recognized in terms of the criteria How do you think the data from the study supports that? how do you think the data from the study supports that

Speaker 7: Yeah. 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. One, this is a very well-published area in the literature of patients of risk factors for maturation failure. As I sort of indicated, women, obesity, diabetes, and 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 patient 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. Yeah. yeah 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. 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 One, this is a very well-published area in the literature of patients of risk factors for maturation failure. one this is a very well-published area in the literature of patients of risk factors for maturation failure As I sort of indicated, women, obesity, diabetes, and some cases elderly have been identified as strong predictors of maturation failure. as i sort of indicated women obesity diabetes and 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 patient 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. in this study we have women and we have obese and diabetes and elderly patient 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

Speaker 2: All right. That's it for me and congratulations on the study results. All right. all right That's it for me and congratulations on the study results. that's it for me and congratulations on the study results

Speaker 7: Okay. Thank you. Okay. okay Thank you. thank you

Speaker 6: Great. Thank you, Bruce. Our next question comes from Izzy McMahon at BTIG. Please go ahead, Izzy. Great. great Thank you, Bruce. thank you bruce Our next question comes from Izzy McMahon at BTIG. our next question comes from izzy mcmahon at btig Please go ahead, Izzy. please go ahead izzy

Speaker 3: Hi, everyone. Thanks for taking the questions. Just to start, I was hoping to follow up on that last point that Bruce was just making. Hi, everyone. hi everyone Thanks for taking the questions. thanks for taking the questions Just to start, I was hoping to follow up on that last point that Bruce was just making. just to start i was hoping to follow up on that last point that bruce was just making

Speaker 6: Yeah Yeah yeah

Speaker 3: Maybe think about it from the practicality standpoint of the ATEV. 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. Maybe think about it from the practicality standpoint of the ATEV. maybe think about it from the practicality standpoint of the atev 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. 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

Speaker 5: Yeah. Great question. I'm happy to think about it from a clinician standpoint. I think there's two 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 end that you're planning on using. That's a decision one can make in clinic or in hospital, 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. You may have a patient who has an infected access, and it needs to be revised pretty quickly. Yeah. yeah Great question. great question I'm happy to think about it from a clinician standpoint. i'm happy to think about it from a clinician standpoint I think there's two scenarios. i think there's two 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 end that you're planning on using. 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 end that you're planning on using That's a decision one can make in clinic or in hospital, any other setting that one sees a patient that they think is an appropriate candidate for this type of conduit. that's a decision one can make in clinic or in hospital 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. the other scenario is the urgent situation You may have a patient who has an infected access, and it needs to be revised pretty quickly. you may have a patient who has an infected access and it needs to be revised pretty quickly In that scenario, I think as a surgeon, I would also consider this and would 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 have been infected, may have ruptured, or may have other issues that come up. In that scenario, I think as a surgeon, I would also consider this and would 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 have been infected, may have ruptured, or may have other issues that come up. in that scenario i think as a surgeon i would also consider this and would 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 have been infected may have ruptured or may have other issues that come up

Speaker 3: Okay. Appreciate that. Thank you. 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 two 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? What do you think this could mean for longer-term outcomes? Thanks for taking the questions. Okay. okay Appreciate that. appreciate that Thank you. thank you Then just one follow-up. 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 two for this V012 study. based on the data from the v007 trial i think we would expect to see similar outcomes for patients extended into year two 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? 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 What do you think this could mean for longer-term outcomes? what do you think this could mean for longer-term outcomes Thanks for taking the questions. thanks for taking the questions

Speaker 5: Thank you for the question. I think these are very promising one-year results, we'd love to see how things pan out over two years. I think it's very promising that the patients are staying off catheters, that their risk of infections will be lower. If they're not getting suboptimal vein accesses or that may have to be revised by conduits that get infected at a higher rate, I do anticipate that the risk of infection would be lower long term. The nice thing about this is it does integrate really well with the human tissues. We know that there is a delayed risk of infection with prosthetic conduits because of repeated cannulation three times a week, every week when they go to dialysis. Thank you for the question. thank you for the question I think these are very promising one-year results, we'd love to see how things pan out over two years. i think these are very promising one-year results we'd love to see how things pan out over two years I think it's very promising that the patients are staying off catheters, that their risk of infections will be lower. i think it's very promising that the patients are staying off catheters that their risk of infections will be lower If they're not getting suboptimal vein accesses or that may have to be revised by conduits that get infected at a higher rate, I do anticipate that the risk of infection would be lower long term. if they're not getting suboptimal vein accesses or that may have to be revised by conduits that get infected at a higher rate i do anticipate that the risk of infection would be lower long term The nice thing about this is it does integrate really well with the human tissues. the nice thing about this is it does integrate really well with the human tissues We know that there is a delayed risk of infection with prosthetic conduits because of repeated cannulation three times a week, every week when they go to dialysis. we know that there is a delayed risk of infection with prosthetic conduits because of repeated cannulation three times a week every week when they go to dialysis When you have a conduit like this made out of human cells that integrates with all the tissues you would anticipate that the risk of these delayed infections is also lower, would be very much looking forward to the results. When you have a conduit like this made out of human cells that integrates with all the tissues you would anticipate that the risk of these delayed infections is also lower, would be very much looking forward to the results. when you have a conduit like this made out of human cells that integrates with all the tissues you would anticipate that the risk of these delayed infections is also lower would be very much looking forward to the results

Speaker 6: Great. Thanks for the questions, Izzy. Our next question comes from RK at H.C. Wainwright. Please go ahead. Great. great Thanks for the questions, Izzy. thanks for the questions izzy Our next question comes from RK at H.C. our next question comes from rk at h.c Wainwright. wainwright Please go ahead. please go ahead

Speaker 8: Good afternoon, and thank you very much for hosting this session. Couple of quick questions for Dr. Hussain. Given that this is a women only and U.S. only 80 patient interim analysis that we 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? Good afternoon, and thank you very much for hosting this session. good afternoon and thank you very much for hosting this session Couple of quick questions for Dr. Hussain. couple of quick questions for dr hussain Given that this is a women only and U.S. only 80 patient interim analysis that we 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? given that this is a women only and u.s only 80 patient interim analysis that we 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

Speaker 5: Yeah. Thank you for the question. I think the way I look at this is just the next addition of the clear data that we have. I was part of the V007 trial, which was all comers, men and women. That was also positive with patients who received the ATEV, met the primary endpoint and had better durable accesses. Yeah. yeah Thank you for the question. thank you for the question I think the way I look at this is just the next addition of the clear data that we have. i think the way i look at this is just the next addition of the clear data that we have I was part of the V007 trial, which was all comers, men and women. i was part of the v007 trial which was all comers men and women That was also positive with patients who received the ATEV, met the primary endpoint and had better durable accesses. that was also positive with patients who received the atev met the primary endpoint and had better durable accesses The subgroup analysis of course showed the women and the high-risk subgroup of that evidence. Now we have level A evidence in women, which again, we don't have in the AV access space. I'm just very excited we have that. I'm also a clinical trialist, and I get excited about level A evidence. 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. The subgroup analysis of course showed the women and the high-risk subgroup of that evidence. the subgroup analysis of course showed the women and the high-risk subgroup of that evidence Now we have level A evidence in women, which again, we don't have in the AV access space. now we have level a evidence in women which again we don't have in the av access space I'm just very excited we have that. i'm just very excited we have that I'm also a clinical trialist, and I get excited about level A evidence. i'm also a clinical trialist and i get excited about level a evidence 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. 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 Certainly, I would feel a lot more comfortable as further applying that data in the high-risk patient cohort, which includes the women and certain men without the appropriate conduit options available and the fistula options available. Certainly, I would feel a lot more comfortable as further applying that data in the high-risk patient cohort, which includes the women and certain men without the appropriate conduit options available and the fistula options available. certainly i would feel a lot more comfortable as further applying that data in the high-risk patient cohort which includes the women and certain men without the appropriate conduit options available and the fistula options available

Speaker 8: Thank you. I have one more question for you, doctor. As we know, some of this patient population are candidates for transplant. How meaningful is the immunogenicity advantage that you had discussed in the data? Does the implantation with the ATEV preserve and actually improve the eligibility of these patients for transplants rather than having grafts or fistulas? Thank you. thank you I have one more question for you, doctor. i have one more question for you doctor As we know, some of this patient population are candidates for transplant. as we know some of this patient population are candidates for transplant How meaningful is the immunogenicity advantage that you had discussed in the data? how meaningful is the immunogenicity advantage that you had discussed in the data Does the implantation with the ATEV preserve and actually improve the eligibility of these patients for transplants rather than having grafts or fistulas? does the implantation with the atev preserve and actually improve the eligibility of these patients for transplants rather than having grafts or fistulas

Speaker 5: Yeah. Good question. I'll let the Humacyte team talk about specifically immunogenicity part. 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. 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. Yeah. yeah Good question. good question I'll let the Humacyte team talk about specifically immunogenicity part. i'll let the humacyte team talk about specifically immunogenicity part I think from a clinician standpoint, patients who are not candidates for, or are not great candidates for transplant are as follows. 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. of course they have active infections sepsis which we hope this would have a lower risk for 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. 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 Some of the fistulas, for example, we create become very high flow because they become aneurysmal and they cause pulmonary hypertension and heart blocks. From the ultrasound data that we've seen and the steal data that you saw today, the rate of steal was very low in the women who received data, which indicates to me that this conduit is not dilating. Some of the fistulas, for example, we create become very high flow because they become aneurysmal and they cause pulmonary hypertension and heart blocks. some of the fistulas for example we create become very high flow because they become aneurysmal and they cause pulmonary hypertension and heart blocks From the ultrasound data that we've seen and the steal data that you saw today, the rate of steal was very low in the women who received data, which indicates to me that this conduit is not dilating. from the ultrasound data that we've seen and the steal data that you saw today the rate of steal was very low in the women who received data which indicates to me that this conduit is not dilating It's not becoming aneurysmal, which hopefully means better for the patient's heart and better for the transplant candidacy. That's how I look at the patient and the access when we think about transplant candidacy from a cardiopulmonary standpoint, which can be affected by the access. I'll let the Humacyte team talk about the immunosuppression part as well. It's not becoming aneurysmal, which hopefully means better for the patient's heart and better for the transplant candidacy. it's not becoming aneurysmal which hopefully means better for the patient's heart and better for the transplant candidacy That's how I look at the patient and the access when we think about transplant candidacy from a cardiopulmonary standpoint, which can be affected by the access. that's how i look at the patient and the access when we think about transplant candidacy from a cardiopulmonary standpoint which can be affected by the access I'll let the Humacyte team talk about the immunosuppression part as well. i'll let the humacyte team talk about the immunosuppression part as well

Speaker 7: Yeah. Unlike when putting in a PTFE graft, which is essentially plastic, the body does develop antibodies to it, and we have panel reactive antibodies to it. Humacyte graft or Symvess does not have that issue. It's human cells, and it has shown zero immune rejection or signs of clinical immunogenicity in terms of clinical reactions in over 1,200 patient years to date. The more the antibodies, the greater is the chance of rejection in dialysis. There is an advantage, versus especially PTFE, in terms of less immunogenicity, with ATEVs. The second is about infections and less infection rate versus PTFE, as was commented on before. Yeah. Yeah. yeah Unlike when putting in a PTFE graft, which is essentially plastic, the body does develop antibodies to it, and we have panel reactive antibodies to it. unlike when putting in a ptfe graft which is essentially plastic the body does develop antibodies to it and we have panel reactive antibodies to it Humacyte graft or Symvess does not have that issue. humacyte graft or symvess does not have that issue It's human cells, and it has shown zero immune rejection or signs of clinical immunogenicity in terms of clinical reactions in over 1,200 patient years to date. it's human cells and it has shown zero immune rejection or signs of clinical immunogenicity in terms of clinical reactions in over 1,200 patient years to date The more the antibodies, the greater is the chance of rejection in dialysis. the more the antibodies the greater is the chance of rejection in dialysis There is an advantage, versus especially PTFE, in terms of less immunogenicity, with ATEVs. there is an advantage versus especially ptfe in terms of less immunogenicity with atevs The second is about infections and less infection rate versus PTFE, as was commented on before. the second is about infections and less infection rate versus ptfe as was commented on before Yeah. yeah

Speaker 8: Thank you. Thank you all for taking my questions. Thank you. thank you Thank you all for taking my questions. thank you all for taking my questions

Speaker 6: Thanks, RK. Our next question comes from Allison Bratzel at Piper Sandler. Please go ahead, Allison. Thanks, RK. thanks rk Our next question comes from Allison Bratzel at Piper Sandler. our next question comes from allison bratzel at piper sandler Please go ahead, Allison. please go ahead allison

Speaker 1: Hey, good afternoon, team, and thanks for taking the questions. Just actually two questions for the company on the regulatory path. 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? Just how will data from V006 be considered in the review? 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? Just what was FDA feedback on the ability to file just on the 12-month versus 24-month data? Thank you. Hey, good afternoon, team, and thanks for taking the questions. hey good afternoon team and thanks for taking the questions Just actually two questions for the company on the regulatory path. just actually two questions for the company on the regulatory path 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? 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 Just how will data from V006 be considered in the review? just how will data from v006 be considered in the review 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? 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 Just what was FDA feedback on the ability to file just on the 12-month versus 24-month data? just what was fda feedback on the ability to file just on the 12-month versus 24-month data Thank you. thank you

Speaker 7: Great questions. We had a discussion with the FDA once V007 was over, they were open to us filing with V007 data. At the time, we had V012 ongoing, we wanted to wait for results of V012 study, especially the interim analysis was around the corner. 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, it will be going in 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. That's the discussion we would have planned with the FDA. Great questions. great questions We had a discussion with the FDA once V007 was over, they were open to us filing with V007 data. we had a discussion with the fda once v007 was over they were open to us filing with v007 data At the time, we had V012 ongoing, we wanted to wait for results of V012 study, especially the interim analysis was around the corner. at the time we had v012 ongoing we wanted to wait for results of v012 study especially the interim analysis was around the corner We have had ongoing dialogue with FDA. we have had ongoing dialogue with fda They are aware that we are very interested in filing a BLA. they are aware that we are very interested in filing a bla We have actually sent a letter to the FDA, it will be going in 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. we have actually sent a letter to the fda it will be going in 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 That's the discussion we would have planned with the FDA. 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 gives us 5-year durability data because we did continue that study for five years in ATEV patients. We are going to look at the women 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 five years. We're going to use the two years data from V007, which we briefly showed earlier in the presentation today. With that, we're going to show the one-year analysis of this V012 study. It's up to the FDA. They can always request more data, but we will also have ongoing data that we will share with the FDA during the file review. Regarding your point about how we're going to use the data from V007 and V006 gives us 5-year durability data because we did continue that study for five years in ATEV patients. regarding your point about how we're going to use the data from v007 and v006 gives us 5-year durability data because we did continue that study for five years in atev patients We are going to look at the women 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 five years. we are going to look at the women 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 five years We're going to use the two years data from V007, which we briefly showed earlier in the presentation today. we're going to use the two years data from v007 which we briefly showed earlier in the presentation today With that, we're going to show the one-year analysis of this V012 study. with that we're going to show the one-year analysis of this v012 study It's up to the FDA. it's up to the fda They can always request more data, but we will also have ongoing data that we will share with the FDA during the file review. they can always request more data but we will also have ongoing data that we will share with the fda during the file review There is something called 120-day 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 V012 of these first 80 patients. I think we have a strong package, if you will, a clinical package. I think we are the most tested product ever in AV access before being approved, quite honestly. I think we feel confident of both the clinical package, the clinical arguments, and the benefit risk of our product versus the other competitors we had in our trial. I hope that answers your question. There is something called 120-day 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 V012 of these first 80 patients. there is something called 120-day 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 v012 of these first 80 patients I think we have a strong package, if you will, a clinical package. i think we have a strong package if you will a clinical package I think we are the most tested product ever in AV access before being approved, quite honestly. i think we are the most tested product ever in av access before being approved quite honestly I think we feel confident of both the clinical package, the clinical arguments, and the benefit risk of our product versus the other competitors we had in our trial. i think we feel confident of both the clinical package the clinical arguments and the benefit risk of our product versus the other competitors we had in our trial I hope that answers your question. i hope that answers your question

Speaker 1: Thank you. Thank you. thank you

Speaker 6: Great. Thank you for the questions, Allison. This concludes our Q&A session for today. I'll turn it back to Laura for some quick closing remarks before we wrap up. Great. great Thank you for the questions, Allison. thank you for the questions allison This concludes our Q&A session for today. this concludes our q&a session for today I'll turn it back to Laura for some quick closing remarks before we wrap up. i'll turn it back to laura for some quick closing remarks before we wrap up

Speaker 4: 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. 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. 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. Well, again, I want to really thank the audience and the analysts for providing thoughtful and insightful questions. 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 an exciting time for humacyte and i agree with dr parikh This is the most studied conduit in dialysis access prior to approval ever. this is the most studied conduit in dialysis access prior to approval ever 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 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. we also expect additional publications to be forthcoming later this year to really fill out the clinical story 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. 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 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. With that, we'll close it up. Thank you so much. 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. 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 With that, we'll close it up. with that we'll close it up Thank you so much. thank you so much