Q2 2024 BioCardia Inc Earnings Call

Speaker Change: Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia second quarter 2024 financial results and business update conference call.

Operator: Good afternoon, and welcome to the BioCardia Second Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode.

Unknown Attendee: Good afternoon and welcome to the BioCardia second 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.

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

Operator: 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 1 on your telephone keypad.

Speaker Change: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Unknown Attendee: 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. To withdraw your question, please press star, then two.

Speaker Change: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2.

Unknown Attendee: 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.

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.

Speaker Change: A webcast replay of the call will be available approximately one hour after the end of the call.

Miranda Peito: I would now like to turn the call over to Miranda Peito of BioCardia investor relations. Please go ahead, Miranda.

Operator: To withdraw your question, please press star then 2. 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 Paito of BioCardia Investor Relations. Please go ahead, Miranda.

Speaker Change: I would now like to turn the call over to Miranda Paito of Biocardia Investor Relations. Please go ahead, Miranda.

Miranda Peito: Thank you. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, Ph.D., president and chief executive officer and David McClung, the company chief financial officer.

Miranda Paito: Thank you. 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 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. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those expressed.

Speaker Change: Thank you. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are

Speaker Change: PhD, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer.

Miranda Peito: During this call, management will be making forward-looking statements, including statements that address BioCardia's expectations for future performance and operational results, references to management intentions, beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. Overlooking statements involve risks and other factors that may cause actual results to differ materially from those statements.

Speaker Change: During this call...

Speaker Change: Management will be making forward-looking statements, including statements that address biocardi's expectations for future performance and operational results, references to management's intentions, beliefs, projections, outlook, analyses, and current expectations.

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

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

Miranda Peito: 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, and subsequently filed Form 10-Qs.

Speaker Change: For more information about these risks, please refer to the risk factors and cautionary statements described in biocardi's report on form 10K, filed with the SEC March 27, 2024.

Miranda Peito: The content of this call contains time-sensitive information that is only accurate as of today, August 13, 2024.

Speaker Change: and in subsequently filed Form 10-Q. The content of this call contains time-sensitive information that is only accurate as of today, August 13th, 2024.

Miranda Peito: 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.

Speaker Change: 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.

Peter Altman: It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's president and CEO. Peter, please go ahead. Thank you, Miranda, and good afternoon to everyone on the call. This has been a tough quarter for our share price, even as we continue to deliver the milestones that underlie our business, with signs of both safety and patient benefits from each of our efforts. Our lead autologous cell therapy for the treatment of heart failure is being studied today in two clinical trials. The Cardiamp Heart Failure One trial expects last patient follow-up at the end of September this year.

Miranda Paito: 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, and in subsequently filed Form 10-Q. The content of this call contains time-sensitive information that is only accurate as of today, August 13, 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 is now my pleasure to turn the call over to Dr. Peter Altman, BioCardi's President and CEO. Peter, please go ahead.

Peter Altman: Thank you, Miranda, and good afternoon to everyone on the call. This has been a tough quarter for our share price, even as we continue to deliver the milestones that underlie our strategy, with signs of both safety and patient benefit from each of our efforts. Our lead autologous cell therapy for the treatment of heart failure is being studied today in two clinical trials. The CARDI-AMP Heart Failure I trial expects to finish patient follow-up at the end of September this year.

Speaker Change: Thank you, Miranda, and good afternoon to everyone on the call.

Speaker Change: This has been a tough quarter for our share price.

Speaker Change: even as we continue to deliver the milestones that underlie our business with signs of both safety and patient benefit from each of our efforts.

Speaker Change: Our lead autologous cell therapy for the treatment of heart failure is being studied today in two clinical trials.

Speaker Change: The CARDI-AMP Heart Failure I trial expects last patient follow-up at the end of September this year.

Peter Altman: We are hopeful that the monitor data on all patients will reflect the same results that we have seen with 90% of the patient follow-up data obtained in the interim review last year. Last year. Across all patients enrolled, this data showed trends in treated patients having improved survival, reduced major adverse cardiac events, and improved quality of life. Cardiac heart failure, one trial, is enormously important, particularly if these interim results are in line with the final results. The fully enrolled study is one of the largest cardiac cell therapy studies performed for the treatment of heart failure in the United States, with clinical results showing patient benefits that are meaningful for both patients and the physicians who care for them.

Peter Altman: We are hopeful that the monitored data on all patients will reflect the same results that we have seen with 90% of the patient follow-up data obtained in the interim review last year across all patients enrolled. This data showed trends in treated patients having improved survival, reduced major adverse cardiac events, and improved quality of life. The Cardiac Heart Failure 1 trial is enormously important, particularly if these interim results are in line with the final results.

Speaker Change: We are hopeful that the monitored data on all patients will reflect the same results that we have seen with 90% of the patient follow-up data obtained in the interim review last year.

Speaker Change: patients enrolled. This data showed trends in treated patients having improved survival,

Speaker Change: reduced major adverse cardiac events and improved quality of life.

Speaker Change: The cardiac heart failure one trial is enormously important, particularly if these interim results are in line with the final results.

Peter Altman: The fully enrolled study is one of the largest cardiac cell therapy studies performed for the treatment of heart failure in the United States, with clinical results showing patient benefits that are meaningful for both patients and the physicians who care for them. Our team has been working to monitor sites and be prepared to lock the data for final readout.

Speaker Change: The fully enrolled study is one of the largest cardiac cell therapy studies performed for the treatment of heart failure in the United States with clinical results showing patient benefits that are meaningful for both patients and the physicians who care for them.

Peter Altman: Our team has been working to monitor sites and be prepared to lock the data for final readout this year. The data from this trial is intended to provide support for future product approvals and commercialization of the cardiac cell therapy in Japan and the United States. As we seek to complete cardiac heart failure one, and confirm the final results are as good as we believe them to be, we are advancing a second confirmatory clinical trial in cardiac heart failure two, which focuses on the remarkable benefits and patients treated with elevated NT-ProBMP, a well-established biomarker of an active heart failure.

Speaker Change: Our team has been working to monitor sites and be prepared to lock the data for final readout this year.

Peter Altman: The data from this trial is intended to provide support for future product approvals and commercialization of the Cardi-M cell therapy in Japan and the United States. As we seek to complete CARDI-AMP Heart Failure 1 and confirm whether the final results are as good as we believe them to be. We are advancing a second confirmatory clinical trial in CARDI-AMP Heart Failure II that focuses on the remarkable benefits in patients treated with elevated NT-PRO-BNP, a well-established biomarker of an active heart.

Speaker Change: The data from this trial is intended to provide support for future product approvals and commercialization of the Cardi-M cell therapy in Japan and the United States.

Speaker Change: As we seek to complete CARDI-AMP Heart Failure 1 and confirm the final results are as good as we believe them to be.

Speaker Change: We are advancing a second confirmatory clinical trial in CARDI-AMP Heart Failure II, which focuses on the remarkable benefits in patients treated with elevated NT-PRO-BNP, a well-established biomarker of active heart failure.

Peter Altman: Results in these patients presented at the Technology and Heart Failure Therapeutics Conference in March 2024 showed a remarkable 86% relative risk reduction in heart death equivalence, and a 24% relative risk reduction in non-fatal major adverse cardiac and cerebral vascular events. 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% over a five-year period. The cardiac heart failure two trial is the only confirmatory pivotal trial of a cell therapy in heart failure that has ever been initiated.

Peter Altman: Results in these patients presented at the Technology and Heart Failure Therapeutics Conference in March 2024 showed 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. This is particularly exciting as therapies that are available today do not have a significant impact on mortality, and unfortunately, mortality for these patients is still approximately 50% over a five-year period. The Cardiac Heart Failure II trial is the only confirmatory pivotal trial of a cell therapy in heart failure that has ever been initiated.

Speaker Change: Results in these patients presented at Technology and Heart Failure Therapeutics Conference in March 2024 showed a remarkable 86% relative risk reduction in heart death equivalents

Speaker Change: and a 24% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events.

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

Speaker Change: And unfortunately, mortality for these patients

Speaker Change: is still approximately 50% over a five year period.

Speaker Change: The Cardiac Heart Failure 2 trial is the only confirmatory pivotal trial of a cell therapy and heart failure that has ever been initiated.

Peter Altman: It has a greater than 90% power for statistical probability of success to meet the primary end point based on the cardiac heart failure trial in term results. The world-class cardiologists on the cardiac heart failure one executive steering committee on the data safety monitoring board and on the clinical events committee are all continuing with us to support the cardiac heart failure two trial. Two additional world-class heart failure clinicians have also joined our executive steering committee. The first is Dr. Wilson Tang, cardiac heart failure one trial investigator, professor and medicine at the Cleveland Clinic, Learner College of Medicine, and research director of heart failure and transplant in the Department of Cardiovascular Medicine.

Peter Altman: It has a greater than 90% power for statistical probability of success to meet the primary endpoint based on the cardiac heart failure trial interim results. The world-class cardiologist, on the Cardiac Heart Failure One Executive Steering Committee, on the data safety monitoring, and on the clinical events, are all continuing with us to support the CARDI-AMP Heart Failure II trial. Two additional world-class heart failure clinicians have also joined our executive steering committee.

Speaker Change: It has a greater than 90% power for statistical probability of success to meet the primary endpoint based on the CARDI-AMP heart failure trial interim results.

Speaker Change: the world-class cardiologists.

Speaker Change: on the Cardiac Heart Failure-1 Executive Steering Committee.

Speaker Change: on the Data Safety Monitoring Board.

Speaker Change: and on the Clinical Events Committee.

Speaker Change: are all continuing with us to support the CARDI-MPART Failure II trial.

Speaker Change: Two additional world-class heart failure clinicians have also joined our executive steering committee.

Peter Altman: The first is Dr. Wilson Tang, Cardiac Heart Failure I Trial Investigator, Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, and Research Director of Heart Failure and Transplant in the Department of Cardiovascular Medicine. The second is Dr. Leslie Miller, cardiac heart failure one trial investor, at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida, and a former president of the International Society of Heart and Lung Transplantation.

Speaker Change: The first is Dr. Wilson Tang, Cardiac Heart Failure I Trial Investigator.

Wilson Tang: Professor of Medicine at the Cleveland Clinic, Lerner College of Medicine, and Research Director of Heart Failure and Transplant in the Department of Cardiovascular Medicine.

Peter Altman: The second is Dr. Leslie Miller, cardiac heart failure one trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida. And a former president of the International Society of Heart and Lung Transplantation. Dr. Miller's site is the first site activated in the CardiAMP Heart Failure 2 study, and this reported that five patients have already been consented for the trial by his clinical research team. Combined, these 12 world-class cardiologists, all of whom have seen our data and have worked with us on Cardiamp Heart Failure 1, are supporting the Cardiamp Heart Failure 2 study.

Speaker Change: The second is Dr. Leslie Miller, cardiac heart failure one trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida and a former president of the International Society of Heart and Lung Transplantation.

Peter Altman: Dr. Miller's site is the first site activated in the CARDI-AMP Heart Failure 2 study, and it is reported that five patients have already been consented for the trial by his clinical researchers. Combined, these 12 world-class cardiologists, all of whom have seen our data and have worked with us on Cardiac Heart Failure 1, are supporting the Cardiac Heart Failure 2 study. We are more than thankful for each of their involvement, extensive experience, valuable advice, and ongoing support.

Speaker Change: Dr. Miller's site is the first site activated in the cardiac heart failure 2 study and it is reported that five patients have already been consented for the trial by his clinical research team.

Speaker Change: combined these 12 world-class cardiologists, all of whom have seen our data and have worked with us on cardiac heart failure 1, are supporting the cardiac heart failure 2 study.

Peter Altman: We are more than thankful for each of their involvement, extensive experience, valuable advice, and ongoing support. BioCardia intends to become an enrolling machine in the CardiAMP Heart Failure 2 clinical trial. Enrollment is expected to be significantly enhanced because of the positive data and experience from the CardiAMP Heart Failure 1 trial, which we feel is compelling for heart failure physicians and their patients. Enrollment will be further enhanced by efforts we have taken to streamline the clinical study and by the enormous experience in the broader CardiAMP clinical team.

Speaker Change: We are more than thankful for each of their involvement, extensive experience, valuable advice, and ongoing support.

Peter Altman: BioCardia intends to become an enrolling machine in the cardiac heart failure 2 clinical trial. Enrollment is expected to be significantly enhanced because of the positive data and experience from the CARDIAC Heart Failure I trial, which we feel is compelling for heart failure physicians and their patients. Enrollment will be further enhanced by efforts we have taken to streamline the clinical study and by the enormous experience in the broader Cardi-Am clinical team. There are other advances in cardiac autologous cell therapy that we hope to be able to announce soon, expected to further enhance enrollment in the CARDI-AMP Heart Failure II trial over that which was possible in CARDI-AMP Heart Failure I.

Speaker Change: Bioparty intends to become an enrolling machine in the cardiac heart failure II clinical trial.

Speaker Change: Enrollment is expected to be significantly enhanced because of the positive data and experience from the CARDIAC Heart Failure 1 trial, which we feel is compelling for heart failure physicians and their patients.

Speaker Change: Enrollment will be further enhanced by efforts we have taken to streamline the clinical study and by the enormous experience in the broader Cardi-Am clinical team.

Peter Altman: There are other advances to the Cardiamp Autologous Self Therapy that we hope to be able to announce soon, expected to further enhance enrollment in the Cardiamp Heart Failure 2 trial over that which was possible in Cardiamp Heart Failure 1. Beyond our lead Autologous Self Therapy Program in Heart Failure, we have also made progress this quarter in other programs. In April, open label clinical results from Cardiamp Self Therapy and Chronic Myocardial Schemia were shared with greater benefits than other established therapies. We discussed this data in our last quarterly call, and the last role in cohort patient is now scheduled for treatment later this month.

Speaker Change: There are other advances to the cardiac autologous cell therapy that we hope to be able to announce soon Expected to further enhance enrollment in the cardiac heart failure to trial over that which was possible in cardiac heart failure one

Peter Altman: Beyond our lead autologous cell therapy program and heart failure, we have also made progress this quarter in other programs. In April, open-label clinical results from cardiac cell therapy and chronic myocardial ischemia were shared, with greater benefits than other established therapies.

Speaker Change: Beyond our lead autologous cell therapy program in heart failure, we have also made progress this quarter in other programs.

Speaker Change: In April, open-label clinical results from cardiac cell therapy and chronic myocardial ischemia were shared, with greater benefits than other established therapies.

Peter Altman: We discussed this data in our last quarterly call, and the last rolling cohort patient is now scheduled for treatment later this month. In May, our partner CellProThera announced the results of their cell therapy in the indication of acute myocardial infarction. We discussed this result in our last quarterly call and are excited about salprothera and, These three programs and three distinct clinical indications of heart failure, chronic myocardial ischemia, and acute myocardial infarction demonstrate the broad utility and performance of BioCardia's helix delivery system for the delivery of biologics locally to the heart. One element of the helix delivery system is our morphed DNA steerable introducer

Speaker Change: We discussed this data in our last quarterly call and the last rolling cohort patient is now scheduled for treatment later this month.

Peter Altman: In May, our partner Cell Prosthera announced the results of their cell therapy in the indication of acute myocardial infarction. We discussed this result in our last quarterly call and are excited for Cell Prosthera and their data. These three programs and three distinct clinical indications of heart failure, chronic myocardial ischemia, and acute myocardial infarction demonstrate the broad utility and performance of Biocardia's Helix delivery system for the delivery of biologics locally to heart tissue. One element of the Helix delivery system is our morph DNA steerable introducer. This morph DNA product design has performed well for our procedures and has potential to enhance many other clinical procedures as a commercial product with a broader product family configuration.

CellProThera: In May, our partner CellProThera announced the results of their cell therapy in the indication of acute myocardial infarction.

CellProThera: We discussed this result in our last quarterly call and are excited for CellProThera and their data.

CellProThera: These three programs and three distinct clinical indications of heart failure, chronic myocardial ischemia, and acute myocardial infarction demonstrate the broad utility and performance of BioCardio's Helix delivery system for the delivery of biologics locally to heart tissue.

Speaker Change: One element of the Helix Delivery System is our Morph DNA Steerable Introducer.

Peter Altman: This MorphDNA product design has performed well for our procedures and has potential to enhance many other clinical procedures as a commercial product with a broader product family configuration. In late July, we announced that we had completed an FDA submission for market clearance for a broader product family of morphed DNA steerable introducers. We are hopeful for market clearance at the end of this quarter. On the business development front, we have active partnering discussions with the potential to be meaningful for our business with respect to all four of our platforms. Cardiamp, Cardiallo, Helix, and more.

CellProThera: This MorphDNA product design has performed well for our procedure.

CellProThera: is a commercial provider.

Peter Altman: In late July, we announced that we had completed an FDA submission for market clearance for a broader product family of morph DNA steerable introducers. We are hopeful for market clearance at the end of this quarter.

CellProThera: In late July, we announced that we had completed an FDA submission for market clearance for a broader product family of morphed DNA steerable introducers.

CellProThera: We are hopeful for market clearance at the end of this quarter.

Peter Altman: On the business development front, we have active partnering discussions with potential to be meaningful for our business with respect to all four of our platforms: Cardiamp, Cardialo, Helix, and Morph. For Cardiamp, our autologous self-therapy platform, the focus has been on discussions with potential distributors, even as the therapy is not yet approved. Receiving approval in a first-world country, such as the USA or Japan, is also expected to enable distribution partnerships to be realized in other regions of the world. We have had a number of discussions this quarter around distribution partnerships in Japan, Brazil, and the United Arab Emirates.

CellProThera: On the business development front, we have active partnering discussions with potential to be meaningful for our business with respect to all four of our platforms.

CellProThera: Cardiamp, Cardiallo, Helix, and Morph.

Peter Altman: ProCardiamp, our autologous cell therapy platform. The focus has been on discussions with potential distributors, even as the therapy is not yet approved in a first world country such as the USA or Japan. Receiving approval in a first world country such as the USA or Japan is also expected to enable distribution partnerships to be realized in other regions of the world.

CellProThera: For Cardi-Amp, our autologous self-therapy platform, the focus has been on discussions with potential distributors even as the therapy is not yet approved.

CellProThera: Receiving approval in a first world country such as USA or Japan is also expected to enable distribution partnerships to be realized in other regions of the world.

Peter Altman: We have had a number of discussions this quarter around distribution partnerships in Japan, Brazil, and the United Arab Emirates. There is potential to enter into such distribution arrangements in advance of approval, as this has the advantage for potential partners in that they can bring their experience to the table in positioning the therapeutic offering in their country of focus with respect to the physician community and payers. For example, Cardi-Alo, our allogeneic cell therapy currently in the clinic for heart failure.

Unknown Attendee: Good afternoon and welcome to the BioCardia Second 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.

CellProThera: We have had a number of discussions this quarter around distribution partnerships in Japan, Brazil, and the United Arab Emirates.

Peter Altman: There is potential to enter into such distribution arrangements in advance of approval, as this has the advantage for potential partners and that they can bring their experience to the table and positioning the therapeutic offering in their country of focus with respect to the physician community and payers. For Cardi Allo, our allogeneic South Therapy currently in the clinic for heart failure, we have extensive clinical experience from three trials. We have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease, with one ongoing discussion this past month. For our Helix Biotherapeutic Delivery Platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products, and support capabilities remain active in discussions.

Speaker Change: There is potential to enter into such distribution arrangements in advance of approval as this has the advantage for potential partners and that they can bring their experience to the table and positioning the therapeutic offering in their country of focus with respect to the physician community and payers.

Unknown Attendee: 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. To withdraw your question, please press star then two.

Speaker Change: For CARDI-ALLO, our allogeneic cell therapy, currently in the clinic for heart failure, we have extensive clinical experience from three trials.

Unknown Attendee: 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.

Peter Altman: We have extensive clinical experience from three trials. We have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary, with one ongoing discussion this past summer. For our Helix Biotherapeutic Delivery Platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products, and support capabilities remain active in discussions. Current partners realize that minimally invasive delivery not only enhances future commercialization, but it is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their own therapeutic development.

Speaker Change: We have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease.

Miranda Peito: I would now like to turn the call over to Miranda Peito of BioCardia Investor Relations. Please go ahead, Miranda.

Speaker Change: with one ongoing discussion this past month.

Peter Altman: Lastly, partner therapeutics are expected to benefit enormously from our threefold efficiency of delivery and enhanced pharmacokinetics with our Helix system, supported by data from many. We believe this advantage is due to the stability of the helix. We encourage all partners to perform pharmacokinetic studies, including a surgical delivery control, so that they will have their own data supporting what we have seen.

Speaker Change: for our Helix Biotherapeutic Delivery Platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience.

Miranda Peito: Thank you. Good afternoon and thank you for participating in today's conference call.

Paul Austin: and Paul Austin.

Miranda Peito: Joining me from BioCardia's leadership team are Peter Altman, Ph. D., President and Chief Executive Officer and David McClung, the Company Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address BioCardia's expectations for future performance and operational results, references to management intentions, beliefs, projections, outlook, analyses and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies and obtaining regulatory approvals. Overlooking statements involve risks and other factors that may cause actual results to differ materially from those statements.

Peter Altman: Current partners realize that minimally invasive delivery not only enhances future commercialization, but is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their own therapeutic development. Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery and the enhanced pharmacokinetics with our Helix system, supported by data from many groups. We believe this advantage is due to the stability of the Helix in the beating heart and the self-sealing helical pathway into the tissue. We encourage all partners to perform pharmacokinetic studies, including a surgical delivery control, so that they will have their own data supporting what we have seen.

Paul Austin: current partners realize that minimally invasive delivery not only enhances future commercialization

Speaker Change: but it is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their own therapeutic development.

Speaker Change: Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery and enhanced pharmacokinetics with our Helix system supported by data from many groups.

Speaker Change: We believe this advantage is due to the stability of the helix in the beating heart and the self-sealing helical pathway into the tissue.

Speaker Change: We encourage all partners to perform pharmacokinetic studies, including a surgical delivery control, so that they will have their own data supporting what we have seen.

Miranda Peito: For more information about these risks, please refer to the risk factors and cautionary statements, described in BioCardia's report on Form 10K, filed with the SEC March 27, 2024, and subsequently filed Form 10Qs. The content of this call contains time-sensitive information that is only accurate as of today, August 13, 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.

Peter Altman: Today, we have participated in more than 20 development programs in partnerships with almost every well-known program, some of which are identified in our corporate presentation.

Peter Altman: Today, we have participated in more than 20 development programs and partners, with almost every well-known program, some of which are identified in our corporate presentation. We are now evolving our business approaches with a higher bar for our involvement in therapeutic development, focusing on true partnerships meaningful for our shareholders. This will take time to evolve, but as our experience and products advance, and the field as a whole advances, we do expect to enter into meaningful relationships with other therapeutic partners.

Speaker Change: To date, we have participated in more than 20 development programs and partnerships.

Speaker Change: with almost every well-known program, some of which are identified in our corporate presentation.

Peter Altman: We are now evolving our business approaches with a higher bar for our involvement in therapeutic development, focusing on true partnerships meaningful for our shareholders. This will take time to evolve, but as our experience and products advance in the field, as a whole advances, we do expect to enter into meaningful relationships with other therapeutic partners. Five biotherapeutic delivery partnership discussions have been ongoing throughout this quarter, and all but one of these are previous customers who have positive data with our biotherapeutic delivery team and system. On the more front, the recent FDA submission for clearance is a first step towards revenue generation from these clinical products, which also enhance partnering interests.

Speaker Change: We are now evolving our business approaches with a higher bar for our involvement in therapeutic development, focusing on true partnerships meaningful for our shareholders.

Speaker Change: This will take time to evolve, but as our experience and products advance and the field as a whole advances, we do expect to enter into meaningful relationships with other therapeutic partners.

Peter Altman: It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead. Thank you, Miranda, and good afternoon to everyone on the call. This has been a tough quarter for our share price, even as we continue to deliver the milestones that underlie our business, with signs of both safety and patient benefits from each of our efforts. Our lead autologous cell therapy for the treatment of heart failure is being studied today in two clinical trials.

Peter Altman: Five biotherapeutic delivery partnership discussions have been ongoing throughout this quarter, and all but one of these are previous customers who have positive data with our biotherapeutic delivery team and system. On another front, the recent FDA submission for clearance is a first step towards revenue generation from these clinical products, which also enhances partnering. We expect to have labeling that is appropriate for interventional cardiology, form our helix procedures, but also cardiac electrophysiologists, interventional radiologists, and vascular surgeons, all of which may benefit from our Morph DNA Steerable Introducer platform. We have had a few discussions here on selling off these products, and extensive bench test data from multiple large firms has been generated that has been shared with

Speaker Change: Five biotherapeutic delivery partnership discussions have been ongoing throughout this quarter, and all but one of these are previous customers who have positive data with our biotherapeutic delivery team and system.

Speaker Change: On the more front, the recent FDA submission for clearance is a first step towards revenue generation from these clinical products, which also enhance partnering interests.

Peter Altman: We expect to have labeling that is appropriate for interventional cardiology. who perform our Helix procedures, but also cardiac electrophysiologists, interventional radiologists, and vascular surgeons, all of which may benefit from our morph DNA steerable introducer platform. We have had a few discussions here on selling off these products. An extensive bench test data for multiple large firms has been generated that has been shared with us.

Speaker Change: We expect to have labeling that is appropriate for interventional cardiologists.

Speaker Change: who perform our helix procedures.

Peter Altman: The Cardiamp Heart Failure One trial expects last patient follow-up at the end of September this year. We are hopeful that the monitor data on all patients will reflect the same results that we have seen with 90% of the patient follow-up data obtained in the interim review last year. Last year. Across all patients enrolled, this data showed trends in treated patients having improved survival, reduced major adverse cardiac events, and improved quality of life.

Speaker Change: but also cardiac electrophysiologists, interventional radiologists, and vascular surgeons, all of which may benefit from our Morph DNA Steerable Introducer platform.

Speaker Change: We have had a few discussions here on selling off these products and extensive bench test data from multiple large firms has been generated that has been shared with us.

Peter Altman: It is my expectation that in the coming months, the decline in BioCardia share price will reverse as investors and partners better understand what we are accomplishing in our business, in our own therapeutic programs, in our biotherapeutic delivery partnering and licensing, and anticipated new FDA cleared morph product family.

Peter Altman: It is my expectation that in the coming months, the decline in BioCardia's share price will reverse as investors and partners better understand what we are accomplishing in our business, in our own therapeutic programs, in our biotherapeutic delivery partnering and licensing, and anticipated new FDA-cleared morph product by the end of the current quarter. We intend to deliver on the following objectives. One, become compliant with NASDAQ listing requirements, and complete the last patient visit for the cardiac heart failure one.

Speaker Change: It is my expectation that in the coming months the decline in biocardia share price will reverse as investors and partners better understand what we are accomplishing in our business.

Peter Altman: Cardiac heart failure, one trial, is enormously important, particularly if these interim results are in line with the final results. The fully enrolled study is one of the largest cardiac cell therapy studies performed for the treatment of heart failure in the United States, with clinical results showing patient benefits that are meaningful for both patients and the physicians who care for them. Our team has been working to monitor sites and be prepared to lock the data for final readout this year.

Speaker Change: and our own therapeutic programs in our biotherapeutic delivery partnering and licensing.

Peter Altman: By the end of the current quarter, we intend to deliver on the following objectives: one, become compliant with NASDAQ listing requirements; two, complete the last patient visit for the Cardiant Parts Failure One trial; three, submit Cardiant Part Failure for a general consultation with Japan PMDA in preparation for a future clinical consultation; four, treat the first patients in Cardiant Part Failure Two trial, and begin demonstrating that we can enroll this trial quickly with our world-class clinical partners; five, dose the last roll-in cohort patient for the Cardiant Chronic Myocardial Schemia trial; and six, receive FDA clearance for the morph DNA product family.

Speaker Change: and anticipated new FDA-cleared morph product family.

Speaker Change: by the end of the current quarter.

Speaker Change: We intend to deliver on the following objectives.

Speaker Change: One, become compliant with NASDAQ listing requirements.

Speaker Change: Two, complete the last patient visit for the CARDI-AMP Heart Failure I trial.

Peter Altman: Submit cardiac heart failure for a general consultation with Japan PMDA in preparation for a future clinical consultation. Treat the first patients in the CARDIAC HEART FAILURE II trial and begin demonstrating that we can enroll this trial quickly with our world-class clinical partners. 5, dose the last rolling cohort patient for the CAR DIAMP chronic myocardial ischemia trial.

Speaker Change: 3. Submit cardiac heart failure for a general consultation with Japan PMDA in preparation for a future clinical consultation.

Peter Altman: The data from this trial is intended to provide support for future product approvals and commercialization of the cardiac cell therapy in Japan and the United States. As we seek to complete cardiac heart failure one, and confirm the final results are as good as we believe them to be, we are advancing a second confirmatory clinical trial in cardiac heart failure two, which focuses on the remarkable benefits and patients treated with elevated NT-ProBMP, a well-established biomarker of an active heart failure.

Speaker Change: Four, treat the first patients in cardiac heart failure 2 trial and begin demonstrating that we can enroll this trial quickly with our world-class clinical partners.

Speaker Change: 5. Dose the last rolling cohort patient for the CAR DIAMP chronic myocardial ischemia trial.

Peter Altman: 6, Receive FDA clearance for the Morph DNA Product Sample. I will now pass the call to David McClung, our CFO, who will review our Q2 2024 financial results. David.

Speaker Change: 6. Receive FDA clearance for the morph DNA product family.

David Mcclung: I will now pass the call to David McCleum, our CFO, who will review our Q2 2020-24 financial results. David? Thank you, Peter, and good afternoon, everyone. Revenues were $3,000 for the three-month ended June 2024, comparable to $43,000 for the three-month ended June 2023. Expenses quarter-over-quarter decreased by 53 percent. Research and development expenses decreased to $800,000 during the second quarter of 2024, compared to $2.3 million for the second quarter of 2023. Primarily due to completion of enrollment in the Cardiant Part Failure trial, coupled with related reductions in clinical and supporting function expenses. Selling general administrative expenses decreased $852,000 for the three-month ended June 2024, down from $1.2 million for the same period in 2023, primarily due to reduction in personnel related expenses.

David Mcclung: I will now pass the call to David McClung, our CFO, who will review our Q2 2024 financial results. David?

Peter Altman: Results in these patients presented at Technology and Heart Failure Therapeutics Conference in March 2024 showed a remarkable 86% relative risk reduction in heart death equivalence, and a 24% relative risk reduction in non-fatal major adverse cardiac and cerebral vascular events. 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% over a five-year period.

David Mcclung: Thank you, Peter, and good afternoon, everyone. Revenues were $3,000 for the three months ended June 2024, comparable to $43,000 for the three months ended June 2023. Expenses quarter over quarter decreased by 53 percent; research and development expenses decreased to $800,000 during the second quarter of 2024 compared to $2.3 million for the second quarter of 2023, primarily due to completion of enrollment in the CARDI-AMP heart failure trial, coupled with related reductions in clinical and supporting function expenses. Selling general administrative expenses decreased $852,000 for the three months into June 2024, down from $1.2 million for the same period in 2023, primarily due to a reduction in personnel-related expenses.

David Mcclung: BioCardia's net loss decreased to $1.6 million for the second quarter of 2024 from $3.4 million for the prior year's second quarter, primarily due to the reduction in expenses we just noted. We used $1.4 million in cash for operations in the second quarter of 2024, that's down from $3.2 million in the second quarter of 2023.

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

David Mcclung: Revenues were $3,000 for the three months ended June 2024, comparable to $43,000 for the three months ended June 2023.

Speaker Change: Expenses, quarter over quarter, decreased by 53%.

Speaker Change: Research and development expenses decreased to $800,000 during the second quarter of 2024 compared to $2.3 million for the second quarter of 2023.

Speaker Change: primarily due to completion of enrollment in the CARDI-AMP heart failure trial, coupled with related reductions in clinical and supporting function expenses.

Peter Altman: The cardiac heart failure two trial is the only confirmatory pivotal trial of a cell therapy in heart failure that has ever been initiated. It has a greater than 90% power for statistical probability of success to meet the primary end point based on the cardiac heart failure trial in term results. The world-class cardiologists on the cardiac heart failure one executive steering committee on the data safety monitoring board and on the clinical events committee are all continuing with us to support the cardiac heart failure two trial.

Speaker Change: Selling general and administrative expenses decreased $852,000 for the three months ended June 2024, down from $1.2 million for the same period in 2023, primarily due to reduction in personnel related expenses.

David Mcclung: Biocardia's net loss decreased to $1.6 million for the second quarter of 2024, from $3.4 million from the prior year second quarter, primarily due to the reduction in expenses we just noted. We use $1.4 million in cash for operations in the second quarter of 2024. That's down from $3.2 million in the second quarter of 2023. We expect our cash firm will increase moderately as we advance our trust.

Speaker Change: Biocardia's net loss decreased to 1.6 million dollars for the second quarter of 2024 from 3.4 million dollars from the prior year's second quarter primarily due to the reduction in expenses we just noted.

Speaker Change: We used $1.4 million in cash for operations in the second quarter of 2024. That's down from $3.2 million in the second quarter of 2023.

Peter Altman: Two additional world-class heart failure clinicians have also joined our executive steering committee.

Peter Altman: The first is Dr. Wilson Tang, cardiac heart failure one trial investigator, professor and medicine at the Cleveland Clinic, learner college of medicine, and research director of heart failure and transplant in the Department of cardiovascular medicine. The second is Dr. Leslie Miller, cardiac heart failure one trial investigator at the CHF heart function clinic at BayCare Morton Plant Hospital in Clearwater, Florida. And a former president of the International Society of Heart and Long Transplantate.

Speaker Change: We expect our cash burn will increase moderately as we advance our trials, continuing our track record of operating efficiently and carefully managing the use of capital.

Operator: We expect our cash burn will increase moderately as we advance our trial, continuing our track record of operating efficiently and carefully managing the use of capital. This concludes management's prepared comments. We are happy to now take questions from attendees. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

Speaker Change: This concludes management's prepared comments. We are happy to now take questions from attendees.

Unknown Attendee: We will now begin the question and answer session. To ask a question, you may press star, then one on your touch tone phone. If you are using a speaker phone, please pick up your handset before pressing the keys.

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

Speaker Change: To ask a question, you may press star then 1 on your touch-tone phone.

Speaker Change: If you are using a speakerphone, please pick up your handset before pressing the keys.

Unknown Attendee: If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster.

Peter Altman: Dr. Miller's site is the first site activated in the Cardiamp Heart Failure 2 study and this reported that five patients have already been consented for the trial by his clinical research team. Combined these 12 world-class cardiologists all of whom have seen our data and have worked with us on Cardiamp Heart Failure 1 are supporting the Cardiamp Heart Failure 2 study. We are more than thankful for each of their involvement extensive experience valuable advice and ongoing support.

Speaker Change: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2.

Operator: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question today comes from Joe Pantginis from H.C. Wainwright.

Speaker Change: At this time, we will pause momentarily to assemble our roster.

Joe Pantginis: The first question today comes with Joe Pantginis from HC Weenright. Please go ahead.

Speaker Change: Paul, thank you for joining us.

Joseph Pantginis: Please go ahead. Hi guys, good afternoon. Thanks for taking the questions. A few, if you don't mind.

Speaker Change: The first question today comes with...

Speaker Change: Joe Pantginnis from H.C. Wainwright. Please go ahead.

Joe Pantginis: Hi guys, good afternoon. Thanks for taking the questions. A few if you don't mind. So first, I was curious with the Heart Failure Two study. Maybe a little more color if you don't mind how much the data from heart failure one with regard to improvement of survival and MACE might be helping your enrollment for heart failure two.

Peter Altman: So first, I was curious, you know, with the Heart Failure 2 study, maybe a little more color, if you don't mind, how much or how little the data from Heart Failure 1 with regard to, you know, improvement in survival in MACE might be helping your enrollment for Heart Failure 2? Joe, good day, and thank you for the question. It's a great question.

Speaker Change: Hi guys, good afternoon. Thanks for taking the questions, a few if you don't mind. So first

Joe Pantginnis: was curious, you know, with the Heart Failure 2 study, maybe a little more color if you don't mind, how much the data from Heart Failure 1 with regard to, you know, improvement of survival in MACE might be helping your enrollment for Heart Failure 2?

Peter Altman: BioCardia intends to become an enrolling machine in the Cardiamp Heart Failure 2 clinical trial. Enrollment is expected to be significantly enhanced because of the positive data and experience from the Cardiamp Heart Failure 1 trial which we feel is compelling for heart failure physicians and their patients. Enrollment will be further enhanced by efforts we have taken to streamline the clinical study and by the enormous experience in the broader Cardiamp clinical team.

Peter Altman: Joe, good day, and thank you for the question. It's a great question. I think it's enormously valuable for us in the enrollment ahead. One of the challenges in these trials, which are where the procedures performed by an interventional cardiologist, but it's the heart failure physician who cares for the patient, is the evidence that we now have that supports that. One, this procedure can be done safely, and two, that the signals we're seeing of reduced major adverse cardiac and cerebral vascular events and reduced mortality. It's coupled with an enhanced quality of life are sort of the holy trio for them.

Peter Altman: I think it's enormously valuable for us in the enrollment ahead. One of the challenges in these trials, which are where the procedure is performed by an interventional cardiologist, but it's the heart failure physician who cares for the patient, is the evidence that we now have that, one, this procedure can be done safely, and two, that the signals we're seeing of reduced major adverse cardiac and cerebrovascular events and reduced mortality, coupled with an enhanced quality of life, are sort of the holy trio for them. So for folks caring for these patients, you know, there are no other therapies out there that actually have a meaningful impact on mortality.

Joe Pantginnis: Joe, good day and thank you for the question. It's a great question.

Speaker Change: I think it's enormously valuable for us in the enrollment ahead.

Peter Altman: There are other advances to the Cardiamp Autologous Self Therapy that we hope to be able to announce soon expected to further enhance enrollment in the Cardiamp Heart Failure 2 trial over that which was possible in Cardiamp Heart Failure 1.

Speaker Change: One of the challenges in these trials, which are where the procedure is performed by an interventional cardiologist, but it's the heart failure physician who cares for the patient.

Speaker Change: is the evidence that we now have that supports that, one, this procedure can be done safely, and two, that the signals we're seeing of reduced...

Peter Altman: Beyond our lead Autologous Self Therapy Program in Heart Failure we have also made progress this quarter in other programs. In April open label clinical results from Cardiamp Self Therapy and Chronic Myocardial Schemia were shared with greater benefits than other established therapies. We discussed this data in our last quarterly call and the last role in cohort patient is now scheduled for treatment later this month. In May our partner Cell Prosthera announced the results of their cell therapy in the indication of acute myocardial infarction.

Speaker Change: adverse cardiac and cerebrovascular events and reduced mortality, coupled with an enhanced quality of life, are sort of the holy trio for them. So, for people who have been diagnosed

Peter Altman: So for folks caring for these patients, you know, there are no other therapies out there that actually have a meaningful impact on mortality. And our data suggests that this cell therapy could have a meaningful impact. And particularly with the NT-pro BMP population, that we're targeting in heart failure II. We saw an 86% relative risk reduction in mortality. So that's a huge selling point for physicians to trust their patients into this investigational trial. And that's another reason why we expect enrollment to move apace. And I note that the first center was just activated, you know, a few weeks ago, and they've already consented five patients.

Speaker Change: folks caring for these patients, you know, there there are no other therapies out there that that actually have a meaningful impact on mortality and Our data suggests that this cell therapy could have a meaningful impact and particularly with the NT pro BMP population that we're targeting in heart failure to

Peter Altman: And our data suggests that this cell therapy could have a meaningful impact. And particularly with the NT-proBNP population that we're targeting in heart failure, too, we saw an 86% relative risk reduction in mortality. So that's a huge selling point for physicians to trust their patients into this investigational trial, and that's another reason why we expect enrollment to move apace. And I note that the first center was just activated a few weeks ago, and they've already consented five times.

Peter Altman: We discussed this result in our last quarterly call and are excited for Cell Prosthera and their data. These three programs and three distinct clinical indications of heart failure, chronic myocardial schemia and acute myocardial infarction demonstrate the broad utility and performance of biocardia's helix delivery system for the delivery of biologics locally to heart tissue. One element of the helix delivery system is our morph DNA steerable introducer. This morph DNA product design has performed well for our procedures and has potential to enhance many other clinical procedures as a commercial product with a broader product family configuration.

Speaker Change: we saw an 86% relative risk reduction in mortality. So that's a huge selling point for physicians to trust their patients into this investigational trial. And that's another reason why we expect enrollment to move apace.

Speaker Change: And I note that the first center was just activated, you know, a few weeks ago and they've already consented five patients.

Peter Altman: So, yeah, the data is going to be very important for us. Thank you. Great question. No, I don't understand it.

Joe Pantginis: So, yeah, the data is going to be very important for us.

Unknown Attendee: Thank you.

Speaker Change: and the data is going to be very important for us. Thank you.

Unknown Attendee: Great question. No, I got it.

Peter Altman: Thank you for that. And then you alluded to, you know, maybe some additional details coming up. So I know, Unknown Attendee, David McClung, Miranda Benvenuti, Amish Raval, Carl Pepine, Lander Egaa, BioCardia Yeah, Joe, another great question. So, in designing the CARDI-M Heart Failure II trial, Unknown Attendee, David McClung, Miranda Benvenuti, Amish Raval, Carl Pepine, Lander Egaa, BioCardia are our six-month follow-up visit, and our 18-month follow-up visit can now be done by a phone call if a center wishes.

Joe Pantginis: Thank you for that. And then I know you alluded to, you know, maybe some additional details coming up. So I know you can't discuss them yet about potential further streamlining of the study. But can you discuss what's already in place or remind us?

Speaker Change: No, I got it. Thank you for that. And then I know you alluded to, you know, maybe some additional details coming up, so I know you can't discuss them yet about potential further streamlining of the study, but can you discuss what's already in place or remind us?

Peter Altman: Yeah, Joe, another great question. So in designing the Cardi AM heart failure trial, we have such a strong safety signal that many of the interim endpoints have been lightened. So, for example, our six-month follow-up visit and our 18-month follow-up visit can now be done by a phone call if the center wishes. And the value of that is by eliminating many of the standard follow-up elements at that time point. The first thing is that the coordinator is able to focus on new patients and not necessarily those patients at those time points. But there's also the benefit for BioCardia that reduces our costs in the study.

Peter Altman: In late July we announced that we had completed an FDA submission for market clearance for a broader product family of morph DNA steerable introducers. We are hopeful for market clearance at the end of this quarter.

Speaker Change: Yeah, Joe, another great question. So, in designing the CARDI-AM Heart Failure 2 trial, we have such a strong safety signal that many of the interim end points have been lightened. So, for example,

Peter Altman: On the business development front, we have active partnering discussions with potential to be meaningful for our business with respect to all four of our platforms. Cardiamp, Cardialo, helix and morph. For Cardiamp, our autologous self-therapy platform, the focus has been on discussions with potential distributors, even as the therapy is not yet a and approved. Receiving approval in a first-world country, such as USA or Japan, is also expected to enable distribution partnerships to be realized in other regions of the world.

Joe Pantginnis: our six-month follow-up visit and our 18-month follow-up visit can now be done by a phone call if the Center wishes.

Peter Altman: And the value of that is by eliminating many of the standard follow-up elements at that time point, the first thing is that the coordinator is able to focus on new patients and not necessarily those patients at those time points. But there's also the benefit for BioCardia that it reduces our costs in the... And there are a lot of places where we've looked to do that throughout the program. So I think it's going to be less expensive for the company to advance, and it's going to be easier for the clinical sites to work patients through the trial.

Speaker Change: and the value of that is by eliminating many of the...

Speaker Change: standard follow-up elements at that time point.

Speaker Change: The first thing is that the coordinator is able to focus on new patients and not necessarily those patients at those time points. But there's also the benefit for biocardia that reduces our costs in the study.

Peter Altman: And there's a lot of places where we've looked to do that throughout the program. So I think it's going to be less expensive for the company to advance, and it's going to be easier for the clinical sites to work patients through the trial.

Speaker Change: and there's a lot of places where we've looked to do that.

Peter Altman: We have had a number of discussions this quarter around distribution partnerships in Japan, Brazil, and the United Arab Emirates. There is potential to enter into such distribution arrangements in advance of approval as this has the advantage for potential partners and that they can bring their experience to the table and positioning the therapeutic offering in their country of focus with respect to the physician community and payers.

Speaker Change: throughout the program.

Speaker Change: So, I think it's going to be less expensive for the company to advance.

Peter Altman: And we do have some other things that we hope to share soon that we are not able to share yet. So yeah, it should be a much easier trial for us than the cardiac heart failure true trial, in part because the second time you do things, things get a lot easier, particularly if the data in the first one is as good as we think it is. Got it, no, I appreciate that.

Speaker Change: and it's going to be easier for the clinical sites.

Joe Pantginis: And we do have some other things that we hope to share soon that we are not able to share yet today. So, yeah, it should be a much easier trial for us than the Cardiant Park failure one, true. In part because the second time you do things, things get a lot easier, particularly if the data in the first one is as good as we think it is. Got it. No, I appreciate that.

Speaker Change: to work patients through the trial. And we do have some other things that we hope to share soon.

Speaker Change: that we are not able to share yet today. So yeah, it should be a much easier trial for us than the cardiac heart failure one true trial, in part because the second time you do things, things get a lot easier, particularly if the data in the first one is as good as we think it is.

Peter Altman: For Cardi Allo, our Allogeneic South Therapy currently in the clinic for heart failure, we have extensive clinical experience from three trials. We have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease with one ongoing discussion this past month. For our Helix Biotherapeutic Delivery Platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products, and support capabilities remain active in discussions.

Joe Pantginis: And one last question, if you don't mind. I guess this has to do with trial logistics as well. So if you look at heart failure one, you know, it was really predominantly, I believe it was approximately 90% male populations. So I'm just curious, you know, when you're looking to enroll about 250 patients, you know, what can you do or what's the expected ratio between men and women you're targeting. So that is a very savvy question. It is one of the fundamental problems, and much heart failure research today. And that almost all of the trials tend to be heavily tilted towards a male population.

Peter Altman: And one last question, if you don't mind, I guess this has to do with trial logistics as well. So if you look at heart failure one, you know, it was really predominantly, I believe it was approximately 90% male population.

Speaker Change: Got it. No, I appreciate that and one last question if you don't mind I guess this has to do with trial logistics as well. So if you look at heart failure one, you know, it was really predominantly I believe it was approximately 90% male population. So I'm just curious, you know when you're looking to enroll about 250 patients You know, what can you do or what's the expected? ratio between men and women you're targeting

Peter Altman: So I'm just curious, you know, when you're looking to enroll about 250 patients, what can you do or what's the expected ratio between men and women, your target. So that is a very smart question.

Speaker Change: So

Peter Altman: It is one of the fundamental problems in much heart failure research today in that almost all of the trials tend to be heavily tilted toward a male population. It's something that we have worked on in CARDI-AMP Heart Failure 1, and we even presented on it early in the study and have encouraged centers to think broadly about equity, not only in terms of gender but also different races, making it so that it's a diverse population and that all patients are aware of it.

Speaker Change: That is a very savvy question. It is one of the fundamental problems in much heart failure research today and that almost all of the trials tend to be heavily tilted towards a male population.

Peter Altman: Current partners realize that minimally invasive delivery, not only enhances future commercialization, but is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their own therapeutic development. Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery and the enhanced pharmacokinetics with our Helix system supported by data from many groups. We believe this advantage is due to the stability of the Helix in the beating heart and the self-sealing helical pathway into the tissue.

Peter Altman: It's something that we have worked on in Cardiant Park failure one, and we even presented on it early in the study and have encouraged centers to think broadly about equity, not only in terms of gender, but also different races, of making it so that it's a diverse population that all patients are aware of it. And that's going to be an ongoing exercise in Cardiant Park failure two. My sense is that the data will help us there. I think physicians tend to be more protective of their female patients. And so don't advance them in the clinical trials as aggressively as they do a hearty male patient.

Speaker Change: Thank you.

Speaker Change: It's something that we have worked on.

Speaker Change: in Cardi-Amp Heart Failure 1, and we even...

Speaker Change: presented

Speaker Change: on it early in the study and have encouraged centers to think

Speaker Change: broadly about equity, not only in terms of gender, but also different races, making it so that it's a diverse population and that all patients are aware of it. And that's going to be an ongoing exercise in cardiac heart failure too. My sense is...

Peter Altman: And that's gonna be an ongoing exercise in CARDI-AMP Heart Failure 2. My sense is that the data will help us there. I think physicians tend to be more protective of their female patients and so don't advance them in clinical trials as aggressively as they do with a hearty male patient.

Peter Altman: We encourage all partners to perform pharmacokinetic studies, including a surgical delivery control, so that they will have their own data supporting what we have seen. Today, we have participated in more than 20 development programs in partnerships with almost every well-known program, some of which are identified in our corporate presentation.

Speaker Change: that the data will help us there. I think.

Speaker Change: Physicians tend to be more protective of their female patients and so don't advance them in the clinical trials as aggressively as they do a hardy male patient and I think because we have such

Joe Pantginis: And I think because we have such compelling safety data with real nice signs of efficacy, that there will be a larger percentage of female patients in the trial. I would love it to be 50 percent; although the reality of how these trials are enrolled, that is unlikely. But we're willing for 50 percent if we can achieve it. Thank you for the added details. No great questions, Joe. Thank you so much for being on the call.

Peter Altman: And I think because we have such compelling safety data with real nice signs of efficacy, that there will be a larger percentage of female patients in the trial. I would love it to be 50%, although the reality of how these trials are enrolled is that that is unlikely. But we'll aim for 50% if we can achieve it. Thank you for the attitude.

Speaker Change: compelling safety data with real nice signs of efficacy, that there will be a larger percentage...

Peter Altman: We are now evolving our business approaches with a higher bar for our involvement in therapeutic development, focusing on true partnerships meaningful for our shareholders. This will take time to evolve, but as our experience and products advance in the field as a whole advances, we do expect to enter into meaningful relationships with other therapeutic partners. Five biotherapeutic delivery partnership discussions have been ongoing throughout this quarter, and all but one of these are previous customers who have positive data with our biotherapeutic delivery team and system.

Speaker Change: of female patients in the trial. I would love it to be 50%, although the reality of how these trials are enrolled, that is unlikely. But we'll aim for 50% if we can achieve it.

Peter Altman: Great questions, Joe. Thank you so much for being on the call. The next question comes from James Malloy with Alliance Global Partners. Please go ahead. Hello, this is Laura on behalf of James Malloy.

Speaker Change: Thank you for the added details.

Speaker Change: No. Great questions, Joe. Thank you so much for being on the call.

James Malloy: The next question comes from James Malloy with Alliance Global Partners. Please go ahead.

Speaker Change: David McClung, David McClung,

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

Laura Suriel: Hello, this is Laura on for James Malala. Thank you for taking questions. So how's status right now in the process for submission of cardiac for approval specifically in Japan and do you still plan on obtaining potential approval there next year? So the status with cardiac in Japan for the treatment of a schema card failure is we had our last consultation with Japan's Pharmaceutical and Medical Device Agency in November. As part of that discussion, they provided minutes with a whole series of questions, and almost all of the questions ended with, "please contain this information in your submission for approval."

Laura Suriel: Thank you for taking the questions. So how's the status right now in the process for submission of cardiac for approval specifically in Japan? And do you still plan on obtaining potential approval there next year?

Speaker Change: Hello, this is Laura Ahn for James Malloy. Thank you for taking the questions.

Peter Altman: On the more front, the recent FDA submission for clearance is a first step towards revenue generation from these clinical products, which also enhance partnering interests. We expect to have labeling that is appropriate for interventional cardiology, who perform our Helix procedures, but also cardiac electrophysiologist, interventional radiologist, and vascular surgeons, all of which may benefit from our morph DNA steerable introducer platform. We have had a few discussions here on selling off these products, an extensive bench test data for multiple large firms has been generated that has been shared with us.

Laura Ahn: So how's the status right now in the process for submission of CARDI-AMP for approval specifically in Japan and do you still plan on obtaining potential approval there next year?

Peter Altman: So, the status with Cardi-Amp in Japan for the treatment of ischemic heart failure is we had our last consultation with Japan's pharmaceutical and medical device agency in November as part of that discussion. They provided minutes with a whole series of questions, and almost all of the questions ended with, "please contain this information in your submission for approval," none of the questions we felt were daunting. One of the key things that we need to do is to have a general consultation addressing the differences in care for heart failure patients in Japan and in the United States and then, hopefully, move to a clinical consultation with the final data from the CARDI-AMP Heart Failure II trial, which is one of the things that they would like to see.

Speaker Change: So the status with Cardi-Amp in Japan for the treatment of ischemic heart failure is we had our last consultation with Japan's Pharmaceutical and Medical Device Agency in November. As part of that discussion

Speaker Change: They provided minutes with a whole series of questions.

Speaker Change: and almost all of the questions ended with, please contain this information in your submission for approval.

Peter Altman: And none of the questions we felt were daunting. One of the key things that we need to do is we need to have a general consultation addressing the differences in care in heart failure patients in Japan and in the United States. And then hopefully move to a clinical consultation with the final data from the cardiac part failure to trial, which is one of the things that they would like to see. The thought process we have is that we're in pretty good shape to complete a submission if the data is as good as we think it is.

Peter Altman: It is my expectation that in the coming months, the decline in BioCardia share price will reverse as investors and partners better understand what we are accomplishing in our business, in our own therapeutic programs, in our bio therapeutic delivery partnering and licensing, and anticipated new FDA cleared morph product family.

Speaker Change: and none of the questions we felt were daunting. One of the key things that we need to do is we need to have a general consultation addressing the differences in care in heart failure patients in Japan and in the United States.

Speaker Change: and then hopefully move to a clinical consultation with the final data from the CARDI-AMP Heart Failure II trial, which is one of the things that they would like to see.

Peter Altman: By the end of the current quarter, we intend to deliver on the following objectives, one, become compliant with NASDAQ listing requirements, two, complete the last patient visit for the Cardiant Parts Failure One trial, three, submit Cardiant Part Failure for a general consultation with Japan PMDA in preparation for a future clinical consultation, four, treat the first patients in Cardiant Part Failure Two trial, and begin demonstrating that we can enroll this trial quickly with our world-class clinical partners, five, dose the last roll-in cohort patient for the Cardiant Chronic Myocardial Schemia trial, and six, receive FDA clearance for the morph DNA product family.

Peter Altman: The thought process we have is that we're in pretty good shape to complete a submission if the data is as good as we think it is, and we feel there's a very good chance that Japan's PMDA will support that submission for approval. And so that's really where we're focused. Once the submission is in, once they invite that process, there's an enormous amount of details that they go through, including, I believe, a site visit to assess the manufacturing, but our sense is we're ready for all of those questions, and the key element is, you know, will they allow us to submit for approval based on the CARDI-AMP Heart Failure I data?

Speaker Change: Thank you.

Speaker Change: The thought process we have is that we're in pretty good shape to complete a submission if the data is as good as we think it is, and we feel there's a very good chance

Peter Altman: And we feel is a very good chance that Japan PMDA will support that submission for approval process. And so that's really where we're focused. Once the submission is in, once they invite that process, there's an enormous amount of details that they go through, including, I believe, a site visit to assess the manufacturing, but our scent is we're ready for all of those questions. And the key element is, you know, will they allow us to submit for approval based on the cardiac heart failure one data. And the reasoning there, which I've said a few times in the past that we think they will, is we've already treated approximately 20 times as many patients.

Speaker Change: that Japan PMDA will support that submission for approval process.

Speaker Change: And so that's really where we're focused. Once the submission is in, once they invite that process, there's an enormous amount of details that they go through, including, I believe, a site visit to assess the manufacturing.

Speaker Change: But our sense is we're ready for all of those questions and the key element is, you know Will they allow us to submit for approval based on the cardiac heart failure one data?

David Mcclung: I will now pass the call to David McCleum, our CFO, who will review our Q2 2020-24 financial results. David? Thank you, Peter, and good afternoon, everyone. Revenues were $3,000 for the three-month-cended June 2024, comparable to $43,000 for the three-month-cended June 2023. Expenses quarter-over-quarter decreased by 53 percent. Research and development expenses decreased to $800,000 during the second quarter of 2024, compared to $2.3 million for the second quarter of 2023. Primarily due to completion of enrollment in the Cardiant Part Failure trial, coupled with related reductions in clinical and supporting function expenses.

Peter Altman: And the reasoning there, which I've said a few times in the past, that we think they will is that we've already treated approximately 20 times as many patients, so 200 patients relative to 10 patients for other cardiac cell therapies that they've either approved, or they've had discussions about approving after 10 patients. Those three other cardiac cell therapies all require an open chest. Procedures for delivery of the cells, and ours is a minimally invasive therapy.

Speaker Change: and the reasoning there, which I've said a few times in the past, that we think they will...

Speaker Change: is we've already treated approximately 20 times as many patients. So, 200 patients relative to 10 patients for other cardiac cell therapies that they've either approved or they've had discussions on approving after 10 patients.

Peter Altman: So 200 patients relative to 10 patients for other cardiac cell therapies that they've either approved or they've had discussions on approving after 10 patients. Those three other cardiac cell therapies all require open-chest procedures for delivery of the cell, and ours is a minimally invasive therapy. I also note that our cardiac cell processing platform is already approved in Japan and being used for orthopedic applications, and our delivery system has historically been approved in Europe under CE Mark. And so that's sort of a badge support for it as well. And then the last piece is we have reimbursement in the United States that will enable the Ministry of Health, Labor and Welfare to at least have an index for supporting cardiac cell therapy going forward.

Speaker Change: those three other cardiac cell therapies.

Speaker Change: all require open chest procedures.

Speaker Change: for delivery of the cells, and ours is a minimally invasive therapy.

Peter Altman: I also note that our cardiac cell processing platform is already approved in Japan and being used for orthopedic applications. And our delivery system has historically been approved in Europe under the CE mark, and so that's sort of a badge of support for it as well. And then the last piece is that we have reimbursement in the United States that will enable the Ministry of Health, Labor, and Welfare to at least have an index for supporting cardiac cell therapy going forward.

Speaker Change: I also note that our cardiac cell processing platform is already approved in Japan.

Speaker Change: and being used for orthopedic applications.

David Mcclung: Selling general administrative expenses decreased $852,000 for the three-month-cended June 2024, down from $1.2 million for the same period in 2023, primarily due to reduction in personnel related expenses. Biocardia's net loss decreased to $1.6 million for the second quarter of 2024, from $3.4 million from the prior year second quarter, primarily due to the reduction in expenses we just noted. We use $1.4 million in cash for operations in the second quarter of 2024. That's down from $3.2 million in the second quarter of 2023. We expect our cash firm will increase moderately as we advance our trust.

Speaker Change: and our delivery system has historically been approved in Europe under CE mark and so that's sort of a badge of support for it as well.

Speaker Change: And then the last piece is...

Speaker Change: We have reimbursement in the United States that will enable the Ministry of Health, Labor, and Welfare

Speaker Change: to at least have an index.

Peter Altman: So all of those stars are what we are working to help make a line. And that's why the cardiac heart failure one final data is the last patient follow-up visit expectancy, and this September is so critically important for us. Even though we have 90% of the data, you know, until you have all of the final data, it's an estimate of the outcome, not the final outcome. And that will be coming.

Speaker Change: for supporting Cardiac.

Peter Altman: So all of those stars are what we are working to help make align, and that's why the Cardiac Heart Failure 1 final data at the last patient follow-up visit expected at the end of September is so critically important for us. Even though we have 90% of the data, you know, until you have all of the final data, it's an estimate of the outcome, not the final outcome, and that will come. I got it.

Speaker Change: cell therapy going forward. So all of those stars are what we are working to help make align and that's why the cardiac heart failure one final data

Speaker Change: that the last patient follow-up visit expected at the end of September is so critically important for us. Even though we have 90% of the data, until you have all of the final data, it's an estimate of the outcome, not the final outcome, and that will be coming shortly.

Laura Suriel: Thank you for the clarity, and just one more question from me. How the collaboration is going right now for itself if you're especially following now the recent phase 2 trial. And when do you think you might start a subsequent phase 3 trial with them, as well as any potential timelines or interim looks for this trial as well?

Peter Altman: Thank you for the clarification. And I have just one more question for you. How's the collaboration going right now for CELF with you, especially following the recent phase two trial? And when do you think you might start a subsequent phase three trial with them as well as any potential timelines or interim looks for this trial as well? Well, that's a great question as well. I'd rather point to the fact that that's a clinical indication for which there are only two companies that have gone after intramyocardial delivery for that indication.

Speaker Change: Got it. Thank you for the clarity. And just one more question for me. How's the collaboration going right now for CELFs if you're especially following now the recent Phase 2 trial? And when do you think you might start a subsequent Phase 3 trial with them, as well as any potential timelines or interim looks for this trial as well?

Unknown Attendee: We will now begin the question and answer session. To ask a question, you may press star than one on your touch tone phone. If you are using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.

Peter Altman: Well, that's a great question as well. I'd rather point to the fact that that's a clinical indication that there are only two companies that have gone after interim myocardial delivery for that indication. One was BioCardia; we did a small study there ourselves many years ago, and Cell Protera, and they benefit from much higher efficiency as of delivery than intracoronary artery infusion of their cells, which is what everybody else has done in the indication of acute myocardial infarction. And you know, the value proposition of efficiency of delivery, I like to use the analogy that we have about 18-fold the retention relative to intracoronary delivery.

Speaker Change: Well, that's a great question as well. I'd rather point to the fact that that's a clinical indication

Speaker Change: that there's only two companies that have gone after...

Peter Altman: One was BioCardia, we did a small study there ourselves many years ago, and CellProthera, and they benefit from much higher efficiencies of delivery than intracoronary artery infusion of their cells, which is what everybody else has done in the indication of acute myocardial infarction, and you know the value proposition of efficiency of delivery. I like to use the analogy that you know we have about 18-fold the retention relative to So if anybody on the call has had a headache, it's the difference between taking, you know, 18 aspirin to get an effect versus one.

Speaker Change: intramyocardial delivery for that indication. One was myocardia. We did a small study there ourselves many years ago.

Speaker Change: and Cell Prothera, and they benefit from much higher efficiencies of delivery than intracoronary artery infusion of their cells, which is what everybody else has done in the indication of acute myocardial infarction.

Joe Pantginis: The first question today comes with Joe Pantginis from HC Weenright. Please go ahead. Hi guys, good afternoon. Thanks for taking the questions. A few if you don't mind. So first, I was curious with the heart failure two study. Maybe a little more color if you don't mind how much the data from heart failure one with regard to improvement of survival and mace might be helping your enrollment for heart failure two. Joe, good day and thank you for the question.

Speaker Change: and the value proposition of efficiency of delivery.

Speaker Change: I like to use the analogy that, you know, we have about 18-fold the retention relative to intracoronary delivery. So, if anybody on the call has had a headache, it's the difference between taking, you know, 18 aspirin to get an effect versus one.

Peter Altman: So if anybody on the call has had a headache, it's the difference between taking 18 aspirin to get an effect versus one.

Peter Altman: So I typically don't speak to a partner's efforts going forward. I can tell you that we've been working together for many years, and we have great respect for them as a team.

Peter Altman: So I don't speak typically to a partner's efforts going forward. I can tell you that we've been working together for many years. We have great respect for them as a team. They've done a lot moving forward. They need to address their regulatory and strategic pathways forward, whether or not they wish to do a trial only in Europe, whether it was to do a trial in Europe in the United States, whether they wish to do a trial in the United States home, and you know, how they wish to roll it out with which investigators. And we can be helpful to them on all fronts.

Speaker Change: So, I don't speak typically to a partner's...

Speaker Change: efforts going forward. I can tell you that we've been working together for many years. We have great respect for them as a team. They've done a lot moving forward.

Joe Pantginis: It's a great question. I think it's enormously valuable for us in the enrollment ahead. One of the challenges in these trials, which are where the procedures performed by an interventional cardiologist, but it's the heart failure physician who cares for the patient is the evidence that we now have that supports that. One, this procedure can be done safely and two, that the signals we're seeing of reduced major adverse cardiac and cerebral vascular events and reduced mortality.

Peter Altman: They've done a lot of moving forward. They need to address their regulatory and strategic pathways forward, whether or not they wish to do a trial only in Europe, whether they wish to do a trial only in the United States, whether they wish to do a trial only in the United States, and you know how they wish to roll it out with which investigators, and we can be helpful to them on all fronts.

Speaker Change: they need to address their regulatory and strategic pathways forward.

Speaker Change: whether or not they wish to do a

Speaker Change: trial only in Europe, whether they wish to do a trial in Europe and the United States, whether they wish to do a trial

Speaker Change: in the United States hold me.

Speaker Change: and, you know, how they wish to roll it out with which investigators.

Peter Altman: So conversations are ongoing, and it's a really compelling program with a very real market and some nice data that they have in their phase two program. So, and I know that's not exactly the question you wanted answered, Laura, but it's about all I can share because we really try to be respectful of our partners and let them share their strategy going forward as well as share their data going forward. And one of the challenges in this space is that to be a great partner, you have to be trusted, and we work very hard on that.

Peter Altman: So conversations are ongoing, and it's a really compelling program with a very real market and some nice data that they have in their phase two program.

Speaker Change: and we can be helpful to them on all fronts. So, conversations are ongoing and it's a really compelling program with a very...

Laura Suriel: So I know that's not exactly the question you wanted answered, Laura, but it's about all I can share because we really try to be respectful of our partners and let them share their strategy going forward as well as share their data going forward. And it's one of the challenges in this space is to be a great partner. You have to be trusted, and we work very hard on that every day. And I said, thank you for seeing the questions. No, I appreciate the question, Laura.

Speaker Change: real market and some nice data that they have in their phase two program, so

Joe Pantginis: It's coupled with a enhanced quality of life are sort of the holy trio for them. So for folks caring for these patients, you know, there are no other therapies out there that actually have a meaningful impact on mortality. And our data suggests that this cell therapy could have a meaningful impact. And particularly with the NT pro BMP population, that we're targeting in heart failure two. We saw an 86% relative risk reduction in mortality.

Speaker Change: and I know that's not exactly the question you wanted answered, Laura, but it's about all I can share because we really try to be respectful of our partners.

Speaker Change: and let them share their strategy going forward as well as share their data going forward. And it's one of the challenges in this space is to be a great partner you have to be trusted and we work very hard on that every day.

Laura Suriel: Understood. Thank you for taking the questions. No, I appreciate the question, Laura. As a reminder, if you would like to ask a question, please press star then 1 to join the question queue. The next question comes from Kevin Marshall. Please go ahead.

Laura Ahn: Understood, thank you for taking the questions.

Unknown Attendee: As a reminder, if you would like to ask a question, please press star, then one to join the question queue.

Laura Ahn: No, I appreciate the question, Laura.

Joe Pantginis: So that's a huge selling point for physicians to trust their patients into this investigational trial. And that's another reason why we expect enrollment to move a pace. And I note that the first center was just activated, you know, a few weeks ago, and they've already consented five patients. So, yeah, the data is going to be very important for us. Thank you. Great question. No, I got it. Thank you for that. And then I know you alluded to, you know, maybe some additional details coming up.

Laura Ahn: As a reminder, if you would like to ask a question, please press star then 1 to join the question queue.

Kevin Marshall: The next question comes from Kevin Marshall. Please go ahead.

Laura Ahn: The next question comes from Kevin Marshall. Please go ahead.

Kevin Marshall: All right, thank you everyone for taking my question. You know, Dr. Robbins, I know you mentioned getting in compliance with the NASDAQ listing requirements. I'm just curious if you can shed any details on how, you know, the company's planning on going about doing that. If that would have any value effects on current shareholders.

Kevin Marshall: Thank you, everyone, for taking my question. You know, Dr. Altman, I know you mentioned getting in compliance with the NASDAQ listing requirement. I'm just curious to know if you can shed any details on how, you know, the company's planning on going about doing that, and if that would have any bad effects on current shareholders. Kevin, that's a great question. So, for NASDAQ, there are two requirements. One is the share price being over a dollar a share, and the second is minimum equity requirements or market capitalization requirements.

Speaker Change: Joseph Pantginis, Peter Altman, Unknown Attendee

Speaker Change: Thank you, everyone, for taking my question. Dr. Altman, I know you mentioned

Kevin Marshall: getting in compliance with the NASDAQ listing requirements. I'm just curious to know if you can shed any details on how the company's planning on going about doing that, and if that would have any negative effects on current shareholders.

Joe Pantginis: So I know you can't discuss them yet about potential further streamlining of the study. But can you discuss what's already in place or remind us? Yeah, Joe, another great question. So in designing the Cardi am heart failure to trial, we have such a strong safety signal that many of the interim endpoints have been lightened. So for example, or our six month follow-up visit and our 18 month follow-up visit can now be done by a phone call of the center wishes.

Peter Altman: Kevin, that's a great question. So for NASDAQ, there are two requirements. One is the share price being over a dollar share. And the second is minimum equity requirements or market capitalization requirements. If you look at our financials that came out today, you will realize that we don't have any enormous amount of resources in the bank today. So we are exploring pathways to secure funding. We have on Friday, there was an S1 that was put on file. And I can't speak to whether or not we'll be doing anything under it. But our strategy is always to pursue all opportunities for success and ultimately select the one that makes the most sense for us.

Kevin Marshall: Kevin, that's a great question. So for NASDAQ, there are two requirements. One is the share price.

Kevin Marshall: being over dollar share and the second is minimum equity requirements or market capitalization requirements.

Peter Altman: If you look at our financials that came out today, you will realize that we don't have an enormous amount of resources in the bank today, so we are exploring pathways to secure funding. On Friday, there was an S-1 that was put on file, and I can't speak to whether or not we will be doing anything under it, but our strategy is always to pursue all opportunities for success and ultimately select the one that makes the most sense for us.

Speaker Change: If you look at our financials that came out today, you will realize that we don't have an enormous amount of resources in the bank today. So we are exploring pathways to secure funding. We have on.

Joe Pantginis: And the value of that is by eliminating many of the standard follow-up elements at that time point. The first thing is that the coordinator is able to focus on new patients and not necessarily those patients at those time points. But there's also the benefit for BioCardia that reduces our costs in the study. And there's a lot of places where we've looked to do that throughout the program. So I think it's going to be less expensive for the company to advance and it's going to be easier for the clinical sites to work patients through the trial.

Speaker Change: Friday there was an S-1 that was put on file.

Speaker Change: and I can't speak to whether or not we'll be doing anything under it, but...

Speaker Change: Our strategy is always to pursue

Speaker Change: all opportunities for success and ultimately select the one.

Peter Altman: I would have folks think about dilution as it is a significant issue, but as we advance, we historically have fought very hard as a company to avoid any dilutive impact for our shareholders. And so, I think today's market cap is remarkably low. I think that if we, as we advance the company, some of the milestones we have could be enormously valuable. So, we are not talking about 2X or 3X.

Peter Altman: I would have folks think about dilution as, you know, it is a significant issue. But, you know, as we advance, we historically have fought very hard as a company to avoid any dilutive impact for our shareholders. And so I think today, our market cap is remarkably low. I think that if we, as we advance the company, some of the milestones we have could be enormously valuable. And so it's, we're not talking about 2X or 3X. We're talking, you know, multiples of that. And so, as we go downstream, that's something we need to deliver. And we always need to be cognizant of dilution.

Speaker Change: Thank you.

Speaker Change: makes the most sense for us.

Speaker Change: I would have folks think about dilution as...

Speaker Change: You know, it is a significant issue, but as we advance, we historically have fought very hard.

Speaker Change: as a company to avoid any dilutive impact for our shareholders.

Joe Pantginis: And we do have some other things that we hope to share soon that we are not able to share yet today. So yeah, it should be a much easier trial for us than the Cardiant Park failure one true. In part because the second time you do things, things get a lot easier, particularly if the data in the first one is as good as we think it is. Got it. No, I appreciate that.

Speaker Change: And so I think today our market cap is remarkably low. I think that if we, as we advance the company, some of the milestones we have could be enormously valuable.

Speaker Change: And so, we're not talking about 2X or 3X, we're talking, you know,

Peter Altman: We are talking about, Unknown Attendee, David McClung, Miranda Benvenuti, Amish Raval, Carl Pepine, Lander Egaa, BioCardia. Thank you. I appreciate it. Any time. I appreciate the question, Kevin. This concludes our question and answer session. I would like to turn the conference back over to Dr. Altman for any closing remarks. Thank you very much, Betsy. So, all that we have accomplished here at BioCardia so far is to the credit of our amazing BioCardia team, our incredible clinical partners, the hundreds of patients who have participated in our trials, the FDA and the PMDA, which have been helpful in their reviews and input, and to the investors who have enabled our efforts.

Speaker Change: multiples of that and so as as we go downstream that's something we need to deliver and we always need to be cognizant, Kevin, of dilution.

Joe Pantginis: And one last question if you don't mind, I guess this has to do with trial logistics as well. So if you look at heart failure one, you know, it was really predominantly, I believe it was approximately 90% male populations. So I'm just curious, you know, when you're looking to enroll about 250 patients, you know, what can you do or what's the expected ratio between men and women you're targeting. So that is a very savvy question.

Kevin Marshall: But at the same time, we have to run the business. So we'll see it unfold and share it as it unfolds for everyone who has been supporting us. And we do appreciate your support.

Kevin Marshall: At the same time, we have to run the business. So we'll see it unfold and share it as it unfolds for everyone who has been supporting us. And we do appreciate your support.

Kevin Marshall: Thank you. Appreciate it. Anytime. I appreciate the question, Kevin.

Kevin Marshall: Thank you. Appreciate it.

Kevin Marshall: Any time. I appreciate the question, Kevin.

Unknown Attendee: This concludes our question and answer session.

Peter Altman: I thank everyone who has helped our mission to develop and enhance therapies to treat cardiovascular disease. We expect to deliver a rewarding end to 2024 and an incredible 2025 if we are successful in our efforts. Thank you for being on the call and have a great afternoon. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Joe Pantginis: It is one of the fundamental problems and much heart failure research today. And that almost all of the trials tend to be heavily tilted towards a male population. It's something that we have worked on in Cardiant Park failure one and we even presented on it early in the study and have encouraged centers to think broadly about equity, not only in terms of gender, but also different races of making it so that it's a diverse population that all patients are aware of it.

Peter Altman: I would like to turn the conference back over to Dr. Altman for any closing remarks. Thank you very much, Betsy. So all that we have accomplished here at BioCardia so far is to the credit of our amazing BioCardia team. Our incredible clinical partners, the hundreds of patients who have participated in our trials, to the FDA and the PMDA, which have been helpful in their reviews and input, and to the investors who have enabled our efforts. I thank everyone who has helped our mission to develop and enhance therapies to treat cardiovascular disease. We expect to deliver a rewarding end to 2024 and an incredible 2025 if we are successful in our efforts.

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

Dr. Altman: Thank you very much, Betsy.

Dr. Altman: So...

Dr. Altman: All that we have accomplished here at BioCardia so far is to the credit of our amazing BioCardia team.

Dr. Altman: our incredible clinical partners, the hundreds of patients who have participated in our trials, to the FDA and the PMDA which have been helpful in their reviews and input, and to the investors who have enabled our efforts.

Joe Pantginis: And that's going to be an ongoing exercise in Cardiant Park failure two. My sense is that the data will help us there. I think physicians tend to be more protective of their female patients. And so don't advance them in the clinical trials as aggressively as they do a hearty male patient. And I think because we have such compelling safety data with real nice signs of efficacy that there will be a larger percentage of female patients in the trial.

Dr. Altman: I thank everyone who has helped our mission to develop and enhance therapies to treat cardiovascular disease.

Dr. Altman: We expect to deliver a rewarding end to 2024 and an incredible 2025 if we are successful in our efforts.

Unknown Attendee: Thank you for being on the call, and have a great afternoon.

Dr. Altman: Thank you for being on the call and have a great afternoon.

Unknown Attendee: The conference is not concluded. Thank you for attending today's presentation.

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

Unknown Attendee: You may now disconnect.

Joe Pantginis: I would love it to be 50 percent, although the reality of how these trials are enrolled, that is unlikely. But we're willing for 50 percent if we can achieve it. Thank you for the added details. No great questions, Joe. Thank you so much for being on the call.

James Malloy: The next question comes from James Malloy with Alliance Global Partners. Please go ahead.

Laura Suriel: Hello, this is Laura on for James Malala, thank you for taking questions. So how's status right now in the process for submission of cardiac for approval specifically in Japan and do you still plan on obtaining potential approval there next year? So the status with cardiac in Japan for the treatment of a schema card failure is we had our last consultation with Japan's pharmaceutical and medical device agency in November. As part of that discussion, they provided minutes with a whole series of questions and almost all of the questions ended with please contain this information in your submission for approval.

Laura Suriel: And none of the questions we felt were daunting. One of the key things that we need to do is we need to have a general consultation addressing the differences in care in heart failure patients in Japan and in the United States. And then hopefully move to a clinical consultation with the final data from the cardiac part failure to trial, which is one of the things that they would like to see. The thought process we have is that we're in pretty good shape to complete a submission if the data is as good as we think it is.

Laura Suriel: And we feel is a very good chance that Japan PMDA will support that submission for approval process. And so that's really where we're focused. Once the submission is in, once they invite that process, there's an enormous amount of details that they go through, including I believe a site visit to assess the manufacturing, but our scent is we're ready for all of those questions. And the key element is, you know, will they allow us to submit for approval based on the cardiac heart failure one data.

Laura Suriel: And the reasoning there, which I've said a few times in the past that we think they will, is we've already treated approximately 20 times as many patients. So 200 patients relative to 10 patients for other cardiac cell therapies that they've either approved or they've had discussions on approving after 10 patients. Those three other cardiac cell therapies all require open chest procedures for delivery of the cell and ours is a minimally invasive therapy.

Laura Suriel: I also note that our cardiac cell processing platform is already approved in Japan and being used for orthopedic applications and our delivery system has historically been approved in Europe under CE Mark. And so that's sort of a badge support for it as well. And then the last piece is we have reimbursement in the United States that will enable the Ministry of Health, Labor and Welfare to at least have an index for supporting cardiac cell therapy going forward.

Laura Suriel: So all of those stars are what we are working to help make a line. And that's why the cardiac heart failure one final data is the last patient follow-up visit expectancy and this September is so critically important for us. Even though we have 90% of the data, you know, until you have all of the final data, it's an estimate of the outcome, not the final outcome. And that will be coming.

Laura Suriel: Thank you for the clarity and just one more question from me. How the collaboration is going right now for itself if you're especially following now the recent phase 2 trial. And when do you think you might start a subsequent phase 3 trial with them as well as any potential timelines or interim looks for this trial as well? Well, that's a great question as well. I'd rather point to the fact that that's a clinical indication that there's only two companies that have gone after interim myocardial delivery for that indication.

Laura Suriel: One was BioCardia, we did a small study there ourselves many years ago, and Cell Protera, and they benefit from much higher efficiency as of delivery than intracornary artery infusion of their cells, which is what everybody else has done in the indication of acute myocardial infarction. And you know, the value proposition of efficiency of delivery, I like to use the analogy that we have about 18 fold the retention relative to intracornary delivery.

Laura Suriel: So if anybody on the call has had a headache, it's the difference between taking 18 aspirin to get an effect versus one. So I don't speak typically to a partner's efforts going forward. I can tell you that we've been working together for many years. We have great respect for them as a team. They've done a lot moving forward. They need to address their regulatory and strategic pathways forward, whether or not they wish to do a trial only in Europe, whether it was to do a trial in Europe in the United States, whether they wish to do a trial in the United States home and you know, how they wish to roll it out with which investigators.

Laura Suriel: And we can be helpful to them on all fronts. So conversations are ongoing and it's a really compelling program with a very real market and some nice data that they have in their phase two program. So I know that's not exactly the question you wanted answered Laura, but it's about all I can share because we really try to be respectful of our partners and let them share their strategy going forward as well as share their data going forward. And it's one of the challenges in this space is to be a great partner. You have to be trusted and we work very hard on that every day.

Laura Suriel: And I said thank you for seeing the questions. No, I appreciate the question Laura.

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Kevin Marshall: The next question comes from Kevin Marshall. Please go ahead. All right, thank you everyone for taking my question. You know, Dr. Robbins, I know you mentioned, you know, getting in compliance with the NASDAQ listen requirements. I'm just curious if you can shed any details on how, you know, the company's planning on going about doing that. If that would have any value effects on current shareholders.

Peter Altman: Kevin, that's a great question. So for NASDAQ, there are two requirements. One is the share price being over a dollar share. And the second is minimum equity requirements or market capitalization requirements. If you look at our financials that came out today, you will realize that we don't have any enormous amount of resources in the bank today. So we are exploring pathways to secure funding. We have on Friday, there was an S1 that was put on file.

Peter Altman: And I can't speak to whether or not we'll be doing anything under it. But our strategy is always to pursue all opportunities for success and ultimately select the one that makes the most sense for us. I would have folks think about dilution as, you know, it is a significant issue. But, you know, as we advance, we historically have fought very hard as a company to avoid any dilutive impact for our shareholders.

Peter Altman: And so I think today, our market cap is remarkably low. I think that if we, as we advance the company, some of the milestones we have could be enormously valuable. And so it's, we're not talking about 2X or 3X. We're talking, you know, multiples of that. And so as we go downstream, that's something we need to deliver. And we always need to be cognizant of dilution. But at the same time, we have to run the business. So we'll see it unfold and share it as it unfolds for everyone who has been supporting us. And we do appreciate your support. Thank you. Appreciate it. Anytime. I appreciate the question, Kevin.

Unknown Attendee: This concludes our question and answer session.

Peter Altman: I would like to turn the conference back over to Dr. Altman for any closing remarks. Thank you very much, Betsy. So all that we have accomplished here at BioCardia so far is to the credit of our amazing BioCardia team. Our incredible clinical partners, the hundreds of patients who have participated in our trials, to the FDA and the PMDA, which have been helpful in their reviews and input, and to the investors who have enabled our efforts. I thank everyone who has helped our mission to develop and enhance therapies to treat cardiovascular disease.

Unknown Attendee: We expect to deliver a rewarding end to 2024 and an incredible 2025 if we are successful in our efforts. Thank you for being on the call and have a great afternoon. The conference is not concluded.

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