Humacyte, Inc. (NASDAQ:HUMA) Q3 2024 Earnings Call Transcript

Humacyte, Inc. (NASDAQ:HUMA) Q3 2024 Earnings Call Transcript November 9, 2024

Operator: Good morning, ladies and gentlemen, and welcome to the Humacyte Third Quarter 2024 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 will now turn the call over to Lauren Marek with LifeSci Advisors. Please go ahead.

Lauren Marek: 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 the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements except as required by law.

Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after filing may be accessed from the Investors 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 during the quarter in recent weeks, and Dale will review the company’s financial results for the quarter ended September 30, 2024. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Dr. Niklason.

Laura Niklason: Thank you, Lauren. Good morning, everyone, and thank you for joining us for our third quarter, 2024, financial results and business update call. This has been a very productive time for Humacyte. While the FDA review of our ATEV BLA in vascular trauma is still ongoing, the entire Humacyte team continues to engage in commercial preparation to support our planned U.S. market launch, if approved. Importantly, we submitted our new technology add-on payment, or NTAP, application to the Centers for Medicare and Medicaid Services in early October. In addition, positive top-line results and subgroup analyses from our V007 Phase 3 clinical trial of the ATEV in hemodialysis were recently presented at Kidney Week, and this presentation was followed by a webinar of key opinion leaders in dialysis access who discussed the implications of the study.

Regarding our pipeline, the U.S. Patent Office allowed a patent covering the design and the composition of the biovascular pancreas, or BVP, product candidate for treating Type 1 diabetes. And we’re planning to present results of our coronary artery bypass preclinical program at the American Heart meeting later this month. And finally, we completed a registered direct offering of Humacyte stock of approximately $30 million. During today’s call, I’ll review each of these developments in more detail before turning the call over to Dale for a review of our financial results. Then we’ll be happy to open the call up to your questions. I’ll begin with our program in vascular trauma. As you’ll recall from last quarter, we announced that the FDA will require additional time to complete its review of the BLA that we submitted in the vascular trauma indication.

As a reminder, the ATEV trauma program BLA was submitted to the FDA in December of 2023 and was granted priority review status in February 2024, and it was assigned an original PDUFA date of August 10, 2024. The day before the PDUFA date, the Center for Biologics reached out to Humacyte to inform us that they needed more time with the BLA file in order to complete their review. Our BLA remains under review, and the FDA has not yet provided a timeline for completion of their review. During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and our clinical trial sites. They’ve also actively engaged with us in multiple discussions regarding our BLA filing, including agreement on post-marketing commitments as well as labeling discussions.

We continue to maintain confidence in the approvability of the ATEV in vascular trauma based upon our interactions with the agency to date. Our entire commercialization team is continuing their work to position Humacyte for a successful U.S. launch of the ATEV in vascular trauma upon approval by the FDA. Surgical sales executives who were brought on during August have been completing training on the science and the medical impact of our ATEV in trauma patients. The sales representatives have also been identifying key accounts and contacts within their respective regions, which we believe will accelerate market adoption once the ATEV receives FDA approval. To support reimbursement of the ATEV after FDA approval, on October 7th, Humacyte submitted an application for a new technology add-on payment, or NTAP, to the Centers for Medicare and Medicaid Services, or CMS.

The window for filing the NTAP applications occurs only once annually, with decisions being made the following year. Our application is for the fiscal year 2026 NTAP cycle, which would make the NTAP payment effective starting October 1st, 2025. Receiving the NTAP reimbursement can allow hospitals to receive up to approximately 65% of the sales price of a biologic product. Requirements for receiving NTAP reimbursement are several, including technological novelty, as well as clear evidence of clinical improvement for patients. Humacyte believes that the ATEV meets these qualifications, and we look forward to receiving review of our NTAP proposal in the coming months from CMS. As we await our decision from the FDA, we continue to generate additional data supporting ATEV’s use in vascular traumatic injuries.

Positive long-term results from the humanitarian program in Ukraine were featured in a presentation at the Military Health System Research Symposium in August. This symposium is the U.S. Department of Defense’s foremost academic clinical meeting. Long-term follow-up of vascular trauma patients whose injuries were treated with the ATEV showed high rates of patency, or blood flow, of 87%. Remarkably, there were no cases of ATEV infections or amputations of affected limbs or deaths of patients that were related to the ATEV. This is despite the severe nature of the injuries, including those sustained from mind blasts, shrapnel, and high-velocity ballistics. We’re very pleased that these long-term results are consistent with the 30-day results initially observed in the Ukraine population, and we continue to be grateful to our Ukrainian colleagues and all of those involved in the humanitarian program.

In addition, Humacyte anticipates the publication of our civilian and military clinical trial outcomes in vascular trauma later this month in a high-impact medical journal. Stay tuned. In September, we held a virtual Key Opinion Leader meeting where surgeons discussed the unmet clinical needs in treating extremity vascular trauma. This event highlighted, through individual patient case studies, the potential civilian applications and military usage of our ATEV as a treatment for vascular injuries. A replay of this event can be found on our website. Turning now to our program in dialysis access, positive results from our V007 Phase 3 trial of the ATEV in arteriovenous access were featured in a presentation at the American Society of Nephrology’s Kidney Week meeting 2024, which is the premier nephrology meeting in the world.

As we announced in July of 2024, this trial met its primary endpoint by demonstrating superior function and patency of the ATEV at 6 and 12 months as compared to autogenous fistula, which is the current gold standard of care for hemodialysis patients. The presentation at Kidney Week further highlighted the ATEV’s superior function and patency, particularly in women, obese patients, and diabetic patients. These are high-need subgroups in the dialysis population who have historically poor outcomes with arteriovenous fistula procedures. Females, obese, and diabetic patients who received the ATEV, all had significantly higher 6 and 12 month patency rates than those patients receiving arteriovenous fistula. In addition, these patients all achieved a significantly longer duration of dialysis using the ATEV over the first 12 months as compared to fistula.

Humacyte is currently preparing these results for publication in the peer-reviewed literature. These results, as well as several case studies, were also recently discussed in a virtual KOL event featuring Dr. Charles Keith Ozaki, Dr. Mohamed Hussain, and Dr. Timmy Lee. A replay of that event can also be found on Humacyte’s website. We’re highly encouraged by these results in dialysis access and believe that they demonstrate the potential of the ATEV to improve arteriovenous access in patients who are underserved by the current standard of care, thereby expanding the potential clinical utility of our engineered blood vessels. We’re also making progress in our program in Advanced Peripheral Artery Disease, or PAD. PAD is a cardiovascular disease of blood vessels, most commonly affecting the arteries in the legs.

As many as 40% of patients who require a bypass to those arteries in the lower leg do not have autologous vein available for revascularization, and autologous vein is the standard of care for such patients. In July, the FDA granted RMAT designation, or Regenerative Medicine Advanced Therapy designation, to the ATEV in the PAD indication. Following vascular trauma and AV access in dialysis, this RMAT designation in PAD marks the third indication for which the ATEV has received this important designation. RMAT designation is designed to provide pathways for expedited development and review of regenerative medicine therapies that treat serious or life-threatening diseases or conditions. The designation also allows for close interactions with the FDA and potentially an expedited or a priority review of a BLA, which has proved to be extremely helpful in our communications with the FDA during our BLA review in vascular trauma.

In the same time, we’ve also received IND clearance for the ATEV in PAD. Turning now to our biovascular pancreas, or the BVP, in September, the U.S. Patent Office allowed a patent covering the design and the composition of the BVP, which is our product candidate for the treatment of type 1 diabetes. The BVP is designed to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes. Positive results from ongoing non-human primate studies support the potential of the BVP to improve the care of patients with type 1 diabetes. These preclinical studies continue to show islet survival and ongoing insulin production months after BVP implantation, with C-peptide, which is a precursor of insulin, C-peptide being detectable in primate circulation.

Currently, Humacyte is working on islet dosing in the BVP to optimize for purposes of these animal models to most efficiently reverse clinical diabetic states in the non-human primates. And finally, in October, we completed a registered direct offering, resulting in approximately $30 million of gross proceeds to Humacyte. And with that, I’ll now turn it over to Dale for a review of our financial results and other business developments.

Dale Sander: Thank you, Laura. Regarding our financial results, there was no revenue for the third quarter of either 2024 or 2023, and no revenue for the nine months ended September 30, 2024, and 2023. Research and development expenses were $22.9 million for the third quarter of 2024, a slight decrease compared to the $23.8 million for the second quarter of 2024. The decrease in expenses compared to the prior quarter were due to a reduction in clinical trial costs. Research and development expenses for the third quarter of 2024 were $22.9 million compared to $18.6 million for the third quarter of 2023, and were $67.9 million for the nine months ended September 30, 2024, compared to $56.4 million for the nine months ended September 30, 2023.

The year-over-year increases resulted primarily from increased materials and personnel expenses to support expanded research and development activities and our clinical trials, including the expansion of manufacturing activities and support of the FDA review of the BLA in vascular trauma. General and administrative expenses were $7.3 million for the third quarter of 2024, compared to $5.7 million for the second quarter of 2024. The increase in expenses compared to the prior quarter was due to the increased sales and marketing expenses in anticipation of the planned commercial launch of the ATEV in vascular trauma. General and administrative expenses for the third quarter of 2024 were $7.3 million compared to $6.1 million for the third quarter of 2023, and were $18.4 million for the nine months ended September 30, 2024, compared to $17.5 million for the nine months ended September 30, 2023.

The increases during 2024 resulted primarily from preparation for the planned commercial launch of the ATEV. Major changes in expenses included increases in personnel expenses, external services and professional fees, partly offset by decreases in non-cash stock compensation expense and insurance expense. Other net expense was $9.0 million for the third quarter of 2024, compared to $27.2 million for the second quarter of 2024. The decrease in other net expense compared to the prior quarter was due to a reduction in the non-cash remeasurement of the contingent earn-out liability associated with the company’s 2021 going public transaction. Other net expenses for the third quarter of 2024 were $9.0 million compared to $1.4 million for the third quarter of 2023, and other net expenses of $41.5 million for the nine months ended September 30, 2024, compared to $11.8 million for the nine months ended September 30, 2023.

The year-over-year increase in other net expenses resulted primarily from the non-cash remeasurement of the contingent earn-out liability. Net loss was $39.2 million for the third quarter of 2024, compared to $56.7 million for the second quarter of 2024. The decrease in net loss compared to the prior quarter was due to the reduction in the non-cash remeasurement of the contingent earn-out liability and the net effect of the operating expense changes we described earlier. Net loss was $39.2 million for the third quarter of 2024, compared to $26.0 million for the third quarter of 2023. And net loss was $127.8 million for the nine months ended September 30, 2024, compared to $85.7 million for the nine months ended September 30, 2023. The year-over-year increase in net loss resulted primarily from the non-cash remeasurement of the contingent earn-out liability and the operating expense increases described earlier.

Humacyte reported cash, cash equivalents, and restricted cash of $71.0 million as of September 30, 2024. Subsequent to September 30, 2024, the company received an additional $29.6 million in net proceeds from the sales of common stock and warrants. Total net cash used was $9.9 million for the first nine months of 2024, compared to net cash used of $49.4 million for the first nine months of 2023. The decrease in net cash used resulted primarily from the receipt of approximately $43 million in net proceeds from an underwritten public offering of Humacyte’s common stock in March 2024 and $20 million in additional proceeds from a draw under its funding arrangement with Overland Capital Management. With that, I’ll turn it back to Laura for some concluding remarks.

Laura Niklason: Thank you, Dale. We are very excited about the future of Humacyte. We’re confident that the FDA approval of the ATEV in vascular trauma is imminent, and we’re also continuing to prepare for commercialization of our first product if we’re approved. We also remain committed to advancing our other promising pipeline programs, which continue to demonstrate the potential of the ATEV across a wide range of diseases and injuries and chronic conditions. This is a transformational period for us and, I believe, a transformational technology, and we’re grateful for your continued support. Thank you all for joining us today. Operator, we’re ready to take questions.

Operator: Thank you. We will now be conducting a question and answer session. [Operator Instructions]. Our first question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.

Q&A Session

Ryan Zimmerman: Good morning. Thanks for taking our questions, Lauren and Dale.

Laura Niklason: Good morning.

Ryan Zimmerman: Thank you. Good morning. It’s very encouraging to hear the FDA’s active discussions, after the PDUFA date delay. I’m just wondering, Laura, if you could talk a little bit more about kind of those – the nature of those discussions. It sounds like there have been facility inspections post the original PDUFA dates. So it sounds, again, all very encouraging, and just want to get a little bit more sense of kind of the nature of those?

Laura Niklason: Yes. So, when we discussed during the course of the BLA review, the inspections and stuff, that that encompasses everything that happened from December through to now. I will say that almost all of the substantive interaction occurred before the PDUFA date. So since the PDUFA date, and when the FDA told us they needed more time, we’ve since had occasional what I’m calling pinging. We reach out to the CBER leadership every few weeks and ask them, offer them material that may help in the review, ask them if they have timelines or questions for us. And we have offered additional material, for example, some of the webinars that we’ve shown that they’ve accepted. But they have not given us a new date, and they have not really engaged in much question asking.

I will say that we’ve gotten a couple requests for sort of standard documentation on the CMC side just in the last couple weeks that our quality team and our CMC team are responding too timely. But it would be too far to say that we’re having substantive discussions with them. We are offering them the material, and they’ve asked us a couple of paperwork questions.

Ryan Zimmerman: Okay. All right. Well, it’s still, I think, good that again communication, I think, is important. Maybe, as I think about just the timing of everything, I mean, given the AV access BLA submission, given the timing of the PDUFA delay on vascular trauma, help us understand kind of all these moving pieces, particularly as it relates to 2025 and into 2026. And is there a point at which you regulate some of your activities, maybe in AV access, to focus on vascular trauma. Just given that it may be you don’t want to bite off more than you can chew, I guess. And I’m just kind of trying to understand the prioritization of your efforts in 2025, given the nature of both of those indications?

Laura Niklason: Yes, Ryan, that’s a very good question. And I would say it’s something that Dale and I strategize about probably on a weekly basis. And I’m going to let him chime in here after I answer. But, you know, again, I would say that, as you know, we’ve brought in a very conservatively sized sales team. We have 10 sales representatives that are outstanding, that are laying the groundwork so that we can hit the ground running once we do get an anticipated approval in trauma. On the dialysis access side, the spend there is not huge. I mean, V007 is largely wrapping up. We are enrolling the VO12 study, but that’s a fairly small study. And that’s more than probably more than halfway enrolled right now. So in terms of our — we certainly don’t have any commercial efforts focused on AV access at all.

Really, our AV access — in terms of driving the AV access indication forward, it’s much more around doing KOL events, writing publications and getting a meeting with the FDA in the next couple of months to talk about a potential indication of a supplemental BLA. So the spend on dialysis is not huge. The mental effort, the personal effort is pretty significant. But it’s not a huge spend right now.

Ryan Zimmerman: Okay, very helpful, Laura.

Operator: Thank you. Our next question comes from the line of Josh Jennings with TD Cowen & Company. Please proceed with your question.

Josh Jennings: Hi, good morning. Thanks for the questions. I wanted to ask about the AV access indication. You guys do have this Fresenius agreement in place. We’ve now seen the data is presented at the ASN. That agreement states that where there is a clinical benefit for Fresenius, we’ll use a ATEV for AV access in their vascular surgery centers. It’s clear that there’s a benefit in women, diabetics, obese patients. Do you think that what’s been put on the on the tape here is enough for that agreement to be fulfilled, assuming the BLA approval is in place? Or do you need this second study to demonstrate clinical benefit? Where do you think you stand relative to that for Fresenius agreement that’s put in place in the AV access indication?

Laura Niklason: Well, I think that’s going to require continued discussions with our partners at Fresenius. I can tell you that one of the Chief Medical Officers from Fresenius joined us at the post-presentation lunch at after ASN. And his biggest comment and what he said, what mattered most to him, because he oversees a lot of the provision of care at dialysis centers, is that a decrease in catheter time. In terms of reimbursement for the services that Fresenius provides, a decrease in total catheter time and exposure is huge for them. Because in prior guidelines for AV access, reimbursement to dialysis centers was based more on what fraction of patients were using a fistula. Those guidelines have been revised, understanding that not all patients are suitable for fistula.

And so, now the current guideline really seeks to minimize total catheter time. So the fact that we could show significant decreases in catheter time for women and then all diabetics and all obese patients, which if you add those up, that’s more than half of the dialysis population. I think that’s significant from the standpoint of Fresenius’s business, whether the numbers of patients that we’ve shown it in here will be sufficient to really carry the day with them? I don’t know. But regardless, I think we have our VO-12 trial, which again is making great strides in enrollment and where we expect to see the same outcomes. So, this is going to be a process, even if we file sometime in mid 2025 for a supplemental BLA and dialysis, it’s going to take a while to get approval.

By that time we’ll have data on VO-12 and I think, you know, we’ll be able to look at the whole of the data and really make a powerful argument.

Josh Jennings: Understood. That makes sense. And during the KOL webinar, you hosted one of the things that stuck out for us was commentary around ATEV’s potential utility in revision cases. And one surgeon talked about, his revision cases were 2X, his de novo AV access surgeries or procedures that may just be a hole in my understanding of the opportunity here. But can you just help us understand a little bit better?

Laura Niklason: Sure, sure.

Josh Jennings: Opportunity and just, ATEV. I think it’s clear that ATEV could play a meaningful role in those revisions, AV access procedures.

Laura Niklason: So, yes. So, the revisions tend to occur for different reasons. So in fistula patients, which is still the majority of patients in the U.S., particularly forearm fistulas, those can become hugely aneurysmal and when they do, they become painful and if they rupture, they can become fatal. And so revising aneurysmal fistulas by taking out the aneurysmal segment and then replacing it with a conduit, preferably one that doesn’t get infected, is something that a lot of access surgeons do. So I think that’s one type of revision that Dr. Osaki has done. That’s one type of revision is revision of us of a synthetic graft that may have become occluded locally occluded or may have become infected with a local infection.

Again, in that case, you can’t put another synthetic graft back into that wound. And so having something that that is going to have a low incidence of infection is going to be vastly preferable. So there are a lot of revisions that occur because once you have a functioning access, if there’s a problem with it, the surgeon would much rather try to salvage it than go through the months and months of trying to generate a new access and go back on catheter and all that rigmarole.

Josh Jennings: And does your market diligence suggest just broadly that the revision opportunity is bigger? Or is that just a select practice where you see that dynamic?

Laura Niklason: I think it’s highly variable by practice. Certainly the practice at the Brigham has its own very I don’t want to say idiosyncratic, but the guys there have spent a lot of time thinking very hard about what they think is the best way to handle dialysis patients. And so, their practices may not reflect sort of more broad based private practice activity. But nonetheless, all vascular access surgeons do some number of revisions. It may be that Keith does more than others.

Josh Jennings: And just one last one, just on the congratulations on the arm after the PAD indication, can you just help us think about, I don’t know if you’ve laid out any timelines or whether that’s TBD [ph] for the clinical development program there and just how much investment is required to run that trial and expand the label to the PAD indication? Thanks.

Laura Niklason: Well, we’re very excited about PAD. As we’ve said, I think on earlier calls, we think it may be our largest market. And certainly, I have a number of vascular surgeons who are constantly hectoring me to start a Phase 3 trial in PAD. Given the delay with the FDA and the delay and bringing in revenue. This is not the time to bite off another large project. That said, as we’ve thought about the trial design for a PAD study, this is not going to be a 600 patient huge basal like trial. This will be a couple hundred patients, probably fewer than 200 prospective randomized head-to-head against another standard of care for treating patients with critical limb threatening ischemia. If I had if I had the money, I would start it next week. But I think that improving our cash position, either through financing or potentially through a partnership is what’s going to be required to make a Phase 3 trial go.

Josh Jennings: Thank you, Laura.

Operator: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

Kristen Kluska: Hi, everyone. Congrats on a great quarter in the recent presentation. And sounds like you have your handful with a couple coming up here. Wanted to ask about AV access, the end point of the trial. Can you clarify for us if the FDA wanted the six and 12 months to be looked at as a separate end points or if it was combined? And then when you had discussions with them ahead of the trial, what’s your level of confidence that a number of patients is going to be sufficient for potential filing?

Laura Niklason: Well, the FDA, so to answer your first question, the discussions around the primary end point in V007 date back to 2017. And there was some back and forth thing, but essentially we round up at a six and 12 month co-primary end point. We submitted to the FDA in the spring before the data — before the trial finished enrolling and before we locked the database, we submitted our statistical approach for measuring that co-primary end point to the FDA. So they have that in hand. I would also say that that the VO7 trial does have a special protocol assessment, an SPA. So while certainly no guarantee that increases the chances that the FDA upon looking at this trial would be successful, would be willing to field a BLA application on the basis of just this trial.

That said, we also have, as you know, a tremendous amount of data from our prior V006 trial. And if anything, that’s a larger trial with more patients and longer follow up. So certainly in terms of durability and safety outcomes with our vessel in dialysis patients, we also have a tremendous amount of data there. So that’s really why we’re requesting this meeting with the FDA in the next couple months is to present the totality of what we have, including the successful V07 and also the historical information that we have from V06 and say, you know, we believe that this is sufficient to support an indication in dialysis. And do you agree? And we’ll see.

Kristen Kluska: Okay. Thank you for that. And I remember being at your VEITHsymposium event last year. And obviously the big focus was on vascular trauma, given these data hadn’t come out yet. And I remember a number of surgeons were actually mentioning there that they were particularly really excited about AV access in particular. So I’m curious now that you have a lot more data out there. You just had this late breaking presentation at a premier conference. What the general sense of the community you’re getting is. I know you also hosted an event with us last week. But just generally speaking, has that enthusiasm changed at all? Now that you have the full top line data, any color would be really helpful here?

Laura Niklason: Well, I’ll tell you, it seems like VO12 is enrolling faster now. Now that the results are out and more broadly disseminated, especially for these high risk subgroups like patients who are diabetic or obese, who really, I mean, clinicians know that fistula do so poorly in those patients. And the fact that these data have come out showing significant improvements in those vulnerable groups, I think it’s making the VO12 investigators. And just to remind the folks on this call, our VO12 trial is a woman only trial. Comparing head-to-head, our vessel against fistula, which is the standard of care, but it’s strictly in a woman population. This type of trial and dialysis has never been done before. But we designed this in close collaboration with the FDA because the FDA agrees that women writ large are an underserved population for dialysis access.

So anyway, as these results have come out, it has seemed to me that enrollment is picking up because I think our investigators are even more excited about this and want to get to the answer quicker.

Kristen Kluska: Great to hear. Thanks for taking my questions.

Operator: Thank you. Our next question comes from the line of Bruce Jackson with the Benchmark Company. Please proceed with your question.

Bruce Jackson: Hi, good morning and thanks for taking my questions. Turning to the supplemental BLA for the AV access, can you tell us a little bit about the pathway to getting that filed and how it relates to the trauma BLA? So can you parallel pass any activities and then ultimately, what’s the lag time that you’re anticipating between the BLA approval and the submission of the supplemental BLA?

Laura Niklason: Thanks for your question, Bruce. It’s something that we’re maneuvering on a weekly basis. So to simplify it, we believe that the decision to file and the review of the BLA in dialysis access is actually fairly independent of the trajectory of the trauma file. That said, we’re assuming that we’re going to get approval in trauma at some point. And if that is true, then the filing for dialysis access wouldn’t be a full BLA, it would be a supplemental BLA. So timing of a supplemental BLA in AV access will really be dictated by how much follow-up the FDA is going to want to see from our V07 data. So as I mentioned, we have data going out to five years in dialysis patients from our V06 trial. And in V07, we have almost all of our patients out to two years and many patients out past two years.

But we won’t have every single patient at two years until April of 2025 in the V07 trial. So when we speak with the FDA in a couple months, we’re going to bring forward the data that we have in V07, which is all patients for one year and some patients with longer follow-up and combine that with V06. If they say that’s sufficient to file, then we would proceed with a filing, hopefully by mid-year of 2025, pulling all the data together. If the FDA says they want full two years on everybody in V07, which that comes in April, then we would file after that. So that would delay the filing by a few months. And to me, that’s really kind of the open question there, is whether they’ll accept one-year data or will want to go to two-year data. And that we just have to get from them.

But once we file, because it’s a supplemental BLA, I believe, to the best of my understanding, that that’s a six-month review.

Bruce Jackson: Okay, that’s very helpful. Thank you. And then my other question is about the CABG program. You’re showing some data at AHA. What’s going on right now in terms of the current research on the on the CABG, ATEV? And do you have a date in mind for first in man?

Laura Niklason: Well, that’s also a very good question. So from prior discussions that we had with the FDA, they had asked us to go to a third animal model. So we’ve tested it. We’ve tested it. We’ve done a third animal model. So we’ve tested our CABG graphs in pigs for the short term and in primates for long-term studies. And it’s the primate data that we’ll be sharing at American Heart in a couple weeks. The FDA has asked for a third animal model, which is a sheep model. It’s an immunosuppressed model where we will carry out our vessels for up to six months in sheep who are immunosuppressed so that they don’t reject our human vessels. We have a discussion scheduled with the FDA in the next couple months to lay out this experimental plan that they’ve suggested and to confirm with them that once we complete the sheep studies, that then we would be in a position to file an IND.

So it’s a little bit of a waiting game because we still have to probably have one more conversation with the FDA about whether this third animal model in CABG will be sufficient to move forward with an IND. So I wish I had a better answer for you, but I think I’ve got to say stay tuned.

Bruce Jackson: All right, that’s it for me. Thank you for taking my questions and congratulations on all of the progress.

Laura Niklason: Thank you.

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

Vernon Bernardino: Hi, Lauren Dale. Good morning. Thanks for taking my question. And thank you for the review and updates on the ATEV programs. The question I have actually is on BVP. I know it’s an investigational product and the results are early, but I hope you saw late last month that there has been success as far as acellular implantation in type 1 diabetes patients. I was just wondering what would be the next steps when you may consider a clinical study in humans with BVP? The results that were presented last month were from the University of Chicago Transplantation Institute. Three patients had achieved insulin independence and so the BVP investigational product is really intriguing to me and seems like something that could be done with low spend as far as research is concerned, because that study in three patients was an initiated study. Just wondering if you could give a little update on the BVP program? Thank you.

Laura Niklason: So, Vernon, yes, thanks for that question. I’ll try to answer as succinctly as possible. So we’re working on the BVP along about three or four parallel avenues. The one that we talk about most commonly in these quarterly calls is assessing the principle of the BVP, which is basically using our vessel as a delivery vehicle to deliver a therapeutic number of islets to a recipient in such a way that the islets survive the transplantation and don’t die of hypoxia. So we have been testing that concept in primates for the last couple of months. As I mentioned earlier, we’ve shown that islets survive for months and we can detect C-peptide which is an insulin precursor from our transplanted islets into these monkeys.

What we’re doing now is we’re doing dosing studies to try to understand what’s going to be the most effective islet dose so that we can not just detect C-peptide but also reverse the diabetic state. So I believe in my heart that this concept is going to work and that it’s going to be a very efficient and reliable islet delivery method, but that is still being proved out. But once we prove that out in primates then it’s important to understand that our vessel could be used to deliver any islet. It could be used to deliver a stem cell derived islet, an immune evasive islet, it could be used to derive a native islet that’s derived from a pancreas. So we are looking at developing islets that are derived from stem cells, both wild type stem cells and immune evasive stem cells, and we’re doing that work very actively here at Humacyte.

But we also have sources of native human islets that we’re also testing in the BVP platform. And so I think for us, it’s a matter of evaluating all of these different islet sources as we prove out the BVP principle in large animal. Once we’ve proved out the principle in large animals then I think it will be on us to select the best islet source that we might bring forward for a first in man experience either as an investigator sponsored trial or as a standard IND. I think we just have to evaluate where we are at the time. But I remain confident about the technology and for me importantly this can be used with any islet source. And really the technology is designed to deliver a curative number of islets efficiently and in a way that the islets can be also retrieved.

So currently if you inject islets into the liver, if those islets develop a problem you can’t get them back. It’s a one-way trick, one-way trip. So being able to deliver islets efficiently but also being able to remove them should that be necessary. I think is an important advantage of the platform that we’re developing.

Vernon Bernardino: Thanks for that update. When may we see as a follow-up some of those early results in the primates?

Laura Niklason: Well, I think you’re just going to have to stay tuned. I think it’s probably going to be a few more months. Not sure.

Vernon Bernardino: Okay. Excited and waiting. Congrats on the progress. Looking forward to further work from the FDA. Thank you.

Operator: Thank you. I’m showing no further questions in the queue at this time. This concludes the Humacyte third quarter results conference call. Thank you all for participating.