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spk09: Good morning, ladies and gentlemen, and welcome to the EMSITE second 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'll now turn the call over to Lauren Merrick with LifeSciAdvisors. Please go ahead.
spk03: Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed at 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 Humacyte 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, and Dale will review the company's financial results. Following their prepared remarks, the management team will be available for questions. I will now turn the call over to Dr. Nicholson.
spk00: Thank you, Lauren. Good morning, everyone, and thank you for joining us for our second quarter 2022 financial results and business update call. During this call, I'll review our recent highlights and progress of our key programs before turning the call over to Dale for a review of our financial results. Then we will be happy to open up the call for your questions. I'm very pleased with the great progress Humacyte has made throughout the second quarter. in advancing our universally implantable bioengineered human tissue platform. We're continuing to add to the robust body of data, showing that our lead candidate, the human acellular vessel, or HAV, may be uniquely suited for vascular and complex organ applications in which the current standard of care is either unavailable or inadequate. We've also strengthened our board of directors and leadership team with the respective appointments of Dr. Diane Simons, and Dr. Shamik Parikh, who both bring global drug development experience that will be invaluable as we move closer to our goal of bringing the HAV to market. I'll begin with an update on our initiative to provide HAVs to multiple hospitals in Ukraine for the treatment of wounded civilians suffering from vascular trauma injuries. We launched this humanitarian initiative in May in collaboration with the Office of International Programs within the U.S. Food and Drug Administration. as well as the Ukraine Ministry of Health, to coordinate the export and import of our investigational HAV. We're very proud to report that HAVs have been successfully implanted into several Ukrainian patients with vascular trauma injuries. To date, all HAVs that have been implanted have been reported to be functional and infection-free, salvaging limbs in patients who were injured in this wartime conflict zone. This humanitarian program is providing further real-world evidence of the potential impact of the HAV in the treatment of vascular trauma injuries. We're honored to contribute to the ongoing medical relief efforts in Ukraine and to help patients in frontline hospitals that are affected by this humanitarian crisis. In addition, we're inspired by the dedicated medical teams on the ground who were quickly trained on the use of the HAV. As patients are treated with the HAV in Ukraine, we'll continue to work with the FDA and with the Ukrainian Ministry of Health in an effort to help save limbs and save lives in patients of need. Moving on to our late-stage program for the 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 HAVs for vascular repair, reconstruction, and replacement in trauma injury settings. Currently, we have enrolled a total of 55 patients. We're pleased with the results of this study to date, showing very low rates of infection, less than 2%. We've also had no reports of limb amputations that have occurred as a result of HAV malfunction, and we've observed high patency rates of the HAV conduit. Results from the trial are expected to support our planned BLA filing with the FDA, which we plan to submit by the end of 2022 or early 2023. We're continuing to discuss the required number of subjects to be enrolled in the trial with the FDA. The FDA has previously indicated that the HAV for the indication of vascular trauma qualifies for the accelerated approval pathway. The potential of HAVs in vascular trauma was further highlighted in a webinar that we hosted in July, featuring key opinion leaders, Drs. Ernest Moore and Dr. Greg McGee. This was an enlightening discussion of the capacity of the HAV to address current limitations in the standard of care for both vascular and trauma perspectives. And we're grateful to Drs. Moore and McGee for their insightful presentations. A replay of the webinar can be found on the events page of the Humacyte website. The HAV was also the subject of multiple presentations at scientific conferences and journal publications throughout the second quarter. In a publication in the June 2022 edition of JAMA Surgery, clinical researchers emphasized the potential of the HAV to make a significant impact on the clinical care of patients with vascular disease and trauma. This manuscript also highlighted favorable data from multiple clinical trials, encompassing nearly 500 patients and over 1,000 patient years of follow-up. Researchers described the potential advantages of the HAV over existing approaches. I'd like to turn now to our development program of HAVs for arteriovenous, or AV, access in hemodialysis patients. Enrollment is nearing completion in our Phase III trial, which 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. With 222 patients currently enrolled, we are on track for enrollment to be completed this year with top-line results anticipated in late 2023 based upon the one-year follow-up period that's built into the study. Results from the trial, if successful, will support a BLA filing for the dialysis access indication. In addition, in June at the American Transplant Congress, Humacyte presented data on more than 500 patient years of exposure from phase two and phase three clinical trials, demonstrating that the HAV does not stimulate an increase in panel reactive antibodies, which is an adaptive immune response that's correlated with tissue rejection. In addition, in a phase three trial of patients with end-stage renal disease who received either the HAV or synthetic PTFE graft or polytetrafluoroethylene for AV access, the HAV-implanted patients exhibited fewer instances of sensitization than the patients who received the PTFE graft. The benefit of the HAV appeared to be even greater in women who demonstrated fewer increases in antibodies as compared to women who received the PTFE grafts. These results are further consistent with the absence of HAV rejection that's been observed across trials that have been performed with 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 leader in kidney care services, products, and value-based care. We're partnering with Franova, which is the clinical research group owned by Fresenius, to evaluate complications and cost of hemodialysis access care for vulnerable patients in both the US and Europe. These evaluations will assist with development of health economic models and value propositions for the HAV in patients with kidney failure. In our earlier stage programs, we're continuing to advance preclinical studies of the HAV, particularly in coronary artery bypass grafting, or CABG. In July, we presented positive results from a preclinical study of our small diameter HAVs in CABG at the American Heart Association Basic Cardiovascular Sciences Scientific Session. In a non-human primate model, the HAV maintained structural integrity and patency for up to six months post-implantation and showed evidence of robust host cell remodeling and repopulation. We're excited that our small-diameter HAVs continue to show promise in preclinical CABG models, and we look forward to publication of this study in a September issue of the Circulation Research. Finally, humusitis strengthened our Board of Directors and leadership team this quarter with the appointments of seasoned experts in global clinical development. In June, we welcomed Diane Simons, Ph.D., to our Board of Directors. Dr. Simons brings over 22 years of international drug development, partnering, and managerial experience in the biopharmaceutical industry. In 2013, she co-founded Biopharma Excellence, serving as its chief executive officer until its acquisition in 2021. In addition, as announced last quarter, we welcome Shameek Parikh, MD, as our new chief medical officer. Dr. Parikh leads our global clinical development strategy, including oversight of the preclinical and clinical development, clinical operations, and the medical affairs function. We're so pleased to have Drs. Simons and Parikh 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 developments.
spk11: Thank you, Laura. As of June 30, 2022, we reported cash, cash equivalents, and short-term investments of $189 million, compared to $225.5 million as of December 31, 2021. The $36.5 million net use of cash, cash equivalents, and short-term investments for the first six months of 2022 resulted from spending related to net operating activities for the period, including clinical and earlier stage research and development programs. in preparation for our anticipated commercial launch. We believe that our cash, cash equivalents, and short-term investments are adequate to fund operations through 2024 past our current expected timelines for anticipated approval of the HAV in vascular trauma. Revenue is $1.3 million for the second quarter of 2022 compared to $0.7 million for the second quarter of 2021 and was $1.5 million for the six months ended June 30, 2022 compared to $0.8 million for the six months ended June 30, 2021. Revenue in all periods related to grants supporting the development of the HAB. Research and development expenses were $14.7 million for the second quarter of 2022 compared to $14.6 million for the second quarter of 2021 and were $31 million for the six months ended June 30, 2022, compared to $29.7 million for the six months ended June 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 $5.2 million for the second quarter of 2022, compared to 5.4 million for the second quarter of 2021, and were 10.9 million for the six months into June 30, 2022, compared to 10.2 million for the six months into June 30, 2021. The increase during the six months into June 30, 2022, compared to the prior year period, resulted primarily from the transition to being a public company and preparation for the anticipated U.S. commercial launch of the HAV, including increased personnel costs, professional fees, and insurance costs. The decrease for the quarter June 30, 2022, compared to the prior year quarter, resulted primarily from non-cash stock compensation expense incurred in 2021 related to restructuring of the management team to accommodate the transition to being a public company. Other net income was $55.4 million in the second quarter of 2022, compared to $2.1 million for the second quarter of 2021, and was $57.3 million for the six months ended June 30, 2022, compared to $1.5 million for the six months ended June 30, 2021. The current period increases in other net income resulted primarily from non-cash gains related to the re-measurement of the contention earn-out liability associated with the August 2021 merger with the Alpha Healthcare Acquisition Core. Net income was $36.9 million for the second quarter of 2022 compared to a net loss of $17.2 million for the second quarter of 2021. And net income was $17 million for the six months into June 30, 2022 compared to a net loss of $37.5 million for the six months into June 30, 2021. The current period increases in net income resulted from the increases in other net income described already, partially offset by expense increases also described above.
spk08: With that, I'll turn it back over to Laura for concluding remarks.
spk00: Thank you, Dale. To conclude, we're pleased with the progress that we've made across multiple indications in the first half of the year. As we move into the latter half of 2022, We're entering an exciting time for Humacyte. With an anticipated cash runway to carry us through significant value inflection points and beyond, we believe we are well positioned to deliver on clinical and regulatory milestones in the coming months. Operator, we're ready to take questions.
spk08: Thank you. And at this time, we'll be conducting a question and answer session.
spk09: If you would like to ask a question, If you would 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 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.
spk08: One moment please while we poll for questions. Our first question comes in the line of Brooks O'Neill with Lake Street Capital Markets.
spk09: Please proceed with your question.
spk01: Thank you and good morning. I have a couple of big picture questions. So the first one is, obviously you're going after a number of big markets, all of which have significant unmet clinical needs. Can you just tell us, Laura, which one of these markets you are most excited about and think offers Humacyte the most potential long-term?
spk00: Thank you, Brooks. You know, that's an interesting question. It's a little bit like being asked which of your children you love the best. I would say that in the short term, obviously, the trauma indication, I think, just has huge appeal for the company. I think the fact that we have... had such good success with our humanitarian efforts in Ukraine just illustrates the fact that this product can go out into the field into just terrible circumstances and surgeons can be trained and outcomes can be excellent. And so it just validates everything that we've been saying all along. And our KOL meeting that we had in July where Dr. Moore and Dr. McGee spoke about the product and about where they thought its utility was in civilian trauma, I think was just reinforcing of that. So again, we anticipate being on the market with trauma first. And I anticipate that when this is in level one trauma centers and in the hands of experienced trauma and vascular surgeons, that it will see a lot of use in a broad range of applications. Dialysis is also something that obviously we've been focused on for a number of years. I'm particularly excited about the results of the clinical research studies that we're doing with Franova as part of our Fresenius collaboration right now. And that's because we expect the data from the Franova study to help us understand which dialysis patients really are going to benefit the most from our product, both in the US and Europe. We're looking at hundreds of thousands of patients' worth of data, so it's a tremendous opportunity for us to really hone in on those patients who will best benefit.
spk01: Great. I have to say, having visited your facilities and talked with your people just a few weeks ago, I mean, it's tremendously impressive, all that you've accomplished and all you're doing, and I'm really excited about all of these indications, so I think it's great. One more question, I guess maybe most suited to Dale, but either of you, please feel free to comment. Obviously, SPAC mergers have come under a lot of pressure, and I think a lot of people comment that that was an ill-advised time in the marketplace. For you guys, I think it's positioned you extremely well for the future, but can you just comment on how you feel today about having participated in a SPAC merger and what that's done for you as a company?
spk08: Yeah, Brooks, I mean, certainly the SPAC transaction we undertook allowed us to
spk11: transitioned to being a public company, which we think was important in our evolution, and also provided resources that take us well past the anticipated approval timeline for our first launch, which we expect to be in vascular trauma here in the United States. So I think it was a transaction that served us well. For me, I've been in the biotech industry directly more than 30 years and had worked on four IPOs during that time. multiple in the U.S. and one over in Europe. And I guess as a relatively newly public company, I don't feel any different as a SPAC company than I did as an IPO in my prior companies. And our expectation is this has given us the resources to improve value for shareholders. And we'd expect that as we hit our milestones, our shareholders will be rewarded just like shareholders in any other company that have gone public.
spk01: Absolutely makes sense to me.
spk08: Thank you very much and congratulations on all the progress. Thank you. Our next question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.
spk12: Good morning. Thanks for taking my questions. Laura, I think at the site visit, you had talked about some new enrollment sites for V005, the trauma trial. And just wanted to see, I think those were in Israel, if I'm not mistaken. Newish, I guess I should say. You know, what's the status of those? And, you know, are you starting to be able to, you know, get some patients in the door at least to start the enrollment process for the V005 trial?
spk00: Yes, so we're looking at four sites in Israel. One or two of those sites have been fully activated, and we're anticipating activating the other sites very soon. Israel obviously is a site with some active domestic conflict, as we know, and also the consenting process under Israeli law is a little bit different than it is in the U.S. So we are, while of course we would never wish anyone injury, we are expecting and hoping that enrollment contributions by the Israeli sites will be substantial. But it's still something that we're activating right now.
spk12: Okay, fair enough. And then I imagine, I think I know the answer to this question, but there's no potential to utilize any of the Ukrainian patients for getting HAVs as part of the enrollment in the V005 trial, is that correct?
spk00: So that's correct. I mean, this is a humanitarian effort. We're certainly not doing a clinical trial in a war zone with patients in need. So I do want to make that very clear. That said, any summary of data in the trauma indication that is provided to regulators, whether it's in the U.S. or Europe, would certainly include information on the real-world outcomes of this humanitarian effort. So on the one hand, these are not V005 study patients, but on the other hand, the information that we're able to glean will, I think, bolster our overall case for the trauma indication.
spk12: Yeah, no, I completely agree with that. It makes perfect sense. And lastly for me, and I'll hop back in queue, Dale, operating expenses came in a little bit lower than we were expecting this quarter, and just wanted to see, you know, if there's anything specific to call out as to, you know, if I look at R&D costs, for example, is down, you know, a healthy amount relative to last quarter. Anything to call out there, just how to think about OPEX for the balance of the year? Thanks, Dale. Thanks, Laura, for taking the questions.
spk11: Yeah, Ron certainly can comment on that. We have a you know, as you've seen as a company near the public, we haven't actually given forward-looking projections or set ranges for expenses or any other financial parameters right now. But, you know, the expenses are in line with our expectations. You know, R&D expenses have been slowed depending on where you are within the clinical trial life cycles and, you know, how many patients are newly enrolled versus, you know, when you think about The DO7 trial in AV access, even though enrollment is expected to be completed quickly, the bulk of the patients, you know, are through their implants. And so we are seeing some wind down of costs there. Beyond that, you know, if you were to extrapolate what we've done for the first six months forward through the remainder of the year, it's probably going to be close to where we expect to end up.
spk02: okay appreciate that thank you and our next question comes in the line of matthew o'brien with piper sandler please proceed with your questions morning thanks for taking my questions just on the enrollment um laura it looks like from may until i i'm assuming that the latest information you're giving us is probably as of today um the enrollment's been fairly slow in both the the trauma and fistula studies so So to make sure everything's on track as far as patient enrollment goes with those two studies.
spk00: Yeah, so on the dialysis study, on the fistula study, we do anticipate, you know, we're enrolling some number, some, a handful of patients every month. We certainly, you know, we anticipate that we'll be at or very near 240 by the end of the year. And then that would mean that we would have top line results in late 2023 because the end point is a year away. With respect to the trauma trial, you're right. The enrollment in the trauma trial is a little bit more, how shall I say, herky-jerky because it's not like there's a continuous increase reliable flow of patients that come in the door because these are acute trauma patients. Again, we saw enrollment pick up substantially in the spring and it slowed down the last month or two, but we're hoping to have it pick up in coming months. We're certainly doing things, as I've mentioned, we're bringing on the Israeli sites, we've brought on the Mayo Clinic as an additional site, And we're also working to support the sites with clinical trial monitors and support, because that's really been a limitation not just for us, but for a lot of companies who are working on clinical trials, is that the nursing shortage, which we've all heard about, is really impacting the ability of some clinical trial centers to staff their trials. And so we're also actively trying to support nursing support for these trials. We're pulling out everything we can. I think that we're still on track to file a BLA, perhaps late this year, perhaps early next year. Certainly we've had no indications from the FDA that the numbers that they're expecting are any different. I'm still expecting around 70 or 75 total patients as we've enunciated in the past.
spk02: Okay, and to that point, Laura, when do you think you'll have full clarity on the exact number? I know it can be up to 75 plus or minus, but, I mean, when do you think you'll know if it's going to be 75, going to be 70, going to be 80? Any sense for that?
spk00: We have continued to work with the FDA very closely. We have not shared exact timing on when we're going to have an exact number, so I'm afraid I can't provide that at this time. But all I can say is that I believe we're still tracking. And when we have more information, we'll share it.
spk08: Got it. Thank you. Our next question comes from the line of Siraj Kallia with Oppenheimer. Please proceed with your question.
spk05: Morning, Laura. Dale, can you hear me all right?
spk03: Yep.
spk05: Perfect. Hey, so Laura, I just wanted to follow up on Matt's question.
spk06: Forgive me for belaboring VO5. The discussions with the FDA have been going on for some time. Let's say 20 additional patients, maybe 25, right? Israel comes online, Mayo comes online, fine. But what specifically is the nature of the discussions with the FDA that have been ongoing for some time?
spk00: Well, as far as what I can share in this setting, Suraj, it's really been about understanding how many total patients, but also how the FDA should think about the data, given that this is a single-arm trial in an acute injury population in trauma patients where it's physically not possible to randomize. In this trial, we specify that patients who are enrolled must provide consent, but they also must not be suitable for other options such as saphenous vein grafting. So that has an effect of providing a patient population that is very much in need, because by definition, if they're acutely injured and the saphenous vein is not suitable, then these are patients who are facing amputation. or other significant morbidity. So it's really been about discussing how to interpret the data that are coming out of the trial. And frankly, the Center for Biologics is filled with outstanding and smart people who have typically though regulated biologics. They typically regulate antibodies and proteins and gene editing technology. And they're frankly thinking about clinical trials that involve what is essentially a device, even though we're regulated as a biologic. You know, thinking about a clinical trial that involves a device in an acutely injured population with no active comparator, that's just required a lot of discussion. But I really see CBER as being a great partner with us here. I think that the benefits of the product are obvious to us. And I think they will be obvious to the regulators. But it's been a process. It's taken time.
spk06: Got it. Laura, can you give us some additional color on the status of the anastomotic junction for the six-month primate in your cabbage pilot or feasibility?
spk00: So what we've reported in January and I believe also in July is that is that the anastomoses in general are fine in our primate cabbage studies. I will say that, as you may be aware, Suraj, we're studying adult human-sized vessels, which are 3.5 millimeters in diameter, in a large primate, but it's not a large primate in an absolute sense. These animals weigh about 60 pounds. And their coronary arteries are about a millimeter in diameter. And so it's a little bit like, it is like sewing an adult human vessel onto a pediatric patient. And so there are technical challenges with doing this type of study. It just comes with the territory. But aside from the technical challenges of sewing a three and a half millimeter vessel to a one millimeter vessel, we haven't seen anything unique or surprising about the anastomotic response in these experiments compared to what we've seen in our clinical trials or compared to what we've seen in earlier primate work.
spk06: Got it. Final question, Dale. Have your expectations for cash runway changed somewhat? And the reason I ask is, you know, there's been a subtle shift in the language in terms of your cash or runway from prior quarters. Just any additional color or clarity would be appreciated. Thank you for taking my questions.
spk11: Yeah, I think, Sraj, in terms of our overall thoughts in terms of cash runway, even, I guess, going back to our original launching of the program, the transaction without the healthcare we had always expected that the net proceeds from the transaction would take us through the end of 2024. And that's still the case today. I think, you know, certainly we're mindful about, you know, the current state of the market out there and ensuring that we get past the value inflection points with the cash on hand. And so we think about ways of modulating some of maybe the medium priority projects and deferring efforts to extend that even beyond that point. But we have not modified currently our expectations in terms of how far the cash takes us. That current cash balance takes us past the expected time frame of our first market approval or anticipated approval launch.
spk08: Thank you. And our next question comes from the line of Josh Jennings with Cowan. Please proceed with your question.
spk10: Hi, good morning. Thanks for taking the questions. I wanted to just follow up on the Franova collaboration and just better understand how this will inform Fresenius once you get to the commercial stage for HIV and the dialysis access indication. And just remind us of the agreement there and then also how this investigation will inform pricing as well.
spk00: Thanks, Josh. That's a multi-part question. I'll try to handle what I can and Dale may jump in as well. But as you'll recall, the Fresenius Agreement stipulates that for some of the early indications, which include trauma, dialysis access, and peripheral arterial disease, that Fresenius would have the rights for marketing and distribution of those indications in Europe. For those same indications in the U.S., Humacyte will shoulder the marketing and distribution of those products in those indications. As far as the data that we're collecting with Franova, This is a project that's been going on for several months, and we expect the readout on these several hundred thousand patients to come in the next month or two. I'm excited about this project because it will really give us granular, hard data on how many patients and what types of patients tend to have repeated problems with their dialysis access in terms of patency loss, in terms of repeated infection, in terms of For example, what types of patients tend not to mature their fistulas and then are stuck on a catheter for a long period of time? So really identifying those patient subsets in the US and Europe that tend to have chronic difficulties with their access will really allow us to focus on those patients in terms of subsequent marketing and commercialization. There's a second part to this project which we're going to undertake. Once we understand which patients have the most difficulties, then we will work to putting cost estimates of those difficulties in these different geographies, both in the U.S. and Europe. And I would expect that that would inform pricing and what the market will bear in terms of the HAV treating these patients who are currently not acceptably treated by existing therapies.
spk10: Great. Thanks for that. And just a follow-up from our headquarter visit and facility tour. I think during our discussion, Laura, you mentioned that true intimal hyperplasia hadn't been experienced in any implanted HAV to date. I just wanted to follow up and just ask, I mean, how strong of a signal do you think you have? And maybe a hypothesis of mechanism of action of why you haven't seen true intimal hyperplasia in an HAV. It would be great to better understand. Thanks for taking the questions.
spk00: Yeah, Josh, so that is a little bit of scientific speculation on my part, and I will admit to that. As you and I discussed and as we discussed at the site visit, certainly we have seen what we would call panacea in growth, which is in growth of tissue across the anastomosis. We've seen this in some of our dialysis patients and some of our PAD patients. This is a standard biological phenomenon. It's seen with essentially all types of vascular grafting. There's nothing extraordinary about that, and we have seen that, and that has contributed to anastomotic stenosis. I guess what I would say, though, is that particularly in our peripheral arterial disease population, which is a population where the vessel is not getting stuck with needles three times a week, as it is in dialysis. That's a little bit of a cleaner signal. I would say that we have not to date seen any convincing evidence of intimal hyperplasia in the length of the graft in those patients. But again, I have to qualify that statement. We don't have biopsies to confirm that because most of these patients are just walking around with their grafts. And so frankly, I think it's going to take us a couple years to really nail down the complete accuracy of that statement. That statement that I made is a scientific conjecture and a belief on my part, but we haven't documented it fully yet.
spk08: Understood. Thanks for clarifying and I appreciate it. Thank you.
spk09: And just as a quick reminder, if anyone has any questions, you may press star 1 to join the question and answer queue. Our next question comes from the line of Bruce Jackson with the Benchmark Company.
spk07: Please proceed with your question. Hi. Good morning and congratulations on all of the progress. So, Laura, getting back to your favorite children, With the biovascular pancreas project, anything to look forward to over the next few months?
spk00: As we've said earlier, we have partnered with some smaller stem cell companies to look at our ability to produce islets from stem cells that would be part and parcel of the biovascular pancreas product. We are making progress there. We have no plans for any scientific presentations in the next several months, but I will say that we're making progress in our islet differentiation efforts. And we are also progressing toward doing initial proof of principle studies in large animals by late this year. So we remain still on track for that. So I'm hesitant to share any more than that because I want to be definitive when we share the information. But I would say that the biovascular pancreas is still on track compared to everything that we've been saying earlier in the year.
spk07: Okay, great. And then a question for Dale. Last year there was a little bit of seasonality in the research and development expense. Is that going to be a similar pattern this year or...? Is it just going to be lumpy because of the clinical trial activity?
spk11: Yeah, Bruce, part of it's just the ebb and flow of clinical trials. Part of it is there are other meaningful components to our R&D expenses. As a biologics company, the actual development and ongoing enhancements and really preparation for an anticipated launch of our manufacturing facilities also drives costs through our bioprocessing facility that maybe don't get the visibility in terms of press releases and scientific presentations, but as a key component, as you just saw from the tour of the technology platform with Humacyte. So there are ebb and flow costs associated with bioprocessing also, depending on when we're doing production runs or depending on when we're doing certain experimentation either to support new product development or other activities that are additive to whatever cycles of costs that you see on the clinical side also.
spk08: All right. Thank you. That's it for me. And thank you. I'm showing no further questions in the queue at this time.
spk09: This concludes the Human Psych second quarter results conference call. Thank you for
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