Q3 2024 Humacyte Inc Earnings Call
Speaker Change: [music].
Good morning, ladies and gentlemen, and welcome to the human side 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.
This conference call is being recorded.
Speaker Change: Now I'll turn the call over to learn Barrick with last night. Please.
Speaker Change: Please go ahead.
Thank you.
Speaker Change: Before we proceed with the call I would like to remind everyone that certain statements made during this call. Our forward looking statements under U S. Federal Securities Law. 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 acts.
Speaker Change: The results to differ from statements made on this call is contained in our periodic reports filed with the SEC.
Speaker Change: 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.
Speaker Change: 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 human psyche website.
Joining me on today's call from Hemocyte are Dr. Larry Nicholson, <unk>, President and Chief Executive Officer, and Dale Sanders, Chief Financial Officer, and Chief Corporate Development Officer Doctor Nicholson 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 32002.
Speaker Change: 24.
Speaker Change: Following their prepared remarks, the management team will be available for your questions I will now turn the call over to Dr. <unk>.
Speaker Change: Thank you Lauren good morning, everyone and thank you for joining us for our third quarter 2024 financial results and business update call.
Speaker Change: This has been a very productive time for human site, while the F. D. A review of our age have BLA in vascular trauma is still ongoing the entire human site team continues to engage in commercial preparation to support our planned U S market launch if approved importantly, we submitted our new tech.
Speaker Change: <unk> add on payment or in tap application to the centers for Medicare and Medicaid services in early October.
Speaker Change: In addition positive topline results in subgroup analyses from our V O seven phase three clinical trial of the eighth haven't hemodialysis were recently presented at kidney week and this presentation was followed by a webinar of key opinion leaders in dialysis access who discuss the implications of the.
A study.
Speaker Change: Regarding our pipeline the U S patent office allowed a patent covering the design and the composition of the bio vascular pancreas or B V. P product candidate for treating type one diabetes and we're planning to present results of our coronary artery bypass preclinical program at the American Heart meeting later this.
Speaker Change: <unk>.
Speaker Change: And finally, we completed a registered direct offering of humans site stock of approximately $30 million.
Speaker Change: 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.
Speaker Change: I'll begin with our program and vascular trauma.
Speaker Change: 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.
Speaker Change: As a reminder, the H have trauma program B L. A was submitted to the F. D. A in December of 2023 and.
Speaker Change: It was granted priority review status in February 2024.
Speaker Change: And it was assigned an original producer date of August 10th 'twenty 'twenty four.
Speaker Change: The day before the Paducah date, the center for Biologics reached out to human side to inform us that they needed more time with the BLA file in order to complete their review.
Speaker Change: Our BLA remains under review.
Speaker Change: And the FDA has not yet provided a timeline for completion of their review.
Speaker Change: During the course of the BLA review the F. D. A is conducted inspections of our manufacturing facilities in 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.
Speaker Change: We continue to maintain confidence in the approve ability of the H have in vascular trauma.
Speaker Change: He used upon our interactions with the agency to date.
Speaker Change: Yeah.
Speaker Change: Our entire commercialization team is continuing their work to position humans site for a successful U S launch of the H F and vascular trauma upon approval by the F D. A.
Speaker Change: Sales executives, who were brought on during August have been completing training on the science and the medical impact of our eighth having trauma patients.
Speaker Change: The sales representatives have also been identifying key accounts and contacts within their respective regions, which we believe will accelerate market adoption once the a to have received FDA approval.
Speaker Change: To support reimbursement of the eighth have after FDA approval on October 7th humans site submitted an application for a new technology add on payment or N tap to the centers for Medicare and Medicaid services or CMS.
Speaker Change: The window for filing the IND tap applications occurs only once annually with decisions being made the following year.
Speaker Change: Our application is for the fiscal year, 'twenty, 'twenty, six and tap cycle, which would make the untapped payment effective starting October 1st 2025.
Speaker Change: Receiving the untap reimbursement can allow hospitals to receive up to approximately 65% of the sales price of a biologic product.
Speaker Change: Requirements for receiving and tap reimbursement are several including technological novelty as well as clear evidence of clinical improvement for patients.
Speaker Change: Human side believes that the H have meets these qualifications and we look forward to receiving review of our intact proposal in the coming months from CMS.
As we await a decision from the F. D. A we continue to generate additional data supporting a tells us in vascular traumatic injuries.
Speaker Change: Positive long term results from the humanitarian program in Ukraine were featured in a presentation at the military health system Research Symposium in August.
Speaker Change: This symposium is the U S Department of Defense is foremost academic clinical meeting.
Speaker Change: Long term follow up of vascular trauma patients, whose injuries were treated with the eighth have showed high rates of patency or blood flow of 87%.
Speaker Change: Remarkably there were no cases of H have infections, and or amputations are affected limbs or deaths of patients that were related to the 18th.
Speaker Change: This is despite the severe nature of the injuries, including those sustained from mine glass shrapnel and high velocity ballistics.
Speaker Change: 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.
Speaker Change: In addition, human side anticipates, the publication of our civilian and military clinical trial outcomes in vascular trauma later, this month and our 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.
Speaker Change: This event highlighted through individual patient case studies the potential civilian applications in military usage of our H have as a treatment for vascular injuries.
Speaker Change: A replay of this event can be found on our website.
Speaker Change: Yes.
Speaker Change: Turning now to our program in dialysis access.
Speaker Change: Positive results from our V O seven phase three trial of the eight have an arteriovenous access were featured in a presentation at the American Society of Nephrology kidney week meeting 'twenty 'twenty, four which is the premier nephrology meeting in the world.
As we announced in July of 2020 for this trial met its primary endpoint by demonstrating superior function in patency of the H have at six and 12 months as compared to Autogenous fistula, which is the current gold standard of care for hemodialysis patients.
Speaker Change: The presentation at kidney week further highlighted the eighth have superior function in patency, particularly in women obese patients in diabetic patients.
Speaker Change: These are high need subgroups in the dialysis population, who have historically poor outcomes with arteriovenous fistula procedures.
Speaker Change: Females obese and diabetic patients who received the eighth have all had significantly higher six and 12 month patency rates than those patients receiving arteriovenous fistula.
Speaker Change: In addition, these patients all achieved a significantly longer duration of dialysis using the H have over the first 12 months as compared to fistula.
Speaker Change: Human side is currently preparing these results for publication in the peer reviewed literature.
Speaker Change: These results as well as several case studies, where also recently discussed and a virtual K O L event, featuring Doctor Charles Keith Ozaki, Dr. Mohammed Hussein and Dr. Jimmy Lee.
Speaker Change: A replay of that event can also be found on human sites website.
We're highly encouraged by these results in dialysis access and believe that they demonstrate the potential of the eight have 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.
Speaker Change: We're also making progress in our program in advanced peripheral artery disease or P. E D.
Speaker Change: P. D is a cardiovascular disease of blood vessels, most commonly affecting the arteries in the legs.
Speaker Change: 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.
Speaker Change: And autologous vein as the standard of care for such patients.
Speaker Change: Today, the FDA granted RMAT designation, or Regenerative Medicine Advanced Therapy designation, to the ATAV in the PAD indication.
Speaker Change: Following vascular trauma and AV access and dialysis, this RMAT designation in PAD marks the third indication for which the ATEV has received this important designation.
Speaker Change: Our MAT designation is designed to provide pathways for expedited development and review of regenerative medicine therapies that treat serious or life-threatening diseases or conditions.
Speaker Change: 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.
Speaker Change: In the same time, we've also received IND clearance for the ATAV and PAD.
Speaker Change: 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.
Speaker Change: The BVP is designed to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes.
Speaker Change: Positive results from ongoing non-human primate studies support the potential of the BVP to improve the care of patients with type 1 diabetes.
Speaker Change: 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.
Speaker Change: 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 nonhuman primates.
Speaker Change: And finally, in October, we completed a registered direct offering, resulting in approximately $30 million of gross proceeds to Humacyte.
Speaker Change: And with that, I'll now turn it over to Dale for a review of our financial results and other business developments.
Thank you, Laura.
Dale: 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.
Dale: 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.
Dale: The decrease in expenses compared to the prior quarter were due to a reduction in clinical trial costs.
Dale: 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.
Dale: 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.
Dale: The year-over-year increases resulted primarily from increased materials and personnel expenses to support expanded research and development activities and our clinical trials.
Dale: including the expansion of manufacturing activities and support of the FDA review of the DLA and vascular trauma.
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Dale: 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.
Dale: 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.
Dale: 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.
Dale: 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.
Dale: The increases during 2024 resulted primarily from preparation for the planned commercial launch of the ATIV.
Dale: 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.
Dale: Other net expense was $9.0 million for the third quarter of 2024 compared to $27.2 million for the second quarter of 2024.
Dale: 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.
Dale: Other net expenses for the third quarter of 2024 were $9.0 million compared to $1.4 million for the third quarter of 2023.
Dale: 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.
Dale: The year-over-year increase in other net expenses resulted primarily from the non-cash remeasurement of the contingent earn-out liability.
The End
Dale: 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-free measurement of the contingent earn-out liability and the net effect of the operating expense changes we described earlier.
Dale: Net loss was $39.2 million for the third quarter of 2024, compared to $26.0 million for the third quarter of 2023.
Dale: And that 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.
Dale: The year-over-year increase in that loss resulted primarily from the non-cash-free measurement of the contingent earn-out liability and the operating expense increases described earlier.
Dale: Hume site reported cash, cash equivalents, and restricted cash of $71.0 million as of September 30, 2024.
Dale: Subsequent to September 30, 2024, the company received an additional $29.6 million in net proceeds from the sales of common stock and warrants.
Dale: Total net cash use was $9.9 million for the first nine months of 2024, compared to net cash use of $49.4 million for the first nine months of 2023.
Dale: The decrease in net cash used resulted primarily from the receipt of approximately $43 million in net proceeds from an underwritten public offering of Humicide's common stock in March 2024.
Dale: and $20 million in additional proceeds from a draw under its funding arrangement with Oberlin Capital Management.
Speaker Change: With that, I'll turn it back to Laura for some concluding remarks.
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Thank you, Dale.
Speaker Change: We are very excited about the future of Humacyte. We're confident that the FDA approval of the ATEV in vascular trauma is imminent.
Speaker Change: 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.
Speaker Change: 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.
Thank you.
Thank you.
Speaker Change: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone feedback. A confirmation tone will indicate your line is in the question queue. You may press star 2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.
and one moment please while we pose for questions
Speaker Change: Our first question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.
Ryan Zimmerman: Good morning. Excuse me. Thanks for taking our questions, Laura and Dale.
Speaker Change: Thank you. Good morning. It's very encouraging to hear the FDA's, you know, an active discussion, you know.
Speaker Change: after the Paducah State 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's been...
Speaker Change: Facility Inspections post the, you know, original PDUFA date. So it sounds, again, all very encouraging and I just want to get a little bit more sense of kind of the nature of those.
Speaker Change: Yeah, so when we discussed, you know, during the course of the BLA review, the inspections and stuff, that that encompasses everything that happened from
Speaker Change: what I'm calling pinging, you know, we reach out to CBER leadership every few weeks and ask them...
Speaker Change: offer them material that may help in the review, ask them if they have timelines or questions for us.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: That our that our quality team and our CMC team are responding to timely But but I it would be too far to say that we're having substantive discussions with them That's that you know, we are offering them the material and they've asked us a couple of paperwork questions
Speaker Change: Okay, all right. Well, you know, it's still, I think, good that, you know, again, communication, I think, is important. Maybe, as I think about just the timing of everything, I mean...
Speaker Change: Given the AV access DLA submission, given the timing of the PDUFA delay and vascular trauma
Speaker Change: Help us understand, you know, kind of all these moving pieces, particularly as it relates to 2025 and into 2026, and, you know, is there a point at which you...
Speaker Change: regulate some of your activities maybe in AV access to focus on vascular trauma.
Speaker Change: You know, just given that it may be, you know, you don't want to bite off more than you can chew, I guess. And I'm just, you know, kind of trying to understand the prioritization of your efforts in 2025, given the nature of both of those indications.
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Speaker Change: Yeah, 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.
Speaker Change: But, you know, again, I would say that, you know, as you know, we've brought in a very conservatively-sized sales team. We have ten sales representatives that are outstanding that are laying the groundwork so that we can, you know,
Speaker Change: hit the ground running once we do get an anticipated approval in trauma.
Speaker Change: On the dialysis access side, the spend there is not huge. I mean, VO7 is largely wrapping up. We are enrolling the VO12 study, but that's a fairly small study, and that's probably more than halfway enrolled right now.
Speaker Change: 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.
Speaker Change: doing KOL events, writing publications, and getting a meeting with the FDA in the next couple months to talk about a potential indication of a supplemental BLA. So the spend on dialysis
Speaker Change: is not huge. The mental effort, the personal effort is pretty significant, but it's not a huge spend right now.
Okay, very helpful Laura.
Thank you for having me.
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Thank you.
Speaker Change: Our next question comes from the line of Josh Jennings with DD Coward and Company. Please proceed with your question
Hi, good morning. Thanks for the questions.
Speaker Change: I wanted to ask about the AV access indication. You guys do have this percentious agreement in place.
Speaker Change: We've now seen the data that's presented at ASN. That agreement states that where there is a clinical benefit, Fresenius will use ATEV for AV access in their vascular surgery centers.
Speaker Change: and it's clear that there's a benefit in women, diabetics, obese patients. Do you think that what's been put on the tape here is enough for that agreement to be fulfilled, assuming the BLA?
Speaker Change: approval is in place, or do you need this this second study to demonstrate clinical benefit? Where do you think you stand relative to that percentage agreement that's put in place in the AV access indication?
Speaker Change: 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
Speaker Change: joined us at the post-presentation lunch after ASN and his biggest comment and what he said what mattered most to him.
Speaker Change: because he oversees a lot of the provision of care at dialysis centers.
is that.
Speaker Change: a decrease in catheter time in terms of reimbursement for the services that Fresenius provides.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: So, the fact that we could show significant decreases in catheter time for women and then all diabetics and all obese patients.
Speaker Change: 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' business.
Speaker Change: whether the numbers of patients that we've shown it in here will be sufficient to really carry the day with them, you know, 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.
Speaker Change: 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.
Speaker Change: by that time we'll have data on V012 and I think we'll be able to look at the whole of the data and really make a powerful argument.
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Speaker Change: understood that that makes sense. 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
Speaker Change: you know, his revision cases were 2x, his de novo AV access surgeries or procedures.
Speaker Change: that may just be a hole in our and my understanding of the opportunity here but can you just help us understand a little bit better
Speaker Change: that sure sure opportunity and yeah just you know the because I think it's clear that ATEV could could play a meaningful role in those revision AV access procedures
Speaker Change: So, yeah, so with the revisions tend to occur for different reasons. So in
Speaker Change: in fistula patients, which is still the majority of patients in the U.S.
particularly forearm fistulas, those can become hugely aneurysmal.
Speaker Change: And when they do, they become painful, and if they rupture, they can become fatal.
Speaker Change: 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.
Speaker Change: is something that a lot of access surgeons do. So I think that's one type of revision that Dr. Osaki was talking about.
Speaker Change: The other type of revision is revision of a synthetic graft that may have become occluded, locally occluded, or may have become infected, you know, with a local infection. You know, again, in that case, you can't put another synthetic graft back into that wound.
Speaker Change: And so having something that is going to have a low incidence of infection is going to be vastly preferable.
Speaker Change: So there are a lot of revisions that occur because once you have a functioning access
Speaker Change: you know, 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.
And as your market diligence suggests...
Speaker Change: just broadly that the revision opportunity is bigger or is that just a select practice where you see that dynamic? I think it's I think it's highly variable.
Speaker Change: yeah yeah I think it's highly variable by practice certainly the practice at the Brigham
Speaker Change: 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.
Speaker Change: sort of more broad-based, you know, private practice activity, but nonetheless, you know, all vascular access surgeons do some number of revisions. It may be that Keith does more than others.
Speaker Change: Just one last one. Just a congratulation on the RMAP for the CAD education. Can you just help us think about, I don't know if you've laid out any timelines or whether that's TBD for the clinical development program there and just how much investment is required to...
to run that trial and
and expand the AITES label to the PID indication. Thanks.
Speaker Change: Well, we're very excited about PAD. As we've said, I think, on earlier calls, we think it may be our largest market.
Speaker Change: and certainly I have a number of vascular surgeons who are constantly hectoring me to start a phase three trial in PAD.
Speaker Change: given the delay with the FDA and the delay in bringing in revenue, this is not the time to bite off another large project. That said, as we've thought about
Speaker Change: the trial design for a PAD study, this is not going to be a 600 patient huge
Speaker Change: basal-like trial. This will be, you know, 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.
Speaker Change: 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.
Thank you, Laura.
Speaker Change: Thank you. Our next question comes from the line of Christian Koska with Cancer Fitzgerald. Please proceed with your question.
Speaker Change: Hi everyone, congrats on a great quarter in the the recent presentation and sounds like you have your handful with a couple coming up here. I wanted to ask about AV access. The the end point of the trial, can you clarify for us if the FDA wanted the 6 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?
Speaker Change: Well, the FDA, you know, so to answer your first question, the discussions around the primary endpoint in VO7 date back to 2017, and there was some back and forthing, but essentially we wound up at a 6 and 12 month co-primary endpoint.
Speaker Change: We submitted to the FDA in the spring, you know, before the trial finished enrolling and before we locked the database.
Speaker Change: 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 the VO7 trial does have a special protocol assessment, an SPA.
Speaker Change: would be willing to field a BLA application on the basis of just this trial.
Speaker Change: That said, we also have, as you know, a tremendous amount of data.
Speaker Change: from our prior VO6 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.
Speaker Change: 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 VO7 and also the historical information that we have from VO6.
Speaker Change: and say, you know, we believe that this is sufficient to support an indication in dialysis and do you agree? And we'll see.
Okay.
Speaker Change: Thank you for that. And I remember being at your Veep Symposium 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 aviaxis 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, you know, has that enthusiasm changed at all now that you have the full top-line data? Any color would be really helpful here.
Speaker Change: Well, I'll tell you, it seems like VO-12 is enrolling faster now. You know, now that the results are out and more broadly disseminated, especially for these
Speaker Change: high-risk subgroups, like patients who are diabetic or obese, who really, you know, I mean, clinicians know that fistulas do so poorly in those patients, and the fact that these data have come out showing significant improvements in those vulnerable groups
Speaker Change: I think it's making the the VO-12 investigators, and just to remind the folks on this call, our VO-12 trial is a woman-only trial.
Speaker Change: comparing head-to-head our vessel against fistula, which is the standard of care.
Speaker Change: But it's strictly in a woman population. This trial, 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
Speaker Change: 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.
Thank you.
Great to hear. Thanks for taking my questions.
Speaker Change: Thank you. Our next question comes from the line of Bruce Jackson with the Benchmark Company. Please proceed with your question.
Hi, good morning and thanks for taking my questions.
Thank you. Bye-bye.
Speaker Change: 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?
Speaker Change: Thanks for that question, Bruce, and it's something that we're maneuvering on, you know, on a weekly basis.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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 VO7 data. So as I mentioned, we have data going out to five years.
in dialysis patients from our VO6 trial.
Speaker Change: and in VO7 we have almost all of our patients out to two years and many patients out past two years.
Speaker Change: But we won't have every single patient at two years until April of 2025 in the VO7 trial.
Speaker Change: So, when we speak with the FDA in a couple months, we're going to bring forward the data that we have in VO7, which is all patients for one year, and some patients with longer follow-up, and combine that with VO6. If they say that's sufficient to file,
Speaker Change: then we would proceed with a filing, hopefully by, you know, mid-year of 2025, pulling all the data together. If the FDA says they want full two years on everybody in V07, which we would...
Speaker Change: which that comes in April, then we would file after that. So that would delay the filing by a few months.
Speaker Change: 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...
Speaker Change: 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.
For more information visit www.FEMA.gov
Speaker Change: 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 CABG ATEV, and do you have a date in mind for first in man?
Speaker Change: 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 our cabbage grafts 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.
Speaker Change: 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.
Speaker Change: We have a discussion scheduled with the FDA in the next couple months.
Thank you.
Speaker Change: 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.
Speaker Change: about whether this third animal model in cabbage 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.
Speaker Change: All right, that's it for me. Thank you for taking my questions and congratulations on all of the progress.
Thank you.
Speaker Change: Thank you. Our next question comes from the line of Vernon Bernardino with H.C. Wainwright. Please proceed with your question.
Speaker Change: Hi, Laura and Dale. Good morning. Thanks for taking my question and thank you for the review and updates on the ATF programs.
Speaker Change: 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 islet cell implantation in type 1 diabetes patients. I was just wondering...
What?
would be the next steps when you may
Speaker Change: consider a clinical study in humans with VVP. The results that were presented last month were from the University of Chicago Transplantation Institute. Three patients,
Speaker Change: had achieved insulin independence. And so the BBP investigational product's really intriguing to me, and seems like something that could be done with low spend as far as research is concerned.
Speaker Change: 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.
Speaker Change: Laura Niklason, Dale Sander, Tom Johnson, Laura Niklason, Tom Johnson, Laura Niklason,
Speaker Change: So Vernon, yeah 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 BV which is
Speaker Change: basically using our vessel as a delivery vehicle to deliver a therapeutic number of islets.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: so that we can not just detect C-peptide, but also reverse the diabetic state.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: an immune-invasive islet, it could be used to derive a native islet that's derived from a pancreas. So you know, we are looking at...
Speaker Change: We are looking at developing islets that are derived from stem cells, both wild-type stem cells and immune-invasive stem cells, and we're doing that work very actively here at Humacyte.
Speaker Change: But we also have sources of native human islets that we're also testing in the BVP platform.
Speaker Change: 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 animals.
Speaker Change: Once we've proved out the principle in large animals, then I think...
Speaker Change: 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.
Speaker Change: 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
Speaker Change: 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.
Speaker Change: one-way trip. So, you know, 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.
Speaker Change: Thanks for that update. When may we see as a follow-up some of those early results in the primates?
Speaker Change: 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. Okay. Okay. Excited and waiting. And congrats on the progress. Looking forward to further work from the FDA.
Thank you.