HUMA

Good morning, ladies and gentlemen, and welcome to the Humacyte first quarter 2026 earnings conference call. Currently, all participants are in listen-only mode. Later, we'll conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I'll now turn the call over to Thomas Johnson with LifeSci Advisors. Please go ahead, Tom.

Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. 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 date hereof, and the company undertakes no obligation to update or revise 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 website.

Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer, and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Niklason will provide a summary of the company's progress for the first quarter and in recent weeks, and Dale will review the company's financial results for the quarter ended March 31, 2026. I will now turn the call over to Dr. Niklason. Laura.

Thank you, Tom. Good morning, everyone, and thank you for joining us for our 1st quarter financial results and business update call for 2026. To remind this audience, Humacyte's key corporate goals for this year include advancing the U.S. and global commercial launch of Symvess, completion of the V012 phase III pivotal trial of our ATEV in dialysis access, the planned filing of a supplemental BLA with the FDA in the dialysis indication, the commencement of a human study of our coronary tissue engineered vessel or CTEV in coronary artery bypass grafting. During today's call, I'll review progress across those commercial and developmental programs before turning the call over to Dale for a review of our financial results for the quarter.

During our first quarter and in recent weeks, we continued to make progress in our U.S. market launch of Symvess, as well as expand commercialization into international markets. First quarter sales of Symvess were $0.5 million in 2026 as compared to $0.1 million in the first quarter of 2025. While we've seen expansion in the commercial uptake of Symvess, we also recognize that more rapid product uptake and sales growth is necessary and is warranted based on Symvess' tremendous potential. To that end, we recently announced substantial new hires in senior commercial and clinical leadership positions. Industry veteran Jim Mercadante has been brought in as our new Chief Commercial Officer, while Dr. Todd Rasmussen has been brought in as our Chief Surgical Officer.

Jim is an accomplished medtech commercial leader with an extensive track record of field-specific success in vascular and cardiothoracic surgery markets. Dr. Rasmussen is one of the trailblazers of modern vascular surgery, particularly vascular trauma and peripheral artery disease, and he will be instrumental in guiding our education strategy for Symvess going forward. We're also adding commercial talent that will more thoroughly cover important U.S. markets and will engage directly with large integrated delivery networks or IDNs. We look forward to working with this new revamped and restructured commercial and clinical leadership team to accelerate and expand patient access to Symvess in the U.S. and globally. In parallel with our U.S. launch of Symvess, we're also taking steps to expand the commercialization into international markets. In March, we submitted a marketing authorization application or MAA with the Israeli Ministry of Health for Symvess for arterial injury repair.

In April, our MAA was accepted for review by the Israeli Ministry of Health. The Ministry of Health has set a 180 working day review period for our MAA. International interest has been highlighted by the $1.475 million purchase commitment that we announced for the Kingdom of Saudi Arabia. This funding will facilitate clinical evaluation and outreach programs in hospitals within the kingdom. The planned clinical evaluation will be conducted in parallel with ongoing negotiations with a kingdom-based entity for establishment of a joint venture and license to commercialize Symvess within country. As previously announced, the U.S. Department of Defense has dedicated funding for evaluation and incorporation of new biologic vascular repair technologies. In appropriating this funding, lawmakers demonstrated that they recognize the need for human-derived bioengineered vessels to save life and limb on 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 whenever and wherever they need it. We look forward to working with leaders in our military and at our military health facilities to ensure that the American service personnel will have access to this groundbreaking technology. In May of 2026, Humacyte implemented a restructuring of its workforce to reduce total headcount by 45 employees or roughly 25%. We did this by trimming some current staff and by deferring some planned hires for this year. Other operating expenses were also trimmed, and this was enabled by the successful completion of multiple technical and clinical projects at Humacyte over the past year.

These spending reductions were done thoughtfully, and Humacyte has retained personnel, resources, and initiatives to meet its key corporate goals and milestones. These key corporate goals include, as mentioned earlier, advancing the U.S. and global commercial launch of Symvess, completion of the V012 phase III trial in dialysis, the planned filing of our supplemental BLA in dialysis in the U.S., and the commencement of a first-in-human study of CTEV in CABG. With this reorganization, we've grown the support for the commercial mission by taking advantage of prior successes in the technical sphere that have allowed Humacyte to reduce run costs while maintaining our laser focus on medical education, sales, and marketing.

As a result of the restructuring, Humacyte estimates that we'll incur aggregate charges representing a one-time cash expenditure for severance and other employee termination benefits of approximately $0.8 million, of which the majority is expected to be incurred during the second quarter of 2026. We further estimate a savings for the remainder of 2026 of approximately $14.3 million, which is net of the severance and benefits. I'll turn now to the program that's our next priority, which is dialysis access, which will reach an exciting milestone later this quarter. Further illustrating the platform nature of Humacyte's technology, we're nearing the presentation of top-line interim results for our phase III trial in dialysis access. These results should be ready for presentation by June 11, 2026, at the Vascular Annual Meeting in Boston.

Thus far, a total of 120 patients have been enrolled to date in the V012 phase III clinical trial, which is designed to assess the efficacy and safety of the ATEV in dialysis access in comparison to AV fistulas in female patients. We're currently working to complete a pre-specified interim analysis of our ongoing V012 trial, which is being conducted in women. These top-line interim results are expected to be available for reporting around June 11th, as I mentioned, in Boston. Subject to the results, our plan is to submit a supplemental BLA in the second half of 2026 to add dialysis as an indication for Humacyte's ATEV.

The compelling unmet needs for hemodialysis access among female and other underserved patients were also highlighted in a key opinion leader event that we hosted on April 28th, featuring Dr. Prabir Roy-Chowdhury of the University of North Carolina and Dr. Mohammad Hamed Eslami of the Brigham and Women's Hospital at Harvard Medical School. This was a very well-attended event, which we believe speaks to the interest in alternatives to the current treatments for access in hemodialysis patients. I'll briefly discuss one of the pipeline programs that we're also very excited about. Our Coronary Tissue Engineered Vessel, or CTEV, for use in coronary artery bypass grafting, or CABG. We're on track to commence our phase I-II trial of CTEV and CABG in the second half of 2026.

In support of Humacyte's first-in-human study in CABG, we submitted an investigational new drug application, or IND, to the FDA late in 2025. For this study, we initiated the first large-scale manufacturing lot of CTEV in our commercial production facility, which is nearing completion. Our CTEV vessels have a diameter of 3.5 millimeters, which is suitable for the coronary circulation and which is smaller than the FDA-approved 6-millimeter vessels that are being used in the limbs. We plan to commence the CABG study in the second half of 2026 upon completion of manufacturing and clearance by the FDA. I'll now turn this over to Dale for a review of our financial results for the first quarter.

Thank you, Laura, and good morning, everyone. Commercial sales of Symvess were $0.5 million or 29 units in the first quarter of 2026 compared to $0.1 million or 5 units in the first quarter of 2025. Contract revenue from a research collaboration with a large medical technology company was $2,000 in the first quarter of 2026 compared to $0.4 million in the first quarter of 2025. This decrease related to the completion of this phase of the collaboration. Cost of goods sold were $2 million for the first quarter of 2026 compared to $0.1 million for the first quarter of 2025.

For the first quarter of 2026, $0.2 million of the cost of goods sold related to cost of units recorded as sales revenue during the quarter, and the remainder was primarily comprised of a $1.6 million inventory reserve recorded to reduce certain inventory balances to their estimated net realizable value as well as overhead related to unused production capacity, which was recorded as an expense in the period. Research and development expenses for the first quarter of 2026 were $19.5 million compared to $15.4 million for the first quarter of 2025.

The increase related to $4.3 million in material costs, primarily from non-commercial manufacturing runs associated with CTEV production, as well as process improvement designed to improve future cost of goods sold. General and administrative expenses for the first quarter of 2026 were $7.9 million, consistent with the $8.1 million incurred in the first quarter of 2025. Other net income was $11.3 million for the first quarter of 2026, compared to $62.3 million for the first quarter of 2025. The decrease in 2026 of Other net income compared to the prior year resulted primarily due to a decrease in non-cash income from the remeasurement of the contingent earn-out liability.

Net loss was $17.6 million for the first quarter of 2026, compared to net income of $39.1 million for the first quarter of 2025. The increase in 2026 net loss compared to the prior year period was primarily due to the decrease in non-cash income from the remeasurement of the contingent earn-out liability I described earlier. We had cash equivalents, and restricted cash of $48.9 million as of March 31, 2026. Net cash used was $2.0 million for the first three months of 2026, compared to net cash provided of $17.9 million for the first three months of 2025.

The increase in net cash used for the first quarter of 2026 resulted from $47.0 million in net proceeds from a public offering completed in March 2025, partially offset by $23.3 million in net proceeds from sales and shares during 2026. With that, I'll turn the call back to Laura.

Thank you, Dale. With our outstanding and augmented commercial and medical team, our strong commercial execution, our very promising pipeline programs, and our dedicated employees at Humacyte, we remain committed to delivering truly transformational regenerative medicine solutions that will improve patient outcomes and lives. We believe we are positioned for growth and value generation for 2026 and beyond. Thank you all for joining us today. Operator, we're ready to take questions.

Thank you. First question is from the line of Matt Miksic with Barclays. Please proceed with your questions.

Hey, good morning. Thanks for taking the questions. I wanted to ask about the commercial efforts that you're putting in place to sort of drive greater adoption in the, I guess, the U.S. market for trauma away from some of the government contracts that you've established, which are great. You know, what can you tell us about the sort of the pace that we should expect, you know, the trajectory of revenues that we might see from those efforts? I have a follow-up.

Yeah, Matt, this is Laura Niklason. Thank you so much for the question. You know, I do think we're still a little too early to provide guidance for 2026. I personally am hoping to provide guidance by the end of the year. We have restructured the commercial team, and we've strengthened it and grown it. The approach that we're taking to driving commercial uptake is really much more customer-focused now. Our customers are primarily vascular and trauma surgeons. We're revamping how we approach the customer and how we educate them about Humacyte and about the products, but also about our platform and potential future indications.

You know, I think one learning that we've taken away over the last year is that we have to provide better education on the technology, which we've been doing, but we also have to view the new technology from the surgeon's perspective, and help show them the ways in which the technology can help their patients now, but also in future as we gain additional indications. You know, we've really revamped the team with a very experienced medical device sales team that has worked for decades in high-end vascular and aortic devices and procedures. We think we've really targeted the correct team. Now we have to change the way we engage with surgeons.

I believe those will result in accelerating revenues during 2026, but it's too early for us to predict the shape of that ramp.

Sure. No, that's understandable. You know, from your comments, it sounds like a shift or pivot, I don't want to say away from, but, you know, the emphasis maybe this time last year was working your way through the value analysis committees and approvals and hospital contracts and establishing that sort of first use. Now it sounds now from your comments, almost just to repeat what you talked about is more, you know, call point service and education to support the use or encourage the use of the device.

Yeah.

in the appropriate setting. Is that fair?

Yeah, I think that is fair. I mean, we're certainly working. We've still got, I think, I don't know how many exactly, but roughly 45 VAC applications in various funnels. We are still working on, you know, getting on the board or getting on the shelf in hospitals. We're certainly not happy with the number of hospitals where we are on the shelf. What's become clear is that just getting it on the shelf, but then not providing additional surgeon support and education and sort of letting them see the value of the product for its approved indications, not just now, but in the future, I think that's something that we're really leaning into a lot more in addition to trying to expand how many hospitals where we're on the shelf.

You know, as part of the geographical expansion, we're also revamping our territories, and we're bringing on some additional sales people with a lot of experience with Integrated Delivery Networks. It's leaning into both aspects. I would say you're correct, Matt, that leaning into surgeon support and education and viewing the product and the product experience from their eyes is a critical pivot for us.

Okay. Just one follow-up, if I could, on, you know, this process experience in Symvess and the trauma center and, how, you know, what you've taken from that or how we, you know, investors should expect the eventual introduction into the dialysis indication to be, you know, what have you learned that's applicable, and how will that be different perhaps would be helpful color?

You know, what we've learned about use and uptake in trauma centers, and in very difficult and infected and contaminated cases is that most surgeons are very happy with how the product works. I, you know, I think we're going to have a series of case reports coming out this year of cases where surgeons thought that patients were essentially unreconstructable, and had no other means to sustain life. In many cases, not all, but in many cases, our product was able to reconstruct their vasculature. The word is getting around that the product works even in the most difficult circumstances.

One of our goals with engaging with surgeons is to get them to think about this not just for the most difficult cases but for more standard cases because the outcomes are so much better than many of their alternatives. As far as dealing with or what we've learned in trauma and how that will apply to dialysis, certainly, many, not all, but many of the surgeons who we talk to about trauma and peripheral vasculature are also doing dialysis access on Wednesday mornings or what have you. The awareness of the product translates directly over there.

In fact, we have a lot of enthusiasm from surgeons who are very eager to hear about these top-line results that are coming out in just a few weeks, because, you know, the particularly the problem of dialysis access in women, which is a chronic problem that folks have never been able to solve, and also the problem of infected dialysis grafts that need to be removed and, where you need to restore some sort of conduit, and you don't wanna put a catheter in. Those are really recalcitrant, difficult problems that dialysis surgeons are really hoping to get a better answer for.

I think that the fact that our vessel has done so well in some of these very challenging vascular injury reconstructions just helps inform the same surgeons about how we'll do in dialysis, provided the data are positive.

That's great. Thank you, Laura.

Our next questions are from the line of Ryan Zimmerman with BTIG. Please proceed with your questions.

Good morning, thanks for taking our question. You know, Laura, on the unit volume growth, you did see sequential growth this quarter from fourth quarter, which was, you know, encouraging to see on Symvess. I'm just curious, you know, of the existing users, you know, maybe if you could talk a little bit about just the repeat usage from some of your early adopters. You know, are you seeing that versus maybe new account growth? Again, I know you're, you know, going through this transition commercially with how you approach the market, but I'm just curious kind of if within the existing usage of Symvess, what that looks like. Then I have a couple other questions on some other components.

Yeah. Well, we're talking about, you know, 30 or more sites, it's a little difficult to have a blanket response, but I'll try. You know, in most of the sites that are using, in the last quarter, what we've seen is examples of Because as with any new technology or device, you know, typically there's 1 surgeon that's using at the site, and then other surgeons start to pick it up. In the last quarter, we've seen more of that, where, you know, it's not just the index surgeon at a particular site that's using, but some of his colleagues are also starting to do cases.

We've seen that at multiple of our high-use sites, which to me speaks to, you know, confidence, growing confidence at these individual hospitals. you know, I think what we're also seeing is that we have product on the shelf in some institutions, but I think because of insufficient support, the product isn't getting pulled. That's really sort of a missed opportunity for us that I think our behavior as a commercial team can improve upon.

Okay, that's helpful. You know, as we look ahead to AV access, you know, we're gonna get interim results at the meeting in June, I believe it is, SVS. You know, as you think about submitting for AV access, one, you know, how similar is that to your trauma application? Is it easier because you have the trauma indication now? You know, I guess what investors would wanna understand is how de-risk you think clearance is for the AV access indication and what you think about in terms of, you know, the risk or potential timing when that comes to market. Just one more on operating expenses when you're done.

Yeah. Thank you. That's a good set of questions. Again, I just wanna preface with the fact that I never know what the FDA is going to do. I would never sit here and tell you what I think the FDA is going to do. I can only tell you what I anticipate and what I hope will happen. If the results are positive on the interim analysis, which we're announcing in several weeks, then by pre-specification in the protocol, the trial stops. Because if by analyzing half the patients, if we have a clear superiority over standard of care, which is fistula, then it's probably not even ethical to continue the study. If we hit our endpoint, the study stops.

At which point we will analyze data on all of the patients that have been enrolled and followed up, that will be the lead V012 study will be the lead clinical file that will go into the BLA. The BLA will be supplemented with our prior V007 study, which also compared our vessel to fistula in catheter-dependent patients. Only the V007 study was in both men and women. These, if both studies are positive, since the last study was positive, these are 2 positive prospective randomized head-to-head studies done in the U.S. that would show superiority of Symvess or our ATEV to the standard of care.

Even with all of the FDA turmoil, which, you know, continues day after day, still the most conservative stance by the Center for Biologics has been that they like to see two prospective randomized head-to-head trials showing similar outcomes, which I believe if our, if our outcomes in V012 are positive, I think that's what we'll have. In addition, the because it's the same product as what is already approved in trauma, there are parts of the BLA application, like the manufacturing pieces and the preclinical and the safety and toxicity and what have you, all of that is essentially the same from what we've already filed and they've already reviewed. It will really be a matter of reviewing the clinical data, which we expect to submit before the end of the year.

If we were to submit, say I'm making this up, I'm making this up, but if we were to submit in November, then they would have 2 months to accept the file, which would put us in January. We would ask for Because we have an RMAT designation, we would ask for an accelerated review, which would be a 6-month review, which would put us in July of 2027. We may or may not get that accelerated review.

Right. Okay. That's very helpful, Laura. Dale, just on the reduction in operating expenses, I appreciate, you know, the savings estimates. Is that evenly spread through the remainder of the year, or does that build, you know, towards the tail end of the year, just as you wind down some of those expenses? Thank you for taking the question.

Yeah, Ryan, it's relatively evenly spread across the remainder of 2026. I mean, clearly there's a severance period which comes in, and obviously, when you take these measures, for example, in May, there's costs that have already been incurred. For the second half of 2026, you could expect that the $14.3 million in savings that's estimated will be spread pretty evenly over that period.

Okay. Thank you.

Our next question comes from the line of Joshua Jennings with TD Cowen. Please proceed with your questions.

Hi. Good morning, Laura and Dale. Thanks for taking the question. I was hoping to just follow up on Ryan's questions around the BLA submission. Are you able to share any recent kind of color from the FDA just on this path, the submission path? Also just curious if the Fresenius clinical team or regulatory team is involved in any way in terms of this BLA submission for AV access.

Thanks for that, Josh. In terms of the Fresenius contribution, they have certainly worked with multiple Fresenius sites because some of the key data in this clinical trial is how dialysis patients are doing, whether or not they're dependent on catheter or whether the dialysis center is able to take the catheter out. We've had to partner pretty closely with a lot of Fresenius centers, where a lot of our patients are being treated, to collect that data. They've certainly been part of this process.

I would not say they're part of the BLA filing, that's really held entirely by Humacyte, but they've certainly been supportive partners in gathering the data for this indication. As far as recent discussions with the FDA, we have not had recent discussions on dialysis access. We had discussions with them regarding our plan for executing on the V012 trial, and if that was positive, we let them know that we would plan to file a supplemental BLA. We had that meeting about 12, 18 months ago. Certainly, we are looking at preparing a application for a pre-BLA meeting should these results be positive. At the pre-BLA meeting, we would then really lay out our top-line results and our strategy for filing, and we'd get a little bit more clarity there.

I will say that despite all of the turnover at the FDA, which continues, as we know, the clinical review team in the Center for Biologics, which has reviewed our trauma application and which also will review our dialysis application, has remained relatively intact. We had a meeting with the trauma with that clinical team on another indication in PAD just a couple months ago, many of the reviewers are the same. I do believe there will be some continuity there, which is good for us.

Thanks for sharing that. Just my follow-up, I wanted to just better understand the funding allocated by the Department of Defense. What are the next steps for Humacyte with the Department of Defense, and how do you see the path to, you know, potentially procurement orders and/or stockpiling, and relative timing if there's anything you can share there. Appreciate you taking the time.

We have our executive VP of strategy, who used to work in federal government for 20 years in procurement, it has really been spearheading this effort. This is a collaborative effort between Humacyte, the Department of Defense, and several surgeons at different Military Treatment Facilities or MTFs. It's difficult for me to give precise timing. We are hoping to have this purchase completed by around September. The purchase would then be involved in training surgeons and in clinical use at different MTFs. But as with the FDA, it's very difficult for me to sit here and predict timing on DoD actions.

Thank you.

The next question is from the line of Joshua Jennings with Piper Sandler. Please just proceed with your questions.

Hi there. Thanks for taking the call. Following the recent amendment of the Fresenius agreement, what is your current priority for international commercialization? If you could elaborate on your ex-U.S. strategy, specifically regarding any plans for the European market, and the steps you're taking to advance those initiatives. Thank you.

Dale, you wanna take that?

Absolutely. Clearly the reacquisition of our ex-U.S. rights due to, or as a result of the amendment of Fresenius, creates a lot of opportunities for us. We had already initiated a number of efforts within the Middle East, and those continue and will likely expand. That's just an area that for a variety of reasons, in part due to the current conflict and in part due to longer-term interest we've had from that region, you know, we continue to push that forward extensively. As you infer, we also have the ability now to pursue a European or other major region ex-U.S. partners, including Japan or Europe, and have initiated outreach to commence those discussions.

Thank you.

Our next question is from the line of Bruce Jackson with StoneX. Please proceed with your questions.

Hi, good morning. I'd like to ask a question about the dialysis market, and in particular, I'd like to ask about the CMS End-Stage Renal Disease Quality Incentive Program for 2026, which provides some incentives to use fistulas or grafts instead of catheters. The in particular, the long-term catheter rate is a key measure. Does this provide any kind of incentive for more rapid uptake in the dialysis market compared to trauma? Does this also dovetail with the applicability in the female population?

Yes, Bruce, thank you for that. I'm still getting used to the whole StoneX thing, but forgive me. Yes, absolutely. As you mentioned, as we're well aware, CMS has instituted a payment system whereby dialysis clinics who maintain large numbers of patients on catheters actually suffer in terms of their reimbursement. Dialysis centers, for reasons of patient care but now also for reasons of reimbursement, are eager to get patients off of catheter. For women in particular, as we know, if you look at the USRDS, nearly 1 in 3 women dialyzes in the U.S. on a catheter. Many of these are not by choice.

It's because they cannot get a fistula to mature, and surgeons are unwilling to put a graft in the patient, typically because of infection risk. This is a hard number to get unstuck because there have been no other alternatives, particularly for women, in decades. We believe that that is going to be the sweet spot for patient care and patient outcomes and also for reimbursement for dialysis centers. If we can target women who are remaining on catheter and suffering all those complications, and all that expense, we believe we can improve outcomes while decreasing costs. You know, the cost of an average hospitalization for a catheter infection can be nearly $30,000.

And patients who are on catheter who then get a fistula, but the fistula fails, the cost of that patient in the first year is $45,000 because of all the return trips to the operating room and rehospitalization. Remaining on catheter is expensive. Trying to get off catheter and failing is even more expensive. We believe that Symvess may offer an alternative that will reliably work in women, that won't fail to mature, and that will have a low infection rate. That I think could represent a real benefit for this population.

All right. That's very helpful. Thank you. Thank you. At this time, I'll turn the floor back to management for closing remarks.

Well, I'd like to thank the analysts for their thoughtful and insightful questions this morning and also to the audience for listening to us. We have had a tremendous number of developments. Humacyte, I would say, is firing on all cylinders to both expand our current commercial footprint in the U.S. and worldwide, also to take advantage of the huge number of opportunities that this platform technology is affording us. I am impressed and grateful to the people at Humacyte who have been so incredibly productive and have accomplished so much over these past several years, and I'm very excited about what the rest of 2026 is going to bring. Thank you for your attention.

Thank you. Ladies and gentlemen, this will conclude today's conference. You may disconnect your lines at this time. Have a wonderful day.

Good morning, ladies and gentlemen, and welcome to Humacyte's 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 LifeSci 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 on 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 release was issued this morning and in our Form 10-K, which, after filing, may be accessed from the investor page of the Humacyte website.

Joining me on today's call are from Humacyte Dr. Laura Niklason, President and Chief Executive Officer, and Dale Sander, Chief Financial Officer and Chief Development Officer. Dr. Niklason 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 ended December 31, 2025. I will now turn the call over to Dr. Niklason. 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 Symvess 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 Symvess. We continued to execute our U.S. market launch of Symvess, 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 Symvess in the U.S.

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 Symvess, with the majority of these hospitals placing reorders. Q4 product sales were $0.4 million for the quarter and $1.4 million for the year. We're pleased that the U.S. Department of Defense 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 Symvess 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 Symvess within the country. Also, in March, we submitted a marketing authorization application, or MAA, with the Israeli Ministry of Health for Symvess for arterial trauma repair.

In response to surgeon requests, we're also pursuing a mechanism for making Symvess available in Israel on a hospital-by-hospital basis, even in advance of MAA approval. Commercial adoption of Symvess was further supported by publication of several important papers, including long-term safety data from our V005 phase II/III trial in the Journal of Vascular Surgery Cases, Innovations and Techniques. These data were also presented last January by Dr. Michael Curry of the New Jersey Medical School at the annual winter meeting of the Vascular and Endovascular Surgery Society. Among those treated in the V005 study were 54 patients who underwent extremity vascular repair with Symvess 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. Symvess 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 V005 study, with Symvess diameters maintained constant over three years of follow-up. Importantly, no deaths or amputations or mechanical failures were attributed to Symvess 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 Symvess to provide meaningful benefits for patients who are facing life or limb-threatening injuries, 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 Academic Military Medicine, which describes positive long-term results from a humanitarian program using Symvess to treat wartime vascular injuries in Ukraine. The publication reported on 17 trauma patients with wartime extremity injuries who were treated with Symvess and were followed for up to 18 months. These wartime patients were observed to have a high Symvess patency rate of 87.1% and also 100% limb salvage, showing the durability of Symvess in treatment of real-world combat injuries.

Also in October, a new study comparing the clinical outcomes of Symvess to autologous vein in the treatment of extremity arterial trauma was published in the American Association for the Surgery of Trauma, or the AAST's Trauma Surgery & Acute Care Open journal. This study showed that in comparison to trauma registry preexisting patients who were treated with autologous vein, the patients who were treated with Symvess 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 Symvess and the prior registry patients who had been treated with autologous vein. 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 V007 phase III trial of the ATEV in 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. 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 U.S., 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 U.S. 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 ATEV. We're nearing an exciting milestone, and we're currently working to complete a pre-specified interim analysis of our ongoing V012 phase III trial that is being conducted in women specifically. The V012 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 V012s and the V007 phase III pivotal study to add dialysis, which is a major market, as an indication for the ATEV. 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 2025. In that study, the CTEV was observed to sustain blood flow, recellularize with the animal's cells, 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 planned 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 I/II study in coronary artery bypass in the second half of 2026 upon completion of manufacturing and clearance by the FDA. 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 31, 2025, of which $0.4 million related to U.S. sales of 25 Symvess 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 31, 2025 was $2.0 million, of which $1.4 million related to U.S. sales of 61 Symvess units, and the remainder resulted from the research collaboration. There was no revenue for either the three months or the year ended December 31, 2024. Cost of goods sold were $9.1 million and $9.7 million for the three months and the year ended December 31, 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 31, 2024.

Research and development expenses were $14.6 million for the three months ended December 31, 2025, compared to $20.7 million for the three months ended December 31, 2024, and were $69.3 million for the year ended December 31, 2025, compared to $88.6 million for the year ended December 31, 2024. The decrease reflects in part the transition from development activities to commercial operations following FDA approval of Symvess in December 2024, including the current year allocation of manufacturing costs to inventory and cost of sales, costs that in 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 V005 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 31, 2025, compared to $25.8 million for the year ended December 31, 2024. The increase in 2025 expenses compared to the prior year periods resulted primarily from the U.S. commercial launch of Symvess in the vascular trauma indication, including increased personnel expenses.

Other net income for the three months ended December 31, 2025 was net income of $6.0 million, compared to $7.1 million for the three months ended December 31, 2024, and other net income was $67.3 million for the year ended December 31, 2025, compared to other net expenses of $34.3 million for the year ended December 31, 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 earnout 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 31, 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 31, 2025 resulted primarily from the increase in other net income and the decrease in operating expenses, partially offset by the inventory reserves.

We had cash and cash equivalents of $50.5 million as of December 31, 2025. Subsequent to December 31, 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 funded fully at close, and an additional two tranches of up to an aggregate of $37.5 million available to Humacyte, 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. 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 one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Good morning. Thanks for taking our questions, Laura Niklason and Dale Sander. 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, you know, topic in terms of commercialization. Just, you know, one, how are sites responding to the new pricing of Symvess? And then, the second question, you know, 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 you know, 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. 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 can be upwards of $20,000. This price point of $17,000 puts us in a good range. In my personal communications with surgeons and also those of the surgical sales force, that's been a uniform commentary. The result there has been a higher rate of VAC approvals, a higher percentage. We're up above 70% now.

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 larger GPOs that cover you know 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 in several integrated delivery networks or IDNs.

you know, 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. Showing that our outcomes are similar to vein has also made an important impact with surgeons. We're just gonna continue growing.

Understood, Laura. Thank you. 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 in Q4. once you get past that, maybe just talk to us about kind of the submission for BLA for dialysis access. You know, what's on your list to check off? How are 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 and the CMC data will all be the same. It's all 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. We really have no sort of standing queries with the agency right now. It'll really be about the clinical package. After we get the top-line results, which based on V007, we anticipate will be positive.

I don't know the results, but based on V007, if they're similar to V007, they'll be positive. 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 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 Kolbert with D. Boral Capital. Please proceed.

Good morning and congratulations on all the progress. Laura, could you talk us through a little bit about how important the sales cycle is? Where I'm asking the question is it's in relation to SG&A. 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 numbers? Where would you focus those efforts? What percentage would be domestic? What percentage would be international? Thanks.

Right. 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 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.

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. We anticipate that a lot of the sales personnel would be provided by our distributors in country.

Gotcha. That makes a lot of sense. 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. It's hard for me to answer that question. You know, 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. Surgeons, a new surgeon will typically wanna watch the first patient and then reuse, and that's what we've been seeing. You know, 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. I look forward to more updates.

Thank you.

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

Good morning, and thank you for taking my question. This is Peter Spanogiannopoulos for Ali Brazell from Piper Sandler. On the commercial front for Symvess, you noted that 27 hospitals have ordered to date, with the 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 the 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. 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.

Thank you.

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

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

The way we're working with, in particular our Saudi partners, our commercialization partners over there, the initial orders will be chunky. 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. In addition to that, there's also a large PAD market. There's a tremendous opportunity for Symvess in Saudi.

The strategy with our partner is that 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, you know, 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. I don't know exactly how that's gonna look yet.

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

Yeah. Thank you for that. No. 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. The word is getting out in the surgical community. I mean, some surgeons post on social media on their use of the vessel, and they go back and forth with each other on their experiences. 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. 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 300 or 400 level twos. I still think that we're, I don't wanna say we're scraping the surface, but we're still at the beginning. 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 Swayampakula Ramakanth from H.C. Wainwright. Please proceed.

Good morning, Laura and Dale. This is RK from H.C. Wainwright. A couple of quick questions from me. Regarding the DoD procurement that you are expecting, since I believe this particular funding you know 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 the 2027 budget year or, you know, for 2027, is it a completely new application all over again?

Yeah. No. I'll do my best to answer your question, RK. 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 Symvess. Probably more than half of the funding is for military procurement. 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. 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.

There's roughly 40 vascular surgeons in the U.S. military, and probably four or five of them have used Symvess in their patients. That leaves a large number who still could remain to be trained in addition to trauma surgeons. 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. You know, regarding the VAC approvals, you know, between Q3 announcement and now, you know, two additional VAC approvals came on board. I'm just trying to understand, you know, a couple things. One, is the VAC approval time, is the time got extended because of some of the holidays and stuff? Or, and also, what's the conversion? Is the conversion getting better between VAC approval and procurement of the product itself?

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. During the holidays, VACs tend to meet less often, and they often have a backlog of cases. I don't see this as fundamental at all, the low number of additional approvals. 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, negotiate the contract and get on the shelf after the VAC approval, at the current price point.

In addition to improving the success rate in VACs, which is over 70% all told, it's also, I think, speeding up getting product on the shelf. You know, at the higher price point in the very early days, our VAC approval rate was less than 50%. 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, I mean, negotiate a price over in Saudi Arabia? 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. We have not begun negotiating pricing with the Ministry of Health yet in Saudi. 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 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 gonna have to be paying a distributor. I think that there will. It certainly will not be less than $17. You know, there will be some additional real-world costs that will be additive there. I don't know what the final number will be.

Again, I strongly believe that our continued excellent data in trauma and the published data that we've seen in phase II trials in 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. 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 Joshua Jennings with TD Cowen. 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 Q4 in your commentary on 2026, certainly appreciate that it's too early to provide formal guidance or you're likely not to. Just any color you could provide on, you know, what may have caused the shortfall between Street expectations. Again, thank you for the puts and takes around some of the revenue components in the year ahead. Do you feel the Street is accurately modeling directionally what the year will look like? Just had one quick follow-up.

Yeah. Again, it's hard for me to comment on what the Street is saying without giving projections. It's, as you know, a little bit of a tightrope. Also, as you know, different analysts have come out with a broad range of expectations. The higher ones I think are, you know, probably not in line with reality. I think that, you know, like if there's an analyst that says we're gonna sell $30 million next year, I think that's probably not true. I think our growth is gonna be more gradual than that. 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 VAC 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. 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. Just following up on that, cash for the quarter came in essentially right in line with the pre-announcement. Just as you go through this commercialization process, you know, do you see an opportunity to maybe reduce your cash burn rate? Probably too early to talk about, you know, maybe a steady-state growth profile, but what does cash burn look like in the quarters ahead?

Yeah. Again, we're not gonna give guidance on burn, but certainly, we're looking very closely at burn. You know, 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 gonna have to continue to work on. We're definitely looking at the spend side.

Okay, great. Thank you very much.

Yeah. In addition to that, we're also looking at business development opportunities. We've had a great deal.

Yeah

of interest in our platform from preclinical to clinical. I think that's evidenced by the interest we're seeing internationally just for Symvess, 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 gonna continue to do so. 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 gonna keep pushing ahead. 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.