Q4 2023 BioCardia Inc Earnings Call
Operator: Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2023 year-end 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 competent specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions; to ask a question, you may press star then one on your telephone keypad. To adjourn your question, please press star then 2.
Ladies and gentlemen, thank you for standing by.
Good afternoon, and welcome to the bio cardio 'twenty two 'twenty three year end financial results and business update conference call.
At this time all participants are in a listen only mode.
Should you need assistance. Please signal ex all those specialists by pressing the star followed by zero.
After todays presentation, there will be an opportunity to ask questions.
To ask a question Star then one on your phone keypad too.
To withdraw your question. Please press Star then two.
Operator: Participants on 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 Peto of BioCardia and Vascular Relations. Please go ahead, Miranda.
Participants on 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 after one hour absolutely and on the call.
I would now like to turn the call over to Miranda Pizza.
Miranda Peto Benvenuti: Cardio Investor Relations. Please go ahead Miranda.
Miranda Peto Benvenuti: Thank you Rocco and good afternoon, and thank you for participating in today's conference call. Joining me from myocardial leadership team are Peter I'll mention ph D, President and Chief Executive Officer, and David Mcclung, The company's Chief Financial Officer drew.
Miranda Peto: 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, Outlook, Analysis, and Current Expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approval. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.
During this call management will be making forward looking statements, including statements that address myocardial <unk> expectations for future performance and operational result references to management's intentions beliefs projections.
Miranda Peto Benvenuti: Outlook analyses and current expectations.
Miranda Peto Benvenuti: Factors include among others, the inherent uncertainties associated with developing new products technologies and obtaining regulatory approvals.
Miranda Peto Benvenuti: We're looking statements involve risks and other factors that may cause actual results to differ materially from those statements.
Miranda Peto: 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 this morning. The content of this call contains time-sensitive information that is accurate only as of today, March 27, 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 Peter Altman, PhD, BioCardia's President and CEO. Peter, please go ahead.
Miranda Peto Benvenuti: More information about these risks please refer to the risk factors and cautionary statements. Just go ahead and buy a car you report on Form 10-K filed with the SEC. This morning.
Miranda Peto Benvenuti: This call contains time sensitive information that is accurate only as of today March 'twenty seven 'twenty 'twenty four except as required by law. The company disclaims any obligation to publicly update or revise any information to reflect events or.
Miranda Peto Benvenuti: Instead of them occur after this call.
Miranda Peto Benvenuti: Now my pleasure to turn the call over to Peter Ho.
Peter Ho: E D Cardenas, President and CEO Peter Please go ahead.
Peter A. Altman: Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's current efforts are focused on advancing its autologous and its allogeneic cell therapy platforms to treat significant unmet cardiovascular diseases, specifically ischemic heart failure and chronic myocardial. All of our cell-based therapies involve local delivery of the therapeutic to the heart where we intend them to act locally. For example, our lead cardiac autologous cell therapy is targeted to treat ischemic heart failure of reduced ejection fraction. Today, heart failure of reduced ejection fraction remains a significant unmet clinical need as none of the recently approved therapies reduce mortality, which remains at approximately 10% per year. To put this into context, it has been reported that heart failure is as malignant as some common cancers; men with heart failure have a worse five-year survival than do men with either prostate or bladder cancer. Women with heart failure have been shown to have a worse five-year survival than women with breast cancer.
Peter Ho: Thank you Miranda and good afternoon to everyone on the call.
Peter Ho: Myocardial current efforts are focused on advancing its autologous and allogeneic cell therapy platforms to treat significant unmet cardiovascular diseases, specifically ischemic heart failure and chronic myocardial ischemia.
Speaker Change: All of our cell based therapies involves local delivery of the therapeutic.
Well, we intend them to act locally.
Speaker Change: Our lead car T autologous cell therapy is targeted to treat ischemic heart failure of reduced ejection fraction.
Speaker Change: Today heart failure reduced ejection fraction remains a significant unmet clinical need as none of the recently approved therapies reduce mortality, which remains at approximately 10% per year.
Speaker Change: To put this into context. It has been reported that heart failure is as malignant and some common cancers.
Speaker Change: Men with heart failure have a worst five year survival than do men with either prostate or bladder cancer.
Speaker Change: Women with heart failure had been shown to have a worst five year survival than women with breast cancer.
Peter A. Altman: Heart failure also impacts more than 5 million patients in the United States and is growing; in our lead cardiac cell therapy, patients have cells taken from their bone marrow, processed at Point of Care in our Disposable Cell Processing Kit, and delivered through our minimally invasive steerable catheter system to 10 targeted regions around damage in the heart. We now have three clinical trials in the treatment of heart failure with CARDI-AMP cell therapy that lends support for both its safety and therapeutic efficacy for patients having ischemic heart failure of reduced ejection fracture.
Speaker Change: Heart failure also impacts more than 5 million patients in the United States and is growing.
Speaker Change: And our lead cardiac cell therapy.
Speaker Change: Patient has cells taken from their bone marrow processed at point of care and our disposable cell processing kit and.
Speaker Change: And delivered through our minimally invasive gerbil catheter system to 10 targeted regions around damage in the heart.
Speaker Change: We now have three clinical trials in the treatment for heart failure with the cardiac cell therapy that lend support for both safety and therapeutic efficacy for patients, having ischemic heart failure reduced ejection fraction.
Peter A. Altman: Our recent experience, in missing the primary pre-specified endpoint in our cardiac heart failure clinical trial, while not our chosen path, is not a unique experience for those developing therapies for this disease. Our world-class Executive Steering Committee and the distinguished cardiologists on our Data Safety Monitoring Board see that the results just presented from the cardiac heart failure trial are compelling, as evidenced by our investigators and our Data Safety Monitoring Board continuing to support and be involved in the program. The interim data presentation from the CARDI-AMP Heart Failure Trial presented scientifically earlier this month shows a 37% relative risk reduction in heart death equivalent. 9.2% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events, reduced cardiac arrhythmias, and enhanced heart function in treated patients relative to the control patient. In addition, the available interim data showed that for an important subset of patients who presented at the Screening Baseline Visit with higher levels of NT ProBMP, a well-established biomarker of active heart failure and stress to the heart.
Speaker Change: Our recent experience.
Speaker Change: And missing the primary three.
Speaker Change: Specified endpoint in our cardiac heart failure clinical trial.
Speaker Change: While not our chosen path.
Speaker Change: It's not a unique experience for those developing therapies for this disease.
Speaker Change: Our World Class Executive Steering committee and the distinguished Cardiologists on our data safety monitoring board.
Speaker Change: The results just presented from the cardiac heart failure trial are compelling.
Speaker Change: As evidenced by our investigators and our data safety monitoring board continuing to support and be involved in the program.
Speaker Change: The interim data presentation from the cardiac heart failure trial presented scientifically earlier. This month shows 37% relative risk reduction arc guests equivalents, nine 2% relative risk reduction and non fatal major adverse cardiac and cerebral vascular events reduced cardiac arrhythmias.
Speaker Change: Enhanced heart function in treated patients relative to the control patients.
Speaker Change: In addition, the available interim data showed that for an important subset of patients who presented at the screening baseline visit with higher levels of NT Pro BNP, a well established biomarker of active heart failure and stress to the heart.
Peter A. Altman: The reduction in heart death equivalents was even greater; of note, all current leading heart failure trials where we have looked require elevated NT-ProBNP for patients to be eligible to participate in these trials. In these patients, an analysis of all available data up to two years in the cardiac heart failure trial with a mean of 20 months of follow-up shows improvements over controls, including an 86% relative risk reduction in mortality and a 24% relative risk reduction of major adverse cardiac and cerebrovascular events. Further, all clinical outcomes included in this subset analysis favored cell therapy, including improved quality of life as measured using the Minnesota Living with Heart Failure Questionnaire, reduction of NT pro BNP level, greater six-minute walk test, and Improved Echocardiography Parameters of Left Ventricular Ejection Fraction, Left Ventricular End Systolic Volume, and Left Ventricular End Diastolic Volume. Both the reduced heart death equivalents and improved quality of life outcomes demonstrate statistical significance favoring therapy in this subset analysis.
Speaker Change: The reduction in heart gets equivalents were even greater.
Speaker Change: Of note all current leading heart failure trials, where we have looked require elevated NT pro BNP for patients to be eligible to participate in these trucks.
Speaker Change: In these patients and analysis of all available data up to two years in the cardiac heart failure trial with a mean of 20 months follow up shows improvements over controls, including an 86% relative risk reduction in mortality and a 24% relative risk reduction.
Speaker Change: Of nonfatal major adverse cardiac and cerebral vascular events.
Speaker Change: Further all clinical outcomes included in this subset analysis favorite cell therapy, including improved quality of life as measured using the Minnesota living with heart failure questionnaire reduction of N T Pro BNP levels, greater six minute walk test distance and improved echocardiographer.
Speaker Change: <unk> left ventricular ejection fraction left ventricular end systolic volume and left ventricular end diastolic volume.
Speaker Change: Both the reduced heart deaths equivalents and improve quality of life outcomes demonstrated statistical significance favoring therapy in this subset analysis.
Peter A. Altman: This is the subgroup we have designed the CARDI-AMP Heart Failure II confirmatory trial around, which was approved by FDA in December, activated in February, and approved for reimbursement by Medicare in March. We continue to monitor patients enrolled in the cardiac heart failure clinical study in which both patients and evaluating physicians are blinded to the treatment, and we expect a complete follow-up in this study in October 2024. As we already have more than 90% of the patient follow-up data that we will ultimately have in the final analysis, we don't expect the results to change significantly.
Speaker Change: This is the subgroup we have designed the cardiac heart failure to confirmatory trial around which was approved by FDA in December activate it in February and approved for reimbursement by Medicare in March.
Speaker Change: Yeah.
Speaker Change: We continue to monitor patients enrolled in the cardiac heart failure clinical study in which both patients and evaluating physicians are blinded to the treatment group and we expect to complete follow up in this study in October 2024.
Speaker Change: As we already have more than 90% of the patient follow up data that we will ultimately have in the final analysis, we don't expect the results to change significantly.
Peter A. Altman: This final data on the patients already treated is expected to be provided to Japan's Pharmaceutical and Medical Device Agency toward approval for the indication of ischemic heart failure. Our formal consultation in November 2023 suggested that if the data remains as good as it currently appears to be at the final analysis, they are inclined to support approval based on this data without requiring a trial. Subsequent interactions and consultations with Japan's Pharmaceutical and Medical Device Agency are expected. The confirmatory Heart Amp Heart Failure 2 study approved by FDA in December 2023 is a phase 3, multi-center, randomized, double-blind, controlled study of up to 250 patients, with NT pro BMP levels greater than 500 picograms per milliliter, at up to 40 centers in the United States.
Speaker Change: This final data on the patients already treated is expected to be provided to Japan's pharmaceutical and medical device agency toward approval for the indication of ischemic heart failure.
Our formal consultation in November 2023 has suggested that if the data remains as good as it currently appears to be at the final analysis. They are inclined to support approval based on this data without requiring a trial in Japan.
Speaker Change: Subsequent interactions in consultations with Japan's pharmaceutical and medical device agency are expected.
Speaker Change: The confirmatory party at heart failure, two study approved by FDA in December 2023 is a phase three multicenter randomized double blind controlled study of up to 250 patients with NT pro BNP levels greater than 500 <unk>.
Speaker Change: <unk> per milliliter and up to 40 centers in the United States.
Peter A. Altman: The primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis, tiers, starting with the most serious events would be tier one, all caused including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event. Tier 2 Non-Fatal Major Adverse Coronary and Cerebral Vascular Events, and Tier 3 change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months.
Speaker Change: The primary endpoint is an outcomes composite score based on a three tiered finkelstein schoenfeld hierarchical analysis.
Speaker Change: The tears, starting with the most serious events would be tier one all cause deaths.
Speaker Change: Including cardiac deaths equivalents, such as heart transplant or left ventricular assist device placement ordered by time to event.
Tier two non fatal major adverse coronary and cerebral vascular events and tier three change from baseline and quality of life at a minimum of 12 months and a maximum of 24 months.
Peter A. Altman: The trial, as designed, 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. We are actively working with our heart failure network and leaders in cardiology to enroll and complete this study as soon as possible. We expect additional news throughout the year on this. Our Cardiac Cell Therapy Trial for Chronic Myocardial Ischemia, or BCDO2, is a Phase 3 multicenter, randomized, double-blinded control study intended to include up to 343 patients at up to 40 clinical sites.
Speaker Change: The trial is designed as a greater than 90% power for statistical probability of success to meet the primary endpoint based on the cardiac heart failure trial interim results.
Speaker Change: We are actively working with our heart failure network leaders in cardiology to enroll and complete the study as soon as possible.
Speaker Change: We expect additional news throughout the year on this study.
Speaker Change: Our cardiac cell therapy trial for chronic myocardial ischemia or <unk> is a phase III multicenter randomized double blind controlled study intended to include up to 343 patients at up to 40 clinical sites.
Peter A. Altman: The company expects to complete enrollment in the rolling cohort soon and begin the randomized phase of the trial. A number of leading investigators, including both principal investigators in this trial, believe this to be the most compelling indication for the cardiomyopatologist cell. Planning for the randomization phase continues based on promising experience in the patients treated to date. Part of this planning includes utilizing the Medicare reimbursement in place for both the control and treatment arms of this investigational therapeutic study to offset clinical costs.
Speaker Change: The company expects to complete enrollment in the rolling cohorts soon and begin the randomized phase of the trial are.
A number of leading investigators, including both principal investigators in this trial believes this to be the most compelling indication for the cardiac autologous cell therapy.
Speaker Change: Planning for the Randomization phase continues based on promising experienced in the patients treated to date.
Speaker Change: Part of this planning includes utilizing the Medicare reimbursement in place for both the control and treatment arms of this investigational therapeutic study to offset the clinical costs.
Peter A. Altman: The company's CARDI-ALLO, or Allogeneic Cell Therapy for Ischemic Heart Failure, or BCDAO-3, is a Phase I-II clinical program encompassing 69 patients. We have reported first patient enrolled in the fourth quarter of 2024. At the technology and heart failure therapeutics meeting earlier this month, it was also reported that there have been no adverse events and follow-up. The CARDI-ALLO heart failure study is intended to build on three previous trials of mesenchymal stem cells in ischemic heart failure using the company's proprietary Helix delivery, Encompassing 93 patients treated with no treatment emergent serious adverse events and compelling early signals for benefit, This is a precision medicine study as we are focusing this therapy for the first times on patients who have elevated NT-proBNP and elevated high-sensitivity C-reactive protein, a marker of inflammation that has been reported for patients with heart failure, most responsive to immunomodulatory mesenchymal disease.
Speaker Change: The Companys Carty, aloe or allogeneic cell therapy for ischemic heart failure or BCD L. Three is a phase one two clinical program encompassing 69 patients.
Speaker Change: We have reported first patient enrolled in the fourth quarter of 2024 at the technology and heart failure Therapeutics meeting earlier. This month. It was also reported that there've been no adverse events and follow up.
Speaker Change: The Carty Allo heart failure study is intended to build on three previous trials of messing time will stem cells in ischemic heart failure, using the company's proprietary helix delivery system encompassing 93 patients treated with no treatment emergent serious adverse events and compelling early signals for benefit.
Speaker Change: This is a precision medicine study as we are focusing this therapy for the first times on patient who have elevated NT pro BNP and elevated high sensitivity C. Reactive protein a marker of inflammation that has been reported for patients with heart failure, most responsive to immuno <unk>.
Speaker Change: Modulus Tory message kind of stem cells.
Peter A. Altman: Our strategy to advance our CardioloHF program is to seek partnerships and grant funding as it will not have the benefit of Medicare reimbursement in the United States. We intend the Phase 2 portion of the study to be performed in both the United States and Japan, where it has the potential to receive conditional approval based on this one trial, in 2023. We evolved our Helix Biotherapeutic Delivery partnering business to focus on long-term partnerships where BioCardia shareholders participate meaningfully in the value created. Our Helix Trans Endocardial Biotherapeutic Delivery System is a therapeutic platform for minimally invasive targeted delivery of biological agents to the heart.
Speaker Change: Our strategy to advance our cardiac slow HFF program is to seek partnerships and grant funding as it will not have the benefit of Medicare reimbursement in the United States.
Speaker Change: We intend to phase II portion of the study to be performed in both the United States.
Speaker Change: And in Japan, where it has potential to receive conditional approval based on this one trial.
Speaker Change: In 2023.
Speaker Change: We evolved our helix biotherapeutic delivery partnering business to focus on long term partnerships, where biochar to your shareholders participate meaningfully and the value created.
Speaker Change: Our helix trends endocardial biotherapeutic delivery system as a therapeutic enabling platform for minimally invasive targeted delivery of biologic agents to the heart.
Peter A. Altman: This platform enables all of our therapeutic development efforts, and it empowers a seamless transition from bench to commercialization for partners. Our biotherapeutic delivery partnerships are expected to enhance future treatment options for millions of patients suffering from heart disease, offset the cost of biotherapeutic delivery for our own therapeutic programs, and provide our shareholders with meaningful revenue sharing should our partnering efforts contribute to successful therapeutic development. In September 2023, our biotherapeutic delivery partner, CellProThera, announced completion of enrollment in their Phase I-II cell therapy study in post-myocardial infarction, and results are expected soon. In March of 2024, we announced a biotherapeutic delivery partnership with StemCardia for a long-term partnership to advance StemCardia's investigational pluripotent stem cell product candidate for the treatment of heart failure, initially through a Phase I-II clinical study.
Speaker Change: This platform enables all of our therapeutic development efforts and it empowers a seamless transition from bench to commercialization for partners.
Speaker Change: Our biotherapeutic delivery partnerships are expected to enhance future treatment options for millions of patients suffering from heart disease, offset the cost of biotherapeutic delivery for our own therapeutic programs and provide our shareholders with meaningful revenue sharing should our partnering efforts contribute to successful therapeutic.
Speaker Change: Development.
Speaker Change: In September 2023, our biotherapeutic delivery partner self Rothera announced completion of enrollment in their phase one to cell therapy study in post myocardial infarction and results are expected soon.
Speaker Change: In March 2024, we announced the biotherapeutic delivery partnerships with stem cardia for a long term partnerships to advance them cardiac <unk> investigational pluripotent stem cell product candidate for the treatment of heart failure initially through a phase <unk> clinical study.
Peter A. Altman: Two additional premier biotherapeutic delivery partnerships are expected in 2024; our MorphAccess Innovations Business is based on the steerable catheter systems through which we perform all of our helix procedures for biotherapeutic intervention. We are working to obtain FDA approval in Q3 2024 for a product family of morphed DNA steerable sheath introducers in a variety of sizes and lengths with clinical indications for use in the heart and peripheral BioCardia is actively exploring pathways for commercializing these products in the second half of the year. In summary, we have increased confidence in the potential of our autologous cardiac cell therapy program in both ischemic heart failure and in chronic myocardial ischemia based on the data we have before us.
Speaker Change: Two additional premier biotherapeutic delivering partnerships are expected in 2024.
Speaker Change: Yeah.
Speaker Change: Our more access innovations business is based on the steer will catheter systems through which we perform all of our helix procedures for bio therapeutic intervention.
Speaker Change: We are working to obtain FDA approval in Q3 2024 for a product family of morph DNA steer will sheet introduces and a variety of sizes and lengths with clinical indications for use in the hearts and peripheral vasculature.
Speaker Change: <unk> is actively exploring pathways for commercializing these products in the second half of the year.
Speaker Change: In summary, we have increased confidence in the potential of our autologous cardiac cell therapy program in both ischemic heart failure and in chronic myocardial ischemia based on the data we have before US we are focused strategically on advancing these two clinical programs in a cash neutral fashion with the benefit of the Medicare.
David Mcclung: We are focused strategically on advancing these two clinical programs in a cash-neutral fashion with the benefit of the Medicare reimbursement we already have. Similarly, we are working on securing grants and partnerships around our allogeneic programs to support their continued clinical development, and implementing a recurring revenue biotherapeutic delivery partnering model that includes revenue sharing with our experienced world-class team and our Helix biotherapeutic delivery system. In the coming weeks, we anticipate enrollment of patients in our Cardiac Heart Failure II Confirmatory Study, and we will be working on a number of business development activities I will now pass the call to David McClung, our CFO, who will review our Q3-Q4 2023 financial results.
Speaker Change: Reimbursement, we already have in place.
Emily we are working on securing grants and partnerships around our allogeneic programs to support their continued clinical development.
Speaker Change: In implementing our recurring revenue biotherapeutic delivery partnering model that includes revenue sharing with our experienced world class team and our helix biotherapeutic delivery system.
Speaker Change: In the coming weeks.
Speaker Change: We anticipate enrollment of patients in our cardiac heart failure to confirmatory study and we will be working on a number of business development activities, which have potential to be impactful in our pant plans for staying listed on NASDAQ.
Speaker Change: I will now pass the call to David Mcclung, Our CFO, who will review our Q3 Q4 2023 financial results. Thank you Peter.
David Mcclung: Thank you, Peter, and good afternoon, everyone. Revenues were $0.5 million in 2023 compared to $1.4 million in 2022, primarily due to the timing of revenue earned from new and existing collaborative partners, coupled with the fulfillment of performance obligations. In 2022, expenses year over year decreased by 9%. Research and development expenses decreased to $7.7 million in 2023, compared to $8.8 million in 2022, primarily due to the completion of enrollment in the CARDI-AMP heart failure trial, coupled with reduced expenses in clinical and related supporting functions. Selling general and administrative expenses were unchanged at $4.4 million in both 2023 and 2022.
David Mcclung: And good afternoon, everyone.
David Mcclung: Revenues were $5 million in 2023 compared to $1 4 million in 2022, primarily due to the timing of revenue largely to do with existing collaborative partners coupled with the fulfillment of performance obligations in 2022.
David Mcclung: Expenses year over year decrease by 9%.
Research and development expenses decreased to $7 $7 million in 2023 compared to $8 $8 million in 2022, primarily due to the completion of enrolment in the cardiac heart failure trial, coupled with reduced expenses and clinical and related supporting functions.
David Mcclung: Selling general and administrative expenses were unchanged at $4 $4 million in both 2023 and 2022.
David Mcclung: Our net loss in 2023 was $11.6 million compared to $11.9 million in 2022. We used $10 million in cash for operations in 2023 compared to $10.6 million in 2022. And BioCardia ended the year with $1.1 million in cash and cash equivalents, which together with financing proceeds in the first quarter of 2024, provide runway into the second quarter of 2020. However, as disclosed in our recent SEC filings, the company has received a determination letter from NASDAQ advising us that the company is not in compliance with listing standards and is subject to delist. BioCardia intends to remain listed on NASDAQ Capital Marks.
David Mcclung: Our net loss in 2023 was 11 6 million compared.
David Mcclung: Compared to a $11 $9 million in 2022.
David Mcclung: We used $10 million in cash for operations in 2023 compared to $10 $6 million in 2022.
David Mcclung: And Biochar do you ended the year with $1 1 billion in cash and cash equivalents, which together with financing proceeds in the first quarter of 2024 provide runway into the second quarter of 2024.
David Mcclung: As disclosed in our recent SEC filings. The company has received a determination letter from NASDAQ advising us that the company is not in compliance with listing standards and is subject to delisting.
David Mcclung: <unk> intends to remain listed on NASDAQ capital markets.
Operator: Accordingly, BioCardia is appealing the decision and has requested a hearing where the company will submit its plan to regain compliance. BioCardia has a state NED listing or suspension of the company securities pending the, This concludes management's prepared comments, and we're happy to take questions from attendees. Thank you. At this time, we will open the call to questions. Should you wish to ask a question on today's call, you will need to press star then the number one on your telethon. If your question has been answered and you wish to withdraw your request, you may do so by pressing star then 2.
David Mcclung: Accordingly, myocardial appealing the decision has requested a hearing where the company will submit its plan to regain compliance.
David Mcclung: Fuel has stayed anybody listening or suspension of the company's securities pending the hearing.
David Mcclung: This concludes management's prepared comments and we're happy to take questions from attendees.
None: Thank you.
None: At this time, we will open the call to questions.
None: Should you wish to ask a question on today's call.
None: Press Star then the number one on your telephone.
None: For your question.
None: Wish to withdraw your request you may do so by pressing Star then two.
Operator: If you are using a speakerphone, please pick up your handset before entering your request and speaking on the call. One moment please for the first question. And today's first question comes from Jim Smith at Alpha Street. Please go ahead. Hello, Mr. Smith, your line is open, sir.
None: There isn't a speakerphone please pick up your handset.
None: Question.
None: On the call one moment please for the first question.
None: The first question comes from Joe Smith. Please go ahead.
Hello, Mr. Smith's your line is open Sir.
None: Yes.
Operator: And it appears we have lost Mr. Smith's connection. Our next question today comes from Brent Pearson, a private investor. Please go ahead. Good afternoon, gentlemen.
None: And it appears.
Joe Smith: We lost connection.
Joe Smith: Our next question today comes from Bryan Pearson, a private Investor. Please go ahead.
Joe Smith: Yes.
Bryan Pearson: Good afternoon gentlemen.
Bryan Pearson: I saw that in Q4, you filed a $50 million prospectus.
Brent Pearson: I saw that in Q4, you filed a $50 million prospectus. Is that planned to get funding through your BCDA-01 and 02 trials for the next few years? Is part of that to be put into a ramp-up if devices get approved, or if you get approval in Japan and you need to ramp up production? Could you give us any commentary that would help us understand the intention for that $50 million, David?
Bryan Pearson: Is that plans to get funding through your <unk>, one and <unk> two trials for the next few years as part of that to be.
Bryan Pearson: Put into a ramp up if devices get approved or if you get approval in Japan, and you need to ramp up production could you give us any any commentary that would help us understand.
Bryan Pearson: The intention for that $50 million.
None: So I'll take David Okay.
David Mcclung: Okay. Well, this is an S3 we had on file that expired in October. Simply just refreshing RS3 again so we have another one on file.
None: Okay.
David Mcclung: Well this is.
David Mcclung: We have our industry, we had on file that expired in October.
David Mcclung: This is simply just refreshing RFS III again, so we have another another one on file to typical resource that we want to have available to us we'll use for Atms and other other.
David Mcclung: It's a typical resource that we want to have available to us. We'll use it for ATMs and other things as we need. Unknown Speaker Okay, understood. Okay, well, I appreciate the color there.
David Mcclung: Things that we need.
None: Understood, Okay, well I appreciate the color there. So it's just it's more along the lines of bumping along and existing prospectus that you want to keep open in terms of your capital needs throughout the rest of the year I assume youre going to look at at the market financings as as as things are.
David Mcclung: So it's just it's more along the lines of bumping along and existing perspectives that you want to keep open. In terms of your capital needs throughout the rest of the year, I assume you're going to look at market financings as things become apparent. And I assume that you don't expect to have a much different capital usage than you had through 2023. Is that something that we can count on? Joe, Joe, these are great questions.
None: Uh huh become apparent and I assume that you don't expect to have.
None: A much different capital usage than you had through 2023 is that is that something that we can count on.
None: Joe Joe These are great questions and as where we are right. Now. This is actually this is sort of the eye of the storm.
David Mcclung: And as for where we are right now, this is actually, you know, this is sort of the eye of the storm. Our ongoing business development activities, as we've shared, interweave with this. And so, you know, we are proceeding with really all options on the table, and things will evolve in the coming months as we have our discussions with NASDAQ. So I think that's probably the best way to describe it.
Joe Smith: Our ongoing business development activities as we've shared inter we've with this and so we are we are proceeding with really all options on the table.
Joe Smith: And things will evolve in the coming months as we have our discussions with with NASDAQ.
Joe Smith: So I think thats, probably the best way to describe it as far as your second follow up question.
David Mcclung: As far as your second follow-up question, you know, our cash needs, I would actually say that, you know, our cash needs today are modest. We have publicly disclosed that our burn rate has been significantly reduced as we turn down the spend on the clinical trial that we're now doing follow-up on. The spend could go back up as we accelerate in cardiac heart failure to be closer to what it was last year. And the variety of partnerships that are coming together could actually result in a non-dilutive reduction in our burn rate. So, you know, these are the forces that are playing out here right now. I don't expect a significant increase in the burn rate, even if we had no revenues to date, primarily because of Medicare reimbursement and the stage of the three programs we're advancing.
Joe Smith: Our cash needs.
Joe Smith: <unk>.
Joe Smith: I would actually say that our cash needs today are modest we have publicly disclosed that our burn rate has been significantly reduced as we turned down the spend on the clinical trial that were now doing follow up on.
Joe Smith: The spend could go back up as we get to accelerate in the cardiac heart failure too to be closer to what it was last year.
Joe Smith: And the variety of partnerships that are coming together could actually.
Joe Smith: Results in non dilutive reduction in our burn rate. So these are the forces that are playing here right now I don't expect.
Joe Smith: <unk>.
Joe Smith: A significant increase in the burn rate.
Joe Smith: Even if we had no revenues.
Joe Smith: <unk>.
Joe Smith: Primarily because of the Medicare reimbursement and the stage of the three programs. We're advancing the first to have the reimbursement and then the third program is still in the phase one dose escalation phase which is.
Brent Pearson: The first two have reimbursement, and then the third program is still in the phase one dose escalation phase, which is more limited. But we are seeking significantly non-dilutive financing for that. And Brent, forgive me; I referred to you as Joe earlier. My apologies. No, no, no worries. I appreciate the color there. I guess my last question was, we saw that there were some partner developments mentioned in Q2 and Q3. Does the horizon look about the same? Is there any color that you can provide on that front?
Joe Smith: More limited, but we are seeking a significantly non dilutive financing for that and Brent forgive me I.
None: I referred you as Joe earlier, my apologies no.
None: No no worries I appreciate the color there I guess my last question was we.
Brent: We had seen that there was some partner developments mentioned in Q2 and Q3.
Brent: Does the horizon look about the same is there any color that you can provide on that front.
Peter A. Altman: Yes, so I did share that we expect to have two additional biotherapeutic partnerships this year, and I even believe we have one targeted to be completed this next quarter. But I'd have you think about it in this fashion when we do work with a partner.
None: Yes, so I did share that we expect to have.
None: Two additional biotherapeutic.
None: Hartner ships this year and I, even believe we have one targeted to be completed this next quarter.
None: The.
None: But I'd have you think about it in this fashion when we do work.
None: With a partner oftentimes, we create a very significant data set that takes a period of a year or two to develop and then they think about how to take that forward into the clinic or they are in the clinic already they think about how to take that to the next stage of development and so each time, we partner we receive.
Peter A. Altman: Often, we create a very significant data set that takes a period of a year or two to develop, and then they think about how to take that forward into the clinic, or they are in a clinic already, and they think about how to take that to the next stage of development. And so each time we partner, we receive revenues, but the amount of resources being spent on the program is far more significant for our partners. One of the things that we're choosing to do is we're focused completely on long-term partners. We do not sell delivery; we partner.
None: <unk> revenues, but the amount of resources being spent on the program is far more significant by by our partners.
None: One of the things that we're choosing to do is we're focused.
None: <unk> on long term partnerships, we do not sell delivery systems, we partner and that means that if there is value created from the collaboration.
Peter A. Altman: And that means that if there's value created from the collaboration, then we, meaning the BioCardia shareholders, will ultimately benefit from that, even if BioCardia does not actually wind up commercializing alongside our partners in the future, which if we do, the value for our shareholders would be quite, And that's really our goal at the end of the day, but if we're going to do the work with a partner, enable them access to our technology and know-how and experience team, we not only need to get paid for the work we do along the way and the products we provide, but the value creation on the therapeutic side, we also need to participate in. And so that's a new structure that we're having going forward. Understood. Thank you so much.
None: Then we meaning the biochar dear shareholders will ultimately benefit from that even if biochar, yet does not actually wind up commercializing alongside our partners in the future, which if we do the value for our shareholders would be quite significant.
None: And that's really our goal at the end of the day, but we don't if we're going to do the work with a partner enable them access to our technology and Knowhow and experienced team.
None: We not only need to get paid for the work, we do along the way and the products, we provide but the value creation on the therapeutic side, we also need to participate in and.
And so that's a new structure that we're having going forward.
None: And it makes sense it doesn't cause it's a little different but it doesn't cause anyone any undue concerns.
Brent Pearson: I appreciate the questions, Brad. Thank you. And our next question today comes from George Well with No Company Given. Please go ahead. Hello.
None: Understood. Thank you so much.
None: I appreciate the questions rent.
Thank you and our next question comes from George well with no company given please go ahead.
George: Hello, Yes.
George Well: Yes, thank you for taking my questions. Peter, I just had, actually, you just answered most of, you've provided most of the information I had for regarding partnerships, but I guess it looks like you've picked up an additional partner this year, per the press release this afternoon.
George: My questions.
George: Peter just had actually you just answered most of.
George: Most of that you've provided most of the information I have for regarding partnerships, but I guess it looks like you picked up an additional partner.
George: This year per the press release this afternoon.
George Well: There were two at the end of the last year, and it looks like you have two. And then in the press release, StemCardia came out, but then you have two additional partnerships that are lined up for this year. Is that accurate?
George: There were two at the end of last year and it looks like you have to then in the press release stem cardiac came out but then you have two additional partners chips that are lined up for this year is that accurate.
Peter A. Altman: Right now, so just a broad brushstroke, we have our three programs that we're advancing, and we have two partners under this structure that we've been public about. There are other folks we do work with that we're not public about, and the other two players are CellProThera and StemCardia. But we have said in the press release, in the targeted milestones, that we expect to enter into two additional biotherapeutic delivery partnerships in the year ahead. And I think we've also said that the first one of those we expect to close in Q2. The challenge is always, how do you create all the value that's inherent in a platform? And how do you do it...
None: Right now we have so just a broad brush stroke, we have our three programs that we're advancing and we have two partners under this structure that we've been public about there's other folks we.
None: <unk> worked with it we're not public about.
None: And the other two players are sell pro thera and stem cardiac.
None: We have said in the press release and the targeted milestones that we expect to enter into two additional biotherapeutic delivery partnerships in the year ahead and I think we've also said that the first one of those and we expect to.
None: Close in Q2.
None: This year.
None: So that's.
None: The idea is to create this long term value in everything that we do is trying to we have these platforms and the challenge is always how do you create all the value that's inherent in our platform and how do you. So for cardiac it goes into a number of indications we are advancing two of those for our allogeneic platform. It goes in many directions.
Peter A. Altman: So for CardiAmp, it goes into a number of indications or is advancing two of those. For our Allogeneic platform, it goes in many directions, and we're focused on the one where we have the most experience and data. But we've had discussions around taking that into a number of indications already. And the third platform we have is our Helix Biotherapeutic Delivery Platform. And this is this biotherapeutic partnering business.
None: And we're focused in on the one where we have the most experience in data, but we've had discussions around taking that into a number of indications already.
None: And the third.
None: <unk> platform, we have is our helix biotherapeutic delivery platform and this is this biotherapeutic partnering business.
Peter A. Altman: And what's nice is the data I share with our lead program utilizes our Helix platform. And so that safety data is really compelling for folks developing their own L-gene or protein-based therapy for the heart. And these clinical indications we're going after are so enormous that it's in our investors' interest, and it's in our ethical interest as a group trying to help these patients to enable these partners. I like to say that at the end of the day, if there are two therapeutics competing for the same patient, I think that market penetration will accelerate because the clinical consideration will be not should I treat or should I not treat, but which should I treat with when So that's sort of the nature of the partnering. And then the last piece, this is where we're talking about partnering and getting value from platforms. Our Helix system uses our state-of-the-art Morph DNA steerable introducer platform for all of its procedures.
None: And what's nice is at the data I shared.
None: With our lead program utilizes our helix platform and so that safety data is really compelling for folks developing their own L gene or protein based therapy for the heart and these clinical indications we're going after are so enormous.
None: <unk>.
None: It's in our investors' interest and it's in our ethical interest as a group trying to help these patients to enable these partners.
None: I like to say that at the end of the day, if theres two therapeutics competing for the same patient.
None: Think that the market penetration will accelerate because the clinical consideration will be not should I treat or should I not treat.
None: Which should I treat with when and how often will become the new mindset. So that's sort of the nature on the partnering and then the last piece because we're talking partnering.
None: And getting value from platforms, our helix system uses our state of the art morph DNA <unk>.
None: <unk> introduced your platform for all of its procedure. So every helix procedure and every cell therapy procedure. We're advancing users are FDA cleared product and so we are going to be securing this year a product family based on that design for <unk>.
Peter A. Altman: So every Helix procedure and every cell therapy procedure we're advancing uses our Morph FDA-cleared product. And so we are going to be securing this year a product family based on that design for broad indications in cardiac and peripheral vascular disease. And although it doesn't have the same value proposition as our... Biotherapeutic Development Efforts, it's a way we can take our existing product, because it's already FDA-cleared, and expand it, that platform design, into other indications where it can have value. And I share with you, with a previous version of this, we did more than 10,000 procedures with our Morph platform, and we had a great relationship So it shows you that even though our cash is extremely tight, we are getting enormously valuable things done for shareholders.
None: Broad indications and cardiac and peripheral vascular disease.
None: Although it doesn't have the same value proposition.
None: As our.
None: Biotherapeutic development efforts, it's a way we can take our existing product because it's already FDA cleared and expanded that platform designed into other indications where it can have value and I share with you with a previous version of this we've done more than 10000 procedures with our more platform and we had a great <unk>.
None: <unk> shipped with a customer that just didn't make sense.
<unk>.
None: Financially.
None: But today, we've done some things with this has potential to have some really nice legs on it. So it shows you that even though our cash is extremely tight.
None: We are getting enormously valuable things done for shareholders.
George Well: Thank you. I appreciate that information. That clears a lot. I just had one other question regarding BCDA1 with the interim data that was presented at the HART conference this month. There was a reduction in arrhythmias for the treated group, and I was curious, is there any thought of, you know, why that reduction? where those results came from. I know that was something the University of Washington had worked on years ago to try to reduce that with stem cells. Any thoughts there that you could provide? I do.
None: Thank you I appreciate that information that clears up a lot.
None: I had one other question regarding <unk>, one with the interim data that was presented at the Heart conference.
None: Month, there was a reduction in the in the arrhythmia.
None: For the treated group and I was curious is there any thought of why why that reduction.
None: Where those results came from I know that was something like the University of Washington.
None: I'd worked on years ago to try to try to reduce the reduce that with the stem cells.
None: Any thoughts there or that you can provide.
Peter A. Altman: So, George, and by the way, great question. The arrhythmia signal is actually a pretty strong signal in our data, and it's remarkable. We present it as safety data, but one of the greatest concerns from a safety point of view is arrhythmia. And if you trigger a cardiac arrhythmia, it can actually be life-threatening. That's basically what a heart attack is. It's a cardiac arrhythmia that's caused by an obstruction in a blood vessel. Once your heart starts fibrillating, you know, you have basically two minutes to live because you're not pumping blood anymore.
I do so George.
George: That's a great question the arrhythmia signal is actually.
George: A pretty strong signal in our data and it's remarkable.
George: We presented a safety data, but one of the in this field where people are putting things.
George: Bell's genes and proteins into the heart one of the greatest concern from a safety issue is the arrhythmias and if you trigger a cardiac arrhythmia. It actually can be life threatening that's basically what our heart attack is it's a cardiac arrhythmia that's caused by an obstruction and a blood vessel that once you start.
George: Heart start stimulating.
George: Have basically two minutes to live because youre not pumping blood anymore.
Peter A. Altman: So that arrhythmia data is compelling evidence. Our investigators have been quite excited about it. Reduction in cardiac arrhythmias will be a pre-specified secondary endpoint in the Cardiac Heart Failure II trial because that's an efficacy claim in its own right. And you mentioned the group in Seattle. Interesting enough, that's the same group, I expect, that's behind stem cell therapy. The idea with some of those other cell types is that the great concern has been arrhythmias, because when you, and our cells don't become heart cells, but when you put a cell into the heart and it becomes a heart cell, all heart cells have what they call automatism, and that means they can create what's called an ectopic foci and trigger an arrhythmia.
George: So that arrhythmia data as compelling data.
None: Our investigators have been quite excited about it.
None: Reduction in cardiac arrhythmias will be a pre specified secondary endpoint in the cardiac heart failure to trial, because that's an efficacy claim in its own right.
None: And you mentioned the group in Seattle.
None: Interesting enough that that's the same group I expect that's behind stem cardiac.
None: The the idea with some of those other cell types.
None: Concern has been arrhythmia, because when you and ourselves don't become heart cells, but when you put a sell into the heart and it becomes a heart cell all heart cells have what they call automaticity and that means that can create what's called an ectopic foci and trigger an arrhythmia.
Peter A. Altman: And so the fact that we can go into the heart with our cells in CARDI-AMP or BCD-01 and deliver them to 10 different locations, I think we've shared. It's just hundreds of millions of cells.
None: And so the fact that we can go into the heart.
None: With ourselves in cardiac <unk>, CDO, one and deliver at 10 different locations.
None: I think we've shared.
None: Let's just say hundreds of millions of cells and we don't have any issues with arrhythmia, but rather we're seeing a great reduction in arrhythmias.
Peter A. Altman: And we don't have any issues with arrhythmias, but rather, we're seeing a great reduction in arrhythmias. I'm going to hypothesize here, because you asked, perhaps what's happening is the enhanced microvascular impacts of what we're delivering increase the healthiness of the cells locally so that we're reducing the number of ectopic foci in our own patients without trying to make heart cells. I also note that that result, that reduced arrhythmia burden that we see in the patient, could also be supporting why we have reduced mortality and reduced major adverse cardiac events. All of these things are linked together, but I'm sort of going out on a limb here, and one of the difficulties in medicine is always proving why something is happening. I guess the end result of that signal is that it's a nice signal.
None: Suggests that for.
None: Perhaps I'm just I'm going to hypothesize here because you asked perhaps what's happening is the.
None: The enhanced.
None: Microvascular impacts of what we're delivering increases the healthiness of the cells locally so that we're reducing the number of ectopic foci.
None: Our own patients without trying to make cart cells. I also note that that result that reduced.
None: Arrhythmia burden that we see in the patients.
None: Could also be supporting why we have reduced mortality and reduced major adverse cardiac events. In these studies now all of these things are linked together, but I'm sort of going out on a limb here and one of the difficulties in medicine is all proving why something is happening one way I guess the end result of that signal is it's a nice signal it has.
Peter A. Altman: It has excited our investigators, and we think it's quite valuable for these patients. That's great. That's all for me.
None: Cited our investigators and we think it's quite valuable for these patients.
None: Mhm Mhm that's great.
None: That's all for me thank you.
George Well: Thank you. Best of luck to you. So I appreciate George.
None: Best of luck.
None: I appreciate George.
Operator: And as a reminder, ladies and gentlemen, to ask a question, please press star then 1. Our next question is from Joe Smith with Alpha Street. Please go ahead. Hi, good afternoon, everyone. Can you hear me?
None: And as a reminder, ladies and gentlemen to ask a question. Please press Star then one.
None: As soon as from Joe Smith was also sorry. Please go ahead.
Joe Smith: Hi, Good afternoon, everyone can you hear me.
Joe Smith: Yes, we can, Joe. Oh, hi, this is Lanzaron for Joe Pantginis from A2Invite. Thanks for taking our questions. So I wanted to ask if you can provide some color on the estimated timelines from data readouts, especially from Cardium's HF2 trial, which has a minimum follow-up period of 12 months. Is there any chance that we may have an interim data readout or preliminary data readout before those time points in 2024? So there's always the possibility.
Joe Smith: Yes, we can Joe.
Joe Smith: Oh, Hi, this is landon on for Joe <unk> from H C. Wainwright. Thanks for taking our questions. So I wanted to ask if you can provide some color on the estimated timelines from.
Landon: Data readouts, especially from <unk> II trial, which has a minimum follow up period of 12 months is there any chance that we may have an in between data read out on preliminary data we have had before those time points during 2024.
Landon: Yeah.
None: So there is always possibility right now we're focused on enrolling in that trial.
Peter A. Altman: Right now, we're focused on enrolling in that trial. My sense is, you know, it is the great question: when will everything be done? I would say in 2024, we're going to have the primary readout on BC01, the trial we've just completed, and we're aiming to take that to Japan. I think that's the biggest near-term news. And we'll keep folks posted on how we're doing in enrollment in the CARDI-AMP Heart Failure II confirmatory study. As I'm sure you can appreciate, we have 20 centers around the United States that have great experience. They can see that they helped their patients in the last trial. That's very helpful to us in recruiting patients. We also expect that we've done some things in the trial design to eliminate interim visits that we don't see as necessary now that we have such a great safety data set. So, the trial will be easier to perform.
None: Alright.
None: Is it is the great question when will everything be done.
None: I think.
None: I would say in 2024, we're going to have the primary readout on Bcl one of the trial, we just completed.
None: And we're aiming to take that to Japan, I think that's the biggest near term news.
None: And we will keep folks posted out we're doing in enrollment in the cardiac heart failure to confirmatory study.
None: As I'm sure you can appreciate we have 20 centers around the United States that have great experience. They can see that they help their patients in the last trial.
None: That's very helpful to us in enrollment we also expect.
None: We've done some things in the trial design to eliminate interim visits that we don't see as necessary now that we have such a great safety dataset.
None: So the trial will be easier to perform.
Peter A. Altman: And we also have the advantage that, you know, COVID is not omnipresent these days. So, we also think that it's going to significantly enhance our enrollment activities. I can share an anecdote that at some centers, you know, one of the biggest lead times in contracting a center for a clinical trial is actually the contract. And our contract for this study, at the centers where we've just been active, has the potential to be as short as a half page. That's a much easier contract to get done.
None: And we also have the advantages that COVID-19 is not omnipresent. These days. So we also think thats going to significantly enhance our enrollment activities I can share an anecdote that at some of the centers one of the biggest lead times and contracting of center on a clinical trial is actually the contract and our contract for this study.
None: At the centers, where we've just been active.
None: Has potential to be as short as a half a page.
None: That's a much easier contract to get done and so we will be advancing cardiac heart failure too.
Peter A. Altman: And so, we'll be advancing cardiac heart failure too. And we'll be sharing, as we enroll patients and we add sites, whether or not we introduce an interim analysis is TBD. I'd have, for now, I'd have you assume that we will not.
None: And we'll be sharing as we enroll patients and we add sites.
None: Whether or not we introduced an interim analysis.
None: Is TBD.
None: I would have.
None: For now I'd have you assumed that we will not.
Peter A. Altman: Because I think we've got some pretty good clarity on the direction to go with respect to this, and we've got a lot going on. And implementing that adaptive design review last year was a huge effort, and it was a huge accomplishment by our team, even though it did not result in a great victory. But it did provide us with the value proposition that we have today, that we have a very large data set that we're using, and we're on target. And we have hypotheses as to why some of the study design issues did not go our way.
None: Because I think we've got some pretty good clarity on the direction to go with respect to this and and we've got a lot going on.
None: And implementing that adaptive design review last year was a huge effort.
None: And it was a huge accomplishment by our team even though it did not result in you know.
None: Great victory.
None: But it did provide us with the value proposition that we have today that we have a very large datasets that we're using and we're on target and we have hypothesis as to why some of the study design issues did not go our way, but I think that.
Peter A. Altman: But I think that we're not trying to prove why things went wrong; we're trying to prove why this therapy is right. And that's where. Perfect, that's helpful. Thanks for the update. I appreciate the question. Please pass along my warm regards.
None: We can't we're not trying to prove why things went wrong. We're trying to prove why this therapy is right and that's where we're going ahead.
None: Perfect. That's helpful. Thanks for the update.
I appreciate the question.
None: Please pass along my warm regards to scope.
Operator: Thank you. And our next question is a follow-up from George Well. Please go ahead.
None: Yes.
None: Yeah.
None: And our next question is a follow up from George well. Please go ahead.
George Well: Peter, I'm sorry; I forgot if you already mentioned this, and maybe I just didn't hear it. Is BioCardia still on track to have a consultation with Japan in the second or third quarter of this year? We have said that we will have additional consultations with Japan PMDA. I haven't; I'm not currently tracking exactly when it's going to happen. My focus today has been on the completion of the data, but as we get closer to, you know, Mid-Q2, we will be assessing when we're going to be meeting with them. And it's a process where you need to submit the requisite information, and then they will schedule it a few weeks out.
George: Peter I'm, sorry, if you already mentioned this maybe I just didn't hear it as Biochar do you still on track to have a consultation with Japan, the second or third quarter of this year.
George: Okay.
George: We have said that we will have.
None: Additional consultations with Japan P M D a.
None: I haven't I'm not currently tracking exactly when it's going to happen.
None: My focus today has been around the completion of the data.
None: But as we get closer to.
None:
None: No.
Mid Q2, we will be assessing when we're going to be meeting with them.
None: The process, where you need to.
None: Submit the requisite information and then they will schedule. It a few weeks out. So we don't exactly have perfect control on when that occurs but they've been very sophisticated and all of our interactions with <unk>, we've been very impressed by them.
Peter A. Altman: So we don't exactly have perfect control over when that occurs, but they've been very sophisticated in all our interactions with PMDA. We've been very impressed by them. Okay, great. All right. Thanks. Sorry about that.
None: Okay, Great alright, thanks, sorry about that.
George Well: No worries, George. Thank you. And that concludes our question and answer session. I'd like to turn the conference back over to Dr. Peter Altman for closing remarks. Thank you, Raka. Our therapeutic candidates and technologies have significant potential to help millions of patients with heart disease. We now have five RDX biotherapeutic programs in development, including our biotherapeutic delivery partner. Each of these programs has the potential to provide meaningful returns for our investors.
None: George.
George: Thank you and that concludes our question and answer session I would like to turn the conference back over to Dr. Peter <unk> for closing remarks.
Peter Ho: Thank you Rocco, our therapeutic candidates and technologies have significant potential to help millions of patients with heart disease.
Peter Ho: We now have five.
Peter A. Altman: Cardiac biotherapeutic programs in development, including our biotherapeutic delivery partners.
Peter A. Altman: Each of these programs has the potential to provide meaningful returns for our investors.
Peter A. Altman: I thank all of you for participating in today's call, for your interest in BioCardia, and for the support you provide for our primary mission to treat heart disease. Have a great afternoon. Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
None: I think all of you for participating in today's call for your interest in Biochar to you and support you provide for our primary mission to treat heart disease have a great afternoon.
None: Thank you Sir.
None: Today's conference call. Thank.
None: Thank you all for attending today's presentation.
None: So much for your lines, who have a wonderful day.
None: Yes.
None: [music].