Good morning, ladies and gentlemen and welcome to the Humacyte's First Quarter Results Conference Call. Currently, all participants are in a listen-only mode. Later we will conduct a question-and-answer sessions, instructions will follow at that time. As a reminder, this conference is being recorded. I will now turn the conference call over to Tom Johnson with LifeSci Advisors. Please go ahead, sir.

Thank you, operator. Before we proceed with the call, we'd 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 historic experience or present expectations. 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 after filing may be accessed from the Investor page of the Humacyte's 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 BJ Scheessele, Chief Commercial Officer. Dr. Niklason will provide a summary of the company's progress for the first quarter and recent weeks and Dale will review the financial results for the quarter ended March 31, 2025. Following their prepared remarks, BJ will join Laura and Dale for the Q&A session. I will now turn the call over to Dr. Niklason. Laura?

Thank you, Tom and good morning, everyone and thank you for joining us for our first quarter 2025 financial results and business update call. Following the landmark success of obtaining FDA approval of Symvess for the treatment of extremity vascular trauma late last year, we're keenly focused on the commercial launch of this groundbreaking product. Supporting the launch is our number one priority and we're pleased by the traction gained in our interactions with hospitals despite the current volatile economic environment. Based upon our March 2025 financing and some recent cost reductions, we've taken steps to extend Humacyte's cash runway. With this extended runway, we'll continue to aggressively expand our commercial launch while creating additional enterprise value from our bioengineering pipeline. Upcoming major value drivers that we anticipate include publication of additional clinical results in trauma and in dialysis access and filing an IND with the FDA later this year to enable first-in-human clinical testing of our small-diameter ATEV in coronary artery bypass grafting. In addition, as a result of reaching a major milestone in enrollment in our V012 Phase 3 trial in dialysis, we're also on track for filing a supplemental BLA for the ATEV in dialysis in 2026. During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results. BJ Scheessele, our Chief Commercial Officer, will then join us to help answer your questions. As I start the review of the quarter, I want to acknowledge the strong support that we've had from surgeons, who have treated patients with Symvess and the resiliency of our team members in the face of some unfounded negative press regarding Symvess and Humacyte. As you probably know, we've addressed these critiques in public statements in recent weeks. In short, we believe that these criticisms are ill-informed and without merit. Over the last two decades, we've worked hard to build Humacyte into what it is today. The body of clinical results supporting the use of Symvess in extremity vascular trauma will be further strengthened by upcoming publication in peer-reviewed medical journals of our long-term patient outcomes. We will continue to combat unfounded attacks with science-based facts. With that out of the way, I'm proud to report that Humacyte commenced its commercial launch of Symvess in late February 2025. The first commercial shipments containing multiple units of Symvess were made during the first quarter to three level 1 trauma centers. As a reminder, commencement of sales to hospitals for new products typically requires review and approval by a value analysis committee or VAC, which is a centralized decision-making body within the institution. Only a few months after commercial launch, we're excited that 45 hospitals have already commenced an evaluation of Symvess as part of their VAC approval process, approximately one quarter of all Level 1 trauma centers nationwide. The VACs of five hospitals have already approved the purchase of Symvess and we expect this number to grow throughout the second quarter based on current discussions with hospitals. Our commercial launch of Symvess is further supported by publication in March of 2025 of our budget impact model in the peer-reviewed Journal of Medical Economics. This publication shows that Symvess provides economic value to the healthcare system. By reducing conduit infections and limb amputations, Symvess provides a strong opportunity for cost reduction as compared to synthetic conduits and compared to xenografts and the like. In addition to the civilian market, Humacyte has been working to address the military market for Symvess and extremity vascular trauma. Multiple military treatment facilities have already expressed an interest in purchasing Symvess. To facilitate these purchases, we expect that Symvess will shortly be listed in the Electronic Catalog or ECAT, which is an Internet system that provides the Department of Defense and other federal agencies with access to manufacturers' products. As we've previously reported, due to the nature of the VAC process, we have consistently forecast that the majority of first-year sales will occur in the second half of the year. We're pleased that the sales and the VAC activity to-date is in line with our goals for this early period of market launch. The U.S. commercial launch of Symvess this quarter was a major milestone for Humacyte and we're excited to provide this transformative product to surgeons and patients in need of a new option to save limbs and lives. Let me turn now to the ATEV indication that is our next priority, which is in dialysis access. As you'll recall, about six months ago, we reported top-line results on our prospective randomized head-to-head V007 Phase 3 trial, which compared our vessel to the gold standard, which is autogenous fistula. This trial met its primary endpoints and showed superior patency at six and 12 months as compared to fistula. We were also able to identify two subgroups of patients, who could benefit the most from the ATEV, which includes all women and men with diabetes and obesity. These two groups make up more than half of the dialysis access market. We believe that the efficacy and safety results in the subgroups combined with the approximately 50% failure rate of standard of care in these vulnerable populations means that they are important targets for the marketing of ATEV in dialysis access. We expect that the results from the V007 Phase 3 trial will be published in a major peer-reviewed medical journal in the near-term. We're also conducting an ongoing Phase 3 dialysis access trial in women, which has passed a major enrollment milestone. The V012 study is a small Phase 3 trial of 150 patients, which compares the efficacy and safety of ATEV to fistula for hemodialysis. A total of 84 patients has already been enrolled in the trial to date. An interim analysis for the V012 trial is planned for April 2026 when the first 80 patients will have reached the 12-month follow-up. Our plan is to submit a supplemental BLA in the second half of 2026, which includes data from the V012 and V007 phase 3 pivotal studies and to add AV access for hemodialysis as an indication for the ATEV. Finally, I'll briefly discuss some of our earlier-stage programs that we're also excited about. Our small-diameter ATEV for the treatment of coronary artery disease. During the first quarter, we announced plans to file an IND application with the FDA to allow for the first-in-human clinical testing of the small-diameter acellular tissue engineered vessel, which is 3.5 millimeters in diameter rather than the 6-millimeter diameter of the approved Symvess conduit. Our plans for IND filing in 2025 to support a first-in-human trial in coronary bypass are based on the outcome of a recent meeting held with the FDA. To date, only the 6-millimeter configuration of our vessel has been studied in human trials to include AV access for hemodialysis, trauma, and peripheral arterial disease. We're very pleased to be moving closer to human clinical studies of the small diameter ATEV in coronary artery bypass surgery. And we believe our planned IND filing and initiation of the first-in-human study after FDA clearance will be another major milestone for Humacyte. So, we're off to a good start in 2025 and we look forward to sharing our continued progress with all of you as the rest of the year unfolds. And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.

Thank you, Laura. In March 2025, we completed a public offering that provided $46.7 million in net proceeds to Humacyte. Subsequent to the financing, in part due to current market conditions, we implemented a plan to reduce our workforce by approximately 31 employees. We also deferred additional new planned hires and reduced other operating expenses. These reductions have been done thoughtfully and we've retained key personnel, resources, and initiatives to meet our corporate goals and milestones. We have undertaken these cost reductions to extend cash runway and better align our organizational structure with our top business objectives. These objectives include the commercial launch of Symvess, including sales, marketing and manufacturing completion of the V012 Phase 3 pivotal trial of the ATEV and dialysis, and the planned filing of a supplemental BLA with the FDA and the filing of an IND to commence human study of the small-diameter ATEV in coronary artery bypass grafting or CABG. We estimate that we will incur aggregate charges representing one-time cash expenditures for severance and other employee termination benefits of approximately $800,000, of which the majority is expected to be incurred during the second quarter of 2025. We estimate a net savings due to the workforce reductions, operating cost reductions and reduced capital expenditures, net of termination severance and benefits, totaling approximately $13.8 million in 2025. Net savings are estimated to be as much as $38 million in 2026 for a total estimated savings of over $50 million in 2025 and 2026 relative to our original forecast. Regarding the first quarter financial results, there was $517,000 in revenue for the first quarter of 2025, of which $147,000 related to the initial U.S. Commercial launch of Symvess in trauma. The remaining $370,000 in revenue resulted from a research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications. There was no revenue for the first quarter of 2024. Cost of goods sold was $147,000 for the first quarter of 2025, and includes overhead related to unused production capacity, which was recorded as an expense during the first quarter. There was no cost of goods sold for the first quarter of 2024. Research and development expenses for the first quarter of 2025 were $15.4 million, compared to $21.3 million for the first quarter of 2024. The decrease in 2025 expenses compared to the prior year was all primarily from decreased material costs as we began capitalizing expenditures for inventory during the first three months ended March 31st, 2025, following the commercial launch of Symvess, as well as a reduction in clinical study costs. General and administrative expenses for the first quarter of 2025 were $8.1 million, compared to $5.3 million for the first quarter of 2024. The increase in 2025 expenses compared to the prior-year period resulted primarily from the U.S. Commercial launch of Symvess in vascular trauma, including the increased personnel expenses associated with the sales effort. Other net income for the first quarter of 2025 was $62.3 million, compared to a net expense of $5.3 million for the first quarter of 2024. The increase in 2025 of other net income compared to the prior year resulted primarily due to an increase in the non-cash remeasurement of the contingent earn-out liability associated with our August 2021 merger with Alpha Healthcare Acquisition Corp. Net income was $39.1 million for the first quarter of 2025, compared to a net loss of $31.9 million for the first quarter of 2024. The increase in 2025 net income compared to the prior-year period was primarily due to the increase in the non-cash remeasurement of the contingent earn-out liability described previously. We had cash, cash equivalents and restricted cash of $113.2 million at March 31st, 2025. Total net cash provided was $17.9 million for the first three months of 2025, compared to net cash provided of $35.1 million for the first three months of 2024. The net cash provided for the first three months of 2025 included the net proceeds from the March 2025 public offering. The decrease in net cash provided during the first three months of 2025 compared to the prior year resulted primarily from the receipt of $20 million in proceeds under a draw from our funding arrangement with Oberland Capital, which occurred in 2024, but did not reoccur in 2025. With that, I will turn the call back over to Laura.

Thank you, Dale. The approval and launch of Symvess exemplify our commitment to providing transformative regenerative medicine solutions that enhance patient outcomes. Humacyte remains dedicated to fulfilling our promises to both physicians and patients. With our successful commercial execution, promising pipeline programs, and committed team, we are confident in our ability to continue.

Please stand by one moment.

Hello, operator. We're ready to take questions now.

Thank you. We will now begin the question-and-answer session. The first question comes from Ryan Zimmerman with BTIG. Please proceed.

Thank you. Can you hear me, okay?

Yes, we can hear you.

Okay, great. Thanks for taking the questions. Congrats on the first sales of Symvess. Maybe, on those three sites that have purchased, Laura, and I'd love to understand kind of what their experience has been since they've purchased, whether you service those cases, how you're servicing those cases, et cetera. And then as we think about kind of the uptake of Symvess this year, I appreciate your commentary about it being kind of second half loaded. Love to understand how those 45 or so sites are running through the process and how you expect that maybe to translate into initial sales after you've now had a lot of kind of VAC experience under your belt?

Well, I'll take the first part of the answer to this question and then I'll ask our Commercial Officer, BJ Scheessele, to weigh in as well. So, as far as the three commercial sites, we have performed our first implant. At that particular site, our sales rep was able to be there for the implant. Although I will say that at many of the sites that have used the vessel before, having a sales rep in the OR is certainly not necessary. In addition to the clinical trial experience that a lot of surgeons have had, we have also been conducting sort of hands-on training in hospitals, where our sales executives have approached, surgeons and VACs to get on the formulary. So, it's certainly not necessary to have a sales representative in the OR for the initial cases, although sometimes we do that. As far as our experience with the VACs, we have had a fairly good conversion rate of VAC approvals. I would say that there was a little bit of a headwind that was imparted by the New York Times article, particularly during April, but that seems to be receding as the facts of the clinical experience become clearer to surgeons and to hospitals. And we also expect that publication of long-term data will also further improve our position there. The health economic model that we published in March is also a huge help because it shows pretty clearly that on a per-patient basis, the total cost of the initial admission for patients, who are treated with Symvess, should be lower than the total cost of the initial admission for patients, who are treated with a synthetic graft. And this is independent of any NTAP reimbursement. So, I think that the growing number of publications and the growing factual story around the conduit is helping us get traction. But I'll let BJ weigh in here as well.

No, Laura. I think you covered things well. Yes. Ryan, I would add that where not only of where those three institutions have acquired product, but even of the VAC submissions is a good mix of hospitals and surgeons that have known us from our clinical studies, but others that have no experience with us. So, I think that's a good sign. And in terms of the VAC submissions and the sales funnel, feeling good about that we're laying the groundwork now. We have a full sales funnel with the 45 submissions. We continue to add those on a regular basis. As Laura mentioned, we had some quick wins. On the other side, absolutely, the New York Times article with a couple of the VACs, some pushback for us that we've now had to respond to get back on track. I think also, the tough economic environment we're in has pushed out some of the VAC reviews and add in additional financial reviews to bring in a new product to market. We still see this as a three to six-month VAC process for the majority of the ones that we're facing, and that we submitted to. And as Laura mentioned, the early feedback from those where we have had the formal VAC review, the conversion to approval has been strong. Now, with the five approvals and obviously looking to build upon that. So, it's now building momentum currently and we absolutely expect to see in the back half of the year, the full impact of that.

Yes. that's very helpful and I appreciate that. And on the ECAT and some of the government hospitals or the federal hospitals whatever you want to call them, is the process similar? I mean, I'm curious once you get on the ECAT can VA hospitals or whoever within that order, Symvess as needed? Or is there more hurdles to go through on that side of things?

Well, again…

Oh, go ahead, Laura.

I'm sorry. Yes. BJ, I'll ask you to weigh in too. The ECAT process, which we are nearing completion on, does allow military hospitals and VAs to order the product. However, in military institutions, there usually need to be surgeon champions involved. In addition to working with civilian hospitals, our sales executives have been closely collaborating with some military institutions. We also have established relationships in some military care facilities that participated in our clinical trials and compassionate use cases. We are working on building out surgical support for the product. Military hospitals often do not have a formal VAC process, though this may not be the case for all of them. Ultimately, having surgeon champions and the right distribution while being on the ECAT are critical factors. I'll let BJ correct me if I'm wrong.

No. I think that’s exactly right. In addition to building surgeon advocacy, which we relate back to clinical studies in our sales efforts, you obviously have to navigate the procurement processes, and getting on the ECAT is going to be a significant milestone for ordering. We’ve been fortunate to work with an outside DoD procurement partner who is helping us in that area due to their expertise and connections. That gives you a sense of where we stand in this particular situation.

That's very helpful, BJ. And just last one, I'll sneak it in. Do you have to expand the sales force or can you service the military hospitals with your existing sales force right now, as well as the 200 or so Level 1 trauma?

Our current sales team is confident in their ability to meet the sales targets in the regions where we have hospitals and are submitting to the VACs. You got a sense of the entire sales pipeline, and the military treatment facilities align well with where our sales representatives are stationed. As we achieve greater success in both civilian and military sectors, we will consider expanding our sales team at that point.

Okay. Thanks for taking my questions. Absolutely.

The next question comes from Josh Jennings with TD Cowen. Please proceed.

Hi, good morning. Congrats on the progress with your Symvess launch. Laura and Dale, you guys were gracious enough on the last earnings call to just comment on where street estimates stood for 2025. And just wanted to check back in after last month and a half of the experience and the progress you've made. Do those estimates still seem reasonable or in the ballpark of kind of the internal expectation for the revenue ramp here?

I think, we remain in the same place with our expectations. but I'll let Dale comment further.

Yes, I agree. I think we gave some guidance, Josh, on the first. I'm sorry, it seemed like a first quarter call, but that was our year-end call that happened in March. Based on the traction we're seeing in a number of hospitals that are involved in the VAC processes, as BJ mentioned, we're still comfortable with the guidance. And again, as Laura mentioned earlier in the call, due to that VAC ramp, we expect most of those revenues to come in the second half. but we're not seeing anything currently that would suggest we need to move off those estimates.

Appreciate that. And just wanted to ask about V012 and you guys are enrolling that nicely. I was hoping for just a review on some terms of how the clinical development team or your team have applied the learnings from other Phase 3 studies clearly in the patient selection and the subgroups you guys are going after is one. But just I think, what the learnings are being applied yet is anything from just the procedural technique to anything else that you want to comment on in terms of helping us think about the potential for success for V012?

Yes, Josh. We have treated many dialysis patients, and as you know, this is a complex and ill population, and we have gained from our previous clinical experience. There are a couple of key aspects that we are monitoring. First, it's not just the surgical implantation of the conduit; what happens to the conduit in the dialysis center and how various interventionists manage it is crucial to the study's outcome. We are closely observing how dialysis centers are managing the conduit and adhering to the clinical trial protocol. We are also doing the same with interventionalists, as our surgeons do an excellent job with the procedure. However, it's essential to follow up with these later healthcare providers who also work with the patients. We are focusing heavily on this. Additionally, I believe that the female population faces significant challenges with fistulas. We expect the results of this trial to be positive.

Great. Maybe just one follow-up on the access indication. Just in terms of the kind of partnership with Fresenius, the investment there, have there been any changes? And then, I guess the second layer is, how involved are they in the V012 and in terms of the design of the trial, anything else that you can share? Thanks for taking the questions. Appreciate it.

Yes. So, the partnership with Fresenius remains strong. I think that the Fresenius leadership were particularly encouraged by the wonderful results that we had in V007. Fresenius is also fully aware that women, in particular, but also patients with obesity and diabetes, not only have trouble with their access, but they're very expensive to care for. And in some cases, Fresenius as sort of a holistic healthcare provider for these patients has to bear those costs. So, as I think I've mentioned in previous calls, we have been working with Fresenius to quantify the added costs that are incurred in patients, who have an access that isn't working or in patients, who are forced to remain on catheter. And those costs are significant and we believe there's going to be a strong health economic case. I think, I also pointed out on the last call that dialysis access centers used to be penalized for not having a sufficient number of fistulas, but the reimbursement penalty now has been altered so that if centers have too many patients on catheter, their reimbursement is penalized. And so, I believe that Symvess in the dialysis access space, which has the potential to get so many patients off of catheter, really aligns with the reimbursement objectives and the business objectives of Fresenius.

Thanks, Laura.

The next question comes from Kristen Kluska with Cantor Fitzgerald. Please proceed.

Hi. good morning, everybody. At your Analyst Day two months ago, you gave us a very early review and we heard from some surgeons directly. So now that you've added about 20 more hospitals since that time, I'm just curious on the VAC questioning if you're hearing that it's fairly consistent. It sounded like at that event that the surgeons were alluding that it was pretty straightforward. Sometimes they were asking about how often the products would be used and cost, but has anything changed since you've added more hospitals?

Yes. I'll let BJ answer this as well. But I would say that, no, the dialogue and the talk track is pretty similar. The clinical data that we published in JAMA Surgery in November are very strong. And the label is really not, I mean, that just doesn't come up as an issue very often. We do have to talk about the price point. And so, leveraging our published budget impact model that came out in March, I think, is going to continue to be important. When we get in front of VACs and when we present the budget impact model, our success rate is very high. BJ, do you have anything to add?

No, I think that covers it well. Yes, strong clinical belief and understanding based not only on clinical data, but their personal experience, questions on price value. But again, as Laura mentioned, our published BIM and the data from that, again, showing that the cost offsets fewer infections, fewer amputations, more than offsets the upfront cost of our product versus a synthetic or versus an allograft or xenograft. And then, I think just the other piece of the equation is obviously we're working on our NTAP. And so, the proposed ruling was put out by CMS. We're in the process of putting our response back, due mid-June and then ultimately you hear in August and then hopefully enacted in October. So that's obviously piece of the equation to the incremental reimbursement part of the effect and the follow-on effect with private insurers.

Thanks so much. And of the 45 hospitals, can you give us a sense of roughly what percent of them were involved in your clinical trials and have prior experience?

Yes, it's interesting. I would say it's actually the minority, so less than 50% would have to look up exactly what that is. And so, yes, back to my earlier point, I think there was a lot of understanding and visibility, both from publications, the clinical data, the approval, industry conferences, medical education and events that we've held that brought visibility to what we're doing that gave us a jump start when we went into these institutions. And then obviously, our sales force through their relationships and being able to communicate the clinical and economic value have brought these surgeons, advocates and hospitals along through the VAC process. So, a good mix and knowing that that's going to be important going forward, because you kind of work through those that tell you. but the majority do not and feel good about our conversion rate at this point.

Thank you.

The next question comes from Bruce Jackson with Benchmark Company. Please proceed.

Hi. good morning and thank you for taking my questions. I was hoping to get a little color around the surgeon adoption patterns that the accounts using the products. So usually, you get the surgeon advocate champion, who starts during the first procedures, and then the other doctors will follow along. So, do you have any anecdotal information on how that's going?

Well, it is truly anecdotal, Bruce. We do have a vascular surgeon, who was actually new to the product, who treated a patient at one of our commercial sites and said he had a great experience and 'was looking forward to using the product again.' But you're right. I think that in most institutions, this will start with one or two surgeons, and then move outward. There's always an early adopter in every crowd and those are probably the first surgeons, who we'll work with.

Okay. Great. And then oh, go ahead.

I would just add that it's a combination of vascular surgeons and trauma surgeons, with more emphasis on vascular. Trauma surgeons, in certain instances, are the first to see these patients and play a role in not only treating them but also in introducing new technologies to the hospital. We view it as a crossover opportunity; as we gain traction in one group, it can translate to the other. Whether we start with vascular and move to trauma or vice versa, it's still early, but we are seeing the potential to convey our message from one group to another and build interest from there.

Okay, great. And then a question on the pipeline. Is there anything new on the BioVascular Pancreas or any upcoming, data?

Yes. We have continued primate implants in the BioVascular Pancreas. We're also continuing laboratory experiments. I don't have anything new explicitly to report now as compared to our last call six weeks ago, but we are going to publish preclinical results probably later this year.

Okay, great. Thank you very much.

You got it.

Thank you. At this time, I would like to turn the call back over to the management for closing comments.

Yes. Thank you, operator. This has been a great opportunity to share our progress. These are exciting times in the world as we all know. and with all of the flux going on in the economic markets and in the healthcare markets, we're pleased that despite all of that, we are getting important and substantial traction at Level 1 trauma centers with our first commercial launch. So, our fabulous commercial team will continue to work this and we anticipate more good news going forward. So, thank you for your time.

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a great day.