Humacyte Third Quarter 2026 Earnings Conference Call - HUMACYTE INC

Good morning, ladies and gentlemen, and welcome to the Humacyte 3rd Quarter 2026 Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead. Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actually results to defer from statements made on this call is contained in periodic reports with the sec the forward statements forward-looking statements made during this call speak only as the date hereof and the company undertakes no obligation to update or revise the forward-thinking statements except as required by law information presented on this call is contained in the press release we issued this morning and in our form 10-q which after filing may be accessed from the investor page of the huma site website Joining me on today's call from Humusite are Dr. Laura Nicholson, President and Chief Executive Officer, Jim Mercadante, Chief Commercial Officer, and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Nicholso will provide a summary of the company's progress for the third quarter and recent weeks. Jim will provide an update of the commercial transformation and progress with the Symbus market launch. And Dale Sanger will review this company's financial results for the quarter end of September 30th, 2026. I will now turn the call over to Dr. Nicholson. Laura. Thank you, Tom, and good morning, everyone. And I want to thank you for joining us for our third quarter financial results and business update call. I would like to, I could not be more excited to share the progress that we're making at Humacyte. What we're doing at Humacype is exceptionally challenging, and we have created a first-in-class biologic solution that addresses some very significant and broad-based health problems. We have built a team of incredibly talented scientists and other professionals and an outstanding manufacturing facility. I wish that you all had the opportunity to come down and take a tour of our facility. Even representatives from much larger medical device and pharma organizations walk away in awe of what we have built. I believe that the momentum that we have demonstrated this quarter, along with the upcoming filings and clinical trials, have set the stage for a very significant value creation story in the months and years ahead. It's taken a lot of work to get to this point and my sincere hope is that we will all look back on today's call as an inflection point for the company. On today's call, after my overview, we'll begin with Jim's review of our commercial progress for SimVest. As you know, Jim was appointed as our Chief Commercial officer in May and he's already making a considerable and demonstrable impact on the execution of our commercial strategy. I'll then review progress across our development programs before turning it over to Dale for a review of our financial results for the third quarter. We'll then be happy to open up the call and take your questions. Let's begin. As we've mentioned previously, our focus for 2026 has been on advancing three main goals. Transforming and advancing our commercial programs for Symbeth, preparation and submission of our Supplemental Biologics License Application, or SBLA, with the FDA for our ATEV product in the Dialysis Access Indication, and commencement of a human study of our Coronary Tissue Engineered Vessels, or CTAVs in coronary artery bypass grafting. I'm pleased to report that we've made substantial progress on all three of these goals. Commercial adoption of SimVest accelerated during the third quarter, with sales increasing 151% over the second quarter to slightly over $1 million. Our Supplemental Biologics License Application, or SBLA, is on track for submission later this month. and we're pleased to announce that we have initiated our first human Phase IIa clinical study of CTEV in coronary artery bypass grafting, or CABG, and we are now open and screening patients. I'll now turn the call over to Jim for his review of our commercial results before I recap the progress on our pipeline programs. Thank you, Laura, and good morning, everyone. It's a pleasure to be speaking with all of you. As I mentioned on the last call, when I joined Humacyte, my immediate focus was to rebuild and reinvigorate our commercial effort for Synvest. I was captivated by the potential to capture meaningful market share in an area where patient outcomes can improve materially. At a baseline level, our revitalized program was designed to drive adoption of the products by hospitals, expand utilization of Synvest, and establish a path to sustained growth for Synbest. To accomplish this, we completely remodeled the commercial team with a focus on ensuring our professionals had critical long-term relationships in the vascular surgery space. Our team has already demonstrated the impact of deep industry relationships and the trust they have built across the market. We also refined our introductory pricing and incentive programs and approached a peer-to-peer professional education and our focus on hospital adoption. These initiatives were designed to ensure each element worked together to help create a scalable engine that converts interest in our first-in-class product into approvals, utilization, and ultimately sustained revenue growth. I am pleased to report that during our third quarter, the result of this approach is absolutely delivering immediate impact. As Laura mentioned, SIVVET sales revenue for that period was $1 million. Our revenue more than doubled from the second quarter, and we achieved our internal goal that we set for the quarter. Hospital adoption also expanded significantly with the number of hospitals ordering SIDVETS increasing by 44%, from 34 hospitals at the end of the second quarterback to 49 hospitals at end of September 30th. For those of you that understand the challenges of becoming approved as a new provider to a hospital, you can appreciate how excited we are about these results. As momentum has continued into fourth quarter, with October sales now reaching 800,000, with the current levels of hospital adoptions and physician agreement we are seeing, and expect fourth quarter sales to at least double our Q3 results. By the end of the year, we anticipate at least 20 new hospitals to order through our network. Our strategy is delivering results. Our commercial momentum is building, and we believe Synvest is now well-positioned to continue accelerating adoption and driving meaningful, sustainable growth. Like Laura, I am incredibly excited about the outlook for our business. With that, I will turn it back to Laura to review our pipeline. Thank you, Jim. So I'll start with ATEV and dialysis access. Following discussions with the FDA, our plan is to file a supplemental BLA for the ATEv in dialysis access later this month. This SBLA will be supported by results from three Phase III clinical studies. Publication of the VO7 Phase III results in the Lancet Digital Health was very recent in the last few months, and we also recently presented the results of our VO12 Phase III study in a late-breaking session at the American Society of Nephrology Kidney Week just a few weeks ago. These presentations have given the vascular surgery and nephrology communities an overview of the data that form the basis of our BLA filing. The Phase III results on VO12 were presented by Prabir Roy Chowdhury of the University of North Carolina of Chapel Hill and also a former president of the ASN. In the VO12 Phase III trial, women on dialysis treated with the ATEV achieved functional access and use for dialysis more than three months sooner and spent significantly more time free of dialysis catheters over the first year than did women who received an AV fistula, which is the current standard of care for hemodialysis access. These results also support our belief that the ATEV could represent the first major advance in dialysis access in decades, offering surgeons and patients an alternative option for patients whose risk factors for AV fistula maturation make AV fistula maturation more difficult. As many of you know, we appointed Dr. Prabir Roy Chowdhury and Dr. Robert Kossman as advisors to Humacyte. These are leading nephrologists who will help us prepare for the planned commercialization of the ATEV in dialysis access after it's approved by the FDA. They will also contribute to the development of health economic, reimbursement, and market access strategies, as well as provide important peer-to-peer scientific support, as they already have, and medical education. Let me turn next to another meaningful opportunity for Humacyte, the CTEF and coronary artery bypass grafting, or CABG. The FDA accepted our investigational new drug application for a first-in-human clinical study of the CTEV in CABG. And we initiated a Phase IIa study of CTEF in CBEV patients this month. Also, just this past weekend, three scientific presentations related to CTEB were made at the American Heart Association Scientific Sessions Medical Conference. John Alexander, Professor of Medicine and Cardiology at the Duke Clinical Research Institute, and Alan Kipson, a cardiothoracic surgeon from UNC-Rex Hospital, presented an overview of the Phase IIa clinical trial protocol for our study. And researchers from Humacyte also presented preclinical results supporting the progression of the CTEV into the first in-human study based on extensive large animal results and work. No new off-the-shelf conduits have been introduced for study in cabbage in the U.S. in the past 40 years. And our preclinical results suggest that CTEV may be a promising off-The-shelf alternative to saphenous vein grafts. To support this study, we've already completed the first large-scale manufacturing lot of our CTEV product in our commercial scale manufacturing facilities. And with that, it's my pleasure to hand the call over to Dale now for a review of our third quarter financial results. Dale? Thank you, Laura. Commercial sales of CIMBES increased to $1 million for the third quarter of 2026 compared to 0.4 million in the second quarter of 2026 and 0.7 million in the third quarter of 2025. Sequential quarter sales growth and growth compared to the prior year quarter resulted from the commercialization initiatives implemented during the first half of 2036 that Jim described and an increase in the number of hospitals ordering SimVest during the most recent quarter. For the nine months ended September 30, 2026, commercial sales of CEMVEST were $1.9 million compared to $1 million for the nine-months-ended September 30 2025. Contract revenue was minimal during the third quarters of 2026 and 2025 and for the 9-month-ended September 30 2026 due to the completion of a research project and was $0.6 million for The nine months ended September 30, 2025. Cost of goods sold was $1.4 million for the third quarter of 2026 compared to $0.3 million for the third corner of 2025. In the third corridor of 2027, the cost of goods was $0,000,000 for the first quarter of 2028, $06 million of cost of good sold related to the cost of units recorded as sales revenue during the period, and $08 million was primarily comprised of overhead related to unused production capacity. Cost of goods sold was $4.7 million for the nine months ended September 30, 2026, compared to $0.6 million for nine months end September 30 2025. In the nine-months ended September 20, 2027, $1.2 million of cost of goods related to the cost of units recorded as sales revenue during that period, $2.3 million related to inventory reserves, and $1,2 million was primarily comprised of overhead related to unused production capacity. Research and development expenses were $14.1 million and $51.7 million for the three and nine months ended September 30, 2026, respectively, compared to $17.3 million and 54.7 million for same periods in 2025. The decrease in research and development expense during the third quarter of 2026 and during the nine months ended September 30, 2026, compared to the prior year periods, was primarily due to a reduction in noncommercial manufacturing runs and the wind down of certain programs. Research and development expenses have declined sequentially each quarter in 2026 and the $14.1 million incurred in the third quarter of 2026 was $4 million less than the $18.1 million incurring in the second quarter of 2020. and administrative expenses were $9.0 million and $25.0 million for the three and nine months ended September 30, 2026, respectively, compared to $7.6 million and $23.6 billion for the same periods in 2025. The current year increase in general and administrative expenses was primarily related to $0.6 million in net expense related to a reserve for settlement of shareholder litigation and legal costs related to the litigation. Other net income was $8.0 million and $9.5 million for the three and nine months ended September 30, 2026, respectively, compared to other net income of $6.9 million and $61.3 million forthe same periods in 2025. Other net income for all periods resulted primarily from the non-cash remeasurement of the contingent earn-out liability and other derivative liabilities. Net loss was $15.5 million and $70.0 million for the three and nine months ended September 30, 2026, respectively, compared to a net loss of $17.5 and $16.0 for the same periods in 2025. The decrease in net loss for the third quarter of 2026 was primarily related to the decrease in research and development expenses. The increase in net loss for the nine months ended September 30, 2026 was primarily due to the non-cash remeasurement of the contingent earn-out liability described earlier. We had cash, cash equivalents and restricted cash of $64.9 million as of September 30 2026. During the quarter, the cost reduction measures that we put in place earlier in the year certainly flowed through and our net cash use and operations have has declined substantially total net cash used in operating activities was 15.0 million and 62.1 million for the three and nine months into september 30 2026 respectively compared to 23.9 million and 78.9 million to the same periods in 2025. cash use in operations decreased in 26 primarily due to lower inventory production costs and the cost reduction measures that were put in place earlier this year. With that, I will turn the call back to Laura. Thank you, Dale. So we're very pleased with our progress that we've made this past quarter and with our remodeled commercial team and our excellent progress in our pipeline programs. With our outstanding and dedicated team, we remain committed to delivering truly transformative regenerative medicine solutions that improve patient outcomes and save limbs and save lives. We're positioned for growth and value generation for the balance of 2026 and beyond. I want to thank you for your interest in Humacyte. And operator, we're now ready to take questions. Thank you. We will now be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Ryan Zimmerman with U.S. Bank Corp. BTIG. Please go ahead. Good morning, and congrats on all the progress. It's exciting to see the momentum, Laura, Dale, and Jim. Maybe for Jim, just to understand more about kind of what you changed, how you think about the durability of adoption this quarter, particularly with all these new sites. You mentioned a little bit about incentive pricing, I think, to get hospitals on board. Maybe you could just give us some more color on some of these dynamics, Jim. I think that would be very helpful. thank you sure happy to do so and thanks for the question uh you know first and foremost i think one of the biggest impact that we had we're hiring the right uh leadership team and specifically those that have those vascular surgery uh experiences and relationships across the united states uh that that was one key element that we executed on all throughout uh q2 that impacted It ended in Q3, that impacted Q3 and now impacting Q4. That's first. The second is we did redevelop and retool our marketing, our messaging, and our training at the same time. Again, doing this all throughout Q2 and partially Q3. And what is it? It relates to pricing. It's no question that sometimes you have to, when you're launching a particular healthcare system and they want to try out the product, and, of course, outcomes and patient care is of utmost. You want to give some type of introductory price before you get them going and get them started. So I think the combination of all that has allowed us to take off commercially. And you can see that not only in Q3, but you see that with the takeoff in Q4. As I said a little earlier, we expect to double from Q3 to Q4, continuing that trend. So we're very excited about the progress we made. The progress will continue. And I think there's no question in our mind we've got the right product. Now we have the right people and programs in place to get this off commercially. I hope that answers your question. Very helpful. And, Laura, it's turning to you on the pipeline. You're, you know, a couple weeks away here of getting that supplemental BLA in. How are you feeling about, you now, dialysis access as an approved indication? Can you give us a sense for timing of when you expect, you know, we should think about commercial activity beginning and just any other, you know, thoughts around the build-out of the dialysis access program from a commercial perspective? Thanks for taking the questions. Yeah, well, on the commercial part of that question, I might toss it back over to Jim. But in general, the SBLA is coming together very well. As I mentioned on the call, we have three Phase III trials supporting this indication. Our target indication, not yet approved, of course, but our target indication will be in all women and in men who have certain risk factors for fistula non-maturation. I can tell you that looking at our clinical trial data across Phase III trials, our outcomes in women are remarkably consistent and remarkably good. And this is some really strong data, and I am so pleased to be submitting this package. So the package will go in sometime in November, and then the FDA has 60 days to accept the filing. So we expect to get BLA acceptance sometime in January, which we would, of course, announce. At that time, we'll learn about whether or not we're getting a priority review. We believe that we deserve a priority review because we have an RMAT designation for the product. However, we'll learn that in January. If we do get priority review, then that would mean we could have a PDUFA date sometime in May and then a commercial launch soon thereafter, perhaps in June. If we don't get priority reviews, then we're going to have to wait until the end of the year. If we not get priority view from the FDA, then that would push our PDUVA date into September and we would launch after that. So that's sort of the binary question there. With respect to commercial readiness, we've already built out a budget impact model. Given that our patient populations who most benefit from ATEV and dialysis, it's been pretty clear from the data that's allowed us to build out a budget impact model, and we're in the process of combining that now with Medicare closed claims data from the fee-for-service database to really understand how our vessel could impact both costs of access care and total costs of care, which CMS is very focused on, for our target populations and dialysis. So all of that thinking work is well underway. And as far as the other sort of commercial approach? I'll let Jim speak to that. Sure, Laura, and thanks for going through that. I get to tell you that, you know, just when you think about the dialysis launch, we're more than excited about it. As we are planning for this particular launch, and as Laura said, we have to figure out the actual launch date, but behind the scenes, we are actively planning our marketing campaigns and so many other things that we'll do on a commercial launch. What we get excited about are a couple of things. One, if you know dialysis and you know that market size, it's about 500,000 patients in the US and about 100,000 patients enter into dialysis every year, maybe another 20,000 revisions. So when you start to calculate a total available market for dialysis, again, this is total available market now. You're looking at a $2 to $3 billion opportunity annually in the United States, which is exciting to us. Not to mention the tens of thousands of lives we will impact in a positive manner, whether from infection or saving a life. And as Laura said earlier, saving lives and limbs is one of our key mottos. And I can tell you, that is one of the things that we talk about every single day. Every patient matters, every life matters, every limb matters. Hopefully that answers your question. Yeah, thank you guys. Congrats on the progress. Our next question comes from Josh Jennings with TD Cohen. Please go ahead. Hi, good morning. Laura Dale, Jim. Echo Ryan's congratulations on the progress. I was hoping to just get your view on the vascular trauma indication. Any updated thoughts just on the addressable opportunity? I mean, is this still, in your eyes, a multi-hundred million dollar market in the United States? And are there any plans to expand internationally for vascular trauma indication or other indications? So again, I'll probably take that and then let Jim jump in. Yes, certainly we have seen, you know, with our current approval in vascular injury, we've seen an expansion in sales, as you've mentioned. So we are actively targeting, continuing to target very busy trauma centers in major metropolitan areas, but also very busy vascular surgery practices where a fraction of their work is also trauma. So that we're continuing to push very hard. We also, as we've said before, we have filed an MAA application in Israel, and that's marching along. So, that's under active review right now, and we're also looking at other opportunities in the Middle East. You know, I believe that the uptake in vascular injury is going to continue to grow as we're at different sites. As I've mentioned before on previous calls, occasionally when a surgeon is using our vessel for the first time, he doesn't want to be using it at two in the morning when somebody's bleeding to death. That's not the first Time he wants to try our vessel. So the pattern that we're seeing is that surgeons are using it in more cases in the daylight that are somewhat more planned, getting some experience there, and then moving over and using it more in trauma. And that's just sort of an organic progression that's naturally occurring in hospitals. So we're going to continue to push that because everywhere that we seed in a hospital that takes care of trauma patients, that's also going to be a hospital, that once we're approved in dialysis, is taking care of dialysis patients. Excellent. And then, you know, it's encouraging that I think in the press release earlier in the quarter, the team commented on physicians submitting real-world some of those patient case studies for presentation. I was hoping to just get any flavor in terms of some case highlights, real- world case highlights that you can share, and then also, will some of these case studies that will be presented occur at VEEF, and will they include any off-label utilization, including in, you know, really challenging AV fistula, like REDU's, infected EPDF, EPDFE grafts, et cetera, multi-tiered question, but thanks for taking the questions, and congrats again. Jim, do you want to take that, or do you want me to take it? Sure. No, Laura, I'm happy to take it. So, let me just at least start with part of the question. So, these will be an exciting time for us, and it's the largest vascular surgery meeting in the world that takes place in New York City. And we've really geared up this year and changed a lot of things and specifically marketing strategies for this year's V. So we're real excited about it. Put that aside and say, yes, there will be multiple case presentations given by physicians. We tend to don't get into that because those are physician presentations. You can always find some of physicians' comments, especially lately on LinkedIn or some other social media. We're certainly seeing more and more adoption of our product across the country. We open up new accounts each month, and certain physicians have put out press releases already about their experience and their adoption of it, and certainly, certain ones are waiting to present at FEEF to give their feedback and opinion, but we're getting lots of positive feedback and really successful cases in the United States, and we're excited about that. Laura, you probably have a follow-up, I'm sure. Yeah, the other thing that I would mention is that, you know, along with onboarding Jim in April, we also onboarded Todd Rasmussen, our chief surgical officer, and he and his medical science liaisons have just been outstanding on sort of the proactive education front, really connecting with surgeons at individual new locations and really teaching them about the most effective way and the most compliant way to use SimVest in their patients. You know, having a surgeon on Humacyte's team who has done more implants than maybe any other surgeon in the U.S. of our vessel has been just an outstanding tool for us because it makes surgeons out in the field who've never used the product before, it makes them more comfortable, and also because they're better educated, their outcomes are better, and so it's a virtuous cycle. Thanks for that, and good luck down the homestretch with the supplemental BLA filing. Our next question comes from Chris Pasquale with Barclays. Please go ahead. Thanks. You talked about refining your introductory pricing strategy. I was hoping you could give us some color on where your ASP came in for 3Q, or if you want to talk about it sort of the other way, what the million dollars in revenue translated to from a volume perspective. Well, I mean, we tend not to talk about particular pricing on this call because a lot of our hospital administrators are listening, but what I can tell you is our average price for SinVest or around our list price is about $17,000 a unit. But again, when we're starting a particular healthcare system out, there could be introductory pricing, there can be evaluation pricing. So a lot things go into that. And sometimes when you're doing that calculation, it kind of dilutes it. But I can tell you moving forward and as each quarter goes on, the ASP tends to get stronger and stronger with the adoption of the product. So I can't give you very specific information and there's reasons for that, but hopefully that answers your question, gives you an idea of where we are and where we're headed. Okay. Okay. And then as we see revenue stepping up here, it should improve the ability to absorb some of the overhead costs that have been flowing through COGS. So do you expect to have a positive gross margin in the fourth quarter, given where the commercial adoption is trending? How should we think about that? Yeah, the biggest – this is Dale. Chris, the greatest impact on COGS in terms of unused production capacity is whether we're actually in production at a particular point in time. And we had really great success with our production as we closed out 2025. I think at some point in time we had close to nine or ten lots in a row that passed without failure. And because of that, we've been able to run limited production runs in 2026, which means that we have had this unused overhead flowing into cost of goods sold, which likely will continue for the fourth quarter, too. So based on how sales are ramping, we have a very robust production schedule plan for 2027, and so as we move into 2027 you should not see the unused production capacity continuing to flow into cost of goods sold. Okay, thank you. Our next question comes from Henry Ware with HC Wainwright. Please go ahead. Hi, this is Henry on for Arte. And just going back to dialysis, as you're preparing for the potential launch, how much can you build on the existing hospital relationships and the experience established through trauma? And with the two new nephrology advisors, I guess, what additional work are you guys doing on reimbursement and education, that could help with adoption if approved. Thank you. Laura, you want me to take the first part or both? Yep, and I'll take the second. You got it. So, great question. We believe that the adoption obviously continues throughout Q4 in 2027 of our current indication, and yes, it will directly, in a positive manner, impact our launch when we do get approval for dialysis, and the reason is because the same vascular surgeons that are using, for the most part, eight out of ten times, the same vast surgeons that are using our product today also do dialysis access, and so it transforms beautifully when your physician is already experienced with implanting our product, to be able to do that in dialysis, it's not seamless at all, but there's a real familiarity with it and it allows us for a much quicker adoption cycle than it would just coming in fresh. Yeah, and with respect to Drs. Roy Chowdhury and Kosman, these are outstandingly experienced nephrologists, one from the private sector. Rob Kosman is the former chief medical officer for CENIUS, and he actually ran all of their dialysis centers in the U.S. for many years. And then Prabir Roy Chowdhury is also, you know, very closely involved with the academic leadership in nephrology and past, present, and the ASN. So both of these gentlemen have been actively advising us for probably about the last six months, and they've really helped us hone in on some of the things that are going to be important both to Medicare but also to value-based care organizations that are functioning under the kidney care choices model that is supported by CMS. So in terms of the amount of risk that certain value-base care organizations take on, Some of these organizations take on 100% of the risk of total cost of care for their dialysis patients. And so these organizations are extremely focused on improving outcomes so that patients have fewer complications and fewer hospitalizations and drive down total costs of care. But these organizations Are also very focused on certain metrics like optimal start, which is a scenario whereby a patient can start newly on hemodialysis and avoid a catheter altogether. So we're already partnering closely with leaders, chief medical officers, and CEOs of various value-based care organizations to understand what their pain points are and to really create a robust financial model that will help them understand how our vessel can both help their patients and get better outcomes, but also help them meet some of their metrics and drive down total cost of care. And frankly, a lot of these interactions have been facilitated from the advice of Dr. Roy Chowdhury and Dr. Kostman. We're also speaking with them about CMS reimbursement and other topics. So they're not our only advisors in this area, but they've been profoundly helpful. Thank you. And then regarding the VO12 study presented at ASN, I guess as follow-up continues, are you collecting any additional data, and do you plan to share any of that publicly? Yeah. So, we stopped enrolling the VO12 study when we met our primary interim analysis endpoint. So we had targeted 150 patients total. We had enrolled 120 by the time we completed our interim analysis. So we've got 120 patients enrolled. We have pre-specified with the FDA that we would follow all of those patients through year two, and we're doing that. So the first-year data has actually been written up and is being submitted to a major vascular surgery journal as we speak. We also, as I mentioned before, we've published the one-year results in the VO7 study, and we are looking at publishing additional long-term results in the VO 7 study, which also compared our vessel to fistula as well. in men and women so I see a number of publications coming out even in advance of FDA approval I see, a number, of publications, coming out relevant to dialysis access in phase three trials thank you thanks it's helpful our next question comes from Bruce Jackson with Stonex please go ahead Hi, good morning and thanks for taking my questions. I apologize if I missed this, but what's the status of the biovascular pancreas and are there going to be any public data points coming up here in the future? So the bio vascular pancreatic is still certainly a pipeline project for Humacyte. We actually have a publication that's in press right now on some of our primate work that we've done showing long-term islet survival in an allogeneic primate model I would say that right now this quarter and next quarter we're focused pretty pretty tightly on manufacturing and and the sales ramp so we we're continuing to work at a benchtop level on the bio vascular pancreas but you know as a company I think we're focusing most of our energy on on growing the commercial story, making product and making sure that we don't stock out because Jim is selling so much. We don't want to run out, so we're going to make a lot more. And that's really the primary focus for us right now. The biovascular pancreas project is something that I think we'll put more resources into probably next year when we have a little bit more daylight around cash flow. But that's where we are. So we're continuing. We have a publication and we're continuing benchtop work as of right now. Okay, great. Got it. Thank you. We have reached the end of our question and answer session. I would now like to turn the floor back over to Laura E. Nicholson for closing comments. Yes, thank you, Operator. You know, this has been such a journey, and I'm just so grateful to the employees at Humacyte and also our investors who have been with us on this long and sometimes sometimes arduous journey. I want to emphasize that I believe this is a turning point for Humacype. The revamped commercial structure has already had an amazingly positive impact in an amazingly short period of time. I think this would not be true if we did not have a good product that works and that physicians like and that saves limbs and saves lives and I believe that that's all true and I our commercial execution now is much better I think than it was previously and we're seeing the dividends of that so I always say I'm excited on these calls but but I am really excited this quarter and I and I think that next quarter and then 2027 are going to have a lot more growth so stay tuned This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. I filed an MAA application in Israel, and that's marching along, so that's under active review right now, and we're also looking at other opportunities in the Middle East. I believe that the uptake in vascular injury is going to continue to grow as we're at different sites. I've mentioned before on previous calls occasionally when a surgeon is using our vessel for the first time he doesn't want to be using it at 2 in the morning when somebody's bleeding to death that's not the first time he wants to try our vessel so the pattern that we're seeing is that surgeons are using it in in more cases in the daylight that are somewhat more planned getting some experience there and then moving over and using it more in trauma. And that's just sort of an organic progression that's naturally occurring in hospitals. So we're going to continue to push that because everywhere that we seed in a hospital that takes care of trauma patients, that's also going to be a hospital that once we're approved in dialysis is taking care of dialysis patients. Excellent. And then I was encouraging that I think in the press release earlier in the quarter, the team commented on physicians submitting real-world system-based patient case studies for presentation. I was hoping to just get any flavor in terms of some case highlights, real- world case highlights that you can share, and then also will some of these case studies that will be presented occur at VEEF, and will they include any off-label utilization, including in really challenging AV fistula, like REDU's infected at EPDF, EPDFE graphs, et cetera, a multi-tiered question, but thanks for taking the questions and congrats again. Jim, do you want to take that or you want me to take that? Sure. No, Laura, I'm happy to take it. So let me just at least start with part of the question. So these will be an exciting time for us. I mean, it's the largest vascular surgery meeting in the world that takes place in New York City. And we've really geared up this year and changed a lot of things and specifically marketing strategies for this year's V. So, we're real excited about it. Put that aside and say, yes, there'll be multiple case presentations given by physicians. We tend to don't get into that because those are physician presentations. You can always find some of physicians' comments, especially lately on LinkedIn or some other social media. We're certainly seeing more and more adoption of our product across the country. We open up new accounts each month, And certain physicians have put out press releases already about their experience and their adoption of it, and certain ones are waiting to present it to give their feedback and opinion. But we're getting lots of positive feedback and really successful cases in the United States, and we're excited about that. Laura, you probably have a follow-up, I'm sure. Yeah, the other thing that I would mention is that, you know, along with onboarding Jim in April, we also onboarded Todd Rasmussen, our chief surgical officer, and he and his medical science liaisons have just been outstanding on sort of the proactive education front, really connecting with surgeons at individual new locations and really teaching them about the most effective way and the most compliant way to use SimVest in their patients. You know, having a surgeon on Humacyte's team who has done more implants than maybe any other surgeon in the U.S. of our vessel has been just an outstanding tool for us because it makes surgeons out in the field who've never used the product before, it makes them more comfortable, and also because they're better educated, their outcomes are better, and so it's a virtuous cycle. Thanks for that, and good luck down the homestretch with the supplemental BLA filing. Our next question comes from Chris Pasquale with Barclays. Please go ahead. Thanks. You talked about refining your introductory pricing strategy. I was hoping you could give us some color on where your ASP came in for 3Q, or if you want to talk about it sort of the other way, what the million dollars in revenue translated to from a volume perspective. Well, I mean, we tend not to talk about particular pricing on this call because a lot of our hospital administrators are listening, but what I can tell you is our average price for SinVest around our list price is about $17,000 a unit. But again, when we're starting a particular healthcare system out, there could be introductory pricing, there can be evaluation pricing. So a lot things go into that. And sometimes when you're doing that calculation, it kind of dilutes it. But I can tell you moving forward and as each quarter goes on, the ASP tends to get stronger and stronger with the adoption of the product. So I can't give you very specific information and there's reasons for that. But hopefully that answers your question, gives you an idea of where we are and where we're headed. Okay. And then as we see revenue stepping up here, it should improve the ability to absorb some of the overhead costs that have been flowing through COGS. So do you expect to have a positive gross margin in the fourth quarter, given where the commercial adoption is trending? How should we think about that? Yeah, the biggest – this is Dale. Chris, the greatest impact on COGS in terms of unused production capacity is whether we're actually in production at a particular point in time. We had really great success with our production as we closed out 2025. I think at some point in time we had close to nine or ten lots in a row that passed without failure. And because of that, we've been able to run limited production runs in 2026, which means that we have had this unused overhead flowing into cost of goods sold, which likely will continue for the fourth quarter, too. Based on how sales are ramping, we have a very robust production schedule planned for 2027. And so as we move into 2027, you should not see the unused production capacity continuing to flow into cost of goods sold. Okay, thank you. Our next question comes from Henry Ware with HC Wainwright. Please go ahead. Hi, this is Henry on for Arte. And just going back to the dialysis, as you're preparing for the potential launch, how much can you build on the existing hospital relationships and the experience established through trauma? And with the two new nephrology advisors, I guess, what additional work are you guys doing on reimbursement in education that could help with adoption, if approved? Thank you. Laura, you want me to take the first part, or both? Yep, and I'll take the second. You got it. So, great question. we believe that the adoption obviously continues throughout the Q4 and 2027 of our current indication. And yes, it will directly, in a positive manner, impact our launch when we do get approval for dialysis. And the reason is because the same vascular surgeons that are using, for the most part, eight out of 10 times, the same vast surgeons that Are using our product today also do dialysis access, and so it transforms beautifully when the physician is already experienced with implanting our product. To be able to do that in dialysis, it's not seamless at all, but there's a real familiarity with it, and it allows us for a much quicker adoption cycle than it would just coming in fresh. yeah and with respect to doctors uh roy chowdhury and costman um these these are outstandingly experienced nephrologists one from the private sector rob costman is the former chief medical officer for senius and he actually ran all of their dialysis centers in the u.s for many years um and then premier roy choudhury is also you know very closely involved with the academic leadership in nephrology and past, present, and the ASN. So both of these gentlemen have been actively advising us for probably about the last six months, and they've really helped us hone in on some of the things that are going to be important both to Medicare but also to value-based care organizations that are functioning under the kidney care choices model that is supported by CMS. So in terms of the amount of risk that certain value-based care organizations take on, some of these organizations take on 100 percent of the risk of total cost of care for their dialysis patients. So these organizations are extremely focused on improving outcomes so that patients have fewer complications and fewer hospitalizations and drive down total costs of care. but these organizations are also very focused on certain metrics like optimal start, which is a scenario whereby a patient can start newly on hemodialysis and avoid a catheter altogether. So we're already partnering closely with leaders, chief medical officers, and CEOs of various value-based care organizations to understand what their pain points are and to really create a robust financial model that will help them understand how our vessel can both help their patients and get better outcomes, but also help them meet some of their metrics and drive down total cost of care. And frankly, a lot of these interactions have been facilitated from the advice of Dr. Roy Chowdhury and Dr. Kostman. We're also speaking with them about CMS reimbursement and other topics. So they're not our only advisors in this area, but they've been profoundly helpful. Thank you. And then regarding the VO-12 study presented at ASN, I guess as follow-up continues, are you collecting any additional data and do you plan to share any of that publicly? Yeah. So, we stopped enrolling the VO12 study when we met our primary interim analysis endpoint. So we had targeted 150 patients total. We had enrolled 120 by the time we completed our interim analysis. So we've got 120 patients enrolled. We have pre-specified with the FDA that we would follow all of those patients through year two, and we're doing that. So the first-year data has actually been written up and is being submitted to a major vascular surgery journal as we speak. We also, as I mentioned before, we've published the one-year results in the VO7 study, and we are looking at publishing additional long-term results in the VO 7 study, which also compared our vessel to fistula as well. in men and women. So I see a number of publications coming out even in advance of FDA approval. I see number of publication coming out relevant to dialysis access in phase three trials. Thank you. Thanks. It's helpful. Our next question comes from Bruce Jackson with StoneX. Please go ahead. Hi, good morning and thanks for taking my questions. I apologize if I missed this, but what's the status of the biovascular pancreas and are there going to be any public data points coming up here in the future? So the bio vascular pancreatic is still certainly a pipeline project for Humacyte. We actually have a publication that's in press right now on some of our primate work that we've done showing long-term islet survival in an allogeneic primate model I would say that right now this quarter and next quarter we're focused pretty pretty tightly on manufacturing and and the sales ramp so we we're continuing to work at a benchtop level on the bio vascular pancreas but you know as a company I think we're focusing most of our energy on on growing the commercial story, making product and making sure that we don't stock out because Jim is selling so much. We don't want to run out. So we're going to make a lot more. And that's really the primary focus for us right now. The biovascular pancreas project is something that I think we'll put more resources into probably next year when we have a little bit more daylight around cash flow. But that's where we are. So, we're continuing. We have a publication and we're continuing benchtop work as of right now. Okay, great. Got it. Thank you. We have reached the end of our question and answer session. I would now like to turn the floor back over to Laura E. Nicholson for closing comments. Yes, thank you, Operator. You know, this has been such a journey, and I'm just so grateful to the employees at Humacyte and also our investors who have been with us on this long and sometimes sometimes arduous journey um i i want to emphasize that i believe this is a turning point for huma site the revamped commercial structure has already had an amazingly positive impact in an amazingly short period of time i think this would not be true if we did not have a good product that works and that physicians like and that saves limbs and saves lives and I believe that that's all true and I our commercial execution now is much better I think than it was previously and we're seeing the dividends of that so I always say I'm excited on these calls but but I am really excited this quarter and I and I think that next quarter and then 2027 are going to have a lot more growth so stay tuned This concludes today's teleconference You may disconnect your lines at this time Thank you for your participation