Operator: Thank you. Our next question comes from the line of Matthew O’Brien with Piper Sandler. Please proceed with your question.
Phillip Paul Dantoin: Hey, this is Phil on for Matt. Thanks for taking our questions. I guess just to piggyback off Ryan’s question there. For the V005 trial, that 63 patient number is current and not at the end of 2022, which would imply you’re adding, what, 7 over, call it a 1.5 quarters, almost two quarters. Can you just speak to the current pace of additions here for that remaining six? And then can you just touch on the delta between needing only four more, but you guys are going to go for six there?
Laura Niklason: Sure. Well, as I mentioned, the — historically, the pace of enrollment in V005, which was negatively impacted by COVID for sure, just like every other trial in North America, but previously, we’ve been around one patient per month. That has picked up a little bit in the last couple of months with addition of these sites. So again, all I can say is that we think it will take a few months to enroll the four to six patients. The reason we’re saying six right now is because with each of these patients and having very heterogeneous injuries. Our current strategy is to provide a little bit of a buffer or cushion slightly above the targeted number of patients of 50 that we’ve discussed with the FDA. But the reality is that we currently have 46 patients that fall into the category that the FDA would like us to focus on.
And so, at a minimum, we would need four more patients to hit that target number of 50. I think one thing I do want to emphasize is that we’ve really been able to partner very well in recent months with the FDA and have had a very active dialogue with them. And getting clarity on the subset of patients that they were most focused on and the types of analysis they would like us to do and the patient number has really allowed us to be — to provide a lot more clarity on our glide path for filing.
Phillip Paul Dantoin: That’s helpful. Thank you. And then just shifting gears really quickly. Are you preparing in any way for commercial activities? What’s going on, on that front as you prepare for this stage and eventually making it to market for trauma?
Laura Niklason: Well, I’ll answer that a little bit, and then I’ll ask Dale and also Heather to weigh in a little bit more. But essentially, as you may recall, we began filling out our commercial team even in the latter part of 2021. So currently, we have staff in place to lead the commercialization effort with really a focus on health economics and market access and reimbursement, although we are bringing on a VP of Marketing in the next few weeks. So the groundwork that we’re laying now is really around the cost-benefit analysis and the health economic analysis that we’ll be able to bring to payers and to health care providers around the benefits that the HAV can provide the patients into the system. But I’ll let Dale speak to staffing up for commercialization. And I’ll also ask our COO, Heather Prichard, to speak to our commercial manufacturing readiness.
Dale Sander: Yes. Thanks, Lauren, in that, certainly, beyond W. J. Scheessele, our Chief Commercial Officer, we did have a core marketing team in right now in addition to the budget impact model that Laura described, much of the emphasis are on the longer lead time items that need to be prepared for in advance of launch, and that includes preparing for the NTAP, pass-through reimbursement from CMS, which we think will be important to us. And also things that may seem mundane, like naming the product, but there are long lead time items that work is underway right now, which requires going through both trademark issues, as well as the FDA. Beyond that, there’s certainly a great deal of effort going on to prepare from a manufacturing point of view, and I’ll let Heather address that.
Heather Prichard: Thanks, Dale and Laura. From a manufacturing standpoint, we are on track, as you know, to be able to produce our product for commercialization. And we don’t anticipate any complications, but we continue to prepare for our preapproval inspection and also update our modules to our BLA filing.
Phillip Paul Dantoin: Very helpful. Thanks so much.
Operator: Thank you. Our next question comes from the line of Josh Jennings with TD Cowen. Please proceed with your question.
Josh Jennings: Hi, good morning. Thanks for taking the questions. Sorry to bring trauma indication again. But just wanted to make sure that the — or get an update or just reiteration of the total addressable market. That hasn’t changed, has it? And just with this update from the FDA, I assume no, but just wanted to get clarity there. And also, any incremental thoughts on ultimate pricing of the HAV once you get BLA approval.
Laura Niklason: Yes. We — again, we don’t see the total addressable market really being materially impacted by this initial indication statement. As you know, the HAV at 6 millimeters in diameter really is most suited for injuries in the upper and lower extremities. And as I mentioned earlier, aortic injury was never anything that we really contemplated in any of our financial models. So I think that the TAM really isn’t impacted here. And again, although Humacyte would never advocate or market the product for any off-label use, I think the reality is that in trauma centers, the HAV will get pulled off the shelf and will get used in instances where surgeons feel it’s best for the patient, independent of the letter of the indication statement. So I don’t think the TAM is really addressed by these clarifications. I’ll let Dale speak to product pricing.
Dale Sander: Yes, Josh, good to talk to you. As you know, the pricing is a complex decision that generally isn’t announced until the time of launch. I guess, if you were to dig back to our earliest SEC filings where we were required to put placeholders in there, there is commentary about potential price ranges, which at that time suggested something in the $25,000 per HAV range, although decisions around pricing will be made at the time of launch. That being said, I can tell you that the work we’ve done to date in terms of looking at the budgetary impact of using the HAV versus standard of care or other treatments. And also our discussions with hospital administrators would suggest that the price kind of strawman that we originally had is certainly acceptable and pricing could be even somewhat higher than that, particularly within the vascular trauma market.
So that’s everything we’ve seen kind of progressed since our original SEC filings close to two years ago, and nothing has changed that other than to indicate even more so the viability of pricing at that level within this indication due to the major cost savings associated with things such as avoidance of amputation and avoid some infection and the impact those have on length of stay in the hospital and other costs.
