Q4 2022 Humacyte Inc Earnings Call
Speaker 1: The.
Speaker 1: And.
Speaker 1: The.
Speaker 2: and year-end 2022 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.
Speaker 2: I will now turn the call over to Lauren Merrick with Life Science Advisors. Please go ahead.
Speaker 3: 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 law.
Speaker 3: These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Speaker 3: 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.
Speaker 3: The forward-looking statements made during this call speak only as of the date thereof, and the company undertakes no obligation to update or revise the forward-looking statements except as required by law.
Speaker 3: Information presented on this call is contained in the press release we issued this morning and in our Form 10-K , which will be filed today and may be accessed from the investors page of the Humasite website.
Speaker 3: Joining me on today's call from HemaSite are Dr. Laura Nicholson, President and Chief Executive Officer, Dale Sander, Chief Financial Officer and Chief Corporate Development Officer, and Dr. Heather Pritchard, Chief Operating Officer.
Speaker 3: Dr. 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 and year ended December 31, 2022.
Speaker 3: Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Dr. Nicholson.
Speaker 4: Thank you, Lauren. Good morning, everyone, and thank you for joining us for our fourth quarter and year-end 2022 Financial Results and Business Update call.
Speaker 4: Humacyte has made significant progress throughout 2022 in advancing our universally implantable, bioengineered human tissue product candidate, the HAV, or human acellular vessel.
Speaker 4: We're very close to completing enrollment in two trials of the HAV, both in vascular trauma and in arteriovenous access.
Speaker 4: And we also continue to advance our earlier stage programs.
Speaker 4: As we begin 2023, we remain focused on advancing our HAV towards regulatory milestones and commercialization.
Speaker 4: beginning with the vascular trauma indication. During this call, I will review our recent highlights and the progress of our key programs before turning the call over to Dale for a review of our financial results.
Speaker 4: Then we'll be happy to open up the call to your questions.
Speaker 4: I'll begin with our HAV program in vascular trauma.
Speaker 4: We're pleased that our Phase 2.3.V05 trial is nearing enrollment completion.
Speaker 4: We currently have a total of 63 patients who received the HAV in the VO5 trial and an additional 17 patients who've been treated with the HAV under our humanitarian program in Ukraine, bringing the total patients treated with the HAV for traumatic injury to 80.
Speaker 4: All patient results will be included in our upcoming BLA filing with the FDA.
Speaker 4: The efficacy of the endpoint of the HAV and trauma will be based on the 30-day patency in 50 patients from the VO5 trial who suffered vascular trauma in an extremity, either the arm or the leg.
Speaker 4: The primary efficacy analysis will not include torso injuries or iatrogenic trauma, which is trauma caused by physicians in patients who were enrolled in the VO5 trial, although data from these patients will contribute to the safety database.
Speaker 4: Currently, in the VO5 trial, 46 patients comprising the extremity injury population have been treated with the HAV.
Speaker 4: We expect to enroll approximately six additional patients to support the BLA filing.
Speaker 4: This should bring us past the target of 50 patients that was discussed with the FDA in recent meetings.
Speaker 4: We're working expeditiously to enroll the remaining six patients in V05.
Speaker 4: In addition to the recent addition of clinical sites in Israel, we now have efforts underway to add sites in Ukraine to the VO5 trial in order to speed enrollment. We've been pleased to partner with the USFDA and map out our strategy for BLA filing and trauma.
Speaker 4: within approximately four months after completion of the VO5 trial with the additional six patients.
Speaker 4: We plan to file a BLA for accelerated approval for an indication in vascular trauma.
Speaker 4: The targeted indication will be an accelerated approval of the HEV for arterial repair following extremity trauma when synthetic graft is not indicated and when autologous vein is not feasible.
Speaker 4: Our plans for the BLA filing, including the primary efficacy analysis,
Speaker 4: are consistent with a recent pre-BLA meeting and other meetings that we've held with the FDA over the past several months.
Speaker 4: The potential of the HAV and vascular trauma, particularly in the wartime setting, was further highlighted in a webinar that we hosted in December , featuring Ukrainian surgeons, Dr. Alexander Sokolov, Dr. Vazyl Shaprinsky, and Dr. Alexander Stanko, who shared their experiences using the HAV to treat patients with wartime traumatic injuries.
Speaker 4: Results have demonstrated a 30-day patency that is excellent with zero cases of infection in all the patients treated.
Speaker 4: A replay of the webinar can be found on the investors page of the HumanSight website.
Speaker 4: In addition to the webinar, our Ukrainian colleagues also presented patient outcomes at two vascular conferences in December of last year.
Speaker 4: the Congress of Vascular Surgeons, Phlebologists and Angiologists in Ukraine, and the Munich Vascular Conference in 2022.
Speaker 4: We extend our sincere gratitude to our colleagues for joining us for this webinar and sharing their positive experiences using the HAV for the medical community.
Speaker 4: Similar to our vascular trauma trial, our phase 3 VO7 trial of the HAV and arteriovenous access in hemodialysis patients is also nearing completion.
Speaker 4: As a reminder, the V07 trial is designed to assess the usability of the HAV for hemodialysis in comparison to autogenous fistulas. This will be done in up to 240 patients with end-stage renal disease.
Speaker 4: We're pleased to report that as of today, 238 patients have been enrolled in this trial, meaning that we are on track to complete enrollment with the remaining two patients very shortly.
Speaker 4: Top-line results are anticipated about one year after enrollment completion.
Speaker 4: And this is based on the one year follow-up period built into the study.
Speaker 4: If successful, results from this trial will support a BLA filing for its secondary indication in dialysis access.
Speaker 4: Turning to our earlier stage programs, we're happy to provide updates on our recent progress, particularly in peripheral arterial disease.
Speaker 4: coronary artery bypass grafting, and type 1 diabetes.
Speaker 4: Results from our Phase II trial in Peripheral Arterial Disease, or PAD, were recently published in the Journal of Vascular Surgery, Vascular Science.
Speaker 4: This publication describes the six-year analysis of the Phase II study, and researchers observed that HAVs provide long-term blood flow to patients with critical limb ischemia.
Speaker 4: with a secondary patency rate of 60% at six years.
Speaker 4: Importantly, there was no evidence of graft rejection or infection over this follow-up period and no patients underwent amputation of the treated limb.
Speaker 4: We're pleased that these results highlight the long-term durability of the HAV.
Speaker 4: in a relevant and a clinically complex patient population. We also continue to make progress in our preclinical coronary artery bypass grafting, or CABG, program.
Speaker 4: In November of 2022, Dr. Alan Kipson of UNC Rex Hospital presented a six month patency update of the HAV in a baboon cabbage model at an oral presentation at the annual American Heart Association Scientific Sessions meeting.
Speaker 4: In his presentation, Dr. Kipson highlighted that the HAV maintained structural integrity and patency for up to six months post-implantation as a heart bypass graft, and also showed evidence of robust host cell repopulation and remodeling.
Speaker 4: We're thrilled about the promising results of our small diameter HAVs and preclinical CABG models, and we look forward to providing additional updates on this exciting program as it continues to advance into IND-enabling preclinical studies. In addition, Humacyte is happy to announce that we have a new
Speaker 4: recently funded award from the Juvenile Diabetes Research Foundation or JDRF.
Speaker 4: JDRF is the world's largest nonprofit funder of type 1 diabetes research.
Speaker 4: Humacyte and the JDRF will collaborate on the development of Humacyte's product candidate, the Biovascular Pancreas, which is directed at the treatment of patients with type 1 diabetes.
Speaker 4: financial results and other business developments.
Speaker 5: Thank you, Laura. As of December 31, 2022, we had cash, cash equivalents, and short-term investments of $151.9 million, compared to the $225.5 million as of December 31, 2021..
Speaker 5: The $73.6 million net use of cash, cash equivalents, and short-term investments for the year ended December 31, 2022, resulted in spending related to net operating activities for the period, including clinical and earlier-stage research and development programs, and preparation for our anticipated commercial launch.
Speaker 5: We have been prudent with our expenditures and our use of cash for 2022 was approximately $8 million less than we had budgeted.
Speaker 5: We will continue to monitor our rate of expenditure, and we believe that our cash, cash equivalence, and short-term investments are adequate to fund operations through the end of 2024, past our current expected timelines for potential approval of the HAB in vascular trauma.
Speaker 5: There was no revenue for the fourth quarter of 2022 compared to $177,000 of revenue for the fourth quarter of 2021. Revenue was $1.6 million for the year ended December 31, 2022, compared to $1.3 million for the year ended December 31, 2021.
Speaker 5: Revenue in all periods related to grants supporting the development of the HAB. Research and development expenses were $15 million for the fourth quarter of 2022 compared to $16.3 million for the fourth quarter of 2021.
Speaker 5: And they were 63.3 million for the year ended December 31st, 2022.
Speaker 5: compared to $61.3 million for the year ended December 31, 2021.
Speaker 5: The decrease for the quarter ended December 31, 2022, compared to the prior year quarter, resulting primarily from a decrease in non-cash stock-based compensation expenses.
Speaker 5: The increase during the year ended December 31, 2022, compared to the prior year, resulted primarily from increased personnel and materials expenses designed to support expanded clinical and research initiatives in support of our clinical studies.
Speaker 5: General and administrative expenses were $5.8 million for the fourth quarter of 2022 compared to $5.6 million for the fourth quarter of 2021.
Speaker 5: And we're 22.9 million for the year ended December 31st, 2022.
Speaker 5: compared to 21.1 million for the year ended December 31, 2021.
Speaker 5: The small current year increases resulted primarily from the transition to being a public company and preparations of the anticipated U.S. commercial launch of the HAB, including increased personnel costs, external services, and insurance costs.
Speaker 5: Other net income was $17.1 million for the fourth quarter of 2022 compared to $64.2 million for the fourth quarter of 2021 and was $72.6 million for the year ended December 31, 2022.
Speaker 5: compared to $54.7 million for the year ended December 31st.
Speaker 5: to $54.7 million for the year ended December 31, 2021.
Speaker 5: The reduction in other net income for the fourth quarter of 2022 and the increase in other net income for the year December 31st, 2022 resulted primarily from non-cash gains related to the remeasurement of the contention earn-out liability associated with the August 20, 2021
Speaker 5: 21 merger with the Alpha Healthcare Acquisition Corps. Net loss was $3.7 million for the fourth quarter of 2022 compared to net income of $42.6 million for the fourth quarter of 2021.
Speaker 5: And that loss was 12 million for the year ended December 31st, 2022.
Speaker 5: compared to net loss of $26.5 million for the year ended December 31st, 2021.
Speaker 5: The increase in net loss for the current year fourth quarter compared to 2021 resulted from a decrease in other net income described previously.
Speaker 5: The decrease in net loss during the year ended December 31st, 2022, compared to the prior year.
Speaker 5: resulted from the increase in other net income described above partially offset by operating expense increases also described previously.
Speaker 5: With that, I will turn it back to Laura for concluding remarks.
Speaker 4: Thank you, Dale. To conclude, we've made significant progress throughout 2022 in both our clinical and our preclinical programs.
Speaker 4: We're excited to move closer to our BLA filing in vascular trauma. We will be pleased to close the enrollment soon in our AV-ACCESS trial, the V07 trial.
Speaker 4: 2023 is shaping up to be a significant year for Humasite and we are poised to build on our momentum from the past year. We look forward to providing further updates as we approach clinical and regulatory milestones.
Speaker 4: Operator, we're now ready to take questions.
Speaker 2: Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker 2: Our first question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.
Speaker 5: Good morning. Thanks for taking the questions, Lauren Dale, and appreciate it. I want to talk about the VO5 trial a little bit. Sounds like the FDA maybe had some feedback for you guys in terms of how you think about
Speaker 5: usage of the HAV in trauma. Laura, I was wondering if you could kind of speak to that specifically and how that impacts both utilization going forward and commercialization once you get that product to market.
Speaker 4: Yeah, so we're really happy that we've gotten
Speaker 4: clarity and direction from the FDA as far as number of patients and the analysis in VO5 as well as the targeted indication statement. The indication statement is really based on the fact that our VO5 trial has always been designed to be a
Speaker 4: for patients who do not have autologous vein, saphenous vein for treatment of their vascular injury. The contraindication for saphenous vein and for synthetic grafts really falls out of both the VO5 trial design, but also the fact that most of...
Speaker 4: traumatic injuries actually are not deemed suitable for synthetic grafts. So for example, penetrating injuries but also many blunt injuries that are that are half contaminated wounds are all known to be at high risk for infection. And so if you speak with most vascular or trauma surgeons, most of these people will indicate that a synthetic graft is really
Speaker 4: not suitable in many or most cases of trauma.
Speaker 4: So the limitation as far as the indication really speaks to patients who do not have available Safinasane, which is the enrollment criteria in the VO5 trial. Something that we didn't speak to in our comments earlier is the fact that it was an accelerated approval
Speaker 4: The FDA also asks that we perform a confirmatory study after we gain approval, after we're granted approval in the trauma indication. And we're currently designing that Phase IV confirmatory study with the FDA right now. Our anticipation is that the design of the confirmatory study would...
Speaker 4: sort of throw the gates open to a broader patient population and completion of that study, we would anticipate, would allow us to broaden the indication. But that said, the indication statement, we do not believe, is very narrowing from the standpoint that having something that's immediately available that doesn't require the hour of staff.
Speaker 6: What is it? Is it limited? The HIV is limited.
Speaker 6: to extremity injuries because I appreciate that you're including some of those other injuries in the safety data, but I just want to be clear about where you can or you think potentially you can or cannot use the HAV after BLA.
Speaker 4: So, the indication statement is focused on extremity injury because the data subset that we're analyzing in the trauma trial focuses on patients who have at least one anastomosis in an extremity. So, some of these patients have an anastomosis also in the pelvis or the thorax, but at least one anastomosis is in the extremity.
Speaker 4: The FDA asked us to do this because traumatic injury, as you would imagine, is very heterogeneous. And the focus on extremity injury was a way of sort of focusing on a slightly more homogeneous group of patients, although these patients still have a wide variety of patients.
Speaker 4: isn't a good match. So we believe that the extremity focus in the indication really doesn't change functionally where the HAV will be used very much.
Speaker 6: Yeah, no, that makes sense. Okay, and then just last question from me, I'll hop back in queue. In terms of timing, you know, I think we're kind of thinking middle of this year previously in terms of getting enrollment complete. I know you're bringing up some sites in Israel.
Speaker 6: and Ukraine, do you think the timing for the HAV VO5 trial can still maintain completion kind of mid 23, or do you think you're maybe pushing back a little bit just because the nature of
Speaker 4: of the patients you're targeting? Well, it's always hard to predict enrollment in a trauma trial. Certainly, we're going to work as hard as possible to get the remaining six patients enrolled. We're targeting six.
Speaker 4: Technically, we need a minimum of four more enrollments. So I will say that our prior enrollment rate of one per month has picked up a little bit recently with the addition of the Israeli sites.
Speaker 4: If we're able to bring up Ukrainian sites, I would expect that the enrollment would pick up above one per month because frankly the Ukrainian sites all by themselves enroll per month or more. So again, hard to predict, but I would hope that in the next couple months that we'll complete enrollment. I'll see you guys next time!
Speaker 7: question.
Speaker 5: Hey, this is still on format. Thanks for taking our questions. I guess just to piggyback off Ryan's question there for the VO 5 trial. That 63 patient number is current and not at the end of 2022, which would imply you're adding what 7 over.
Speaker 5: call it a quarter and a half, almost two quarters. Can you just speak to the current pace of additions here for that remaining six? And then can you just touch on the delta between needing only four more but you guys are going to go for six there?
Speaker 4: Sure. Well, you know, as I mentioned, the, you know, historically the pace of enrollment in V05. COVID-19 doesn't mean you're not Wanting to surrender and trying but trying still
Speaker 4: which was negatively impacted by COVID for sure, just like every other trial in North America. But previously we've been around one patient per month. That has picked up a little bit in the last couple months with addition of these sites.
Speaker 4: So, again, all I can say is that we think it will take a few months to enroll the four to six patients. The reason we're saying six right now is because, you know, with each of these patients and having very heterogeneous injuries.
Speaker 4: Our current strategy is to provide a little bit of a buffer or cushion, slightly above the targeted number of patients of 50.
Speaker 4: that we've discussed with the FDA. But the reality is that we currently have 46 patients that fall into the category that the FDA would like us to focus on. And so at a minimum, we would need four more patients to hit that target number of 50.
Speaker 4: I think one thing I do want to emphasize is that we've really been able to partner very well in recent months with the FDA and have had a very active dialogue with them and getting clarity on the subset of patients that they were most focused on.
Speaker 4: and the types of analysis they would like us to do and the patient number has really allowed us to provide a lot more clarity on our glide path for filing.
Speaker 5: That's helpful, thank you. And then just shifting gears really quickly, are you preparing in any way for commercial activities? What's going on on that front as you prepare for this stage and eventually making it to market for trauma?
Speaker 4: Well, I'll answer that a little bit and then I'll ask Dale and also Heather to weigh in a little bit more. But essentially, as you may recall, we began filling out our commercial team even in the latter part of 2021.
Speaker 4: So currently we have staff in place to lead the commercialization effort with really a focus on health economics and market access and reimbursement, although we are bringing on a VP of marketing in the next few weeks. So the groundwork that we are laying now is really around the
Speaker 4: Dale speak to staffing up for commercialization and I'll also ask our COO Heather Pritchard to speak to our commercial manufacturing readiness.
Speaker 5: Thanks, Laura and Matt. Certainly beyond BJ Shesley, our Chief Commercial Officer, we have a core marketing team in right now in addition to the budget impact model that Laura described. The emphasis are on the longer lead time items that need to be.
Speaker 5: prepared for in advance of launch and that includes preparing for the NTAP pass-through reimbursement from CMS which we think will be important to us and also you know things that may seem mundane like naming the product but are long lead time items that you know that work is underway right now.
Speaker 5: which requires going to both trademark issues as well as the FDA. Beyond that, there's certainly a great deal of effort going on.
Speaker 5: to prepare from a manufacturing point of view, and I'll let Heather address that.
Speaker 4: Thanks, Val and Laura. From a manufacturing standpoint, we're in track, as you know, to be able to produce our product for commercialization. We don't anticipate any complications, but we continue to prepare.
Speaker 4: for a pre-approval inspection and also update our modules to our PLA filing.
Speaker 4: pre-approval inspection and also update our modules to our PLA filing. Very helpful. Thanks.
Speaker 2: Thank you. Our next question comes from the line of Josh Jennings with TD Cowan. Please proceed with your question. Nike.
Speaker 5: Hi, good morning. Thanks for taking the questions. Sorry to interrupt.
Speaker 5: I just wanted to make sure that the, or get an update or just reiteration of the total addressable market. That hasn't changed, has it? No, just with this update from the FDA, I assume now, but just wanted to.
Speaker 5: get Clary there. And also any incremental thoughts on ultimate pricing of the HIV once you get the early approval.
Speaker 4: Yeah, again, we don't see the total addressable market really being materially impacted by this initial indication statement. As you know, the HAV at 6 millimeters in diameter really is most suited for injuries in the upper and lower.
Speaker 4: for any off-label use. I think the reality is that, you know, in trauma centers, the HAV will get pulled off the shelf and will get used in instances where surgeons feel it's best for the patient, you know, independent of the letter of the indication statement.
Speaker 4: So I don't think that TAM is really addressed by these clarifications. I'll let Dale speak to product pricing. Yeah, Josh, good to talk to you. As you know, pricing is a...
Speaker 5: complex decision that generally isn't announced until the time of launch. I guess if you were to dig back to our earliest FCC filings where we were required to put placeholders in there there is commentary about potential.
Speaker 5: price ranges.
Speaker 5: Which at that time suggested something in the $25,000 per HIV range, although decisions around pricing will be made at the time of launch. That being said, I can tell you that the work we've done to date in terms of looking at the budgetary impact of using the HIV versus standard of care or other treatments and also our discussions with hospital administrators would suggest.
Speaker 5: the PICE kind of straw man that we originally had is certainly acceptable and Pricing could be even somewhat higher than that particularly within the vascular trauma market. So that You know everything we've seen kind of progressed since our original SEC filings
Speaker 5: Close to two years ago, nothing has changed that other than to indicate even more so the viability of pricing at that level within this indication due to the major cost savings associated with things such as avoidance of amputation and avoidance of infection and the impact those have on the stay in the hospital and other costs.
Speaker 8: Excellent. Thanks for that. I want to just follow up on just about the, we get some questions on the pace of enrollment for V005 and our understanding just in terms of connecting the dots with the ultimate market opportunity. I mean, could you just review some of the hurdles in enrollment? I mean, our understanding of tech.
Speaker 8: market and some of the hurdles that your investigator sites face enrolling these patients.
Speaker 4: Yeah, Josh, you know that that's a really excellent question. So, you know, the number of vascular injuries in the US, you know, is what it is it's it's 10s of thousands per year, even in peacetime. But again, the hurdles and the difficulties.
Speaker 4: is injured enough that they require acute repair of an artery that is big enough to be treated by the HAV. That means that this patient is essentially bleeding to death. Typically, these events occur in the off hours in the middle of the night, and also by definition, if a patient is bleeding that much.
Speaker 4: they're typically not able to provide consent. So targeting patients with injuries severe enough to require acute repair, but finding patients who are not sedated or who are conscious and able to give consent or have a family member standing right next to them who could give consent, that just becomes a vanishingly small pool. So...
Speaker 4: you know, the realities of human clinical research are that, of course, you know, we have to abide by all regulations and consent every patient. But for this type of trial, it just places enormous hurdles on enrollment. So Humacye continues to believe that the realities of the marketplace are very different from that sort of tightly constrained.
Speaker 8: limitations that we've had to deal with in this trial. I appreciate that. And just lastly, thinking about the pipeline and the different indications that you're pursuing for HIV, is there any way to think about a prioritization in terms of how you're going to allocate investment dollars?
Speaker 4: to each of those pipeline projects. Thanks for taking all the questions. Well, the pipeline products that we're focused on most intensely are the coronary artery bypass graft, the small-caliber vessel, as well as the bivascular pancreas. Now, both of those studies—both of those—
Speaker 4: Product candidates are in large animal trials, so we're in primates for both of those candidates, which is very exciting. We're certainly pushing forward with large animal implantations in the CABG application and really filling out the preclinical database for that indication.
Speaker 4: And the same thing is true in the bio vascular pancreas. That said, the total dollars, even for primate work, because the numbers of primates aren't hundreds, you know, it's single digits or low double digits. So that's on the order of several million dollars for those programs.
Speaker 4: which is really a small total fraction of our total spend, because obviously, you know, with active phase three clinical programs in a couple different areas and, you know, fully scaled manufacturing, the vast majority of the spend is still going there. So we've made strategic decisions to continue to push forward what we believe are incredible.
Speaker 2: Thank you. Our next question comes online of Siraj Kalyot with Oppenheimer. Please proceed with your question. Good morning, Laura, Dale. Can you hear me all right? Yep. Yes. Perfect. Congrats on all the progress.
Speaker 9: So Laura, just following up on V05, and forgive me if I got my numbers wrong, wasn't the trial originally supposed to enroll 75?
Speaker 9: I guess where I'm headed is during your discussion to the FDA, were there any questions about efficacy in non-extremities which led to the 50 number of cases?
Speaker 9: Just trying to understand this new number and the difference in adjudication for efficacy versus safety, if at all. Yeah, Suraj, those are very good questions. So guidance that we've been providing to yourself and to the market.
Speaker 4: really since the summer of 2021, has been that we expected to enroll approximately 75 patients, give or take, in VO5 before we could file. And that was really an estimate based on what was then ongoing discussions with the FDA about which patient subset and we would...
Speaker 4: we would focus on and what the total number of patients required would be. So currently, as I mentioned, we're at 63 total patients, but the 50 number as a subset, again, was really an effort by the FDA to focus on
Speaker 4: a set of patients that was more homogeneous. So the number of, so just to be specific, the number of torso injuries that we have in the trial is actually pretty small. It's only five patients. And the extent of the injury in those patients is really a very different ballgame because if you have vascular disruptions, significant vascular disruptions in.
Speaker 4: So we have, gosh, I don't know, 10 or 12 iatrogenic injury patients, which the FDA views as actually a healthier patient subset because these wounds tend to be in a more sterile environment. They tend to be more discreet. So the FDA actually asked us for purposes of statistical analysis.
Speaker 4: to carve out patients with severe, oftentimes fatal injuries, which were the torso patients, and then perhaps more discrete injuries, which were the iatrogenic patients. So that left sort of the majority of the patients in the middle with limb injuries. And vascular injuries in the limb really are the majority of vascular injuries that occur in.
Speaker 9: are two additional patients remaining to be enrolled. Obviously, this is an open label. So I'm curious.
Speaker 9: You know, just given what's happened in view of five, why do we still need, is this some statistical issues that we are still, we need to get to 240 just trying to understand the difference between the FTS approach here also.
Speaker 4: Well, certainly the V07 trial is open label, quote, unquote, but I just want to emphasize that Humacyte is not privy to the results. This is a prospective randomized trial that is open label to the investigators, but Humacyte and Humacyte staff are blinded.
Speaker 4: And, you know, we're just following the trial protocol that we agreed to with the FDA a number of years ago, and the target patient number of 240 was based on the power calculations that we performed at the outside of the trial. So we've just been trying to hew to what we agreed to with the FDA.
Speaker 4: And again, you know, these patients are obviously, dialysis patients are obviously not as acute as trauma patients. These surgeries are elective, and the enrollment rate really took a hit during COVID, as we know. So we're just pleased to be finally wrapping up this trial.
Speaker 9: and getting to the enrollment target that we agreed to with the agency. Fair enough. And Laura, finally from my side, I'll hop back and cue GDRF. You know, congratulations on that partnership.
Speaker 9: The BVP, is that going to involve, I shouldn't say plain vanilla IPSC's, but are you all going to edit in any genes, knock out any genes, any timelines, any additional color would be greatly appreciated. Thank you for taking my questions.
Speaker 4: Yes, so we are focusing on stem cell-derived islets. I mean, we're taking a sort of a multiplexed approach. We're looking at the potential of using cadaveric native islets as part of the BVP program, but we're also looking very closely at stem cell-derived islets.
Speaker 4: because obviously that brings in manufacturability and control of eyelet supply, which is gonna be very important in any commercial setting. We are certainly looking at immune privileged IPX cells. I do not believe we've yet shared with the broader investment community.
Speaker 4: what exact types of immune privilege we're looking at, but I will generally say that as a general rule,
Speaker 4: overexpressing genes and adding in new stuff into a cell line that's then going to be therapeutic for a patient.
Speaker 4: It's generally a little harder from a regulatory standpoint than taking stuff out. So in other words removing genes that might be immunogenic, we anticipate will be an easier path forward rather than over expressing or adding in new proteins which might add more regulatory hurdles.
Speaker 2: Thank you. Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad. Our next question comes in line of Bruce Jackson with the Benchmark Company. Please proceed with your question.
Speaker 10: Hi, good morning and thank you for taking my questions. Quick follow up on the pre-approval inspection for manufacturing. Is that scheduled yet?
Speaker 4: Heather, do you want to take that? No, Bruce. We have... Oh, go ahead. No, Bruce. Nice to talk to you. We have not had that scheduled yet, so that pre-approval inspection will be scheduled by the SDA after they get our filing, our BLA filing. So it will be scheduled by then after we file. Okay, great. And then one quick follow-up. Okay.
Speaker 4: international meetings already on the BVP program and we expect to continue to present on the CABG program. I'm not really in a position to let you know which meetings we're presenting at, but these are both active, you know, primate level programs and so we're going to continue to keep the market apprised. Okay, great. That's it for me. Congratulations. Thank you,
Speaker 2: You may now disconnect your lines.