Q4 2025 BioCardia Inc Earnings Call

March 24, 2026

Speaker #2: All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by 0.

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Speaker #2: 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 conference over to Miranda Peto of BioCardia Investor Relations.

Speaker #2: Please go ahead, Miranda. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, president and chief executive officer, and David McClung, the company's chief financial officer.

Operator 2: Please go ahead, Miranda.

Operator: Please go ahead, Miranda.

Miranda Peto: Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, 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, 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, technologies, and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10-K filed with the SEC today, 24 March 2026.

Miranda Peto Benvenuti: Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, 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, 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, technologies, and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10-K filed with the SEC today, 24 March 2026.

Speaker #2: 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.

Speaker #2: Such factors include among others the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

Speaker #2: 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 SEC today, March 24, 2026.

Speaker #2: The content of this call contains time-sensitive information that is accurate only as of today March 24, 2026. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

Miranda Peto: The content of this call contains time-sensitive information that is accurate only as of today, 24 March 2026. 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.

Miranda Peto Benvenuti: The content of this call contains time-sensitive information that is accurate only as of today, 24 March 2026. 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 #2: It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Speaker #3: Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's mission is to develop and enhance therapies to treat cardiovascular disease. We are doing this today with three primary platforms: our CardiAmp autologous minimally processed cell therapy, our Cardiallo allogeneic off-the-shelf mesenchymal cell therapy, and our Helix transendocardial biotherapeutic delivery system.

Peter Altman: Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's mission is to develop and enhance therapies to treat cardiovascular disease. We are doing this today with three primary platforms. Our CardiAMP autologous minimally processed cell therapy, our CardiALLO allogeneic off-the-shelf mesenchymal cell therapy, and our Helix transendocardial biotherapeutic delivery system, which is used by both our CardiAMP and CardiALLO cell therapy programs. Our lead program remains the CardiAMP cell therapy for roughly 1 million patients in the United States and 150,000 patients in Japan with ischemic heart failure with reduced ejection fraction. These are patients who've had coronary disease, may have had a heart attack, and have subsequently developed heart failure characterized by a larger dilated heart that unfortunately pumps inefficiently. CardiAMP therapy includes CD34 and CD133 cells that have long been recognized as endothelial progenitor cells that promote new capillary formation.

Speaker #3: Which is used by both our CardiAMP and CardioALLO cell therapy programs. Our lead program remains the CardiAMP cell therapy for roughly 1 million patients in the United States and 150,000 patients in Japan, with ischemic heart failure and reduced ejection fraction.

Speaker #3: These are patients who have had coronary disease, may have had a heart attack, and have subsequently developed heart failure characterized by a larger dilated heart that unfortunately pumps inefficiently.

Speaker #3: CardiAmp therapy includes CD34 and CD133 cells that have long been recognized as endothelial progenitor cells, that promote new capillary formation. Pre-clinical data also provides support that these cells reduce fibrosis in the heart.

Peter Altman: Preclinical data also provides support that these cells reduce fibrosis in the heart. Based on these mechanisms to effectively treat microvascular dysfunction, CardiAMP cell therapy is introducing a new therapeutic modality to the significant unmet need in ischemic heart failure that is primarily managed today by neurohormonal modulation. The clinical outcomes with this approach have been excellent. We now have complete and final data from three clinical trials of the CardiAMP therapy, with the latest results from our Phase III CardiAMP HF trial presented as a late-breaking clinical trial at the Technology and Heart Failure Therapeutics meeting this month. The presentation was titled Autologous Cell Therapy May Curb Pathological Ventricular Remodeling in Chronic Ischemic Heart Failure of Reduced Ejection Fraction Patients Selected for Favorable Cell Characteristics. The key takeaway from these new results is in this title.

Speaker #3: Based on these mechanisms to effectively treat microvascular dysfunction, CardiAmp cell therapy is introducing a new therapeutic modality to the significant unmet need in ischemic heart failure that is primarily managed today by neurohormonal modulation.

Speaker #3: The clinical outcomes with this approach have been excellent. We now have complete and final data from three clinical trials of the CardiAmp therapy, with the latest results from our Phase 3 CardiAmp HF trial presented as a late-breaking clinical trial at the Technology and Heart Failure Therapeutics meeting this month.

Speaker #3: The presentation was titled, "Autologous Cell Therapy: May Curve Pathological Ventricular Remodeling in Chronic Ischemic Heart Failure of Reduced Ejection Fraction Patients Selected for Favorable Cell Characteristics." The key takeaway from these new results is in this title.

Speaker #3: The CardiAmp HF echocardiography clinical results, which measure heart chamber sizes over time by a truly blinded, world-class echocardiography core laboratory, show reductions in left ventricular volume indices when the heart ventricle is fully dilated with a p-value of 0.06, and when the heart is fully contracted with a p-value of 0.09.

Peter Altman: The CardiAMP HF echocardiography clinical results, which measure heart chamber sizes over time by a truly blinded world-class echocardiography core laboratory, show reductions in left ventricular volume in disease when the heart ventricle is fully dilated with a p-value of 0.06, and when the heart is fully contracted with a p-value of 0.09. For the pre-specified subgroups of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful, greater than 20 milliliters per meter squared and 15 milliliters per meter squared, respectively, and statistically significant with a p-value of 0.02 and p of 0.01, respectively. This echocardiographic data further supports our previous results of reduced fatal and non-fatal major adverse cardiac and cerebral vascular events and improved quality of life in the treated patients.

Speaker #3: For the pre-specified subgroups of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful—greater than 20 milliliters per meter squared and 15 milliliters per meter squared, respectively.

Speaker #3: And statistically significant, with a p-value of 0.02 and p of 0.01, respectively. This echocardiographic data further supports our previous results of reduced fatal and non-fatal major adverse cardiac and cerebrovascular events, and improved quality of life in the treated patients.

Speaker #3: They are similarly strongest in the pre-specified subgroup of patients having elevated biomarkers of heart stress. When considered together, with the significant reductions in left ventricular end-systolic volume and left ventricular end-diastolic volume in the treatment group versus the control group, these results provide a basis for linking intramyocardial mononuclear cell therapy with suppression of pathological ventricular remodeling and beneficial clinical outcomes.

Peter Altman: They are similarly strongest in the pre-specified subgroup of patients having elevated biomarkers of heart stress. When considered together with the significant reductions in left ventricular end-systolic volume and left ventricular end-diastolic volume in the treatment group versus the control group, these results provide a basis for linking intramyocardial mononuclear cell therapy with suppression of pathological ventricular remodeling and beneficial clinical outcomes. This trial result is also considered consistent with observations from other heart failure with reduced ejection fraction therapies showing an association between suppression of pathological ventricular remodeling and improvement in mortality. This data is consistent across all three of our clinical studies, which saw reduced major adverse cardiac and cerebral vascular events and improved heart function. I also note that two of these trials were randomized, double-blinded clinical trials, which provide the greatest scientific rigor and the least investigator bias to study outcomes.

Speaker #3: This trial result is also considered consistent with observations from other heart failure with reduced ejection fraction therapies, showing an association between suppression of pathological ventricular remodeling and improvement in mortality.

Speaker #3: This data is consistent across all three of our clinical studies, which saw reduced major adverse cardiac and cerebrovascular events and improved heart function. I also note that two of these trials were randomized, double-blinded clinical trials, which provide the greatest scientific rigor and the least investigator bias to study outcomes.

Speaker #3: This is the data we will soon be discussing with the Food and Drug Administration in the United States, and which we have been discussing with Japan's Pharmaceutical and Medical Devices Agency, or PMDA, regarding potential for approval with rigorous post-marketing studies to collect further evidence with respect to both safety and efficacy.

Peter Altman: This is the data we will soon be discussing with the Food and Drug Administration in the United States and which we have been discussing with Japan's Pharmaceuticals and Medical Devices Agency, or PMDA, regarding potential for approval with the rigorous post-marketing studies to collect further evidence with respect to both safety and efficacy. We expect to soon submit a Q-Sub request on approvability of the CardiAMP system to FDA Center for Biologics Evaluation and Research, or CBER, based on the safety and compelling signals of patients' benefits with elevated biomarkers of heart stress from our three clinical trials. This discussion is expected to focus on our already FDA-approved CardiAMP cell processing platform to extend existing labeling from in vitro diagnostic use to a therapeutic indication for ischemic heart failure with reduced ejection fraction.

Speaker #3: We expect to soon submit the Q sub-request on approvability of the CardiAMP system to FDA Center for Biologics Evaluation and Research, or CBER, based on the safety and compelling signals of patients’ benefits with elevated biomarkers of heart stress from our three clinical trials.

Speaker #3: This discussion is expected to focus on our already FDA-approved CardiAmp cell processing platform, to extend existing labeling from in vitro diagnostic use to a therapeutic indication for ischemic heart failure of reduced ejection fraction.

Speaker #3: The dedicated HELIX transendocardial delivery catheter has a pre-submission actively under review by the FDA Center for Devices and Radiological Health. In Japan, we expect to soon have our formal clinical consultation to align with PMDA on the acceptability of the existing clinical data from our three trials to allow us to submit the CardiAMP system.

Peter Altman: The dedicated Helix transendocardial delivery catheter has a pre-submission actively under review by FDA Center for Devices and Radiological Health. In Japan, we expect to soon have our formal clinical consultation to align with PMDA on the acceptability of the existing clinical data from our three trials to allow us to submit the CardiAMP system. If PMDA determines that existing clinical data is acceptable with respect to safety and efficacy, submission for Shonin approval would likely soon follow. BioCardia is not alone in seeking approvals to provide therapeutic options to these patients and the physicians who care for them today. Japan has recently granted conditional approval to another allogeneic cell therapy for ischemic heart failure that involves the placement of sheets of cells on the surface of the heart in a surgical procedure.

Speaker #3: If PMDA determines that existing clinical data is acceptable with respect to safety and efficacy, submission for Shonin and approval would likely soon follow. BioCardia is not alone in seeking approvals to provide therapeutic options to these patients and the physicians who care for them today.

Speaker #3: Japan has recently granted conditional approval to another allogeneic cell therapy for ischemic heart failure that involves the placement of sheets of cells on the surface of the heart in a surgical procedure.

Speaker #3: A US-listed company has announced that they will be filing for a biological licensing application for their allogeneic cell therapy to also treat patients in a surgical setting.

Peter Altman: A US-listed company has announced that they will be filing for a Biologics License Application for their allogeneic cell therapy to also treat patients in a surgical setting. We expect a third company will also soon be applying for approval for surgically delivered cells. The need here is great, and we wish each of these peers and potential future delivery partners every success ahead. In parallel to these efforts to wrap up the CardiAMP HF trial and seek approvals based on this data, we have initiated the CardiAMP HF II confirmatory clinical study. CardiAMP HF II focuses on the patients who were the greatest responders in CardiAMP HF and applies all of our learnings with regard to endpoint and trial design. In October and November, University of Wisconsin–Madison and Henry Ford Health in Detroit, Michigan, enrolled their first patients in CardiAMP HF II, respectively.

Speaker #3: We expect a third company will also soon be applying for approval for surgically delivered cells. The need here is great, and we wish each of these peers and potential future delivery partners every success ahead.

Speaker #3: In parallel to these efforts, to wrap up the CardiAmp HF trial and seek approvals based on this data, we have initiated the CardiAmp HF2 confirmatory clinical study.

Speaker #3: CardiAmp HF2 focuses on the patients who are the greatest responders in CardiAmp HF and applies all of our learnings with regard to endpoint and trial design.

Speaker #3: In October and November, University of Wisconsin at Madison and Henry Ford Health System in Detroit, Michigan, enrolled their first patients in CardiAmp HF2, respectively.

Speaker #3: Emory University in Atlanta, Georgia, has also been activated as a study site. With Morton Plant MES in Clearwater, Florida, there are four centers actively enrolling in this study today.

Peter Altman: Emory University in Atlanta, Georgia, has also been activated as a study site. With Morton Plant Mease in Clearwater, Florida, there are four centers actively enrolling in this study today. If FDA supports an earlier approval, there is potential the trial design will be modified and become our post-marketing registry. There is also potential that the CardiAMP HF II trial may benefit from the previous trial and a shorter pathway to approval be identified. We will have clarity here soon. We have made progress on our CardiAMP cell therapy clinical program for chronic myocardial ischemia and for our CardiALLO allogeneic cell therapy for heart failure. The status of these efforts is in our earnings announcement today. There could be significant upside from these clinical efforts in the near term. We have four catalysts before us in the next quarter.

Speaker #3: If FDA supports an earlier approval, there is potential the trial design will be modified and become our post-marketing registry. There is also potential that the CardiAMP HF2 trial may benefit from the previous trial, and a shorter pathway to approval may be identified.

Speaker #3: We will have clarity here soon. We have made progress on our CardiAMP cell therapy clinical program for chronic myocardial ischemia, and for our CardioALLO allogeneic cell therapy for heart failure.

Speaker #3: The status of these efforts is in our earnings announcement today. There could be significant upside from these clinical efforts in the near term. We have four catalysts before us in the next quarter.

Speaker #3: First, the FDA CardiAMP Heart Failure Q submission for approval pathway under Breakthrough Designation has been drafted and is under legal review. We are targeting submission as soon as possible.

Peter Altman: First, the FDA CardiAMP HF II submission for approval pathway under breakthrough designation has been drafted and is under legal review. We are targeting submission as soon as possible. Second, we have a formal clinical consultation scheduled with Japan PMDA on approvability of CardiAMP cell therapy. Third, we have an FDA substantive feedback meeting scheduled on approvability of our Helix transendocardial delivery system via the de novo pathway. Fourth, we have an abstract on CardiAMP and chronic myocardial ischemia that has been accepted for oral presentation at EuroPCR in May. I will now pass the call to David McClung, our CFO, who will review our Q4 2025 financial results. David?

Speaker #3: Second, we have a formal clinical consultation scheduled with Japan PMDA on approvability of CardiAmp cell therapy. Third, we have an FDA substantive feedback meeting scheduled on approvability of our HELIX transendocardial delivery system via the De Novo pathway.

Speaker #3: And fourth, we have an abstract on CardiAmp and chronic myocardial ischemia that has been accepted for oral presentation at EuroPCR in May. I will now pass the call to David McClung, our CFO, who will review our fourth-quarter 2025 financial results.

Speaker #3: David?

Speaker #2: Thank you, Peter. Good afternoon, everyone. I'll now provide an overview of our financial results for the year ended December 31, 2025. Total expense accretes approximately 3% year over year to $8.3 million in 2025, compared to $8.1 million in 2024.

David McClung: Thank you, Peter. Good afternoon, everyone. I'll now provide an overview of our financial results for the year ended December 31, 2025. Total expense increased approximately 3% year over year to $8.3 million in 2025, compared to $8.1 million in 2024. The primary driver of this change, research and development expense, increased to $5 million in 2025 compared to $4.4 million in 2024. The 13% increase was primarily due to the cost of closeout activities in the CardiAMP heart failure trial, inception of enrollment in the CardiAMP HF II trial during the year, and regulatory activities to advance CardiAMP in Japan. We anticipate R&D expenses will increase modestly in 2026 as we continue advancing our therapeutic candidates in both the United States and Japan.

Speaker #2: The primary driver of this change—research and development expense—increased to $5.0 million in 2025 compared to $4.4 million in 2024. The 13% increase was primarily due to the cost of close-out activities in the CardiAMP heart failure trial, inception of enrollment in the CardiAMP HF2 trial during the year, and regulatory activities to advance CardiAMP in Japan.

Speaker #2: We anticipate R&D expenses will increase modestly in 2026 as we continue advancing our therapeutic candidates in both the United States and Japan. Selling, general, and administrative expenses decreased 10% in 2025 to $3.3 million, as compared to $3.7 million in 2024, primarily due to lower professional fees coupled with reduced share-based compensation expense.

David McClung: Selling, general, and administrative expenses decreased 10% in 2025 to $3.3 million, as compared to $3.7 million in 2024, primarily due to lower professional fees coupled with reduced share-based compensation expense. We expect 2026 SG&A expenses to remain close to these 2025 levels. Our net loss increased modestly to $8.2 million in 2025 from $7.9 million in 2024. Net cash used in operations was approximately $7.5 million during the year in 2025. That's down from $7.9 million in 2024. The company ended the year with cash and cash equivalents totaling $2.5 million, very comparable to the $2.4 million as of December 31, 2024.

Speaker #2: We expect 2026 SG&A expenses to remain close to these 2025 levels. Our net loss increased modestly to $8.2 million in 2025 from $7.9 million in 2024.

Speaker #2: Net cash used in operations was approximately $7.5 million during the year into 2025. That's down from $7.9 million in 2024. The company ended the year with cash and cash equivalents in the millions.

Speaker #2: Very comparable to the $2.4 million as of December 31, 2024. We expect our cash burn will be relatively consistent in 2026, continuing our track record for carefully managing the use of resources and capital.

David McClung: We expect our cash burn will be relatively consistent in 2026, continuing our track record for carefully managing the use of resources and capital. This concludes management's prepared remarks. We are happy now to take questions from attendees.

Speaker #2: This concludes management's prepared remarks. We are happy now to take questions from attendees.

Speaker #1: Thank you. At this time, we will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchpad.

Operator 2: Thank you. At this time, we will now begin the question-and-answer session. To ask a question, you may press star then one on your touchpad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw the question, please press star and then two. At this time, we will pause momentarily to assemble our roster. The first question will come from Joseph Pantginis with H.C. Wainwright & Co. Please go ahead.

Operator: Thank you. At this time, we will now begin the question-and-answer session. To ask a question, you may press star then one on your touchpad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw the question, please press star and then two. At this time, we will pause momentarily to assemble our roster. The first question will come from Joseph Pantginis with H.C. Wainwright & Co. Please go ahead.

Speaker #1: If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw the question, please press star, then 2.

Speaker #1: At this time, we will pause momentarily to assemble our roster. And the first question will come from Joe Pentginnis with H.C. Wainwright. Please go ahead.

Speaker #3: Hello, everyone. This is Lander Owen for Joe. Thanks for the updates, and thanks for taking our questions. We have a few, so let me start with the ECHO data presented at THT.

[Analyst] (H.C. Wainwright & Co.): Hello, everyone. This is Landeron for Joe. Thanks for the updates and thanks for taking our questions. We have a few. Let me start with the echo data presented at THT. I wonder if you can provide some color on the P values for the end-diastolic and end-systolic volumes in the complete population. How do you think this data can support the narrative you're presenting to the PMDA? Hello?

Speaker #3: So, I wonder if you can provide some color on the p-values for the end-diastolic and systolic volumes in the complete population, and how you think this data can support the narrative you're presenting to the PMDA?

Speaker #3: Hello?

Speaker #1: Sorry, Lander Owen.

Peter Altman: Sorry, Landeron.

Speaker #3: Oh, thank you for the question. Thank you for the question. And I really appreciate your eye on the ECHO data. So, this data is remarkably lovely data.

[Analyst] (H.C. Wainwright & Co.): Oh, okay. No worries.

Peter Altman: Thank you for the question.

[Analyst] (H.C. Wainwright & Co.): Yeah.

Peter Altman: I really appreciate your eye on the echo data.

[Analyst] (H.C. Wainwright & Co.): Yeah.

Peter Altman: This data is remarkably lovely data. I'll start off for everybody. Typically in these trials, for all of these therapies, very few companies have long-term, truly blinded echo data. It's a very rare thing, and we have it in this trial. The core laboratory at Yale University is world-class. Your question, Landeron, was across all patients, you know, the p-values are not statistically significant, but they're approaching it.

Speaker #3: And I'll start off for everybody. Typically, in these trials, for all of these therapies, very few companies have long-term truly blinded ECHO data. It's a very rare thing.

Speaker #3: And we have it in this trial. And the core laboratory at Yale University is world-class. And so your question, Lander Owen, was across all patients, the p-values are not statistically significant, but they're approaching it.

[Analyst] (H.C. Wainwright & Co.): Yeah.

Peter Altman: To even see that kind of trend is wonderful. Our expectation is that our approvals, both in the United States and in Japan, will not be for the full cohort, but will be for the subgroup with elevated NT-proBNP. Because those patients, NT-proBNP is a marker that's released when the heart is under stress. When you have high stress in the heart, it continues to dilate. What we're seeing is that in those patients who are decompensated and are continuing to dilate, the mononuclear cell therapy appears to stop that process. That's what's exciting about this data. We see it across the full population with a p-value just above the key 0.05 threshold.

Speaker #3: But to even see that kind of trend is wonderful. So, our expectation is that our approvals, both in the United States and in Japan, will not be for the full cohort, but will be for the subgroup with elevated NT-proBNP.

Speaker #3: And because those patients—NT-proBNP is a marker that's released when the heart is under stress. And so, when you have high stress in the heart, it continues to dilate.

Speaker #3: And so, what we're seeing is that in those patients who are decompensated and are continuing to dilate, the mononuclear cell therapy appears to stop that process.

Speaker #3: So that's what's exciting about this data. We see it across the full population with a p-value just above the key 0.05 threshold.

[Analyst] (H.C. Wainwright & Co.): Yeah, right there.

Speaker #1: Yeah, right there.

Speaker #3: But in the subgroup, we're looking at p-values of 0.02 and 0.01 for ECHO measures. And these are large magnitude changes that were presented at the THT conference.

Peter Altman: In the subgroup, we're looking at p-value of 0.02 and 0.01 for echo measures. These are large magnitude changes that were presented at the THT conference. Another value proposition above and beyond just talking to regulators with respect to this data, Landeron, is this data is compelling to cardiologists who are trying to advance therapies for their patients, and the patients that we have treated are on guideline-directed medical therapy. The patients in this trial have already been advanced on everything that's available to them that's not extremely invasive, and they still are dying at a rate of approximately 10% per year. The big lament in heart failure is that nothing is changing mortality.

Speaker #3: Another value proposition, above and beyond just talking to regulators with respect to this data, Lander Owen, is this data is compelling to cardiologists who are trying to advance therapies for their patients, and the patients that we have treated are on guideline-directed medical therapy.

Speaker #3: So the patients in this trial have already been advanced on everything that's available to them that's not extremely invasive, and they still are dying at a rate of approximately 10% per year.

Speaker #3: The big lament in heart failure is that nothing is changing mortality. And here we're seeing a therapy that not only appears, at a high level, to be reducing mortality in MACE, but it's also showing these changes in left ventricular volumes that have a long history of being correlated with reduced mortality as well.

Peter Altman: Here we're seeing a therapy that not only appears at a high level to be reducing mortality in MACE, but it's also showing these changes in left ventricular volumes that have a long history of being correlated with reduced mortality as well. I think there'll be a lot of excitement in the cardiology community, and that will translate into excellent enrollment in the CardiAMP HF II trial when we put our full weight behind it.

Speaker #3: So I think there'll be a lot of excitement in the cardiology community. And that will translate into excellent enrollment in the cardio and heart failure II trial when we put our full weight behind it.

Speaker #1: Perfect. That's helpful, yeah. And do you have an estimate of the Cardio and submission to the FDA, if everything goes according to plan? And how are you thinking about the potential requirements for post-marketing studies and their execution?

[Analyst] (H.C. Wainwright & Co.): Perfect. That's helpful. Yeah, do you have an estimate of the CardiAMP submission to the FDA if everything goes according to plan? And how are you thinking about the potential requirements for post-marketing studies and their execution?

Peter Altman: For CardiAMP HF, we are, as I shared in my remarks, we're imminently going to file for a discussion on approvable pathways. They already have all of the data from the trial. We will be providing other analyses that have been done, but that's imminent. I expect the timeline will be, because this has FDA breakthrough designation, it'll be under a standard Sprint discussion, which I estimate is roughly a 45-day turnaround. Then the subsequent, you know, if they're supportive, it will take time for all of the details regarding a submission to be put forward. There's two approval pathways. Even though this is regulated by CBER, it is a device system. Again, CBER, the Center for Biologics Evaluation and Research, the device pathway has both the PMA and the de novo pathway.

Speaker #3: So for cardio and HF, we are—as I shared in my remarks—we're imminently going to file for a discussion on approval pathways. So they already have all of the data from the trial.

Speaker #3: We will be providing other analyses that have been done, but that's imminent. I expect the timeline will be—because this has FDA breakthrough designation—it'll be under a standard sprint discussion, which I estimate is roughly a 45-day turnaround.

Speaker #3: And then the subsequent—if there's supportive—it will take time for all of the details regarding a submission to be put forward. And there's two approval pathways.

Speaker #3: Even though this is regulated by CBIR, it is a device system. And so the approval pathway—again, CBIR, the Center for Biologics Evaluation and Research—the device pathway has both the PMA and the De Novo pathway.

Peter Altman: Because of the safety profile we see with CardiAMP, it actually could go down the de novo pathway, which is really interesting. De novo is for devices that are safe, and there's no safety-

Speaker #3: With CardioAMP, it actually could go down the de novo pathway, which is really interesting. De novo is for devices that are safe, and there are no safety issues I'm aware of right now with respect to CardioAMP.

[Analyst] (H.C. Wainwright & Co.): Okay.

Peter Altman: No issues I'm aware of right now with respect to CardiAMP. If that's the door that's open and we decide to pursue it could be a very short timeline, and relatively straightforward to secure approval.

Speaker #3: So, if that's the door that's open and we decide to pursue it, it could be a very short timeline and relatively straightforward to secure approval.

Speaker #3: But if it's a PMA pathway, which has certain strategic advantages, it could be a little longer. The key question for FDA and for Japan PMDA is: Is this data acceptable for safety and efficacy for market release?

[Analyst] (H.C. Wainwright & Co.): All right.

Peter Altman: If it's a PMA pathway which has certain strategic advantages, it could be a little longer. The key question-

[Analyst] (H.C. Wainwright & Co.): I know.

Peter Altman: for FDA and for Japan PMDA is this data acceptable for safety and efficacy for market release? Now, your second part of the question, Landeron, was how do you think about the post-marketing study?

Speaker #3: Now, your second part of the question, Lander Owen, was: how do you think about the post-marketing study? So, post-marketing studies—you cannot have patients come in and not have an option to therapy.

[Analyst] (H.C. Wainwright & Co.): Yeah.

Peter Altman: Post-marketing studies, you cannot have patients come in and not have an option to therapy. You can't truly randomize. We would expect these to be relatively extensive studies on many hundreds of patients that we would follow over time. We will be collecting, you know, long-term survival data, potentially echo data, potentially biomarker data. It's something to be discussed with respect to the agency's guidance on this from each area. Those measures I just identified are standard measures, so it wouldn't necessarily put an enormous undue burden on BioCardia. Echo measures, NT-proBNP measures, and understanding survival could be done relatively cost-effectively in an open label setting. That's how we think about it.

Speaker #3: You can't truly randomize, so we would expect these to be relatively extensive studies on many hundreds of patients that we would follow over time.

Speaker #3: And we would be collecting long-term survival data, potentially ECHO data, potentially biomarker data. It's something to be discussed with respect to the agencies' guidance on this from each area.

Speaker #3: Those measures I just identified are standard measures, so it wouldn't necessarily put an enormous undue burden on BioCardia. ECHO measures and NT-proBNP measures, and understanding survival, could be done relatively cost-effectively in an open-label setting.

Speaker #3: So that's how we think about it. So clearly, it's a partnership with the regulatory bodies on their past experience, and securing their support based on this data is really, really the focus.

[Analyst] (H.C. Wainwright & Co.): Yeah.

Peter Altman: Clearly it's a partnership with the regulatory bodies on their past experience and securing their support based on this data is really, really the focus.

Speaker #1: Perfect. That makes sense. Yeah, thank you for that. And you already talked about this a little bit, but how do you see CardioAMP HF competing or not with other cell therapies for heart failure that are currently in regulatory discussions?

[Analyst] (H.C. Wainwright & Co.): Perfect. That makes sense. Yeah, thank you for that. You already talked about this a little bit, but how do you see CardiAMP HF competing or not with other cell therapies for heart failure that are currently in regulatory discussions?

Peter Altman: With respect to what are called the four pillars of therapy in heart failure.

Speaker #3: So the—so with respect to what are called the four pillars of therapy in heart failure, the patients that guideline-directed medical therapy that's established, all of the patients in our cardio amp HF and in our cardio amp HF II trial are already on guideline-directed medical therapy.

Peter Altman: With respect to what are called the four pillars of therapy in heart failure.

[Analyst] (H.C. Wainwright & Co.): Mm-hmm.

Peter Altman: Of the patients, that's guideline-directed medical therapy that's established, all of the patients in our CardiAMP HF and in our CardiAMP HF II trial are already on guideline-directed medical therapy. It's not instead of, but really it's in addition to, and we're seeing these benefits in addition to. With the newer cell therapies that are seeking approval in the United States.

Speaker #3: So it's not instead of, but really it's in addition to. And we're seeing these benefits in addition to. With the newer cell therapies that are seeking approval in the United States, they're all surgical delivery so far.

[Analyst] (H.C. Wainwright & Co.): Yeah.

Peter Altman: They're all surgical delivery so far. I believe that they've all expressed interest publicly on pursuing different approaches for minimally invasive delivery such as we are pursuing, and we could be helpful to them there. I see the competitive landscape as one where, at the end of the day, I think CardiAMP will always remain one of the leading therapies because of how straightforward it is and how cost-effective it will be.

Speaker #3: I believe that they've all expressed interest publicly on pursuing different approaches for minimally invasive delivery such as we are pursuing. And we could be helpful to them there.

Speaker #3: I see the competitive landscape as one where at the end of the day, I think cardio amp will always remain one of the leading therapies because of how straightforward it is and how cost-effective it will be.

[Analyst] (H.C. Wainwright & Co.): Mm-hmm. Mm-hmm.

Peter Altman: At the same time, you know, this is the nature of waves of therapeutic development. There will ultimately be head-to-head trials for different therapies, and it's good for patients, if they have different therapeutic options and they're well-studied. My sense is, from an efficacy perspective, I actually think the CardiAMP therapy is among the most robust therapeutic data that's out there. If you look at the magnitudes of changes we're seeing compared to all of the pivotal trials for the guideline-directed medical therapy, the magnitudes are compelling. You know, it's gonna be interesting. I think the key thing is to continue to collect data, for evidence of both safety and efficacy. Like all great therapies, you know, things will evolve slowly over time. I'm not concerned about the competitive issues.

Speaker #3: At the same time, this is the nature of waves of therapeutic development. There will ultimately be head-to-head trials for different therapies, and it's good for patients.

Speaker #3: If they have different therapeutic options and they're well-studied, my sense is, from an efficacy perspective, I actually think the CardioAMP therapy is amongst the most robust therapeutic data that's out there.

Speaker #3: If you look at the magnitudes of changes we're seeing, compared to all of the pivotal trials for the guideline-directed medical therapy, the magnitudes are compelling.

Speaker #3: And so it's going to be interesting. I think the key thing is to continue to collect data for evidence of both safety and efficacy and, like all great therapies, things will evolve slowly over time.

Speaker #3: But I'm not concerned about the competitive issues. I think it's great for these patients that there's a number of folks pursuing therapies, because the need here is enormous.

Peter Altman: I think it's great for these patients that there's a number of folks pursuing therapies because the need here is enormous. In the United States-

[Analyst] (H.C. Wainwright & Co.): Awesome.

Peter Altman: Just in our indication, it's 1 million patients. That's how we see it.

Speaker #3: In the United States, just in our indication, it's a million patients. So that's how we see it.

[Analyst] (H.C. Wainwright & Co.): Perfect. Yeah. Awesome. Awesome. Well, thank you so much. Thank you so much for clarifying this. Thanks.

Speaker #1: Perfect. Yeah. Awesome. Awesome. Well, thank you so much. Thank you so much for clarifying this. Thanks.

Peter Altman: I appreciate the questions, Landeron. Thank you so much.

Speaker #3: I appreciate the questions, Lander Owen. Thank you so much.

[Analyst] (H.C. Wainwright & Co.): Of course. Thank you.

Speaker #1: Of course. Of course. Thank you.

Peter Altman: Be well.

Speaker #3: Be well.

Operator 2: Again, if you have a question, please press star and then one. The next question will come from James Molloy with Alliance Global Partners. Please go ahead.

Operator: Again, if you have a question, please press star and then one. The next question will come from James Molloy with Alliance Global Partners. Please go ahead.

Speaker #2: Again, if you have a question, please press star and then one. The next question will come from James Malloy with Alliance Global Partners. Please go ahead.

James Molloy: Hey, guys. Thank you for taking my questions. I was wondering if you could talk a little bit about the enrollment in the HF2 trial. I know you have a few patients enrolled. Talk about sort of how that's building, any anecdotal sort of stories from the enrollment, the challenges they're facing or maybe the challenges you aren't facing, and what's sort of the best centers, best practices they're using to sort of get folks into this HF2 trial.

Speaker #4: Hey, guys. Thank you for taking my questions. I was wondering if you could talk a little bit about the enrollment in the HF II trial.

Speaker #4: I know you have a few patients enrolled. Talk about sort of how the how that's building any anecdotal sort of stories from the enrollment, the challenges they're facing, or maybe the challenges you aren't facing.

Speaker #4: And what are the best centers, best practices you're using to sort of get folks into this HF II trial?

Peter Altman: Yeah, no. Great question, Jim, and I really appreciate you being on the call. So if you actually look at our updated corporate presentation that we just came out a little while ago, we have pictures of three of the clinical teams at these sites for CardiAMP HF II. We put the pictures in there, first off, because it's really these centers that do all the work. Second, because you can see everybody smiling after these procedures. That's a signal of how well it's going as we're doing these procedures and also the relationships around doing this work. Enrollment numbers right now, we haven't detailed, but we're starting this enrollment slowly because almost all of our clinical team is focused on the efforts, enormous efforts in taking a Phase III trial data set through for regulatory submission.

Speaker #3: Yeah. No. Great question, Jim. And I really appreciate you being on the call. So, if you actually look at our updated corporate presentation that we just put out a little while ago, we have pictures of three of the clinical teams at these sites for CardioAMP HF II.

Speaker #3: And we put the pictures in there. First off, because it's really these centers that do all the work. But second, because you can see everybody's smiling after these procedures.

Speaker #3: And that's a signal of how well it's going as we're doing these procedures, and also the relationships around doing this work. Enrollment numbers right now, we haven't detailed, but we're starting this enrollment slowly because almost all of our clinical team is focused on the efforts—enormous efforts—in taking a Phase 3 trial data set through for regulatory submission.

Peter Altman: All of that is coming to a head. The beauty of this effort is that that data will be a primary driver in enrollment ahead. Our expectation is as soon as we complete these conversations with PMDA and FDA, we'll know whether or not the CardiAMP HF II trial should continue to be a randomized double-blind trial or should be migrated to a potentially open label post-marketing study. That impacts, you know, our efforts. Second, you know, if it stays a randomized trial, our team will have the strength of this data set, which will help on the enrollment side. We have quite a few sites that are interested in getting involved in the study.

Speaker #3: But all of that is coming to a head. And the beauty of this effort is that that data will be a primary driver in enrollment ahead.

Speaker #3: So, our expectation is that as soon as we complete these conversations with PMDA and FDA, we'll know whether or not the CardioAMP HF II trial should continue to be a randomized, double-blind trial or should be migrated to a potentially open-label, post-marketing study.

Speaker #3: And that impacts our efforts. And second, if it stays a randomized trial, our team will have the strength of this data set, which will help on the enrollment side.

Speaker #3: So, we have quite a few sites that are interested in getting involved in the study. It's primarily a bandwidth and resource basis for why that has not gone faster.

Peter Altman: It's primarily a bandwidth and a resource basis for why that has not gone faster, but that will come soon ahead. I hope that answers your question, Jim.

Speaker #3: But that will come soon ahead. So, I hope that answers your question, Jim.

James Molloy: It does indeed. Thank you very much. Maybe moving over to the CMI. We're looking for the six-month data here at the EuroPCR in Paris in May. What sort of good, bad, equivocal, what should we be looking for as that data comes rolling out?

Speaker #1: It does indeed. Thank you very much. And then, maybe moving over to the CMI, we're looking for the six-month data here at the EuroPCR in Paris in May.

Speaker #1: What sort of good, bad, equivocal—what should we be looking for as that data comes rolling out?

Peter Altman: I think that the data is as we've shared sort of a top line. I think you'll get more visibility into the physician and patient experience in that trial. I think the interesting thing about the CMI trial is right now there's not a lot of options for patients with CMI. The main value of, you know, we're right now not driving forward aggressively in enrolling the randomized portion of that trial, where we sort of put it on pause to focus on the heart failure program. You know, from a business development perspective, it effectively doubles the market potential of CardiAMP HF. If we had resources, we could very easily advance the CardiAMP CMI trial all the way through its pivotal cohort.

Speaker #3: Data is, as we've shared, sort of a top line. I think you'll get more visibility into the physician and patient experience in that trial.

Speaker #3: And I think the interesting thing about the CMI trial is, right now, there's not a lot of options for patients with CMI. And the main value of—we're right now not driving forward aggressively in enrolling the randomized portion of that trial.

Speaker #3: We've sort of put it on pause to focus on the heart failure program. But from a business development perspective, it effectively doubles the market potential of CardiAMP HF.

Speaker #3: And so, if we had resources, we could very easily advance the CardiAMP CMI trial all the way through its pivotal cohort. But those are some of the things that we're talking about in business development settings.

Peter Altman: You know, those are some of the things that we're talking about in business development settings.

James Molloy: How would you characterize the environment for potential partnerships currently?

Speaker #1: And how would you characterize the environment for potential partnerships currently?

Peter Altman: That's a big question. Right now, there's a lot of folks focused on different things. I'll keep you posted. I think in the past, we've been, you know, rather forthcoming on all the conversations we have with respect to our various assets and platforms. I think what will happen, Jim, is with the first cardiac cell therapy approved in Japan on 19 February, this is still pretty brand-new stuff for all of those folks in business development who are used to looking at years of a runway with cash flow. I think there will be great interest. I think the interest in CardiAMP CMI will primarily be driven by the interest in CardiAMP HF.

Speaker #3: That's a big question. Right now, there's a lot of folks focused on different things. I'll keep you posted. I think in the past, we've been rather forthcoming on all the conversations we have with respect to our various assets and platforms.

Speaker #3: And I think what will happen, Jim, is with it, the first cardiac cell therapy approved in Japan on the 19th of February. This is still pretty brand new stuff for all of those folks in business development who are used to looking at years of a runaway with cash flow.

Speaker #3: I think there will be great interest. I think the interest in CardioAMP CMI will primarily be driven by the interest in CardioAMP HF.

Peter Altman: My sense is with CardiAMP HF on a path to potential an early approval in the US or in Japan. There will be great interest and support in CardiAMP CMI as well as in CardiALLO.

Speaker #3: In my sense, with cardio amp HF on a path to potential an early approval in the US or in Japan, there will be great interest and support in cardio amp CMI as well as in cardio ally.

James Molloy: Thank you very much for taking the questions.

Peter Altman: Appreciate them, Jim. I really appreciate you being on the call. Thank you.

Speaker #1: Thank you very much for taking the questions.

Speaker #3: Appreciate them, Jim. I really appreciate you being on the call. Thank you.

Operator 2: This concludes our question and answer session. I would like to turn the conference back over to Peter Altman for any closing remarks.

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

Speaker #2: This concludes our question and answer session. I would like to turn the conference back over to Peter Altman for any closing remarks.

Peter Altman: Thank you, Nick. Our efforts advancing our cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. Our base plan remains to complete the confirmatory CardiAMP HF II trial while we engage with FDA and PMDA on potential near-term approvals. On behalf of our entire BioCardia team, I thank all shareholders for their continued support as you make our efforts possible. Thank you.

Speaker #3: Thank you, Nick. Our efforts advancing our cell-based therapies for ischemic heart failure are showing important benefits for patients. Through the treatment of microvascular dysfunction, our base plan remains to complete the confirmatory CardioAMP HF II trial.

Speaker #3: While we engage with FDA and PMDA, I'm potential near-term approvals. On behalf of our entire BioCardia team, I thank all shareholders for their continued support as you make our efforts possible.

Speaker #3: Thank you.

Operator 2: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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

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