Q1 2024 BioCardia Inc Earnings Call

Ladies and gentlemen, thank you for standing by good afternoon, and welcome to the bio car T. S first quarter 'twenty 'twenty four financial results and business update conference call. At this time all participants are in a listen only mode should you need assistance.

Operator: Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia First Quarter 2024 Financial Results and Business Update conference call. At this time, all participants are in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad.

Conference Specialist: Please signal a conference specialist by pressing the star key followed by zero.

Speaker Change: After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your telephone keypad to withdraw your question. Please press Star then two.

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 purposes, a web cast replay of the call will be available approximately one hour after the end of the call.

Operator: To withdraw your question, please press star, then two. 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. I would now like to turn the call over to Miranda Pato of BioCardia Investor Relations. Please go ahead, Miranda.

Speaker Change: I would now like to turn the call over to Marando Miranda Peyto of myocardial <unk> Investor Relations. Please go ahead Miranda.

Speaker Change: Yeah.

Miranda Peto Benvenuti: Thanks, Debbie. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, PhD, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer. During this call, management will be making four forward-looking statements, including statements that address BioCardia's expectations for future performance and operational results, as well as references to management's intentions, beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products and technologies and obtaining regulatory approval.

Debbie: Thanks Debbie.

Afternoon, and thank you for participating in today's conference call. Joining me from bio cardiac leadership team are Peter Hoffman Ph D, President and Chief Executive Officer.

Debbie: And David Mcclung, the company's Chief Financial Officer.

call management: This call management will be making forward looking statements, including statements that address myocardial <unk> expectations for future performance and the operational result.

Management: References to management's intentions beliefs projections outlook analyses and current expectations.

Management: Such factors include among others, the inherent uncertainties associated with developing new products and.

David Mcclung: Technologies and obtaining regulatory approvals.

Speaker Change: Forward looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

Speaker Change: For more information about these risks please refer to the risk factors and cautionary statements describe and bio car T. As reports on Form 10-K filed with the SEC on March 27th 2020 for the content of this call contains time sensitive information that is.

Company Representative: Accurate only as of today may 14th 2024, except as required by law. The company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call.

Miranda Peto Benvenuti: Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10-K, filed with the SEC on March 27, 2024. The content of this call contains time-sensitive information that is accurate only as of today, May 14, 2024. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Speaker Change: It's now my pleasure to turn the call over to Dr. Peter Altman myocardial President and CEO. Peter Please go ahead.

Company Representative: Yeah.

Company Representative: Thank you Miranda and good afternoon to everyone on the call.

Peter A. Altman: Thank you, Miranda, and good afternoon to everyone on the call. This has been a big quarter for BioCardia, as our clinical investigators have presented positive results from each of our three ongoing autologous and allogeneic cell therapy clinical trials to treat ischemic heart failure and chronic myocardial ischemia. In this call, we will share an update on these product candidates in active clinical development. Our lead CARDI-AMP autologous cell therapy is targeted to treat ischemic heart failure of reduced ejection fraction, an enormous unmet clinical need.

Speaker Change: This has been a big quarter for Biochar deal as our clinical investigators presented positive results from each of our three ongoing autologous and allogeneic cell therapy clinical trials to treat ischemic heart failure and chronic myocardial ischemia.

In this call we will share an update on these product candidates in active clinical development.

Yeah.

Speaker Change: Our lead Carty Amp autologous cell therapy is targeted to treat ischemic heart failure reduced ejection fraction and enormous unmet clinical need.

Carty Amp: We now have results from three clinical trials tab me.

Peter A. Altman: We now have results from three clinical trials, TaqHIFT, and CardiAMP-HF with the CardiAMP cells, that support both the safety and therapeutic efficacy of these cells for patients with ischemic heart failure of reduced ejection fraction. Although we have seen positive signals of reduced mortality and reduced major adverse cardiac events in all patients treated in the most recent cardiac heart failure trial, The Remarkable Benefits in Patients Treated with Elevated NT Pro BNP.

CAC gift: CAC gift and cardiac H F with the cardiac cells that support both the safety and therapeutic efficacy of these cells for patients, having ischemic heart failure reduced ejection fraction.

Speaker Change: Although we have seen positive signals, a reduced mortality and reduced major adverse cardiac events and all patients treated in the most recent cardiac heart failure trial.

Speaker Change: The remarkable benefits in patients treated with elevated NT pro BNP.

Peter A. Altman: A well-established biomarker of active heart failure is where we are focused today. Results in these patients shared late in the first quarter show a remarkable 86% relative risk reduction in heart death equivalents and a 24% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events. Heart death equivalents include all-cause death, cardiac transplantation, and implantation of a left ventricular assist device to replace heart function.

Speaker Change: A well established biomarker of heart of active heart failure is where we are focused today.

Speaker Change: Results in these patients shared late in the first quarter show, a remarkable 86% relative risk reduction in heart desk equivalents, and a 24% relative risk reduction and non fatal major adverse cardiac and cerebral vascular events.

Speaker Change: Our guests equivalents include all cause deaths cardiac transplantation and implantation of a left ventricular assist device to replace heart function.

Speaker Change: This is particularly exciting as therapies that are available today do not have a significant impact on mortality for these patients.

Peter A. Altman: This is particularly exciting as therapies that are available today do not have a significant impact on mortality for these patients, and, unfortunately, mortality for these patients is still approximately 50% at 5 years. Further, the recent interim results in these patients show all clinical outcomes favored cardiac cell therapy, including improved quality of life as measured using the Minnesota Living with Heart Failure Quest, reduction of NT pro BMP levels, greater six-minute walk test, and Improved Echocardiography Parameters of Left Ventricular Ejection Fraction, Left Ventricular Encystolic Volume, and Left Ventricular Endiastolic Volume. Both the reduced heart death equivalents and improved quality of life outcomes demonstrated statistical significance favoring therapy in patients with elevated NT-PRO-BNP.

Speaker Change: And unfortunately mortality for these patients is still approximately 50% at five years.

Speaker Change: Further the recent interim results in these patients.

Speaker Change: All clinical outcomes favorite cardiac cell therapy, including improved quality of life as measured using the Minnesota living with heart failure questionnaire reduction of N T Pro BNP levels, greater six minute walk test distance and improved echocardiographer parameters in left ventricular ejection fraction left ventricular end.

Speaker Change: Systolic volume and left ventricular end diastolic volume.

Speaker Change: Both the reduced heart gets equivalents and improved quality of life outcomes demonstrated statistical significance favoring therapy in patients with elevated and key pro BNP.

Speaker Change: Our goal is to have final results available for both scientific presentation.

Peter A. Altman: Our goal is to have final results available for both scientific presentation and for regulatory submission in the fourth quarter of 2024. There is an enormous amount of ongoing activity by the BioCardia team to monitor patients enrolled in this study. As we already have more than 90% of the patient follow-up data that we will ultimately have in the final analysis, we don't expect the results to change significantly. The final results are expected to be provided to Japan's Pharmaceutical and Medical Device Agency as a key element of a submission for approval.

Speaker Change: And for regulatory submission in the fourth quarter of 2024.

Speaker Change: There was an enormous ongoing activity by the bio cardiac team to monitor patients enrolled in this study.

Speaker Change: As we already have more than 90% of the patient follow up data that we will ultimately have in the final analysis, we don't expect the results to change significantly.

Speaker Change: The final results are expected to be provided to Japan's pharmaceutical and medical device agency is a key element of our submission for approval.

Speaker Change: Our previous consultations with Japan's pharmaceutical and medical device agency supported that if the data remains as good as it currently appears to be at the final analysis. They are willing to consider approval based on this data without requiring an additional clinical trial in Japan.

Peter A. Altman: Previous consultations with Japan's Pharmaceutical and Medical Device Agency supported that if the data remains as good as it currently appears to be at the final analysis, they are willing to consider approval based on this data without requiring an additional clinical trial in Japan. Subsequent interactions and consultations with Japan's Pharmaceutical and Medical Device Agency are expected. A post-marketing study is already in active discussion with world-class heart failure cardiology and interventional cardiology leaders in Japan who attended our last consultation with the agency. We are thankful for their involvement.

Speaker Change: Subsequent interactions in consultations with Japan's pharmaceutical and medical device agency are expected.

Speaker Change: Our post marketing study is already in active discussion with World class Heart failure, cardiology, and interventional cardiology leaders in Japan, who attended our last consultation with the agency.

Speaker Change: We are thankful for their involvement.

Speaker Change: The confirmatory cardiac heart failure to trial in the United States is focused on the patients with elevated N T Pro BNP.

Peter A. Altman: The confirmatory cardiac heart failure two trial in the United States is focused on patients with elevated NT pro BNP. The trial was approved by FDA in December, activated in February, and approved for reimbursement by Medicare in March. We estimate that the Medicare reimbursement will reduce the cost of doing this study by more than $5 million as we record payments from centers as a reduction in our R&D expenses as these dollars are then paid back to centers to cover research costs for patient follow-up.

Speaker Change: The trial was approved by FDA in December activated in February and approved for reimbursement by Medicare in March.

Speaker Change: We estimate that the Medicare reimbursement reduces the cost of doing this study by more than $5 million as we record payments from centers as a reduction in our R&D expense. As these dollars are then paid back to centers to cover research costs for patient follow up.

Speaker Change: This confirmatory trial as a greater than 90% power or statistical probability of success to meet the primary endpoint based on the cardiac heart failure trial interim results.

Peter A. Altman: This confirmatory trial has a greater than 90% power or statistical probability of success to meet the primary endpoint based on the cardiac heart failure trial interim results. Our world-class Executive Steering Committee and the distinguished cardiologists on our Data Safety Monitoring Board are continuing to support this program. We expect additional world-class heart failure clinicians to join our Executive Steering Committee soon. We are actively working with our heart failure network and leaders in cardiology to enable this study to be fully enrolled in two years from the first patient enrolled, with results being available in three years. This is an aggressive goal, but we feel that the experience and data that we have will enable this to be achieved. We are actively onboarding sites, and this effort will accelerate in the months ahead.

Speaker Change: Our World Class Executive Steering committee and the distinguished Cardiologists on our data safety monitoring board or continuing to support this program.

Speaker Change: We expect additional world class heart failure clinicians to join our executive steering Committee soon.

Speaker Change: We are actively working with our heart failure network and leaders in cardiology to enable this study to be fully enrolled in two years when the first patient enrolled with results being available in three years.

We: This is an aggressive goal, but we feel that the experience and data that we have will enable this to be achieved.

Speaker Change: We are actively onboarding sites and this effort will accelerate in the months ahead.

Speaker Change: Our cardiac cell therapy trial for chronic myocardial ischemia, where beef CDA owed to.

Peter A. Altman: Our Cardiac Cell Therapy Trial for Chronic Myocardial Ischemia, or BCDA-02, is a phase three, multi-center, randomized, double-blinded, controlled study intended to include up to 343 patients at up to 40 sites. The company roll-in cohort results were presented in a call last month showing patients with refractory angina demonstrating an average 107-second increase in exercise tolerance and an 82% reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. Planning for the randomized phase continues based on these positive results. Part of this planning includes utilizing the Medicare reimbursement in place for both the control and treatment arms of this investigational therapeutic study to offset clinical costs.

Speaker Change: Is a phase III multicenter randomized double blinded controlled study intended to include up to 343 patients at up to 40 sites.

Company Representative: The company role in cohort results were presented on our call last month, showing patients with refractory angina, demonstrating an average of 107 second increase in exercise tolerance and an 82% reduction in angina episodes at the primary six month follow up endpoint.

Speaker Change: Compared to before receiving the study treatment.

Speaker Change: Planning for the randomized phase continues based on these positive results.

Speaker Change: Part of this planning includes utilizing the Medicare reimbursement in place for both the control and treatment arms of this investigational therapeutic study to offset the clinical costs.

Speaker Change: Yeah.

The company: The Companys Carty Allo allogeneic cell therapy for ischemic heart failure or B C. D. E. L. Three is a phase one two clinical trial program encompassing 69 patients.

Peter A. Altman: The company's CARDI-ALLO Allogeneic Cell Therapy for Ischemic Heart Failure, or BCDA-03, is a Phase I-II clinical trial program encompassing 69 patients. At the Technology and Heart Failure Therapeutics meeting in March, it was reported that there were no adverse events and follow-up in the first low-dose cohort patient enrolled. The CARDI-ALLO Heart Failure Study is intended to build on three previous trials of mesenchymal stem cells in ischemic heart failure that we have co-sponsored at BioCardia.

The company: That's a technology in heart failure Therapeutics meeting in March It was reported that there had been no adverse events and follow up on the first low dose cohort patient enrolled.

Biochar: The Carty Allo heart failure study is intended to build on three previous trials of messing time will stem cells in ischemic heart failure that we have co sponsored it biochar to yet.

Peter A. Altman: This is a precision medicine study as we are focusing this therapy for the first time on patients who have elevated NT-proBNP and elevated high-sensitivity C-reactive protein, a marker of inflammation that has been correlated with responsiveness to immunomodulatory mesenchymal stem cells in a significant previous study. We intend the Phase II portion of the CARDI-ALLO study to be performed in both the United States and Japan, where it has the potential to receive conditional approval based on this one trial.

Carty Allo: This is a precision medicine study as we are focusing this therapy for the first time on patients who have elevated NT pro BNP.

Speaker Change: And elevated high sensitivity C reactive protein a marker of inflammation that has been correlated with responsiveness to immuno modular Tory messing kind will stem cells in a significant previous study.

Speaker Change: We intend the phase two portion of the Carty Allo study to be performed in both the United States and in Japan.

Speaker Change: Where it has potential to receive conditional approval based on this one trial.

Speaker Change: Our biotherapeutic delivery partnering business.

Peter A. Altman: Our biotherapeutic delivery partnering business focuses on long-term partners, where BioCardia participates meaningfully in the value created. In March 2024, we announced a biotherapeutic delivery partnership with StemCardia to advance StemCardia's investigational pluripotent stem cell product candidate for the treatment of heart failure, initially through a Phase I-II clinical study. In May of 2024, biotherapeutic delivery partner CellProThera announced that they would have results this week at the European Society of Cardiology Heart Failure Meeting in Lisbon from their Phase I-II cell therapy study in post-myocardial infarction.

Speaker Change: This is on long term partnerships, where biochar to participate meaningfully in the value created.

stem cardiac: In March 2024, we announced the biotherapeutic delivery partnership with stem cardiac to advance them cardiac investigational pluripotent stem cell product candidate for the treatment of heart failure initially through a phase one two clinical study.

Pro Thera: In May of 2024, biotherapeutic delivery partner sell pro Thera announced that they would have results. This week at the European Society of Cardiology Heart failure meeting in Lisbon from their phase one to cell therapy study in post myocardial infarction.

I: Today, I am delighted to congratulate sell pro thera on the positive clinical results they have just announced.

Peter A. Altman: Today, I am delighted to congratulate Cellprothera on the positive clinical results they have just announced. In summary, with our three cardiovascular biotherapeutic clinical programs and our biotherapeutic delivery partner. We have multiple pathways to succeed as a business and provide significant shareholder returns on investment. We are aiming for approval of a first therapy based on our lead program in Japan as early as 2025, which could be followed in the USA soon thereafter. I will now pass the call to David McClung, our CFO, who will review our Q1 2024 financial results.

Pro Thera: Yeah.

Pro Thera: In summary.

Pro Thera: With our three cardiovascular biotherapeutic clinical programs.

unknown: And our biotherapeutic delivery partnering we have multiple pathways to succeed as a business and provide significant shareholder returns on investment.

Speaker Change: We are aiming for approval of our first therapy based on our lead program in Japan as early as 2025.

Speaker Change: Which could be followed in the USA soon thereafter.

Speaker Change: I will now pass the call to David Mcclung, Our CFO, who will review our Q1 2024 financial results.

Speaker Change: David.

David Mcclung: Thank you Peter and good afternoon, everyone.

David Mcclung: Thank you, Peter, and good afternoon, everyone. Revenue $55,000 for the three months ended March 2024, comparable to the $65,000 for the three months ended March 2023. Expenses quarter over quarter decreased by 35 percent, research and development expenses decreased to $1.2 million during the first quarter of 2024, compared to $2.4 million for the first quarter of 2023, primarily due to completion of enrollment in the CARDIAC heart failure trial in the fourth quarter of 2023, coupled with related reductions in clinical and supporting function expenses, selling general and administrative expenses decreased modestly to $1.1 million for the three months ended March 2024 from $1.2 million for the three months ended March 2023.

David Mcclung: Revenues $55000 for the three months ended March 2044 comparable to the $65000 for the three months ended March 2023.

David Mcclung: Expenses quarter over quarter decrease by 35%.

David Mcclung: Research and development expenses decreased to $1.2 million during the first quarter of 2024 compared to $2 $4 billion for the first quarter of 2023.

Speaker Change: Primarily due to completion of enrollment in the cardiac heart failure trial in the fourth quarter of 2023, coupled with related reductions in clinical and supporting function expenses.

Speaker Change: Selling general and administrative expenses decreased modestly to one $1 billion, who the three months ended March 'twenty 'twenty four from $1 $2 million for the three months ended March 2023.

Bio courteous: Bio courteous net loss decreased to $2.3 million for fourth quarter 2024 from $3 $5 million for the prior year's first quarter, primarily due to the reduction of expenses previously noted.

David Mcclung: BioCardia's net loss decreased to $2.3 million for the first quarter of 2024 from $3.5 million for the prior year's first quarter, primarily due to the reduction in expenses previously noted. We used $1.5 million in cash for operations in the first quarter of 2024. That compares to $2.6 million in the first quarter of 2023. While use of cash is expected to increase moderately as we advance our trials, our track record demonstrates BioCardia's ability to operate efficiently and accomplish goals in a very capital-efficient fashion. This concludes management's prepared comments. We're happy to take questions from attendees.

Bio courteous: We used $1.5 million in cash for operations in the first quarter of 2024 that compares to $2 $6 million in the first quarter of 2023.

Speaker Change: Well, we use of cash is expected to increase moderately.

Speaker Change: We advanced our trials, our track record demonstrates <unk> ability to operate efficiently.

Bush: Bush goals in a very capital efficient fashion.

Management: This concludes management's prepared comments, we were happy to take questions from attendees.

Speaker Change: We will now begin the question and answer session.

Operator: We will now begin the question and answer session. To ask a question, please press star and then one on your telephone keypad. If your question has been answered and you would like to withdraw your request, you may do so by pressing the pound key. If you are using a speaker, please use a microphone. And actually, I'm sorry, it's not the pound key, but it's star number two. Amish Raval, Carl Pepine, BioCardia Amish Raval, Carl Pepine, BioCardia Amish Raval, One moment, please, for the first question. The first question comes from Joe Pantginis with H.C. Wainwright, please go ahead.

Speaker Change: To ask a question. Please press Star then one on your telephone keypad.

Speaker Change: If your question has been answered and you would like to withdraw your request you may do so by pressing the pound key.

Speaker Change: If you are using a speaker.

Speaker Change: Hum.

Speaker 1: And actually I'm, sorry, it's not the pound key but its star two.

Speaker Change: Well withdraw your question and if youre using a speakerphone. Please pick up your handset before entering your request and speaking on the call.

Speaker Change: One moment please for the first question.

Speaker Change: Okay.

Speaker Change: The first question comes from Joe Pat Guinness with H C. Wainwright. Please go ahead.

Landon: Hi, everyone. This is landon on for Joe. Thanks for taking our question. So I wanted to ask about the card beyond CMI program should we expect additional patients to be added to the rolling Court if I'm not wrong. There's one patient that has not completed the six months follow up or do you think that the rolling data with <unk>.

Landeron: Hi, everyone. This is Landeron speaking for Joe.

Landeron: Thanks for taking our question. So I wanted to ask about the Cardium CMI program. Should we expect additional patients to be added to the rolling cohort? If I'm not wrong, there's one patient that has not completed the six-month follow-up, or do you think that the rolling data with four patients is enough to proceed to the randomized?

Joe: For patients who is enough to proceed to the randomized phase.

Landon: Okay.

Peter A. Altman: Thank you, Lenderon. I really appreciate the question.

Len: Thank you Len.

Lender: Lender on I really appreciate the question so for cardiac chronic myocardial ischemia and patients with refractory angina, you're correct that there is one other patient who has been consented that has not yet been treated and that patient is.

Peter A. Altman: So, for chronic myocardial ischemia and patients with refractory angina, you're correct that there is one other patient who has been consented that has not yet been treated, and that patient is moving through the pipeline. What we have done is we have stopped enrollment for additional patients. We feel very comfortable with enrolling in the randomized cohort ahead. The trial results in the first patients enrolled have been excellent, and so we will be taking steps to initiate the randomized phase of the trial ahead.

Len: Moving through the pipeline what we've done is we have stopped enrollment for additional patients we feel very comfortable.

Speaker Change: With enrolling in the randomized cohort ahead the trial results in the first patients enrolled have been.

Lender: Excellent and.

Speaker Change: And so we will be taking steps to initiate the randomized phase of the trial ahead on this as I've shared historically this is a pivotal trial.

Peter A. Altman: And this, as I've shared historically, this is a pivotal trial. This trial is intended to have an adaptive readout after 100 patients have been randomized. The follow-up endpoint is a shorter endpoint. It's a six-month follow-up. And I have to note that the safety data, which we've presented in our heart failure program, will also support and buttress this program because we have essentially the same therapy in another clinical indication that actually precedes ischemic heart failure.

Speaker Change: This trial is intended to have an adaptive readout. After 100 patients have been randomized the follow up endpoint is a shorter endpoints at six months follow up.

Speaker Change: And I have to note that the safety data, which we presented in our heart failure program will also support and buttress. This program because we have essentially the same therapy in another clinical indication that actually precedes ischemic heart failure. So so the.

Peter A. Altman: So the answer to your question is yes, there is one more patient. We don't know whether or not they will ultimately be part of the rolling cohort because there's a long process as these patients move through the trial, but we are going to honor that they've been enrolled, and we are very comfortable moving to the randomized controlled trial ahead.

Speaker Change: Answer to your question is yes, there is one more patient, we don't know whether or not that they will ultimately be part of the rolling cohort because there's a long process as these patients move through the trial.

Speaker Change: But we are going to honor that they've been enrolled and and we are very comfortable moving to the randomized.

Speaker Change: Controlled trial ahead.

Peter A. Altman: Okay, perfect. Thanks for clarifying. And for Cardi-AMP-HF in Japan, besides the final results from the original Cardi-AMP-HF program, are there any other discussion points that you think that are important that are still going on with the PMDA?

Speaker Change: Okay.

Speaker Change: Thanks for clarifying and Florida economy on page here.

Florida economy: In Japan. Besides stem final results from the original kind of beyond <unk> program is the window of the discussion points that you think that are important that are still going on.

Florida economy: We have the P M D.

Peter A. Altman: So, so, yes, so the status with PMDA is we last met with them in November. And in November, they made it clear to us that they would accept, what is foreign data for them, data from the United States in support of approval. They were very interested in seeing the data that we will have at the end of this year.

Speaker Change: So so yes, so the status with P. M D a.

Speaker Change: As we last met with them in November.

Speaker Change: In November they made it clear to us that they would accept.

Speaker Change: What what is foreign data for them data from the United States.

Speaker Change: In support of approval they were very interested in seeing the data that we will have at the end of this year.

Peter A. Altman: And, you know, because the trial is not yet completed, although, as I've noted in my comments, we have 90% of the follow-up data on these patients, so we don't expect any significant changes, but that said, we still need to complete the follow-up and the quality assessment of the data as it's been entered and prepare for that submission. So there will be further dialogue with PMDA ahead, following the normal course, and we feel pretty optimistic with respect to this submission.

Speaker Change: And you know because the trial is not yet completed although as I've noted in my comments, we have 90% of the follow up data on these patients. So we don't expect any.

Speaker Change: Significant changes, but that said, we still need to complete the follow up and the quality assessment of the data as it has been entered and prepare for that submission. So there will be other dialogue with.

Speaker Change: P. M. D ahead, following the normal course, and we feel pretty optimistic.

Speaker Change: With respect to this submission one nuance I'll share for folks is that they have approved cell therapy for heart failure in Japan based on seven patients treated there's another therapy, that's expected to apply for approval based on approximately 10 patients enrolled both of those therapies.

Peter A. Altman: One nuance I'll share for folks is that they have approved a cell therapy for heart failure in Japan based on seven patients treated. There's another therapy that's expected to apply for approval based on approximately 10 patients enrolled. Both of those therapies are therapies that have the potential to trigger arrhythmias and require surgical intervention to provide those therapies, none of which we have. We have so much more data than any of those other therapies that there is a good potential for them to approve this and ultimately result in head-to-head studies of the two in Japan. So yeah, we're pretty excited about taking this forward, and we're honored to be working with some of the great luminaries in Japan on these conversations that we're having.

Peter A. Altman: Perfect. That's helpful. Thank you very much. I appreciate the question. Thank you.

Speaker Change: Yes.

Speaker Change: Our therapies that have potential to trigger arrhythmias and require surgical intervention that provides us therapies, none of which we have we have so much more data than any of those other therapies that.

Speaker Change: That there is a good potential for them to approve this and ultimately result in head to head studies of therapies in Japan.

Speaker Change: So yes, we're pretty excited about taking this forward and we're honored to be working with some of the great luminaries in Japan.

Speaker Change: On these conversations that we're having.

Speaker Change: Perfect.

Speaker Change: So thank you very much.

Speaker Change: I appreciate the question. Thank you so much.

Peter A. Altman: I appreciate the question. Thank you so much.

Speaker Change: The next question comes from Brent Pearson.

Operator: The next question comes from Brent Pearson, as a private investor. Please go ahead.

Brent Pearson: As a private investor. Please go ahead.

Brent Pearson: Good afternoon, gentlemen, I wanted to wish you congratulations on both your partnership front in your trial front.

Brent Pearson: Good afternoon, gentlemen. I wanted to wish you congratulations on both your partnership front and your trial front. The first question I had today was around the results from cell protheras. Announcement today. It appears that they've announced some positive results from their Phase 1, 2B trial, and I seem to recall that there was potentially an ability with the EMA to apply for a conditional marketing authorisation based on this study. And I was wondering if you guys had any color. I know it's early and that this is pretty new information, but any expectation around an advancement of that conditional approval?

Brent Pearson: The first question I had today was around the results from Sulphur theater as well.

Brent Pearson: Announcement today, it appears that they've announced some positive results around there.

Speaker Change: Phase one to be trial.

Speaker Change: And I seem to recall that there was potentially an ability with the MAA to apply for a conditional marketing approval based on this study and I was wondering if you guys had color I know, it's I know it's early in that that this is this is pretty new information, but any expectation around and advancement.

Speaker Change:

Speaker Change: That conditional approval.

Speaker Change: So Brent I. Thank you for the question and.

Peter A. Altman: So, Brent, I thank you for the question. And one of the nuances of our biotherapeutic partnering is that we need to let our partners tell their stories. So there is potential in Europe for early access. That's something that Cellprothera, looking at their business and their clinical trial efforts ahead, will have to assess on their own. So we don't comment on that, but we are very encouraged by their results. We think what they have done with their therapy and their development strategy makes enormous sense.

Brent I.: One of the nuances of our biotherapeutic partnering is we need to let our partners tell their stories.

Brent I.: So there is potential in Europe for.

Brent I.: Early access that's something that sell through there are looking at their business and their clinical trial efforts ahead, we will have to assess on their own.

Speaker Change: So we don't comment on that but we were very encouraged by the results we think what they have done.

Speaker Change: With their therapy and their development strategy makes enormous sense and in our own data that we've published on we've shown that.

Peter A. Altman: And in our own data that we've published on, you know, we've shown that you can have approximately 18 times the efficiency of delivery of these types of cells when delivered intramyocardially. And so in their clinical indication, all of the past data has been done with an intracoronary artery infusion, which has a very low long-term retention of these types of cells.

Speaker Change: You can have approximately 18 times the efficiency of delivery.

Speaker Change: All of these types of cells when delivered inter myocardial <unk> and so in their clinical indication all of the past data has been done.

Speaker Change: With an intra coronary artery infusion, which has very low.

Speaker Change: Long term retention of these types of cells. So I think they've done a great job. They followed their phase one work they've got phase II data that they just presented today.

Brent Pearson: So I think they've done a great job. They followed their phase one work. They have phase two data that they've just presented today. And we're hopeful that the project and programs together will continue.

Speaker Change: And we're hopeful that the projected programs together will continue.

Speaker Change: Great I completely understand and I. Appreciate your response, there and my my follow up question was simply we we had heard that there were some potential developments on the on the partner for unexpected towards.

Peter A. Altman: Great. I completely understand, and I appreciate your response there. And my follow-up question was simply, we had heard that there were some potential developments on the partner front expected towards the end of Q2 and then potentially towards the end of 2024. I just wondered if there was any update on that front, and that'll be it for me. Thank you.

Speaker Change: The end of Q2, and then potentially towards the end of 'twenty 'twenty. Four just wondering if there was any update on that front and that'll be it for me. Thank you.

Peter A. Altman: No, these are great questions, Brent. So, in partnering, for the two partners we have, we are involved long-term, and we really transfer as much of our experience and knowledge to help them be successful. We typically attend every single procedure for a partner's clinical trials with very senior staff. And so there are, right now, quite a few folks developing different approaches for these significant unmet clinical needs that are earlier in their development efforts.

Speaker Change: These are great questions Brent so in partnering.

Speaker Change:

Speaker Change: So.

Brent: For the two partners. We have we are we are involved long term, we really transfer as much of our experience and knowledge to help them be successful. We typically attend every single procedure for our partners clinical trials with very senior staff.

Speaker Change #100: And so there are right now quite a few folks.

Speaker Change #102: Developing different approaches for these significant unmet clinical needs that are earlier in their development efforts many of them already have.

Peter A. Altman: Many of them already have excellent data with BioCardia, as you can see in our corporate slide deck. And so much of it depends on their initiative to take the next steps and go forward. There are also many folks who have data with us that aren't on that slide deck.

Speaker Change #100: Excellent data with Biochar tier as you can see in our corporate slide deck and so much of it depends on their initiative to take the next steps and go forward. There's also many folks who have data with us.

Speaker Change #100: That aren't on that slide deck.

Speaker Change #103: Where we're partnering with folks is non trivial and so we're coming in and we are we are a significant partner here and we are seeking value for our shareholders long term and.

Peter A. Altman: Partnering with folks is non-trivial, and so we're coming in, and we are a significant partner here. And we are seeking value for our shareholders long-term. Unknown Attendee, David McClung, Miranda Benvenuti, Amish Raval, Carl Pepine, BioCardia, What we view is the fundamental technology for the whole future of biotherapeutic intervention in the heart.

Speaker Change #100: We feel we've demonstrated the capabilities of.

Speaker Change #100: Our current delivery technologies, and if you look at our intellectual property estate we have.

unknown: What we view as the fundamental technology for the whole future of biotherapeutic intervention in the heart and so we're delighted to work with folks, but we have to be respectful of our shareholders. So I don't have any updates on business development discussions other than there are quite a few.

Peter A. Altman: And so we're delighted to work with folks, but we have to be respectful of our shareholders. So I don't have any updates on business development discussions other than there are quite a few groups out there who are going to need a delivery solution, and nobody else has a delivery solution that's in the clinic today, and nobody else has the level of experience we have in preclinical and clinical models for all of the clinical indications we've talked about today.

unknown: Groups out there who are going to need a delivery solution and.

Speaker Change #100: And nobody else has a delivery solution that's in the clinic today and.

Speaker Change #106: And nobody else has the level of experience we have.

Speaker Change #106: In preclinical and clinical models for all of the clinical indications we've talked about today. So we're hopeful that they will move forward. We do believe in our delivery programs and we do believe we're a good partner.

Peter A. Altman: So we're hopeful that they will move forward. We do believe in our delivery programs, and we do believe we're a good partner, but it's often hard for folks to tie their valuable assets to another company that's in the same space. So we'll see, each day brings new discussions, and so there are some that are at late stage discussions where term sheets have been exchanged, and there's been lots of conversations, and there's a lot of experience together. But getting to a final agreement does take time. I'm sorry for the long winded answer, Brent. It's just the nature of these things.

Speaker Change #104: But it's often hard for folks to to tie their valuable assets to a another company thats in the same space. So we'll see.

Speaker Change #105: Each day brings a new discussion and so there are some that are at late stage discussion where term sheets have been exchanged and there's been lots of conversations and there's a lot of experience together, but.

Speaker Change #107: Getting to a final agreement does take time and I'm sorry for the long winded answer Brent. It's just it's the nature of these things.

Brent Pearson: I completely understand, and again, it looks like there's a lot of positive developments out there, and I just wanted to wish my congratulations and thank you for taking my question. I appreciate it, Brent. Thank you so much.

Speaker Change #107: Completely understand and again.

Speaker Change #105: It looks like there's a lot of positive developments out there and I just wanted to wish my congratulations and thank you for taking my questions.

Speaker Change #111: I appreciate it Brent thank you so much.

Speaker Change #105: Yeah.

Operator: Next in the queue is... George Will, a private investor. Please go ahead.

Speaker Change #105: Next in the queue is.

George Bush: George will a private investor. Please go ahead.

George Bush: Hello, Good afternoon, and thank you for taking my call. Peter can you provide a little I guess some commentary.

George Will: Hello, good afternoon. Thank you for taking my call. Peter, can you provide a little, I guess, some commentary on The BioCardiaCardiaM, Unknown Attendee, David McClung, Miranda Benvenuti, Amish Raval, Carl Pepine, BioCardia To move forward on BioCardiaZone, would you look to partner with a larger firm? What would be the strategy there?

George Bush: If.

George: And Biochar D a cardiac.

Peter: Treatment moves forward and let's say you are due to receive approval in Japan, what would be the strategy there for commercializing that there is it.

Peter: To move forward on bio Cardio zone would you look to partner with a larger firm what would be the strategy. There if anything that you could share or that's a day.

Peter: Stay tuned.

Peter: Item.

Peter A. Altman: George, it's a great question, and I'll share how we think about things. So right now, we've learned an enormous amount about the Japanese market and have been delighted to interact with some fabulous physician luminaries in Japan. And so we've built a large number of relationships. Our first choice is to do a relationship where we have a partner that distributes Cardi-Amp for the heart failure indication but also for the chronic myocardial ischemia indication in the future.

Peter: George It's a great question and I'll share, how we think about things so right now.

Peter: We've learned an enormous amount.

George: About the Japanese market and have been delighted with interacting with some fabulous physician luminaries in Japan.

George: And so we've built up a large number of relationships our first choice.

Speaker Change #117: Is to do.

George: Okay.

Speaker Change #113: A relationship where we have a partner that distributes cardiac for the heart failure indication, but also for the chronic myocardial ischemia indication in the future.

Speaker Change #113: And the reason for that is that they have experience in Japan with all of the nuances that we have not yet confronted.

Peter A. Altman: And the reason for that is, you know, that they have experience in Japan with all of the nuances that we have not yet encountered. Even as we're working on the approval process, we've had a number of active conversations with a number of entities about, you know, getting involved in the study. And they're very interested in commenting, and they know the very distinguished advisors that we have in Japan. But at the same time, they haven't yet stepped forward.

Speaker Change #112: Even as we're working on the approval process, we've had a number of active conversations with a number of entities on.

Speaker Change #123: Getting involved in the study and then they they they are very interested in in commenting and they know they're very distinguished advisers that we have in Japan.

Speaker Change #114: But at the same time, they haven't yet stepped forward and part of the reason for that is.

Peter A. Altman: And part of the reason for that is, you know, this is a significant deal. This is a significant value proposition. So, we are requesting that they have some significant skin in the game in order to be our partner and commit to carrying Cardi-Amp forward. That said, Cardi-Amp is actually quite remarkable as far as a new therapy goes. There are roughly a million patients in Japan with heart failure who could potentially benefit from cardiac cell therapy.

Speaker Change #114: This is a significant deal this is a significant value proposition.

Speaker Change #116: So we are requesting that they have some significant skin in the game in order to be our partner and commit to.

Speaker Change #112: Carrying cardiac forward.

Speaker Change #126: That said.

Speaker Change #119: Party Amp is actually quite remarkable as far as a new therapy.

Speaker Change #122: Roughly 1 million patients in Japan, with heart failure, who could potentially benefit from cardiac cell therapy.

Peter A. Altman: Reimbursement in the United States is a touch point for the Japanese reimbursement. But I note that the other cardiac cell therapy that's approved in Japan has an enormous price tag on it of around $124,000 US for each treatment. I don't expect, and we're not pursuing, that level of reimbursement, but even on what we have in the United States, there is potentially a very significant margin. This is the type of therapy on which we could build a subsidiary that's profitable in Japan in short order. That said, our first choice is to have a partner step up, put some skin in the game, and really be involved in CARDI-AMP as it's being advanced for both of the two reclinical indications.

Speaker Change #124: Our reimbursement in the United States as a touch point.

Speaker Change #115: For the Japanese reimbursement, but I note that the other.

Speaker Change #120: Cardiac cell therapy, that's approved in Japan has an enormous price tag on it of around $124000 in U S for each treatment.

Speaker Change #120: I don't expect and we're not pursuing that level of reimbursement.

Speaker Change #118: But even on what we have in the United States. There is potentially a very significant margins.

Speaker Change #125: This is the type of therapy on which we could build.

Speaker Change #125: Our subsidiary that's profitable in Japan.

Speaker Change #125: In short order.

Speaker Change #127: That said our first choice is to have a partner step up put some skin in the game and and really be involved in cardiac <unk> as its advancing for both of the two lead clinical indications we have.

Speaker Change #125: Yeah.

Speaker Change #127: That's great. Thanks, so much.

Peter A. Altman: That's great. Thanks so much. That was all I had.

Speaker Change #131: No problem.

George Will: No problem. Get it, and you will have a great day. Thank you, George. You have a fabulous afternoon.

Speaker Change #125: Good day.

Speaker Change #125: Thank you George you have a fabulous afternoon.

Speaker Change #125: Okay.

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

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

Debbie: Thank you kindly Debbie.

Peter A. Altman: Thank you kindly, Debbie. Our therapeutic candidates and technologies have the significant potential to help millions of patients with heart disease. We now have five cardiac biotherapeutic programs in development, including our biotherapeutic delivery partner. Each of these programs has the potential to provide meaningful returns for our investors. I thank all of you for participating in today's call, for your interest in BioCardia, and for the support you provide for our primary mission, to develop and enhance therapies to treat heart disease.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Speaker Change #130: Our therapeutic candidates and technologies have significant potential to help millions of patients with heart disease.

Peter: We now have five cardiac biotherapeutic programs in development, including our biotherapeutic delivery partner.

Peter: Each of these programs has the potential to provide meaningful returns for our investors.

Speaker Change #121: I think all of you for participating in today's call for your interest in Biochar to you and support you provide for our primary mission.

Speaker Change #121: To develop and enhance therapies to treat heart disease.

Speaker Change #121: Have a great afternoon.

Speaker Change #121: Yeah.

Speaker Change #129: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.