Humacyte - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 delivered no revenue, but net loss narrowed sharply to $20.9M from $39.2M in Q3 2024 (-46.7% QoQ) and from $25.1M in Q4 2023 (-16.7% YoY), driven by a favorable non-cash remeasurement of the contingent earnout liability.
• FDA granted full approval of Symvess on December 19, 2024, and Humacyte commenced commercial launch with first shipments in late February 2025; 34 hospitals have initiated the VAC process and 3 have approved purchase, establishing a clear commercialization catalyst.
• Operating discipline: R&D fell to $20.7M from $22.9M in Q3 (-9.6% QoQ), while G&A held relatively flat at $7.4M; management expects R&D to trend down in 2025 as trials wind down and manufacturing costs shift to inventory/COGS.
• Liquidity: cash, cash equivalents and restricted cash were $95.3M at year-end, supplemented by ~$46.6M net proceeds from a March 2025 equity offering, supporting launch and pipeline milestones (NTAP decision targeted for Oct 2025 start if approved).
• Estimates context: S&P Global Wall Street consensus for Q4 2024 EPS and revenue was unavailable; we therefore cannot assess beats/misses versus consensus (values would be retrieved from S&P Global; unavailable)*.

What Went Well and What Went Wrong

What Went Well

• FDA approval and commercial start: “The past year has been a landmark time… highlighted by the FDA’s approval of Symvess… We are thrilled to deliver this transformative innovation” (CEO). First shipments were made just 16 days after commercial inventory became available.
• Early market traction: 34 hospitals initiated VAC reviews and 3 approved purchase; one hospital ordered even before VAC completion, reflecting urgency and surgeon champion support.
• Pipeline progress: V007 Phase 3 dialysis results showed superior function/patency vs AV fistula; V012 enrolled 76 female patients with interim analysis at 80 and plan to file supplemental BLA in H2 2026.

What Went Wrong

• No revenue in Q4 and full-year: Humacyte remained pre-commercial in Q4 2024; revenue began only after launch in late Feb 2025 (management: “we have… started booking commercial revenues… within the last several weeks”).
• Contingent earnout liability volatility: FY other net expense increased materially to $34.3M, reflecting non-cash remeasurements; while Q4 benefited from $7.1M other net income, the liability contributes to earnings volatility.
• External scrutiny: Management addressed a “controversial article” (NYT) and noted plans to make surgeons’ rebuttal public, underscoring headline risk amid early commercialization.

Transcript

Speaker 5

Good morning, ladies and gentlemen. Welcome to the Humacyte fourth quarter results 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. Just a reminder, this conference call is being recorded. I'll now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead, sir.

Speaker 0

Thank you, Operator. Before we proceed with today's call, I would like to remind everyone that certain statements made during the call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historic experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call are contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise 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-K, 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 major events for the fourth quarter in recent weeks, and Dale will review the company's financial results for the year ended December 31, 2024. Following their prepared remarks, we will open the call to questions from covering analysts. With that, I will now turn the call over to Dr. Niklason. Laura?

Speaker 1

Thank you, Tom. Good morning, everyone, and thanks for joining us for our fourth quarter and full year 2024 financial results and business update call. 2024 has been a landmark year for Humacyte, highlighted by the FDA's full approval of SYMVESS for the treatment of extremity vascular trauma. SYMVESS is a biological product that went through more than 20 years of research and development, and we believe that this first-in-class approval marks an important new era in vascular surgery. We're thrilled to deliver this transformative innovation to surgeons and to patients in need of a new option to save limbs and lives. Results from our preclinical studies and our clinical studies suggest that there are patients walking around on their own legs today who would not be doing so if SYMVESS were not available.

Our commercial launch of Cimvest is proceeding at full speed, and we're excited with the response to date from hospitals and healthcare providers. So far, the market has responded well, with 34 hospitals already having initiated their value analysis committee, or VAC, approval process. These hospitals are a mix of leading trauma centers that were participants in Humacyte's clinical studies and are combined with institutions that have been newly introduced to Cimvest. VACs have been engaged in individual institutions and in centers from much larger networks, meaning that individual VAC approvals could apply to multiple hospitals. Although the VAC process often takes three to six months to complete, three hospitals have already approved the purchase of Cimvest. We're also excited that just 16 days after having the commercial inventory availability, we made our first shipments of Cimvest.

These first commercial shipments were made last week to several level one trauma centers. The potential health benefits of Cimvest are also supported by our budget impact model that was just published in the Journal of Medical Economics. This paper concludes that the avoidance of vascular infections and amputations drives the cost reductions that are associated with the use of Cimvest in traumatic injury. Based on the model, the per patient cost of treating patients with Cimvest is estimated to be less than the cost of treating trauma patients with either synthetic grafts, cryopreserved allografts, or xenografts. On a related note, in October 2024, we submitted a new technology add-on payment, or NTAP, application for Cimvest to the Centers for Medicare and Medicaid Services, or CMS, and we presented the Cimvest data at a public town hall with CMS in December of 2024.

There are really two important criteria for getting an NTAP. First is that the technology is new, for which we clearly qualify. The second is that the technology provides an important clinical benefit above and beyond what's currently available. We believe that we check both of these boxes and that we have a strong case for getting NTAP reimbursement. If successful, NTAP reimbursement will begin on October 1, 2025, offering hospitals additional payment to cover the cost associated with purchasing Cimvest. In January of 2025, Humacyte was issued a new U.S. patent covering key aspects of the manufacturing system for Cimvest and other bioengineered human tissues. The newly issued patent provides protection into 2040. The new patent complements a family of existing patents and patent applications encompassing the design and the composition of matter of Cimvest and our other product candidates, as well as their methods of manufacture.

Before moving into development elsewhere in our pipeline, I'd like to take a moment to acknowledge our exceptional commercial team, which is led by BJ Scheessele, our Chief Commercial Officer, and which has been crucial in the early success of this launch. To drive adoption, we recruited and trained a highly experienced sales team for the commercial launch of Cimvest. All sales team members are multi-year Presidents Club winners, representing the top 10% of achievers in their prior sales organizations. Team members also have experience in vascular and trauma surgery, prior experience selling regenerative therapies, and are expert at selling clinically differentiated and disruptive technologies and premium-priced portfolios. This is a highly experienced and a highly motivated group that is deeply committed to ensuring that Cimvest reaches hospitals and vascular surgeons, both civilian and military.

We have complete confidence in their ability to execute our commercial strategy and drive adoption, and their expertise has been invaluable in these early stages of commercial launch. This team will continue to work closely with healthcare providers to make Cimvest available to patients in need nationwide. Going beyond the trauma indication, we're also very excited about the ATAV program right behind it, which is in dialysis access. As you'll recall, in last October, our VO7 phase three clinical trial of the ATAV in AV access for patients with end-stage renal disease was presented at the American Society of Nephrology Kidney Week. The phase three study met its co-primary endpoints, and the ATAV was observed to have superior function and patency at 6 and 12 months as compared to AV fistula, which is the current standard of care for hemodialysis patients.

The ATAV was also observed to have superior function in female, obese, and diabetic patients, each of which is a high-risk subgroup having historically poor outcomes with AV fistula. In addition, we've already enrolled 76 patients in our VO12 phase three clinical study, which is a trial designed to assess the usability of the ATAV for dialysis as compared to fistulas in female patients. This is the first study of its kind that's been done in females. An interim analysis is planned when the first 80 female patients reach one year of follow-up, and we're very close to this 80-patient interim enrollment target. Subject to these interim results, our plan is to submit a supplemental BLA in the second half of 2026 that includes data from the VO12 study and the VO7 study in order to add AV access for hemodialysis as an indication for the ATAV.

Finally, I'll briefly discuss one of our earlier stage programs that we're also very excited about: our small diameter ATAV for the treatment of coronary artery bypass grafting, or CABG. In January, we announced our plans to file an IND application with the FDA to allow a first-in-human clinical testing of our small diameter 3.5 millimeter ATAV in coronary artery bypass. Our plans are based on the outcome of a recent meeting held with the FDA, including agreements that were reached with the agency on the filing of an IND. The planned IND filing is supported in part by the results of a six-month preclinical study of the small diameter ATAV in primates, which was presented in November 2024 at the American Heart Association.

In the preclinical CABG model, our small diameter ATAV was observed to sustain patency, it recellularized with the host animal's cells, and it also remodeled so as to match the size of the animal's native coronary arteries. We are very pleased to be moving closer to human clinical studies of the ATAV in CABG, and we believe our IND filing and initiation of first-in-human study after the FDA clearance of the IND will be another major milestone for Humacyte. 2025 will be an exciting year for all of us, and we look forward to sharing our progress with all of you as the year unfolds. With that, I'll now turn it over to Dale for a review of our financial results and other business developments.

Speaker 5

Thank you, Laura, and good morning, everyone. There was no revenue for the fourth quarter of 2024 or 2023, and there was no revenue for the years ended December 31, 2024, and 2023. Obviously, with the commencement of launch in the last several weeks, we have obviously started booking commercial revenues for the first time in the company's history within the last several weeks. Research and development expenses were $20.7 million for the fourth quarter of 2024, less than the $22.9 million incurred for the third quarter of 2024. The decrease in expenses compared to the prior quarter was primarily attributed to a reduction in materials expenses due to the timing of manufacturing runs. Research and development expenses for the fourth quarter of 2024 were $20.7 million, a slight increase compared to the $20.2 million incurred in the fourth quarter of 2023.

Research and development expenses were $88.6 million for the year ended December 31, 2024, compared to $76.6 million for the year ended December 31, 2023. The increase in expenses during the full year ended December 31, 2024, resulted primarily from increased material expenses associated with manufacturing runs and personnel expenses. These increases supported expanded research and development initiatives and clinical trials, including the expansion of manufacturing activities in support of the FDA review of the BLA in extremity vascular trauma. General and administrative expenses were $7.4 million for the fourth quarter of 2024, consistent with the $7.3 million incurred for the third quarter of 2024. General and administrative expenses were $7.4 million for the fourth quarter of 2024, compared to $6 million for the fourth quarter of 2023, and were $25.8 million for the year ended December 31, 2024, compared to $23.5 million for the year ended December 31, 2023.

The increases during 2024 resulted primarily from preparation for the planned commercial launch of Cimvest, including increases in personnel expenses and professional fees. These increases were partially offset by a decrease in non-cash stock compensation expense during 2024. Other net income or expense was net income of $7.1 million for the fourth quarter of 2024, compared to net expense of $9 million for the third quarter of 2024. The increase in other net income compared to the prior quarter was due to the non-cash remeasurement of the contingent earn-out liability associated with the company's 2021 merger with Alpha Healthcare Acquisition Corp.

Other net income for the fourth quarter of 2024 of $7.1 million compared to other net income of $1.1 million for the fourth quarter of 2023, and other net expense of $34.3 million for the year ended December 31, 2024, compared to net expense of $10.7 million for the year ended December 31, 2023. The increase in other net income during the fourth quarter of 2024 compared to 2023, and the increase in other net expense during the year ended December 31, 2024, compared to 2023, resulted primarily from non-cash remeasurement of the contingent earn-out liability mentioned earlier. Net loss was $20.9 million for the fourth quarter of 2024, compared to $39.2 million for the third quarter of 2024, and to $25.1 million for the fourth quarter of 2023.

The decrease in net loss for the fourth quarter of 2024 compared to the prior quarter and to the prior year resulted from the non-cash remeasurement of the contingent earn-out liability described earlier. Net loss was $148.7 million for the year ended December 31, 2024, compared to $110.8 million for the year ended December 31, 2023. The year-over-year increase in net loss in 2024 compared to 2023 resulted again from the non-cash remeasurement of the contingent earn-out liability. We had cash, cash equivalents, and restricted cash of $95.3 million as of December 31, 2024. Subsequent to December 31, 2024, this week, we completed an underwritten public offering of common stock that provided approximately $46.6 million in additional net proceeds, with the potential for another $7.1 million in net proceeds subject to an underwriter option.

Total net cash provided was $14.5 million for the year ended December 31, 2024, compared to total cash used of $69.0 million for the year ended December 31, 2023. The increase in net cash provided resulted primarily from the receipt of proceeds from public offerings and a direct registered offering of stock completed throughout 2024, and proceeds from an additional draw under our funding agreement with Oberlin Capital Management. With that, I will turn the call back to Laura.

Speaker 1

Thank you, Dale. The approval and launch of Cimvest is a powerful example of our commitment to delivering truly transformative regenerative medicine solutions that improve patient outcomes. With our strong commercial execution and our promising pipeline programs and our dedicated team, we are confident that Humacyte will have positive impacts in the care of vascular patients in the years to come. Thank you all for joining today, and Operator, we're ready to take questions.

Speaker 2

Thank you. At this time, we'll now be conducting a question-and-answer session. If you'd like to ask a question today, you may press Star 1 from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. If you'd like to withdraw your question from the queue, you may press Star 2. For participants that are using speaker equipment, it may be necessary to pick up the handset before pressing the Star keys. We'll pause a moment to assemble the queue, and once again, it is Star 1 to ask questions. Thank you. Thank you. Our first question today is coming from the line of Joshua Thomas Jennings with TD Cowen. Please proceed with your questions.

Hi, good morning. Thanks, Laura and Dale, and congratulations on the first commercial shipments of Cimvest. I was hoping to just ask a couple of questions on the U.S. launch. You've had three hospitals that have approved Cimvest for use in. I wanted to just better understand the characteristics of those three hospitals and what drove that really fast approval timeline. Do you expect more of the same as you move through some of these other 31 VAC processes that are in play?

Speaker 1

I think what speeds the VAC process—thanks for the question, Josh—what speeds the VAC process is either a VAC that's committed to improving patient care and getting the best products on their shelf, and/or having one or two surgeon champions at the institution who very much want to bring it into the hospital. This is a small N, but I can tell you that our VAC approvals are at—let me think about this—at two hospitals that—no, actually, one hospital that participated in our clinical trials, in our trauma trial. One hospital that did not participate in our trials, but where there was a compassionate use case, where the vascular surgeon felt strongly that his patient retained her limb because of our vessel. That was actually our first VAC approval.

There was another VAC approval in an institution where actually Cimvest has not been used before, but where one of the senior vascular surgeons had seen the data and found it very compelling and moved quickly to get it on the shelf. It is different scenarios, but in general, what we are finding is that our investigators and also our compassionate use investigators, of which there are many—we have done 30 compassionate use cases all over the country—and also just surgeons who are paying attention to the literature, I think there is a lot of enthusiasm across those three groups. I am hoping that will continue to drive rapid VAC approvals.

Great. I don't know if you're willing to share.

Speaker 5

Josh.

Sorry, Dale.

Sorry, Josh. I was also going to point out that one of the first two hospitals ordering still has the VAC process underway, but elected to order anyway to be able to treat cases while the VAC review was ongoing.

Excellent. I do not know if you're willing to share maybe some high-level kind of colors of the goals for the launch this year, 2025, in terms of just how many trauma centers do you expect to have your All-Star sales team kind of engage and get a VAC process initiated or even achieve VAC approval? I know it's a concentrated market. You guys were already off to a pretty strong start with 34.

Speaker 1

I'm hesitant to give guidance on this topic because as soon as I say it, I know that it will be wrong, Josh. I will give you estimates with the statement that this is not intended to be guidance. What I can tell you is that over the last several weeks, we've added two or three or four VAC processes to our initiation pile every week. If that rate were to continue, then by doing the math, many or the majority of level one trauma centers, we would have had at least initiated the VAC process by the end of the year. As far as number of conversions and how long those will take, it's very difficult to say because we only have three acceptances so far, although I think we're hearing about a couple more next week. So far, the response, though, has been pretty good.

I would expect—I think this is a conservative expectation—that the majority of VACs would agree to bring the product onto the shelves. Again, as we've messaged the market, this is a process that takes time. I think that the consensus among the analysts is that we will sell anywhere between, I think, $7 million and $13 million worth of product this year. That's probably not too far off. I would also say that most of those sales are going to occur in the second half of the year just because of the realities of the time it takes to get through VAC meetings and approvals and then ordering. We are clearly having a trickling of sales now. It'll be slightly more than a trickle in the second quarter, but the majority of it will be in the second half.

I do think that I'll just take this opportunity, though, to speak more broadly to some projections that are in the market now from some analysts about our 2026 sales. I think that there was some earlier modeling that incorporated an expectation that we would be on the market with AV grafting in dialysis sometime in 2026. We now know that that's no longer true because our plan now is to file our supplemental BLA in dialysis in the second half of 2026, which would mean sales wouldn't hit until 2027. I'd be happy to discuss with analysts and kind of recalibrate where we think these approvals are going to march out, and then in that way, recalibrate anticipated revenues in the out years.

Understood. Thanks for that. Lastly, there was a controversial article published earlier this week. Humacyte issued a response yesterday. I was hoping maybe you could share, Laura, just some of the surgeon feedback you received this week either from the investigators or from some of these surgeon champions that are trying to get Cimvest approved at their hospitals through the VAC process. Thanks for taking all the questions.

Yeah, Josh, thanks for that question. I will say that several of our surgeons who participated in our trauma trials were incensed. I think that's probably the right word at the article, which they felt was biased and inaccurate. Several very prominent surgeons, who I'm not going to name here, drafted a rebuttal letter to The New York Times that was sent the next day on Tuesday. The New York Times did not publish this. We've waited several days and have prompted them, but my anticipation is that they will not publish the rebuttal from the surgeons who have actually used the product in trauma patients. Our plan is to issue this letter into the public domain in some form that the surgeons are comfortable with.

Again, this is a letter coming from the surgeons at major medical centers that treat a lot of trauma, and this is really their call. I would say incensed is a really good word to characterize their responses.

Great. Thanks again.

Speaker 2

Thank you. The next questions are from the line of Ryan Zimmerman with BTIG. Please proceed with your questions.

Speaker 5

Good morning, Laura and Dale. Thanks for taking our questions, and congrats on this early progress commercially. It's exciting to see. I want to follow up on some of Josh's questions here, but I want to actually focus on the VO12 trial first. You have an interim analysis potentially coming pretty quickly just based on the enrollment pace. Remind us what we're looking for there, what you'd consider success on that interim analysis, and then just the timing for the combined BLA supplement and VO12 and VO07. Thank you.

Speaker 1

Yeah, Ryan, thanks for that question. The VO12 trial we started about a year, year and a half ago because even at that time, it had become clear to us that our vessel might offer real benefits for women in particular. The number of patients that were women that were enrolled in our VO7 trial was actually pretty small. As you and I have discussed before, women have smaller veins than men do. When you sew an artery and a vein together to make a fistula, that vein has to dilate up to 6 or 7 centimeters. If you're a woman with small veins of 2 millimeters, that's pretty hard. It's a lot harder than if you're a man with a vein of 4 or 5 millimeters. Historically, surgeons have always known that women have a hard time with fistula maturation.

Still, many fistulas are put into women because it's the standard of care. They believe that if the fistula does mature, that the patient will do well. The fact is many don't, and these women are stuck on catheters for long periods of time, and that's dangerous and costly. We initiated this trial, again, more than a year ago, and the endpoint is actually catheter-free days during the first year. The goal is to establish dialysis access as quickly as possible and to maintain it so that these women can get catheters out of their necks and can avoid septic episodes and hospitalizations. That's our endpoint. It's a clinically very meaningful endpoint. It's the endpoint that nephrologists are thinking about most closely right now.

It also pertains to how reimbursement works in dialysis access centers right now because dialysis centers are graded by CMS by how many catheter patients they have. The fewer catheter patients, the better the reimbursement for dialysis because CMS understands that getting catheters out of patients is really important. We are going to, again, we're four patients away from our 80-patient enrollment for the interim analysis. Of course, we're going to continue enrolling. We're not going to stop enrolling, but we are going to make a cut at 80. One year after that, we'll get the top-line data. We expect those data to be positive based on data in women that we've already seen in our other trials. We expect this to be positive. If it is, then it would support a supplemental BLA along with VO7.

Speaker 5

Right. Okay. Very helpful. On the article, and again, not to harp on it, I thought the response last night was important. One of the things I was curious if you could talk about is just your supplement for the BLA with Cimvest. Is it the same review team that looked at it for vascular trauma, their familiarity with it, their comfort with it? It would seem to suggest that they're very aware of kind of the first trial as you pursue additional indications.

Speaker 1

I think there is some overlap with the clinical review teams. I am sure that they're not identical. For example, there are several nephrologists on the clinical review team right now at Seaber, and I would expect that those clinical nephrologists would take a larger role in review of our supplement and dialysis than they did in the review of our trauma application. I don't know this, but I'm assuming that that will be the case. Many of these folks were present on many of our meetings and obviously were part of the deliberations with Cimvest. I think it's important with respect to the article and the dissent by Dr. Lee, who is not in the Center for Biologics. He's retired now, but he was in the Center for Devices, and he was just a consultant.

It's important to note that during the four and a half months that his comments were being weighed and considered and evaluated and discussed. Where Seaber came out at the end in December was that the label and the indication and the warnings were identical verbatim to what we had negotiated with them back in August before our PDUFA date. Not one word was changed in our label. There was a four and a half month delay, but it did not change the final conclusions of the review team at all.

Speaker 5

Yeah. It's an important point, Laura. I appreciate you calling that out. If I could sneak one more in for Dale. It cost stepped down just a hair on the R&D line, Dale, this quarter. Any comments or thoughts around expense guidance for 2025? Maybe not even guidance, but just kind of with the clinical trials that are ongoing, kind of how to think about maybe some of your R&D costs in 2025?

Speaker 2

Yeah. I think it's a fair point. Ryan, as you point out, we haven't given guidance, but we've, I think, indicated directionally where R&D can and should go during the year. In general, there'll be somewhat of a ramp down in R&D expenses really driven by two items. One is we have a pretty significant wind down of trauma clinical trial expenses. There's some long-term follow-up, but those trials are on their tail end and the costs are reduced compared to prior years. VO7 will be winding down also. That leaves VO12 as kind of the principal still enrolling trial that drives the majority of clinical costs. Kind of wind down the trials brings down the R&D costs. The other factor that brings down the R&D costs is that historically, through the end of 2024, anything related to manufacturing flowed through into R&D.

As you know, our manufacturing system, it's biologic manufacturing. It's living organism. It's not just equipment and facilities, but it's people. To have a manufacturing system, it has to be out there producing. All those costs historically have flowed into R&D. Where as sales ramp up, those costs that previously were expenses R&D will start flowing into inventory and cost of sales that will further reduce the R&D spend.

Speaker 5

Okay. Appreciate it, Dale. Thanks for taking the questions.

Speaker 2

Thank you. The next questions are from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your questions.

Hi, and good morning. This is Ayaan on Kristen's line. Our question is on the PADD program. Any thoughts on the timeline for the phase three trial? You previously mentioned needing to improve your cash position to proceed with this trial. I guess we're wondering how much investment is required here to expand the ATAV label to the PADD indication. Thank you for taking our questions.

Speaker 1

Thank you. Thank you for that question. I'm going to be wishy-washy on this because this is still something that we're trying to sort out. Based on our phase two studies in 80 or 90 patients, we believe strongly that there is a terrific market for our vessel in PAD, particularly in patients with critical limb ischemia who have no vein and who need revascularization below the knee. There are tens of thousands of these patients every year in the U.S., many of whom go on to amputation. I believe that real clinical benefits could be provided by our vessel. That said, we are continuing to design the phase three trial. We do not plan an enormous trial. Our goal is to do a small trial with a very clearly defined endpoint. That said, I think we do have to evaluate our cash position right now.

As is in the public domain, we did do a recent raise, which was terrific. We are going to sit back and look at our priorities and timing. We are fully committed to pursuing the PAD program. We think it is vitally important for patients and for the company. Surgeons have been clamoring for it for years. We will continue to evaluate our cash position and our longer-term spend and decide on timing at that time.

Thank you for that, Paula.

Speaker 2

Thank you. Our next question comes from the line of Vernon Bernardino with H.C. Wainwright. Please proceed with your questions.

Speaker 5

Hi, Laura and Dale. Thanks for taking my questions. Congratulations again on the approval and the launch. Twenty years is a long time, and that's great perseverance. Regarding the VAC process, visiting this, you mentioned that the hospitals in the process are a mix of leading trauma centers that were participants in the clinical trials and then also individual institutions. Could you describe for us how those, I guess, different types of institutions are detailed by the salesforce? What kind of education process they may have, especially institutions that have been newly introduced to Cimvest?

Speaker 1

Right. Yeah. Vernon, that's a great question. We don't have a huge salesforce. It's 10 sales executives plus a few managers and instructors who also build out the team. One of the few good things about the FDA delay last fall was that we brought on our sales team on August 12 because we fully believe we were getting approval on August 9. We hired our people August 12. They came in. They had a long time to get educated on the technology, on how the vessel is made, how it works, how it functions in the patient, the biological responses, the durability. They became very, very steeped in the science and the surgery and the medicine of our product before they had to go out and approach surgeons about it.

They also had a number, more than 1,500 touchpoints during the fall with both surgeons in their territories at major medical centers, but also hospital personnel to sort of set the stage for when Cimvest was eventually approved in December. As far as the education, I think that the education, obviously, it's a combination of the salesforce, which educates by law with respect to the label. Our sales executives can teach only to the label. In addition, we have medical affairs specialists, many of whom are MDs and PhDs, all of whom are MDs and/or PhDs. They can also accompany our sales executives and teach surgeons who are unfamiliar with the product on the underlying biology, but also on our published clinical trial results. For the uninitiated surgeon, I think we have sort of a one-two punch.

We have a two-prong team to educate the surgeon on the technology and the label and also the published clinical results. The last thing I'll add is that as we go through these VAC processes, especially since our budget impact model was just recently published a couple of weeks ago in the Journal of Medical Economics, we now have excellent tools to educate surgeons and VAC committees on the financial impacts for the hospital of bringing Cimvest into the mix for their trauma patients. We also take active roles in educating surgeons and VAC committee members on what the model means and what it can mean for hospitals in terms of cost savings. It is a real education. I mean, everything about Humacyte has been an education.

The one area I'll finish, the one area that actually doesn't need a lot of education is how to handle the vessel. The biggest part of educating on Cimvest is educating the surgeon on how to get it out of the bag because most surgeons, once they put a couple of stitches in it, they feel very comfortable. There is not a huge training process for the implantation.

Speaker 5

Thanks for that. It's a testament, I think, to your faith and your sales team. If I were on the team back in August, I might have started to worry as the approval took longer and longer. A second question I had is with the supplemental BLA plan to submit for ATAV or Dale second half 2026, if the supplemental BLA, would the approval take less time than it would have for the FDA's review for ATAV and vascular trauma?

Speaker 1

I certainly hope so. I mean, the time from our submission to approval was more than 12 months. It exceeded even a standard approval timeline. I would certainly hope that it would be shorter. The standard review time for a supplemental BLA, I believe, is nine months. We will apply for an accelerated review, a priority review. We do not know if we will get that. Even if we do get it, we do not know if those timelines will be followed. I long ago gave up predicting how long it is going to take the FDA to do something. I do know that they are very thorough and they take their own timelines. I will not speculate further.

Speaker 5

Yeah. I just thought I'd ask. Last question I have, and I apologize for so many follow-ups. Regarding the small diameter ATAV for CABG, and I apologize for not having insight into this, will the manufacturer of that size ATAV be just about the same cost as manufacturer of the size used for vascular trauma?

Speaker 1

That's a very good question. In general, there's a couple of aspects to the answer. The first answer is that the large equipment that we use, the Luna 200s that we've built and installed, can all be converted over to CABG grafts if we wanted to. We would never do that. My point is that it's the same equipment. We don't have to build new equipment. In order to make the smaller caliber and shorter grafts, we need smaller caliber and shorter plastic bags that are easy to make. Then we install them in these machines. In general, the cost of it doesn't perfectly scale, but there's an approximate scale of the cost of production with the mass of the tissue that's made.

Yes, to your point, we believe that the cost to us of producing a 3-millimeter vessel that's only 20 centimeters long will be less than the cost of producing a 6-millimeter vessel that's 40 centimeters long. I can't give you a number as far as how much less it will cost us. I just haven't done that math. It will be less costly to produce.

Speaker 5

Appreciate the insight. Thanks for taking my questions. Congratulations again on the Cimvest launch.

Speaker 2

Thank you. The next question is from the line of Bruce Jackson with The Benchmark Company. Please proceed with your questions.

Speaker 3

Hi, good morning and congratulations on all of the progress. Just one question for me on the pipeline. Could you give us a quick update on the biovascular pancreas project?

Speaker 1

Yes. I have to be careful about what's in the public domain and what's not. We are continuing primate work in the biovascular pancreas. We have shown most recently that islets survive not just for weeks, but for months. They continue to produce insulin that's detected in the bloodstream. We have detected this insulin in the bloodstream even in diabetic primates. We have one diabetic primate that's being treated with our BVP right now. We have seen some therapeutic impact of our implant. We're at a phase now where we're sort of tweaking the composition. What I believe the data that we've shared so far has proven is that our BVP can keep islets alive for three or six months or longer. If they stay alive for three or six months or longer, they're going to stay alive forever.

I mean, if they live for three months, they're not going to die of hypoxia at month four. Long-term engraftment, I believe we have shown. We've also shown long-term insulin production. These were the two key sort of technological hurdles that we had to prove to ourselves. I think that we've proven those. We are now tweaking the design and the dosing to ensure that we can get the maximal therapeutic effect. I'm encouraged by the fundamentals of what we're seeing in the primate studies.

Speaker 5

Okay. Great. Thank you very much. That's it for me.

Speaker 2

Thank you. At this time, we've reached the end of our question-and-answer session. That will also conclude today's teleconference. We thank you for your participation. You may now disconnect your lines at this time and have a wonderful day.