Humacyte, Inc.

Morning, ladies and gentlemen, and welcome to the Humusite First Quarter Results Conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a -and-answer session. Instructions will follow at that time. As a reminder, this conference is being recorded. I will now turn the conference to call over to Tom Johnson with Lifestyle Advisors. Please go ahead, sir.

Thank you, Operator. Before we proceed with the call, we'd like to remind everyone that certain statements or 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. Forward-looking statements made during this call speak only as a date hereof, and the call under takes 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 Humusite website. Joining me on today's call from Humusite are Dr. Laura Nicholson, President and Chief Executive Officer, Dale Sander, Chief Financial Officer and Chief Corporate Development Officer, and Dr. Nicholson will provide a summary of the company's progress for the first quarter in recent weeks, and Dale will review the financial results for the quarter ended March 31, 2025. Following their prepared remarks, B.J. will join Laura and Dale for the Q&A session. I will now turn the call over to Dr. Nicholson. 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 SIMVAS 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 VO12 phase three 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 Schesley, 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 SIMVESS and the resiliency of our team members in the face of some unfounded negative press regarding SIMVESS 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 SIMVESS and 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 SIMVESS in late February 2025. The first commercial shipments containing multiple units of SIMVESS 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 SIMVESS 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 SIMVESS, and we expect this number to grow throughout the second quarter based on current discussions with hospitals. Our commercial launch of SIMVESS is further supported by publication in March 2025 of our Budget Impact Model in the peer-reviewed Journal of Medical Economics. This publication shows that SIMVESS provides economic value to the health care system. By reducing conduit infections and limb amputations, SIMVESS provides a strong opportunity for cost reduction as compared to synthetic conduits and as compared to xenografts and the like. In addition to the civilian market, Humisite has been working to address the military market for SIMVESS and extremity vascular trauma. Multiple military treatment facilities have already expressed an interest in purchasing SIMVESS. To facilitate these purchases, we expect that SIMVESS 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 SIMVESS this quarter was a major milestone for Humisite, 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 -to-have 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 -to-head VO7 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 6 and 12 months as compared to fistula. We were also able to identify two subgroups of patients who could benefit the most from the -to-have, 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 percent failure rate of standard of care in these vulnerable populations, means that they are important targets for the marketing of -to-have in dialysis access. We expect that the results from the VO7 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 VO12 study is a small phase 3 trial of 150 patients, which compares the efficacy and safety of -to-have to fistula for hemodialysis. A total of 84 patients has already been enrolled in the trial to date. An interim analysis for the VO12 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 VO12 and VO7 phase 3 pivotal studies, and to add AV access for hemodialysis as an indication for the ATEF. Finally, I'll briefly discuss some of our earlier stage programs that we're also excited about, our small-diameter ATEF for the treatment of coronary artery disease. During the first quarter, we announced plans to file an IND application with the FDA to allow -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 SIMVEST conduit. Our plans for IND filing in 2025 to support a -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 ATEF in coronary artery bypass surgery, and we believe our planned IND filing and initiation of -in-human study after FDA clearance will be another major milestone for human sight. 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 human sight. 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 operation 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 crash runway and better align our organizational structure with our top business objectives. These objectives include the commercial launch of Symbus, including sales, marketing, and manufacturing, completion of the BO-12 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 cabbage. 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 Symbus 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 of the year, ended March 31, 2025, following the commercial launch of Symbus, 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 Symbus in vascular trauma, including increased personnel expenses associated with the sales effort. Other net income for the first quarter of 2025 was $62.3 million compared to 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 2021 merger with Alpha Health Care Acquisition Corps. 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 31, 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 Oberlin 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 in the launch of SIMVESS is a powerful example of our commitment to delivering truly transformative regenerative medicine solutions to improve patient outcomes. Humisite continues to deliver on our promises to physicians and patients. With our strong commercial execution, our promising pipeline programs, and our dedicated team, we're confident in our ability to continue...

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Once again, ladies and gentlemen, we thank you for your patience. Please stand by. We will resume momentarily.

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

Thank you. We will now conduct a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in a question queue. You may press star 2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star 1 to ask a question at this time. One moment while we pull for our first question. The first question comes from Ryan Zimmerman with BTIG. Please proceed.

Oh, 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 Simvest. 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've serviced those cases, how you serviced in those cases, et cetera. And then as we think about kind of the uptake of Simvest this year, I appreciate your commentary about it being kind of second half loaded. I'd 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 back 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 Chesley, 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 do that. As far as our experience with the VACs, you know, 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. You know, 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 SIMVAS 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 you know, 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 cover things well. Yeah, Ryan, I would add that we're not only of where those three institutions have acquired the product, but even of the VAC submissions is a good mix of hospitals and surgeons that have known us, known us from our clinical studies, but others that have no experience with us. So I think that's a good sign. You know, 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. You know, as Laura mentioned, we had some quick wins. You know, on the other side, absolutely. You know, the New York Times article with a couple of the VACs, some pushback for us that we've now had to respond to, to get back on track. I think also the tough economic environment we're in has pushed out some of the VAC reviews and adding additional financial reviews, you know, under to bring in a new product to market. You know, 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've submitted to. And, you know, as Laura mentioned, the early feedback from those where we have had the formal VAC review, the conversion to approval has been strong, you know, now with the five approvals and obviously looking to build upon that. So, you know, it's now building momentum, you know, currently, and we absolutely expect to see in the VAC happy new year, the full impact of that.

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

Well,

again, oh,

I'm sorry, yeah, BJ, I'll ask you to weigh in too. So, the ECAT process, which we're nearing completion on, does technically allow military hospitals and VA's to order the product. However, typically, you know, certainly in military institutions, there's also has to be, you know, surgeon champions. Certainly, we've in addition to working with civilian hospitals, as I mentioned, our sales executives have been working closely with some military institutions. And we, in fact, have previous relationships in some military care facilities who participated in our clinical trials and our compassionate use cases. So, you know, we are building out that sort of surgical support for the product. So, military hospitals tend not to have a formal VAC process. I'm not sure if that's true in all cases. But really having surgeon champions and being on the, having the correct distribution and being on the ECAT are really key inputs there. And I'll let Dale, I'm sorry, I'll let BJ correct me where I'm wrong.

No, I think that's exactly right. In parallel with building surgeon advocacy, which we, you know, back to clinical studies, to our sales effort, you obviously absolutely have to jump through those procurement hoops. And, you know, soon getting on the ECAT is going to be a big milestone and ability to order. And yeah, we've been fortunate, we've actually been working with an outside DOD procurement partner to help in that regard, given their expertise and connection. So, I think that gives you a sense of where we're at in this particular.

That's very helpful, BJ. And this 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, you know, 200 or so level one trauma?

Yeah, I would say now our current sales force feel comfortable being able to cover you know, the sales targets for the geographies that we have, those hospitals and submitting to those vacs. And again, you kind of got a sense of the full sales pipeline. And then certainly early from the military treatment facilities match up well with where we have our sales reps and sales force deployed. I think, you know, as we increase success, both civilian and military will look to add to our sales force at that time.

Okay. Thanks for taking my question.

Absolutely.

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

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

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

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

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

Yeah, Josh. So so we certainly have we've treated a lot of dialysis patients. And as you know, this is a complicated and sick population and we have benefited from our prior clinical experience. So, you know, there are a couple of key key outputs that I think we're following. One is, you know, it's not just that the surgical implantation of the conduit, what happens to the conduit in the dialysis center and in the hands of various interventionalists for these patients is very important to the outcome of the study. And so we're paying close attention to to how the dialysis centers are handling the conduit and what and how the dialysis centers are adhering to the clinical trial protocol. And we're doing the same thing with interventionalists because, you know, that our surgeons do a great job of sewing the vessel in. But what's important for the execution of clinical trial is that we follow up on these on these later health care providers who are also working with patients. So so we're paying a lot of attention to that. And I again, I think that the female population struggles so poorly, struggle struggle so much with fistula. We do anticipate that the results of this trial will be positive.

Great. Maybe just one follow up on the access indication is 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 in the V012 and, you know, in terms of the design of the trial, anything else that you can share? Thanks for taking the questions. Appreciate it.

Yeah, so the partnership with Fresenius remains strong. I think that the Fresenius leadership were particularly encouraged by the wonderful results that we had in V07. Fresenius is also fully aware that women in particular, but also patients with obesity and diabetes are not only not only have trouble with their access, but they're very expensive to care for. And in some cases, you know, Fresenius as as sort of a holistic health care provider for these patients has to bear those costs. So as I think I've mentioned in previous calls, you know, 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. You know, I think I also pointed out on the last call that dialysis access centers used to be 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 that SIMVESS in the dialysis access space, which has the potential to get so many patients off of catheter, really aligns with the reimbursement objectives and business objectives of Fresenius.

Thanks, Laura. The next question comes from Kristen Cluster with Cancer Fish Darrow. 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 costs, but has anything changed since you've added more hospitals?

Yeah, I'll let BJ answer this as well. But I would say 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. Yeah, strong clinical belief and understanding based not only on our 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 offset fewer infections, fewer amputations more than offset the upfront cost of our product versus a synthetic or versus an allograft or a xenograft. And then I think just the other piece of the equation is obviously we're working on our end taps. 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 too, the incremental reimbursement part of the end tap 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?

Yeah, 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 yeah, 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 were doing that gave us a jumpstart when we went into these institutions. And then obviously our Salesforce through their relationships and being able to communicate the clinical and economic value have brought these surgeons, advocates and hospitals along through the back process. So a good mix and knowing that that's going to be important going forward because you kind of work through those that you know 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 at the accounts using the products. Usually you get the surgeon advocate champion who starts doing 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 move outward, you know, there's always an early adopter in every crowd and that those are probably the first surgeons who will work with.

Okay, great. And then, oh, go ahead.

Oh, go ahead.

Go ahead, Bruce.

No, no, no, no, go ahead.

Oh, yeah, no, I would just add, you know, and it's also a mix between vascular surgeons and trauma surgeons. Ultimately more vascular than trauma, but trauma, obviously, in some ways, see these patients can be first and also, you know, influence on being able to not only treat these patients, but bring in new technologies into the hospital. So I think we see it, you know, as a mix of that, you know, wherever we get the traction, I think we're able to port over to that other group. Be it if you start with a vascular to go to a trauma or trauma, go to a vascular, we've, you know, again, it's early, but we've seen the ability to get that message, you know, with one group to the other group and then obviously build upon 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 management for closing comments.

Yes, thank you, operator. You know, 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 one trauma centers with our first commercial launch. So our fabulous commercial team will continue to work with 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 this time. Thank you for your participation and have a great day.