Humacyte, Inc. (HUMA) Q3 2026 Earnings Call Transcript

And welcome to the Humasite third 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 actual results to differ from statements made on this call is contained in our periodic reports with the SEC. The 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-looking 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 Humasite website. Joining me on today's call from Humasite 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. Nicholson 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 SimBest market launch, and Dale Sander 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 HumaSight. What we're doing at HumaSight 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 SimVest. 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 And we're pleased to announce that we have initiated our first human Phase 2A 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 Hemocyte, 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 SinVest, and establish a path to sustain growth for SinVest. 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, an approach to 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, civic sales revenue... 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 SIDVEST increasing by 44%, from 34 hospitals at the end of second quarter to 49 hospitals at the 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 position 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 in 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 Premier Roy Chowdhury of the University of North Carolina, 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 Humacite. 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 Humocyte, the CTEF in Coronary Artery Bypass Grafting, or CABG. The FDA accepted our investigational new drug application for a first-in-human clinical study of the CTEF in CABG, and we initiated a Phase II-A study of the CTEF in CABG patients this month. Also, just this past weekend, three scientific presentations related to CTEF 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 2A clinical trial protocol for our study. And researchers from Humocyte 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 CABG 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 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 SimVest 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 2026 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 SimVest 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 nine months 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 quarter of 2025. In the third quarter of 2026, $0.6 million of cost of goods sold related to the cost of units recorded as sales revenue during the period, and $0.8 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 the nine months ended September 30, 2025. In the nine months ended September 30, 2026. $1.2 million of cost of goods sold related to the cost of units recorded as sales revenue during the 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 the same periods in 2025, the decrease in research and development expenses 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 non-commercial 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 incurred in the second quarter of 2026. General 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 million 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 for the same periods in 2025, other net income for all periods resulted primarily from the non-cash re-measurement 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 million and $16.0 million 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 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 for the same periods in 2025. Cash use and operations decreased in 2016, 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 Humocyte. 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, you know, to understand more about kind of what you changed, you know, how you think about the durability of adoption this quarter, particularly with all these new sites. You mentioned a little bit about, you know, 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. You know, first and foremost, I think one of the biggest impact We're hiring the right leadership team and specifically those that have those vascular surgery experiences and relationships across the United States. That was one key element that we executed on all throughout Q2 that impacted and into 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 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. And so we're very excited about the progress we made. The progress will continue. And I think It'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 is 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 know, 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 three 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... ...location 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 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 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, 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 some best patient case studies for presentation. I was hoping to just... Again, 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 VIF, and will they include any off-label utilization, including in a really challenging AV fistula like Redo's, infected EPDFE graphs, et cetera? 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. Laura, I'm happy to take it. So let me just at least start with part of the question. So VEET 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 VEET. So we're really 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 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 the 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 Humicide'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 for 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, you know, we tend not to talk about the... Particular pricing on this call because, you know, a lot of our hospital administrators are listening. But what I can tell you is our average price for CINVEST 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 could be evaluation pricing. So a lot of things go into that. And sometimes when you're doing that calculation 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 biggest 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 10 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. You know, 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 H.C. Wainwright. Please go ahead.

Hi, this is Henry on for RK. 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 and education that would, 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 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 10 times, the same vascular surgeons that are using our product today also do dialysis access. And so it transforms beautifully when you go. 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 Roy Chowdhury and Kosman, these are outstandingly experienced nephrologists, one from the private sector. Rob Kosman is the former chief medical officer for Senius, 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 president of 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, the kidney care choices model that is supported by, by CMS. So, um, In terms of the amount of risk that certain value-based 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. Kossman. 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 had 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're looking at publishing additional long-term results in the VO7 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 III 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 biovascular pancreas is still certainly a pipeline project for Humocyte. 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 tightly on manufacturing and the sales ramp. So we're continuing to work at a benchtop level on the biovascular pancreas. But, you know, as a company, I think we're focusing most of our energy 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 Humasite and also our investors who have been with us on this long and sometimes arduous journey. I want to emphasize that I believe this is a turning point for Humasite. 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 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 I am really excited this quarter, 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.