Good morning, ladies and gentlemen. And welcome to the Humacyte Second Quarter 2022 Results 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 Lauren Marek 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. Any additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of 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 will be filed today and maybe accessed from the Investors page of the Humacyte website. Joining me on today’s call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Dale Sander, Chief Financial Officer and Chief Corporate Development Officer; and Dr. Heather Prichard, Chief Operating Officer. Dr. Niklason will provide a summary of the company’s progress during the quarter and recent weeks and Dale will review the company’s financial results. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Dr. Niklason.

Thank you, Lauren. Good morning, everyone, and thank you for joining us for our second quarter 2022 financial results and business update call. During this call, I’ll review our recent highlights and progress of our key programs, before turning the call over to Dale for a review of our financial results. Then we will be happy to open up the call for your questions. I’m very pleased with the great progress Humacyte has made throughout the second quarter in advancing our universally implantable bioengineered human tissue platform. We’re continuing to add to the robust body of data showing that our lead candidates, the human acellular vessels or HAV, may be uniquely suited for vascular and complex organ applications, in which the current standard-of-care is either unavailable or inadequate. We’ve also strengthened our Board of Directors and leadership team, with the respective appointments of Dr. Diane Seimetz, and Dr. Shamik Parikh, who both bring global drug development experience that will be invaluable as we move closer to our goal of bringing the HAV to market. I’ll begin with an update on our initiative to provide HAVs to multiple hospitals in Ukraine for the treatment of wounded civilians suffering from vascular trauma injuries. We launched this humanitarian initiative in May in collaboration with the Office of International Programs within the U.S. Food and Drug Administration, as well as the Ukraine Ministry of Health to coordinate the export and import of our investigational HAV. We’re very proud to report that HAVs have been successfully implanted into several Ukrainian patients with vascular trauma injuries. To-date, all HAVs that have been implanted have been reported to be functional and infection free, salvaging limbs and patients who are injured in this wartime conflict zone. This humanitarian program is providing further real world evidence of the potential…

Thank you, Laura. As of June 30, 2022, we reported cash, cash equivalents and short-term investments of $189 million, compared to $225.5 million as of December 31, 2021. The $36.5 million net use of cash, cash equivalents and short-term investments for the first six months of 2022 resulted from spending related to net operating activities for the period, including clinical and earlier stage research and development programs, and preparation for our anticipated commercial launch. We believe that our cash, cash equivalents and short-term investments are adequate to fund operations through 2024, as our current expected timelines for anticipated approval of the HAV in vascular trauma. Revenue was $1.3 million for the second quarter of 2022, compared to $0.7 million for the second quarter of 2021 and was $1.5 million for the six months ended June 30, 2022, compared to $0.8 million for the six months ended June 30, 2021. Revenue in all periods related to grants supporting the development of the HAV. Research and development expenses were $14.7 million for the second quarter of 2022, compared to $14.6 million for the second quarter of 2021 and were $31 million for the six months into June 30, 2022, compared to $29.7 million for the six months ended June 30, 2021. The current period increases resulted primarily from increased personnel expenses to support expanded research and development initiatives in the support of clinical trials. General and administrative expenses were $5.2 million for the second quarter of 2022, compared to $5.4 million for the second quarter of 2021 and were $10.9 million for the six months ended June 30, 2022, compared to $10.2 million for the six months ended June 30, 20 21. The increase during the six months ended June 30, 2022 compared to the prior year period, resulted primarily from the…

Thank you, Dale. To conclude, we’re pleased with the progress that we’ve made across multiple indications in the first half of the year. As we move into the latter half of 2022, we’re entering an exciting time for Humacyte, with an anticipated cash runway to carry us through significant value inflection points and beyond. We believe we’re well-positioned to deliver on clinical and regulatory milestones in the coming months. Operator, we’re ready to take questions.

Thank you. [Operator Instructions] Our first question comes from the line of Brooks O'Neil with Lake Street Capital. Please proceed with your question.

Thank you and good morning. I have a couple of big picture questions. So the first one is, obviously, you’re going after a number of big markets, all of which have significant unmet clinical needs. Can you just tell us Laura, which one of these markets you are most excited about and think offers Humacyte the most potential long-term?

Thank you, Brooks. That’s a -- that’s an interesting question. It’s a little bit like being asked which of your children you love the best? I would say that…

Right.

… in the short-term, obviously, the trauma indication I think is just has huge appeal for the company. I think the fact that we have had such good success with our humanitarian efforts in Ukraine just illustrates the fact that this product can go out into the field into just terrible circumstances and surgeons can be trained and outcomes can be excellent and so I -- it just validates everything that we’ve been saying all along. And our KOL meeting that we had in July, where Dr. Moore and Dr. Magee spoke about the product and about where they thought its utility was in civilian trauma, I think, was just reinforcing of that. So, again, we anticipate being on the market with trauma first. And I anticipate that when this is in Level 1 trauma centers and in the hands of experienced trauma and vascular surgeons, that it will see a lot of use in a broad range of applications. Dialysis is also something that, obviously, we’ve been focused on for a number of years. I’m particularly excited about the results of the research -- the clinical research studies that we’re doing with Frenova as part of our Fresenius collaboration right now. And that’s because we expect the data to -- from the Frenova study to help us understand which dialysis patients really are going to benefit the most from our product both in the U.S. and Europe. We’re looking at hundreds of thousands of patients’ worth of data. So it’s a tremendous opportunity for us to really hone in on those patients who will best benefit.

Great. I have to, say, having visited your facilities and talk with your people just a few weeks ago. I mean, it’s tremendously impressive all that you’ve accomplished and all you’re doing, and I’m really excited about all of these indications. So I think it’s great. One more question that I get maybe most suited to Dale, but either of you please feel free to comment. Obviously, SPAC mergers have come under a lot of pressure and I think a lot of people comment that that was an ill advised time in the marketplace. For you guys, I think, it’s positioned you extremely well for the future. But can you just comment on how you feel today about having participated in a SPAC merger and what that’s done for you as a company?

Yeah. Brooks, I mean, certainly, the SPAC transaction merger took a lot of us transition to be in a public company, which we think was important in our evolution and also provided resources that take us well past the anticipated approval timeline for our first launch, which we expect to be in vascular trauma here in the United States. So I think it was a transaction that served as well. I mean, for me, I’ve been in the biotech industry directly more than 30 years and had worked on four IPOs during that time, multiple in the U.S. and one over in Europe. And I guess, as a relatively newly public company, I don’t feel any different as a SPAC company than I did as an IPO in my prior companies. And our expectation is, this has given us the resources to improve value for shareholders and we expect that as we hit our milestones, our shareholders will be rewarded just like the shareholders than any other company that has gone public.

Absolutely make sense to me. Thank you very much and congratulations on all the progress.

Thank you.

Our next question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.

Good morning. Thanks for taking my questions. Laura, I think, at the site visit, you’re talking about some new enrollment sites for V005, the trauma trial, and just wanted to see, I think, those were in Israel, if I’m not mistaken, newish, I guess, I should say. What’s the status of those and are you starting to be able to get some patients in the door at least to start the enrollment process for the V005 trial?

Yes. So we’re looking at four sites in Israel, one or two of those sites have been fully activated and we’re anticipating activating the other sites very soon. Israel obviously is a site with some active domestic conflict as we know. And also the consenting process under Israeli law is a little bit different than it is in the U.S. So we are, while of course, we would never wish anyone injury, we are expecting and hoping that, that enrollment contributions by the Israeli sites will be substantial. But it’s still something that we’re activating right now.

Okay. Fair enough. And then, I imagine, I think, you know the answer of this question, but there’s no potential to utilize any of the Ukrainian patients are getting HAV as part of the enrollment in the V005 trial, is that correct?

So that’s correct. I mean, this is a humanitarian effort. We’re certainly not doing a clinical trial in a war zone with patients in need. So I do want to make that very clear. That said, any summary of data in the trauma indication that is provided to regulators, whether it’s in the U.S. or Europe would certainly include information on the real world outcomes of this humanitarian effort. So on the one hand these are not V005 study patients. But on the other hand, the information that we’re able to glean will I think bolster our overall case for the trauma indication.

Yeah. Yeah. I completely agree with that. Makes perfect sense. And lastly, for me, and I’ll hop back in queue. Dale, operating expenses came in a little bit lower than we were expecting this quarter. And just wanted to see, if there’s any specific call out us to, if I look at R&D costs, for example, is down a healthy amount relative to last quarter, ending the call out there, just how to think about CapEx for the balance of the year? Thanks, Dale. Thanks, Laura, for taking the questions.

Yeah. Ryan, certainly can comment on that. So we have -- as you have seen as a company, the public, we haven’t actually given over looking projections or set ranges for expenses or any other financial parameters right now. But the expenses are in line with our expectations. R&D expenses ebb and flow depending on [inaudible] within the clinical trial, lifecycles and how many patients are newly enrolled versus when you think about the V007 trial in AV access, even though enrollment is expected to be completed quickly, the bulk of the patients are through their implants and so we are seeing some wind down of both cost there. Beyond that, if you were to extrapolate what we’ve done for the first six months forward through the remainder of the year, it’s probably going to be close to where we expected to end.

Okay. Appreciate that. Thank you.

And our next question comes from the line of Matthew O'Brien with Piper Sandler. Please proceed with your questions.

Good morning. Thanks for taking my questions. Just on the enrollment, Laura, it looks like from May until I assuming that the latest information you’re giving us is probably as of today. The enrollment has been fairly slow in both the trauma and fistulas study. So want to make sure everything is on track as far as patient enrollment goes with those two studies?

Yeah. So on the dialysis study on the fistula study, we do anticipate we’re enrolling some number -- some a handful of patients every month. We certainly -- we anticipate that will be at or very near 240 by the end of the year and then that would mean that we would have topline results in late 2023, because the endpoint is a year away. With respect to the trauma trial, you’re right, the enrollment in the trauma trial is a little bit more, how shall I say, herky-jerky, because it’s not like there’s a continuous reliable flow of patients that come in the door, because these are acute trauma patients. Again, we are -- we saw enrollment pick up substantially in the spring and it slowed down the last month or two, but we’re hoping to have it pick up in coming months. We’re certainly doing things, as I’ve mentioned, we’ve brought on the -- we’re bringing on the Israeli sites, we’ve brought on the Mayo Clinic as an additional site and we’re also working to support the sites with clinical trial monitors and support, because that’s really been a limitation not just for us, but for a lot of companies, who are working on clinical trials is that the nursing shortage, which we’ve all heard about is really impacting the ability of some clinical trial centers to staff their trials and so we’re also actively trying to support -- nursing support for these trials. So we’re pulling out everything we can. I think that we’re still on track to file a BLA, perhaps late this year, perhaps, early next year. Certainly, we’ve had no indication from the FDA that the numbers that they’re expecting are any different. We’re -- I’m still expecting around 70 or 75 total patients as we’ve enunciated in the past.

Okay. And to that point, Laura, when do you think you’ll have full clarity on the exact number, I know it can be up to 75 plus or minus? But I mean, when do you think you’ll know if it’s going to be 75, going to be 70, going to be 80, any sense for that?

We have continued to work with the FDA very closely. We have not shared exact timing on when we’re going to have an exact number. So I’m afraid I can’t provide that at this time. But all I can say is that, I believe we’re still tracking and when we have more information, we’ll share it.

Got it. Thank you.

Our next question comes from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.

Good morning, Laura, Dale. Can you hear me all right?

Yeah.

Perfect. Hey. So, Laura, just wanted to follow-up on Matt’s question, forgive me for belaboring V005. The discussions with the FDA have been going on for some time, 20 -- let’s say, 20 additional patients, maybe 25, right. Israel comes online, Mayo comes online, fine. But what specifically is the nature of the discussions with the FDA that have been ongoing for some time?

Well, as far as what I can share in this setting, Suraj, it’s really been about understanding how many total patients, but also how the FDA should think about the data, given that this is a single arm trial in an acute injury population and trauma patients, where it’s physically not possible to randomize. And so, in this trial, we specify that patients who are enrolled must provide consent, but they also must not be suitable for other options, such as saphenous vein grafting. So that has an effect of providing a patient population that is very much in need, because by definition, if they’re acutely injured and if saphenous vein is not suitable, then these are patients who are facing amputation or other significant morbidity. So it’s really been about discussing how to interpret the data that are coming out of the trial. And frankly, the Center for Biologics is filled with outstanding and smart people, who have typically though regulated biologics. They typically regulate antibodies and proteins and gene editing technology. And they’re, frankly, thinking about clinical trials that involve what is essentially a device, even though we’re regulated as a biologic, thinking about a clinical trial that involves a device in an acutely injured population with no active comparator. That’s just required a lot of discussion. But I really see CIBER [ph] as being a great partner with us here. I think that the benefits of the product are obvious to us. And I think they will be obvious to the regulators, but it’s just -- it’s been a process, it’s taken time.

Got it. Laura, can you give us some additional color on the status of the anastomotic junction for the six-month primate in your CABG pilot or feasibility?

So what we’ve reported in January and I believe also in July is that the anastomosis in general are fine in our primate CABG studies. I will say that as you are -- as you may be aware, Suraj, we are studying adult human sized vessels, which are 3.5 millimeters in diameter in a large primate, but it’s not a large primate in an absolute sense. These animals weigh about 60 pounds and their coronary arteries are about 1 millimeter in diameter and so it’s a little bit like -- it is like sewing an adult human vessel onto a pediatric patient. And so there are technical challenges with doing this type of study. It’s just comes with the territory. But aside from the technical challenges of sewing a 3.5 millimeter vessel to a 1 millimeter vessel, we haven’t seen anything unique or surprising about the anastomotic response in these experiments compared to what we’ve seen in our clinical trials or compared to what we’ve seen in earlier primate work.

Got it. A final question, Dale, have your expectations for cash runway changed somewhat? And the reason I ask is, there’s been a subtle shift in the language, in terms of your cash runway from prior quarters. Just any additional color or clarity would be appreciated? Thank you for taking my questions.

Yeah. I think, Suraj, in terms of our overall thoughts in terms of cash runway, you can -- I guess, going back to our original launching of the transaction without the healthcare, we had always expected that the net proceeds from the transaction will takes us through the end of 2024 and that’s still the case today. I think, certainly, we’re mindful about the current state of the market out there and ensuring that we can pass the value inflection points with the cash on hand and so we think about ways of modulating some of maybe the medium priority projects and deferring efforts to extend that even beyond that point. But we have not modified our currently our expectations in terms of how far the cash takes us and that current cash balance takes us past the expected timeframe of our first market approval on or anticipated approval on launch.

Thank you.

Our next question comes from the line of Josh Jennings with Cowen. Please proceed with your question.

Hi. Good morning. Thanks for taking the questions. I want to just follow up on the Frenova collaboration and just better understand how this will inform Fresenius once you get to the commercial stage for HAV in the dialysis access indication? And just remind us of the agreement there and then also how this investigation will inform pricing as well?

Thanks, Josh. That’s a multi-part question. I’ll try to handle what I can and Dale may jump in as well. But as you’ll recall, the Fresenius agreement stipulates that for some of the early indications, which include trauma, dialysis access and peripheral arterial disease, that Fresenius would have the right -- rights for marketing and distribution of those indications in Europe. For those same indications in the U.S., Humacyte site will shoulder the marketing and distribution of those products in those indications. As far as the data that we’re collecting with Frenova, this is a project that’s been going on for several months and we expect the readout on these several 100,000 patients to come in the next month or two. I’m excited about this project, because it will really give us granular hard data on how many patients and what types of patients tend to have repeated problems with their dialysis access in terms of patency loss, in terms of repeated infection, in terms of, for example, what types of patients tend not to mature their fistulas and then are stuck on a catheter for a long period of time. So really identifying those patients subsets in the U.S. and Europe, that tend to have chronic difficulties with their access will really allow us to focus on those patients in terms of subsequent marketing and commercialization. There’s a second part to this project, which we’re going to undertake once we understand which patients have the most difficulties, then we will work to put in costs -- the cost estimates of those difficulties in these different geographies, both in the U.S. and Europe. And I would expect that that would inform pricing and what the market will bear in terms of the HAV treating these patients who are currently not acceptably treated by existing therapies.

Great. Thanks for that. And just a follow-up from our headquarter visit and facility tour. I think during our discussion, you mentioned that, little intimal hyperplasia hadn’t been experienced in any implanted HAV to-date. I just wanted to follow up and just ask, I mean, how strong was single do you think you have and maybe a hypothesis of mechanism of action of why you haven’t seen little intimal hyperplasia in an HAV, would be great to better understand? Thanks for taking the questions.

Yeah. Josh, so that some -- that is a little bit of a scientific speculation on my part and I will admit to that. As you and I discussed, and as we discussed at the site visit, certainly, we have seen what we would call Panis in growth, which is in growth of tissue across the anastomosis. We’ve seen this in some of our dialysis patients and some of our Ph.D patients. This is a standard biological phenomenon. It’s seen with essentially all types of vascular grafting. There’s nothing extraordinary about that and we have seen that and that has contributed to anastomotic stenosis. I guess what I would say, though, is that, particularly in our peripheral arterial disease population, which is a population where the vessel is not getting stuck with needles three times a week, as it isn’t dialysis. That’s a little bit of a cleaner signal. I would say that we have not to-date seen any convincing evidence of intimal hyperplasia in the in the length of the graft in those patients. But again, I have to qualify that statement. We don’t we don’t have biopsies to confirm that, because most of these patients are just walking around with their grafts. And so, frankly, I think, it’s going to take us a couple years to really nail down the complete accuracy of that statement, it -- that statement that I made is a scientific conjecture and a belief on my part, but we really -- we haven’t documented it fully yet.

Understood. No. Thanks for clarifying and appreciate it. Thank you.

[Operator Instructions] Our next question comes from the line of Bruce Jackson with The Benchmark Company. Please proceed with your question.

Hi. Good morning and congratulations on all of the progress. So Laura getting back to your favorite children, with the biovascular pancreas project, anything to look forward to over the next few months?

Well, so as we said earlier, we have partnered with some smaller stem cell companies to look at our ability to produce islets from stem cells that would be part and parcel of the biovascular pancreas product. So we are making progress there. We have no plans for any scientific presentations in the next several months. But I will say that we’re making progress in our islet differentiation efforts and we are also progressing toward doing initial proof-of-principle studies in large animals by late this year. So we remain still on track for that. So it’s a -- I’m hesitant to share any more than that, because I want to be definitive when we share the information. But I would say that the biovascular pancreas is still on track compared to everything that we’ve been saying earlier in the year.

Okay. Great. And then a question for, Dale, last year, there was a little bit of seasonality in the research and development expense. Is that going to be a similar pattern this year or is it just going to be lumpy because of the clinical trial activity?

Bruce, part of it’s just the ebb and flow of clinical trials. Part of it is, there are other meaningful components to R&D expenses. As a biologics company, the actual development and ongoing enhancements in really preparation for an anticipated launch of our manufacturing facilities also drives cost through our bioprocessing facility that maybe don’t get the visibility in terms of press releases and scientific presentations. But as a key component as is often the tour of the technology platform site and just, so there are ebb and flow costs associated with bioprocessing also dependent on when we’re doing production runs or depend on when we’re doing certain experimentation either to support new product development or other activities that are additive to whatever cycles of cost that you see on the clinical side also.

All right. Thank you. That’s it for me.

And thank you, I’m showing no further questions in the queue at this time. This concludes the Humacyte second quarter results conference call. Thank you for participating.