Q4 2021 BioCardia Inc Earnings Call

Ladies and gentlemen, thank you for standing by.

you for standing by. Good afternoon and welcome to the Biocardia 2021 year-end conference call.

Good afternoon, and welcome to the bio cardio 2021 here and conference call.

At this time, all participants are in a listen-only mode.

At this time all participants are in a listen only mode.

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Speaker Change: 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 purpose.

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.

Speaker Change: A webcast replay of the call will be available approximately one hour after the end of the call through June 29, 2020.

A webcast replay of the call will be available approximately one hour. After the end of the call through June 29 2022.

Speaker Change: I would now like to turn the call over to Jules Abraham of Core IR, the company's investor relations firm. Please go ahead.

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

Jo' Abraham: Thank you, Andrea. Good afternoon, everyone, and thank you for participating in today's conference call. Joining me today from BioCardia's Leadership Team are Peter Altman, Ph.D., President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer.

Thank you Andrea and good afternoon, everyone and thank you for participating in today's conference call. Joining me today from bottled cardiac leadership team, Peter Hoffman, Phd President and Chief Executive Officer, David Malone, The Companys Chief Financial Officer.

Jo' Abraham: During this call, management will be making forward-looking statements, including statements that address biocardious 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 third party its expectations for future performance or operational results references to management's intentions beliefs projections outlook analyses or current expectations.

Jo' Abraham: Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and obtaining regulatory approvals. Forward-looking statements involve risks and

Such factors include among others the inherent uncertainties.

Excuse me with developing new products or technologies.

Regulatory approvals.

Forward looking statements involve risks and other factors that.

Jo' Abraham: that may cause actual results to differ materially from those states.

And 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 <unk>. Most recently filed periodic reports on Form 10-K Form 10-Q , and form 8-K filed with the SEC.

Jo' Abraham: 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 files with the SEC, particularly the cautionary statement in them.

Currently the cautionary statement.

Jo' Abraham: The contents of this call contains time-sensitive information that is accurate only as of today, March 29, 2022, acceptance 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 that is accurate only as of today March 29 2022.

As required by law myocardial disclaims any obligation to publicly update or revise any information to them.

Like events or circumstances that occur.

After this call with that it's now my pleasure to turn the call over to Peter Holt and ph D. The company's president and CEO . Peter Please go ahead.

Jo' Abraham: With that, it's now my pleasure to turn the call over to Peter Altman, PhD, the Company's President and CEO . Peter, please go ahead.

Peter Alton: Thank you, Jules, and good afternoon to everyone on the call.

Thank you Julie and good afternoon to everyone on the call.

Peter Alton: Biocardia continues to execute in its efforts to advance its meaningful pipeline of cell-to-cell derived therapeutics to treat significant cardiovascular and pulmonary diseases.

Myocardial continues to execute in its efforts to advance its meaningful pipeline of cell and cell derived therapeutics to treat significant cardiovascular and pulmonary diseases.

2021 was a big year for myocardial team.

Peter Alton: We have progressed significantly in the development of all four of our therapeutic candidates based on our autologous and allogenic cell therapy platform.

We have progressed significantly in the development of all four of our therapeutic candidates based on our autologous and allogeneic cell therapy platforms.

Peter Alton: I'm going to touch on each of these four programs in turn.

I'm going to touch on each of these core programs in turn.

First our.

Peter Alton: Our efforts to complete the Cardiamp Autolia Cell Therapy Pivotal Clinical Trials for the Indications of Heart Failure or BCDO1 and Chronic Myocardial Ischemia or BCDO2 have had some nice milestones.

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

Or B C D O one.

And chronic myocardial ischemia, where BCD owe to have had some nice milestones.

Peter Alton: These include the receipt of an FDA breakthrough designation, successful data safety monitoring board reviews, a Health Canada No Objection letter, and the issuance of a new CMS reimbursement code to support both pivotal cardiac cell therapy clinical trials.

These include the receipt of an FDA breakthrough designation successful data safety monitoring board reviews, and health, Canada, No objection letter and the issuance of the new CMS reimbursement code to support both pivotal cardiac cell therapy clinical trials.

Peter Alton: The FDA grant of breakthrough designation for the cardiac cell therapy system in heart failure is an enormous accomplishment that has been years in the making.

The FDA granted breakthrough designation for the cardiac cell therapy system in heart failure is an enormous accomplishment that has been years in the making.

Peter Alton: This FDA breakthrough designation means that after the FDA performs an extensive review of all of the available patient-by-patient data, the agency made a formal assessment that the cardiac cell therapy has potential to be better than standard of care for patients with ischemic heart failure.

This FDA breakthrough designation means that after the FDA performed an extensive review of all of the available patient by patient data.

Agency made a formal assessment that the cardiac cell therapy has potential to be better than standard of care for patients with ischemic heart failure.

Physicians that care for these patients and the patients themselves can benefit from this independent review by the FDA when they consider the cardiome cell therapy as an option.

Peter Alton: and the patients themselves can benefit from this independent review by the FDA when they consider the Cardi-M cell therapy as an option.

Peter Alton: Although we have said that signals of patient safety and benefit are compelling all along, it adds greatly to the credibility of the therapy for all involved that the FDA's granting of breakthrough designation aligns with this perspective.

Although we have said that signals, a patient safety and benefit our compelling all along it adds greatly to the credibility of this therapy for all involved that the fda's granting of breakthrough designation aligns with this perspective.

Peter Alton: It also shows that the FDA recognizes that current therapies haven't addressed the enormous need that exists for these patients.

It also shows that the FDA recognizes the current therapies haven't addressed the enormous need that exists for these patients.

Peter Alton: The breakthrough designation results in our having significant advantages in our FDA interactions ahead, but most importantly, it is FDA saying that the autologous cell therapy we are advancing for these patients is important.

The breakthrough designation results and are having significant advantages in our FDA interactions ahead, but most importantly, it is F D. A saying that the autologous cell therapy. We are advancing for these patients is important.

Peter Alton: Although the cardiac cell therapy trials are covered by CMS, many private insurers don't follow.

Although the cardiac cell therapy trials are covered by CMS.

Many private insurers don't follow Cms's League.

Peter Alton: As a result, many patients with heart failure who would qualify for our trial.

As a result, many patients with heart failure, who would qualify for our trial.

Peter Alton: have been excluded from receiving this FDA-designated breakthrough cell therapy because of insurance.

Clinically have been excluded from receiving this FDA designated breakthrough cell therapy because of insurance.

Peter Alton: Although the breakthrough designation may increase the frequency that private insurers support covering the Cardiamps cell therapy.

Although the breakthrough designation may increase the frequency the private insurers support covering the cardiac cell therapy.

Peter Alton: We have set out to solve this in three ways.

We have set out to solve this in three ways.

First.

Peter Alton: After significant sequential filings with both the biologics and the device group at Health Canada, the cardiac cell therapy and heart failure was issued a no-objection letter.

After significant sequential filings with both the biologics and the device group at Health, Canada, the cardiac cell therapy in heart failure was issued a no objection letter.

Peter Alton: This letter allows the trials to advance in Canada, where there are world-class sites we seek to bring into this trial.

This letter allows the trials to advance in Canada, where there are world class sites, we seek to bring into this trial.

Peter Alton: These clinical leaders are expected to help the program toward completion as BioCard will be paying for all patients enrolled without the logistical challenges with respect to private insurance reimbursement that exists in the United States.

These clinical leaders are expected to help the program toward completion as Biochar do we paying for all patients enrolled without the logistical challenges with respect to private insurance reimbursement that exists in the United States.

Peter Alton: Second, as sponsor, we are now providing sites with CMS-approved coverage of standard clinical costs for patients whose private insurer has declined to cover our investigational FDA-designated breakthrough cell therapy for patients with heart failure.

Second as sponsor we are now providing sites with CMS approved coverage of standard clinical costs for patients, whose private insurer has declined to cover our investigational F. D. A designated breakthrough cell therapy for patients with heart failure.

Peter Alton: This can allow all patients to receive therapy regardless of insurance and is expected to double the number of eligible subjects in the trial in the United States.

This can allow all patients to receive therapy, regardless of insurance and is expected to double the number of eligible subjects in the trial in the United States.

Peter Alton: Third, we sought additional clarity from CMS in the form of a reimbursement code supporting both the treatment and control arm of the cardi-amp cell therapy procedure.

Third we saw additional clarity from CMS in the form of a reimbursement code supporting both the treatment and control arm of the cardiac cell therapy procedure.

Peter Alton: DM has issued such a new procedure code, C9782, which applies to the cardiac cell therapy clinical trials in both indications.

D. M has has issued such a new procedure code C 972, which applies to the cardiac cell therapy clinical trials in both indications.

Peter Alton: We are thankful for the efforts of Health Canada, FDA, and CMS on these initiatives related to the cardiac cell therapy platform, which enhances the attractiveness of the trial and the therapy for centers, physicians, and patients.

We are thankful for the efforts of health, Canada, FDA and CMS on these initiatives related to the cardiac cell therapy platform, which enhances the attractiveness of the trial.

And the therapy for centers physicians and patients.

Peter Alton: In 2021 and 2022, we have had three Data Safety Monitoring Board reviews of the blinded cardiac heart failure trial results.

In 2021 and 2022 we have had three data safety monitoring board reviews of the blinded cardiac heart failure trial results.

Peter Alton: In all instances, the Data Safety Monitoring Board has said the trial should continue as planned.

In all instances the data safety monitoring Board has said the trial should continue as planned.

These initiatives.

Peter Alton: The continued good data, coupled with the waning of COVID-19 at clinical sites throughout the country, are operationally important for completion of the cardiac autoliocell therapy trials in the United States and in Canada.

And continued good data coupled with the waning of COVID-19 at clinical sites throughout the country are operationally important for completion of the cardiac cardiac autologous cell therapy trials in the United States and in Canada.

Peter Alton: As a last item on the Cardiamp Cell Therapy, we have initiated a discussion with Japan's Pharmaceutical and Medical Device Agency regarding registration of Cardiamp Cell Therapy based on the quality of our clinical data and the regulatory approvals that exist around all of the elements of the Cardiamp Cell Therapy system in Japan, the United States, and the European Union.

As the last item on the cardiac cell therapy, we have initiated a discussion with Japan's pharmaceutical and medical device agency regarding registration of cardiac cell therapy based on the quality of our clinical data and the regulatory approvals that exist around all of the elements of the car T cell therapy system.

In Japan, the United States and the European Union.

Peter Alton: Now I'd like to move to our two allogenic cell therapy product candidates, both supported by our Allogenic Neurokinin-1 Receptor Positive Culture Expanded Mesenchymal Stem Cell Platform, which has progressed greatly over the last year.

Now I'd like to move to our two allogeneic cell therapy product candidates, both supported by our allogeneic neuro Kannan, one receptor positive culture expanded messing kind will stem cell platform, which has progressed greatly over the last year.

Peter Alton: Our Allogenic Neurokinin-1 Receptor Positive Culture Expanded Mesenchymal Stem Cell Program in Heart Failure, which we have designated as BCD03, is targeted to the patients who have been excluded from our LEAD program due to the nature of their cells.

Our allogeneic Neurocrine and one receptor positive culture expanded message <unk> stem cell program in heart failure, which we have designated as BCD three is targeted to the patients who have been excluded from our lead program due to the nature of their selves.

Peter Alton: This program has completed the chemistry manufacturing controls validation and is completing additional pharmacology and toxicology study in animals.

This program has completed the chemistry manufacturing controls validation and is completing additional pharmacology and toxicology study in animals.

Our.

Peter Alton: Allogenic program on the same NeuroKinone-1 receptor-positive culture-expended mesenchymal cells in acute respiratory distress syndrome has also completed chemistry, manufacturing, control, validation, its pharmacology and toxicology studies. And in March of this year, we submitted an IND to the FDA.

Allogeneic program.

On the same neurocrine, one receptor positive culture extend a message <unk> cells in acute respiratory distress syndrome has also completed chemistry manufacturing controls validation its pharmacology and toxicology studies and in March of this year, we submitted an IND to the FDA.

Peter Alton: We expect news in April from the FDA that this therapy may proceed to treat patients or will be placed on clinical hold with additional items to work through.

We expect news in April from the FDA that this therapy may proceed to treat patients or will be placed on clinical hold with additional items to work through.

Peter Alton: In summary, we are advancing four therapeutic cell therapy product candidates based on our autologous and our allogenic platform.

In summary, we are advancing for therapeutic cell therapy product candidates based on our autologous and allogeneic platforms.

Peter Alton: The therapeutic delivery systems we have created for our own programs are actively being used by partner programs, and we believe that both patients and our shareholders will benefit from the success of our partners.

Therapeutic delivery systems, we have created for our own programs are actively being used by partner programs and we believe that both patients and our shareholders will benefit from the success of our partners.

Peter Alton: I will now pass the call to David McClung, our CFO , who will provide some financial perspectives. David? Thank you, Peter. Our financial show that we are disciplined and strategic in the use of capital.

I will now pass the call to David Mcclung, our CFO , who will provide some financial perspectives, David Thank you Peter.

Financial show that we are disciplined and strategic in the use of capital.

David McClong: Revenue for the year into December 31, 2021, totaled just over a million dollars compared to $145,000 for the year end of December 31, 2020. The $870,000 increase was primarily due to collaborations with corporate partners.

Revenue for the year ended December 31, 2021 totaled just over $1 million compared to 145000 for the year ended December 31 2028.

$870000 increase was primarily due to collaborations with corporate partners.

David McClong: This financial contribution helps reduce our operating burden in each of these collaborations as a potential to blossom into a significant collaboration to the cloud.

This financial contribution helps to reduce our operating burn in each of these collaborations has the potential to wassa into a significant collaboration.

David McClong: And that loss for 2021 was $12.6 million compared to a loss of $15 million in 2020.

Net loss for 2021 was $12 6 million compared with up also a $15 million in 2020.

David McClong: Net cash used in operating activities in 2021 was only $10.40 compared to net cash used in 2020 of $12.41.

Net cash used in operation.

Operating activities in 2021 was $10 4 million compared to net cash used in 2020 from $12 4 million.

David McClong: This represents a decrease in overall spending for operations of approximately $2 million through the end of the year, December 31, 2021, compared to December 31, 2020.

This represents a decrease in overall spending in cooperation with approximately $2 million through the end of <unk>.

For the year December 31, 24 compared to December 31, 2020.

David McClong: And we ended in 2021 with just under $13 billion in cash and equivalents, which we anticipate is sufficient with our other planned activities to carry us through 2022.

And we enter 2021, just under $13 million in cash and equivalents, which we anticipate a sufficient with our other planned activities just curious through 2022.

David McClong: We have also completed the transition of our laboratories and manufacturing to our new Sunnyvale facility which has been designed to accommodate our clinical, commercial manufacturing and office needs for both our cell and cell drive therapies and our device delivery systems.

We have also completed the transition of our laboratories and manufacturing to our new Sunnyvale facilities, which has been designed to accommodate our clinical commercial manufacturing and office needs for both ourselves and sole drawn therapies and our device delivery systems.

David McClong: Most of this transition and construction expenses were borne in 2021, and with our new Sunnyvale lease, we have reduced annual facility expense by roughly $500,000 going forward, while significantly enhancing our facility's hand capability.

Most of this transition with construction expenses were awarded in 2021 and with our new Sony believes we have reduced annual facility expense five roughly $500000 going forward.

<unk> significantly enhances our facilities full capabilities.

David McClong: The two deals we entered into in 2021 have gone well from our perspective.

The two deals we entered into in 'twenty, one looks all well from our perspective.

David McClong: One of these has been extended and the other is ongoing. We look forward to continuing expanding all of our collaborations as our partners advance and their strategies evolve.

One of these has been extended and the other is ongoing we look forward to continuing expanding all of our collaborations with our partners at bass and their strategies.

David McClong: I will now pass the call back to Peter for some final thoughts before we open the call to questions. Thank you, David. In closing, you know, our team.

I will now pass the call back to Peter for some final thoughts before we open the call to questions Peter.

Thank you David.

In closing.

Our team has worked hard in 2021, while in the middle of a pandemic, we advanced all of our programs year over year, we increased our modest revenues by seven fold and decreased our operating cash burn by 16%, we delivered on strategic initiatives to enhance our manufacturing capabilities and reduce cost we invested in our team our technology and are real.

Peter Alton: Year over year, we increased our modest revenues by sevenfold and decreased our operating cash earned by 16%. We delivered on strategic initiatives to enhance our manufacturing capabilities and reduce costs. We invested in our team, our technology, and our relationship.

Peter Alton: We intend to complete the clinical trials before us with scientific rigor, prioritizing patient safety, and with speed, as we believe there are enormous benefits these therapies can bring to patients and their families.

<unk> ships.

We intend to complete the clinical trials before us with scientific rigor prioritizing patient safety and with speed as we believe there are enormous benefits. These therapies can bring to patients and their families.

Peter Alton: Our goals for 2022 include significantly accelerating both autologous cardiome cell therapy clinical programs, treating first patients with our allogenic neurokine 1 receptor positive mesenchymal stem cell therapy, and growing our partnering and commercial product revenue.

Our goals for 2022 include significantly accelerating both autologous cardiome cell therapy clinical programs treating first patients with our allogeneic Neurocrine one receptor positive message kind of stem cell therapy, and growing our partnering and commercial product revenues.

Peter Alton: We are targeting 2023 to complete enrollment in the heart failure trial and to have the chronic myocardial ischemia trial reach enrollment to support planned adaptive readout. We are now ready to take questions.

We are targeting 2023 to complete enrollment in the heart failure trial and to have the chronic myocardial ischemia trial reach enrollment to support planned adaptive readout.

We are now ready to take questions.

Operator.

Yeah.

At this time, we will open the call to questions.

Peter Alton: Should you wish to ask a question on today's call, you will need to press the star, okay, then the number one on your telephone.

Should you wish to ask a question on today's call you will need to press. The Star then the number one on your telephone.

Peter Alton: If you wish, if your question has been answered and you wish to withdraw your request, you may do so by pressing the star key followed by two.

If you wish.

Question has been answered or you wish to withdraw your request you may do so by pressing the star key followed by two.

Peter Alton: If you are using a speaker phone, please pick up your handset before entering your request and speaking on the call. One moment, please, for the first question.

If youre using a speakerphone please pick up your handset before entering your request and speaking on the call.

One moment please for the first question.

Kamar Rajsia: And our first question comes from Kamar Rajah of Brookline Capital Markets. Please go ahead.

And our first question comes from Kumar <unk> of Brookline capital markets. Please go ahead.

Kamar Rajsia: Thanks for taking my questions and also congratulations on all the progress including the breakthrough device designation. So first with regard to the four sites in Canada, how soon do you think you will be able to start recruiting patients there? And in the US, what are you seeing in terms of

Thanks for taking my questions and also congratulations on all the progress include the being the breakthrough device designation.

So first with regard to the port sites in Canada.

How soon do you think you'll be able to start recruiting patients.

And in the U S.

What are you seeing in south.

Kamar Rajsia: the impact in terms of enrollment, how soon do you think we will get to the pace which we had before the COVID pandemic started?

The impact in terms of enrollment.

How soon do you think we really kept the pace, which we had before the Covid pandemic started.

Speaker Change: Thank you, Kumar. Appreciate you joining the call, and I appreciate the question. So first...

Thank you Kumar I appreciate you joining the call and I appreciate the question so first.

Kumar: on sites in Canada, how soon do we expect them to be activated and enrolling?

On sites in Canada, how soon do we expect them to be.

Activated and enrolling.

Speaker Change: The Canadian team, we have four different sites we're working with in Canada and we have been working with them throughout the entire back and forth with Health Canada on both the device side at Health Canada and the biologic side. So I don't think it will be very long for us to bring on all four sites in Canada.

The Canadian team, we have four different sites, we're working with in Canada, and we have been working with them throughout the entire back and forth.

With health, Canada on both the device side at Health, Canada, and the biologic side. So I don't think it'll be very long for us to bring on all four sites in Canada.

Speaker Change: I think it will take some time after the approval for it to roll through administratively, but we're talking a matter of a handful of weeks is how I

I think we it will take some time after the approval for it to roll through administratively, but we're talking.

As a matter of.

A handful of weeks is how I would think about it.

Speaker Change: With respect to, in the United States, the impact on enrollment almost everything we're doing is lined up to really try and reduce barriers for enrollment. And the breakthrough designation that you noted, you know, that addresses, you know, some of the concerns on, you know, cell therapy. And there is criticism on cell therapy because of other programs that have gone before. And having the FDA go through our data.

With respect to in the United States the impact on enrollment.

Almost everything we're doing is lined up to really try and reduce barriers for enrollment and the breakthrough designation that you noted.

That addresses some of the concerns on cell therapy and the the there is criticism on cell therapies because of other programs that have gone before and having the FDA go through our data and say, yes. This is a breakthrough therapy. The way you were doing it with the data that you have in these three clinical trials.

Speaker Change: say yes this is a breakthrough therapy the way you are doing it with the data that you have in these three clinical trials you know they went through our phase one our phase two and all of the data we have in phase three as well as the reports from the data safety monitoring

They went through our phase one or phase two.

And all of the data we have in phase III as well as the reports from the data safety monitoring board. So when management of Biochar D. It says the data is good.

Speaker Change: So, when management at BioCardia says the data is good, you know, the FDA has concurred to it.

The FDA has concurred to a degree.

Speaker Change: And so, I guess that's my perspective on enrollment. We expect it to be coming online.

And so I guess, that's my perspective on enrollment, we expect it to be coming online.

Speaker Change: much more rapidly with some acceleration. We had a consent I can share today. And that's really where it starts. The process for enrollment begins initially with patient being consented. And after that, they go through a series of tests.

Much.

More rapidly with some acceleration we had a consent I can share today.

And that's really where it starts the process for enrollment.

Begins initially with patient being consented and after that they go through a series of tests as we all know we have this assay that we perform the cell potency assay.

Speaker Change: As we all know, we have this assay that we perform, the cell potency assay, that essentially identifies the patients who are most likely to respond to therapy. Unfortunately, that inclusion criteria results in us having 30% of those patients eliminated from the potential to be enrolled in the trial.

That essentially identifies the patients who are most likely to respond to therapy. Unfortunately that inclusion criteria results in us having 30% of those patients eliminated.

Eliminated from the potential to be enrolled in the trial.

Speaker Change: And so, you know, the process for enrollment takes time to move through the inclusion exclusion, but I can share with all in the call that, you know, COVID does appear to be waning across the nation.

And so.

The process for enrollment.

Next time to move through the inclusion exclusion, but I can share with all on the call that you know.

Covid does appear to be waning across the nation.

Speaker Change: of all of these regulatory elements that have come to us from FDA, CMS, and Health Canada make this trial easier to perform, easier to enroll, enhance physician comfort, and enhance patient comfort, and the DSMB reviews further enhance physician comfort. So all of these pieces are coming together to really push these trials forward.

All of these regulatory elements that have come to us from FDA, CMS and health, Canada make this trial easier to perform easier to enroll enhance physician comfort and enhanced patient comfort.

And the DSM V reviews further enhance physician comfort. So all of these pieces are coming together to really push these trials forward.

Speaker Change: Thank you and maybe you can talk a little bit about the next DSMB review and its expectations and I will get back in the line.

Thank you and maybe you can talk a little bit about the next DSM behavior and its expectations and I'll get back in the line. Thank you.

Speaker Change: Thank you, Kumar. So the next DSMB review is scheduled, I think, for, I think, the cusp of August , September . I don't know exactly when the date is yet, but we will update folks when we have it. And keep in mind, the DSMB review not only looks at all of the data of the treatment, but all of the follow-up data as well. And so we're working towards, I think, that review will hopefully have the increased enrollment we're working towards, as well as some significant follow-up on these patients.

Thank you Kumar so the the next <unk> review scheduled I think for I think the cusp of August September I don't know exactly when the date is yet, but we will update folks when we have it and keep in mind. The SNB review not only looks at all of the the data of the <unk>.

<unk>, but all of the follow up data as well and so we're working towards.

That review will hopefully have the increased enrollment we're working towards as well as some significant follow up on these patients and I'll just throw. It also we have crossover patients now we have seven crossover patients. Those are open label treatment. So we're gonna be able to share data with folks on our crossover patients.

Speaker Change: And I'll just throw it also, we have crossover patients now, we have seven crossover patients.

Speaker Change: Those are open-label treatment, so we're going to be able to share data with folks on our crossover patients as they reach the endpoints in their subsequent trial, if you will.

As they reach the end points in their subsequent trial, if you will.

So.

Next question.

Speaker Change: The next question comes from Emanuella Brainchetti of H.C. Rainwright & Cow. Please go ahead.

The next question comes from Emmanuel <unk> Shetty of H C. Wainwright <unk>. Please go ahead.

Speaker Change: Good afternoon, guys, and thank you for taking my questions. I was wondering, Peter, can you give us a sense on how many patients did not access the trial because of the lack of insurance coverage you were mentioning?

Okay.

Good afternoon, guys and thank you for taking my questions.

I was wondering Peter can you give us a sense on how many patients did not access to tie up because of the lack of insurance cost that as you were mentioning.

Peter: Yeah, so these are hard numbers to get at, Manuela. Our expectation is in this patient demographic, approximately 50% of the patients are Medicare patients.

Yeah. So Rs I mean, these are hard numbers to get at and then while I. Our expectation is in this patient demographic approximately 50% of the patients are.

Peter: In addition, you know, the reimbursement that Medicare has put forth for us is typically followed by United and Aetna, and they cover about 150 million lives in the United States. So, you know, that's a pretty significant number.

Medicare patients.

In addition.

The reimbursement that Medicare has put forth for US is typically followed by United and Aetna and they cover about 150 million lives in the United States. So that's a pretty significant group.

Peter: but it also, you know, when you're at a center.

But it also.

When you're when you're at a center and you have to go in.

Peter: and you have to go and pre-qualify a patient for a therapy, it becomes frustrating if they're not united or Etna and the insurer denies them. And so the elements that we're putting together that will enhance that is first,

Pre qualify a patient for a therapy it becomes frustrating if theyre not United the retina and the insurer.

<unk> so the elements that we're putting together that will enhance that is first you know we're pointing out that hey, this is available in Canada.

Peter: You know, we're pointing out that, hey, this is available in Canada. Second, the...

Hum.

Peter: the reimbursement we're putting in place enables us to sponsor to cover the decline cost of the insurers. And that's from a CMS, it's an approach that CMS has blessed previously.

The reimbursement, we're putting in place enables us to a sponsor to cover the decline cost of the insurers and that's from a CMS.

The approach that CMS is blessed previously and then and then lastly, with the reimbursement code, we're making it clear that we're able to both the.

Peter: And then lastly, with the reimbursement code, we're making it clear that we're able to, that both the control arm and the treatment arm are covered. And those three pieces all go together to address pretty much all the questions that any site has. So we're hopeful that we'll see these contribute to enrollment, but Census,

Control arm and the treatment arm are covered in those three pieces. All go together to address pretty much all the questions at any site tests. So we're hopeful that we'll see these contribute to enrollment.

Peter: You know, we're still going to see heavily Medicare patients, and hopefully this will bring in the United and Netna patients, as well as other insurers who will follow this because of the breakthrough in part.

But since as you know, we're still going to see heavily Medicare patients and hopefully this will bring in the United and Aetna patients as well as other insurers who will follow this because of the breakthrough in part.

Speaker Change: Mm-hmm, got it, got it. Thank you. Yeah, maybe, you know, staying on these on these subjects You're getting it seems as if you're getting feedback from investigators on the site Are there any other elements you're working on to optimize the environment other than the one you just mentioned?

Mhm got it got it thank you.

Yeah, maybe you know.

Staying on visa and the subjects.

You're getting it seems like you are getting a feedback from investigators the site Oh that of any other elements you had working on to optimize the government other than the one you just mentioned.

Speaker Change: There are, that we have a policy in place that there's an opinion that just came out at the Office of the Inspector General at Health and Human Services related to our ability to cover the co-pays of patients.

There are.

That.

We have a policy in place that.

Theres an opinion that just came out of the office of the Inspector General at health and human services related to our ability to cover the co pays of patients.

Mhm.

Got it.

Speaker Change: That's a more esoteric element, but we've hit this with a full court press to address every single issue that we think acts as a barrier to enrollment in this trial.

And so.

That's up more esoteric element, but we've hit this with a full court press to address every single issue that we think acts as a barrier to enrollment in this trial.

Speaker Change: And I think most, if not all, of those barriers have been addressed, including the significant one of the waning of COVID.

And I think most if not all of those barriers have been address including the significant one of the waning of Covid.

Speaker Change: Yeah, absolutely. And in fact, you know, my other question was this was around the COVID situation. And if you can give us a sense of, you know, what you're seeing in different centers and geography and geographies, if you, you know, could give us more color on how the COVID situation is waning.

Mhm.

Yeah, absolutely and in fact, you know my my other question was these are both around the Covid situation and if you can give us a sense of.

What you are seeing in defense centres in geography, and shall I guess, Ian if you could give us some more color on how the COVID-19 situation is waning.

Speaker Change: Sure. So for folks, there's two pieces to the COVID impacts clinical trials from our perspective. Remember, we only know our trials. And the first is.

Sure. So so for folks there's two pieces to how COVID-19 impacts clinical trials from our perspective remember, we only know our trials and the first is.

Speaker Change: Centers can only do elective procedures for certain periods. Patients don't want to go to centers. It's all related to the potential for interactions around COVID.

Centers can only do elective procedures for certain periods patients don't want to go to centers, it's all related to the.

The potential for interactions around Covid.

Speaker Change: The second, though, is related to staffing. So a lot of folks got used to working from home. Coordinator staffing at different centers has been problematic across the country. And so how we're seeing that change, you know, there's one leading center that's been very quiet for us for a very long time. They now have three patients in the day.

Second though is related to staffing so a lot of folks got used to working from home coordinator staffing at different centers has been problematic across the country.

So how we're seeing that change there's one leading center, it's been very quiet for us for a very long time.

We now have three patients in the queue.

Speaker Change: Another center was very quiet, and they just appeared on the radar screen and said, yes, they just approved the trial internally, and they want to get into the trial. And so there's other centers that we're still bringing on board as well. So I think it's happening. As anybody on the call who's hired people know, the staffing process can take time. But I think that piece is evolving in our favor as well.

Another center was very quiet.

And they just appeared on our radar screen and he said, yes. They just approved the trial internally they want to get into the trial and so there's other centers that we're still bringing on board as well. So I think it is happening as anybody on the call who is hired people know.

The staffing process can take time, but I think.

I think that pieces evolving in our favor as well.

Speaker Change: Makes sense. Thank you. And, you know, my last question, you know, the relevance of the potency assays as taken center stage recently has always been important, obviously, but as taken center stage recently, I was wondering for cell therapies, and I was wondering if you can give us a sense of how much dialogue have you had with the FDA regarding your potency assay?

Makes sense. Thank you and my last question at you know that the relevance of their potency assays. That's taken center stage recently has always been part and obviously, but it's taken lessons and incentive stage recently and I was wondering you can get for Santana piece and I was wondering if you can give us a sense of how much dialogue.

<unk> had with the FDA they got it in your pocket Trc.

So.

Speaker Change: This is a cell selection assay in which we are identifying a number of biomarkers that based on all of the data before us support that the patient would have a high probability of benefit.

This is a cell selection.

Assay in which we are identifying a number of biomarkers that based on all of the data before a support that the patients would have a high probability of benefiting.

Speaker Change: And so really it's an inclusion exclusion criteria in our trial. We have called it a cell potency assay and it does relate to it, but it's it's it's different from a a Cell potency assay under the state of the terms that the the agency would would look at

And so really it's an inclusion exclusion criteria in our trial, we have called it a cell potency assay.

And it does relate to it but it's it's it's different from a a cell potency assay under the state of the terms that the agency would would look at.

Speaker Change: And so, I think, I know that cell potency assays are center stage for the agency with respect to many of the other advanced cell therapies out there. I think the things that we're doing, we do have cell potency assay efforts that we're looking at. We assess not only the viability of cells in each and every procedure, but also their ability to form colony forming units, and that has been used in other studies in the past as a potency assay as well.

And so I think I know that cell potency assays are center stage for the agency with respect to many of the other advanced cell therapies out there I think the things that we're doing.

We do have cell potency assay efforts that we're looking at we assess.

Not only the viability of cells in each and every procedure, but also their ability to form colony, forming units and that has been used in other studies in the past is potency assay as well. So I think in total the selection diagnostic aspect and the things that we're doing from a cell potency assay perspective.

Speaker Change: So I think, in total, the selection diagnostic aspect and the things that we're doing from a cell potency assay perspective support

Support.

Speaker Change: our friends at CBER are looking for, but fundamentally this is a regulated-as-a-device system and so it's probably not going to have the same criteria because we can't generate cell potency for a patient that's already been treated.

What.

Our friends at <unk> are looking for.

But fundamentally this is a regulated as a device system. So it's probably not going to have the same criteria.

Because we can't generate cell potency.

For a patient that's already been treated.

Speaker Change: It's something that we're doing after the patient is treated in our core laboratory.

It's something that we're doing after the patient is treated in our core laboratories.

Speaker Change: Mm-hmm understood. Thank you very much. However, I'll just one more step and then whether but for our

Mhm.

Good.

However.

One more step and then weather, but for our allo.

Speaker Change: Allogenic programs, we absolutely will have a cell potency assay, and it will be derived from some of the knowledge we have on our lead programs and all of the work we've done on colony forming units with respect to these expanded mononuclear cells in the lead program. They also feed into what we're doing on the neurokynone allogenic cells in programs three and four.

Allogeneic programs, we absolutely will have a cell potency assay.

And it will be derived from some of the knowledge we have on our <unk>.

Lead programs in all of the work we've done on colony, forming units with respect to these.

Expanded mononuclear cells in the lead program. They also feed into what we're doing on the neuro kind of one allogeneic cells.

In programs three and four.

Understood. Thanks.

I appreciate the question.

Speaker Change: The next question comes from Michael Okunovic of Maxim Group, please go ahead.

The next question comes from Michael <unk> Maxim Group. Please go ahead.

Hey, Thanks for taking my question.

Michael o'koitch: So, I guess first, I'd like to ask something just in the context of mesoblast discussions with regulators regarding their cell therapy and heart failure, specifically with moving into ischemic and diabetic patients where they saw the greatest benefit in subgroup analysis.

So I guess first I'd like to add something just in the context of mesoblast discussions with regulators regarding their cell therapy in heart failure, specifically with with moving into a schematic of diabetic patients where they saw the greatest benefit in subgroup analyses.

Michael o'koitch: Can this be viewed as validating of your targeting of ischemic heart failure patients with BCDA01 representing the right patient for a cell therapy product?

Can this be viewed as validating of you're targeting about ischemic heart failure patients with <unk> zero, one representing the right patient for a cell therapy product.

Speaker Change: Well, Michael, so first, I want to acknowledge that mesoblast data at three-year follow-up in the New York

Well, Michael it's so first I want to I want to acknowledge that mesoblast data at three year follow up.

In the New York Heart Association class III patients.

Speaker Change: and the ischemic ideology as we've looked at the data sets that they've shared publicly, it's good.

And the ischemic etiology as we've looked at the datasets that they've shared publicly.

Speaker Change: Now, that's exciting, that's the signal that's stronger than any of the other pivotal trials we've seen for the latest heart failure therapies that are out there. That said, it is a different therapy than we are advancing, and it uses a different delivery platform.

It's good data now that that's exciting that's what signaled a stronger than any of the other pivotal trials. We've seen from the latest heart failure therapies that are out there.

That said it is a different therapy, then we are advancing and it uses a different delivery platform.

Speaker Change: However, the patients that they say responded greater in their trials does line up substantially with the patients we're targeting in our trial.

However.

The patients that they say responded greater in their trials does line up substantially with the patients we're targeting in our trials. So there theyre focusing on New York Heart assessing class two they've said going forward.

Speaker Change: So they're focusing on New York Heart Assisting class two, they've said, going forward.

In our trial I believe.

Speaker Change: I don't know if I'm allowed to say the numbers, but a large portion of the patients in New York Heart Association Class 2, that the delta between what they're doing and what we're doing is they require hospitalization in the six months prior to treatment, and they required a high NT pro BNP level, which is a measure of the status of the heart failure. We don't require either of those. So I think we're leaning into patients who are less sick.

I don't know if I'm allowed to say the numbers, but a large portion of the patients with New York Heart, especially in class II that the delta between what they're doing and what we're doing is they required hospitalization in the six months prior to treatment and they required a high N T pro BNP level, which is a measure of the <unk>.

Status of the heart failure, we don't require either of those so I think we're leaning into patients who are less sick, which is what they've said, they're going to do going forward and the reason we've leaned in these patients all along is.

Speaker Change: which is what they've said they're going to do going forward and the reason we've leaned in these patients all along is

Speaker Change: The CAR-DM cell therapy is not an event-driven trial. We're not looking for the sickest of the sickest because we're big believers that the art of clinical trial design is optimizing signal to noise. And we think in these New York Heart Association class, two patients,

The Cardiome cell therapy is not an event driven trial, we're not looking for the sickest of the sickest, because we're big believers that the art of clinical trial design is optimizing signal to noise and we think in these New York Heart Association class III patients and the threes that are not so significantly sick that they have high end.

Speaker Change: and the threes that are not so significantly sick that they have high NT pro BMP and they've recently had a MACE event such as a hospitalization are the right patients to go after. And so they are saying yes those are the patients they're going to go after going forward.

<unk> Pro BNP and recently had a mace events such as the hospitalization are the right patients to go after and so they are saying, yes. Those are the patients they're going to go after going forward.

Speaker Change: It's too much though for us to rely on their data because again, they're delivering a different cell therapy They're delivering it with a different delivery system But it is an intramyocardial

It's too much though for us to rely on their data because again, they are delivering a different cell therapy, they're delivering it with a different delivery system.

But it is an intra myocardial.

Speaker Change: bone marrow-derived cell therapy, which is what ours is. So I'm trying to support kind of what you're saying, but also point to the limitations which are significant.

Bone marrow derived cell therapy, which is what ours. So.

There's I'm trying to support kind of what youre, saying, but also point to the limitations which are significant.

Speaker Change: Yeah, no, thank you. I appreciate the additional color. I'd also like to see if you could remind us of what the biomarkers in your cell selection, potency, assay are selecting for on a mechanistic basis.

Yeah no. Thank you I appreciate the additional color.

I'd also like to see if you could remind us of.

What the Biomarkers and yourself selection potency assay are selecting for on a mechanistic level.

Speaker Change: So we've only so we have a number of biomarkers. We're looking at the only one we detail publicly is the CD 34 sub

So we've only so we have a number of biomarkers. We're looking at the only one we detail publicly as the CD 34 cell counts and this is.

Speaker Change: and this is a marker that's been used in other clinical trials in the past. Just this past in 2021, we presented data on the dosage we're achieving in the current Tivital Trial and Heart Failure and the dosage we're able to achieve with the combination of the cell potency assay, selecting patients with high CD34.

A market that's been used in other clinical trials in the past just this past.

In 2021, we presented data on the dosage, we're achieving in the current pivotal trial in heart failure.

The dosage, we're able to achieve with the combination of the cell potency assay selecting patients with high CD 34.

Speaker Change: cell processing platform and its efficiency on only a 60 cc marrow aspirate and the efficiency of delivery is actually higher than every major

The cell processing platform and its efficiency on only a 60 cc marrow aspirate and the efficiency of delivery is actually higher than every major cell therapy trial that has shown signs of efficacy.

Speaker Change: self-therapy trial that has shown signs of efficacy.

Speaker Change: based on CD34 cells, so I think it's promising from that perspective.

Based on CD 34 cells. So I think it's promising from that perspective, the mechanisms that folks look to on CD 34 is one often of angiogenesis and enhanced microvascular.

Speaker Change: The mechanisms that folks look to on CD34 is one often of

Speaker Change: uh... angiogenesis and enhanced microvascular uh... elements

Speaker Change: That may not be the only element that's going on. I mean, again, we're treating ischemic.

Elements that may not be the only element that's going on I mean again, we're treating ischemic heart failure patients treat their diseases caused by ischemia, but we are not treating actively ischemic patients is our focus.

Speaker Change: heart failure patients between their diseases caused by ischemia.

Speaker Change: But we are not treating actively ischemic patients as our focus.

Speaker Change: And that's an important delineation because we were the first group to say we want ischemic etiology and heart failure, and we don't need for them to be actively ischemia, ischemic. So there's other mechanisms of action probably woven into this as well.

And that's that's an important delineation because we were the first group to say, we want ischemic etiology and heart failure, and we don't need for them to be actively ischemia ischemic. So theres other mechanisms of action probably woven into this as well.

Speaker Change: All right, thank you. And then just one last one. With the addition of, you know, these Canadian trial sites coming online, do you think that the different reimbursement environment could make that easier to enroll than the U.S.? Or, given the developments with CNS, they should be about equally as easy?

Alright. Thank you and then just one last one.

With the addition of.

Canadian trial sites coming online do you think that the.

Different reimbursement environment could make that easier to enroll in the U S than the U S or given the developments with CNS they should be about equally as easy.

Speaker Change: That's a great question. We don't know.

That's a great. That's a great question, we don't know is the answer.

Speaker Change: We started the process in Canada in part because we know some great KOLs there, key opinion leaders who've done enormous work in this space historically and been involved in other trials. But there was also an element that, you know, it becomes a test case without having the reimbursement.

We started the process in Canada in part because we.

We know some great kols there.

Key opinion leaders who've done enormous work in this space historically and been involved in other trials, but there was also an element that.

It becomes a test case without having the reimbursement issues and so we will have to pay for everything in Canada.

Speaker Change: And so we will have to pay for everything in Canada. It's not as expensive to do clinical trials in Canada, although,

It's not as expensive to do clinical trials in Canada, although the paperwork of going through two separate agencies for the approval process was daunting.

Speaker Change: the paperwork of going through two separate agencies for the approval process was daunting. Our expectation is that Canada enables us to test that question without necessarily sacrificing the value proposition of our reimbursement for both trials in the United States.

Our expectation is that Canada enables us to test that question without necessarily sacrificing the value proposition of our reimbursement for both trials in the United States.

Speaker Change: And in addition to working on Health Canada, we were taking a belt and suspenders approach and we've worked through the nuances of what was causing sites some difficulties. And so we think that our friends at CMS have done a lot of work on that.

And in addition to working on Health, Canada, we were taking a belt and suspenders approach and we've worked through the nuances of what was causing sites. Some difficulties and so we think that our are our friends at CMS.

Have done.

Speaker Change: made good efforts to help us to get some of those issues resolved, and we think that's going to roll through the system well going forward.

<unk> made.

It made good efforts to help us to get some of those issues resolved and we think that that's going to roll through the system well going forward.

Speaker Change: It will be interesting to see the impact of these different elements at the end of the day.

So it will it will be interesting to see the impact of these different elements at the end of the day.

Speaker Change: You know, we won't be able to tease out exactly which element is resulting in the enhanced enrollment at which site.

We won't be able to tease out exactly which element is resulting in the enhanced enrollment at which site, but it is a sign that we at biochar to you're constantly listening to our clinical sites and trying to understand what is a problem for them. How can we make this trial easier provide more support for it from a scientific.

Speaker Change: But it's a sign that we at BioCardi are constantly listening to our clinical sites and trying to understand what is a problem for them, how can we make this trial easier, provide more support for it from a scientific...

Speaker Change: a reimbursement perspective, while we also, you know, optimize the value propositions we have of the Medicare reimbursement.

Reimbursement perspective, while we also optimize the value propositions, we have of the Medicare reimbursement.

Speaker Change: All right. Thank you very much. I appreciate you taking the time to answer my question.

Alright. Thank you very much I appreciate you taking the time to answer my question.

Thank you Michael I appreciate it.

Speaker Change: The next question comes from James Malloy of Alliance Global Partners. Please go ahead.

The next question comes from James Molloy of Alliance Global Partners. Please go ahead.

Jimes Malloy: Thank you for taking my question. And thank you very much for all the insight into the expectations on the trial. On 01, you guys give a guidance for expectations for another DSMB here for the fourth quarter. Any thoughts or is there a way to get an idea of when you look at the trial given how enrollment's getting better with COVID kind of waning?

Thank you for taking my question and thank you very much further insight into the expectations on the trial on an old one.

You guys gave a guidance for expectation for another deals can be here for the fourth quarter.

Any thoughts or is there a way to get an idea of when you look at the ramp to trial given.

Enrollment is getting better with the COVID-19 kind of waning.

Speaker Change: So, yes. So, Jim, we're targeting, I think, third quarter for the DSMB review in BCD01, which is the CardiAmp Cell Therapy for ischemic heart failure. And we're targeting completing enrollment of that

So yes, so so Jim we're targeting I think third quarter for the DSM V review in BCD of one which is the cardiac cell therapy for ischemic heart failure.

And we are targeting completing enrollment of that lead program. In 2023. We're also targeting completion of enrollment for the adaptive readout in the same therapy, but for the indication of chronic myocardial ischemia.

Speaker Change: lead program in 2023. We're also targeting completion of enrollment for the adaptive readout in the same therapy, but for the indication of chronic malchloroschemia in the same year.

In the same year. So 2023 is going to be a very big year for us and you know.

Speaker Change: So 2023 is going to be a very big year for us. And, you know, I can't provide any more specificity on it than that. We'll find out. We will report out the enrollment as we go. And, but, you know, as we budget things, we're budgeting for success here. So we are pushing hard on the enrollment activities today. And these are not the only things we're doing, the things that have happened in 2021 and subsequent to 2021, based on the efforts in 2021. There's a lot going on to make this trial be completed.

I can't provide any more specificity on it and that we will find out we will report out the enrollment as we go and.

But as we budget things we're budgeting for success here. So we are we are pushing hard on the enrollment activities.

Today and these are not the only things we're doing the things that are that have happened in 2021 and subsequent to 2021 based on the efforts in 2021, there's a lot going on to make this trial.

Be completed as soon as possible.

Speaker Change: Excellent, then maybe How does how does the given the environment has been obviously been a challenging environment first half of the year biotech across the board? has the environment for potential acquisitions or partnerships Changed gotten more or less Active given what's been going on with some of the stocks really getting you know really getting getting down to dramatically low level

Excellent so maybe.

How does it how does the given the environment has been obviously been a challenging environment first half of the year biotech across the board.

Has the environment for.

Central acquisitions or partnerships changed gotten more or less.

Active given what's been going on with some of the stocks really getting really getting.

Getting on to dramatically low levels.

Speaker Change: You know, Jim, I can only speak to the business development activities that we have underway. And so – and those are not really tied into M&A, although there is, you know, licensing on a couple elements. So just to – I'll recap them briefly. So, you know, one of the efforts we have ongoing is –

Hi, Jim I can only speak to the business development activities that we have underway and so.

Those are not really tied into M&A.

M&A, although there is.

Licensing on a couple of elements so just to recap them briefly so.

One of the efforts we have ongoing is.

Speaker Change: identifying a partner for Cardiamp outside the United States and specifically in Japan.

Identifying a partner for cardiac outside the United States and specifically in.

Speaker Change: That would involve a partnership, not an acquisition, and I can share that there is interest in light of all the things that I've just shared that have been taking place.

In Japan.

That would be involve a partnership not an acquisition and I can share that there is interest.

In light of all the things that I've, just shared sort of that have been taking place.

Speaker Change: In our 10K, we've detailed that we are meeting with PMDA in the near future.

In our in our 10-K, we've detailed that we are.

Meeting with P. M D a.

Speaker Change: And so, you know, we'll be having conversations with them in parallel to having conversations with potential partners to help.

The near future and so we'll we'll be having conversations with them in parallel to having conversations with.

Potential partners to help advance the Cardiome cell therapy in Japan, where there's there's a million patients there with with heart failure, and it's a great unmet need and I also note that the only cardiac cell therapy. That's approved that we're aware of is in Japan and it has a reimbursement. This is the heart sheet by <unk>.

Speaker Change: advance the cardiac cell therapy in Japan where there's there's a million patients there with with heart failure And it's a great unmet need and I also note that the only cardiac cell therapy that's approved that we're aware of

Speaker Change: is in Japan and it has a reimbursement. This is the heart

Speaker Change: sheet by Terumo, it has a reimbursement of I think $124,000 US dollars in yen equivalents. So there's a support for regenerative medicine in Japan that also will hopefully put some wind behind the therapies we're advancing.

It is it reimbursement or they think of 124000 U S dollars and yen equivalents so.

There there is a support for regenerative medicine in Japan that also will hopefully put some.

Wind behind the therapies were advancing.

Speaker Change: So, that's one. The second level of partnering that we're involved in is around our biotherapeutic delivery platform.

So that's one the second level of partnering that we're involved in is around our biotherapeutic delivery platform.

Speaker Change: So today, we actually feel we have the,

So today, we actually feel we have the.

E C.

Safest.

Speaker Change: most efficient at delivery and easiest to use delivery system that's appropriate for cell gene and protein delivery to the heart.

Most efficient at delivery and easiest to use deliver.

<unk> delivery system, that's appropriate for Celgene and protein delivery to the heart.

Speaker Change: And so we can, all of the things we've solved are available for parking.

And so we can all of the things, we've solved or available for partners.

Speaker Change: And so, we're trying to move more towards significant corporate partnerships. We would like to enable other significant entities to have their own delivery system. Even though it would compete with us and potentially be cannibalistic, our perspective is that these therapies will ultimately compete, and if our shareholders can benefit from both therapies, great. If patients can benefit from all that we've learned on delivery, great.

And so we're we're trying to move more towards significant corporate partnerships, we would like to enable other significant.

Entities to have their own delivery system, even though it would compete with us and potentially be cannibalistic. Our perspective is that these therapies will ultimately compete and if our shareholders can benefit from both therapies, great. If patients can benefit from all that we've learned on delivery great.

Speaker Change: great. So that's an area that we're very active in today and that reflects the two deals we did in 2021. The last area is in actually monetizing assets that we've developed that don't fit our core

So that's an area that we're very active in today and that reflects the two deals we did in 2021 and the last area is in actually monetizing assets that we've developed that don't fit our core.

Speaker Change: initiatives, and one of those assets is our AVANT's transeptal sheet, which is an FDA-cleared product. It's based on technology that is

Initiatives and one of those assets is our advance <unk>.

<unk>, which is an FDA cleared product.

Its based on technology that.

Speaker Change: elegant we use it the technology in our what we call our morph DNA product which is part of our biotherapeutic delivery systems.

<unk> is.

Elegant we use it the technology in our what we call our morph DNA product, which is part of our biotherapeutic delivery systems, but the advanced addresses an existing market in the United States, It's extremely competitive.

Speaker Change: But the AVANCE addresses an existing market in the United States, it's extremely competitive, of around 500,000 procedures a year. And we're having conversations around identifying a partner to monetize that with the idea that we will enable them to have that technology and that product. And at the same time, the dollars will come in and feed some of the other initiatives here at BioCardi.

Around 500000 procedures, a year and we're having conversations around identifying a partner to monetize that with the idea that.

We will enable them to have that technology in that product.

And at the same time, the dollars will come in and feed some of the other initiatives here at Biochar, yet and so those are really the three types of.

Speaker Change: So, those are really the three types of efforts we have of note, the international partnering and the international partnership.

Efforts, we have of note.

International partnering and the advance monitors.

Speaker Change: monetization activities, those can only be done with one partner, but the biotherapeutic delivery activities, you know, we can work with a number of partners.

Monetization activities those can only be done with one partner, but the biotherapeutic delivery activities. We can we can work with a number of partners and we treat our partner information.

Speaker Change: And we treat our partner information as strictly confidential. I think we have a very good relationship and reputation amongst our current and past partners.

Strictly confidential I think we have a very good relationship and reputation amongst our current and past partners and sometimes programs don't go forward. It has nothing to do with delivery, it's often related to the therapy or funding for the therapy or other elements, but those programs.

Speaker Change: And sometimes programs don't go forward. It has nothing to do with delivery. It's often related to the therapy or funding for the therapy or other elements. But the programs we inked last year are still ongoing. And we're optimistic that we'll be doing some nice partnering in the year ahead.

Last year are still ongoing and and we're optimistic that we'll be doing some nice partnering in the year ahead.

Great. Thank you for taking the questions.

Appreciate it Jim.

Speaker Change: The next question comes from Jason Colbert of Boston, James. Please go ahead.

The next question comes from Jason Kolbert of Dawson James. Please go ahead.

Speaker Change: Hi, Peter. Thank you. Most of my questions have been answered, but I'd like to talk a little bit about the end point of the trial. And can you help me understand kind of what the critical measures are, associate? I think it's Finkelstein-Schoenfeld hierarchical analysis. What are the key critical aspects there, and what other significant drugs?

Hi, Peter Thank you most of my questions have been answered, but I want to talk a little bit about the endpoint of the trial and can you help me understand kind of what the critical measures are associated I think its finkelstein schoenfeld hierarchical analysis.

What are the key critical aspects, there and what other significant.

Drugs have been approved using that endpoint.

Speaker Change: So Jason, I appreciate the question, and it is a good one. The Fingalstein-Schollfeld three-tier composite endpoint that we're using in the trial is a hierarchical endpoint that includes mortality,

So Jason appreciate the question and it is a good one.

The Finkelstein schoenfeld, three tier composite endpoint that we're using in the trial is a hierarchical endpoint that includes.

Mortality.

Speaker Change: major adverse cardiac events, and then functional capacity as measured by six-minute walk. There have been a number of other heart failure programs that have been advanced with that as an endpoint. And I think more important than identifying a specific other drug that's been approved, I would say the FDA recommended this endpoint.

Major adverse cardiac events, and then functional capacity as measured by six minute walk there've been a number of other heart failure programs that have been.

<unk> advanced with that as an endpoint and I think more important in identifying a specific other drug that's been approved I would say the F. D. A recommended this endpoint to us and specifically guided us to use this endpoint and I may have shared in the past, but this endpoint.

Speaker Change: and specifically guided us to use this in.

Speaker Change: And I may have shared in the past, but this endpoint, we had something that was a little bit more sophisticated from a statistics perspective.

We had something that was a little bit more sophisticated from a statistics perspective, but the agency did us a great service in nudging us to the Finkelstein schoenfeld three tier because it's something that clinicians understand and what we had was something that was difficult to describe even though it was probably more sophisticated.

Speaker Change: But the agency did us a great service in nudging us to the Finkelstein-Schonfeld treat here because it's something that clinicians understand. And what we had was something that was difficult to describe, even though it was probably more sophisticated and substantially equivalent by

And substantially equivalent by by moving it towards the Finkelstein Schoenfeld, we wind up with an endpoint that everybody understands and accepts because.

Speaker Change: By moving it towards the Finkelstein-Schonfeld, we wind up with an endpoint that everybody understands and accepts because the way it works is, is the therapy better for the patient?

The way. It works is is the therapy better for the patient so if a patient dies there they are in the worst shrink.

Speaker Change: So if a patient dies, they're in the worst.

Speaker Change: we want patients to live first and foremost. If there's a MACE event, that's the next rank.

Want patients to live person foremost if theres a mace event, that's the next rank and but there's no doubt.

Speaker Change: If there's no death and no mace in a patient, how do you know whether they're better or not? And the third tier of the functional capacity as measured by six minute walk is how this plays out.

If there's no deaths and no Mason a patient how do you know whether they are better or not and the third tier of the functional capacity as measured by six minute walk.

Is how this plays out.

Speaker Change: And the results we have so far are good. Six minute walk is a non-trivial endpoint. It can be subject to manipulation by a clinical trial coordinator who's cheering a patient on one day and not cheering the patient on the next day.

The results we have so far are good six minute walk as a as a non trivial end point it can be subject to.

Manipulation by a clinical trial coordinator, who is chairing a patient on one day and not sharing the patient on the next day.

Speaker Change: We've been very disciplined in rolling this out, working with leadership at NHLBI, National Heart Blood Institute, related to a six-minute walk. And so our sense is we're doing it as rigorously as we can do it.

We've been very disciplined in rolling this out working with leadership.

Yep.

N H L. B I related to six minute walk excuse me National Heart lung and blood Institute related to six minute walk and so our sense is we're doing it as rigorously as we can do it and combined.

Speaker Change: and combined. It's an endpoint that the FDA has effectively blessed by recommending it to us in the market.

Endpoint that the FDA has effectively blessed by recommending it to us.

In the modification and I does that answer all your questions or is there another element there that maybe.

Speaker Change: And does that answer all your questions, or is there another element there that I may be able to... Well, I'd like to just pick up on something you said, which is the data so far is pretty good. Can you expand upon that?

Pick up on something you said, which is the data so far is pretty good can you expand upon that.

Speaker Change: Well, so I don't we don't see any of the data in the in the blinded um trial, but if you look at you know published results so far for our You know our our actually worst data is in our phase one where we had a 10 percent mortality rate at three years

Well, so I don't we don't see any of the data and the and the blinded.

Trial, but if you look at.

Published results so far for our.

Our actually worst state is in our phase one where we had a 10% mortality rate at three years.

Speaker Change: And I note that 10% of three years, if you look at all of the data coming out of the very large drug trial.

And I know, it's 10% of three years, if you look at all of the data coming out of the very large drug trials.

Speaker Change: The mortality rates at three years are roughly 21%.

The mortality rates at three years or roughly 21%.

Speaker Change: I note that if you look at mesoblast data in their phase two, you know, I think they are under a 10% mortality at three years.

I note that if you look at mesoblast data in their phase II.

I think they are under a 10% mortality at three years.

Speaker Change: So there's that's in the New York Heart Association class 2. So, you know, our our data in phase 2 as we had no patients Lost that one-year follow-up and in the phase 3 I can only share the one-year data that was published But we have no patients lost in that role in coporative

So there's that's in the new York's harder searching class II. So.

Our data in phase two as we had no patience.

Lost at one year follow up and in the phase III I can only share the one year data that was published but we have no patients.

Lost in that rolling cohort of the phase three trial.

Speaker Change: Okay, sure, that makes sense, so it's encouraged and that's what you're saying.

Okay sure that makes sense. So it's encouraging that that's what you're saying.

Speaker Change: Yeah, so, again, these are very sick patients, and the fact that they're doing well in those metrics is great, but if you look at the other elements of those data sets, you know, the phase one, we saw improvement in exercise tolerance. We saw improvement in heart function. Phase two, we saw improvement in exercise tolerance, we saw improvement in heart function. Phase three, we see improvement in heart function.

Yes. So these again. These are these are these are very sick patients and the fact that they're doing well.

And those metrics is great, but if you look at the other elements of those datasets you know the phase one we saw improvement in exercise tolerance.

We saw improvement in heart function phase II, we saw improvement exercise tolerance, we saw improvement in heart function phase III, we see improvement in.

Speaker Change: Exercise tolerance, we see improvement in heart function, we see improvement in quality of life, we, you know, it all holds together. So, it's not as if we have a data set that doesn't include one element of those benefits. And these data sets are complicated. So, we're hopeful if we repeat the results we had in phase two, we have potentially a new therapy for patients. And these therapies

Exercise tolerance, we see improvement in heart function, we see improvement in quality of life weeks. It all holds together so it's not as if we have a dataset that doesn't include.

One element of those benefits in these datasets are complicated.

So we're hopeful if we repeat the results we had in phase two we have a potentially a new therapy for these patients.

These therapies.

Speaker Change: that we're advancing, you know, it's a one-time treatment of concentrating the patient's own selves around the damaged tissue in the heart.

That we're advancing it's a onetime treatment of concentrating the patient's own cells around the damaged tissue in the heart and so it's from a safety perspective.

Speaker Change: And so it's, from a safety perspective, at the end of a procedure, if you get the safety check at the end of the procedure, we feel very good at the end of the procedure.

At the end of the procedure, if you get the safety check at the end of the procedure, we feel very good at the end of the day.

Speaker Change: There's no, you know, with normal drug trials, there's compartmentalization, and drugs get localized in the adipose tissue, and you can have toxicity events.

Theres no.

Normal drug trials, just compartmentalize Asian, and drugs look at localizing, the adipose tissue and you can have toxicity events downstream with other device therapies, where you have an implant implants can erode that can become infected. So we don't have any of those long term safety ramifications in what we're doing in the cardiac cell therapy programs.

Speaker Change: downstream. With other device therapies where you have an implant, you know, implants can erode, they can become infected. So we don't have any of those long-term safety ramifications in what we're doing in the CARDI-AMP cell therapy programs. There are procedural risks and again, there are also risks for the cells that haven't been fully adjudicated. This is not an approved therapy, but as we think about it, we think that the safety profile is pretty compelling.

There are procedural risks and again there are also risks for the cells that havent been fully adjudicated. This is not an approved therapy, but as we think about it we think that the safety profile is pretty compelling.

Thanks Peter.

Thank you Jason I appreciate you being on the call.

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

This concludes our question and answer session I would like to turn the conference back over to Peter <unk> for any closing remarks.

Peter Alton: Thank you, Andrea. I want to thank all of you participating on today's call and for your interest in biocardia. We look forward to sharing our conversation.

Thank you Andrea.

Want to thank all of you participating on today's call and for your interest in Biochar to you.

We look forward to sharing our continued progress.

Speaker Change: Thanks, stay healthy, be kind, and have a wonderful day.

Thanks stay healthy be kind and have a wonderful day.

Speaker Change: The conference is now concluded. Thank you for attending today's presentation and you may now disconnect.

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

Speaker Change: P but.

Okay.

Okay.

[music].

Speaker Change: Pro we pro.

Uh huh.