Humacyte, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Well, thanks for that, RK, and it's great to be here. It's been a great meeting. I would say that the answer to your question is sort of a little bit of both in the sense that for our first approved indication for SYMVESS, which is our 40 centimeter long by 6 millimeter diameter vessel. For that vessel and for the dialysis indication, it's the same product. In terms of our filing in dialysis, which we're very excited about because our clinical data's extremely strong, that will be a supplemental BLA because all of the manufacturing for the product is the same. We're providing new information to the FDA in the form of three phase III clinical trials, all of which have shown consistent results, in outcomes, particularly in women, which is a really underserved population in the enormous dialysis market.

When you were asking about a beachhead, I really do believe that the vascular injury indication, which we got a year and a half ago, really is a beachhead for dialysis. Because dialysis access is typically performed by all the same surgeons and in the same hospitals as vascular injury repair is performed. There are some subtle differences and non-overlaps, but most of all, vascular injury will really be a beachhead. In every hospital where we have our vessel on the shelf for vascular injury repair, once we do get approval in dialysis access, which I hope, I anticipate will be sometime middle of next year, 2027, then if it's on the shelf, we'll be able to send a letter notifying the hospital of the approval, and physicians will be able to pull the product and use it on label.

All of the initial startup activities that we've had to do in our first indication won't be true here.

Right. Thank you for that. Jim Mercadante, who's our new Chief Commercial Officer, he came on April 1st, right at the beginning of Q2 of this year. When he joined us, we also had Todd Rasmussen join as our Chief Surgical Officer. He's a vascular surgeon with the Mayo Clinic and also provides a lot of peer-to-peer support as far as our commercial launch of SYMVESS. What I would say was probably not working with launch 1.0 was that we had many members of the commercial team really did not have the deep relationships with vascular surgeons that are really needed to launch a first-in-class product that is completely new to a market that hasn't seen a new conduit in 40 years. The revamp that Jim has done is not only himself, but also bringing in other very senior people from such heavyweights as Medtronic.

We've had a number of very successful salespeople leave very good jobs and come and work for Humacyte because we've got these great commercial leaders in place, and their reputation precedes them. We anticipate that with the more experienced and deeper relationships with hospitals and surgeons, that we'll penetrate the market better. In addition, I think how we talked about SYMVESS to surgeons and hospitals is changing, and we're really pointing out the value of the vessel for patients and for hospitals and surgeons. For example, we have programs in place now where if one of our vessels becomes infected early in the postoperative course, and if it's clear that it was not just a surgical error- Then we replace that product at no charge to the hospital.

That's really kind of a bold move, but it really reflects how confident we are in the properties of our product. That level of confidence when expressed by the sponsor goes a long way when you're talking to surgeons and hospitals.

The last part of your question, in general, how long does that cycle take? That's probably the hardest part of the question to answer, because in some cases we've seen very accelerated uptake, and in some cases, it can take months. With respect to the first part of your question, which dealt with national accounts, that was another, I think, thing that Jim, when he came on, built out a national accounts force, which really seeks to engage larger groups of hospitals like HCA Healthcare and Ascension and what have you. Really engage them in a contracting process, which is not the same as the VAC process.

The contracting process is really critical, especially for these larger systems, because without being on contract, even if you do have VAC approval, it's very hard to get the product on the shelf. Dealing with the contracting is a huge area of focus for us with these larger systems. I think that contracting, which takes time, I think is going to progress over the third quarter and fourth quarter. I think we'll really start to see the impacts of that in the fourth quarter of this year, and then starting in the first quarter of next year.

Yeah. The 3 months of catheter-free days on average in women that we had just in the first year is just the beginning of the benefit of our vessel, SYMVESS, as compared to fistula. What our clinical data have shown in the VO7 trial, which is another trial that compared our vessel to fistula, and the results of which were just published in The Lancet a few weeks ago. What that trial showed and what the ongoing V012 trial just in women is continuing to show, is that we have an advantage in catheter-free days in year 1, and this extends into year 2. The 2-year data, for example, in the VO7 study have already shown across all patients a 5- to 6-month benefit in terms of catheter-free days. What does that mean? In terms of nephrologist goals, in the care of dialysis patients, one of the metrics that nephrologists and dialysis centers are measured against is how many patients are dialyzing via catheter.