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spk08: Good morning, ladies and gentlemen, and welcome to the UMass site third quarter 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. I will now turn the call over to Lauren Merrick with the LifeSci advisors. Please go ahead.
spk01: 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. 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 will be filed today and may be accessed from the investor's page of the HemaCite website. Joining me on today's call from HemaCite 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. Dr. Nicholson will provide a summary of the company's progress during the quarter and recent weeks, and Dale will review the company's financial results. Following their prepared remarks, the management team will be available for your questions. I will now turn the call over to Dr. Nicholson.
spk06: Thank you, Lauren. Good morning, everyone, and thank you for joining us. on our third quarter 2022 financial results and business update call. During this call, I'll review our recent highlights and our progress in our key program 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. We had an exciting third quarter in advancing our bioengineered human tissue platform, which produces the human acellular vessel, or HAV. We completed a productive meeting with the FDA in October for our arterial trauma indication. Also in our pipeline, we initiated an important partnership to facilitate the development of our type 1 diabetes HAV product candidate. We've also strengthened our board of directors and our leadership team with the respective appointments of Lieutenant General Bruce Green and Dr. Cindy Kao. who bring significant experience in public health, drug and biotechnology development that will be invaluable as we move closer to our goal of bringing the HAV to market. I'll begin with an important update on our late stage program for the HAV in arterial trauma. The FDA has previously indicated that the HAV for the indication of vascular trauma qualifies for the accelerated approval pathway. we're pleased to report that we completed a meeting with the FDA in late October. Discussions in the meeting were productive and they focused on a statistical plan that incorporates data from our current ongoing VO5 clinical trial and from patients who we have treated in Ukraine. The discussions during this meeting inform our plan to file the BLA for the trauma indication in mid 2023. Our VO5 Phase 2-3 trial, which is a single-arm study evaluating the use of the HAV in trauma injury settings, currently has 56 patients enrolled, and the results of these patients were shared with the agency at our recent meeting. In addition to the VO5 patients, we've treated nine patients to date in Ukraine with the HAV, and the results of these implants were also shared with the agency. We're continuing to work with the FDA on the complete data package that will be necessary for filing the BLA. Previously, we've guided the market to an expectation of approximately 75 total patients as being needed in order to support a BLA filing in vascular trauma. Including patients from Ukraine and from DO5, that guidance of around 75 total patients remains our current estimate. Importantly, we're also submitting a clinical trial application to Ukraine in preparation for planned addition of Ukrainian sites into the VO5 trial. We continue to be encouraged with our results to date in vascular trauma, which show high rates of patency, a low rate of amputation, and only one case of HAV infection within the VO5 trial. We look forward to continued collaboration and dialogue with the FDA as we advance toward BLA filing next year. The HAV in the vascular trauma context was also the subject of multiple presentations at scientific conferences and publications throughout the third quarter. In October, the U.S. Army published an update in Task and Purpose, describing the use of the HAV in treating the war wounded in Ukraine. In the article, it was also noted that officials with the Defense Department encouraged Humacyte to collaborate with the Medical Technology Enterprise Consortium, or MTAC, EmTech has provided more than $6.8 million in funding to Humacyte to develop the HAV for vascular trauma, and we're grateful for their support. At the European Society for Vascular Surgery annual meeting in September, Ukrainian surgeons presented patient outcomes from the use of the HAV to treat wartime vascular injuries, including blast trauma, shrapnel injuries, and gunshot wounds. The surgeons observed that access to the HAV greatly assisted in limb salvage by improving their ability to perform vascular reconstruction and by eliminating the need to harvest saphenous vein or venous conduit. In addition, Dr. Todd Rasmussen presented an update on the HAV for the treatment of vascular trauma at the 44th International Committee of Military Medicine World Congress in September. Dr. Rasmussen spoke to an audience of NATO and other international surgeons and concluded that injured service members as well as civilians with complex injuries could benefit from the use of a readily available and infection-resistant vascular conduit such as the HAV that would facilitate quick implantation, especially in the setting of contaminated wounds. I'll now provide a quick update on our program of HAVs for arteriovenous or AV access in hemodialysis patients. Enrollment in our current ongoing phase three trial in dialysis access, which is designed to assess the usability of the HAV for dialysis in comparison to autogenous fistulas, is nearing completion of enrollment. With 227 patients out of a target of 240 total patients as of October 26th, We are on track for enrollment to be completed soon. Top line results are anticipated one year after enrollment completion, based upon the one year follow up period that's built into the study. If successful, results from the trial will support a BLA filing for the dialysis access indication for the HAV. As we progress toward commercialization in this indication, We're continuing to strengthen our relationship with our global partner and shareholder, Fresenius Medical Care, which is the global market leader in kidney care services, products, and value-based care. We're partnering with Franova, the clinical research arm owned by Fresenius, to evaluate complications and costs of dialysis access care for vulnerable patients in both the US and Europe. Granular data from more than 600,000 anonymized patients concerning demographics, access complications and failures, access infections, hospitalizations and mortality is being analyzed to provide targeted information on those dialysis patients who may most benefit from the HAV. We're also happy to provide updates in our earlier stage programs as we make progress in preclinical studies of the HAV, particularly in type 1 diabetes and in coronary artery bypass grafting or CABG. In October, we initiated a research partnership with the Diabetes Research Institute, which is a global leader in preclinical studies of novel diabetic therapies in order to facilitate the development of our biovascular pancreas, or BVP. The BVP is our HAV product candidate that is coated with islets and designed to deliver insulin to type 1 diabetics. We're excited for the opportunity to work with the experts at the Diabetes Research Institute in Miami and to accelerate the development of the BVP. Preclinical results from our small diameter HAZ program in CABG were also presented at both the American Heart Association basic cardiovascular sciences sessions in July, as well as at the American Heart Association scientific sessions meeting earlier this month. In a non-human primate model, the HAZ maintains structural integrity and patency for up to six months post implantation as a coronary artery bypass graft. In addition, the HAVs showed evidence of robust host cell repopulation and remodeling. We're excited about our small diameter HAVs that they continue to show promise in an important preclinical CABG model, and we remain hopeful that these HAVs have the potential to address the long-term patency, availability, and consistency issues that are associated with the current standard of care which is harvesting saphnous veins. Finally, Humacyte strengthened our Board of Directors and Leadership Team this quarter with appointments of accomplished medical and industry experts. In September, we welcomed Lieutenant General Bruce Green to our Board of Directors. General Green is a former Surgeon General of the United States Air Force and is an expert in disaster relief and military medical response operations around the globe. In addition, we also welcome Dr. Cindy Cao as our Chief Regulatory Officer. Dr. Cao brings over 20 years of industry experience with expertise in global and U.S. regulatory strategy and policy on biologics, small molecules, and devices. We're very pleased to have General Green and Dr. Cao join us, and we look forward to adding their insights and expertise to the Humacyte team. With that, I'll now turn it over to Dale for a review of our financial results and other business development.
spk02: Thank you, Laura. As of September 30, 2022, we had cash, cash equivalents, and short-term investments of $171.7 million, compared to $225.5 million as of December 31, 2021. The $53.8 million net use of cash, cash equivalents, and short-term investments for the first nine months of 2022 resulted from spending related to net operating activities for the period, including clinical and earlier stage research and development programs, and preparation for the company's anticipated commercial launch. We believe that our cash, cash equivalents, and short-term investments are adequate to fund operations through 2024, past the current expected timeline for potential approval of the HAV in vascular trauma. Revenue was $31,000 for the third quarter of 2022 compared to $0.2 million for the third quarter of 2021 and was $1.6 million for the nine months ended September 30, 2022 compared to $1.1 million for the nine months ended September 30, 2021. Revenue in all periods related to grants supporting the development of the HAV. Research and development expenses were $17.3 million for the third quarter of 2022 compared to $15.4 million for the third quarter of 2021 and were $48.3 million for the nine months ended September 30, 2022 compared to $45.1 million for the nine months ended September 30, 2021. The current period increases resulted primarily from increased personnel expenses to support expanded research and development initiatives and the support of clinical trials. General and administrative expenses were 6.2 million for the third quarter of 2022, compared to 5.4 million for the third quarter of 2021, and were 17.1 million for the nine months ended September 30, 2022, compared to 15.6 million for the nine months ended September 30, 2021. The current period increases resulted primarily from the transition to being a public company in preparation for the anticipated U.S. commercial launch of the HAV, including increased personnel costs, professional fees, and insurance costs. Other net expense was $1.8 million for the third quarter of 2022, compared to $11.0 million for the third quarter of 2021. and other net income was $55.5 million for the nine months ended September 30, 2022, compared to other net expense of $9.5 million for the nine months ended September 30, 2021. The reduction in other net expense for the current year third quarter and the increase in other current net income for the current year nine months resulted primarily from the re-measurement of the contingent earn-out liability associated with the August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $25.3 million for the third quarter of 2022, compared to $31.6 million for the third quarter of 2021. And net loss was $8.2 million for the nine months ended September 30, 2022, compared to $69.1 million for the nine months ended September 30, 2021. The current period decreases in net loss resulted from the reduction in other net expense and increase in other net income described previously, partially offset by operating expense increases also described previously. With that, I'll turn it back to Laura for concluding remarks.
spk06: Thank you, Dale. To conclude, we've made significant progress over the last quarter in both our clinical and our preclinical programs. As we approach year-end, we're excited by the coming months and the prospect of bringing this important technology to surgeons and to patients in need. And we look forward to providing further updates as we approach clinical and regulatory milestones.
spk07: Operator, we're ready to take questions now.
spk08: We will now begin the question and answer session. To ask a question, you may press star then one on your touch-down phone. To withdraw your question, please press star then two. The first question is from Josh Jennings with Cohen and Company. Please go ahead.
spk00: Hi, this is Eric for Josh. Thanks for taking the question. I wanted to start in vascular trauma. I'm just thinking about your discussions with the FDA and their thoughts on the inclusion of the Ukrainian HIV experience. do you think there's any possibility that the bar for your 75 patient enrollment number could be lowered in your phase three trial? And if that is possible, when do you think we would hear about a lower enrollment target? Do you have any upcoming FDA meetings where this could be discussed?
spk06: Thank you, Eric. This is Laura Nicholson. Yeah, that's a very good and insightful question. I'll answer it to the best of my ability. So the discussions late last month with the FDA were productive. We shared with them both the VO5 data, in which we've enrolled 56 patients, and also the nine patients in Ukraine, which add up to about 65 total patients. Clearly, our results in Ukraine have been very positive and are strongly supportive of the 56 patients. patients that we have in VO5, and clearly the Ukraine scenario is a real world scenario where you could argue the wounds are dirtier and the care of the patients is more difficult. I want to be clear, the humanitarian use patients in Ukraine are not part of the VO5 study, at least not yet, although we are contemplating adding sites in Ukraine to the VO5 trial. I think it's too early to say that a specific number of patients. What we're talking about now with the FDA is really statistical tools that will drive the size of the total number of patients that are under consideration. But it remains our estimate that the total number of patients, if you were to include the VO5 patients, and the Ukraine patients, which is now at 65, it remains our estimate that all patients added together is approximately 75. But this is going to be based on finalizing our statistical approach with the agency. Does that help?
spk00: That does. Yeah, that makes sense. Thank you. And then secondly, I know it's still early on, but as your later stage trials come to an end and we start thinking about top line readouts and potential approval submissions, is there any work you're doing to set up or organize the commercial infrastructure? And again, I know it's still very early on, but when do you think we may hear more updates on that front?
spk07: Dale, you want to take that?
spk09: Yeah, absolutely.
spk02: Yeah, certainly, Eric. We've brought on a head of... commercial operations BJ Shesley which has been with the company for a little bit more than a year now and has a team around him that is doing many of the long-term planning activities that are going to be required to support all the commercial launches but in particular our initial commercial launch expected in vascular trauma yes we've talked about before vascular trauma within the United States is certainly a nice place for the initial launch. It's a relatively concentrated market with about 200 level one trauma centers in the United States. So it requires a relatively smaller sales force than other locations might. And as we get closer to the actual anticipated launch date, we'll continue to add other open marketing infrastructure in longer term activities that are required, such as reimbursement and patient access and things along that nature. And then as we get even closer to that swim, we'll start bringing on the actual sales force.
spk09: Okay, understood. Thank you for the questions.
spk10: The next question is from Matthew O'Ryan with Piper Sandler.
spk08: Please go ahead.
spk11: Hey, this is Phil on for Matt. Thanks for taking the questions. Just a quick one on the VO5 trial. Now call it 56 plus 9 patients here. You added one patient ex-Ukraine in the quarter. Do you have any line of sight into patient ads here in Q4? Can we expect things to kind of accelerate into the end of the year and early next year?
spk06: Yeah, that's a good question. We have overall been enrolling about one patient per month in the trial with ebbs and flows, certainly. We're working all the time to accelerate that. We have brought several sites up in Israel in recent months. And as I mentioned, we're going to be working in the spring with the government in Ukraine to try to bring on several hospitals that have been using the HAV already on the front line to bring them into the VO5 trial. Given the rapid use of the HAV in the Ukraine war setting, we anticipate that adding the sites in Ukraine and in Israel will help to speed enrollment, although inherently by the nature of trauma, It's hard to predict. But I would say overall, during the trial, we've enrolled a little more than one patient per month. And we're hoping that that rate maintains or accelerates somewhat.
spk11: No, that's very helpful. And I guess just shifting gears here, can you speak to you entering this partnership with the DRI down in Miami? and when we could maybe start to see some preclinical data on the BBP. Thank you so much.
spk06: Yes, I think, you know, we've been in discussions with the leaders at the DRI for a number of months. As you may know, and some of these listeners may not, the Diabetes Research Institute is really probably the premier organization in the world that has been experimenting with islet transplantation. And they've been doing experiments in non-human primate models for decades with this therapy. And so since the biovascular pancreas is really an islet transplantation delivery method or technology, we view the partnership with the DRI as being a really important tool accelerator for what we're going to be able to do because of their expertise in primate models and immunosuppression and islet isolation, et cetera, et cetera. With that being said, I think that, again, I hate to predict, but I think that we will have updates on the BVP project, certainly by the middle of next year, perhaps earlier. We have multiple work streams underway, not just the work with the Diabetes Research Institute, but also work with various stem cell lines and various sources of islets that we would use in the BDP. So it's a little bit like duck's feet underwater. We've got a lot going on, and I would expect more updates probably in the next six to nine months.
spk09: Great, great. Thanks so much.
spk10: The next question is from Suraj Dalia with Oppenheimer. Please go ahead.
spk09: Good morning, Laura. Dale, can you hear me all right?
spk07: Yes.
spk05: Perfect. Hey, Laura, a lot of questions have been asked on VO5, and I was curious, the conditions for humanitarian use, as I understand it, they're usually different than and that in a clinical trial setting, please correct me if I'm wrong, and I'm just curious if this would become apples and oranges if we tried to reach the N is equal to 75.
spk06: So I hear what you're saying, Suraj, and let me try to clarify a little bit more. So as you may be aware, the Humacyte HAV for the trauma indication qualifies for an accelerated approval pathway. And what the FDA typically specifies is that in an accelerated approval pathway or in single arm trials, they often look for confirmatory information either from other clinical trials or from laboratory-based studies, et cetera, et cetera, or even other indications. So the humanitarian data in Ukraine really fall into the category of confirmatory or supporting data. They're not primary clinical trial data in the VO5 trial. However, because actually the patients who are receiving humanitarian use of the HAV actually fall under the inclusion and exclusion criteria that we've applied for the VO5 trial, so they have the same types of injuries These are injuries to the arteries and the limbs with arteries of a certain diameter that's addressable by the HAV, et cetera, et cetera. So actually the comparability of the patients and the clinical use scenarios is higher than you might think. Although I will say that the complexity of the injuries and the contamination level of the injury in Ukraine is actually probably worse than the US because a lot of these patients have shrapnel and mind blast injuries that are fairly horrific. So from our conversation with the FDA, they view the Ukraine data not as equivalent to the VO5 data, but as strongly supportive. And indeed, they view clinical success in Ukraine as sort of meeting a higher bar than a clinical trial site in the US because it's a more austere environment.
spk05: Got it. And Laura, a couple of questions on the Fresenius and the AV fistula part of the equation. The 600,000 patients being analyzed, Laura, maybe you can give some parameters in terms of what specific criteria are being used and how many of those potentially could be candidates for HAV And on the same token, Dale, if I could just throw one question your way. Maybe you can help us understand 171 million on hand, a lot of stuff going on in the Fresenius side of the equation. Just characterize where you are in terms of Fresenius' relationship with human side. Thank you for taking my questions.
spk06: So, Suraj, I'll start with the Franova research. So, as I've mentioned on previous calls, this is an exciting project that we're doing with them, but it's a big project. Obviously, 600,000 patients in the U.S. and Europe. What we're, the types of data we're obtaining, you know, I included in our remarks and in our press release, we're really trying to understand with respect to access, dialysis access per se, Who are the patients who have essentially repeated problems with their access? Who are the patients who have an access placed initially but then who see multiple failures or see multiple infections with their access or whose fistula is never mature and so they're left with catheter and then their catheters become infected? And really the question that we're asking with Franova is what is the profile of a patient who, is very likely to have multiple problems with their access and multiple failures. So, for example, if you're a 75-year-old diabetic woman and if you're being considered for a fistula, the data may tell us from Franova that statistically a 75-year-old diabetic woman is very unlikely to mature her fistula and is likely to have three hospitalizations from sepsis, and so you probably shouldn't go that route. And it's really a different kind of data analysis than has ever been done in this field. Certainly the USRDS never analyzes data in this way. But it's really a patient-centric approach to identify the type of patient who has the most trouble with their access, because we believe that that is the patient population who really may benefit from the rapid usability for dialysis and the low infection rate of the HAV. So how many of those, you know, what fraction of those 600,000 patients, you know, it's hard to know right now because we're still deep in the analysis. But again, our prior guidance as far as market capture has been about 20% of the total market, you know, at full market penetration. So it's still a fairly conservative assessment. Again, there are data out there that says that women and particularly older women or diabetic women or the elderly in general tend to not mature their fistulas and tend to spend a lot of time on catheter. If I were to guess, I would say it's that segment that will most benefit from the HAV. The beauty of this project is that it's going to allow us to have very hard quantitative numbers that we think will be compelling. for insurers and healthcare providers and hospitals.
spk09: This is Ed Dale with regards to your second question around Fresenius.
spk02: You may have been referencing some of the recent leadership changes as well as structural changes within Fresenius. Regardless of those events, we certainly don't see any lack of enthusiasm or change in the enthusiasm level at Fresenius for the HAV and the potential impact it promises with regards to the care of AV access patients, including improving patient outcomes. It's more inferred from the Franova research, also providing the cost savings and the treatment of appropriate patients that are targeted. We continue to work very closely with them, and I can tell you that we're still high on their priority list. The new leadership within Fresenius is actually visiting our offices next month to our facilities. So the relationship continues as strong as it's ever been.
spk09: Thank you.
spk10: The next question is from Bruce Jackson with the Benchmark Company.
spk08: Please go ahead.
spk03: Hi, good morning, and thank you for taking my question. I wanted to start with the pace of enrollment for the AV access trial, the V007 trial. So last year, I think you were some, last year, last quarter, you were someplace around 222 patients, up at 227 this quarter. Given that sort of five to six patients per quarter case and extrapolating it out, it looks like you've got maybe two to three more quarters of enrollment to go. So maybe you could talk to us about the pace of enrollment in that trial and if there are any anticipated changes here going forward.
spk06: Yes, I think the last quarter was disappointingly slow. It certainly was slower last quarter than we've seen in other quarters, and I'm not sure that that's representative. I think that we have had follow-on meetings with many of our high-enrolling investigators, and we've activated several new sites in the trial with a lot of new investigator enthusiasm. Part of the slowdown last quarter may have been I just think investigator fatigue. This trial has been going on throughout COVID, and it's been a tough trial to enroll because this is sort of an elective surgical population that sort of cycled in and out of care during the COVID pandemic and all the lockdowns. So again, I'm hoping that it's certainly not going to take several more quarters. You know, the number of patients that we're planning to enroll is approximately 240. So could be a few more, could be a few less. And again, all I can say is that we're very close and we're leaning into it very hard.
spk03: Okay, great, great. And then once you've completed the follow-up and the data analysis, I'm assuming that the turnaround to filing with the FDA is gonna be fairly quick.
spk06: Well, it depends on what the results are, as always. But yes, this would be an amendment to the BLA, presumably by the time we file the dialysis access indication, we would already have the trauma indication in place and granted. And certainly the manufacturing components and the preclinical components and the quality components of the BLA for the dialysis indication would be identical to what has already been filed in trauma. So it really comes down to a summary of the clinical trial. So you're right, the hurdles to filing a BLA, assuming that the outcomes from VO7 are what we're hoping, that timeline could definitely be shortened. But again, we're still enrolling, Bruce, and I'm not going to be the one to say I know what the outcomes are.
spk03: Okay, okay, great. And then a quick question for Dale on the operating expense profile here going forward. So as we're looking toward 2023, should we be taking the current operating expense for the quarter and kind of like moving that forward? And then how do you see that profile changing over the course of 2023 as you ramp up the marketing expenses for the product launches.
spk02: Yeah, Bruce, you're right. We are going to, as we get closer to, you know, with a mid-2023 filing, that approval, you know, some period of time after that, we can talk about estimates of what it will take to go through the VLA process. But, you know, at the relevant point in time, we're going to see a ramp up in commercialization expenses. Now much of those come near time of approval with the bringing on of Salesforce. Since that's a little later in the process than some of the other hires on the marketing side that came in earlier. But that being said, when we talk about expenditures in 2023 and 2024, the level of expenditure is not set. It's going to be somewhat at our discretion. You're right in that commercialization expenses will increase But certain other clinical trial expenses will be winding down, such as B05 and B07 during that time frame. So the actual ultimate burn rate is going to be somewhat dependent upon our election in terms of how quickly we move certain programs and expand our pipeline, particularly with more advanced stage clinical development of some of the earlier stage programs. And part of that determination is just going to be made, to be honest with you, based on market conditions and how things are flowing at that point in time. Clearly, we have the cash on hand to get past major value inflection points. The rate we're spending right now, from today, we've got about 2.4 years of cash on hand. We also believe we've got meaningful debt capacity available to us, particularly for the working capital requirements and some other requirements associated with the launch. We're not going to draw a line in the sand right now in terms of what the expenditure levels are going to be for 2023, because part of that's going to be based on our discretion, depending upon what's happening in the world as we move into that year.
spk09: Okay, got it. Thank you very much for taking my questions. You're welcome.
spk10: Last question.
spk08: The last question is from Ryan with BTIG. Go ahead.
spk12: Hey, good morning. Thanks for taking the questions. I apologize if I missed this, Laura. But did you, given the enrollment pace for B05, when do you expect top-line data ahead of, you know, putting together the BLA submission?
spk06: So, yes, we didn't cover that, and so that is a good question. So the position of the FDA continues to be the same, that because we're on this accelerated approval pathway, that it's really 30-day patency, primary patency, that will be the primary endpoint in this trial. And other endpoints such as patient survival and limb salvage will be secondary endpoints. So because this is a single-arm, open-labeled trial and because we've been following all along, once the last patient hits their 30-day endpoint, we will have top-line results in hand. So I think that the time delta between when we finish enrolling and when we have top-line results will be short. And again, also because of this and because much of our BLA in terms of manufacturing has already been submitted to our IMD, We think that the time between when we finish enrolling and when we file the BLA will only be a couple months. It'll be pretty quick.
spk12: Yeah, no, that makes sense, and I would assume that, you know, similar to other submissions, a lot of that, a lot of it's already done, and it's really this last clinical piece that you're waiting on. Just as an aside, I know you were bringing on the Israeli sites. Are those enrolling at this point, those Israeli sites? Obviously, you know, numbers are, the patient numbers are where they're at, but are they actively up and running at this stage?
spk06: They're actively up and running. In fact, we had a visit from one of our operations people to Israel just last week. Israel has not enrolled as of yet, but we anticipate that they will.
spk12: Okay, that's very helpful. And then last one for me, just, you know, what commercial activities are you guys preparing for? As we think about V05 and getting the BLA ready, you know, you have started to make some hires on the commercial side with BJ, and so I was curious kind of what commercial activities are you preparing for at this stage as you think about V05, you know, eventually making it to market?
spk06: Yeah, go ahead, Lowe. No, I'll just say a little bit, Dale. I mean, certainly we have BJ, and we're building out the commercial team in terms of marketing. We have some staff on board as far as health economics, and we're looking at growing the team in terms of market access. We've also been using a lot of third-party vendors to do market analysis for us and to look at price sensitivity issues. and scenarios according to hospitals and healthcare providers as far as where they think the HAV would be most useful in trauma. So again, a lot of that has been like duck's feet underwater and it hasn't represented hires per se because a fair bit of this work has been outsourced, but we're actually fairly far down the path as far as analyzing the market by virtue of these third party vendors. But I'll let Dale continue.
spk09: No, I think you actually covered it all, Laura.
spk10: Thank you. I'm showing off for the questions in the Q&A.
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