Humacyte, Inc.

Good morning, ladies and gentlemen, and welcome to Humacyte fourth quarter and full year 2025 earnings conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question and answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSite Advisors. Please go ahead.

Thank you, Operator. Before we proceed with the call, I'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 historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made in this call is contained in our periodic reports filed with the SEC. Forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise these forward-looking statements except as required by law. Information presented on this call is contained in the press releases issued this morning and in our Form 10-K, which after filing may be accessed from the investor page of the HumaCite website. Joining me on today's call from HumaCite are Dr. Laura Nicholson, President and Chief Executive Officer, and Dale Sander, Chief Financial Officer. and Chief Development Officer. Dr. Nicholson will provide a summary of the company's progress for the fourth quarter and in recent weeks, and Dale will review the financial results for the quarter and year end of December 31, 2025. I will now turn the call over to Dr. Nicholson. Laura?

Thank you, Tom. Good morning, everyone, and thank you for joining us for our 2025 fourth quarter and year financial results and business update call. I'm pleased to report that our fourth quarter and recent weeks have been a productive period for Humacyte with continued execution of our commercial program for Symbeth and the advancement of other bioengineered vessel programs. During today's call, I'll review progress across our commercial and development program before turning the call over to Dale for a review of our financial results for the year. I'll begin with the commercial launch of Symbeth. We continue to execute our U.S. market launch of Symbeth, and in parallel, we've taken major steps to expand the commercialization of the product into international markets. To date, there are a total of 27 VAC approvals for Symbeth in the U.S., and furthermore, an additional 43 VAC committees are currently conducting their review process. Our rate of success with VAC submissions is roughly 70%, which is a good success rate. To date, 27 hospitals have ordered SimVest, with the majority of these hospitals placing reorders. Fourth quarter product sales were $0.4 million for the quarter and $1.4 million for the year. We're pleased that the U.S. Defense Department has dedicated funding for evaluation and incorporation of new biologic vascular repair technologies. In appropriating the funding, the lawmakers demonstrated that they recognize and understand the need for human-derived bioengineered blood vessels to save life and limb in the battlefield. We believe this historic, first-of-its-kind federal investment will help ensure that our soldiers continue to have access to cutting-edge treatments and state-of-the-art care wherever and whenever they need it. We look forward to working with leaders in our military and in the DoD to ensure that the American service personnel will have access to this groundbreaking technology. Internationally, interest in CIMVIS has been highlighted by two recent announcements. Early this month, we received a $1.475 million purchase commitment that will facilitate the clinical evaluation and outreach program in hospitals within the Kingdom of Saudi Arabia. The planned clinical evaluation program is going to be conducted in parallel with ongoing negotiations with a kingdom-based entity for establishment of a joint venture and a license to commercialize SimVest within country. Also, in March, we submitted a marketing authorization application, or MAA, with the Israeli Ministry of Health for SimVest for arterial trauma repair. In response to surgeon requests, we're also pursuing a mechanism for making SimVest available in Israel on a hospital-by-hospital basis, even in advance of MAA approval. Commercial adoption of CINVEST was further supported by publication of several important papers, including long-term safety data from our V005 Phase 2-3 trial in the Journal of Vascular Surgery Cases, Innovations, and Techniques. These data were also presented last January by Dr. Michael Currie of the New Jersey Medical School. at the annual winter meeting of the Vascular and Endovascular Surgery Society. Among those treated in the VOO5 study were 54 patients who underwent extremity vascular repair with Simvest, for whom treatment with autologous vein, which is the standard of care, was not feasible. Within this patient population, once early complications from the traumatic injuries resolved, the rates of conduit infection, limb salvage, and patient survival plateaued, and remained relatively constant through the three years of follow-up. StimVest maintained an infection-free rate of 92.9% from months three to 36 with no infections after day 37. Limb salvage rates were 87.3% at 12 months and 82.5% at 24 months, despite a severely injured trauma cohort. Long-term mechanical durability was also demonstrated during the VO5 study, with SimVest diameters maintained constant over three years of follow-up. And importantly, no deaths or amputations or mechanical failures were attributed to SimVest in this high-risk trauma population. There were no evidence of spontaneous ruptures or structural failures in any patient throughout the follow-up period. These outcomes point to the potential of SimVest to provide meaningful benefits for patients who are facing life or limb-threatening injury where autologous reconstruction is not an option. In addition, durability data in the military trauma setting was highlighted in an October 2025 publication in Oxford Academics Military Medicine, which describes positive long-term results from a humanitarian program using SimVest to treat wartime vascular injuries in Ukraine. The publication reported on 17 trauma patients with wartime extremity injuries. who were treated with SimVest and were followed for up to 18 months. These wartime patients were observed to have a high SimVest patency rate of 87.1% and also 100% limb salvage, showing the durability of SimVest in treatment of real-world combat injuries. Also in October, a new study comparing the clinical outcomes of SimVest to autologous vein in the treatment of extremity arterial trauma was published in the American Association for the Surgery of Trauma, or the AAST, Trauma Surgery and Acute Care Open Journal. This study showed that in comparison to trauma registry pre-existing patients who were treated with autologous vein, the patients who were treated with CIMVES experienced similar short-term outcomes for patency and limb salvage and infection. In fact, there were no significant differences for any of these outcomes. between patients who were treated with CIMBES and the prior registry patients who had been treated with autologous pain. I'll now turn to our program, which is our next priority, which is dialysis access. As we reported last quarter, positive two-year results from the VO7 Phase III trial of the ATEV and dialysis patients were presented at the American Society of Nephrology's Kidney Week. The ATEV demonstrated superior duration of use over 24 months compared to the gold standard autogenous fistula, particularly in high-need subgroups having historically poor outcomes with AV fistula procedures. In particular, women who received ATEV for dialysis access had approximately six additional months of usability of the access as compared to fistula. This is a dramatic and significantly longer duration of ATEV use over two years in female patients. And this observation could greatly reduce the reliance on catheters for dialysis access for these patients. Catheters are a major cause of complications, morbidity, and cost for dialysis patients, especially women in the US, where nearly 30% rely on catheters for dialysis. The complications from dialysis catheters result in excess costs of tens of thousands of dollars per year per patient. Indeed, the catheter use nationwide in the US has been rising for both men and women since 2019. Women and men with obesity and diabetes make up more than half of the dialysis access market and are historically underserved by fistulas, which often fail to mature or become usable in these patients. It's been known for decades that women suffer lower rates of fistula maturation than do men. as evidenced by the fact that only 50% of women dialyze with a fistula nationwide, compared to more than 60% of men. However, a chronic lack of better access options has limited progress for these high-risk and expensive patients. We believe that the efficacy and safety results in these high unmet need groups, combined with the approximately 50% failure rate of fistulas, makes women and high-risk men a potentially important population for treatment with ATEP. We're nearing an exciting milestone, and we're currently working to complete a pre-specified interim analysis of our ongoing V12 Phase III trial that is being conducted in women specifically. The V12 trial compares the ATEV to fistula for hemodialysis access in female patients. A total of 116 patients have been enrolled to date in the trial. The planned interim analysis will be conducted when the first 80 patients reach one year of follow-up. and the top line interim results will be reported by early June, 2026. Subject to these interim results, our plan is to submit a supplemental BLA in the second half of 2026, which will include data from VO12 and the VO7 phase three pivotal study to add dialysis, which is a major market, as an indication for the ATEP. And finally, I'll briefly discuss one of our earlier stage programs that we're also very excited about. our coronary tissue engineered vessel, or CTEV, for use in coronary artery bypass grafting. Positive results of a preclinical study evaluating the CTEV as a coronary artery bypass graft in a non-human primate model were published in September of 2025. In that study, the CTEV was observed to sustain blood flow, recellularize with the animal cell, and remodel to bring the diameter of the CTEV in line with the animal's native coronary artery. We're on track with our plan to advance CTEV into first in human use in coronary artery bypass grafting later in 2026. We submitted an investigational new drug application to the FDA for this indication late last year in the fourth quarter. To support this plan study, we initiated the first large-scale manufacturing of CTEV in our commercial-scale manufacturing facility. We plan to commence the first in human phase 1-2 study in coronary artery bypass in the second half of 2026 upon completion of manufacturing and clearance by the FDA.

And with this, I'll turn it over to Dale.

Thank you, Laura. There was 0.5 million in revenue for the three months ended December 31st, 2025, of which 0.4 million related to U.S. sales of 25 CIMBES units. The remaining 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. Revenue for the year ended December 31st, 2025 was $2.0 million, of which $1.4 million related to U.S. sales of 61 CEMVEST units, and the remainder resulted from the research collaboration. There was no revenue for either the three months or the year ended December 31st, 2024. Cost of goods sold were $9.1 million and $9.7 million for the three months and the year ended December 31st, 2025, respectively. Cost of sales for both periods included a reserve of $8.9 million to reduce inventory to its net realizable value as a consistent sales history has not yet been established, and we were required under financial accounting standards to essentially reduce inventory to the level equivalent to our 2025 historic sales. Cost of sales also included overhead related to unused production capacity, which was recorded as an expense in the period incurred. There were no cost of goods sold for either the three months or the year ended December 31st, 2024. Research and development expenses were 14.6 million for the three months ended December 31st, 2025, compared to 20.7 million for the three months ended December 31st, 2024, and were 69.3 million for the year ended December 31st, 2025, compared to 88.6 million. for the year ended December 31st, 2024. The decrease reflects in part the transition from development activities to commercial operations following FDA approval of CMBES in December 2024, including the current year allocation of manufacturing costs to inventory and cost of sales. TOSFET and prior years were included within research and development expenses. In addition, during 2025 clinical study costs decreased due to the completion or winding down of certain clinical programs, including the B005 study in trauma. Selling general and administrative expenses were $7.6 million for the three months ended December 31, 2024, compared to $7.4 million for the three months ended December 31, 2024. and were $31.2 million for the year ended December 31st, 2025, compared to $25.8 million for the year ended December 31st, 2024. The increase in 2025 expenses compared to the prior year periods resulted primarily from the U.S. commercial launch of Symbus in the vascular trauma indication, including increased personnel expenses. Other net income for the three months ended December 31st, 2025 was net income of 6.0 million compared to 7.1 million for the three months ended December 31st, 2024. And other net income was 67.3 million for the year ended December 31st, 2025 compared to other net expenses of 34.3 million for the year ended December 31st, 2024. The increase in other net income for the year ended December 31, 2025, primarily resulted from $98.2 million in non-cash gains, consisting of a $59.5 million fair market remeasurement of our contingent earn-out liability and a $38.8 million fair market remeasurement of derivative liabilities, partially offset by a $22.3 million loss on extinguishment of debt. Net loss was $24.8 million for the three months ended December 31, 2025, compared to a net loss of $20.9 million for the three months ended December 31, 2024. And net loss was $40.8 million for the year ended December 31, 2025, compared to a net loss of $148.7 million for the year ended December 31, 2024. The increase in net loss for the three months ended December 31st, 2025 primarily resulted from the inventory reserve partially offset by a decrease in operating expenses. The decrease in net loss for the year ended December 31st, 2025 resulted primarily from the increase in other net income and the decrease in operating expenses partially offset by the inventory reserve. We had cash and cash equivalents of $50.5 million as of December 31st, 2025. Subsequent to December 31st, 2025, we raised an additional $18.4 million in net proceeds from a registered direct offering of common stock and net proceeds of $4.6 million from the sale of common stock through our at-the-market facility. In December 2025, we entered into a credit facility with a fund of the Avenue Capital Group. providing up to $77.5 million in new financing. The credit agreement, which has a term of four years, includes an initial tranche of $40 million, which was fully funded at close, and an additional two tranches of up to an aggregate of $37.5 million available to Humasite, subject to the satisfaction of certain revenue regulatory and liquidity conditions. Proceeds from the initial $40 million tranche were used primarily to retire our existing debt facility. Total net cash used was $44.4 million for the year ended December 31, 2025, compared to total net cash provided of $14.5 million for the year ended December 31, 2024. The increase in net cash used in 2025 resulted primarily from the 2025 debt extinguishment. and an additional debt draw during 2024 that did not occur in 2025. With that, I will turn the call back over to Laura.

Thank you, Dale.

And I think, as you can see, we've had a very busy and productive 2025, as well as early 2026. We're continuing to execute on our commercial activities. and we are continuing to expand into international markets and also expand our pipeline both clinically and pre-clinically. I think at this point, operator, we can take questions.

Thank you. 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 the question queue. You may press star 2 if you would like to remove your question from the queue and for participants using speaker equipment, it may be necessary to pick up your handset before pressing the start keys. Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Good morning. Thanks for taking our questions, Lauren Dale. Certainly a lot of different directions to go on the questions here, but I guess I want to stick with trauma just because it is kind of the present day topic in terms of commercialization. So just One, how are sites responding to the new pricing of SynVest? And then the second question, again, appreciate that you're looking forward to dialysis access, but what do you expect and what are your thoughts on the year ahead within trauma adoption and any forward commentary? I know, again, it's still early to guide, but any forward commentary is appreciated.

Yeah, it is too early to guide, Ryan. Thank you very much. But, you know, we have seen a positive response to the new price point of $17,000. You know, this puts us in a price range that is not that different from other products that are used by vascular and aortic surgeons. Certainly some aortic stents and other reconstruction devices certainly can be upwards of $20,000. So this price point of $17,000 puts us in a good range. And in my personal communications with surgeons and also those of the surgical sales force, that's been a uniform commentary. So the result there has been a higher rate of VAC approvals, a higher percentage. So we're up above 70% now. And also we're getting more usage and more repeat usage because surgeons are less hesitant to pull the product because it's quote unquote expensive. The timelines as far as VAC committees continue to be what they have been, fairly long, six to nine months, which is followed by contracting. What I didn't mention is that we are beginning to engage with group purchasing organizations, GPOs, and working to get on contract with with larger GPOs that cover many hospitals. If you get on contract with GPOs, then that doesn't eliminate the VAC process, but it eliminates the subsequent contracting process that we've heretofore been doing with individual hospitals. We also are working with several IDNs. We have VAC approvals and several integrated delivery networks, or IDNs. So while we can't really guide for 2026, You know, I do think that the price difference has made an important impact. The publication of long-term data has made an important impact, and showing that our outcomes are similar to vein has also made an important impact with surgeons. So we're just going to continue growing.

Understood, Laura. Thank you. And then, you know, as we look ahead to dialysis access, I think, you know, a lot of people will be focused on the interim top-line results, which is huge. Once you get past that, maybe just talk to us about kind of the submission for BLA, for dialysis access. What do you, you know, what's on your list to check off? How are you, you know, de-risking that now and, you know, as you think about kind of what you need to do to submit and subsequently get a clearance for dialysis access in the second half of this year?

Sure. Well, we've actually already got a team focused on this with a timeline for all the document submissions. You know, again, what's helpful for us here is that the clinical data will be different in dialysis, but all of the preclinical and the toxicity in the CMC data will all be the same. It's already been submitted and reviewed and approved by the agency. We've had some submissions to update the CMC, but all of those have gone through. And we really have no sort of standing queries with the agency right now. So it'll really be about the clinical package. So after we get the top line results, which based on VO7, we anticipate will be positive. I don't know the results, but based on VO7, if they're similar to VO7, they'll be positive. Then we will schedule a pre-BLA meeting with the agency and advise them as to the structure of the clinical data content in the BLA. We will also, we have a priority designation in AV Access, so we'll also ask for a six-month review cycle once the BLA has been accepted by the agency, and that usually takes about two months.

Thank you, Laura.

Our next question is from Jason Colbert with the Borough Capital. Please proceed.

Good morning. Congratulations on all the progress. Laura, can you talk us through a little bit about how important the sales cycle is? And where I'm asking the question is, it's in relation to SG&A. And what I'm wondering is if you were to spend, you know, put more resources and more aggressively build the sales force, will that more aggressively ramp the sales number up? And where would you focus those efforts? What percentage would be domestic? What percentage would be international? Thanks.

Right. So we're focusing in both places. And I would say we're looking at adding to the sales team. And I've communicated this to the market before. We're looking at adding to the sales team domestically. We already have added some experts. medical affairs people. We're looking at adding sales people to extend our reach to more metropolitan areas. But in addition, the Israeli and the Saudi commercialization efforts, we see those more as partnered. We have a putative partner for commercialization in Israel and also one in Saudi. I can't share names right now, but we have putative partners who are very excited about the product and the technology and getting it in country. So we would imagine that in terms of sort of additional G&A hires, there would probably be more educational hires, medical affairs hires that would be deployed in those countries that we would support and provide. But we anticipate that a lot of the sales personnel would be provided by our distributors in country.

Gotcha. That makes a lot of sense. And the other part of the question is, once you're in an institution, they're kind of going through the learning curve. How long does it take for them to be really users and adopters? I mean, that process, is it a year? Is it 18 months? Is it six months? From your experience, what are you seeing like at a given institution that you're really focused on?

Yeah, well, we've only been on the market for a year. And in a lot of these places, we've been on the shelf for less than six months because of the vac cycle. So it's hard for me to answer that question. But what I can say is that once it's on the shelf and pulled by a surgeon, they will tend to use it, watch the first patient for a little while, a month or two, and then they begin pulling it again. It's just like any other new medical device or implantable technology. A new surgeon will typically want to watch the first patient and then reuse, and that's what we've been seeing. We've really had no blowback as far as how the vessel is being used. I can tell you it's being used in extraordinarily difficult cases. where things are challenging. And I can tell you that from reports I've heard from surgeons, we are absolutely saving limb and life. There is no question.

Yeah, I think that's the title of my next note. Thank you so much. Look forward to more updates.

Thank you.

Our next question is from Ali Brezel with Piper Sandler. Please proceed.

Good morning, and thank you for taking my question. This is Peter Spanaginopoulos for Alibaba from Piper Sandler. On the commercial front for Symbest, you noted that 27 hospitals have ordered to date with a majority reordering. Could you break down what proportion of Q4 sales came from newly onboarded accounts versus reorders? And within those reordering hospitals, are you seeing utilization expand beyond the initial champion surgeon to other trauma surgeons? Thank you.

I'm sorry. I don't have the level of granularity to accurately answer the first part of your question, although we could come back to you. Folks from our commercial team could come back to you for the answer with that. As far as growth to other surgeons beyond the initial sort of champion, we're definitely seeing that in some of our busier centers. And it's definitely a word of mouth type thing as it is with all new devices. In some centers, we have three and four surgeons using. In the majority of centers, we probably still just have one surgeon using, but that's changing every week, every month.

Our next question is from Matt Miksek with Barclays. Please proceed.

Hi, thanks so much for taking the questions. And congrats, Laura and Dale, again, on the really impressive progress on a clinical front and with some of the developments around sort of the defense-oriented and Middle Eastern contracts. It's great. So on that front, I was wondering if you could talk a little bit about how some of those contracts we should expect to kind of fall into, uh, into the revenue flow. Um, you know, since he's sort of like lumpy orders or gradual orders or, you know, contracts to order and, and sort of wait and see on revenues, how would you describe it?

Um, I, I, the, the way, um, we're working with, um, In particular, our Saudi partners, our commercialization partners over there, the initial orders will be chunky. So the 1.475 million order will be realized as a single order. The goal is to get quite a bit of product in country and distributed to multiple leading academic medical centers in Saudi Arabia so that multiple surgeons can be trained and really understand the utility of the vessel. there's a tremendous amount of trauma in Saudi Arabia. It has more car accidents than any other country in the world. And in addition to that, there's also a large PAD market. So there's a tremendous opportunity for SimVest in Saudi. And so the strategy with our partner is that in Saudi, In parallel with submitting for full approval with the Saudi FDA, we're also initiating this physician trialing period, not a clinical trial per se, but a trial period. After approval, we would imagine further chunky orders because some medical acquisitions come from individual hospitals, certainly in Saudi, but some also come directly from the Ministry of Health. And those can be larger, chunky orders. And I don't know exactly how that's going to look yet.

That's fair. That's fair, but helpful. And then back on sort of the hospital, where you are with back approvals and the 43 hospitals in kind of review process or accounts in review process, you know, are we getting to a point where, you know, I know you have a certain set of target hospitals in the U.S. focusing on vascular trauma. Do you feel like we're getting to a a plateau or maybe the opposite in terms of the pricing and the continued experience in clinical data starting to feel more like increasing momentum? How would you describe where we are in that list of whatever, 100, 120 centers?

Yeah, thank you for that. Again, it feels it's lumpy for sure, but it feels like it's accelerating. We're getting more sort of spontaneous inbound calls from surgeons even before they have it on the shelf if they have VAC approval or even before they have VAC approval. The word is getting out in the surgical community. I mean, some surgeons post social media on their use of the vessel and they go back and forth with each other on their experiences. And so there's a lot of sort of organic word of mouth that's happening across medical centers. And that's driving enthusiasm for the product. So, you know, in terms of level one and level two trauma centers, I think that, I don't know the exact number, but it's probably around 50 level one and level two trauma centers where we have VAC approvals. There's a total of 200 level ones and three or 400 level twos. So I still think that we're just, I don't want to say we're scraping the surface, but we're still at the beginning. And the rate, the excitement about the product and the rate of usage I feel is increasing.

Okay, that's super helpful. Well, thanks again for the questions and congrats on the progress.

Thank you.

Our next question is from from HC Wainwright. Please proceed.

Good morning, Laura and Dale. This is RK from HC Wainwright. A couple of quick questions from me. Regarding the DOD procurement that you're expecting, since I believe this particular funding got initiated sometime in February, early February, and as we know, the budget year ends in September, do you have any insight into when some of this procurement could happen or do you think this could bleed into 2027 budget year or, you know, for 2027, is it a completely new application all over again?

Yeah, no, so it's... So I'll do my best to answer your question, RK. So we anticipate that this funding will be spent in calendar 2026. It may bleed over into fiscal 2027. But the funding is really designed to both procure SimVest, probably more than half of the funding is for military procurement. And then the balance, we've drafted a plan working with some leading surgeons in military treatment facilities in the U.S. who are currently soldiers in the military. And we've designed a plan where a little bit more than half of the funding will be utilized for procurement, and the balance will be utilized for training. So there's roughly 40 vascular surgeons in the U.S. military, and probably four or five of them have used Symbest, in their patients, but that leaves a large number who still could remain to be trained, in addition to trauma surgeons. So we've really designed this not just as procurement, but also training, and we're hoping to execute all of that during calendar 2026. In addition, we are working with some of our congressional delegation, looking at perhaps a larger procurement for the next fiscal year in the budget, but that's still a work in progress.

Thank you for all that. Regarding the WAC approvals, between Q3 announcement and now, two additional WAC approvals came on board. I'm just trying to understand a couple things. One, is the WAC approval time, is the time got extended because of some of the holidays and stuff? And also, what's the conversion? Is the conversion getting better between VAC approval and procurement of the product itself?

So I do think, I'm not exactly sure why the VAC approval slowed down. I don't think it represents anything fundamental. I think it was probably more to do with holidays and meeting cycles you know during the holidays uh vacs tend to meet less often um and they often have a backlog of cases uh so i i don't see this as fundamental at all uh the low number of additional approvals um in terms of in terms of the conversion from vac approval to getting product on the shelf i do think that the lower price point has really increased the rate of the speed of that. It's much easier to get on the shelf and negotiate the contract and get on the shelf after the VAC approval at the current price point. So that, in addition to improving the success rate in VACs, which is over 70%, all told, it's also, I think, speeding getting product on the shelf. At the higher price point in the very early times, our VAC approval rate was less than 50%. So the price shift has had a meaningful input in our ability to get product into hospitals.

One last question, if I may. Regarding the Saudi Arabia opportunity, can you maintain the 17,000 price point there, or do you have to renegotiate a price over in Saudi Arabia? And given the demand or the expected market over there, which is higher than here in the United States, do you have to kind of come up with a certain formula for the pricing?

Yeah, so we have not begun negotiating pricing with the Ministry of Health yet in Saudi. So I think it's a little too early for me to answer your question explicitly. I would say that our expected pricing is probably somewhat above the current U.S. pricing because of just the additional logistics of getting product in country, going through the approval process, doing the distribution process. You know, right now we do our own distribution, so we're going to have to be paying a distributor. So I think that it certainly will not be less than $17 million. there will be some additional real-world costs that will be additive there. I don't want to know what the final number will be. But again, I strongly believe that our continued excellent data in trauma and the published data that we've seen in phase two trials and PAD will mean that this is an important addition to the Saudi medical armamentarium. I mean, amputation in Saudi is a big problem. Between trauma and PAD and diabetes, it's a big problem. So I think we can do a lot of good in country.

Thank you.

Thanks for taking all my questions, Laura.

Our final question is from Josh Jennings with TD Cowan. Please proceed.

Yeah, hi, it's John on for Josh. Thank you for taking the question. Certainly helpful commentary on the VAC approval process and the response to pricing. Just revisiting the 4Q in your commentary on 2026. Certainly appreciate that it's too early to provide formal guidance or you're likely not to. But just any color you could provide on what may have caused the shortfall between street expectations. And again, thank you for the puts and takes around some of the revenue components in the year ahead. But do you feel the street is accurately modeling directionally what the year will look like? And just had one quick follow-up.

Yeah. So, again, it's hard for me to comment on what the street is saying without giving projections. And so, as you know, it's a little bit of a tightrope. But also, as you know, different analysts have said, have come out with a broad range of expectations. The higher ones, I think, are probably not in line with reality. I think that if there's an analyst that says we're going to sell 30 million next year, I think that's probably not true. So I think our growth is going to be more gradual than that. You know, I think that we all, the analysts learned a lot, and I think we learned a lot in this first year of commercial launch. We learned a lot about how to approach VACs better, how to approach the pricing better, how to approach surgeons better. So we're a much more effective commercial team now than we were 12 months ago. And, you know, some of those learnings are just hard to predict. I mean, that's probably not a satisfactory answer, but that's what I got.

No, that's very helpful. And then just following up on that, cash on the quarter came in essentially right in line with the pre-announcement. But just as you go through this commercialization process, do you see an opportunity to maybe reduce your cash burn rate? Probably too early to talk about maybe a steady state growth profile, but what does cash burn look like in the quarter's head?

Yeah, again, we're not going to give guidance on burn, but certainly we're looking very closely at burn. As you know, we did a reduction in force last year around May, and that saved us a total of $50 million in projected burn for 2025 and for this year, 2026. We're continuing to look at spend very, very closely. We understand that the biotech financing market has been challenging, and we understand that the growth ramp for sales is something that we're going to have to continue to work on. We're definitely looking at the spend side.

Okay, great.

Thank you very much. In addition to that, we're also looking at business development opportunities. We've had a great deal of interest in our platform from preclinical to clinical. I think that's evidenced by the interest we're seeing internationally just for Symbus, but we're also seeing a great deal of interest on our other pipeline programs, which is why we made the announcement yesterday about adding a business development executive and That's to help field the inquiries and interest we're getting across our platform in terms of licensing and partnering opportunities, which can help with non-dilutive funding.

Okay, great. Thank you so much.

We have reached the end of our question and answer session. I would like to turn the conference back over to Laura for closing remarks.

Thank you, operator, and thank you for the analysts and all of the attendees on this call. Humacyte is continuing just an incredible journey. I am so proud to have brought this first in class, unbelievably effective product into the surgical market. It is a thunderclap in vascular surgery. We are changing the way vascular surgery is practiced right now. and we're going to continue to do so. And this is a very exciting time, and I'm very proud of our employees, and I'm very proud of our sales force, and we're just going to keep pushing ahead. So thank you very much for your time.

Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.