BioCardia, Inc. (BCDA) Q1 2022 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Good day and welcome to the BioCardia 2022 First Quarter Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through August 11, 2022. I would now like to turn the call over to Jules Abraham of CORE IR, the company's Investor Relations firm. Please go ahead sir.

Thank you, Roco. And good afternoon, everyone. Thank you for participating in today's conference call. Joining me today from BioCardia today is the leadership team Peter Altman Ph.D, President and Chief Executive Officer; and David McClung, the company's Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address BioCardia's expectations for future performance or operational results, references to management's intentions, beliefs, projections, outlook, analysis or current expectations. Such factors include among others, the inherent uncertainties associated with developing new products or technologies and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in BioCardia's most recently filed periodic reports on Form 10-K, Form 10-Q and Form 8-K filed with the SEC, particularly the cautionary statements in them. The content of this call contains time sensitive information as accurate only as of today, May 11, 2022, and except as required by law BioCardia disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It's now my pleasure to turn the call over to Peter Altman Ph.D, the company's President and CEO. Peter, please go ahead.

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 health care research systems across the United States recovers from COVID-19. Our efforts to complete the CardiAMP autologous cell therapy pivotal clinical trials for the indications of heart failure or BCDA-01 and chronic myocardial ischemia or BCDA-02 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 CardiAMP 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 CardiAMP 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 cardiac chronic myopia 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 CardiAMP 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 Cardiac CardiAMP 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 CardiAMP 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 CardiAMP 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 allogeneic cell therapy product candidates based on our allogeneic 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 BCDA-03, 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 IND submission targeted for acceptance by the FDA in 2022. Our program in patients recovering from Acute Respiratory Distress Syndrome, which we have designated BCDA-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 allogeneic cell therapy platforms. From these therapeutic development efforts, we have three active business development initiatives. First is partnering our CardiAMP 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 transseptal introducer sheath product. I will now pass the call to David McClung, our CFO, who will provide some financial perspectives. David?

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 was 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?

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Today's first question comes from Kumaraguru Raja with Brookline Capital Markets. Please go ahead.

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're going to enroll in the trial are there in these areas?

Kumar, thank you for the question. I really appreciate you being on the call. We haven't yet identified the specific clinical sites were active 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 dose the first patient. But there are four sites. They are all moving forward well. The activities for site on-boarding began quite some time ago. If others on the call are experienced with on-boarding 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 is some great folks involved. As far as the potential for enrollment, 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 burden 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 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.

And in the US, 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?

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 to need on their team. And without that person, they can't recruit, so that site is 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 higher 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 in a number of centers that we've seen recently. So -- those are really the big ones. The other is, as we're looking at strategies to enroll, we have all of these things we've done in this first quarter are going to contribute. In addition, the COVID 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 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 onetime 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.

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 time line.

Yes. So well, that's -- we're working on that pretty actively. The number of consultations, we will have at least two more consultations. And there's -- there's a couple of other elements to this that I think are interesting. So the time line, we can only predict what the time line for the next consultation 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 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 from the blood and thought it could provide neovascularization in ischemic hind-limb disease. And at the same time, he was doing that work. There was two physicians that published in the Japanese Journal of Cardiovascular surgery on revascularization and 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 are 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 -- 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 all of these elements, the fact that part of the systems 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 and 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 in this initiative.

Thanks, Peter. We look forward to the progress.

I appreciate Kumar. Thank you.

And our next question today comes from Emanuela Branchetti with H.C. Wainwright. Please go ahead.

Good afternoon everyone and thank you for taking then question. So regarding BCDA-04 and the Phase I to III 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 the 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 BCDA-04 provide other strategies, perhaps other mesenchymal stem cell strategies or over, for example, NK-1 receptor inhibitors?

Wow, that's a big question. So I'll try and detail some of it. Emanuela, thank you for being on the call. I really appreciate it. We're pretty darn excited about having the IND accepted. And it’s said 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 we'll 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 programs. All of them, to my understanding, are allogeneic. 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 asked what is the opportunity. We are going after this slightly differently. We are going after patients recovering 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 is a Phase 1/2 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 1 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, is 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 BCDA-04 program, that same fact is going to drive enrollment in BCDA-01 and BCDA-02. 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 with our Neurokinin-1 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 our safety package. But that said, the mechanism of action, the last part of your question, these cells are well documented as being anti-inflammatory in nature. This is basic messing kina stem cell biology. And there's many, many articles on their impact in this fashion. Our other three programs, BCDA-01 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 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?

Yeah. Sure, you did. And I promise next one is the shorter, shorter question. So with regard to the strategy for potential partnership and deals you mentioned, could you provide a color around the overall strategy and perhaps how mature are the conversations you're having with potential partners?

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 heavy lifting that the partner has that will really drive some of the economics here. And so I can't share any specifics, but it makes sense that BioCardia 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 and 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 considering only significant relationships because each partnership 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 upfront milestones as well as a small portion of the ultimate therapeutic value proposition. Those are significant deals and take time and it's somewhat tricky because we have -- there's some great folks working in this space, but we're in Phase 3. We're running at 26 sites across the United States and adding more in Canada. And nobody else is really yet in the clinic in the United States. There are some folks doing surgical delivery, adjunctive to coronary artery bypass grafting, but 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 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. 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 they would have a portfolio of pathways whereby they could win even if CardiAMP or our allogeneic 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 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. 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, if not, help prevent problems that would cause their programs to fail completely. And so we're delighted. As these move forward, we have a number of them in active conversations, and we'll see where they all pan out. And then the last opportunity is our strategy around our AVANCE transseptal sheet offering. This is an FDA-cleared product that we have. It's -- we developed it because we were developing advances to our biotherapeutic delivery system that I just talked to. And this was -- we had great insights on a new breakthrough technology for how to design these navigation platforms, and we decided to make one appropriate for the transseptal market. It is a real market. There's been two deals announced in this space recently. One deal was Boston Scientific's acquisition of Baylis 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 transseptally. And just a week or two ago, Medtronic acquired the assets of Afib for the same application for $50 million. Of course, the Baylis platform had -- 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 beginning to successfully expand the market reach. But what I expect is 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 transseptal 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, it's a mechanical solution that prevents 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 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.

Got it. That's very helpful. Thank you. And I guess a follow-up to the like should we expect a possible monetization for the in 2022?

I would say at this juncture, predicting partnerships and predicting the market is pretty scary. I would say -- I'd 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.

Great. Thank you very much.

Thank you, Emanuela.

And our next question today comes from Jim Molloy with Alliance Global Partners. Please go ahead.

Hey, guys. Thanks for taking my question. I had a question I want to clarify, that ’01, third quarter, the interim look is on track. It's great to see this year. And then as I heard correctly, you're going to complete enrollment in '23 for that, so we anticipate final data, which just a final data on ‘01 and then on '02 again, you clarified the interim role in safe in 2022, it's excellent. Relative to '01, how far behind in time or close in time - are those two trials to -- getting completed?

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 primary endpoint and ’01 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 if they -- in doing that that would line us up for reporting out results from both in 2024.

Outstanding.

And again, the O2 program is not top-line data on the full trial designed. It's based on the adaptive readout of 100 patients. But I note for those listening that we had a p-value in our lead program in Phase II at 30 patients. The Phase III 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 O2, we expect the data to also be good, but the adaptive readout will tell us essentially how large that trial needs to be. And it could conceivably result in the Data Safety Monitoring Board saying, we recommend you stopped 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 need to enroll 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.

That was good, indeed. Looking at the bigger picture, I mean, obviously, the stocks been under pressure, new good company, because every stock has been under pressure of late. So there’s certainly nothing notable to BioCardia. How is that -- 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 that increase valuations for biotech?

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 the non-profitable biotech space. And so, yeah, that throws a monkey wrench into everything. But at the same time, suddenly, their cash becomes significantly more precious because nobody wants to go to market in this environment. At the same time, 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, 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.

Got it. Thank you for taking the questions.

Appreciate the questions, Jim. Really appreciate you being on the call.

[Operator Instructions] Your next question comes from Carolyn Kenner [ph], a shareholder. Please go ahead.

Hello.

Yes. Is it Caroline Kenner?

It's Caroline Kenner, yes.

So Caroline, this is Peter Altman, the CEO of BioCardia. Do you have a question?

Oh, yes. Let me turn this other phone off. I had – I wasn't prepared to 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 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. Roman. And I was in the phase 3 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 to this kind of stuff. I was unable to walk two blocks hardly without sitting down. I got involved somehow luckily in your program – and I am 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?

Mr. Kenner. So just two things, I just share you are – this is being recorded, and it's publicly being transmitted. So I'd ask you to be careful on sharing your disclosure information. We don't want to un-blind the trial. And it's great. It's absolutely great that you're feeling well. That's the number one for us here at BioCardia. If folks on the call look at our values, 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 Helix transendocardial delivery catheter and our Morph DNA deflectable catheter, the robotics platform through which the Helix is used. Those are all fundamentally – the first, the Helix is approved in Europe, the Morph DNA 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 to the AVANCE platform for transseptal procedures, it's – we have clinical FDA cleared -- clinical-grade FDA-cleared products here on BioCardia on the shelf. And so we are actively working to cell 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 allogeneic cells is also up and running. We might do a video tour for investors in future calls. But it's a great facility. It's -- 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 expect it to reduce our expense profile from just facility costs, which dollars we intend to use elsewhere for our activity. So we do try to be lies 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'd 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 I, Phase II. We may use it for Phase III as well. And there's still some time ahead on that front. We would probably clone this facility for commercial and expand it, make it much larger and located in a more geographically central location near a FedEx hub if we were going commercial with our cell manufacturing. 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 position. 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.

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.