Q3 2025 Humacyte Inc Earnings Call & Business Update

Good morning, ladies and gentlemen, and welcome to the human sight third quarter results conference call.

Currently all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time.

As a reminder, this conference call is being recorded. I'll now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US Federal Securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or pressing 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 major in this call speak only of the date hereof, and the company undertakes. No, obligation to update or revise, before we're 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 may be accessed from the Investor page of the Humacyte website.

Joining me on today's call from Human Side or Dr. Laurel Nicholson president and chief executive officer and Dale, sander Chief Financial Officer and chief corporate and development officer Dr. Nicholas Sim will provide a summary of of the company's progress for the third quarter on recent weeks and still will review the company's Financial results for the quarter end of September 30th 2020,

I will not turn the call over to Dr. Laura Niklason.

Thank you, Tom. Good morning, everyone, and thank you for joining us for our third quarter 2025 financial results and business update call.

I'm pleased to report that our third quarter (Q3) was a productive period for human sight and the continued execution of our commercial launch with Sim, as well as the advancement of our other bioengineered vessel programs.

During today's call, I'll review progress across our commercial and development programs.

Before turning the call over to Dale for a review of his financial of our financial results for the third quarter.

Beginning with our commercial launch of Sims, we're pleased by the traction. We continue to gain in our interactions with surgeons and hospitals.

Now eligible to purchase invest.

As you know, in July we announced that Sim had been awarded the electronic catalog or e-cat listing approval from the US, defense Logistics agency, which provides the Department of Defense and other federal agencies.

E-Cat approval makes investments available to healthcare professionals.

Treating military service members, veterans, and other patients receiving care at military treatment facilities and at U.S. Department of Veterans Affairs hospitals.

Since obtaining ECAT approval, we recorded our first commercial sale to U.S. military facilities.

And we have great interest in improving medical options available to Health Care Professionals, who are treating military personnel, and their families. And we look forward to advancing our discussions with additional DOD Affiliated hospitals,

Our commercial rollout of SIM was supported by the recent publication of three studies demonstrating the potential of this product in vascular trauma.

First, the publication entitled "Bioengineered Human Blood, Blood Vessels to Treat Hospital-Acquired Vascular Complications" was published recently in the Journal of Vascular Surgery.

This publication describes the outcomes of using Sim vest in the treatment of arterial injuries. That are sustained in the process of Medical Care, rather than injuries that are sustained in the community.

And comprise up to 30% of patients, requiring, vascular, injury repairs.

Harvesting of autologous veins to address these consequences and complications produces additional injury for the patient and is not always suitable. The vein may not always be accessible.

This publication describes the outcomes of patients with hospital-acquired iatrogenic injuries, which are complications of vascular surgery procedures. This was a subgroup of our VO5 pivotal Phase 2.3 clinical study that we conducted in the U.S. and Israel.

At the end of an average of follow-up of 23.3 months, 92% of the patients retain, secondary patency, or had blood flow in the conduit.

None of the patients, suffered an amputation. And there were zero infections of sves.

Patients experiencing hospital-acquired vascular complications represent an important subset of vascular trauma patients. It is gratifying to see that the outcomes in this study show that SIM can provide limb salvage and durable patency.

Another publication in the Oxford academic Journal. Military medicine. Described positive long-term results from our humanitarian program using Sim vest to treat wartime vascular injuries in Ukraine.

This publication reported on 17 patients suffering combat related. Uh extremity vascular. Trauma from gunshot wounds blasts and shrapnel.

Up to 18 months after up to 18 months of follow-up, Physicians, observe zero deaths, zero infections, and zero amputations in these treated patients in Ukraine.

Furthermore Sim had a high patency of 87.1% and no instances of immunologic rejection.

These outcomes demonstrate the long-term durability of simstein of real world combat injuries.

And finally, the trauma surgery and acute care open Journal published results of a new study comparing clinical outcomes of Sims to those from resulting from a togus vein in the treatment of extremity arterial. Trauma.

This analysis, leveraged data, from 2, clinical trials.

Humanites Phase, 23 VO5, study and the humanitarian vo7 team study in Ukraine.

And match Sim patients in those trials to patients who had suffered similar injuries and who were previously treated with veins.

Which is the world's largest vascular trauma database.

The comparison between SVEs and vein outcomes found that patients who were treated with SimVest had statistically similar outcomes to patients from the PROBE IT registry who received autologous vein.

Secondary patency for Sim vest versus the autologous. Name group was 91% versus 97.7% the amputation rate was 7.5% versus 8.2%.

And the death rate was 4.5% for both groups, respectively.

There were no significant differences that were noted between the 2 groups for any of these outcomes that were assessed.

The use of autologous vein to repair, um, and injured blood vessel is the current standard of care, because it offers, excellent long-term patency and low infection rates.

However, in many cases, suitable autologous vein may not be available due to extreme limb damage, prior surgeries, or poor vein quality.

Even when available, harvesting the vein is a time-consuming procedure and may not be an option for patients with severe traumatic injuries.

We believe that the results of this study underscores investors potential as a much-needed effective and life life-saving alternative.

Uh, as a treatment for patients, using autologous vein is not feasible.

We're very pleased with these study results, and as a SVES is increasingly adopted by surgeons, we're confident that we will continue to see the benefits of this product validated by further research.

In addition, we have another publication of the long-term results of Sims in vascular trauma in the civilian setting that will be forthcoming soon.

I'll turn now to the program that is our next priority which is dialysis access.

Positive 2 re 2-year results from the vo7, phase 3, trial of the ATV. In dialysis patients were presented last weekend at the American Society of nephrology kidney weeks, 2025, which is the Premier neurology meeting.

The ATF demonstrated superior duration of use over 24 months compared to autogenous fistula in high-need subgroups that have historically poor outcomes with AV fistula procedures.

The significantly longer duration of ATV use over 2 years, in patients with this, High unmet need could greatly reduce, Reliance on catheters for dialysis access.

Which are a major cause of complications more morbidity, and costs for dialysis patients.

Women and men with diabetes and obesity make up more than half of the dialysis access market and our historically underserved by the current standard of care.

It's been known for decades. That women in particular suffer, low rates of official and maturation lower rates official of maturation than do men. But a lack of better Alternatives has limited progress for these patients.

we believe that the efficacy and safety results in this subgroup combined, with the approximately 50% failure rate official is in this subgroup,

makes women and high-risk men and important population for human sight to Target.

We look forward to publication of the results from the vo7 phase 3 trial in a major peer-reviewed medical journal.

Before we file, a supplemental bla for the 87 dialysis access, our plan is to complete a pre-specified interim analysis of the currently ongoing trial, which is the VO2 phase 3 trial, which is being conducted in women on hemodialysis.

the VO2 trial compares, the ATV to women receiving fish oil for hemodialysis access

And an interim analysis is planned. When the first 80 patients reach 1 year of follow-up, meaning that the interim analysis results should be available around April of 2026.

Finally, I'll briefly discuss 1 of our earlier stage programs that were also very excited about our coronary tissue engineered vessel or CV for use in coronary artery, bypass grafting or cabbage.

College of Cardiology.

In this study, the cap was observed to sustain blood flow, remodel with the animal's host cells, and adjust to bring the diameter of the cev in line with the animal's native coronary artery.

We're on track with our plan to advance CV into first, in-human study, and cabbage in 2026.

Um, we have filed an IND with a, with the FDA for the Cabbage indication and if successful, the CV would be, the first novel, conduit to be tested in cabbage, in the US, in decades.

Before turning the call over to Dale, I'll mention last the expansion of our intellectual property estate and the grant of a new U.S. patent covering the composition of a bioengineered esophagus.

This new patent provides protection into 2041 for key. Structural in the mechanical attributes for an esophageal at replacement including size strength and methods of production.

Our tubular prosthesis patent family, now encompasses, granted claims for the composition, and methods for engineered, trachea. Engineered urinary, conduits and engineered esophagus.

So our third quarter has been very productive for human sight. As we've continued to grow our commercial launch and continue to publish strong supportive data for our for our vessel sim in multiple indications. We also look forward to continuing to share our, our progress going forward. And with that, I'll now turn the call over to Dale for a, re a review of our financial results and other business developments.

Thank you, Laura and good morning everyone.

revenue for the 3 months and it's September 30th 2025 was 0.8 million of which point 7 million related to the Us sales of simbas,

the remaining 0.1 million resulted from a research collaboration with a large medical technology company.

Revenue for the 9 months ended September 30, 2025, was $1.6 million, of which $0.9 million related to the U.S. Sales invested in $6 million resulting from the research collaboration.

There was no Revenue either for the 3 or 9 months. Ended September 30th 2024

Cost of goods sold were 0.3 million and 0.6 million for the 3 and 9 months ended September 30th 2025 respectively.

Which includes overhead related to unused production capacity, that was recorded as an expense in the applicable periods.

There was no cost of goods sold for either the 3 or 9 months in its September 30, 2020.

Research and development. Expenses were 17.3 million for the 3 months, ended September 30 2025 compared to 22.9 million for the 5 for the prior year period.

And were 54.7 million for the 9 months. Ended September, 30 2025.

Compared to 67.9 million for the same period in 2024.

The decrease in research and development expenses for the third quarter of 2025 compared to 2024, primarily related to the capitalization of material and overhead costs associated with the commercial manufacturing of simbas.

And cost reductions implemented during the quarter ended June 30, 2025.

The decrease in research and development expenses for the nine months ended September 30, 2025, compared to 2024.

Resulted primarily from decreased material costs. As the company, became began, capitalizing expenditures for inventory.

Following the commercial launch of timbes.

Combined, with the winding down of certain clinical trial programs.

Partially offset by higher non-commercials production runs.

Selling, general, and administrative expenses were $7.6 million for the 3 months ending September 30, 2020.

Compared to 7.3 million for the prior year period.

And we're 23.6 million for the 9 months. Ended September, 30 2025 compared to 18.4% in 2024.

The increase in 2025 is expenses compared to the prior year periods. Resulted primarily from the US commercial launch of simbas in the vascular trauma indication including increased Personnel expenses.

Other net income for the three months ended September 30, 2025, was $6.9 million compared to a net expense of $9.0 million for the prior year period.

The increase in other net income for the 3 and 9 months ended September 30, 2025, compared to the prior year periods, resulted primarily from the non-cash remeasurement.

Of the contingent earnout liability associated with the company's August. 2021 merger, without the healthcare acquisition Corps.

Net loss was 17.5, million from 3 months, ended September, 30 2025.

Compared to a net loss of 39.2 million for the prior year period.

And that loss was $16.0 million for the 9 months.

In mid September, 3020 2025.

Compared to a net loss of 127.8 million for the same period in 2024.

The decrease in net loss for the 3 and 9 months ended September 30th 2025 compared to the prior year periods.

This is primarily due to a non-cash remeasurement of the contingent liability described previously, combined with current period decreases in operating expenses and a decrease in loss from operations.

We had cash cash, equivalents and restricted, cash of 19.8 million at as of September 30th 2025

In addition subsequent to September 30th 2025, we completed the sales come stock and warrants that added an additional net proceeds to our cash position of approximately 56.5 million.

As will further be discussed in the 10-Q to be filed later today.

We believe that gives us cash Runway exceeding, 12 months from today's date.

Told him that cash used in operating expenses was $1,778.9 million for the first 9 months of 2025.

Compared to cash. Net cash used at 71.5 million for the first 9 months of 2024.

The increase in net cash used for operating activities during the first 9 months of 2025. Compared to the prior year, resulted primarily from the dot up of inventory associated with the commercial launch of inventory.

Partially offset by our reduced loss from operations.

With that, I'll turn the call over to Laura.

Thank you Dale, with our strong commercial execution, our promising pipeline pipeline programs and our dedicated team.

We remain committed to delivering, truly transformative, regenerative medicine solutions, to improve patient outcomes.

We believe that we are positioned for growth and value generation in the remainder of 2025 and Beyond.

Thank you all for joining us today.

Operator, we're now ready to take questions.

Thank you. If you'd 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'd 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 comes from the line of Matt Mix with Berkeley. Please proceed with your question.

Hi, this is an essay on Matt Mix.

Um, hi there. How are you?

Good. How are you team?

Good.

um, we wanted to ask, um,

1 of the first questions we just kind of wanted to ask was

uh,

Q2 you mentioned that 12 of the 45 hospitals had initiated the back process. And now you've said that 16 has started ordering how many of those that have started, ordering have begun the reorder process and have you discuss disclosed that data.

We have not disclosed that data, um, previously but I believe the majority have reordered.

Okay.

And then just as a quick follow-up, um,

now that you have this new data from, um,

The.

uh, from the trial for

007. Um, how does that your chain? How does that change your view for the potential for some of this and dialysis, dialysis?

Strong support, uh, when we eventually file, our supplemental, bla application and dialysis.

And again, these subgroups are not small. It's you know, if you combine all women with men having these risk factors it's more than half of the dialysis population.

That's very helpful. Thank you very much.

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

Hi, good morning, Laura del. This is Izzy on Verizon. Thanks for taking the question, and congrats on all the progress, this quarter, uh, just to start out, um, on the launch that you the progress with the launch so far out of the units that you've

Seen. Um, purchased I was curious. What is or how many of those have been used versus what? Our initial stocking orders at these hospitals?

Um, it's very hard to answer that question succinctly. What I can tell you and what we've messaged the market before is that initial stocking orders, um, range from from 1 to 3 units, um, there are a couple hospitals who are ordering on an as-needed basis, although that's less common. Um, you know, typically what we're what we're starting to see with usage and repeat usage, is that as as hospitals, you know, use the vessel and then they come down to their part, then they will reorder when they hit their when they fall below. Their

Part level whether that's 1 or 2 or 3 units. Um, so we have been, you know, again we've been getting good feedback from surgeons as far as how happy they are, you know, using the products surgeons tell us that it's that it's easy to handle and that they're, they're pleased with its function in the oh, um, I would also say, although you didn't ask this question that we have. Uh, we have several um uh presentations on, on the function of our vessel that are being presented at uh, at the vase meeting, which is the large annual, vascular surgery meeting uh in New York every year. Uh, those presentations are are going to be coming online next week.

That's helpful Laura and I believe last quarter you called about the fact that the price has come down for us invest. I was curious what, um, benefits you've seen from that. If it's accelerated any of the adoption or if if it's even decreased the time it's taking for these hospitals to get through their vac approvals,

Yes, and yes, yes. Um you know the market is price sensitive. Now that's certainly true. Um uh as we've discussed before in the postcovid era. Um, hospitals are looking much more closely at budgets and so the price sensitivity is something that we found to be important. Um, you know, with with this a lower price point, what we've seen is that hospitals are, um, moving through the VAC process quicker

There are some hospitals and groups of hospitals that did not consider us at our original price point. Um, but with further discussions on price, they have now reinstituted the VAC process. And so that has reopened other doors.

Um and the VAC process tends to be moving a little bit more quickly. So that this is still, this is still a process that takes time. And once the VAC approvals are obtained, then there's a 1 or 2 or 3 month Contracting process that happens with each hospital. Um, so, you know, there is a Time Factor here, but we've definitely seen an acceleration. Um, both of vac vac, um, submissions and also an acceleration to, to time for approval.

That's helpful. Thank you. And if I could squeeze in just 1 more for Dale, um, I believe you guys have called out some cost savings initiatives. That have been put in place for 25 and 26 for about 50 million in total savings. I was curious if you're still feeling comfortable with this level or if we should expect any changes, as we start to think about next year, thanks for taking the questions and congrats again on the progress.

Yeah, thanks, Izzy. And, uh, you know, absolutely, we are seeing those savings. You know, obviously it's part of the kind of the formal.

Gap reporting out of our financial results, we compared to the prior year, but if you just compare our expense levels to last quarter, we're seeing those drops already, um, you know, research and development in the second quarter were, was 22 million. We've dropped that to 17 million so almost 5 million reduction in R&D there. Uh, sg&a costs were were pretty flat maybe hundred thousand dollars down. So our operating expenses quarter over quarter

Announced our second quarter results.

Thank you. Our next question comes from the line of Josh Jennings with TD Cowen, please proceed with your question.

Hi. Good morning, Lauren Deal. Thanks for taking the questions. I was hoping to just, um, you guys have generated some strong supportive evidence for some of this in the vascular trauma indication and...

it sounds like this question is already been answered but how how impactful has that been just in terms of getting back processes started and and then moving through the process

and and just remind us if you would just how real world outcomes are going to be tracked, is there a post approval registry study and uh I think we'll take some time for that to to formulate but when when could we see any results from from uh any registry Real World Registry outcomes.

Yeah, Josh those, those are good questions. Thank you. So, you know, the steady drum beat of Publications that have been coming out and frankly are going to continue. Um, has certainly been helpful in terms of providing um additional Assurance to surgeons uh as we speak to them at hospitals. Um, our initial endpoint for for the VO5 and vo7 studies was the 30th. And so, having these long-term outcomes that that are now out in the public domain that we can share, has been very powerful.

In terms of bringing surgeons on board. Um, so and again, we're going to continue to lean into that. Um,

and your second question, I'm sorry.

Oh, just about the um just real world outcomes and and how those are being tracked and ah yes process there. Yes.

Sure. So there there is a post-approval study that that we've agreed to with the FDA as part of our as part of our FDA approval and Trauma since we're first in class products, um so this will be a follow-up registry study in uh 100 trauma. Patients following 1. At least 100 patients for at least a year, we have not kicked that trial off. In fact, we're we're continuing discussions about the specifics of the trial design with the FDA. Um, you know, the FDA has been a little bit slower in part because of the shutdown and some other changes and so we're still working through that. But we expect to kick off this, uh, post marketing study sometime in the first half of 2026 and, uh, we expect data to, to come out from that, you know, 6 or 12 months after that, it certainly won't be a full data set, but there will be some information forthcoming. But, you know, frankly, I think that that there will be more information forthcoming just from Individual surgeon Publications and reports on their

Experience, whether it's case reports or short series um and some of that we're even going to see at the V next week.

And, um, I wanted to ask about to invest in the, in the axis indication, you know. Congratulations on a 2 results. Presented. Um, and ASN

You know, in terms of the bla process and this interim analysis, I mean, should we be thinking that if the interim analysis for the first 80, patients? And b012 kind of those results in the air that 1 and 2 year results. And and females from V 007 that that that the packet will be robust enough for for the FDA to consider approval.

Um, yes, we believe so. I mean the the the way, the way we would approach this is that the lead um, the the lead study would be the study in women. The prospective head-to-head, randomized study versus fistula in women. Um if if we met our our uh endpoint at the interim analysis, this would be a very strong indication.

Of s of superiority of our vessel uh compared to the gold standard fissura uh in dialysis. So we would then lead with that uh publication and the vo7 public, the vo7 data which includes data from all comers as you know. But but which has an important subgroup analysis and women in high-risk men, we anticipate that would be supporting data. So this would then be 2 Prospect.

Studies, um, basically, you know, of course, pending the results of the VO V12 analysis, of course. But in that situation, we would have two prospective randomized studies supporting the same message in these patient subgroups.

Appreciate. Uh, thanks d.

Thank you.

Our next question.

Let me call there with Doral Capital. Please proceed with your question.

Into being a commercial entity, I'd like to just ask you a little bit about what's involved in transitioning to Salesforce as you start looking towards hemodialysis and, uh,

Essentially the work you're doing now kind of creating the the awareness in the marketplace, how do you transition that into the commercial opportunity for dialysis?

Thank you. Jason, that's a great question. So um, as your team probably knows we've done the initial launch in trauma with a fairly small sales force about 12 agents who are out in the field uh in different territories that that are essentially high value territories with large metropolitan areas and a lot of Trauma Centers.

Um, we are looking at, as as we've messaged the market. We're looking at, at strategically adding a small number of additional sales representatives in other geographies right now. Um, we're in the process of doing that. Um, but again, as, as we've mentioned there there's only about 3,000 vascular surgeons in the United States. Um, and, uh, it's but as we continue our sales efforts during 2025, and then through 2026, we anticipate having touch points with a large fraction of these surgeons. The, the vascular surgeons, who perform trauma operations are the same surgeons, who also perform dialysis access operations. And so the visibility with these with the

This surgeon cohort we think is going to be tremendously supported by, um, by our trauma efforts in 2025 and 2026. That said, you know, if if the results in VO2 are positive, and if we file the supplemental ba in the second half of 2026, we would aim for approval sometime, in early 2027. And by that time, we would probably bring on an additional sales force. This would not be a huge sales force and we haven't given specific numbers. Um, but there might be, I'm making this up, there might be another 10 or 20 reps be because we would be targeting the same surgeons, but we would be targeting additional call points um because uh dialysis access is primarily an outpatient procedure. It's the same surgeons but it's slightly different facilities.

Yeah, that makes a lot of sense. Thank you. Can you talk also a little bit, just because I'm fascinated by it, um, the work you're doing towards the virtual—well, the actual replacement esophagus, trachea, and the urinary conduit? How did those programs proceed, and how aware are you of all the prior data done by companies like Harvard Apparatus almost a decade ago?

Yeah, so, um, the these other indications are indications that human sight has sought intellectual properties on and obtained. Intellectual property, I would say, we do not have active pre-clinical programs advancing those, those indications right now, frankly, we're we're, we're going to up prioritize that um, as our revenues increase and as our cash position improves. But right now we're not doing active studies there. But of course, you know, from my, uh, from my long-standing work, in this field, I'm very aware of the Harvard apparatus outcomes and and some of the problems that have occurred in the, with the esophagus and with Airway replacements.

Uh, very aware of those, those are clinically challenging environments. Um, and you know, some of the, some of the earlier failures of other Technologies, I believe were driven by frankly uh, failure to consider the um, the proper design criteria for the implant. Um, I would hope that, uh, as we continue to develop these products in the future that that we would, uh, we would make better. We would make better conduits, we would, uh, have meet better design criteria, but we'll have to see.

Yeah, thank you. It's really exciting times. I appreciate it.

Thank you. Our

Benchmark Company. Please proceed with your question.

Hi, good morning. Thanks for taking my questions. Um, wanted to follow up on the um the end tap submission, have you um, reconsidered the strategy and is there a plan to uh, to resubmit?

um, was obviously very surprising for us as we messaged to the market, uh, last quarter, um, and in reviewing sort of their thinking, uh, that, that there the the

The CMS took a very reductionist approach to this and said, because we are a conduit that conducts blood. We are not novel because there are other conduits that conduct blood, um, we decided that it was, it was probably not, um, a good use of our resources, to, to go back at that again. Um, in instead, you know, as you know, we have had some price reductions. Um, actually, you know, it's from around the time of the end, tap decision. And the, the, the the reduction in price has helped to drive activity in the market. So we, we don't really see the the, um,

We don't see it as a good use of effort to to reach at this time.

Okay. Bruce and other consideration. Is that out of the vast or trauma patients. Only about 4% are covered by Medicare so that that was another consideration.

Okay, good. Thank you, D. Um, thank you. The, uh, the other question I had was, um, was around the, um, just some anecdotal information about, um, the reorders and the, the, the market marketing efforts. So in the multi-pro approvals that you've gotten, have you seen, um, additional hospitals ordered order the product and

In the hospitals where you are selling right now often times there's a a single surgeon who is your champion who who does the initial implants have you seen? Um, any expansion beyond your initial initial intending Physicians?

We have we have in in a couple of the hospitals, I I don't want to name them specifically, but in a couple trauma hospitals, we have seen usage Beyond, you know, our initial Champion. Um, you know, as it is with any new surgical product, as you as you know, there's typically an an a lead champion who will use and reuse and then as his colleagues uh, see those outcomes they will they will continue to adopt. So so we we have seen that in several hospitals.

As as far as the hospital systems, um, you know, when we, when we get a vac approval for a hospital system, they're still individual. Uh, Contracting that we must do with each individual hospital. Um, so the the while, while having a a blanket, vac approval helps with an important step in that process, where we are undergoing contract, uh, negotiations right now in in multiple hospitals that are covered by some of these, some of these chains that we've gotten approvals in, if that makes sense.

Yes. Um that does that's very helpful. Um, that's it for me. Thank you.

Of Arkay with HC, Wayne Wright, please. Proceed with your question.

Thank you. Good morning, Laura and Dale. Congratulations. Um couple of questions uh from me. Um, the first 1 being um,

you know, how, how, how, how do you, um,

Initiate a conversation and, and, and maintain your conversations on value prop proposal, um, to the um, to, to the, to the folks on the back committees. Um, and what are the things that resonate, uh, with them? Um, especially, you know, when, when you have to still dislodge, um, the atlus vein, grafts, that's question. Number 1 on the second question. Um, a day it looks like um there's some good operational excellence being being done here. So you you reduce your cash burn. Um, is this the new um,

Um uh got I mean cashews expectations from here onwards and also with the 76 million dollars in in the bank now um you know how how how long of a Runway are you are you going to have um and does that include the um, the BLS submission for the dialysis indication?

So I'll I'll take the first uh question um with regard to to the value. Proposition to va's and hospitals.

Relative to plastic graphs but also relative to other types of graphs like cryovain and Zen. Because we decrease those complication costs, we actually came in cheaper even at our initial 2029500 price point.

With the reduction in price point, that economic argument becomes even stronger.

Um, and so when when we lay that out to to vax, um, it is, it is compelling. Uh, what we see though is that some hospitals are, you know, the, the there are, um, because of changes in Medicaid. I will say that there are some hospitals who are despite despite the compelling uh, budget impact model. Uh, occasionally hospitals will still look at just the initial acquisition price and say, even if it's going to save us money in the longer term, I have to think about what I'm spending today. Um, and so, so there is still in in, in some house hospitals. There is still some push back, um, but the majority of cases, um, in the majority of our vacc emissions. Those are now, um, going through successfully, I think, because these arguments around

Decreased cost of amputation. Decreased cost of infection are really are really driving home especially at our new uh, price point.

Thanks for that love.

Yeah, regarding, uh, spend levels. I mean, obviously quarter over quarter order, we've reduced expenses quite a bit? I think, uh, both operating expenses and lots from operations have come down by about 5 million dollars.

Uh, you know, going out, I think we expect sgna to be somewhat constant. I think we'll continue to see some reductions in the R&D area, uh, as will be further disclosed in our 10.

To files probably later today. Um, you know, we we expect that the cash on hand based on how we expect to operate takes us

Beyond 12 months from where we are today.

and in terms of what Milestones, that, that means as part of your later, question, we believe that takes us past

uh,

Having the interim results from our VO2 study in dialysis.

and based upon those are all results taking us past the bla filing in Dallas's and also taking us past the commencement of human testing and in a part by pass graph surgery so it takes us fast and and there'll be a lot else happening in the company also, but it certainly is sufficient to take us past some very key milestones,

Perfect, thank you. Thank you both for taking my questions.

Thank you, ladies and gentlemen.

Before back to Dr. Nicholson for any final comments,

um, thank you very much, we really appreciate. Um, the time that that our investors and our analysts have taken to, uh, catch up with us on, on the call this quarter.

Um we've continued to execute on the goals that we've said we would execute on. Uh We've continued to expand um our our commercial launch and we're continuing to get to get Traction in the clinical Marketplace as surgeons continue to use our vessel in trauma. So uh, we're very excited with our progress and we look forward to catching up with you with you again, next quarter.

Thank you, this conclusive based teleconference. You may disconnect your lines at this time. Thank you for your participation.

Q3 2025 Humacyte Inc Earnings Call & Business Update

Demo

Humacyte

Earnings

Q3 2025 Humacyte Inc Earnings Call & Business Update

HUMA

Wednesday, November 12th, 2025 at 1:00 PM

Transcript

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