Josh Jennings: Excellent. And thanks for that and I want to just follow-up on — just about we get some questions on the pace of enrollment for V005. And our understanding just in terms of connecting the dots with the ultimate market opportunity. I mean, can you just review some of the hurdles and enrollment? I mean our understanding talking to vascular surgeons, these patients are very hard to consent. And so once you have approval, that total addressable market that you guys have laid out is realistic. But just wanted to get your thoughts on just the pace of enrollment and how that translates into the total addressable market and some of the hurdles that your investigator sites face enrolling these patients.
Laura Niklason: Yes, Josh, that’s a really excellent question. So the number of vascular injuries in the U.S. is what it is. It’s tens of thousands per year even in peace time. But again, the hurdles and the difficulties that we’ve encountered enrolling V005 really just highlights the reason that extremely few interventional trials have ever been done in this type of traumatic injury. By definition, if a patient is injured enough that they require acute repair of an artery that is big enough to be treated by the HAV, that means that this patient is essentially bleeding to death. Typically, these events occur in the off hours in the middle of the night. And also, by definition, if a patient is bleeding that much, they’re typically not able to provide consent.
So targeting patients with injury severe enough to require acute repair, but finding patients, who are not sedated or who are conscious and able to give consent or have a family member standing right next to them who can give consent that just becomes a vanishingly small pool. So the realities of human clinical research are that, of course, we have to abide by all regulations and consent every patient. But for this type of trial, it just places enormous hurdles on enrollment. So Humacyte continues to believe that the realities of the marketplace are very different from that sort of tightly constrained limitations that we’ve had to deal with in this trial.
Josh Jennings: I appreciate that. And just lastly, thinking on the pipeline and the different indications that you’re pursuing for HAV, is there any way to think about the prioritization or is it in terms of how you’re going to allocate investment dollars to each of those pipeline projects? Thanks for taking all the questions.
Laura Niklason: Well, the pipeline products that we’re focused on most intensely are the coronary artery bypass graft, the small-caliber vessel as well as the biovascular pancreas. Now both of those — both of those product candidates are in large animal trials. So we’re in primates for both of those candidates, which is very exciting. We’re certainly pushing forward with large animal implantations in the CABG application and really filling out the preclinical database for that indication. And the same thing is true on the biovascular pancreas. That said, the total dollars, even for primate work, because the numbers of primates aren’t hundreds, it’s on — it’s single digits or low double digits, so that’s on the order of several million dollars for those programs, which is really a small total fraction of our total spend.
Because obviously, with active Phase III clinical programs in a couple of different areas and fully scaled manufacturing, the vast majority of the spend is still going there. So we’ve made strategic decisions to continue to push forward what we believe are incredibly important programs for building the value in the company. But the total spend for 2023 on these pipelines as a fraction of the total budget is actually pretty small. But we think there’s outsized value there.
Josh Jennings: Thanks a lot, Laura.
Operator: Thank you. Our next question comes from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.
Suraj Kalia: Good morning, Laura Dale, can you hear me all right?
Laura Niklason: Yes.
Suraj Kalia: Yes. Perfect. Congrats on all the progress. So Laura, just following up on V005, and forgive me if I got my numbers wrong, wasn’t the trial originally supposed to enroll 75? I guess, where I’m headed is, during your discussions with the FDA, were there any questions about efficacy in non-extremities, which led to the 50 number? Just trying to understand this new number and the difference in adjudication for efficacy versus safety, if at all.
Laura Niklason: Yes. Suraj, those are very good questions. So guidance that we’ve been providing to yourself and to the market, really since the summer of 2021 has been that we expected to enroll approximately 75 patients give or take, in V005 before we could file. And that was really an estimate based on what was then ongoing discussions with the FDA about which patient subset and — we would focus on and what the total number of patients required would be. So currently, as I mentioned, we’re at 63 total patients. But the 50 number, as a subset, again, was really an effort by the FDA to focus on a set of patients that was more homogeneous. So the number of — so just to be specific, the number of torso injuries that we have in the trial is actually pretty small.
It’s only five patients. And the extent of the injury in those patients is really a very different ball game because if you have vascular disruptions, significant vascular disruptions in your torso, by definition, your survival and mortality is just a very different thing than if you have a limb vascular injury. So the FDA wanted to focus again on a more homogeneous set of patients. And that’s also why they had us exclude the iatrogenic patients. So we have — gosh, I don’t know, 10 or 12 iatrogenic injury patients, which the FDA views as actually a healthier patient subset because these wounds tend to be in a more sterile environment. They tend to be more discrete. So the FDA actually asked us for purposes of statistical analysis to carve out patients with severe, oftentimes fatal injuries, which were the torso patients, and then perhaps more discrete injuries, which were the iatrogenic patients.
So that left sort of the majority of the patients in the middle with limb injuries. And vascular injuries in the limb really are the majority of vascular injuries that occur in both the civilian and military settings. So again, this is focusing on the majority, but trying to get a slightly more homogeneous population. But the number of — yes. So — but the 75 number was not a hard number. It was always our estimate.
Suraj Kalia: Fair enough. Laura, on V007, two additional patients remaining to be enrolled. Obviously, this is an open label. So I’m curious just given what’s happened in V005, why do we still need — is there some statistical issues that we are still — we need to get to 240? Just trying to understand the difference between in the FDA’s approach here also.
Laura Niklason: Well, certainly, the V007 trial is €œopen-label,” but I just want to emphasize that Humacyte is not privy to the results. This is a prospective randomized trial that is open label to the investigators, but Humacyte and Humacyte staff are blinded. And we are just following the trial protocol that we agreed to with the FDA a number of years ago. And the target patient number of 240 was based on the power calculations that we performed at the outset of the trial. So we’ve just been trying to hue to what we agreed to with the FDA. And again, these patients are obviously — dialysis patients are obviously not as acute as trauma patients. These surgeries are elective and the enrollment rate really took a hit during COVID, as we know. So we’re just pleased to be finally wrapping up this trial and getting to the enrollment target that we agreed to with the agency.
