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spk05: Thanks, Jules, and good afternoon to everyone on the call. It has been only six weeks since our last call with the 2021 year-end results, and BioCardia continues to execute in its efforts to advance its meaningful pipeline of cell and cell-derived therapeutics to treat significant cardiovascular and pulmonary disease. The first quarter was significant for BioCardia, with progress in the development of both our autologous and allogeneic cell therapy platforms. Our primary focus is the enrollment in our clinical programs, which will be a continuing effort as the healthcare research systems across the United States recovers from COVID-19. Our efforts to complete the cardiac autologous cell therapy pivotal clinical trials for the indications of heart failure, or BCDL1, and chronic myocardial ischemia, or BCDL2, have had some nice milestones this quarter. We have already shared these in our last conference call, but it bears repeating that in this first quarter of 2022, our lead program in heart failure was granted FDA breakthrough designation, providing independent validation that our data to date is truly compelling. We had a successful data safety monitoring board review in our lead heart failure trial. We received Health Canada's no objection letter to expand the heart failure trial in Canada. We received a new CMS reimbursement code to support both pivotal cardiac cell therapy clinical trials. And we received a favorable opinion from the Office of the Inspector General of Health and Human Services, supporting our ability to cover patient co-payments in our heart failure trial. These were the result of efforts throughout 2021 and realized in the first quarter. For the first time, we have three cardiac heart failure trial procedures scheduled on the same day at three sites across the United States in the month ahead. We are working diligently to support our world-class clinical partners and complete enrollment in the cardiac trials as soon as possible. We are working with the goal of a 2023 completion of enrollment in the full 260 patient cardiac heart failure trial. and enrollment of the 100th patient in the CARDI-AMP chronic myocardial ischemia trial to enable its interim readout. We have just had our first consultation with Japan's Pharmaceutical and Medical Device Agency regarding registration of CARDI-AMP cell therapy. This consultation is based on the quality of our clinical data and the regulatory approvals that exist around all of the elements of the CARDI-AMP cell therapy system in Japan, the United States, and the European Union. The meeting with Japan's PMDA went well. We are still on this pathway, aiming for approval of the cell therapy system in Japan based on our current data and planning for our second consultation where we will provide information and data that have been requested by Japan's Pharmaceutical and Medical Device Agency. Although Japan's population is declining, there are many patients in Japan with heart failure that we believe cardiac amp cell therapy can benefit. What is not well appreciated is that Japanese scientists have been central to this field of development that has led to the cardiac amp cell therapy. just as Japanese scientists have been central to the development of induced pluripotent stem cells for which they were awarded the Nobel Prize in Medicine. Now, I'd like to move to our two allogenic cell therapy product candidates based on our allogenic neurokinin-1 receptor-positive mesenchymal stem cell platform, which has progressed in the six weeks since our last call. Our program in heart failure, which we have designated as BCD03, targeted to the patients who have been excluded from our autologous program due to the nature of their cells, is completing what we believe is the last pharmacology and toxicology studies to enable IMD submission, targeted for acceptance by the FDA in 2022. Our program in patients recovering from acute respiratory distress syndrome, which we have designated BCD-04, has been approved by FDA this April to treat patients and we are targeting enrolling first patients as early as next quarter, Q3 2022. We have been invited to present our efforts at the second annual acute respiratory distress syndrome drug development symposium being held in July in Boston alongside leaders from peer companies developing MSCs for acute respiratory distress syndrome. In summary, we are advancing four therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and our allergenic cell therapy platforms from these therapeutic development efforts we have three active business development initiatives first is partnering our cardiac cell therapy platform internationally second is licensing our catheter-based biotherapeutic delivery systems for cell gene and protein therapy candidates in the heart And third, monetizing our Avance transeptal introducer sheath product. I will now pass the call to David McClung, our CFO, who will provide some financial perspectives. David?
spk06: Thank you, Peter. The company ended the quarter with cash totaling $9.9 million, which together with the $1.5 million in proceeds from the ATM in April provide runway into the first quarter of 2023. Our research and development expenses increased by 22% to $2.2 million in the first quarter of 2022 due to increased spending in support of the cardiac heart failure trial. SG&A expenses of $1.2 million in the first quarter of 2022 is unchanged from Q1 2021. The company's net loss for the first quarter was $3.3 million compared to $3 million in the prior year. and net cash used in operations was 2.9 million in Q1 2021, compared to 1.9 million during the prior year's first quarter. The increase is due to the timing of payments from collaboration partners, coupled with the increased research and development expenses during the quarter. We're now ready to take questions. Operator?
spk07: Thank you. We will now begin the question and answer session. Should you wish to ask a question on today's call, you will need to press star then the number one on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing star then two. If you're using a speakerphone, we ask that you please pick up your handset before entering your request and speaking on the call. One moment please for the first question. Today's first question comes from Kumara Guru Raja with Brookline Capital Markets. Please go ahead.
spk01: Thanks for taking my questions. So first with regard to these four clinical sites in Canada, can you talk a little bit about where these are located, how much of potential target population that you can enroll in the trial are there in these areas?
spk05: Kumar, thank you for the question. Really appreciate you being on the call. We haven't yet identified the specific clinical sites we're active in in Canada. We will announce likely, as we've done in the past, the national principal investigator and the efforts at the first site once we've dosed the first patient. But there are four sites. They are all moving forward well. The activities for site onboarding began quite some time ago. If others on the call are experienced with onboarding or securing Health Canada approval, you actually have to have IRB approvals at clinical sites before you can actually get a Health Canada approval. And so it's an interactive process. But yeah, we expect all four sites to come on board in the not too distant future. And there's some great folks involved. As far as their potential for enrollment, You know, that's one of our primary challenges. I think they're all in major, major areas. And I think the advantage that they have is that they're not, they don't have the burdens associated with the billings that we have in the United States with the Medicare reimbursement. So that's one thing that will free them up. The other is, you know, there's not as many competitive activities in Canada. And so that's another advantage that enrollment will have from those sites. But they're all world-class sites with very experienced folks. and we're both delighted and honored to be able to work with them, and we'll identify them ahead.
spk01: And in the U.S., what are you seeing in terms of the challenges from COVID-19? Where do you guys stand there? You see more patients being screened here? Whatever you can share with regard to that.
spk05: Absolutely. And this is something... that we keep hoping will be tamped down. I think I'll give folks an example. We have one Florida site where the patients who are offered to participate have literally said that they don't want to participate in any trials where they have to come to the hospital. And that's one element of this. Even though if anyone's been in Florida, you know that outside of the hospital, Very few people are masked. There's close quarters everywhere. And yet in the hospital, everybody is masked with biosafety. And the investigator at this particular hospital has said that it's actually safer relative to COVID-19 and infectious diseases in the hospital than it is outside the hospital. But that's one element. The second element, Kumar, is staffing. There are difficulties with the evolution of clinical research at major institutions through the COVID period. Many folks began working from home. Some folks positions were eliminated because research was stopped and everybody is currently restaffing. So we have, I'll give you an example. We have one center that's not enrolling any patients because they're currently recruiting a key person they need on their team. And without that person, they can't recruit. So that site's effectively stalled until they get a coordinator on board. And I'm aware of other folks in our space that are actively seeking to pay to hire coordinators for clinical sites to address this issue for their trials. So that's a potentially bigger issue and a longer issue. but it is being resolved and there is progress at a number of centers that we've seen recently. So those are really the big ones. The other is, as we're looking at, you know, strategies to enroll, we have, you know, all of these things we've done in this first quarter are going to contribute. In addition, the COVID you know, fears are being tamped down in many areas and the staffing is going up. But there's also another strategy we're implementing in addition that, you know, classic marketing efforts is tied into going after patients that have already been exposed to certain medical device therapy so that the hurdle of having a interventional procedure, which is what our cell delivery requires, is not seen as daunting. In fact, it's seen as trivial for some of these folks who may have permanent devices on board because this is a one-time catheterization procedure where we deliver their cells, and they're their own cells. The only thing that's left behind are their own cells. So I think that's a compelling pathway, and we're going to be working on that as one of the enrollment initiatives ahead as well.
spk01: And maybe finally with regard to the PMDA in Japan, how many more consultations do you think you need before you are able to move forward and move forward with the filing there and also the timeline?
spk05: Yeah, so we're working on that pretty actively. The number of consultations, we will have at least two more consultations. And there's a couple of other elements to this that I think are interesting. So the timeline, we can only predict what the timeline for the next consultation is, and it's actually quite soon. I think as we lean into this, keep in mind that our cell processing platform is approved in Japan for other indications, and the delivery systems that we have are not only approved in Europe, but we've had conversations and actually inked preclinical collaborations with two partners in Japan who have interest in those delivery systems. And as related to this particular therapeutic strategy, I shared that it began in Japan. There's a physician named Dr. Takayuki Asahara. He was the first to isolate CD34 cells um from the blood and thought it could provide neovascularization and ischemic hind limb disease and at the same time he was doing that work there was uh two physicians um that published in the japanese journal of cardiovascular surgery on revascularization ischemic heart disease with autologous bone marrow transplantation and that's really the earliest work in our space so we're pretty excited and there's some other follow-on breakthrough work by dr asahara So there's a whole series of things that line up that may enable this. I mean, this is an effort that we think can be quite valuable, but the breakthrough designation provides support. The Medicare reimbursement code also provides a point of context. So, you know, all of these elements, the fact that part of the system's approved in Japan, part of the system is approved in Europe, These basic discoveries effectively originate in Japan. The fact that there's other partners interested in using the delivery systems in the clinic in Japan, many of these things line up and I think will be helpful to us as we go forward in these conversations. But at the end of the day, PMDA is a very sophisticated group, and we are working with wonderful co-national principal investigators there who we also have not identified publicly that we think give us the best chance of being successful on this initiative.
spk01: Thanks, Peter. We look forward to the progress. I appreciate it, Kumar. Thank you.
spk07: And our next question today comes from Emmanuel Branchetti with H.T. Wainwright. Please go ahead.
spk02: Good afternoon, everyone. Thank you for taking the questions. So regarding BCDA04 and the phase 1 to 3 trial expected to begin in the third quarter of 2022, I was wondering if you can give us a sense of the opportunity in ARDS related to COVID with the pandemic evolving, but also beyond that, should we expect a proof of concept in COVID to be expanded to other forms of ARDS? And also, when thinking about the mechanism of actions, what advantages does BCD-A04 provide over other strategies, perhaps other mesenchymal stem cell strategies, or over, for example, NK1 receptor inhibitors?
spk05: Wow, that's a big question. So I'll try and detail some of it. Emanuela, thank you for being on the call. Really appreciate it. We're pretty darn excited about having the IND accepted and it's sad that the markets don't appreciate what this is. Our sense is we've just bolted on the value proposition of any of the other large leading mesenchymal cell companies that have not yet been successful in getting to market. We have peers that are going after acute respiratory distress with intravenous administration of their culture-expanded mesenchymal stem cells. In fact, the NIH has a program that's actively enrolling and will soon complete enrollment in a 120-patient trial. So I don't know all the nuances with respect to the chemistry manufacturing controls and nature of the competitive mesenchymal stem cell All of them, to my understanding, are allergenic. There is potential for them to be approved in Japan based on the Helios data with Athersys in the not-too-distant future. And so we're watching and following the data of our peers, and we're wishing them every success. On our end, you ask, what is the opportunity? We are going after this slightly differently. We are going after patients recovering from from COVID-19, not necessarily those who are in the middle of severe ARDS and on a respirator. And we're not sharing a lot of details on that today, but I think the key takeaway is we're coming at it slightly differently initially. Our trial design's a phase one, two trial, and your question on whether or not we will have proof of concept from a efficacy perspective I think right now we're focused on the phase one potion, which has a dose escalation element, and we're pretty confident that we'll get through that without any issues. On the other side of that, we'll be learning where COVID is at at that point in time and what the case rate profile is of acute respiratory distress syndrome secondary to COVID-19. Currently, your point, which is sort of implied as correct, that the number of hospitalizations due to COVID-19 has drastically reduced. And even though that has potential to erode the enrollment rate of the BCD04 program, that same fact is going to drive enrollment in BCD01 and BCD02. So we're actually hopeful that that is the case and that continues. We're going after this indication because this is really where we started. And there's other things going on with these COVID patients. Again, we're going after patients who are recovering from acute respiratory distress syndrome. And there's a lot of information in the media these days around long COVID. I wouldn't say we're going on that head on today, but there is potential for us to expand this to other indications. I note that an intravenous safety package um with our neurocon neurokinin one receptor positive mesenchymal cells has potential to go in many different directions some of the large programs with these cells are focused on other clinical indications that are not respiratory in nature and that provides other partnering opportunities to biocardia once we complete um our safety package um but that said you know the mechanism of action the last part of your question You know, these cells are well documented as being anti-inflammatory in nature. This is basic mesenchymal stem cell biology, and there's many, many articles on their impact in this fashion. Our other three programs, BCA1, 2, and 3, are all local delivery of cells to the heart using our delivery technologies. We are big believers that cells should be locally delivered to target sites where one seeks to have a therapeutic benefit. In this indication, we're delivering them intravenously. They migrate through the venous system to the lungs. Essentially, these are large cells. Think of them as 20 microns in diameter, and they get trapped in the first capillary they hit, which is in the lungs. They have their neurokinin-1 receptor positive. And what's important about that is you know, that is the receptor that binds to substance P. In our slide deck, I love to show a picture from the New England Journal of Medicine, which shows substance P as the primary mediator of inflammation in the lungs. And so will that result in our having differential benefit over other mesenchymal stem cell therapies that are being advanced? We don't know. One would expect that it likely would. But again, I think head-to-head trials will probably not be performed until such time as there's a product on the market and the second one comes along trying to either unseat it or show non-inferiority. As we're initially going after a different indication from others, that may in fact be ours that gets to market first, but time will tell. So did I answer... most of your questions?
spk02: Yeah, sure you did. And I promise next one is the shorter question. So with regard to the strategy for potential partnership and deals you mentioned, could you provide more color on the overall strategy and perhaps how mature are the conversations you're having with potential partners?
spk05: Well, sure. So the first conversation with respect to CardiAmp internationally, I think one of our primary focus is in Japan because there is potential for a near path to market. And those conversations are going well. The strategy we have is this is a partnership. So it all depends upon the level of of heavy lifting that the partner has that will really drive some of, some of the economics here. And so I, you know, I can't share any specifics, but you know, it makes sense that BioCard is a small company is not going to field a distribution organization in another part of the world, unless it becomes our primary focus on the other side. And I think right now we need to stay focused on enrollment in our lead program. CardiAmp has potential to be a cell therapy literally everywhere in the world. The economics of it at volume in a procedure kit are more compelling probably than any other cell therapy that's out there. We really have dialed things in well from that perspective. On the strategy with respect to our biotherapeutic delivery partnering, we are moving closer to you know, considering only significant relationships because, you know, each partnership, you know, does require our senior staff support and involvement. And we view them as partnerships. Underneath those, it would be similar to a standard licensing transaction in which we would receive, you know, upfront milestones as well as a small portion of the ultimate therapeutic value proposition. Um, you know, those are significant deals and take time and it, and it's somewhat tricky because, you know, we have some, there's some great folks working in this space. Um, but you know, we're in phase three, you know, we're running at 20, you know, six sites across the United States and adding more in Canada and, um, nobody else is really yet in the clinic in the United States. There are some folks doing surgical delivery, um, adjunctive to coronary artery bypass grafting. But, you know, for folks who are just beginning, it's hard to enter into a significant licensing deal. That said, some of them are, do have significant resources and, you know, that may be something we take forward. Our thoughts today, as I've shared in our last call, is that partnering is good for patients at the end of the day to enable them to get access to more therapeutic opportunities. You know, if CardiAmp is not successful and another partner of ours is, that's good for patients. And we also view that as good for our shareholders. The idea that, you know, they would have a portfolio of pathways whereby they could win even if CardiAmp or our allogenic neurokinin-1 mesenchymal stem cell program aren't successful in the cardiac arena. So that's sort of inherent in the partnering there. We have entered last year in 2021, we did a number of deals where, you know, they were preclinical collaborations. And those are really intended to demonstrate what we can do to help partners get comfortable to enable them to say this is something they need to incorporate into their therapeutic development activities. And we are very respectful of our partners. We know how sensitive it is to share confidential information. Um, but it's important because I think we bring a lot of experience to bear and we can help them. We can probably cut off years in their development programs, um, if not, um, help prevent problems that would cause their programs to fail completely. Um, and so we're delighted as these move forward, we have a number of them in active conversation, um, and we'll, we'll see where they all, um, pan out. And then the last opportunity is our strategy around our Avance um, transeptal sheath offering. Um, this is a FDA cleared product that we have. Um, it's, we developed it because we were developing, um, advances to our biotherapeutic delivery system that I just talked to. And this was, um, we had great insights on a new breakthrough technology for, um, how to design these navigation platforms. And we decided to make one appropriate for the transeptal market. It is a real market. There's been two deals announced in this space recently. One deal was Boston Scientific's acquisition of Bayless for $1.5 billion, primarily around their access technologies for getting catheters from the right side of the heart to the left side of the heart, transeptally. And just a week or two ago, Medtronic acquired the assets of AFib, for this same application for $50 million. Of course, the Bayless platform was looking at $200 million in revenue. I don't know what the revenue profile on the AFib platform was. And I can share that our revenue profile for our platform is rather trivial, although the product is commercially available today. And we do have folks in the field that one pathway to monetization could be our you know, beginning to successfully expand the market reach. But what I expect is, you know, we'll have a partner that takes it on as a tuck-in asset because it's definitely an improved value proposition in our eyes over the designs that are currently embedded in partner products today. And the technology actually has broad reach, not just in transeptal access, but in fact, all hearable guiding catheter systems that are used robotically can benefit from what is inherent in the Avance platform. And if you look at the patent filing on that technology, you'll see that it goes very broad and very deep through essentially all interventional procedures that may benefit from such a design. And really what the design does is it's a mechanical solution that prevents You know, one from having an unstable position with such a delivery system through a curve in the anatomy. And as many on the call may know, what we do for our cell therapies is we go up the aorta and do a 180 degree turn and come down through the aortic valve for doing our procedures. And so this technology significantly enhances our control in that procedure. And we have a great safety profile today, but it's a sign that we're constantly working on enhancing elements of our therapy as we go downstream. And forgive me for the long-winded answer.
spk02: Oh, got it. That's very helpful. Thank you. And I guess a follow-up to these, should we expect a possible monetization for these in 2022?
spk05: I would say at this juncture, predicting partnerships and predicting the markets is pretty scary. I would say we're going to beat our revenues from last year. I mean, last year we had the best revenue profile we've had as a public company. We're going to beat it in the year ahead. We might significantly beat it, but right now we're just saying we're going to beat it. And we're going to get the enrollment dialed in for these trials. Those are our big efforts.
spk02: Great. Thank you very much.
spk05: Thank you, Emanuela.
spk07: Thank you. And our next question today comes from Jim Malloy with Alliance Global Partners. Please go ahead.
spk03: Hey, guys. Thanks for taking my questions. I had a quick question. I want to clarify. I see that the 01, the third quarter, the interim look is on track, which is great to see this year. And then if I hear correctly, you're going to complete enrollment in 23. For that, should we anticipate final data? Should we anticipate final data on 01? And then on 02, again, you clarified the interim role in safety in 2022, which is excellent. Relative to 01, how far behind in time or close in time are those two trials to getting completed?
spk05: Well, Jim, we're working to try and line them up so they're almost simultaneous. So I note that 02 has a six-month follow-up. for the primary endpoint, and O1 has a one-year follow-up. So we're looking to enroll in those two programs roughly 100 patients each, a little bit more than 100 patients each by the end of next year. And in doing that, that would line us up for reporting out results from both in 2024.
spk03: Outstanding.
spk05: And again, the O2 program. Yep. The O2 program is not top line data on the full trial as designed. It's based on the adaptive readout at 100 patients. But I note for those listening that, you know, we had a P value in our lead program in phase two at 30 patients. You know, the phase three pivotal for our lead program is significantly overpowered with greater than 95% power. And that's reflected in the FDA's breakthrough designation. I mean, the data is really good. For 02, we expect the data to also be good, but the adaptive readout, you know, will tell us essentially how large that trial needs to be. And it could conceivably result in, you know, the data safety monitoring board saying, you know, we recommend you stop the trial because you're already looking at a p-value. But we won't know until we get to that point. And honestly, if the DSMB comes back to us at that 100 patient adaptive readout and says, you know, you need to enroll, you know, 350 patients in the trial, that's still a success. That means that the trial has been self-powered at multi-centers. And so you're dealing with the same variability from site to site and patient to patient because you're doing the adaptation of the size of the trial in the trial. But the big win would be, of course, if the results at 100 patients were, you're good, you should stop the trial because of efficacy. But we can't guarantee that.
spk03: That we could, indeed. Looking at the bigger picture, obviously the stock's been under pressure, and you're a good company because every stock's been under pressure of late, so that's nothing notable to BioCardia. How would you be able to characterize the partnering environment currently given everyone's depressed stock prices or even an outright acquisition? Has that changed at all or has there been more or less activity you've seen given across the board decreased evaluations for biotechs?
spk05: I don't think it's rolled through quite yet. I think it's starting to happen. I think there are parties that have reeling from some of the impact in in the in the non-profitable biotech space um and so yeah that's that throws a monkey wrench into everything but at the same time you know you know suddenly their cash becomes significantly more precious because nobody wants to go to market in this environment at the same time you know since everybody feels their equity is undervalued equity can't become an element of a deal either and so it does make things significantly more challenging in the non-profitable biotech space. The larger players, you know, it's a real opportunity for them. If they have stabilized stock price and they can do some things in today's climate, it's going to be great for them. I'm envious. We won't benefit from that other than if we are party to a relationship or a partnership with one of those entities.
spk03: Got it. Thank you for taking the questions.
spk05: Appreciate the questions, Jim. Really appreciate you being on the call.
spk07: And, ladies and gentlemen, as a reminder, if you'd like to ask a question, please press star then 1. Our next question comes from Carolyn Kenner, a shareholder. Please go ahead.
spk04: Hello.
spk08: Hello.
spk04: Yes. Yes. I'm looking to get on the phone.
spk08: It's Carolyn Kenner, yes.
spk05: So Carolyn, this is Peter Altman, the CEO of BioCardia. Do you have a question?
spk08: Oh, yes, Mr. Altman. Let me turn this other phone off. I wasn't prepared how this works, but I have several questions. One, can you give some idea of the benefits from your catheter and all the program going on there, you know, over the short term, medium term, long term. And secondly, I was wondering, is the factory that you are, or I'm sorry, the new clinic set up in California, is that... near completion? I don't think it would be because it's been up for such a short period of time up. When do you consider that to be finished? And when will you start manufacturing these products and developing the market? I'll tell you one thing. I'm also a patient of yours, Dr. Rollman, and I was in the phase three study in Tampa, Florida with Dr. Leslie Miller, who is such a fine man. I had three heart attacks before somehow I got, I lost like 30% of my heart and all this kind of stuff. Was unable to walk two blocks hardly without sitting down. I got involved somehow luckily in your program. and i am a totally changed after six months i knew what was happening and i have been buying your stock and i will continue to buy it forever well mr mr kenner so just two two things i just share you are this is being recorded and it's publicly being transmitted so i i'd ask you to
spk05: You know, be careful in sharing your disclosure information. We don't want to unblind the trial. And it's great. It's absolutely great that you're feeling well. That's number one for us here at Biocardia. If folks on the call look at our values, you know, our number one priority is patients at Biocardia. So let me try and answer your questions if I can. And so first on the catheter platform. So we have a number of catheters here at Biocardia. We have our therapeutic delivery catheters. The leading ones in that category are our Helix Transendocardial Delivery Catheter and our MorphDNA Deflectable Catheter. It's a robotics platform through which the Helix is used. Those are all fundamentally... First, the Helix is approved in Europe. The MorphDNA is approved in the United States. And we use that system in all of our first three clinical programs for cardiac indications, and we partner that platform out. As regards the Avance platform for transeptal procedures, it's, you know, we have clinical FDA cleared, clinical grade FDA cleared products here on Biocardia on the shelf. And so we are actively working to sell product to the electrophysiologists and the interventional cardiologists who are doing structural heart procedures, and they can benefit from that product today. It's a very competitive market, and so we've made the conscious decision based on where our cash is not to invest in sales expense, although we have signed up a number of 1099 commission-only sales reps so we can staff and support any inbound inquiries. And your second question, on the new facility and where we're at with that. I'm standing in a new facility today. We have our manufacturing for devices is up and running and our manufacturing for the allergenic cells is also up and running. We might do a video tour for investors in future calls, but it's a great facility. Everything in the facility from a manufacturing perspective is brand new. We use some of the equipment we had in our previous facility. And we've done this. All of the work was done substantially last year. All the expenses were born last year. And going forward, we expected to reduce our expense profile from just facility costs, which dollars we intend to use elsewhere for our activities. So we do try to be wise with respect to significant recurring expenses. And it was a significant effort to complete that move and get these facilities up and running. But we're pretty optimistic about the space we're in. And I like to say that instead of having the whole recycling facility out front of the building now, we have a couple of beautiful California redwoods. And it just has that sort of environment. We're also located in a part of California that has more staff people for manufacturing. The area we were before was far more tech workers and IT. And so this is also going to be good for us with respect to expansion and being able to realize production. But the cell manufacturing is only intended for supporting our trials through phase one, phase two. We may use it for phase three as well. And there's still some time ahead on that front. We would probably clone this facility for commercial and expand it and make it much larger and locate it in a more geographically central location near a FedEx hub if we were going commercial with our cell manufacturer. But then again, maybe we'll expand here. I don't know. We haven't made any decisions on that front. But thank you for your questions. And in closing, I'll say Les Miller is a fabulous physician. It's an honor to be able to work with him. And I thank everybody for participating on today's call and for your interest in BioCardia. We look forward to sharing our continued progress ahead. Thanks. Stay healthy. Be kind. And have a wonderful day.
spk07: Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
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