Q1 2022 BioCardia Inc Earnings Call

May 11, 2022

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Ladies and gentlemen, thank you for standing by.

Good day and welcome to the <unk> 2021st quarter Conference call.

Good day and welcome to the BioCardia 2022 First Quarter Conference Call.

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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 Jos Abraham of core IR, The company's Investor Relations firm. Please go ahead Sir.

Thank you Rocco and good afternoon, everyone. Thanks for thank you for participating in today's conference call. Joining me from bio cardiac today is the leadership team Peter <unk> Ph D, President and Chief Executive Officer, and David Mcclelland, The company's Chief Financial Officer.

Thank you, Rocco. And good afternoon, everyone. Thank you for participating in today's conference call. Joining me from Biocardia today is the leadership team, Peter Altman, PhD, 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 myocardial <unk> expectations for future performance or operational results references to management's intentions beliefs projections outlook analyses or current expectations.

Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and obtaining regulatory approval.

Such factors include among others, the inherent uncertainties associated with developing new products or technologies and obtaining regulatory approvals.

Correlation statements involve risks and other factors that may cause actual results to differ materially from those.

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 BioCardi's most recently filed periodic reports on Form 10-K , Form 10-Q , and Form 8-K filed with the SEC, particularly the cautionary statement.

For more information about these risks please refer to the risk factors described in myocardial <unk>. Most recently filed periodic reports on Form 10-K Form 10-Q, and form 8-K filed with the SEC, particularly the cautionary statements with it.

The contents of this call contains time-sensitive information that's accurate only as of today, May 11, 2022, and except it's required by law, BioCardia disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

The contents of this call contains time sensitive information thats accurate only as of today may 11.

In 2022, and except as required by law by Ricardo 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, PhD, the company's president and CEO . Peter, please, go ahead.

It's now my pleasure to turn the call over to Peter Hoffman Ph D. The company's President and CEO . Peter Please go ahead.

Thanks, Jules, and good afternoon to everyone on the call.

Thanks, Julie and good afternoon to everyone on the call.

It has been only six weeks since our last call with the 2021 year-end results.

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-in-cell-derived therapeutics to treat significant cardiovascular and pulmonary disease.

And Biochar day continues to execute in its efforts to advance its meaningful pipeline. It sounds 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 platform.

The first quarter was significant for Biochar deal 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.

Our primary focus is the enrollment in our clinical programs, which will be a continuing effort as a U S health care research systems across the United States recovers from COVID-19.

Our efforts to complete the cardiac autologous cell therapy pivotal clinical trials for the indications of heart failure.

Our efforts to complete the Cardi-Am Autologous Cell Therapy Pivotal Clinical Trials for the Indications of Heart Failure, or BHF, are a result of our efforts to complete the Cardi-Am Autologous Cell Therapy Pivotal Clinical Trials for the Indications of Heart Failure, or BHF,

Or be CDL, one and chronic myocardial ischemia or bcl two they've had some nice milestones this quarter.

and chronic myocardial ischemia, or BCD02, 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.

We have already shared DS 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.

providing independent validation that our data to date is truly compelled.

We had a successful data safety monitoring board review and our lead heart failure trial.

We had a successful data safety monitoring Board review and our lead heart failure trial.

We received Health Canada's no objection letter to expand the heart failure trial.

We received health, Canada has no objection letter to expand the heart failure trial in Canada.

We received a new CMS reimbursement code to support both pivotal cardiac cell therapy clinical trials.

We received the new CMS reimbursement code to support both pivotal cardiac cell therapy clinical trials.

And we received a favorable opinion from the Office of the Inspector General of Health and Human Services supporting our ability to cover patient co-payments in our heart failure.

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.

These were the result of efforts throughout 2021 and realized in the first.

For the first time, we have three cardiac heart failure trial procedures scheduled on the same day at three sites across the United States in the month ahead.

We are working diligently to support our world class clinical partners and complete enrollment in the cardiac trials as soon as possible.

We are working diligently to support our world-class clinical partners and complete enrollment in the CARDI-AMP 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 myocardial ischemia trial to enable its interim readout.

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 100 patients in the cardiac chronic myocardial ischemia trial to enable its interim readout.

We have just had our first consultation with Japan's pharmaceutical and medical device agency regarding registration of cardiac cell therapy.

We have just had our first consultation with Japan's Pharmaceutical and Medical Device Agency.

regarding registration of cardiac 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 cell therapy system in Japan, the United States and the European Union.

The meeting with Japan's P. M D a went well.

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 a second consultation where we will provide information and data that have been requested by Japan's pharmaceutical and medical device agency.

We are still on this pathway, aiming for approval of the cell therapy system in Japan based on our current data and planning for our second consultation where we will provide information and data that have been requested by Japan's Pharmaceutical and Medical Device Agency.

Although Japan's population is declining, there are many patients in Japan with heart failure that we believe cardiac cell therapy can benefit.

Although Japan's population is declining there are many patients in Japan with heart failure that we believe cardiac cell therapy can benefit.

Yeah.

What is not well appreciated is the Japanese scientists had been central to this field of development that has led to the cardiac cell therapy, just as Japanese scientists had been central to the development of induced pluripotent stem cells for which they were awarded the Nobel Prize in medicine.

Japanese scientists have been central to this field of development that has led to the cardiac 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.

Now I'd like to move to our two allogeneic cell therapy product candidates based on our allogeneic neuro kind of one receptor positive messing camel stem cell platform, which has progressed in the six weeks since our last call.

Now, I'd like to move to our two allogenic cell therapy product candidates based on our allogenic NeuroKindin-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 DCD O three.

Our program in heart failure, which we have designated as BCD03

targeted to the patients who have been excluded from our autologous program due to the nature of their cells.

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.

It's 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 BCD04, has been approved by FDA this April to treat patients, and we are targeting enrolling first patients as early as next quarter, Q3 2022.

Our program in patients recovering from acute respiratory distress syndrome, which we have designated BCD. Four 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 M. S cheese for acute respiratory distress syndrome.

In summary, we are advancing well.

for therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and our allergenic self-therapy platforms. From these therapeutic development efforts,

For therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and allogeneic cell therapy platforms.

From these therapeutic development efforts, we have three active business development initiatives.

First, is partnering our Cardi-Amp 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 Avans transseptal introducer sheath product.

First is partnering or cardiac cell therapy platform internationally.

Second is licensing our catheter based biotherapeutic delivery systems for cell gene and protein therapy candidates, the heart and third monetizing our advanced trend subtle introduced your sheet product.

I will now pass the call to David McClellan, our CFO , who will provide some financial perspectives. David?

I will now pass the call it gave them mcclung, our CFO , who will provide some financial perspectives David.

Thank you Peter.

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.

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.

Our research and development expenses increased by 22%, 2.2 million in the first quarter of 2022, due to increased spending in support of the CARDI-AMP heart failure trial.

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.

SG&A expenses of $1.2 million in the first quarter of 2022 is unchanged from Q1 2021.

The company's net loss for the first quarter was $3.3 million compared to $3 million in the prior year.

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.

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.

The increase is due to the timing of payments from collaboration partners, coupled with the increased research and development expenses during the quarter.

The increase was 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.

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Today's first question comes from Kumaraguru Raza with Brookline Capital Markets. Please go ahead.

Today's first question comes from Tomorrow Guru Rosa.

Brookline capital markets. Please go ahead.

Thanks for taking my questions.

Thanks for taking my questions. So first, with regard to these four clinical sites in Canada, can you talk a little bit about where these are located, how much of potential target population that you can enroll in the trial are there in these areas?

First with regard to this poor clinical sites in Canada.

Can you talk a little bit about where these are located.

How much of a potential target.

Target population that you're going to enroll in the try a lot better in these areas.

Okay.

Kumar, thank you for the question. Really appreciate you being on the call. We haven't yet identified the specific clinical sites we're active in in Canada. We will announce

Kumar. Thank you for the question really appreciate you being on the call. We havent yet identified the specific clinical sites were active in and.

In Canada we.

We will announce likely as we've done in the past the national principal investigator.

likely, as we've done in the past, the national principal investigator and the efforts at the first site once we've dosed the first patient.

And the efforts at the first sight once we dose the first patient.

But there are four sites, they are all moving forward well. The activities for site onboarding began quite some time ago.

But there are four sites. They are all moving forward well the activities for site Onboarding began quite some time ago. If others on the call are experienced with Onboarding are securing health, Canada approval, you actually have to have IRB approvals that clinic.

If others on the call are experienced with onboarding or securing Health Canada approval, you actually have to have IRB approvals at clinical sites before you can actually get a Health Canada approval. And so it's an interactive process.

Both sites before you can actually get a health, Canada approval and so it's a it's an interactive process.

But, yeah, we expect all four sites to come on board in the not-too-distant future, and there's some great folks involved. As far as their potential for enrollment, you know, that's one of our primary challenges. I think they're all in major, major areas. And I think the advantage that they have is that they're not – they don't have the burdens of – associated with the billings that we have in the United States with the Medicare reimbursement.

But yeah, we expect all four sites that come on board in the not too distant future and there is some great folks involved as far as their potential for enrollment you know that's one of our primary challenges I think they're all major major areas and I think the advantage that they have is that they're not they don't have the burdens.

Associated with the billings that we have in the United States with the Medicare reimbursement. So that's one thing that will free them up. The other is you know there's not as many competitive activities in Canada and so that's another advantage that enrollment will have from those sites, but they're all world class sites with very experienced folks and we're both delighted and honored to be up.

So that's one thing that will free them up. The other is, you know, there's not as many competitive activities.

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.

To work with them and we'll identify them.

Go ahead.

And in the U.S., what are you seeing in terms of the, you know, 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.

And in the U S. What are you thinking in terms of the.

Challenges from COVID-19, where do you guys find there you'll see more patients being screened here.

Whatever you can share with regard to the dark.

Absolutely. And this is something that we keep hoping will be.

Absolutely.

And it's just something that we keep hoping will be.

tamp down, I think, I'll give folks an example. We have one Florida.

Tamped down.

Zinc I'll give I'll give folks. An example, we have one Florida site, where the patients who are.

where the patients who are offered to participate

Offered to participate have literally said that they don't want to participate 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 there's close quarters everywhere and yet in the <unk>.

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.

Hospital, everybody is massed 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.

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 staff.

But that's one element the second element Kumar is staffing.

There are difficulties with the evolution of...

There are difficulties with the.

The evolution of <unk>.

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 restaffed.

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 re staffing.

So we have, I'll give you an example, we have one center that's not enrolling any patients because they're currently recruiting a key person they need on their team, and without that person, they can't recruit. So that site's effectively stalled until they get a coordinator.

So we have I'll give you. An example, we have one center.

Not enrolling any patients because they are currently recruiting key.

Key person they need on their team and without that person.

They can't recruit.

So that sites effectively stalled until they get a coordinator on board and I'm aware of other folks in our space that are actively.

And I'm aware of other folks in our space that are actively seeking to pay to hire coordinators for clinical sites to address this issue for their crop.

Seeking to pay to hire coordinators for clinical sites to address this issue for their trials.

So, that's a potentially bigger issue and a longer issue, but it is being resolved and there is progress 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, you know, strategies to enroll, we have

So that's that's a potentially bigger issue and a longer issue, but it is being resolved and there is progress at a number of centers that we've seen.

Recently so.

Those are really the big ones. The other is as we're looking at strategies to enroll we have you know.

all of these things we've done in this first quarter are gonna 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 to the plastic.

All of these things we've done in this first quarter are going to contribute in addition.

The the the Covid fears or are being tamped down in many areas and the staffing is going up but there's also another strategy. We're implementing addition that classic.

Classic marketing efforts is tight.

is tied into going after patients that.

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 had seen as trivial for some of these folks who may have permanent devices onboard.

have already been exposed to certain medical device therapies, so that the hurdle of having an interventional procedure, which is what our cell delivery requires, is not seen as daunting. In fact, it's seen as trivial for some of these folks who may have permanent devices on board, because this is a one-time catheterization procedure where we deliver their cells.

<unk>.

Because this is a one time Catheterize Asian procedure, where we deliver their cells.

And they're their own cells. The only thing that's left behind are their own cells.

And they are their own cells. The only thing that's left behind or their own cells. So I think that's a compelling pathway and we're gonna be working on that is one of the enrollment initiatives ahead as well.

So I think that's a compelling pathway and we're gonna 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?

And maybe finally with regard to the B M D D in Japan.

How many more consolidations do you think you need before you are able to move forward and move forward with the filing there.

And also the time line yet.

Yeah, so well that we're working on that are pretty actively the the number of consultations we will have at least two more consultations.

We are working on that pretty actively. The number of consultations, we will have at least two more consultations.

And, you know, there's a couple of other elements to this that I think, you know, are interesting. So the timeline, you know, we can only predict what the timeline for the next consultation is and it's actually quite soon. I think as we lean into this, you know, keep in mind that our cell processing platform is approved in Japan for other indications.

And you know there's there's there's a couple of other elements to this that I think are are interesting. So the timeline, we can only predict what the timeline for the next consultation is and it's actually quite soon.

I think as we lean into this you know 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, you know, we've had conversations and actually inked preclinical collaborations with two partners in Japan who have interest in those delivery systems.

And the <unk>.

Delivery systems that we have are not only approved in Europe .

But you know, we we've had conversations and actually inked preclinical collaborations with two <unk>.

Partners in Japan, who have interest in those delivery systems and as related to this particular therapeutic strategy.

And as related to this, you know, particular therapeutic strategy, you know, I shared that it began in Japan. You know, 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 and ischemic hindlimb disease. And at the same time he was doing that work, there was two physicians

Shared that it it began in Japan.

You know that there's a physician named Doctor Taklha Yoki Asa horror he was the first isolate CD 34 cells.

From the blood and thought it could provide neovascular amortization in ischemic heart disease and at the same time. He was doing that work there was a 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 we're pretty excited and there were some other follow on breakthrough work by Dr. Ross <unk>.

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 was some other follow-on breakthrough work by Dr. Asahara. So, there's a whole...

So theres a whole.

series of things that line up that may enable this. I mean, this is an effort that we think can be quite valuable, but the breakthrough designation provides support. The Medicare reimbursement code also provides a point of context. So, you know, all of these elements.

Series of things that line up that May enable this I mean this is this is.

And the effort that we think can be quite valuable, but the breakthrough designation provides support the Medicare reimbursement code also provides a point of context. So you know all of these elements. The fact that part of the systems approved in Japan part of this system is approved in Europe .

fact that part of the system is approved in Japan, part of the system is approved in Europe .

These basic discoveries effectively originate in Japan.

These basic discoveries.

Effectively originate in Japan.

the fact that there's other partners interested in using the delivery systems in the clinic.

The fact that Theres other partners interested in using the delivery systems in the clinic in Japan. Many of these things line up and I think we'll be hell.

in Japan. Many of these things line up and I think will be helpful to us as we go forward in these conversations. But, you know, at the end of the day, you know, 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

Paul.

To us and as we go forward in these conversations but at the end of the day.

T M D as a very sophisticated group and we are working with.

Wonderful co national principal investigators there, who we also have not identified publicly that we think.

give us the best chance of being successful on this initiative. Thanks, Peter.

Give us the best chance of being successful on this initiative.

Thanks, because we look forward to the progress.

I appreciate it thank you.

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

And our next question today comes from one of our brands out of here.

C. Wainright. Please go ahead.

Good afternoon, everyone. Thank you for taking the questions. And so regarding BCDA04 and the phase one, two, three trial expected to begin in the third quarter of 2022. And I was wondering if you can give us a sense of the opportunity in ARDS related to COVID with the pandemic evolving, but also beyond that, should we expect a proof of concept in COVID to be expanded to other forms of ARDS?

Good afternoon, everyone. Thank you for taking the question.

So regarding B C D E F four and the phase 123 tie and expect it to beginning the third quarter of 2022.

And I was wondering if you can give us a sense of the opportunity in a S. Yesterday, they tend to call that didn't lead the pandemic advertising, but I would say beyond that should be expect that proof of concept in called needed to be expanded to other forms of the air Yeah. Yeah.

And also, when thinking about the mechanism of actions, what advantages does BCDA-04 provide over other strategies, perhaps other mesenchymal stem cells strategies, or over, for example, NK1 receptor inhibitors?

Well, it's still when thinking about the mechanism of action what advantages that the D. C D O for them to buy their other strategies that upside there.

Okay. Thank you my sense that sends out talking to all of our Oh that for example, NK one receptor you need be tourists.

Wow, that's a that's a big question.

Wow, that's a big question.

So I'll try and I'll detail some of it and then well thank you for being on the call really appreciate it.

detail some of it. And Manuela, thank you for being on the call. Really appreciate it.

We're pretty darn excited about having the IND accepted, and it's sad that the markets don't appreciate what this is.

We're pretty darn excited about having the IND accepted and it's.

It 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.

You know our sense is we've just bolted on the value proposition of any of the other large leading messing time will sell companies that have not yet been successful in getting to market.

We have peers that are going after acute respiratory distress with intravenous administration of their culture-expanded mesenchymal stem cells. In fact, the NIH has a program that's actively enrolling and will soon complete enrollment in a 120-patient trial.

We have peers that are going after acute respiratory distress with intravenous administration of their culture expanded messing kind will stem cells. In fact, the NIH has a program that is actively enrolling and and will soon complete enrollment.

And 120 patient trial.

So, I don't know all the nuances.

So I don't know all the nuances with respect to the chemistry manufacturing controls and nature of them.

with respect to the chemistry manufacturing controls and nature of the competitive mesenchymal stem cell programs. All of them, to my understanding, are

The competitive messing time will stem cell.

Programs all of them to my understanding are.

allergenic. There is potential for them to be approved in Japan based on the Helios data with athercyst.

Allogeneic there is potential for.

Them to be approved in Japan based on the Helios data without their system.

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

And then not too distant future and so we're we're watching and following the data of our peers and we're wishing them every success.

On our end you ask what is the opportunity.

We're 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 were not sharing a lot of details on that today, but I think the key takeaway is we're coming at it slightly differently initially.

COVID-19, not necessarily those who are in the middle of severe ARDS and on a respirator. 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.

You know, our trial design is a phase one, two trial, and your question on whether or not we will have proof of concept.

You know our trial designs of phase one two trial and.

Your question on whether or not we will have proof of concept from a efficacy perspective.

from an efficacy perspective, I think right now we're focused on the phase one portion 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.

I think right now we're focused on the phase one portion, which has a dose escalation element and we're pretty confident that we will we will get through that without any issues on the other side of that.

We'll be learning, where COVID-19 is that at that point in time and what the the case rate profile is.

Of acute respiratory distress syndrome secondary to COVID-19 currently your point, which is sort of implied is correct is that the number of hospitalizations due to COVID-19 has drastically reduced.

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 BCD04 program, that same fact is going to drive enrollment in BCD01 and BCD02. So, we're actually hopeful that that is the case and that continues. We're going after this indication because this is, you know, 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.

And even though that has potential to erode the enrollment rate of the B C. D. O. Four program that same fact is going to drive enrollment in D. C to have one in BCD O. Two so where we're at 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 there's other things going on with these COVID-19 patients again, we're going after patients who are recovering from acute respiratory distress syndrome, and theres a lot of information in the media these days around long COVID-19.

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 wouldn't say, where we're going on that head on today, but there is potential for us to expand.

There's two other indications.

I note that an intravenous safety package with our neurocon...

I note that in intravenous safety package.

With our neural con.

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, you know, the mechanism of action, the last part of your question,

Neuro kind in one receptor positive message <unk> 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 biochar to you once we complete.

Our safety package.

But that said you know the mechanism of action for the last part of your question.

You know, these cells are well documented as being anti-inflammatory in nature. This is basic mesenchymal stem cell biology, and there's many, many articles on their impact in this fashion.

These cells are well documented.

As being anti inflammatory in nature. This is basic message kind of stem cell.

Biology, and there's many many articles on.

Their impact in this fashion.

Our other three programs, BCDA 1, 2, and 3, are all local delivery of cells to the heart using our delivery technology.

Our other three programs, we see a one two and three are all local delivery of cells to the heart using our delivery technologies. We are big believers that sells should be locally delivered to target sites, where <unk> seeks to have a therapeutic.

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.

The benefit in this indication were delivering them intravenously.

My great 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 neuro kind in one receptor positive and what's important about that is you know that is the receptor that binds to substance P.

And what's important about that is, you know, that is the receptor that binds to substance P. In our slide deck, I love to show a picture from the New England Journal of Medicine, which shows substance P as the primary mediator of inflammation in the lungs. And so, will that result in our having differential benefit over other mesenchymal stem cell therapies that are being advanced?

In our slide deck I love to show a picture from the New England Journal of Medicine, which shows substance P is the primary mediator of inflammation in the lungs, and so will that result in our having.

Differential benefit over other message kind will 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, you know, there's

We don't know one would one would expect that it likely would.

But again I think head to head trials will probably not be.

<unk> performed until such time.

As you know there is a a.

product on the market and the second one comes along trying to either unseat it or show non inferiority.

Our product on the market and the second one comes along trying to either unseated a show non inferiority as we're initially going after a different indication from others.

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.

That may in fact be ours that gets to market first but time will tell.

So, did I answer most of your questions?

So did I answer most of your questions yeah.

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

Yeah, Yeah, Yeah, you did and that's always nice when he shot though.

Just had a question so with regard to the strategy for a potential partnership and Dr. Hugh You mentioned could you provide more color on the overall strategy and perhaps how much you are much are out of the conversations you're having with potential partners.

Well sure so the the first conversation with respect to <unk>.

first conversation with respect to Cardi-Amp internationally. I think one of our primary focus is in Japan.

Cardiac internationally I think one of our primary focus is.

In Japan, because there is potential for a.

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, you know, I'm.

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 the heavy lifting that the partner has that will really drive some of the some of the economics here and so I.

I can't share any specifics, but it makes sense that BioCardi as 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.

I can't share.

Any specifics, but you know it it makes sense that Biochar D. As a small company is not going to.

Field a distribution organization.

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.

Cardi-Amp has potential to be a cell therapy literally everywhere in the world. The economics of it at volume in a procedure kit are more compelling probably than any other cell therapy that's out there. We really have dialed things in well from that perspective.

Cardiac <unk> has potential to be.

Our 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.

Cell therapy, that's out there, we really have dialed things in well from from that perspective on the strategy with respect to our biotherapeutic delivery partnering.

on the strategy with respect to our biotherapeutic delivery partnering. We are moving closer to considering only significant relationships.

We are we are moving.

Closer to you know considering only significant relationships.

because each partnership does require our senior staff support and involvement. 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.

Each partnership.

Does require our senior staff support and involvement and we view them as partnerships underneath those it would be similar to our standard <unk>.

Licensing transaction in which we would risk.

<unk>.

Upfront milestones.

As well as a small portion of the ultimate therapeutic value proposition.

You know, those are significant deals and take time, and it's somewhat tricky because, you know, we have some, there's some great folks working in this space, but, you know, we're in phase three. You know, we're running at 20.

You know those are significant deals and take time in it and it's somewhat tricky because you know we have some there's some great folks working in this space.

But you know we're in phase III.

We're running at 20.

you know, six sites across the United States and adding more in Canada and

Six 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 its hard to enter into a significant licensing deal.

adjunctive to coronary artery bypass grafting. But, you know, for folks who are.

just beginning, it's hard to enter into a significant licensing deal. That said, some of them 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. If Cardi-Amp is not successful and another partner of ours is, that's good for patients. And we also view that as good for our.

That said some of them are do have significant resources and know that may be something we take forward our thoughts today as I've shared in our last call is that partnering is good for patients at the end of the day to enable them to get access to more therapeutic opportunities.

Cardiac is not successful in another partner of ours is that's good for patients.

And we also view that as good for our shareholders.

The idea that, you know, they would have a portfolio of pathways whereby they could win even if Cardi Amped.

The idea that you know they would have a portfolio of pathways, whereby they could win even if carty amp or our allogeneic neurocrine and one message kind will stem cell program arent successful in the cardiac arena.

or our Allogenic Neurokinin-1 mesenchymal stem cell program aren't successful in the cardiac arena. So, that's sort of inherent in the partnering there. We have entered, last year in 2021, we did a number of deals where, you know, they were pre-clinical collaborations, and those are really intended to demonstrate what we can do to help partners get comfortable to enable them.

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.

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.

Into their therapeutic development activities and and we're 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 of years in their development programs.

If not.

To 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 conversation and we'll see where they all pan out. And then the last opportunity is our strategy around our advance.

And so we're delighted as these move forward, we have a number of them inactive conversation.

And we'll we'll see where they all pan out and then the last opportunity is our strategy around our advance.

transeptal sheath offering. This is a FDA cleared product that we have. We developed it because we were developing advances to our biotherapeutic delivery system that I just talked about.

Trans septal cheap offering this is a 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.

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 transeptal

How to design these navigation platforms, and we decided to make one appropriate for the transcriptome market.

It is a real market. There's been two deals announced in this space recently. One deal was Boston Scientific's acquisition of Bayless for $1.5 billion primarily around their access technologies for getting catheters from the right side of the heart to the left side of the heart, transeptally.

It is a real market theres been two deals announced in this space recently.

One deal was Boston Scientific's acquisition of Balas for $1.5 billion, primarily around their access technologies forgetting catheters from the right side of the heart to the left side of the heart.

Separately.

And just a week or two ago, Medtronic acquired the assets of AFib for this same application for $50 million. Of course, the Bayless platform had, you know, was looking at

And just a week or two ago Medtronic acquired the assets of a fib.

For the same application for $50 million of.

Of course, the Bayless platform had.

I was looking at $200 million revenue I don't know what the revenue profile on the eighth platform was and I can share that our revenue profile.

200 million 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.

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 R. B.

you know, beginning to successfully expand the market reach. But what I expect is, you know, we'll have a partner that takes it on as a tuck-in asset because it's definitely an improved value proposition in our eyes over the designs that are currently embedded in partner products today. And the technology actually has broad reach.

Beginning to successfully expand the market reach but I. What I expect is we will have a partner that takes it on as a tuck in.

Asset because its definitely an improved value proposition in our eyes over that the designs that are currently embedded in partner products today and the technology actually has broad reach.

not just in transeptal access, but in fact, all...

Not just in Transcept of access but in fact all.

You're a bull.

Guiding catheter systems that are used robotically can benefit from what is inherent.

Guiding catheter systems that are used robotically.

Can benefit from what is inherent.

in the advanced platform. If you look at the patent filing on that technology, you will see that it goes very broad and very deep through essentially all interventional procedures that may benefit from such a design. Really what the design does is it is a mechanical solution that prevents one from having an unstable position.

In.

The advanced platform and if you look at the patent filing on that technology, you'll see that it it goes very broad and very deep through essentially all inner.

Interventional procedures that may benefit from 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.

With a 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 as we go up the aorta and do.

And as many on the call may know, what we do for our cell therapies is we go up the aorta and do a 180 degree turn and come down through the aortic valve for doing our procedure.

180 degree turn 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.

And so this technology significantly enhances our control and that procedure and we have a great safety profile to date, 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.

Oh, got it. That's very helpful. Thank you. And I guess a follow up to this, like, should we expect a possible monetization for these in 2022?

Oh got it that's very helpful. Thank you and I guess, a follow up to be like should we expect to a possible monetization for theater at in.

In 2022.

I would say at this juncture, predicting partnerships and predicting the markets is pretty scary. I would say we're going to beat our revenues from last year. 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

I would say at this juncture you know predicting partnerships in predicting the market.

Is pretty scary I would say I'd say, we're gonna 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 gonna get the enrollment dialed in for these trials, those are our big efforts.

And we're gonna get the enrolment dialed in for these trials those are all big efforts.

Great. Thank you very much.

Thank you Manuel.

Thank you and our next question today comes from Jim Malloy with Alliance Global Partners. Please go ahead.

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

Hey, guys. Thanks for taking my questions I had a quick question to clarify.

Hey guys, thanks for taking my questions. I had a quick question to clarify. I see that the 01, the third quarter, the interim look is on track, which is great to see this year. And then, as I hear correctly, you're going to complete enrollment in 23 for that. We anticipate final data, which we anticipate final data on 01. And then on 02, again, you get clarified the interim role and safety should be in 2022, which is excellent.

The Oh, one the third quarter. The interim look is on track, which is great to see this year and then if I heard correctly, you're going to complete enrollment in 'twenty three so that we anticipate final data.

Just my final data on a one.

And then on <unk> again.

Then just to clarify the interim interim role in safety in 2020, which is excellent.

Relative to 01, how far behind in time or close in time are those two trials getting completed?

Relative to one how how far behind in time or her close in time.

Those two trials too.

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.

Well, Jim we're working to try and line them up so they're almost simultaneous.

So I note that.

Oh, two has a six month follow up for.

primary endpoint and O1 has a one-year follow-up. So we're looking to enroll in those two programs roughly a hundred patients each.

The primary endpoint in O. One 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.

A little bit more than 100 patients each by the end of next year and that if they.

In doing that, that would line us up for reporting out results from both in 2024. Outstanding.

In doing that that would line us up for reporting out results from both.

In 2024.

And again the O two program.

Yes.

The O2 program is not top line data on the full trial as designed. It's based on the adaptive readout at 100 patients. But I note for those listening that we had a P value in our lead program in phase two at 30 patients. You know, the phase.

Oh two program is not top line data on the full trial is designed it's based on.

The adapt to read out at a 100 patients.

But I note for those listening that we had a P value in our lead program.

And phase two at 30 patients you know the phase.

three pivotal for our lead program is significantly overpowered with greater than 95% power. And that's reflected in the FDA's breakthrough designation.

Three pivotal for our lead program is significantly overpowered with great greater than 95% power and that's reflected in the Fda's breakthrough designation I mean, the data is really good.

The data is really good. For O2, we expect the data to also be good, but the adaptive readout, you know,

For <unk>, we expect the data to also be good but the adaptive readout.

We will tell us essentially how large that trial needs to be and it could conceivably.

will tell us essentially how large that trial needs to be. And it could conceivably result in, you know, the Data Safety Monitoring Board saying.

Result in you know the data safety monitoring board, saying you know.

you know, we recommend you stop the trial because you're already looking at a p-value, but we won't know until we get to that.

We recommend you stop the trial.

Because you're already looking at a P value, but we won't know until we get to that point.

And honestly, if the DSMB comes back to us at that 100 patient adaptive readout and says, you 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.

Honestly, if the D. S. N V comes back to us at that 100 patient adapt to read out and says.

You know.

You need to enroll you know 350 patients in the trial, that's still a success that means that the trial has been self powered at multi centers and so you're dealing with the same.

Variability from site to site and patient to patient because you're doing the adapt patients of the size of the trial in the trial, but the big win would be of course, if the the results at a 100 patients where you're good you should stop the trial because of efficacy, but we can't guarantee that.

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 we could indeed.

If, looking at the bigger picture, and obviously the stock's been under pressure, and you're a good company, because every stock's been under pressure of late, so that's certainly nothing notable to Biocardia. How would you characterize the partnering environment sort of currently given everyone's depressed stock prices, or even sort of an outright acquisition? Has that changed at all, or has there been more or less activity you've seen given sort of the across the board decreased evaluations for biotech?

If looking at the bigger picture here I mean, obviously the stock's been under pressure as you know the company because every stock's been under pressure of late.

Nothing notable to bio cardiac.

How is that how would you characterize the partnering environment currently given.

Everyone's depressed stock prices or even sort of an outright acquisition has that changed at all or has there been more or less activities you've seen given across the board decrease the valuations for biotechs.

I don't think it's rolled through quite yet. I think it's starting to happen. I think there are parties that, you know, have

I don't think it's it's it's rolled through quite yet I think it's starting to happen I think.

There are parties that you now have.

Reeling from some of the impact in the in the non profitable biotech space.

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, you know, suddenly their cash becomes significantly more precious because nobody wants to go to market in this environment. At the same time, you know, since everybody feels their equity is undervalued, equity can't become an element of a deal either. And so it does make things significantly more challenging in the,

And so yeah, that's that throws a monkey wrench into everything but at the same time you know you know.

And suddenly their cash becomes significantly more precious because nobody wants to go to market in this environment at the same time since everybody feels that your equity is undervalued equity can't become an element of a deal either and so it does make things significantly more challenging.

In the in the nonprofit Auble biotech space.

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 gonna be great for them.

The larger players you know, it's a real opportunity for them if they have stabilized stock price and they can 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.

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.

Ladies and gentlemen, as a reminder, if you voted.

And ladies and gentlemen, as a reminder, if you'd like to ask a question, please press star than one. Our next question comes from Carolyn Kenner, a shareholder. Please go ahead.

So a question. Please press Star then one of them. Our next question comes from Caroline corner.

Shareholders. Please go ahead here.

<unk>.

Hello.

Yes.

In today's environment.

Yes.

I'm looking for you on the phone.

All of them are missing Marilyn learners.

It's Carolyn Kenner, yes.

Okay.

It's Carolyn.

Yes.

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

So Caroline this is Peter <unk>, the CEO of myocardial do you have a question.

Oh, yes, that's true.

Oh yes, Mr. Altman. Let me turn this other phone off.

Let me turn this over for more.

Yeah.

I wasn't prepared how this works, but I have several questions. One, can you give some idea of the benefits from your catheter and all the program going on there, you know, over the short-term, medium-term, long-term, and secondly, I would

Uh huh.

I wasn't here's how this works because I have several questions one.

Can you give some idea of the benefits from your carrots.

The old 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?

Is the factory to or I'm, sorry, the new clinic.

Set up in California is that.

[laughter] near completion, I don't think it would be because it's been so for such a short period of time when do you consider that to be finished.

Near completion, I don't think it would be because it's been up for such a short period of time up when you consider that to be finished.

And when will you start manufacturing these products?

And when will you start manufacturing these products.

and developing the market. I'll tell you one thing. I'm also a patient of yours, Dr. Rollman, and I was in the phase three study in Tampa, Florida with Dr. Leslie Miller.

Developing the markets I'll tell you one thing I'm also a patient of yours.

Aroma and I was in the phase three study in Tampa, Florida.

With Doctor Leslie Miller.

who is such a fine man. I had three heart attacks before somehow I got, I lost like 30% of my heart and all this kind of stuff. Was unable to walk two blocks hardly without sitting down.

Who is such a fine man.

You had three heart attacks before somehow I got lost 30% of the market hard and all this kind of stuff.

So I'm able to walk two blocks hardly without citadel.

I got involved somehow, luckily, in your program.

When I got involved somehow luck greig 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.

And I am a toe totally changed.

Six months I knew what was happening.

And I have been buying your stock and I will continue to buy it.

Forever well, Mr. Our historic downturn, so just two.

forever. Well, Mr. Kenner, so just two things I just shared. This is being recorded and it's publicly being transmitted. So I'd ask you to be careful in sharing your disclosure information. We don't want to unblind the trial. And it's great. It's absolutely great.

Two things I just share you are this is being recorded and it's publicly being transmitted site I'd ask you to be careful on sharing your disclosure information, we don't Wanna Unblinded the trial.

And it's great, it's absolutely great that you're feeling well.

That's number one for us here at BioCardia. If folks on the call look at our values, you know, our number one priority is patients at BioCardia. So let me try and answer your questions if I can and so first on the catheter platform, so we have a number of catheters here at BioCardia.

Number one for US here at Biochar do you folks on the call look at our values. Our number one priority is patients with myocardial.

So let me try and answer your questions. If I can and so first on the catheter platform. So we have a number of catheter is here at Biochar, yet we have our therapeutic delivery catheters, the leading ones in that category are our helix trans endocardial delivery catheter and are more.

We have our therapeutic delivery catheters. The leading ones in that category are our Helix Trans-Endocardial Delivery Catheter and our MorphDNA.

DNA.

deflectible catheter, it's a robotics platform through which the helix is used. Those are all fundamentally...

Deflectable catheter.

It's a robotics platform through which the helix is used those are all fundamentally.

First, the Helix is approved in Europe . The 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 treatment.

First the helix is approved in Europe . The morph DNA is approved in the United States.

We use that system and all of our first three clinical programs for cardiac indications and we partner that platform out.

As regards to the advance.

Platform for Transcept of procedures.

Um, it's, you know, we have clinical.

It's you know we have clinical FDA clear clinical grade FDA cleared product here on bio cardiac on the shelf and so we are actively working to sell product to the electric.

FDA clear clinical grade FDA clear products here on biocardia on the shelf. And so we are actively working to sell product to the Electrophysiologists and the interventional cardiologists who are doing structural heart procedures and they can benefit from that product today It's a very competitive market And so we've made the conscious decision based on where our cash is not to invest

Electrophysiologist and the interventional cardiologists were 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.

in sales expense, although we have signed up.

Sales expense, although we have signed up.

a number of 1099 commission only sales reps so we can staff and support any inbound inquiries.

Number of $10 99 Commission only sales reps, so we can staff and support any inbound inquiries.

And, your second question on the new facility and where we're at with that, I'm standing in a new facility today. We have our manufacturing for devices is up and running, and our manufacturing for the allergenic cells is also up and running.

And your second question.

On the new facility and where we're at with that I'm standing in the new facility today.

We have our.

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.

But it's a 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. We, all of the work was done substantially last year. All the expenses were borne last year.

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 with 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.

And going forward, we expected to reduce our expense profile from just facility costs, which dollars we intend to use elsewhere for our activities. So we do try to be wise with respect to significant recurring expenses. And it was a significant effort to complete that move and get these facilities up and running.

From just facility cost, which dollars, we intend to use elsewhere for our activities. So we do try to be.

Wise with respect to significant recurring expenses and it was a significant effort to complete that move and get these facilities up and running.

Um, but we're, we're pretty, uh, pretty optimistic about, um, the, the space we're in. And, uh, I like to say that instead of having the, um.

But we're we're pretty pretty optimistic about.

The space, we're in and I like to say that instead of having the.

Oh.

recycling facility out front of the building now. We have a couple of beautiful California redwoods and it just has a that sort of environment. We're also located in a part of California that has more staff people for manufacturing.

Recycling facility out front of the building now we have a couple of beautiful, California Redwoods and it just has a that sort of environment, where also located in our 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, you know, realize production. But the cell manufacturing is only intended for supporting our trials through phase one, phase two. We may use it for phase three as well, you know, and there's still.

The area where were before was.

Far more tech workers in I T and so this is also going to be good for us with respect to expansion and being able to.

Realize.

Production, but the cell manufacturing is only intended for supporting.

Our trials through phase one phase two and we may use it for phase III as well.

And Theres still.

some time ahead on that front. We would probably clone this facility for commercial and expand it and make it much larger and locate it in a more geographically central location near a FedEx hub if we were going commercial with our cell manufacturer.

Some time ahead on that front, we would probably close this facility for.

For commercial and expand it and make it much larger and local located in a more geographically central location near a Fedex hub.

If we were going commercial with our cell manufacturing, but then again, maybe it will expand here I don't know, we havent made any decisions on that front.

But then again maybe we'll expand here. I don't know. We haven't made any decisions on that.

So, but thank you for your questions and in closing I'll say Les Miller is fabulous.

So, but thank you for your questions and in closing I'll say Les Miller is a fabulous physician. It's an honor to be able to work with him.

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

<unk>.

And I, thank everybody for participating on today's call.

And for your interest in <unk>.

We look forward to sharing our continued progress ahead.

Thanks stay healthy be kind and have a wonderful day.

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.

Thank you Sir This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines have been wonderful.

Okay.

Yeah.

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