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spk09: Good morning, ladies and gentlemen, and welcome to the Humacyte first 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. If anyone should need operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Merrick with FlightSci 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 laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Any 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 Investors page of the Humasite website. Joining me on today's call from Humacyte 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 before turning it over to Dale for a review of 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.
spk04: Thank you, Lauren. Good morning, everyone, and thank you for joining us. We appreciate your attendance today. I'll just briefly summarize our recent highlights before turning the call over to Dale for a review of the financials for our first quarter. Then we'll be happy to open up the call to your questions. I'm pleased to report that we had a productive first quarter marked by continued progress advancing our universally implantable bioengineered human tissue platform. We believe our lead candidate, the HAV, is uniquely suited for scenarios in which the current standard of care is either unavailable or is inadequate. This week, we were proud to announce a new initiative in which we are providing our HAVs to frontline hospitals in Ukraine. for the treatment of military and civilian vascular trauma injuries that are resulting from the crisis in the region. During the quarter, we also strengthened our team with the appointment of Dr. Shameek Parikh as our chief medical officer. Dr. Parikh joins us at a pivotal time as we look forward to anticipated completion of our late stage clinical trials in vascular trauma and arteriovenous access for hemodialysis. And if approved, as we endeavor to bring the HAV to market for our initial indication. I'll first begin with our announcement earlier this week of a new initiative to provide our HAVs to multiple hospitals in Ukraine for the treatment of wounded civilians and soldiers who are suffering from vascular traumatic injury. This initiative began as a request from one Ukrainian surgeon who was familiar with our technology and requests from the Ukraine quickly grew to include other surgeons and hospitals around the country. Six hospitals in Kiev, Kharkiv, and other cities will be the recipients of our initial shipment. We continue to receive requests from local surgeons for the product candidate, and we plan to coordinate shipments to additional hospital sites as soon as possible. In launching this initiative, Humacyte worked with the Office of International Programs within the US Food and Drug Administration as well as with the Ukraine Ministry of Health to coordinate the export and import of our investigational HAV for humanitarian use. While this humanitarian effort is outside the scope of the company's ongoing trauma trial, we expect that this program will provide additional real-world evidence of the potential impact of the HAV in the treatment of vascular traumatic injuries. As a company, Humacyte is very proud to contribute to the ongoing medical relief efforts in Ukraine and to support the patients and the brave medical practitioners on the ground during this humanitarian crisis. I'm immensely grateful to the Humacyte team for their tireless work seeing this through, as well as to the surgeons in Poland and in the U.S. who have extensive experience with the HAV and who have volunteered to assist in training the Ukrainian surgeons in the use of the product Candidate. Moving on to our broader platform for HAV and vascular trauma, our Phase 2-3 clinical trial is continuing to progress. As a reminder, this trial is a single-arm, non-randomized, open-label study evaluating the use of HAVs for vascular repair, reconstruction, and replacement in traumatic injury settings. We're pleased with the results from this study to date, showing low rates of infection at approximately 2%. We've also had no reports of limb amputation that occurred as a result of HAV malfunction, and we've observed very high patency of the conduit to date. Results from the trial are expected later this year, and we believe these results will support our planned BLA filing with the FDA, which we intend to submit by the end of 2022 or early 2023. We continue to progress in our discussions with the FDA about the trial design and the required number of subjects to be enrolled. You'll recall that the FDA has granted accelerated approval pathway for HAVs in this indication. The HAV was the subject of multiple presentations at scientific conferences and journal publications during the first quarter. Results from a case study of a patient who received the HAV as a replacement for a synthetic infected iliofemoral bypass grafts were published in the Journal of Vascular Surgery, Cases, Innovations, and Techniques. In this case, at 22 months post-implantation, the patient had resumed regular physical activity and had no signs of infection of the HAV implant. In a first U.S. case series that was published, surgeons from the Uniformed Services University of the Health Sciences and Walter Reed National Medical Center reported on the first eight FDA-approved expanded access cases using the HAV for treatment of critical limb ischemia or vascular trauma. In this case series, the HAV was observed to resist infection and to provide reliable patency and also offered surgeons an immediately available biological conduit. The report of this case series was published last month in the April edition of the Annals of Vascular Surgery. And finally, we're looking forward to the planned presentation of new HAV clinical immunogenicity data, reporting on blood work from patients who have received the HAV during a presentation at the American Transplant Congress that will be taking place in June of 2022 in Boston. The presentation will be delivered during the Bioengineering and Transplantation Where Are We and Where Are We Going session on June 8th at 7 a.m. Eastern Time. This talk will provide quantitative insights into the patient responses and tolerance of the HAV when implanted in various clinical indications. Turning now to our development program of HAVs for arteriovenous or AV access in hemodialysis patients. Enrollment in our Phase III trial is nearing completion. This trial is designed to assess the usability of the HAV for dialysis in comparison to autogenous fistulas in up to 240 patients with end-stage renal disease. We expect enrollment to be completed later this year. Based on the one-year follow-up period built into the study, we anticipate top-line results in 2023, followed by a BLA filing for the dialysis indication. Five-year data from a Phase II clinical trial of patients receiving the HAV for dialysis access were published in the journal EJVES Vascular Forum. Results showed long-term durability and usability of the HAV during the five-year follow-up period with no reports of infection or immunogenicity. As we progress toward commercialization, we look forward to building upon our strong relationship with our global partner and shareholder, Fresenius Medical Care. Fresenius is the global leader in kidney care services, products, and value-based care, and is also providing valuable market insights and commercial launch advantages. We're partnering with Phrenova, a clinical research group owned by Fresenius, to evaluate the costs of hemodialysis access care for vulnerable patients in both the U.S. and Europe. These evaluations will assist us with development of health economic models and value propositions for the HAV in patients with kidney failure. Finally, we're also continuing to make progress in our earlier portfolio programs and other indications. The expanded access program for HAVs in patients with emergency vascular conditions, such as severe peripheral arterial disease, continues to progress. To date, we've implanted roughly 20 patients in the U.S. under this program. And the outcomes of the first eight cases were highlighted in a presentation in January. In addition, enrollment of patients in the Mayo Clinic's investigator-sponsored study of HAVs for the treatment of severe PAD is advancing, and we anticipate providing an update on this study later this year. With respect to our preclinical programs, in January we presented positive results from our first preclinical study of our small diameter HAVs for use in coronary artery bypass grafting, or CABG. This presentation was at the Advanced Therapies Week in January. In this study, the HAV was observed to maintain patency and exhibited host remodeling as well as regeneration in a non-human primate model, thus highlighting the potential use of HAVs in coronary artery bypass grafting. In addition, we continue to be encouraged by our efforts in developing HAVs as complex organ systems. Our biovascular pancreas, or BVP, is an HAV that is coated with islets and designed to deliver insulin to type 1 diabetics. BVP results in a diabetic rodent model were published last year in the Journal of Tissue Engineering. And we're currently moving forward into large animal preclinical studies of this exciting program. As far as other corporate updates, as I mentioned earlier, Last month, we were pleased to announce the appointment of Shameek J. Parikh, MD, as our Chief Medical Officer. In his new role, Dr. Parikh will lead our global clinical development strategy, including oversight of the preclinical and clinical development, clinical operations, and medical affairs functions. Dr. Parikh brings to us more than two decades of leadership experience in academia, the NIH, and at global pharmaceutical companies, including his 16-year tenure at AstraZeneca. Dr. Parikh has led clinical research and development, product launches, medical affairs, and drug safety across multiple therapeutic areas. We're very pleased to have Dr. Parikh with us, and we're looking forward to adding his insights and expertise to the Humacyte team. And with that, I'll turn it over now to Dale for a review of our financial results and for other business developments.
spk07: Thank you, Laura. As of March 31st, 2022, we had cash, cash equivalents, and short-term investments of $206.2 million compared to $225.5 million at December 31st, 2021. The $19.3 million net use of cash, cash equivalents, and short-term investments for the first quarter of 2022 resulted from spending related to net operating activities for the quarter. including our clinical and earlier stage R&D programs and preparation for our anticipated commercial launch. We believe that our current cash position is adequate to fund operations through the end of 2024 past our current expected timelines for potential approvals of the HAV in vascular trauma and AV access for hemodialysis. Revenue for the first quarter of 2022 was $233,000. compared to $155,000 for the first quarter of 2021. Revenue for both periods was related to grants supporting the development of the HAB. Research and development expenses were $16.3 million for the first quarter of 2022, compared to $15.1 million for the first quarter of 2021. The current quarter increase resulted primarily from increased personnel and material expenses designed to support expanded research and development initiatives in the support of our clinical trials. General and administrative expenses were $5.7 million for the first quarter of 2022, compared to $4.8 million for the first quarter of 2021. The current quarter increase resulted primarily from the transition to being a public company in preparation for the planned U.S. commercial launch of the HAV, if approved. including increased personnel costs, professional fees, and insurance costs. Other net income was $1.9 million for the first quarter of 2022 compared to net expense of $0.5 million for the first quarter of 2021. The current year increase in other net income resulted primarily from non-cash gains related to the re-measurement of the contingent earn-out liability associated with the August 2021 merger with Alpha Healthcare Acquisition Corp. These gains were partially offset by an increase in interest expense related to our loan facility with Silicon Valley Bank. Net loss was $19.8 million for the first quarter of 2022 compared to a net loss of $20.3 million for the first quarter of 2021. The current quarter decrease in net loss resulted from the increase in other income described earlier, partially offset by expense increases also described earlier. With that, I'll turn it back over to Laura for concluding remarks.
spk04: Thank you, Dale. To conclude, 2022 is off to an exciting start. We launched an important new initiative to assist the humanitarian crisis in Ukraine with our HAV technology. And we have continued to advance our HAV platform in both clinical and preclinical programs. We also strengthened our leadership team with the appointment of Dr. Shameek Parikh as our new CMO. And we have a strong balance sheet with anticipated cash runway to carry us through significant value inflection points. Operator, we're ready to take questions.
spk09: 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 keypad. The confirmation tone will indicate your line is in the question queue. You may press star 2 if you would 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. One moment, please, while we poll for your question.
spk02: Our first questions come from the line of Ryan Zimmerman with VTIG.
spk09: Please proceed with your questions.
spk06: Good morning. Thanks for taking the questions. Hope you're doing well and congrats on the progress. I want to start with both the V005 trial and the V007 trial. I think last quarter the V005 trial was sitting at 50-plus patients enrolled. I believe you only need 40, and so I want to just understand kind you know, what you need to, you know, officially complete enrollment there before submitting. And then I think AV Access, the VO7 trial, I think, again, you were at 210 last quarter. You need 240. So kind of where are you standing there? And if we were to hone in on, you know, enrollment for those two trials in terms of timing, that'd be helpful. Thank you.
spk04: Ryan, this is Laura Nicholas, and thanks very much for those questions. So with regard to VO5, which is our single-arm trauma trial, we've continued to enroll at the rate of a couple patients per month, one or two patients per month, which has been sort of our standard. We are obviously efforting increase in enrollment rate. Currently, I think we sit around 54 patients, although I'm not completely sure, but I think that's roughly the right number. With regard to the 40 number that you mentioned earlier, the guidance that we've given to the streets so far is that we anticipate needing roughly 70 or 75 patients in total to have a sufficient number of evaluable patients for the FDA to accept the BLA. Okay. We are continuing discussions with the FDA and we're actually making progress on those discussions and nailing down this number. So we continue to feel confident that the timelines that we've been communicating so far as far as having enough patients and completing enrollment by the end of this year, we continue to give that guidance. But I can't give you any more specific numbers at this time. With respect to dialysis access, You're right. I think maybe at the last call we were around 210. I can't remember. I think right now we're around 220 patients. Enrollment is picking up a little bit now that COVID restrictions have been pulled back over the last month or two in many locations. So, again, we continue to give the same guidance that we anticipate completing enrollment later this year and then would have top-line results sometime perhaps mid to third quarter of 2023. Got it.
spk06: Very helpful, Laura. Thank you. And then, yeah, I must have mistaken on the 40. On the immunogenicity data, what should we be looking for?
spk04: So as we've given guidance to our analysts and our investors previously, To date, we've seen no evidence of immunogenicity, clinical immunogenicity in any patient that we've studied. However, we've never reported these results in terms of specific blood work outcomes and really more nitty-gritty clinical details. And so the focus of the talk that we'll give in June at the American Transplant Congress really is providing the scientific underpinning and the blood work details around those data. The overall message is going to remain the same, but I can't share any more details now in advance of the presentation.
spk02: Understood. Thanks for taking the questions. Thank you.
spk09: Our next questions come from the line of Saraj Kalyan with Oppenheimer. Please proceed with your question. Morning, Laura.
spk02: Dale, can you hear me all right? Yes.
spk05: Perfect. Hey, so, Laura, in terms of the 005 and 007 trials, just the length of the trials given COVID and everything, should we anticipate any sort of confounders when the enrollment is done and the data is presented?
spk04: So, Suraj, I think I understand your question. I think you're asking You know, whether just the increased duration in enrollment because of slowdown due to COVID, whether that's going to impact outcomes. You know, again, it's a little hard to answer that question because we don't have the alternative hypothesis, which is if we had rolled, you know, quickly, then what would that trial look like? So it's a little speculative on my part. But I will say that in dialysis, it's well known that COVID, when it infects dialysis patients, is particularly lethal. The fatality rate is 20 to 30% in dialysis patients. And we know we've had a number of COVID infections. So I think that the number of deaths that we may see in the dialysis population may be a little bit higher, but I don't think that's going to otherwise impact efficacy of the HAV per se.
spk05: Got it. Laura, in terms of the vascular trauma trial, I know the discussions with the FDA have been ongoing for some time. Is there something specifically, you know, that is, I shouldn't say a point of contention, but, you know, a point of negotiation, so to speak, in the endpoints in the design or anything, you know, any additional color would be greatly appreciated.
spk04: Yes, I think, so you're right, these conversations have been going on for a while. I would say that we're advancing them well now and I'm pleased with the progress. But, you know, the points of discussion are really more around total body of data, both pre-BLA and then potentially post-approval. So as we've mentioned, you know, the FDA has offered an accelerated approval pathway for the product. And so combined with that, with any accelerated approval pathway, is also a post-approval commitment or requirement. And because the trauma population is so diverse, there's been a lot of discussions about the amount of data that the FDA would like to see pre-approval and then post-approval. So that's really kind of one of the major foci of our discussions.
spk05: Okay. That makes a lot of sense. Agreed. Hey, Dale, you mentioned, you know, roughly 200 million on hand. Till year end 24, everything should be kosher. So if I use the 25 million or close there off, burn this quarter, you know, straight line, I get it. Dale, if you could just drill down one more layer When should the clinical spend start relatively tailing off? And when should the SG&A start ramping up still to effectuate a 25 million per quarter burn? And Laura, if I might just throw in one more. Remind me the baboons in BVP, have we decided on the number of baboons? Folks, thank you for taking my questions.
spk04: So, Dale, if you don't mind, I'll just answer the baboon thing. Yeah, go ahead. So we have not begun baboon work yet in the BVP work, and it's too premature for me to talk about how many animals we would implant.
spk03: It's just too early.
spk07: Yes, Raj, with regards to cash burn, I think if you were to take our – current year financials and back out the non-cash expenses i think we indicated the burn for the quarter was about 19 million so you know you're right there is a trail loss of the current clinical study expenses that we would expect would occur in 2023 i mean clearly there's a there's a ramp on the commercialization side that will offset some of those those declines And part of that decision in terms of the timing of those expenses is strategic. You know, we already have our chief commercial officer on board. We've brought in resources in the areas of health economics and, you know, payroll management, which is long lead time items and is critical. And so certainly as we, you know, further define the timelines for expected approval in 2023, we'll start bringing on the infrastructure associated with the commercial group. The decision in terms of field sales reps, in terms of exactly when they come on, is kind of a discretionary thought in terms of how far in advance or do you want to essentially hire them at approval. But I think thinking about them coming on at about the time of approval is probably the best way to think about it.
spk02: Thank you. Thank you.
spk09: Our next questions come from the line of Matthew O'Brien with Piper Sandler. Please proceed with your questions.
spk07: Morning. Thanks for taking the questions. Laura, can you just start with Ukraine and, you know, the number of HAVs you're expecting to be deploying over there? And are you able to charge for those or is it just, are you just giving them to the government there just based on the situation?
spk04: So thanks, Matt. Those are good questions. So we have no specific commitment going forward. We sent an initial batch of HAVs to six hospitals and our intention is to look at the utilization and to understand what the clinical need is as we make plans to make further shipments. So we don't have anything committed that's hard and firm. But we are committed to trying to help Ukrainian civilians and military who are suffering in this humanitarian crisis. As far as – oh, gosh, I'm not sure I remember the second part of your question.
spk07: Just do you get to charge for the HIVs?
spk04: Oh, yes. Are they going to pay you for them? We're not. We're not. This product is not approved in the U.S. or in Europe. and we felt that it would not be appropriate to charge the Ukrainian government for this humanitarian assistance.
spk07: Okay, makes sense. And then, Dale, maybe to follow up on Siraj's question, now that Omicron has kind of fallen away, well, somewhat anyway, the R&D spend for the remainder of the year, how much should it ramp up? And then maybe I'll ask my last question up front here. Just the arrangement with Presidius and the economic studies that you're doing. Can you just talk a little bit more about those? Thanks. Yeah, certainly. From an R&D expenditure point of view, we expect that to be relatively constant throughout the year. We are seeing some wind down of some of the clinical expenses that's been offset by a much more meaningful effort and activities that are underway this year with some of the preclinical efforts in the CABG and BVP, so we end up with a relatively constant R&D spend for this year. Obviously, from quarter to quarter, month to month, it can bounce around a little, but I think the first quarter is pretty indicative of where we're going to end up. With regards to the work being done with ProNovo, which is a subsidiary of Fresenius, with any of these markets, it really a matter of identifying those patients that can have the biggest unmet need. They're not satisfied by the current standard of care and therefore can get the best improvement in outcome in theory by using the HAV versus current standard of care. And we certainly see that in trauma where the patient doesn't have saphenous vein or there isn't time or just use of saphenous vein harvested from the patient is inappropriate. there's a great deal of benefit from our product, and we see that translate into, we believe, into less amputations, less length of stay in the hospital due to infections, and other outcomes that not only improve the life of the patient, but also have an economic benefit to whoever is covering the cost. In the case of trauma, that's generally the trauma center or the hospital. In the case of ABAccess for Novo, again, it's the same thing. Thinking about just the U.S. market, there's close to half a million patients undergoing dialysis at any one point in time during the course of the year. There's probably about 200,000 AV access procedures that are done each year. So the question is, what is the subset of patients that makes the most sense for us to target when we undertake our anticipated launches? Which are the ones that are most underserved today? And so part of that effort was, and we learned part of that in our clinical studies, but part of that is taking advantage of the great database of patients on a non-name basis that's available through the Fresenius network and trying to identify those patients that have the biggest unmet need and therefore have the best clinical and economic benefit of using the HAV. Our friend is not volume. We're not here to be providing, attempting to target every patient at a low cost. Our intent is to identify those patients that have the greatest need, therefore resolving and then that need and hopefully providing economics to ourselves that make more sense based on targeting those highest need patients.
spk04: Dale, I completely agree, and I'll just jump in here a little bit. The other thing that I think is important to point out is that this is one of the many really important interactions between Humacyte and Fresenius. We have a number of programs that are ongoing, but again, many or most companies at our stage of development really don't have access to this kind of very granular data around costs of care and issues with care for patients who are in one of our target therapeutic areas. So our partnership with Fresenius is really something that we're leveraging, I think, very effectively to help us both be more successful.
spk02: Understood. Thank you. Thank you.
spk09: Our next questions come from the line of Bruce Jackson with the Benchmark Company. Please proceed with your questions.
spk08: Hi, good morning, and thank you for taking my questions. Just to follow up on the CABG program, you showed some very promising animal data with good patency, resellerization. Can you tell us about the next step in that program? So more animal studies, I believe, are anticipated. What are the things that you're going to be testing? And when do you think you might kick off the next leg of the development program?
spk04: Bruce, thanks for that. So we are continuing very active CABG work in baboons and large non-human primates throughout 2022. This continues to be a very active program for us. Our outputs from this will be patency and function and durability and remodeling of the HAV in this non-human setting in the chest as a revascularization conduit for the heart. you know, in general as you're developing significant preclinical data in this way, the typical sequence of events is to submit a pre-IND package and then to get agreement with the FDA regarding the types of preclinical data that they're going to want to see and then to go out and execute on that and then to submit the IND package for clearance for a phase one study. So I don't want to give dates here, but I can say that we are absolutely marching along that path.
spk03: And I continue to be very encouraged and excited about this program.
spk02: Okay, great.
spk08: And then speaking of dates, with the BVP program, when do you think you might have your first implant and do you have your trial material ready to go?
spk04: Well, for the BVP implant, arguably we're not as far down the line with the biovascular pancreas as we are with cabbage because we've been in baboons with our cabbage graft since 2021 and we haven't yet done our first baboon implants or primate implants with the BVP. So it's a little bit early for me to project on first in man. Again, I think the BVP concept utilizes in some ways a clinically lower risk approach because our concept is that we'll perform arteriovenous grafting with the HAV exactly analogous to what we've been doing in patients for years, but then coding that HAV with islets and looking at islet function. So, you know, in terms of the patient risk profile for this type of product, you know, you might say that it's a little lower than for CABG, although, you know, I mean, that remains to be discussed with the FDA. But, you know, that's a lot of talking. But to be honest, I really can't give you dates yet. It's just too early.
spk02: Okay. Fair enough. Thank you very much. Thank you. Our next question has come from the line of Josh Jennings with Cowan.
spk09: Please proceed with your questions.
spk10: Hi, this is Eric, all for Josh. Thanks for taking the question. Maybe starting in GAD, Is there any update on the finalization of the phase three trial in this indication area? What sort of discussions have you had with the FDA around the design and just wondering any timeline that you're able to share for when this trial will kick off?
spk04: We are still in the process of designing that trial, I think as I mentioned on our last call. We're engaging with experts in the U.S. and in Europe because we see this as a program that might have real applicability in both geographies. We have not begun discussions with the FDA yet around the specific trial design. Again, we're trying to take a very thoughtful approach to this and really identify the sets of patients with peripheral arterial disease who are going to most benefit from the product, you know, where we have the greatest clinical need. And so that thought process is something that we're taking very seriously and we're undertaking with thought leaders, actually, in the U.S. and in Europe. So when we have more specifics, we'll provide them.
spk10: Understood. That makes sense. And then just with your update on cranes, I'm just wondering, have there been any HAVs used in cases so far, or they've just been shipped at this time? I just want to make sure I have that correct. Could you also just talk a little bit more about how you plan on training surgeons over there that will be using the HAVs?
spk04: As far as the training of surgeons who will be using the HAV, we have a large number of training materials that we've developed over the past several years because, as you know, The HAV has been implanted in more than 60 sites around the world by over 100 surgeons. So we have a tremendous amount of written material but also video instruction material that we've actually translated into Ukrainian and to Russian to make it more accessible to surgeons in the Ukraine. In addition, we've undertaken structured training aided by surgeons in the U.S. and surgeons in Poland who have used the product to really give sort of live virtual training to surgeons who will be implanting the HAV and then taking care of patients thereafter. So we've taken this part very seriously. I think surgical training is very important, particularly in this type of humanitarian situation. And I'm sorry, could you repeat the first part of your question again?
spk10: Sure, yeah. I was just asking if any of the HAVs shipped to Ukraine have actually been used in cases or It may be too early. I understand this is a recent update, but I was just curious.
spk04: Yes, yes, not yet. The HAVs actually left our building seven days ago, and I think they're still in transit to some of the various medical centers, so it is a little too early. But we're obviously maintaining close contact with the surgeons who will be receiving these products, and we've also instituted... reporting mechanisms that are simple and easy to use for these people in this wartime situation. But we're doing our best to collect adverse events and positive clinical outcomes from any patients who receive the HAV. But as yet, no one has received it.
spk10: Okay, excellent. Thank you for the questions.
spk02: Thank you. I'm showing no further questions in the queue at this time.
spk09: This does conclude the Humus site fourth quarter and year end results conference call. Thank you all for participating.
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