Okay, great morning, everybody. Thanks for joining us. My name is Matt O'Brien. I cover MedTech here at Piper. Very happy and lucky to have the management team here from Humacyte. From the company is Laura, who is the CEO of the company, and then Dale, who's the CFO of the company. Thanks so much for coming up.
Great.
Really do appreciate it. Laura, you know, the story might be a little bit new to some folks, even though you've been public for a little while now.
Mm-hmm.
Maybe just give us a little bit of background as far as the development of this product, kind of how it happened?
Sure.
Then where we're at today, and then kind of, you know, next big things to be thinking about for the next year or so.
Well, Humacyte is really a first-in-class technology platform. We are the only company in the world, really, that is engineering human tissues from a cell bank at commercial scale. We can make tissues in different shapes and sizes and are making blood vessels that address a whole range of vascular disease and injury. The technology is unique to us, and we've scaled the manufacturing so that we are, after a number of years of being in the clinic, we're now poised to get FDA approval and go onto the market.
Got it. Okay, so appreciate that. Recently, you showcased the safety outcomes, and other outcomes of the V005 study. Can you just kind of walk us through, you know, some updates there, as well as the outcomes you're seeing in Ukraine?
Well, our engineered blood vessels that we're growing in our manufacturing facility are 40 centimeters long and 6 millimeters in diameter, and this size of blood vessel can be used to treat a broad range of injuries and diseases. So what we recently reported in September was our top-line results in a clinical trial, really a pivotal trial, that looked at the utility of the human acellular vessel, or HAV, in patients who suffered traumatic injury. This study was done at about 20 Level I trauma centers in the U.S., and also a number of centers in Israel. And what we found was that the HAV was incredibly effective in saving life and limb in patients who had really severe injuries from gunshot wounds, car accidents, and industrial accidents.
We saw that at our primary endpoint, after a month, that the HAV had blood flow more than 90% of the time, which means that if you compare it to the alternative for these patients, which would be to get a plastic graft made out of Teflon, those grafts would have lost patency more than twice as often. In addition, and probably more importantly, patients who got the HAV avoided limb amputation more than 90% of the time. So, the limb salvage and the patency were really substantially better than what we're comparing to, which is plastic grafts. In addition, the HAV resisted infection and showed that it was durable.
So this is really, this is really a game changer for patients who have acute injury and who show up in the emergency room, and have no vein, have no way to repair their injuries.
Got it. And, what are you seeing specifically in Ukraine? Because I know that's an area where you've done some humanitarian work.
Right. So, surgeons in Ukraine reached out to us, shortly after the Russian invasion last year, and they asked us if they could get access to HAVs because they had heard about how well they're working in trauma. So we worked with the FDA, and we supplied HAVs to about five frontline hospitals in Ukraine, and they implanted almost 20 patients. Most of those patients had really horrific injuries from mine blasts and shrapnel and gunshot wounds. You know, this is wartime. And what the surgeons found there was that the results with the HAV in a wartime setting were even better than what we saw, clinically in the U.S. So, we had about 95% blood flow patency at one month, but we had 100%, limb salvage and zero infections.
We've included some of that data from Ukraine at the request of the FDA. We're including that in our package that we're preparing right now to gain approval for the trauma indication.
Got it. And, you know, I don't want to keep going down the conflict path. These things keep happening, which is unfortunate. Are you starting to do any work in Israel, specifically with, with the conflict there?
Well, in Israel, as with Ukraine, obviously, there's an active conflict. It's an active war zone. We received requests from surgeons in Ukraine last year, early in that conflict. We've not yet received any formal requests in Israel. So if we were to receive those requests, we would, of course, evaluate them because, you know, Humacyte always wants to do the right thing, and we want to help save life and limb, even though we're pre-commercial. But I will say that the process of getting a pre-approval product into a war zone is non-trivial. It took us four months to get product into Ukraine. So that would be a process that we would consider if we got a formal request.
Okay. Okay, understood. And I do want to get into this manufacturing facility that you have in a little bit, because I, you know, went down there, and it is world-class. But we'll get to that in a second. But Laura, you know, assuming nine months post-BLA filing for the vascular trauma indication, how should we be thinking about the label? Is it going to be indicated, you know, as a replacement for synthetic grafts, or how do we think about that specifically? And then maybe talk a little bit about kind of the low-hanging fruit, you know, with that indication once you get it.
Well, the final label is always a matter of discussion with the FDA, and so I, you know, I would hate to sit here and absolutely predict what the label will say. But right now, what we're discussing with the FDA is that the HAV would be used in trauma patients who don't have vein of their own, either because of time constraints or because the vein isn't available, and in patients who are not good candidates for synthetic grafts, like, made out of Teflon. If you look at trauma, most of those wounds are badly contaminated, and so most trauma surgeons would tell you that there's almost no traumatic wound that's suitable for a Teflon graft. In fact, they're not used very often.
So as far as the low-hanging fruit in the market, we believe that certainly any patient who might otherwise have been forced to get a Teflon graft would instead get our vessel. I think that's a no-brainer. But I also, you know, if we look at the reasons in our clinical trial, where surgeons said they needed to use the HAV, about a third of the time, it wasn't that there was no vein in the patient, it was the fact that the surgeons didn't have time, because it takes hours to get an injured patient into the operating room. By that time, the limb is already at risk, and patients and surgeons want to move quickly.
Got it. So what does that do in terms of a market opportunity then? I mean, it seems like it's still a majority of the patients would be eligible for the HAV.
Do you want to take that, Dale?
Yeah, no, I think you're right. Today, the majority of the patients are treated with saphenous vein, but a number don't have vein available because of injuries to both extremities or other reasons or time constraints. So we think that many, if not the majority of patients that present for vascular trauma, would be candidates for the HAV. Clearly, as Laura said, all the ones currently treated with synthetics or cryopreserved vein today, you know, certainly based on the clinical results we've shown, as well as what we believe are the economic benefits of using the HAV and saving the cost of amputation as well as, you know, for patient outcomes. But also, saphenous vein, in a large part, as Laura mentioned, because of the time constraints involved in harvesting vein from the patient to use as an arterial replacement.
So you're right, we, we do believe that the majority of patients would be candidates for the HAV.
How big is the synthetic-only component of that right now?
It depends on what database you look at. You know, some would suggest that there's about a 90-10 split between saphenous vein being 90, 10 or so-
Okay
... for synthetics. Others, if you'd look at individual hospital settings or look at individual surgeon results, it may be a 75-25 split, but the majority are saphenous vein. But based on, as Laura mentioned, the results we saw from our study and why surgeons chose to use the HAV, the time savings would suggest that even-
Right
... for saphenous vein, the majority of those patients would certainly-
Sure.
... be candidates for the HAV.
What I'm really trying to get at, Dale, and I, I completely agree on the saphenous vein side, but just the low-hanging fruit with the synthetic side, is that like 10,000 cases? And at your ASP, if it's 10,000 cases, I mean, those are going to flip pretty quickly, I would say. And at your ASP, that's $200 million.
Yeah, exactly. So it's not...
That's right
It's not like we're targeting a small subset of a small market.
Right
the suggested or likely sales price of this product, even getting 10% or 15% of the market on the front end, it drives very significant revenue.
Right. Got it. Got it, and once they start using it there, you would think, you know, it'll be easier and easier for them to say: "Yeah, why wouldn't I use this in all my cases?
Exactly.
Yeah, I mean, I think the HAV, because of its handling, because it handles so much like a native human vessel, you know, every surgeon who's been in our clinical trials has said that once this is on the market, that they would probably reach up and use it for things outside of the indication, including peripheral arterial disease and others, other situations. So we would never market to off-label use, of course, but I think the reality is that once these surgeons have this conduit in their hands, they're going to use it more broadly.
Okay. Can you talk a little bit, Laura, about the handling characteristics of this, and how easy it is for the clinicians? Because, again, I've seen it.
Mm-hmm.
I think it's very easy, but can you maybe just-
Mm-hmm
... just detail that a little bit?
Well, I think, you know, if you talk to surgeons who've handled the HAV, they will tell you that it handles a lot like a native human artery from a healthy 25-year-old. That's the phrase that I've gotten. So, it's mechanically strong, it's easy to sew, the needle holes don't bleed. That sounds like a small technical issue, but it's actually important for our surgeons. So, and it's of a size and diameter where it really works in many blood vessels in the body. I think another indication of how easy it is to use is that in Ukraine, we couldn't go there and train those surgeons.
We had to train them over Zoom, and despite that, their outcomes were outstanding, which means that you can, you can train people how to use this, and the learning curve is pretty, pretty short.
Got it. Got it. Sure it'd be much longer for me, but but that's another discussion. All right, so on the RMAT designation that you have for vascular trauma, would you mind sharing, I don't know if you have whether or not you're going to receive priority review for your BLA filing? And you know, I guess, when do you know if you'll have that or not?
So as part of the BLA filing, we're preparing the BLA right now. We've told the market that we're filing our BLA in this quarter, and we are filing our BLA in this quarter. It will happen in December. It's happening. We're very close to filing. As part of the file, we put in a formal request for priority review, which means that after BLA acceptance the review time window would be six months rather than nine or 10 months. So we anticipate that we will get that priority review track. However, we won't hear that until we hear that the file is accepted, which is 60 days after we submit the file.
Okay, and the submission is supposed to be this month. Is that right?
Indeed.
Within 60 days, so February, you'll find out for the next. Okay, got it. Maybe talk a little bit about the launch preparation for HAV. You know, maybe just talk a little bit specifically on the manufacturing side-
Mm-hmm
-of things, because again, you have to go see the facility. It's unbelievable. What can you support from just that facility today?
Well, in terms of our manufacturing process, as Matt has seen, is really, it's a modular process. We have machines that we call Luna 200 units, that are essentially incubators that are about as big as a school bus, and they're modular individual units. Each unit can produce 1,000 HAVs per year. We have eight of those units installed in the building right now, which means that, you know, at the get-go, we could make 8,000 vessels per year, which we think would address a good chunk of the initial trauma market. So I would submit that we're ready to go right now in terms of our manufacturing capacity.
But in the building, we have space shelled out that will allow us to install a total of 35 or 40 Lunas, which means that we could get to about 40,000 vessels per year out of that building.
Okay, and your ASP is expected to be about?
As we've shared in some of our SEC filings, we have provided numbers of the ASP that are around $20,000 or $25,000. But again, that's a number that's not certainly set in stone, but we've used that as sort of a benchmark.
So I guess, what are some of the puts and takes as far as what the ASP may look like, where it could be lower, it could be higher?
Well, I think it's hard to really answer that question definitively now, but what I can say is that starting in the trauma indication, where patients are looking at loss of life and limb, loss of life, but certainly loss of limb is a very expensive prospect. And so the health economic case that can be made to support a strong ASP, I think is very strong in the trauma indication. We're working on a budget impact model for hospitals and for insurers right now that make it clear that, with respect, if you compare even with a very strong ASP for the HAV, if you compare that to the total cost of care for a patient who gets a synthetic graft, hospitals and insurers win from the first couple of cases.
If you compare the cost of care with respect to vein, because we save time in terms of operating room time and in terms of restoring blood flow faster than vein, and so decreasing amputations, there's also savings there. So, again, it's hard to predict where the ASP will land, but I think that, for Humacyte, strategically, it's fortunate that we're starting in trauma because the healthy economic benefits are so clear.
Got it. Okay. So, 35-40 Luna systems. I mean, 40, I can do the math on this. I'm not that good at math, but you're talking $800 million-$1 billion you can support out of a single facility.
Indeed.
Right. And then those eight different Luna lines today, what have you done in terms of validation to make sure that the output of the vessels is uniform, you know, across all eight of those, so that every time a clinician's getting the HAV, it's, you know, it's working like it should?
Well, actually, all of the units have been validated, and all of the units are sort of mechanically identical. You know, this is so the mechanics and the way all of the units are built and will be built, you know, is all the same. So inherently, we've built a lot of control into the manufacturing process and a lot of automation. But fundamentally, this is a biological process. We're growing new human tissues, new human arteries from cells. And I like to say that, you know, we make an artery in two months, which sounds like it may be a long time, but compared to what it takes a fetus, which is nine months, I think we're actually doing okay.
Yeah.
This is a biological process, and so really monitoring the biology of how the vessels are growing over time, that's really the key to ensuring product uniformity and quality.
Okay.
So it's not so much machine-to-machine variability, but we have a lot of monitors on each batch that really... And then a lot of final batch testing that allows us to assure that every vessel that goes out is gonna have the right function. And I think that's illustrated by the fact that, you know, we've been in clinical trials now for 11 years, and we've implanted more than 550 patients. We've been at more than 60 medical centers in seven countries. We have never had a safety issue. Never.
Okay. Knock on wood on that, but okay, got it. Dale, maybe questions, a couple of questions for you. So, you know, submission, you know, early next year, or acceptance, hopefully early next year. Approval, Q3, Q4 next year, something like that. When do you start hiring sales reps? When do you start getting, you know, getting the infrastructure in place to support the selling side of things?
Yeah, and I think we can back up, and even before getting to the sales force, there is a core commercial team in place right now working on the longer lead time items to prepare for a successful launch. So part of that is the budget impact model that Laura described, which is, it's gonna be important to get out there and present that in some medical conferences and maybe even have it published at the time of launch... that it's a robust model that supports the average sales price that we talked about earlier. Beyond that, there's certain things in terms of applying for coding and other aspects of providing market access to, again, assure that all the infrastructure is in place to allow the product to be supported at the time of launch.
In terms of sales itself, those reps are hired much later in the process, right about the time of launch, either shortly before or at the time of launch.
Okay.
Sometimes there's a contingent hire basis that's done, and you bring people on right upon approval and then train them in time for the launch. But, you know, the trauma market is a great place to launch because it's a very concentrated market. There's only about 200 Level I trauma centers in the United States that treat the majority of the trauma patients. Most of those are treated by vascular surgeons, which is, again, a very concentrated market also.
Mm-hmm.
And so we believe that a sales force, well less than 20 reps, will be enough to reach those 200 Level I trauma centers. And so these would be, you know, highly qualified surgical-type sales reps that we would bring on board right about the time of launch to support it. But well in advance of that, there's many activities going on right now to support a successful launch next year.
Coverage you think will be available, you know, especially going through the BLA process right away. Is that fair?
Yeah, and when we talk about... We're focusing very much on trauma today, but when we talk about who's paying for the HAV, it's really gonna be dependent upon where the service is being performed and what indication we're talking. So specific to trauma, the hospitals are generally reimbursed on a DRG-type basis, so essentially a fixed basis based on the diagnoses of the patient and the procedures that are done. So the HAV in that case would essentially be a cost to the hospital-
Mm-hmm
... which is why the budget impact model is so important because we'll be able to demonstrate that not only are we showing improved patient outcomes, but we can also provide a positive budgetary impact for the hospital by avoiding the cost of amputation, infections, and other complications associated with the current standard of care. But also, as a new, very innovative technology, which I think we all agree the HAV is, it should also qualify for an NTAP reimbursement, both from Medicare by the CMS, but also from private pay, which usually have a similar mechanism.
Do you think you're gonna need that right off the bat or... Because, I mean, the HAV is more expensive, obviously, than harvesting the saphenous vein or synthetic. I mean, is that gonna be a gating factor early days?
I don't think it's a gating factor. And again, you know, I think what we arrange with CMS is indicative, and private pay insurers can follow that. But keep in mind, in the trauma population, a real minority of them are actually CMS patients.
Right.
Most are gonna be at a younger age than that.
Okay.
You know, the efforts... As part of these efforts underway right now, it's also interacting with the private pay insurers to explain to them the benefits to them of avoiding long-term rehabilitation associated with amputations and other costs once the patient leaves the hospital, and why they should support the equivalent of an NTAP reimbursement now for the product, because it's gonna save other costs that they're gonna incur with these patients, even in the first year after injury.
Do you think there'll be a stocking benefit right off the bat, right? 'Cause you've gotta have a HAV sitting there 'cause you don't know when these patients are gonna come in. So, you know, Q, you know, the first quarter of launch, you know, you could see some nice revenue just from a stocking perspective.
Well, you're correct in that. You can't ship the HAV on a real-time basis when-
Yeah
... when a patient comes in for trauma, even five or 10 minutes can make a difference.
Right.
The product has to be there that day. But this is a hospital sale, so much of the early efforts are not only convincing vascular surgeons to create a pull-through demand and use the product, it's administratively getting the product into the hospital in the first place, which can quite often mean going through a value analysis committee. And when you launch a product like this, you get surprised on day one of your soft launch. You'll get orders from hospitals you've never even interacted with, and others that participated in clinical trials may go through the whole six-month VAC process.
Right
... before you get the product placed. That being said, we do think that hospitals that bring the product on would stock some level of product. I'm not sure this is a first-month, you know, sales spike where you fill the pipeline like you might with some products. But as hospitals come on board, we would have to expect them to maintain some minimum level of inventory so that the product is available when the patient presents.
Got it. Okay, and... You know, I'm sorry I've spent so much time on the vascular side of things, but obviously, it's pretty near term here. Maybe, Laura, talk us, you know, walk us down this. This is a pipeline or not a pipeline, this is a platform technology that you have here.
Mm-hmm.
Just talk a little bit about, you know, what you're thinking in terms of the AV access program.
Mm-hmm. Well, the AV access program in dialysis patients, if anything, is even a bigger market than trauma for sure. We have completed a Phase 3 trial, where we're comparing AV access. We've completed enrollment of a Phase 3 trial comparing the HAV to an arteriovenous fistula in dialysis patients. We'll have that readout, top-line readout, probably late in the second quarter of next year. And the results there, I think, will determine if we move forward with an amendment to our current BLA, because it's all the same product, and file for an indication in dialysis access. We also have an upcoming,
We haven't announced this yet, but we have an upcoming KOL event that we're doing in a couple of weeks with Fresenius, where we're looking, really looking at the types of patients who really need a better dialysis access, who have problems with infection or problems with repeated failures. And Fresenius's database, because they care for hundreds of thousands of dialysis patients, they have a very robust database. And so we've really been able to pinpoint who are the patients who have difficulties with their access and who would most benefit from the HAV.
Got it. Okay. Well, as I look at the clock, I think we're just about out of time, so I'll go ahead and wrap it up there. Laura, Dale, thanks so much for the feedback this morning. Really appreciate it.
Thank you.
Thank you.
Yeah, thanks.