Q4 2019 Earnings Call

Dead dead dead.

Good afternoon, and welcome to the biocardia cardi amp heart failure trial principal investigators call. All participants will be in a listen-only mode. Did you need assistance, please signal conference specialist by pressing the star key followed by zero after today's presentation. There will be an opportunity to ask questions to ask a question. You may press star one on your telephone keypad to withdraw your question, please press * then two, please note this event is being recorded.

I would now like to turn the conference call over to Peter Altman biocardia chief executive officer, please go ahead.

Thank you. Welcome all to the cardiac heart failure principal investigators. This is Peter Altman and these are interesting time for all of us with the ongoing covid-19 pandemic and I would like to First acknowledge the hard work of all of the conditions and caregivers who are in the front lines of patient diagnosis and Care off on behalf of the many involved in the cardiac heart failure trial. I welcome you to this update call featuring our code National principal investigators doctor Amish revolt and Doctor call Poppy.

Dr. Eric dugar is our chief medical officer's also with us on this call.

Under the leadership of these gentlemen and they're steering committee colleagues the ongoing phase 3 pivotal trial for cardiac cell therapy in ischemic heart failure is not active now at twenty-five centers and a total of 74 patients have been enrolled.

Following today's positive announcement on the data safety monitoring Board review the data from seventy-four subjects and recommendation that the trial continue as planned and now he's stink honor of introducing our code National principal investigators doctor call 15 of the University of Florida. And dr. Amish revolve the University of Wisconsin who will share an update on the trial in the slide. Jack budget is presented along with this call. You will see detailed bios of both doctor and doctor in a short doctor of all is the director of clinical cardiovascular research at the University of Wisconsin-Madison. He has significant experiences National principal investigator or site principal investigator on several cardiovascular regenerative medicine phase one phase two and phase three trials.

Dr. Pettine is an internationally recognized leader in both the clinical scientific areas of cardiovascular medicine. Notably. He is principal investigator off of University of Florida Center for cardiovascular Cell Therapy research Network. He has been or is the principal investigator for many investigator-initiated clinical trials as well as nhlbi trials or national heart lung and Blood Institute clouds. He is also the past president of the American College of Cardiology the national Professional Organization for cardiovascular Specialists. So we've asked dr. Raval to share an overview of the therapy and its potential importance and providing a new therapeutic option for patients with heart failure and we've asked dr. Pepper a pain to share his perspective on the experience to date and the trial and so with that I'll pass the microphone to dr. Revolt.

both of these

And then we'll be available to take questions after the call and uh and hopefully folks are able to see the slides on the simulcast. Thank you very much doctor of all. Thank you Peter our goal Carl and our goal is to be brief and so that to permit questions afterwards and the way we'll kind of conduct. This is I'll just outline buying a side-by-side that's numbered at the bottom. Right? So we get to slide to you know, hopefully people is no mystery to people that heart failure is a global problem affects millions of people worldwide and has a poor mortality. If you kind of narrow the focus on those patients who have heart there with a heart muscle is not Contracting. Well what the most common cause of that is a tax or myocardial infarction. So there are no existing therapies that are Curative. Of course, we're fully aware that there are Pharmaceuticals out there that can slow the progression of disease birth.

But there's a ceiling on that so many patients don't tolerate those doses. There's a dose ceiling that can exists and and in even with devices they they're not Curative. So the emergence of cell therapy held a lot of holes a lot of promise to try to restore heart function, but as of yet no cardiac Cell Therapy has been FDA-approved. And so this was the one of the motivations behind the cardium cell therapy trial and so slide three. I just wanted to highlight the major kind of innovative features of the trial itself will get into more detail in terms of how the tile trial is conducted. But just to give you an idea of the big drivers of why we're interested in this. The first thing is that this is the first therapy trial that's to try to attempting to identify patients who are likely to respond to likely to respond to treatment. And so you'll see that this involves doing a small volume phone number.

And characterizing cells and I separating those patients out who have those cells that we know based on historical evidence to a result in a in a favorable therapeutic outcome. And that's the first time we're doing this sort of personalized approach. The second item is the high-dose. This is of all the various trials systemically across if you look at parse out the individual cell components and the the cells that have been tested in in the past the dose here's is in the high in the high highest range in addition to kind of attempt to to to kind of tease you on the high-dose part of things the catheter delivery system also off towards a high retention. So the combination of the actual cell dose that delivered combined with the retention properties of the delivery system that will talk about in the in a in a moment lead to this notion wage.

High-dose the second. The third thing is the efficiency of the delivery the delivery catheter and

The entire sort of process is a very straightforward thing and works. Well within the duty cycle of a busy hospital system and within a cath lab the there's a quite a bit of efficiency in the teachability of the the delivery therapy is in the catheter itself, and it's something that most Interventional cardiologists or even electrophysiologist potentially could be involved with down in the future. And then finally one of the nice features of this project has been the the notion that the costs costs associated with the fiber components of the of the trial are pretty low in comparison to many other cell manufacturing type costs that are trials that are out there or are in the in the process of being developed how those more expensive trials will fit in within a um, uh, the current Healthcare economy. Is that difficult to Envision birth.

This particular Cell Therapy, um seems to fit the bill in terms of a low-cost option, but it's got to work. And so the the next slide as slide for Jeff talks about the the the steps are the elements of the trial. So if you we're selecting patients who have heart failure who are sort of moderate heart failure not sort hospitalized heart failure patients who are asymptomatic with heart dysfunction, but moderate heart failure their ejection fraction, which is a term to to look at in terms of overall heart performance has to be between 20 and 40% normal is about 60% and and the way that these patients are screened cell bone marrow aspirate is performed a small volume about two weeks before the actual therapy. And in that two weeks cell processing point is is made in that the cells are analyzed birth.

At a core lab to look to determine what those cells the constituents of those cells are and if the patient's sell product meat sauce or if it's the the the criteria then those patients are further screen towards enrolment there after about two weeks later. The page is brought back and we do a bone marrow aspirate. That's a much larger volume and in that same setting for example in the cath lab, we then turn the patient over and that bone marrow arrived from the iliac crest just just above the phone there and we then deliver the cells we have catheter that you'll see in a second that procedure is all done and it can also be done within about an hour and 1/2 or so the patience then I'm covered usually spend the night with us in the very next day to go home and then is and then the trial is following these patients out to two years, although the primary endpoint. Is that one year?

You know, the cellphone CSA is really the most Innovative element of this based on historical evidence and some calculations. We anticipate that down 70% of patients are likely to be screened into the study. So these are the going to be the likely responders versus 30% who are the non-responders and so you may ask why do we do about those 30% Well, maybe they're better suited for other types of sell products or a low genetic, you know therapies for those cells are brought from other donors who are healthier than they are so odd, that's something to be considered. But for right now we're anticipating about 70% and so far the progress has been in that in that direction 70%

The way that the cells work there's a you know, the bone marrow consists of a variety of different cell types on slide six now and those cell types are all desirable are all been there is evidence shows that these cells work through parakram media affects these little packets of proteins and vegetables within these cells probably induces a signal signal bulb other factors within the heart to induce decrease to to induce inflammation suppression, but also to form new blood vessels and that's all part and parcel of the house. There's heart recovery that can happen after injecting bummer of stuff.

The cell processing pregnant. So once you have the high higher volume bone marrow a large volume bone marrow a spread this device this cardiac system is placed in the in the whole point of care system scenario in the cath lab in our case and is the cells are then spun and collected and then dosed out into Severus syringes.

And if you go to slide eight the the cafe or delivery system manufactured by by a cardio looks like this so in the upper left-hand Corner, you'll see the corkscrew-shaped needle tip. It's been highlighted there and that's really a unique thing for this catheter. And the idea is you deliver the cells to the syringe that's located on the on the proximal Hub towards where the hand is held and the catheters delivered on the inside of the heart and the various locations of the heart muscle into the heart muscle itself and you simply deliver the the catheter by rotating once it approximates the internal chamber or the internal wall of the of the heart you rotate the catheter to get it to embed into the muscle itself off then deliver the cells and then you rotate it back out and that active rotation Inward and outward prevents cells from reflexing directly out of the out of that Passage.

Operator: Unknown Attendee, Peter Altman, Laura Suriel, Miranda Peto, David McClung, Miranda Benvenuti, Good afternoon and welcome to the BioCardia Cardi-AMP Heart Failure Trial Principal Investigators' Call. All participants will be in a listen-only mode. If you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2. Please note, this event is being recorded. I would now like to turn the conference call over to Peter Altman, BioCardia's Chief Executive Officer. Please go ahead. Thank you.

Peter A. Altman: Welcome all to the Cardi-Amp Heart Failure Principal Investigators. This is Peter Altman, and these are interesting times for all of us with the ongoing COVID-19 pandemic.

um, so that's proprietary you captured so so very straightforward Catherine said earlier that easily teachable device and tool that most intervention paralyzed should find fairly easy to use

and then I'll have Carl talk about the trials designed specifically and then get into some of the the results or not the results but in terms of the the the pathway how how we're doing so far the progress of the study.

Peter A. Altman: I would like to first acknowledge the hard work of all of the clinicians and caregivers who are in the front lines of patient diagnosis and care. On behalf of the many involved in the Cardiac Heart Failure Trial, I welcome you to this update call featuring our co-national principal investigators, Dr. Ama Chaval and Dr. Karl Pepin. Dr. Eric Dukers, our Chief Medical Officer, is also with us on this call. Under the leadership of these gentlemen and their Steering Committee colleagues, The Ongoing U.S.

Peter A. Altman: Phase III Pivotal Trial for Cardiac Cell Therapy in Ischemic Heart Failure is active now at 25 U.S. centers, and a total of 74 patients have been enrolled. Following today's positive announcement on the Data Safety Monitoring Board review of the data from 74 subjects and recommendation that the trial continue as planned. I now have the distinct honor of introducing our co-National Principal Investigators, Dr. Carl Pippin of the University of Florida and Dr. Amit Shrival of the University of Wisconsin, who will share an update on the trial. In the slide deck that is presented along with this call, you will see detailed bios of both Dr. Reval and Dr. Papin. In short, Dr. Reval is the Director of Clinical Cardiovascular Research at the University of Wisconsin-Madison.

Peter A. Altman: He has significant experience as National Principal Investigator or Site Principal Investigator on several cardiovascular regenerative medicine Phase I, Phase II, and Phase III trials. Dr. Patin is an internationally recognized leader in both the clinical and scientific areas of cardiovascular medicine. Notably, he is Principal Investigator of the University of Florida Center for Cardiovascular Cell Therapy Research Network. He has been, or is, the principal investigator for many investigator-initiated clinical trials, as well as NHLBI trials or National Heart, Lung, and Blood Institute trials. He is also the past president of the American College of Cardiology, the national professional organization for cardiovascular. So we've asked Dr. Raval to share an overview of the therapy and its potential importance in providing a new therapeutic option for patients with heart failure. And we've asked Dr. Patin to share his perspective on the experience to date in the trial. And so with that, I'll pass the microphone to Dr. Raval. Both of these gentlemen will be available to take questions after the call, and hopefully, folks will be able to see the slides on the simulcast. Thank you very much, Dr. Raval.

Well, thank you for that. Wonderful summary introduction. I'm delighted to be here this afternoon. This is a unique novel wage, which one is a very huge phase three trials in the cardiovascular space for cell-based therapies off in the plan is to recruit 250 patients with what we call ischemic heart failure. This is patients who have had a myocardial infarction and develop heart failure signs and symptoms related to reduced level regular function and that's defined as an ejection fraction between $420 and 40% Normally. It should be above well above 50%

Dr. Ama Chaval: Thank you, Peter. Our goal, Carl and I's goal, is to be brief and so that questions afterwards can be permitted. And the way we'll kind of conduct this is I'll just outline slide by slide, which is numbered at the bottom right.

as well

As New York harnesses age and class two and three and patients who are selected based upon passing the potency. May I say that Amish test just described for you?

Just to explain a minute longer. We view this as the first personalized medicine approach in cardiac cell-based therapies. We're actually the patients are selected based upon their personal characteristics in their bone marrow sample pack those the past that that test then are likely to have characteristics of their bone marrow cells that we will promote bandwidth

So the plan is to recruit 250 patients, they're randomized between 150 who received cells and 100 who receive a sham procedure in the catheter laboratory, but do not receive the cells the dose of the cells is 200 million cells

in addition reminded that patients from the phase two trials that biocardia has sponsored who are class 1,000 eliminated from this trial as well as patients who do not pass the potency assays that goes Amish and I described earlier wage. So we believe that this will really enriched the trial who patients who are extremely likely to respond to sell base there at the exact gorilla Comer in point based upon the 6-minute walk distance performed at 12 months off and is adjusted for an adverse event that includes death or other major Adverse Events that might exclude the ability to perform this

Dr. Ama Chaval: So if we get to slide two, hopefully, people know that heart failure is a global problem, affects millions of people worldwide, and has poor mortality. If you kind of narrow the focus on those patients who have heart failure where the heart muscle is not contracting well, the most common cause of that is heart attacks or myocardial infarction. So there are no existing therapies that are curative. Of course, we're fully aware that there are pharmaceuticals out there that can slow the progression of the disease. But there's a ceiling on that. Many patients don't...

6-minute walk test and they would include heart transplantation need to place a left ventricular assist device the stroke or a disabled myocardial infarction or hospitalization due to progression of the patient's heart failure. And there are a number of secondary endpoints are at, which will also be used in the labeling. If in fact benefit is achieved relative to survival relative or two major adverse cardiac events.

Operator: Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia

Dr. Ama Chaval: and even with devices, they're not curative. So the emergence of cell therapy holds a lot of promise to try to restore heart function, but as of yet, no cardiac cell therapy has been FDA-approved. And so this was one of the motivations behind the CARDI-M cell therapy trial. And so, slide three, I just wanted to highlight the major kind of innovative features of the trial itself. We'll get into more detail in terms of how the TILE trial is conducted, but just to give you an idea of the big drivers of why we're interested in it. The first thing is that this is the first cell therapy trial that's attempting to identify patients who are likely to respond to treatment, and so you'll see that this involves doing a small volume bone marrow aspirate and characterizing cells and separating those patients out who have those cells that we know, based on historical evidence, to result in a favorable therapeutic response. And that's the first time we're doing this sort of personalized approach.

Dr. Ama Chaval: The second item is the high dose. This is, of all the various trials, systematically across... If you look at, parse out the individual cell components and the cells that have been tested in the past, the dose here is in the highest range. In addition, to kind of tease you on the high dose part of things, the catheter delivery system also affords high retention. So a combination of the actual cell dose that's delivered combined with the retention properties of the delivery system, which I'll talk about in a moment, leads to this notion of high dose. The third thing is the efficiency of the delivery system. The delivery catheter and the entire process are a very straightforward thing. It works well within the duty cycle of a busy hospital system and within a cath lab.

Dr. Ama Chaval: There's quite a bit of efficiency in the teachability of the delivery therapies in the catheter itself, and it's something that most interventional cardiologists or even electrophysiologists could potentially be involved with in the future. And then finally, one of the nice features of this project has been the notion that the costs associated with the various components of the trial are pretty low in comparison to many other cell manufacturing type costs or trials that are out there or are in the process of being developed. How those more expensive trials will fit in within the current healthcare economy is difficult to imagine, but this particular cell therapy seems to fit the bill in terms of a low-cost option.

Call over to my manager with heart failure questionnaire or heart failure related events such as a heart failure hospitalization.

Dr. Ama Chaval: But it's got to work. And so the next slide, slide four, talks about the steps or the elements of the trial. So if you were selecting patients who have heart failure, who are sort of in moderate heart failure, not sort of hospitalized heart failure or patients who are asymptomatic with heart dysfunction, but moderate heart failure, the rejection fraction, which is a term to look at in terms of overall heart performance, has to be between 20 and 40 percent. Normal is about 60 percent. And the way that these patients are screened, a cell, bone marrow aspirate is performed in a small volume about two weeks before the actual therapy. And in that two weeks, a cell processing point is made, and the cells are analyzed at a core lab to look to determine what those cells, the constituents of those cells are.

In the next slide you should see that the trial is very well distributed across the United States. Of course Amish wage at the University of Wisconsin and I'm at the University of Florida. We entered most of the patients in the phase in the pilot phase of this trial time that enrolled ten patients who were treated and I'll describe those results, too.

Dr. Ama Chaval: And if the patient's cell product meets the bill or fits the criteria,

Dr. Ama Chaval: Criteria.

Dr. Ama Chaval: then those patients are further screened for enrollment. Thereafter, about two weeks later, the patients are brought back, and we do a bone marrow aspirate that's a much larger volume, and in that same setting, for example, in the cath lab, we then turn the patient over, and that bone marrow has arrived from the iliac crest, just above the pelvic bone there, and we then deliver the cells via a catheter that you'll see in a second That procedure's all done, and it can all be done within about an hour and a half or so. The patient's then recovered, usually spends a night with us, and then the very next day, they go home. And then the trial is following these patients out to two years, although the primary end point is that one year. You know, the cell potency assay is really the most...

Among those ten patients who are in the pilot things all of them received the cell preparation the same outcomes in the upper right hand corner and Improvement at 3 Six Pack, 12 months across the follow-up of these twelve patients. After receiving the active cell preparations and that increase June 16th and switch the actual prepared to the pilot Phase 2 results from tax additional. There was Improvement, maybe in a month.

Dr. Ama Chaval: the most innovative element of this study. Based on historical evidence and some calculations, we anticipate that about 70% of patients are likely to be screened into the study. So these are going to be the likely responders versus 30% who are the non-responders.

and also

and then the major function that is and that's how much the heart ejects during the system not compared to its resting blood was the American free in that each of the six and 12-month levels and after 12 months level. The Improvement was not very been in Jack Jack So based upon these metrics. We believed Selleck reparation.

that is processed by the ramp system is highly likely to achieve results in this trial wage as we speak to have been a hundred sixty-one patients across the United States consented 12 or in screening and there are off this Corporation should have been involved in the

And that concludes I think plans presentation are available for questions or clarifications of any phone call. Thank you call could you switch to your handset because you are breaking up a little bit of recall appreciate that if you would be perfect. Thank you so much.

All right, if we're ready for questions at this time in order to ask a question, you may do so by pressing star then one on your telephone keypad. If you're using a speaker phone, please pick up your handset before pressing the keys to withdraw your question, please press * then two at this time. We'll pause momentarily to assemble our roster.

And our first question will come from Kumar Raja with Brookline Capital markets, please go ahead.

Thanks for taking my questions. So first with regard to the inclusion criteria What percentages of patients in your, you know took treatment area of fit into those criteria and what kind of enthusiasm do you see in those patients? Like, you know, I understand the typically some of these are older patients how open are they for this kind of procedure?

So I could probably address this maybe Carl can follow up so Kumar. This is a great question. First of all what she did not mention is that the patients or I didn't mention is the patients who are enrolled into this study have to have been on maximally optimized medical management and device management. So all of these patients follow conventional Management's with guidelines and these and despite that they're still uh, suffering from 6 to 3, heart failure symptoms with the depressed ejection fraction. So in terms of enthusiasm, there is no doubt that these people, you know, live day-to-day feeling out of breath doing my mild or moderate activity and would definitely be interested in getting better. I would say that there is I in with personal anecdotal birth

Dr. Ama Chaval: What do we do about those 30%? Well, maybe they're better suited for other types of cell products or allogeneic therapies where those cells are brought from other donors who are healthier than they are. So that's something to be considered. But for right now, we're anticipating about 70%. And so far, the progress has been in that direction.

Dr. Ama Chaval: The way that the cells work, you know, the bone marrow consists of a variety of different cell types on slide six now, and those cell types are all designed, or all been, the evidence shows that these cells work through parachromia effects, these little packets of proteins and vesicles within these cells probably induce a signal to other factors within the heart to induce, decrease, to induce inflammation suppression, but also to form new blood vessels. And this is all part and parcel of how there is heart recovery that can happen after injecting bone marrow. The cell processing equipment, so once you have the higher volume bone marrow aspirate, the large volume bone marrow aspirate, this device, this cardi-amp system, is placed in the point of care scenario in the cath lab, in our case, and the cells are then spun and collected and then dosed out into various syringes. And if you go to slide eight, the catheter delivery system manufactured by BioCardia looks like this. So in the upper left corner, you'll see the corkscrew-shaped needle tip that's been highlighted there.

And there is Advantage here in that we're talking about at all against therapy. So your own cells of being delivered to yourself. So for some patients who have had apprehension of getting other people sales this this cell therapy, you know process and seems to fit the bill for them that's been just a few people who've mentioned that in terms of the overall burden of these well class to heart failure is the largest group New York conversation class to 3 second and third for is the smallest one. We don't really know one is sort of a symptomatic. There's a lot of people out there who may be minimizing symptoms and such. So I think that's a bit vague. It may be larger than we know but clearly be the target for us in terms of when we look at the the the curves for mortality and so on the target is really class two and three

I would agree with Amish relative to your enthusiasm question. Maybe it's best addressed. Am I in fact that we've been rolled somewhere around fifteen patients and I believe two or three have failed the potency a say all three have you requested that we either try to repeat the buttons a say or that they get into the next trial which is plan, which is the allergies made preparation, which is a cell preparation made from healthy individuals. So there's no lack of enthusiasm or repeating the procedure. I think that's probably the best measure of how this procedure wage.

Dr. Ama Chaval: And that's really a unique thing for this catheter. And the idea is you deliver the cells through the syringe that's located on the proximal hub or towards where the hand is held. And the catheter is delivered inside the heart into various locations of the heart muscle, into the heart muscle itself. And you simply deliver the catheter by rotating. Once it approximates the internal chamber or the internal wall of the heart, you rotate the catheter to get it to embed into the muscle itself and then deliver the cells. And then you rotate it back out. So that's why...

What's perceived by people to her back toward gone through it?

Okay, thanks. And everybody nowadays is worried about the impact of Kobe on clinical trials. Maybe you guys cannot wage. You know, what should we expect obviously you don't have ta is also kind of showing some flexibility in terms of you know, instead of coming to the site having some you know, some more analysis and observations. Maybe you guys can talk a little bit about you know what you're seeing so far and you know, what? What are the expectation going forward?

Operator: Dr. David McClung

Operator: Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia And then I'll have Carl talk about the trial design specifically and then get into some of the results, or not the results, but in terms of the pathway, how we're doing so far, and the progress of this study.

Sure, I can start with that at the University of Florida the department of research based upon FDA and off and guidelines has spent it all quotes on essential clinical trial activities that have to be done face-to-face. In other words. They have forced to move to screen electronically as well as follow up electronically using medical records and electronic means now the hope is

That we as well, I think as the rest of the country is that these restrictions will be lifted probably within the next four or eight weeks and we believe that with the backlog of patients that we have collected relative to our screening visits that we will have a plethora of patience to complete this trial as expected by the by the by the by the pre set date of birth.

Dr. Carl Pippin: Well, thank you, Amish, for that wonderful summary introduction. I'm delighted to be here this afternoon.

Yeah, I'll just I just add to that. I think you know one of the things that we were seeing before the covid-19.

Dr. Carl Pippin: This is a unique, novel trial. It's one of the very few phase three trials in the cardiovascular space for cell-based therapies, and the plan is to recruit 250 patients with what we call ischemic heart failure. This is patients who have had a myocardial infarction and develop heart failure signs and symptoms related to reduced left ventricular function, and that's defined as an ejection fraction between 20 and 40 percent. Normally, it should be well above 50 percent, as well as New York Heart Association class two and three and patients who are selected based upon passing the potency assay that Amish just described for you. Just to explain a minute longer, we view this as the first personalized medicine approach in cardiac cell-based therapies, where actually the patients are selected based upon their personal characteristics in their bone marrow samples, and those that pass that test then are likely to have characteristics of their bone marrow cells that will promote benefit.

Dr. Carl Pippin: So the plan is to recruit 250 patients that are randomized between 150 who receive cells and 100 who receive a sham procedure in the catheter laboratory but do not receive the cells. The dose of the cells is 200 million cells. In addition, be reminded that patients from the Phase 2 trials that BioCardia has sponsored, who are class one, are eliminated from this trial, as well as patients who do not pass the potency assay that both Amish and I described earlier. So we believe that this will really enrich the trial for patients who are extremely likely to respond to cell-based therapy. The trial has a primary outcome or end, based upon the six-minute walk distance performed at 12 months, and is adjusted for an adverse event that includes death or other major adverse events that might exclude the ability to perform the six-minute walk test.

48 weeks seems like a reasonable gas, but we don't really know that for sure.

It's okay. Thank you. I think to to re-emphasize that the review of the first 74 patience either data safety monitoring committee that's independent from either us as the national P eyes or the sponsor identified. No safety concerns and recommends that to trial continue as planned. So that's pretty good when you're that part through trial 74 patients without issues.

Dr. Carl Pippin: And they would include heart transplantation, the need to place a left ventricular assist device, a stroke, or a disabling myocardial infarction or hospitalization due to progression of the patient's heart failure. Additionally, there are a number of secondary endpoints or outcomes which will also be used in the labeling if, in fact, benefit is achieved relative to survival, relative to major adverse cardiac events. Quality of Life Measured by the Minnesota Living with Heart Failure Questionnaire or heart failure-related events such as a heart failure hospitalization.

Okay, great. Thanks for taking my questions.

And our next question will be from Jason McCarthy with Maxim group, please go ahead.

Hi Peter, thanks for taking the questions. Can you give us a sense of you know, you had mentioned that there was an uptick in your enrollment prior to all the all the activity around covid-19.

So is that for so this is Amish here. So I think you know I can attach to that. So the original, you know, very long ago. Our original enrollment birthday was June 21st of next year, but that was there was some you know, our role in Phase happened very efficiently, but it was based on that initial pilot study that we met protocol changes which created some delays and so we think that we're not really sure, you know, in terms of the overall enrollment. All I can tell you is based on the uptick. We're hoping I'm starting to see enrollment of about, you know, 3 screening of three patients per month at each of the various sites and these sites have more of an coming online. I know what the math would end up being in terms of this the specific date final date now in light of this, um, I don't think anybody knows that but I can tell you that compared to other stuff wage.

Dr. Carl Pippin: In the next slide, we should see that the trial is very well distributed across the United States, of course, Amish is at the University of Wisconsin, and I am at the University of Florida. We entered most of the patients in phase, in the pilot phase of this trial that enrolled ten patients who were treated, and I'll describe those results to you. Among those 10 patients who were in the pilot phase, all of whom received, [inaudible] Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia, And numerically, there was an improvement at 3, 6, and 12 months across the follow-up of these 12 patients after receiving the active cell preparation. And that increase in six-minute walk distance was substantial compared to the pilot phase two results from TACF heart failure.

that also involved with

And I think Carlos involved with we're seeing this in a very optimistic light.

Okay, and from an expense perspective, I know you just filed for an extension on the 10K. Like somebody has given all that's going on if there's going to be a delay in a trial. Can you walk us through what you expect expect the expenses to look like over the next couple of quarters and then you know, maybe remind everybody, you know, the impact Medicare does have on the expense line for biocardia. It's a significant component to funding the trial.

Dr. Carl Pippin: Additionally, there was improvement in quality of life measured by the Minnesota outcome, the Minnesota Living with Heart Failure Quality of Life outcome that was seen numerically, 12 Months, 6 Months, and also 12 Months, and again this was higher than latitude by TACF. And then finally, the measure of left ventricular function, that is, global ejection fraction, that is how much blood the heart ejects during fistulae compared to its resting blood volume, was numerically improved at each of the 6- and 12-month levels. And at the 12-month level, the improvement was better than in jackjack.

This is Peter. I'll dive in Jason. Thanks for for calling in. Yeah, this call is focused primarily on the heart failure trial and not on Bayou card is business per se trying to focus on the safety and efficacy issues and and trial design issues. But you know at a very high level, you know, we as well as many others are still figuring things out if the the timeline is as Amish as suggested in Carl has suggested it is it's it's not going to have a significant impact the trial is substantially supported by Medicare and our base operational costs for a few months is is really what the the cost of a delay or pause will be back. If anything the team is taking care of outstanding paperwork issues and working with the sites to make sure that on the other side of this will have a bolus to Thursday.

Dr. Carl Pippin: So, thanks a lot. We will see you next time. Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia, that is processed by the prelamp system is highly likely to achieve beneficial results in this trial, as we speak. There have been 161 patients across the United States consented, 12 are in screening, and there are 74 patients that have been enrolled in the CHOP. So that concludes, I think, our... Plans Presentation. Both Amish and I are available for questions or clarifications of any of these points.

We accelerate so we're not sure it's going to have a Major Impact. Um, if that bowl is does occur on the other side of this trial so, okay great. Thank you for taking the questions.

Once again, if you'd like to ask a question, please press star and one.

The next question will come from Jason kolbert with Dawson James, please go ahead.

Hi guys. Thank you so much. I'd like to build on some of the things that my distinguished colleague. Dr. McCarthy just asked on me. I'm very excited. You're on the call by the way to reverse Wisconsin. And so I hope I have a chance to come sit with you and talk with you when I'm out there. That would be great. It's a it's a it's an amazing University law. And for the people who don't know Wisconsin has been a Pioneer and sell and stem cell therapy for a long long time few things that you mentioned. I wanted to kind of dig into and a little bit more detail the Helix and what role dosing plays in cardiac disease because as you know, you know, we're all waiting for the outcome of the wage HF trial that a competitor is working on and I I I I am both excited and fearful for that data because it's a very different dosing mode off.

Operator: Carl, thank you. Carl, could you switch to your handset because you are breaking up a little bit on the call?

Operator: I would appreciate it if you would. Is that better? Perfect, thank you so much.

Operator: If we're ready for questions at this time, in order to ask a question, you may do so by pressing star and then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we'll pause momentarily to assemble our... And our first question will come from Kumar Raja with Brookline Capital Markets. Please go ahead. Thanks for taking my questions. So first, with regard to the inclusion criteria, what percentages of patients in your, you know, treatment area fit those criteria? And what kind of enthusiasm do you see in those patients, like I understand that typically some of these are older patients; how open are they to this kind of procedure?

And so I'd like to understand how important.

Is it in your opinion and coral you as well? And and and then I want to just pick up on something else you said which is 30% of patients as qualified phone marrow aspirate. So well may not qualify and therefore they could have an you know, potentially an allergenic solution and as you know, biocardia like measles last is working on an allogeneic solution. So if you could kind of tell me a little bit about how that would in reality work because once you pull a bone marrow aspirate, I mean, it's a shame right not to be able to process and move it forward. And and so, you know, it just seems logistically like that would be very problematic. So thank you very much guys. I I know how busy you must be met with all the stuff with the Ovid pandemic going on and so we we really do appreciate your taking the time to do this. Thank you. Hey, no problem. No problem. So first of all happy to meet with your son will dead.

Dr. Ama Chaval: So I could probably address this, and maybe Karl could follow up. So Kumar, this is a great question.

Dr. Ama Chaval: First of all, what we did not mention is that the patients, or I didn't mention, the patients who are enrolled in this study have to have been on maximally optimized medical management and device management. So all of these patients follow conventional management with guidelines. And despite that, they're still suffering from class 2 to 3 heart failure symptoms with a depressed ejection fraction. So, in terms of enthusiasm, there is no doubt that these people, you know, live day-to-day feeling out of breath doing mild or moderate activity and would definitely be interested in getting better. I would say that, with personal anecdotal experience, there is an advantage here in that we're talking about autologous therapy, so your own cells being delivered to yourself.

And anytime after everything settles down of course, right? So we're still preventing people, you know for you know, acknowledging each other indirectly in the hospital. So that being dead now back to the the the dosing with the Helix Cathy. I think you mentioned the heart failure trying I'm assuming you're referring to the dream heart failure trial by mesoblast other phase 3 trial that we're waiting on the results. So this is a bone marrow sell product that includes the cell types that are also sort of factored in with me. So Blas they're also includes a variety of other subjects that have been tested by others including cd34 sales. So that's what the bone marrow constituent. Is there a variety of cell types within it off the the particular proprietary bone marrow. I say that is being you know used to screen these patients has taken into account those what those dead.

Dr. Ama Chaval: So, for some patients who have had apprehension about getting other people's cells, this cell therapy process seems to fit the bill for them. That's been just a few people who have mentioned that. In terms of the overall burden of disease, class II heart failure is the largest group, New York Heart Association class II, III is second, and IV is the smallest group. One, we don't really know, one is sort of asymptomatic, there are a lot of people out there who may be minimizing symptoms and such, so I think that's a bit vague, it may be larger than we know, but clearly, the target for us, in terms of when we look at the curves for mortality and so on, the target is really class II and III.

Are if you look at specifically cd34 in Peter is given permission to allow us to talk about TV. 34-3 cd34 itself is a very potent wage for janitors self. You look at that in particular and you look at prior studies in particular the renew trial and prior to that the activity for CMI trial the CD 34 content of this trial is above that. So when we look at over all those so the dose of the the cells of interest is higher than what others have a used now. The other part of it is the Helix Kath here and we think that the retention of those cells so the effective dose and the kind of the insights you dose and staying home of that dos is higher based on prior published studies that show that if you inject particles that can be tracked that you will have more of those particles around dead.

Dr. Carl Pippin: I would agree with Amish, relative to your enthusiasm question, maybe it's best to be addressed by the fact that we've enrolled somewhere around 15 patients, and I believe two or three have failed the potency assay. All three have strongly requested that we either try to repeat the potency assay or that they get into the next trial, which BioCardia is planning, which is the allogeneic preparation, which is a cell preparation that's made from healthy individuals. So there's no lack of enthusiasm for repeating the procedure, and I think that's probably the best measure of how this procedure is perceived by patients who have actually gone through it.

Hours later than you will if you just injected with a straight needle catheter, for example.

So that's you know, that's kind of the the issue with the dough. So this so now when you get to the 30% group, I think one of the things that is unique about this study is that you know on its surface it might seem like a very arduous thing to undergo a small volume bone marrow aspirate and then a larger volume volume bomber ass but but in all the patients and we may not heard of a single negative statement by anybody in Carl can type in if he has but I haven't that this is a very well-tolerated procedure and it's very straightforward procedure and I think most patients when I speak to them in a screen them and tell them that you know, you may be randomized a little higher than 50% right cuz 150 patients get treatment 500 get get the the Sham group. I tell patients that if you are assigned to the Shangri, that means that your cell content isn't up to Snuff it is dead.

Dr. Ama Chaval: Okay, thanks. And everybody nowadays is worried about the impact of COVID on clinical trials. Um, maybe you guys can add something to us with regard to, you know, what should we expect? Obviously, FDA is also kind of showing some flexibility in terms of, you know, Instead of coming to the site, having some, you know, remote analysis and observations, maybe you guys can talk a little bit about, you know, what you are seeing so far and, you know, what are the expectations going forward.

Likely that you're going to benefit from it. So we're not going to go ahead and do the risky aspects of the treatment on you, you know, and so that's the one thing about this study. The chef is is actually just simply inserting a catheter in an artery in the groin but we don't take the catheter up into the into the heart itself the Helix catheter off. So there's a bit of deception. Sorry. That wasn't my question my question and maybe I'm a little confused cuz you did mention cd34 I'd lived through the trial it might question really had to do with if you're going to see somebody and they have to meet a criteria for an autologous therapy. They don't meet that criteria then what options do they have?

Dr. Carl Pippin: I can start with that. At the University of Florida, the Department of Research, based upon the FDA and NIH guidelines, has suspended all quote non-essential clinical trial activities that have to be done face-to-face. Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia, as well as follow-up electronically using medical records and electronic means. Now, the hope is that we, as well, I think, as the rest of the country, that these restrictions will be lifted probably within the next four to eight weeks, and we believe that with the backlog of patients that we have collected relative to our screening visits, we will have a plethora of patients to complete this trial as expected by the

Yeah, but so so you look at it from that perspective, you know, if they're not meeting that criteria there this back to our standard of care. We're hopeful that we'll have allergy Nick products available. That would be an an obvious regenerative medicine solution to that you no problem, you know, we haven't discounted patience in this trial of you know, getting rid of ads down the road if they qualify for that or a heart transplant, but the reality is they don't have much options many options after you know that today but at the same time, you know, our lifestyle is is focused on trying to see if we can develop a Cell Therapy personalized approach for those 70% to work.

Dr. Ama Chaval: Yeah, I'll just add to that. I think, you know, one of the things that we were seeing before the COVID outbreak really hit the United States was an uptick in enrollment, in fact, in the CARDI-AMP trial. Unfortunately, of course, that's been, you know, new enrollment has been suspended for now in most of our centers. But we're still able to, at our center, as well, preserve the integrity of the patients that have been enrolled. So, for example, if they need to come back for their six-minute walk test or their echo, we have permissions to allow that to happen with, of course, the appropriate precautions in place. So, that's just to maintain the trial integrity. So, I agree with Carl. I don't see this being a defeat of the trial in any sense. But I do think there's a pause. How long that pause is, 48 weeks, seems like a reasonable guess, but we don't really know.

Got it. Perfect. And and you were beginning to talk a little bit about the importance of Dos and the Helix catheter versus say and I are a delivery and my question really is dead is the sustainability of the Helix catheter meaning do this are the cells. Is there any evidence to support that the cells are more resident more than at the end of the day? They're just going to Trophy Club home along along the the hypoxic gradient or a v gradient to to to where they're needed in the heart.

yeah, so

You know, I'm like, um a cute Mi trials, um, where you expect to see homing factors that are still some residual oil oil following a heart attack in the acute phase where if you infuse things intravenously or intracoronary you would expect those cells to kind of migrated to those territories where those factors are in The Chronic ischemic heart failure population. We don't think that those homing factors are there. So I don't think that we're expecting the sales to kind of migrated along any sort of paracord ingredients that way what we're talking about where I'm talking about is just physical geographic location of injecting the cells and because the hearts constitutes cheating if you inject in a corkscrew fashion, and then you pull it out in that Corkscrew, you know reverse Direction those cells reside there are likely to reside there longer and this is again off.

Dr. Carl Pippin: It's also important, I think, to re-emphasize that the review of the first 74 patients by the Data Safety Monitoring Committee, which is independent from either us as the national PIs or the sponsor, identified no safety concerns and recommended that the trial continue as planned. So, that's pretty good when you're that far through trial 74 patients without issues.

Operator: Okay, great. Thanks for taking my questions. And our next question will be from Jason McCarthy with Maxim Group. Please go ahead. Hi Peter.

Been published in a couple of Publications, which I think Peter would be happy to I'd be happy to send it along to to show you about that aspect of the retention properties of it. Now do the fact that the fact that the retaining and these deposits in that location for longer using this technique. Is that going to impart additional therapeutic benefit? We don't really know that. All right, so but we don't see a downside to it and I think a lot of most of us think that keeping the cells they're given that their effect is likely a Peregrine affect local delivery of these, you know protein in Signal signaling pouches, that could be a delivery locally to to Signal, you know, local other cells to be recruited. We think that those that sells persisting they're dead longer is better.

Operator: Thanks for taking the questions. Can you give us a sense of, you know, you mentioned that there was an uptick in your enrollment prior to all the activity around COVID. What would have been the expected timeline to get to data or to at least complete enrollment? And with, you know, potential delays or more than likely delays now for everybody, what does that enrollment timeline look like?

Dr. Ama Chaval: So is that for, so this is the Amish here. So I think I can attest to that.

Dr. Ama Chaval: So the original, very long ago, our original enrollment goal was June 21st of next year. But that was, there were some delays. Our roll-in phase happened very efficiently, but it was based on that initial pilot study that we made some protocol changes which created some delays. And so we think that we're not really sure in terms of overall enrollment. All I can tell you is based on the uptick, we're hoping that we're starting to see enrollment of about, you know, screening three patients per month at each of the various sites. And these sites have more been coming online. So I don't know what the math would end up being in terms of the specific date, or final date now in light of this. I don't think anybody knows that, but I can tell you that compared to other studies that I'm also involved with, and I think Carl's involved with, we're seeing this in a very optimistic light.

Perfect. Thank you very much. Really appreciate it the conversation with me was valuable for my son. What I meant was when I dropped him off at Madison me. Thank you. I'll see you both then.

Ladies and gentlemen, this concludes our question-and-answer session. I would like to kind of coverage back over to Peter Altman for any closing remarks.

Thank you, Chad. So thank you very much doctor of doctor 14 for sharing your perspective on the cardiac heart failure trial. Hopefully, this will be the first of a number of calls that will have enabling those who are supporting biocardia to connect with those who are doing the heavy lifting on the front lines of clinical care and age where everybody on the call. Thank you for joining. Thank you for the questions. Stay safe out there. These are interesting times and have a great afternoon, bye-bye. Thanks. Bye. Thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

Peter A. Altman: Okay, and from an expense perspective, I know you just filed for an extension on the 10k, like so many have done, given all that's going on. If there's going to be a delay in the trial, can you walk us through what you expect the expenses to look like over the next couple of quarters and then, you know, maybe remind everybody, you know, the impact that Medicare does have on the expense line for BioCardia. It's a significant component to funding the trial.

Peter A. Altman: This is Peter. I'll dive in, Jason. Thanks for calling in. Yeah, this call is focused primarily on the heart failure trial and not on BioCardia's business per se. I'm trying to focus on the safety and efficacy issues and trial design issues.

Peter A. Altman: But at a very high level, we, as well as many others, are still figuring things out. The timeline, as Amish has suggested and Carl has suggested, is not gonna have a significant impact. The trial is substantially supported by Medicare, and our base operational costs for a few months are really what the cost of a delay or pause will be. And if anything, the team is taking care of outstanding paperwork issues and working with the sites to make sure that on the other side of this, we'll have a bolus to really accelerate. So we're not sure it's going to have a major impact if that bolus does occur on the other side.

Operator: Okay, great. Thank you for taking the question. Once again, if you'd like to ask a question, please press star and 1. The next question will come from Jason Colbert with Dawson James. Please go ahead.

Operator: Hi guys. Thank you so much.

Operator: I'd like to build on some of the things that my distinguished colleague, Dr. McCarthy, just asked. Amish, I'm very excited you're on the call, by the way. I have a son at the University of Wisconsin, and so I hope I have a chance to come sit with you and talk with you when I'm out there. That would be great.

Operator: It's an amazing university, and for people who don't know, Wisconsin has been a pioneer in cell and stem cell therapy for a long, long time. Two things that you mentioned I wanted to kind of dig into in a little bit more detail. The helix counter and what role dosing plays in cardiac disease, because, as you know,

Operator: You know, we're all waiting for the outcome of the CHF trial that a competitor is working on. And I am both excited and fearful for that data because it's a very different dosing modality. And so I'd like to understand how important it is, in your opinion, and Carl, you as well.

Operator: And then I want to just pick up on something else you said, which is 30% of patients who qualify from the bone marrow aspirate may not qualify, and therefore they could have a, you know, potentially an allogeneic solution. And as you know, BioCardia, like Mesoblast, is working on an allogeneic solution. So if you could kind of tell me a little bit about how that would, in reality, work. Because once you pull a marrow aspirate, it's a shame, right, not to be able to process and move it forward. And so, you know, it just seems logistically like that would be very problematic.

Operator: So thank you very much, guys. I know how busy you must be with all this stuff, with the COVID pandemic going on. And so we really do appreciate your taking the time to do that.

Dr. Ama Chaval: No problem. No problem.

Dr. Ama Chaval: Steinwill, and any time after everything settles down, of course, right?

Dr. Ama Chaval: and others

Dr. Ama Chaval: We're still preventing people, you know, acknowledging each other directly in the hospital. So that being said, now back to the dosing with the Helix catheter. I think you mentioned the heart failure trial. I'm assuming you're referring to the DREAM heart failure trial by Mesoblast, another phase three trial that we're waiting on the results of. So this is a bone marrow cell product that includes the cell types that are also sort of factored in with Mesoblast. It also includes a variety of other cell types that have been tested by others, including CD34 cells. So that's what I think.

Dr. Ama Chaval: and our constituents. There are a variety

Dr. Ama Chaval: Within it, the particular proprietary bone marrow assay that is being used to screen these patients has taken into account what those cells are. If you look at specifically CD34, and Peter has given permission to allow us to talk about CD34, CD34 itself is a very potent endothelial progenitor cell.

Dr. Ama Chaval: If you look at that in particular, and you look at prior studies, in particular the RENEW trial and prior to that, the ACK34 CMI trial, the CD34 content of this trial is higher than that. So when we look at the overall dose, the dose of the cells of interest is higher than what others have used. Now the other part of it is the helix catheter, and we think that the retention of those cells, so the effective dose and the kind of the in situ dose, the staying power of that dose is higher based on prior published studies that show that if you inject particles that can be tracked, you will have more of those particles around hours later than you will if you just inject them with a straight needle catheter, for example.

Dr. Ama Chaval: So that's kind of the issue with the dose. Now when you get to the 30% group, I think one of the things that is unique about this study is that, on its surface, it might seem like a very arduous thing to undergo a small volume bone marrow aspirate and then a larger volume bone marrow aspirate. But in all of the patients, and we have not heard a single negative statement by anybody, and Karl can pipe in if he has, but I haven't, that this is very well-tolerated and it's a very straightforward procedure.

Dr. Ama Chaval: And I think most patients, when I speak to them and I screen them, and I tell them that, you know, you may be randomized a little higher than 50%, right, because 150 patients get treatment, and 100 get the sham group. I tell patients that if you are assigned to the sham group, that means that your cell content isn't up to snuff; it isn't likely that you're going to benefit So we're not going to go ahead and do the risky aspects of the treatment on you, you know. And so that's one thing about this study. The sham is actually just simply inserting a catheter into an artery in the groin, but we don't take the catheter up into the heart itself, the helix catheter.

Dr. Ama Chaval: So there's a bit of.

Operator: [inaudible]

Dr. Ama Chaval: If they don't meet that criteria, then what options do they have?

Dr. Ama Chaval: But so you look at it from that perspective, you know, if they're not meeting that criteria, they're just back to our standard of care. We're hopeful that we'll have allogeneic products available. That would be an obvious regenerative medicine solution to that problem. But we haven't discounted patients in this trial of getting LVADs down the road if they qualify for that or a heart transplant. But the reality is they don't have many options, many options after, you know, today. But at the same time, our trial is focused on trying to see if we can develop a personalized cell therapy approach for those 70% to work.

Dr. Ama Chaval: Got it. Perfect. And you were beginning to talk a little bit about the importance of dose in the helix catheter versus, say, an IRA delivery. And my question really is, what is the sustainability of the helix catheter, meaning are the cells more resident or that at the end of the day, they're just going to trophically home along along the hypoxic gradient or HIF gradient?

Dr. Ama Chaval: Yeah, so, you know, unlike acute MI.

Dr. Ama Chaval: to see homing factors that are still residually available following a heart attack in the acute phase, where if you infuse things intravenously or intracoronally, you would expect those cells to kind of migrate to those territories where those homing factors are. In the chronic ischemic heart failure population, we don't think that those homing factors are there.

Dr. Ama Chaval: We're expecting the cells to kind of migrate along any sort of paracrine gradients that way. What we're talking about, what I'm talking about, is just the physical geographic location of injecting the cells. And because the heart's constantly beating, if you inject it in a corkscrew fashion and then you pull it out in that corkscrew, you know, reverse direction, those cells reside there, are likely to reside there longer. This is, again, it's been published in a couple of publications. I think Peter would be happy to, or I'd be happy to send it along to show you about that aspect of the retention properties of it. Now, the fact that the cells that they're retaining in these deposits in that location for longer, using this technique, is that going to impart additional therapeutic benefit?

Dr. Ama Chaval: We don't really know that, right? But we don't see a downside to it. And I think a lot of us think that keeping the cells there, given that their effect is likely a paracrine effect, local delivery of these proteins and signaling pouches that could be delivered locally to signal local other cells to be recruited. We think that cells persisting there longer is better.

Operator: Perfect, thank you very much. I really appreciate it.

Operator: My conversation with you is invaluable for my son. What I meant was when I dropped him off at Madison. Oh, I see. Thank you. I'll see you both then.

Peter A. Altman: I'll see you both then. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Peter Altman for any closing remarks.

Peter A. Altman: Thank you kindly, Chad. So, thank you very much, Dr. Reval and Dr. Pepin for sharing your perspectives on the cardiac heart failure trial. Hopefully, this will be the first of a number of calls that we'll have enabling those who are supporting BioCardia to connect with those who are doing the heavy lifting on the front lines of clinical care. And for everybody on the call, thank you for joining us. Thank you for the questions. Stay safe out there. These are interesting times. And I have a great afternoon. Bye bye. Thanks.

Operator: Thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your line.