Q2 2022 BioCardia Inc Earnings Call

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Speaker 1: Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through August 24, 2022.

I would now like to turn the conference over to Jules Abraham of core IR, The company's Investor Relations firm. Please go ahead.

Speaker 1: I would now like to turn the conference over to Jules Abraham of CoreIR, the company's investor relations firm. Please go ahead.

Speaker 2: Thank you, Kate. Good afternoon, everyone, and thank you for participating in today's conference call. Joining me from BioCardy is leadership team today, our peer ultimate PhD, President and Chief Executive Officer, and David McClellan, the company's chief financial officer.

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

Speaker 2: During this call, management will be making forward-looking statements, including statements that address myocardial expectations for future performance or operational results, references to management's intentions, beliefs, projections, outlook, analyses, or current expectations.

During this call management will be making forward looking statements, including statements that address myocardial its expectations for future performance or operational results.

Since the management's intentions beliefs projections outlook analyses or current expectations.

Speaker 2: such factors include, among others, the inherent uncertainty associated with developing in products or technologies and obtaining regulatory approval.

Such factors include among others.

And uncertainties associated with developing new products and technologies and obtaining regulatory approvals forward looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

Speaker 2: core looking statement involved risks and other factors that may cause actual a natural relapse to differ materially from those states.

Speaker 2: For more information about these risks, please refer to the risk factors described in biocardia's most recently filed periodic reports on form 10K, form 10Q, and form 8K filed with the SEC, particularly the cautionary statements in this.

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 to caution the cautionary statements in it.

Speaker 2: The content of this call contains time-sensitive information that is accurate only as of today, August 10, 2022. Except as required by law, BioCardio 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 that is accurate only as of today August 10 2022.

As required by law and cardiac disclaims any obligation to publicly update or revise any information to reflect events or circumstances can occur. After this call.

Speaker 2: 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 off in ph D. The company's president and CEO . Peter. Please go ahead.

Speaker 3: Thanks, Jules, and good afternoon to everyone on the call.

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

We've had a great quarter.

Speaker 3: But before we get into the details, let's take a few moments to review what we are doing and why.

But before we get into the details, let's take a few moments to review what we are doing and why we're doing it.

Speaker 3: Iocardia's efforts are focused on advancing two cell therapy platforms to treat significant unmet cardiovascular and pulmonary disease.

Myocardial efforts are focused on advancing to cell therapy platforms to treat significant unmet cardiovascular and pulmonary diseases.

Speaker 3: specifically ischemic heart failure, chronic myocardial ischemia, and acute respiratory distress.

Specifically ischemic heart failure, chronic myocardial ischemia and acute respiratory distress.

Speaker 3: All of our cell-based therapies involve local delivery of the therapeutic to the heart or lungs where we intend them to act. Loc-

All of our cell based therapies involve multiple delivery of the therapeutics to the heart or lungs, where we intend them to act locally.

Speaker 3: In the heart, our proprietary Helix Minimally Invasive Delivery System is used to deliver the missiles to target regions of gamut.

In the heart of proprietary helix minimally invasive delivery system is used to deliver the cells to target regions of damage.

Speaker 3: For the lungs, we intend to use intravenous delivery, which will result in the investigational cells being localized in the small blood vessels of the lung.

For the lungs, we intend to use intravenous delivery, which will result, an investigational cells being localized in the small blood vessels of the lungs.

Speaker 3: Local delivery of therapeutics to the target location where their action is desired maximizes their effective dosage within the tissues where delivered and minimizes potential negative effects remote from the target tissues. Heart failure.

Local delivery of therapeutics to the target location, where their action is desired maximizes their effective dosage within the tissues were delivered and minimize the potential negative effects remote from the target tissues.

Heart failure is the first problem we're going after.

Speaker 3: heart failure is an enormous unmet need that affects more than 26 million people worldwide.

Heart failure is an enormous unmet need that affects more than 26 million people worldwide.

Speaker 3: the latest blockbuster drugs and pretty much the same indication we are going after don't have much of an

The latest blockbuster drugs and pretty much the same indication we're going after.

Don't have much of an impact on mortality.

Speaker 3: Patients in the published results of the pivotal trials for these new drugs have a mortality of roughly 7% per year Regardless of whether they were treated or control patients

Patients in the published results of the pivotal trials for these new drugs have a mortality of roughly 7% per year, regardless of whether they were treated or control patients.

Speaker 3: This data makes clear that heart failure is still a problem in great need of new therapeutic solutions.

This data makes clear that heart failure is still a problem in great need of new therapeutic solutions.

In preclinical studies cardiac mononuclear cell therapy has been shown to released proteins locally within the tissue to facilitate cardiac recovery after heart damage with improvements in heart perfusion and contractile function.

Speaker 3: In preclinical studies, cardiac mononuclear cell therapy has been shown to release proteins locally within the tissue to facilitate cardiac recovery after heart damage with improvements in heart perfusion and contractile function.

Speaker 3: All known previous clinical studies similar to the approach we are taking in our two lead cardiac cell therapy programs have shown patient benefits on it.

All known previous clinical studies similar to the approach we are taking in our two lead cardiac cell therapy programs have shown patient benefits on average.

Speaker 3: In some of these studies, including our own, the benefits have been remarkable.

In some of these studies, including our own the benefits have been remarkable.

Our F D. A breakthrough designation in ischemic heart failure validates this perspective.

Speaker 3: Our FDA breakthrough designation in a Schema Cart failure validates this perspective.

Speaker 3: In granting this designation, the FDA looked through all of our clinical results, patient by patient, and agreed the Cardiamps South-Aryphe Day to date, shows it as promised to provide for more effective treatment for a scheme of cardophilic.

And granted this designation the FDA looked through all of our clinical results patient by patient and agreed the cardiac cell therapy data to date shows that as promised to provide for more effective treatment for ischemic heart failure.

Speaker 3: Advancing this and our other therapeutic candidates is what we are all about.

Advancing this and our other therapeutic candidates is what we're all about.

Speaker 3: Our efforts to complete the Cardiapotologist's South there at the Pivotal Clinical Trots for the indications of heart failure, or BCDO1, and chronic mild carlischemia, or BCDO2, remain our primary source.

Our efforts to complete the cardiac autologous cell therapy pivotal clinical trials for the indications of heart failure or B C. D. L. One and chronic myocardial ischemia or B C. D E O to remain our primary focus.

Speaker 3: A lead heart failure program has 114 patients enrolled, and 10 control patients have crossed over to receive therapy.

The lead heart failure program has 114 patients enrolled and 10 control patients have crossed over to receive therapy.

Speaker 3: Here today we will only detail the new accomplishments towards completion of these studies.

Here today, we will only detail the new accomplishments towards completion of these studies.

Speaker 3: For both of these trials, the Center for Medicare and Medicaid Services or CMS reimburses clinical sites for full-time.

For both of these trials the center for Medicare and Medicaid services or CMS reimburses clinical sites are performing these procedures.

Speaker 3: In May of 2022, CMS increased the reimbursement up to $20,000 per patient procedure for both control and treated patients, retroactive to April 1, 2020.

In may of 2022 CMS increased the reimbursement up to $20000 per patient procedure for both control and treated patients retroactive to April one 2022.

Speaker 3: This is important for our clinical partners as it enhances confidence that they will be paid at the level they seek for both treatment and control procedure.

This is important for our clinical partners as it enhances confidence that they will be paid at the level. They seek for both treatment and control procedures and enhances the blinding of the trial as all patients should be coded identical with respect to billing.

Speaker 3: We have also been adding additional clinical sites and expanding the study.

We've also been adding additional clinical sites and expanding the study.

The first of four anticipated World class sites in Canada was activated must now enrolling in our heart failure trial.

Canadian sites are critically important as the second approach to mitigate potential impact that the CMS reimbursement is causing a delay in enrollment.

We are also working to provide additional educational materials for patients, including a simple, but elegant animation of the cardiac heart failure trial.

Which is now live on our website and which we invite you to view on the sites cell therapy clinical trials page.

We anticipate submitting this animation to clinical sites as soon as other materials are also available for institutional review board approval, which is required for the materials to be shown to patients.

Many patients are believed to not participate in the trial because they want to receive the therapy and prefer to not have a 40% chance of being in the control arm.

Speaker 3: The animation explains why this randomization is important and makes it clear that should patients and the control arm wish to proceed to therapy after they complete the follow-up and the control arm, they may.

The animation explains why this randomization is important and makes it clear that should patients in the control arm wish to proceed to therapy. After they complete the follow up in the control arm they may.

Yeah.

To explain this further.

New patient testimonial is also now available on our website on the same cell therapy clinical trials webpage, telling quote Tim story end quote.

Speaker 3: Tim was an ultra-marathoner and developed heart disease in his 40s. Now in his 70s, he participated in the cardiac heart failure trial at the University of Wisconsin and was in the control.

Tim was an ultra marathon and developed heart disease in his forties now in his seventies. He participated in the cardiac heart failure trial at the University of Wisconsin was in the control group.

Speaker 3: After his two-year follow-up, he elected to receive therapy and is now in the treaty.

After his two year follow up he elected to receive therapy and is now in the treated group.

Speaker 3: We also anticipate submitting the video on Tim's story to clinical sites as soon as other materials are also available for institutional review board approval.

We also anticipate submitting the video on Tim story to clinical sites as soon as other materials are also available for institutional review board approval.

These efforts to enable patients to be well informed on the Cardiome cell therapy heart failure study and to share their experience with experiences with one another are continuing we anticipate this will have a significant impact in the percentage of patients eligible who decide to participate in the car T cell therapy trials.

Speaker 3: These efforts to enable patients to be well informed on the CardiM South Therapy Heart Failure Study and to share their experiences with one another are continuing. We anticipate this will have a significant impact in the percentage of patients eligible who decide to participate in the CardiM South Therapy trial.

Speaker 3: These efforts show we are working diligently to support our world-class clinical partners and complete enrollment in the CardiMpt trials as soon as possible.

These efforts show, we are working diligently to support our world class clinical partners and complete enrollment in the cardiac trials as soon as possible.

Speaker 3: We are working with the goal of a 2023 completion of enrollment in the full 260 patient cardiac part failure trial and enrollment of 100 patients in the cardiac monocardial schemia 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 100 patients in the cardiac chronic myocardial ischemia trial to enable its interim readout.

Speaker 3: We have just had our second consultation with Japan's Pharmaceutical Medical Device Agency regarding registration of CardiM Cell Ther.

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

Speaker 3: 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.

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.

For the second consultation in addition to high level analysis, we provided Japan's P. M D. A with all of our clinical data on a patient by patient basis from all of our trials.

Speaker 3: For the second consultation, in addition to high-level analysis, we provided Japan's PMDA with all of our clinical data on a patient-by-patient basis from all of our.

Speaker 3: The second consultation meeting went well, and there were no questions on our existing clinical datasets provide.

The second consultation meeting went well and there were no questions on our existing clinical data sets provided.

Speaker 3: We are still on this pathway aiming for approval of the Cardiants Self-Aid Therapy System in Japan based on our current data and planning for our next submission where we will provide much of the same data in a new format, more details on our clinical protocols and pre-clinical testing, and provide written responses to questions from our last consultation.

We are still on this pathway aiming for approval of the cardiac cell therapy system in Japan based on our current data and planning for our next submission where we will provide much of the same data in a new format more details on our clinical protocols in preclinical testing and provide written responses to questions from our last consultation.

Speaker 3: Japanese researchers established the building blocks for this therapy many years.

Japanese researchers establish the building blocks for this therapy many years ago.

Speaker 3: The therapeutic approach we are pursuing was first studied in a preclinical model by physician scientists in Yokohama.

Therapeutic approach we are pursuing with first studied in a preclinical model by physician scientist in Yokohama.

Speaker 3: This early work was performed in parallel to another Japanese vast for the biology scientists who identified important aspects of bone marrow derived mononuclear cells and tissue repair.

This early work was performed in parallel to another Japanese vascular biology scientist, who identified important aspects of bone marrow derived mononuclear cells and tissue repair.

Speaker 3: Their early efforts underlie our Cardium Self Therapy and we hope to be able to provide this therapy to the many in Japan who could benefit from it.

Their early efforts underlie our cardiac cell therapy, and we hope to be able to provide this therapy to the many in Japan, who could benefit from it.

Speaker 3: Now I'd like to move to our two allogeneic cell therapy product candidates based on our allogeneic neurokinin 1 receptor positive mesenchymal stem cell platform, which is also

Now I'd like to move to our two allogeneic cell therapy product candidates based on our allogeneic neuro kind in one receptor positive messaging time will stem cell platform, which has also progressed in this second quarter.

Speaker 3: Our Allogeneic MSC program in heart failure, which we have designated as BCDO3, is intended to include the patients who have been excluded from our autologous programs due to the nature of their cells.

Our allogeneic M. S. C program in heart failure, which we have designated a B C. D. L. Three is intended to include the patients who have been excluded from our autologous program due to the nature of their cells.

Speaker 3: This program has completed what we believe is the last pharmacology and toxicology studies to enable IND submission targeted for acceptance in 2022.

This program is completed what we believe is the last pharmacology and toxicology studies to enable our IND submission targeted for acceptance in 2022.

Speaker 3: Much will depend on the final data which we expect soon.

Much will depend on the final data, which we expect soon.

Speaker 3: Our Allogeneic MSC Program in Patients Recovering from Acute Respiratory Distress Syndrome, which we have designated BCD04, was approved by FDA in April to treat patients.

Our allogeneic MSC program in patients recovering from acute respiratory distress syndrome, which we have designated Bcl four was approved by FDA in April to treat patients.

Speaker 3: This program is expected to have clinical cells available from our Sunnyvale production facility and a first clinical site activated this quarter.

This program is expected to have clinical cells available from our Sunnyvale production facility and our first clinical site activated this quarter.

Speaker 3: Our expectation is that enrollment will soon follow after we have final lot release testing of the cell.

Our expectation is that enrollment will soon follow after we have final lot release testing of the cells.

Speaker 3: We are optimistic due to the longstanding promise of mesenchymal stem cells and lung repair and the unique clinical indication we have identified.

We are optimistic due to the longstanding promise of messing camel stem cells and long repair and the unique clinical indication we have identified.

We aim to address the need to reduce local and systemic inflammation. After a patient has taken off respirator support with goals of accelerating recovery enhancing survival and reducing both relapse and hospitalization.

Speaker 3: We aim to address the need to reduce local and systemic inflammation after a patient is taken off respirator support with goals of accelerating recovery, enhancing survival, and reducing both relapse and hospitalization.

Speaker 3: In summary, we are advancing four therapeutic product candidates to address important unmet cardiac and pulmonary diseases based on our autologous and our allogeneic self therapy plans.

In summary, we are advancing for therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and allogeneic cell therapy platforms.

Speaker 3: From these therapeutic development efforts, we have three active business development initiatives.

From these therapeutic development efforts, we have three active business development initiatives first is partnering or cardiome cell therapy platform internationally.

Speaker 3: First is partnering our CardiMself therapy platform internet.

Speaker 3: Second is licensing our catheter-based bio-therapyri delivery system for cell, gene, and protein therapy candidates to the heart. And third, monetizing our robots, transcephal introducer sheep products.

Second is licensing our catheter based biotherapeutic delivery system for cell gene and protein therapy candidates to the heart.

And third monetizing our robots transcept will introduce our sheet product.

Speaker 3: I will now pass the call to David McClung, our CFO , who will provide some financial perspective.

I will now pass the call to David Mcclung, our CFO , who will provide some financial perspective.

David Thank.

Speaker 4: Thank you, Peter. In the second quarter of 2022, we had revenues of approximately 1 million on that loss of 2.5 million, which compares favorably to Q2 2021, where our net loss was 3.5 million.

Thank you Peter.

The second quarter of 2022, we had revenues of approximately 1 million net loss of $2 5 million, which compares favorably to the Q2 2021 where our net loss was $3 5 million.

Speaker 4: This increase in revenue and decrease in net loss is primarily due to increased collaboration of...

This increase in revenue and decrease in net loss is primarily due to increased collaboration works.

Speaker 4: The value of these collaboration revenues is greater than just the dollars we receive and the moderation of our battery. Although we are potentially enabling competitive efforts, success of our partner programs provide additional pathways for bio-cardia to achieve our mission of developing and enhancing their cardiovascular disease and delivering significant value for our share.

The value of these collaboration revenues is greater than just the dollars, we receive and the moderation of our burn rate, although we were potentially enabling competitive efforts success of our partner programs provide additional pathways for bio cardio to achieve our mission of developing and enhancing therapies to treat cardiovascular.

Emphases and delivering significant value for our shareholders.

Speaker 4: Research and development expenses were essentially flat with $2.3 million reported in Q2 2022 compared to $2.4 million in the second quarter of 2021.

Research and development expenses were essentially flat with $2 3 million reported in Q2 2022 compared to $2 4 million in the second quarter of 2021.

Speaker 4: S-GNA expenses of 1.2 million in Q2 of 2022 were also unchanged from the same quarter in 2021.

SG&A expenses of $1 2 million in Q2 of 2022 were also unchanged from the same quarter in 2021.

Speaker 4: And the company ended the second quarter with cash totaling 8.6 million, which provides runway into the first quarter of 2023.

And the company ended the second quarter with cash totaling $8 6 billion, which provides runway into the first quarter of 2023.

To extend our runway we are working on business development activities as Peter have shared that we expect will provide non dilutive financing and we intend to enter into a modest tick those off of our ATM facility at market prices.

Speaker 4: To extend our runway, we're working on business development activities, as Peter has shared, that we expect will provide non-dilutive financing, and we intend to enter into modest takedowns on our ATM facility at market prices if these opportunities present themselves.

These opportunities present themselves.

Speaker 4: For example, during the second quarter we sold 575,000 shares, raising $1.5 million at $2.60 per share under this episode.

For example, during the second quarter, we sold 575000 shares raising $1 $5 billion to $2 60 per share under this facility.

Speaker 4: We do not expect our operational costs to increase significantly. And we believe a series of small raises in addition to continued business development activities that result in non-deludent funding are in the best interest of our shareholders. We do not expect to do large financing in the near-term.??

We do not expect our operational costs to increase significantly and we believe a series of small races. In addition to continued business development activities that result in non dilutive funding are in the best interest of our shareholders. We do not expect to large financing in the near term.

Yeah.

We are now ready to take questions.

Career.

Speaker 1: At this time, we will open the call to questions. Should you wish to ask a question on today's call, you will need to press star, then one on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing star, then two. If you are using a speakerphone, please pick up your handset before entering your question and speaking on the call. One moment, please, for the first question.

At this time, we will open the call to questions should you wish to ask a question on today's call you will need to press Star then one on your telephone if a question has been answered and you wish to withdraw your request you may do so by pressing Star then two if you are using a speakerphone. Please pick up your handset before entering your question.

And speaking on the call one moment. Please for the first question.

Speaker 1: The first question is from Kumar Raja of Brookline Capital Markets. Please go ahead.

My first question is from Kumar <unk> of Brookline capital markets. Please go ahead.

Thanks for taking my questions and also congratulations on getting the first site onboard in Canada.

When do you expect the first patient to be treated in Canada, and when do you expect that other three sites to come onboard.

So as far so.

Thank you Kumar for the question and in Canada. The first side is activated there are currently screening patients today.

You know we were on standby for when a patient clears the enrolment.

Speaker 3: hurdles for inclusion exclusion and, you know, they'll be randomized. There's no delays at this point other than identifying the patients and moving them through the process.

Hurdles for inclusion exclusion and and you know they'll be randomized theres no delays at this point other than identifying the patients and moving them through.

Speaker 3: As far as the other sites were currently targeting, we have, you know, we're very late in the process on the other three sites. We began this in parallel to the submission to health Canada, which was, you know, involved both.

The process.

As far as the other sites, where we're currently targeting we have you know we're very late in the process on the other three sites. We began this in parallel to the submission to health Canada.

Which was a <unk>.

Well both.

Speaker 3: branches, the device branch, and the biologic branch in health Canada to secure approval. But our expectation is those other three sites are coming on board soon as well.

Branches, the device branch and the Biologics branch and health, Canada to secure approval, but our expectation is those other three sites are coming on board soon as well.

Speaker 5: Okay, and in terms of the efforts in U.S. to encourage patient enrollment, what kind of results are you seeing? There are you seeing in terms of screening? Are you seeing any increase in patient being screened?

Okay.

Some of the airports in U S to encourage patient enrollment.

What kind of results you're seeing there are you seeing in terms of screening are you seeing any English and patients being screened.

Speaker 3: So we have wanted to so many folks don't appreciate I shared this in our last call that one of the things that really is difficult for sight.

So we have one of the so many folks don't appreciate I shared this in our last call that one of the things that really is difficult for sites.

Speaker 3: is that a lot of the staff that they had had

Is that a lot of the staff that they had.

Speaker 3: change during the pandemic. And so a lot of sites are staffing back up. So yes, we have sites that are more fully staffed, we have sites that are actively enrolling. And we are throughout this process been working to solve issues or concerns for them. And we have detailed in our press release today the things we've discussed previously.

Has changed during the pandemic and so a lot of sites or staffing backup. So yes. We have sites that are more fully staffed we have sites that are actively enrolling and we we are throughout this process has been working to solve issues or concerns for them and we have detailed.

In our press release today, the things we've discussed previously but.

Speaker 3: But I think, you know, we are working through the process with sites to enhance the ease of enrolling patients in the.

But I think we are working through the process with sites to enhance the ease of enrolling patients in the cardiac heart failure trial. I note also that you know one of the bigger things is patients who don't want to be.

Speaker 3: heart failure trial. I note also that one of the bigger things is patients who don't want to be the patients who are in the control group. I think the materials I identified in the call that are now publicly available show that we're working diligently to help.

The patients who are in the control group I think the materials I identified in the call that are now publicly available show that we're working diligently to help.

Help.

Speaker 3: give them all of the information they would like.

Give them all of the information they would like.

Speaker 3: to make the best choices for themselves in this study. And I think that's gonna have a meaningful impact in the enrollment on its own.

To make the best choices for themselves in this study and I think that's gonna have a meaningful impact in the enrolment on its own.

Speaker 3: So I think sites are all working very hard that have the staffing, the things that are changing are with the breakthrough designation, that's external validation that the data's really...

So I think sites are all working very hard that have the staffing the things that are changing are.

With the breakthrough designation, that's external validation that the data is really solid with the with the reimbursement from CMS site.

Speaker 3: solid with the reimbursement from CMS.

Speaker 3: Sites don't have any concerns about getting paid by either CMS or their insurers if they follow CMS. We have launched some things to cover costs associated with research study.

Sites don't have any concerns about getting paid by either CMS or their insurers if they follow CMS.

We've launched some things.

To cover costs associated with research study.

Speaker 3: a support where an insurer won't provide coverage for this investigational therapy that we're still working on, and then lastly, you know, just really trying to make it easy for centers to identify where these patients are as well as to help those patients that are then identified to understand the trial as well as they can to potentially make the decision to participate in the trial.

Our support where an insurer won't provide.

Coverage for this investigational therapy that we're still working on and.

And then lastly, you know just really trying to make it easy for centers to identify where these patients are as well as to help those patients that are then identified to understand the trial as well as they can.

Two potentially.

Make the decision to participate in the trial.

Speaker 5: OK, great. And finally, with regard to the PMDA, looks like they have some questions which is not related to the clinical data. Maybe you can talk a little bit about it and also the next steps there. Thank you.

Okay, Great and then finally with regard to the P. M B a.

Looks like there are some questions. We just not related to the clinical data maybe you can talk a little bit about it.

And also the next steps there. Thank you.

Okay.

Speaker 3: Yes, so Kumar, thank you for that question. I guess with PMDA, there's lots of nuances that I don't think we should dive into. I think the key thing is...

Yes. So so kumar. Thank you for that question I guess with P. M D. A.

There's lots of nuances that I don't think we should dive into I think the key thing is our clinical data as solid as the breakthrough designation shows and we have treated quite a few patients in the three trials that we've published on as well as the.

Speaker 3: Our clinical data is solid, as the breakthrough designation shows, and we have treated quite a few patients in the three trials that we've published on, as well as the ongoing randomized trial. And keep in mind that there has been a cardiac cell therapy approved in Japan based on only seven patients treated.

Ongoing randomized trial.

And keep in mind that there has been a cardiac cell therapy approved in Japan.

Based on only seven patients treated.

Speaker 3: Furthermore, our self-processing platform is already approved in Japan, and all of our delivery systems are approved in Europe , and one of them is actually approved here in the United States. So the amount of regulatory review we've already had.

Furthermore, you know our cell processing platform is already approved in Japan, and all of our delivery systems are approved in Europe and one of them is actually approved here in the United States. So so the amount of regulatory review we've already had.

Speaker 3: is pretty solid, so our efforts are to enhance their comfort with that data set, and we'll see where it goes. There is potential risk that they won't approve it. We'll get guidance on a clinical protocol that's required, but our initiative today is to secure approval for it based on the data that we have today. Thank you. Thank you.

<unk> is pretty solid and so our efforts are to enhance their comfort with that dataset.

And we'll see where it goes it is there is potential risk that they wont approve it will we'll get guidance on.

Our clinical protocol that's required.

But our initiative today is to secure approval for it based on the data that we have today.

Yeah.

Great. Thanks, so much.

Speaker 1: The next question is from Michael Okunwich of Maxim Group. Please go ahead.

The next question is from Michael Kuhn, which of Maxim Group. Please go ahead.

Speaker 6: Hi, thank you very much for taking my question and congratulations on the progress.

Alright. Thank you very much for taking my question and congratulations on the progress.

Speaker 6: So I guess first off, I'd like to follow up a bit on the discussion about...

So.

I guess first off I'd like to follow up a bit on the discussion about.

Speaker 6: Japan and a bit about your plans for if you do end up getting this approved this drive you to get it to Patience and for commercialization over there.

Japan and a bit about your plans or if if you do end up getting this approved the strategy to get it to patients and for commercialization over there.

Speaker 3: Well, thank you, Michael, for being on the call and second for the question. So the conversations in Japan with PMDA, dovetail with other conversations we're already having with distribution partners and just...

Well. Thank you Michael first of all being on the call and second for the question. So the conversations in Japan.

With P. M D. A dovetail with other conversations we're already having with distribution partners in Japan.

Speaker 3: And there is potential that we enter into a distribution deal that's even before approval, which would involve, you know, development efforts as well. Currently in-

And there is potential that we enter into a distribution deal.

That's even before approval, which would involve <unk>.

Development efforts as well.

Currently in Japan, we have two wonderful co national principal investigators.

Speaker 3: We have two wonderful, co-national principle investigators, who we have not yet identified to support the work that we're pursuing. Our expectation is we will even post approval be working with them to collect additional data supporting the therapy. Should we be successful in having it approved? We've had a lot of interest from

Who we have not yet identified to support the work that we're pursuing so our expectation is we will even post approval be working with them to collect additional data.

Supporting the therapy should we be successful in having it approved.

We've had a lot of interest from.

Speaker 3: potential distribution groups in Japan that are world class outfits and it's an honor to interact and work with.

Potential distribution groups in Japan that are.

World Class outfits, and it's an honor to interact and work with them.

Speaker 3: We have spent time in Japan this past summer. And as we're looking forward, really the initiative is on de-risking efforts in Japan with PMDA on approval, but also the Ministry of Health on reimbursement issues ahead.

We have we have spent time in Japan this past summer.

And as we're looking forward.

You know really the initiative is on Derisking.

Efforts in Japan with P. M D E on approval, but also the ministry of health on reimbursement issues ahead.

Speaker 3: I think that our United States Medicare reimbursement level at $20,000 per patient procedure for both treated and control will be helpful for us ahead. And I note that that reimbursement level...

I think that our United States Medicare reimbursement level at $20000 per patient procedure for both treated and control.

Will be helpful for us ahead.

And I note that that reimbursement level.

Speaker 3: is a reasonable level for us today. I also note that that level is significantly less than the reimbursement level achieved by the other approved self-therapy in Japan, which is closer, I think, to $130,000. And my understanding that therapy has not advanced, in part, because they can't make money at that price point with the nature of that therapy.

Is a reasonable level for us today I also note that that level is significantly less than the reimbursement level achieved by the other approved cell therapy in Japan, which is closer I think to.

130000 U S dollars and my understanding is that therapy has not advanced in part because they can't make money at that price point with the nature of that therapy.

Speaker 3: where we could do quite well. I also note that there's roughly a million patients in Japan with heart failure. And even though it is an aging population in Japan,

Where we we could do quite well.

I also note that there is roughly a million patients in Japan with heart failure, and even though it is an aging population in Japan and.

Speaker 3: And the culture is not one that has found allogeneic organ transplantation attractive.

The the culture is not one that has found allogeneic organ transplantation attractive.

Speaker 3: However, autologous cell-based therapies are quite attractive and have done well in other areas. So, our sense is that this is a real fit and there is, you know, a high degree of potential for this to come together in the short term with a reasonable pathway.

However, autologous cell based therapies are.

Quite attractive and have done well in other areas. So our sense is that this is a real fit.

And there is a high degree of potential for this to come together.

In the short term with a reasonable pathway.

Speaker 3: for approval, if not approval based on the data that we already have. Does that answer your question fully, Michael? Yes. Thank you. Very comprehensive answer.

For approval, if not approval based on the data that we already have.

Does that answer your question fully Michael.

Yes, Thank you a very comprehensive answer.

I'd also like to see given that.

Speaker 6: you know, with the Allogeneic program, that's quickly approaching an IND. But you discuss a bit more about how that program is different compared to other mid and final stem cell approaches, particularly in our...

If the allogeneic program that is quickly approaching and I M D.

Can you discuss a bit more about how that program is differentiated compared to other.

Mesenchymal stem cell approaches, particularly in heart failure.

Speaker 3: I'd be delighted to. So what we find pretty exciting about our cells, so these are cells that we take from the bone marrow from young patients. We expand them here in our cell manufacturing facility here at BioCardia.

I'll be delighted to so what we find pretty exciting about ourselves. So these ourselves that we are taken the bone marrow from young patients we expand them.

Here in our cell manufacturing facility here at bio Cardia and then we we.

Speaker 3: And then we will then ship them in cryo canisters to clinical sites where they will be thought according to our protocols and administered. There's sort of the off-the-shelf strategy others have talked about.

Well, then ship them and cryo canisters, two clinical sites, where they will be thawed. According to our protocols administered they're sort of the off the shelf strategy others have talked about.

Speaker 3: Physicians who don't wish to perform bone marrow aspiration for our autologous program, and patients who don't wish to have bone marrow aspiration will find it quite attractive.

Physicians, who don't wish to to perform bone marrow aspiration for our autologous program and patients who don't wish to have bone marrow aspiration.

You will find it quite attractive.

Speaker 3: So our cell that we're advancing, what we call neuro-kind-in-one receptor positive, NK1 positive.

So ourselves that we're advancing our what we call neuro kind in one receptor positive or NK one positive.

Speaker 3: And that is the primary receptor for substance abuse.

And that is the primary receptor for substance P.

Speaker 3: Substance P being one of the primary mediators of distress in the human body. It's a neural peptide that is involved in all of our flight or flight.

Substance P being one of the primary mediators.

Of distress.

In the human body, it's a it's an it's a neuropeptide that is involved in all of our flight or fight responses you know if you.

Speaker 3: responses, you know, if you stub your toe and feel pain, that substance P, if you, you know, if your foot gets blown off by a landmine, that substance P as well and it causes the mesenchymal stem cells from the bone marrow as part of the normal reparative process to home in. So we think that having the

Stub your toe in feel pain that substance P. If you you know if your foot gets blown off by a landmine that substance P as well and it causes the message kind will stem cells from the bone marrow as part of the normal repair to process the home Inn.

So we think that having the that message kind of stem cells that are neuro kind of one receptor positive is a very compelling.

Speaker 3: The mesenchymal stem cells that are neuro-kind of one receptor positive is a very compelling aspect of our cells. We do not have head-to-head studies with other mesenchymal stem cells in a clinical trial with this formulation, although I do know...

Aspect of ourselves, we do not have head to head studies.

With other messing time will stem cells in a clinical trial with this formulation.

Although I do note that.

Speaker 3: that we have had the Head Studies of our LEAD program relative to both autologous and allogeneic.

We have head to head studies of our lead program relative to.

Both autologous and allogeneic.

Speaker 3: MSCs in the cardiac indication and our lead program actually Fared far more favorably than the MSC programs and we've taken the steps to focus in on these neural kind of one receptor positive cells because They're just so compelling as you as you read up on substance P It's it's a remarkable

M S sees in the cardiac indication and our lead program actually fared far more favorably than the.

The MSC programs and we've taken the steps to focus in on these neural kind of in one receptor positive cells, because they're just so compelling as you as you read up on substance P.

It's a remarkable.

Speaker 3: neuropeptide and it's a signaling peptide that having the cells that actually have the receptor upregulated on their surface to respond to it is exciting. Now that said, we may not have data that is any better than any other group's mesenchymal stem cell program. Our MSCs have all the key hallmarks.

Neuro.

Neural peptide and it's it's a signaling peptide that theyre, having the cells that actually have the receptor.

Up regulated on their surface to respond to it.

<unk> is exciting now that said we may not have data that is any better than any other groups messing hymel stem cell program, our MSC as have all the key hallmarks of other msc's boats in in phenotype and.

Speaker 3: of other MSCs both in in phenotype and surface markers that we assess in a lot release testing, but the

Surface markers.

So we assess and lot release testing, but it's.

Speaker 3: It's the neural kind in one receptor that is the substantial differentiator. And another differentiator is how we're doing.

It's the neuro kind of in one receptor that is the substantial differentiator and another differentiator is how we're doing things.

Speaker 3: So, you know, in our cardiac program, we're going after the patients we've excluded from our lead program.

<unk>.

In our cardiac program, we're going after the patients we've excluded from our lead program.

Speaker 3: And that is a modest population. It will enhance the potential of our LEAD program, but it also potentially sets the stage where we'll have phenomenal safety on everything other than the actual cells in the LEAD program.

And that is a modest population it will enhance the potential of our lead program, but it also potentially sets the stage, where we will have phenomenal safety on everything.

Other than the actual cells in our lead program.

That the.

Speaker 3: NK1 cells will then build upon. So there's potential for an orphan indication there.

N K one cells will then build upon and so there's potential for an orphan indication there ahead.

Speaker 3: I also note that in our indication of acute respiratory distress, where there's some phenomenal work that's been done with mesenchymal stem cells, including a very large NIH trial that is completing enrollment or has just completed enrollment. And we're following those efforts and others, but we're not targeting the patients who are on the rest.

I also note that in our indication of acute respiratory distress.

Where theres some phenomenal work that's been done.

With message <unk> stem cells, including a very large NIH trial that is completing enrollment or has just completed enrollment.

And we're following those efforts and others, but we're not targeting the patients who are on the respirator.

Speaker 3: For those who've heard me talk over the years on our efforts in heart failure.

For those who have heard me talk over the years on our efforts in heart failure.

Speaker 3: We're staying away from the sickest patient primarily because clinical development, we view it as a signal to noisy.

We're staying away from the the sickest patient, primarily because clinical development, we view it as a it's a signal to noise issue and so we're not treating the patients on respirator, we're treating those who have begun recovery had been taken off respirator and that's actually an indication where there is no development.

Speaker 3: And so we're not treating the patients on respirator. We're treating those who have begun recovery and been taken off respirator. And that's actually an indication where there is no development activity today. And it's become...

Activity today.

And it's becoming more and more important.

Speaker 3: We just presented at the second annual Acute Respiratory Distress Syndrome Drug Development Symposium.

We just presented at the second.

Second annual acute respiratory distress syndrome drug development symposium.

Speaker 3: And, you know, we're speaking with, you know, excellent companies with significant phase two and even phase three data sets. And, you know, we are humbly the company that has no clinical data yet in our acute respiratory distress indication. And yet we had quite a favorable response because we're going after an indication where there is no activity today.

And we're speaking with you know excellent companies with significant phase two and even phase III datasets and you know we are humbly. The company that has no clinical data yet in our acute respiratory distress.

Indication and yet we had quite a favorable response, because we're going after an indication where there is no activity today.

Speaker 3: And in fact, even groups who said, well, we're treating patients in that area today, they're referring to the patients on ventilator. And when we clarify that what do they do to the patients once they've cleared ventilator and they've cleared the follow-up, and they realize that they don't have anything for them.

And in fact, even groups, who said well, we're treating patients and in in that area today, they're referring to the patients on ventilators.

And and I and we clarify that what do they do to the patients once they've cleared ventilator and they've cleared the follow up and they've realized that they don't have anything for those patients. So we're focusing to a degree on COVID-19.

Speaker 3: So we're focusing to a degree on COVID.

Speaker 3: confirmed COVID are secondary that it's a very specific indication there is potential for us to expand in the future. Um, but right now, I think, uh,

Confirmed COVID-19 are secondary to that in some very specific indication there is potential for us to expand in the future.

But right now I think.

Speaker 3: that we've gotten some pretty positive signals from our peers in the community that our indication is one that's worth pursuing. And we can learn from the other work that's been done on the other mess and time programs. We're not planning on doing any head-to-head studies, Michael, against the MISIs without neurocognitive one at this point. But that could be something that's done in the future and potentially post approval in the distant future.

But then we've got some pretty positive signals from our peers in the community that our indication is one that's worth pursuing and we can learn from the other work that's been done on.

On the other message Campbell programs, we're not planning on doing any head to head studies Michael against.

MSC is without neuro kind and want at this point, but that could be something that's done.

In the future and potentially post approval.

Approval in the distant future.

Speaker 6: All right, thank you very much. And one more, if you don't mind, I'd like to just follow up on the development in arts and specifically your thoughts on how easier or difficult that could be to an role, especially given the trajectory of COVID-19 can be quite unpredictable.

Alright, Thank you very much and one more if you don't mind I used to just follow up on the on the development in art and specifically your thoughts on how easy or difficult that could be to enroll, especially given you know the trajectory of COVID-19 can be quite unpredictable.

Speaker 3: So, thank you for the question, Michael. That was a hot topic at the second annual ARDS drug development symposium.

So thank you for the question Michael that was a hot topic at the second annual Arts drug development Symposium.

Speaker 3: As we all know, or I hope we're experienced, we've had recent spikes in the infection rate.

As we all know or I hope her experience we've had recent spikes in the infection rates, but at the same time, the hospitalizations have not correlated and that's great News for Society. That's also great news for our lead programs.

Speaker 3: But at the same time, the hospitalizations have not correlated.

Speaker 3: And that's great news for society. That's also great news for our lead programs in heart failure and chronic malachroschemia. But to your question, our trial is, the design, as you can see on clinicaltrials.gov, is a three by three design. So, and we'll have a DSMB review of the data between the DOS escalation cohorts.

In heart failure, and chronic myocardial ischemia, but to your question you know our trial is it's the design as you can see on clinical trials that Gov as a three by three design. So and we will have a D. S. M. B a review of the data between the role the dose escalation cohorts. So we don't need a whole large number of patients.

Speaker 3: So we don't need a whole large number of patients today.

Today.

Speaker 3: And as I also detailed, there's really no therapy for these patients.

And as I also detailed theres really no therapy for these patients.

Speaker 3: currently once there, they've been brought off the respirator. At that point in time, they've probably been hit with the whole gamut of therapies that are out there. And so I think that, you know, it's sort of, we're addressing something that physicians wish they had in their armamentarium today. And we're gonna be advancing, you know, slowly with a few number of patients. So.

Currently once there they've been brought off the respirator at that point in time, they've probably been hit with the whole gamut of therapies that are out there and so I think that.

It's sort of we're addressing something that physicians wish they had in their armamentarium today.

And we're gonna be advancing slowly with a few number of patients. So.

Speaker 3: Also, you know, this is just to reiterate, this is intravenous delivery. And the follow up in these trials is actually rather shorter than it is in our cardiac indications. So it's...

Also this is just to reiterate this is intravenous delivery and the follow up in these trials is actually.

Rather shorter than it is in our.

Cardiac indications so it's.

Speaker 3: it should be a relatively straightforward trial to perform. The difficulties in this trial are really the logistics around the mesenchymal stem cells.

It should be a relatively straightforward trial two to perform the difficulties in this trial are really the logistics around the message came on stem cells.

Their cryopreservation, they're shipping their thawing the preparation for many ministration, but all of that is is we've been involved in that before so.

Speaker 3: their cryopreservation, their shipping, their thawing, their preparation for mid-administration, but all of that is, we've been involved in that before, so we don't see any significant issues ahead.

We don't see any significant issues ahead.

Speaker 6: Yeah, very interesting. Thank you very much for the additional color.

Yes, very interesting. Thank you very much for the additional color.

Thanks for the questions Michael.

Speaker 1: Again, if you have a question, please press star then one. The next question comes from James Mallory of Alliance Global Partners. Please go ahead.

Again, if you have a question. Please press Star then one the next question comes from James Molloy of Orion Global Partners. Please go ahead.

Speaker 2: Thank you guys for taking my questions. I had just a couple of quick questions on timing. And when you look at the Japan next steps, can you walk through what exactly would be next steps for Japan? And when you speak about potentially non-dilutive funding opportunities, in particular, what you mean, are there other opportunities out there that you guys are looking at?

Hey, Thank you guys, taking my questions I had just a couple quick questions on timing.

When you look at the Japan next steps do you walk through what exactly would be next steps for Japan, and when you think about potentially non dilutive fund.

Funding opportunities. This in particular, we mean are there other opportunities out there that you guys are looking at.

Speaker 3: So in Japan, next steps are, you know, the process involves a number of consultations and really the PMDA.

Okay.

So in Japan next steps are the.

The process involves a number of consultations and really the <unk>.

M D a.

Speaker 3: and guides us in this process at each stage. So...

Guides us in this process at each stage so.

Speaker 3: We've shared that our next stage is to essentially resummit much of the information we've already submitted in a new format.

We've shared that our next stage is to essentially resubmit much of the information we've already submitted.

In a in a new format and excuse me.

Speaker 3: And that includes certain sections translated into Japanese. It also includes providing them with full protocols and other details related to conversations we had in the last consultation. And then once we do that, we will likely have their feedback on.

And that includes certain sections translated into Japanese. It also includes providing them with full protocols and and and other details related to conversations we had in the last consultation.

And then once we do that.

We will likely have their feedback on next steps.

Speaker 3: So, that's where we stand today. As regards the timing of it, you know, we're working on that diligently and, you know, as we have this data already, because we do have approvals around the world, you know, I don't expect it to take us that long.

So that's where we stand today as as regards the timing of it you know we're working on that diligently and you know as we have this data already because we do have approvals around the world you know I don't I don't expect it to take us that long.

Speaker 3: We'll report out in the queue that follows our next consultation and whether that's this next queue or not, I don't know at this juncture. A lot of folks review these documents and preparations here, including our school.

We'll report out in the Q that follows our our next consultation and whether that's this next Q or not I I don't know at this juncture a lot of folks review these documents and preparation here, including.

Our staff, our consultant staff as well as our co national principal investigators and we tend to be very respectful of everybody's input and get alignment.

Speaker 3: Our consultant staff as well as our co-national principal investigators and we tend to be very respectful of everybody's input and get a line.

Speaker 3: So as regards the potential for business development activities related to Japan to provide non-deludive funding.

So as regards the potential for business development activities related to Japan to provide non dilutive funding.

Speaker 3: Yes, there is potential there. There's the potential for it on a number of levels, but I don't want to get ahead of ourselves. I think right now,

Yes, there is potential there there's there's the potential for it on a number of levels.

But I don't want to get ahead of ourselves I think right now.

Speaker 3: you know, we need to proceed with derisking this. You know, if you think about this program, you know, it's a significant value proposition. Most late stage heart failure programs are, you know, even in the markets are valued in the billions of dollars, even though they're preclinical and where we are is kind of embarrassed.

We need to proceed.

With Derisking. This if you think about this program you know it's it's a it's.

It's a significant value proposition most most late stage heart failure programs.

Are you know even in the markets are valued in the billions of dollars, even though their preclinical them and where we are is kind of embarrassing.

Speaker 3: That said, we have reimbursement clarity in the United States at a floor while we're doing our clinical studies.

That said you know we have you know reimbursement clarity in the United States at a floor, while we're doing our clinical studies.

Speaker 3: and which is potentially the first time that's ever been done. And, you know, we have breakthrough designation from the FDA. We have the various support polls. So they put together the pieces behind this. I think they have a high degree of confidence that this is coming to Japan. It's just a matter of when.

And which is potentially the first time that's ever been done.

And we.

We have breakthrough designation from the FDA, we have the various full so they put together the pieces behind US I think you have a high degree of confidence that this is coming.

To Japan, it's just a matter of when.

Speaker 3: And so, you know, there's interest in this therapy and firms being able to provide this therapy that, as I shared in our call, originated fundamentally in Japan and fit.

And so you know there's there's interest in this therapy and firms being able to provide this therapy.

That as I shared in our call originated fundamentally in Japan.

And fits very well with the significant.

Speaker 3: very well with the significant disease burden at heart failure that is there in Japan, as well as the cultural sense of keeping the body whole where autologous therapy resonates significantly and the cost profile of our therapy is

<unk> disease burden of heart failure that is there in Japan as well as their the cultural sense of keeping the body hole, where autologous therapies resonate significantly and the cost profile of our therapy is is significantly lower than any other.

Speaker 3: significantly lower than any other autologous therapies because of how we've advanced it. So I.

I'll call it gets therapies because of how we've advanced it. So I think that you know we will be waiting on feedback as we do the submission will wait on feedback after the submission we will keep those who were in conversations with under confidential disclosure agreements Privy of the status.

Speaker 3: We will be waiting on feedback as we do the submission. We'll wait on feedback after the submission. We'll keep those who were in conversations with under confidential disclosure agreements privy of the status.

Speaker 3: And at some point in time, we expect both clarity from PMDA and clarity from our partners in Japan. And forgive me for the longer answer.

And and at some point in time, you know, we expect both clarity from P. M D E and clarity from our partners in Japan, and forgive me for the the longer answer but.

Speaker 2: Over here is one follow up. I could on the first quarter call you indicated that the BCDO one heart failure trial should include should have lead enrollment 2023. Is that still on track and just pay to the top line 2024?

Well, here's what one follow up I could on the first quarter call you indicated that.

<unk> won the heart failure trial should complete enrollment 2023 is that still on track.

Topline 2024.

Speaker 3: Yeah, so James, I wouldn't say it's on track. I would say it's what we are working towards. And so we are going at that full bore as a team. And you're seeing some of the dominoes fall. It does take time for things to roll through into clinical practice, but yeah, we are working diligently to deliver on that. And it's non-trivial to deliver on that based on where we are.

Yeah, So James I wouldn't say, it's on track I would say, it's what we are working towards and so we we are going at that full bore as a team and you're seeing some of the dominoes fall. It does take time for things to roll through into clinical practice, but yeah. We are.

We're working diligently to deliver on that and you know it's.

Its non trivial to deliver on that based on where we are today, but we've got a great team and and I'm I'm.

Speaker 3: But we've got a great team, and I'm doing everything I can to help support them as we pursue it. And the clinicians that we've been having interactions with are also supportive of that. So that's the key thing. Can we deliver it? And it's a lot of work ahead.

Doing everything I can to help support them as we pursue it.

The clinicians that we've been having interactions with are also supportive of that so that that's the key thing can we deliver it.

And it's a lot of work ahead.

Thanks for taking the questions.

I appreciate it James.

Speaker 1: This concludes our question and answer session. I would like to turn the conference back over to Dr. Altman for closing remarks.

This concludes our question and answer session I would like to turn the conference back over to Dr. Hoffman for closing remarks.

Thank you.

Speaker 3: I want to thank everyone for participating on today's call and for the interest in biocardia. We look forward to sharing.

I want to thank everyone for participating on today's call and for the interest in Biochar to you.

We look forward to sharing our continued progress.

Speaker 3: Thanks. Stay healthy, be kind and have a wonderful day.

Thanks stay healthy be kind and have a wonderful day.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker 1: The conference has now concluded. Thank you for attending today's presentation. You may now disconce-

Yes.