BioCardia, Inc.

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia year-end 2025 financial results and business update conference call. 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 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 touch screen or keypad. To withdraw your question, please press star, then two. Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call. I would now like to turn the conference over to Miranda Pato of BioCardia Investor Relations. Please go ahead, Miranda.

Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardio'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 BioCardio'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. Overlooking 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 SEC today, March 24, 2026. 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. It is now my pleasure to turn the call over to Dr. Peter Altman, Biocardia's President and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. Biocardia's mission is to develop and enhance therapies to treat cardiovascular disease. We are doing this today with three primary platforms. our CARDI-AMP autologous minimally processed cell therapy, our CARDI-ALO allogeneic off-the-shelf mesenchymal cell therapy, and our Helix transendocardio-biotherapeutic delivery system, which is used by both our CARDI-AMP and CARDI-ALO cell therapy programs. Our lead program remains the CARDI-AMP cell therapy for roughly 1 million patients in the United States and 150,000 patients in Japan with ischemic heart failure of 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. Preclinical data also provides support that these cells reduce fibrosis in the heart. Based on these mechanisms to effectively treat microvascular dysfunction, cardiac 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 CARDI-AMP therapy with the latest results from our phase three CARDI-AMP 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. The CARDIANTH-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 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 cerebrovascular events and improved quality of life in the treated patients. 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 of 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 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. 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 the rigorous post-marketing studies to collect further evidence with respect to both safety and efficacy. We expect to soon submit the Q sub-request on approvability of the CARDI-AMP 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 cardiac cell processing platform to extend existing labeling from in vitro diagnostic use to a therapeutic indication for ischemic heart failure of reduced ejection fraction. The dedicated Helix Transendocardial Delivery Catheter has a pre-submission actively under review by FDA's 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 show, to allow us to submit the CARDI-AMP system. If PMDA determines that existing clinical data is acceptable with respect to safety and efficacy, submission for shonen 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. 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. 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 CAR-DM-HF trial, and seek approvals based on this data. We have initiated the CARDI-AMP HF2 confirmatory clinical study. CARDI-AMP HF2 focuses on the patients who were the greatest responders in CARDI-AMP HF and applies all of our learnings with regard to endpoint and trial design. In October and November, University of Wisconsin at Madison and Henry Ford Health System in Detroit, Michigan enrolled their first patients in CARDI-AMP HF2 respectively. Emory University in Atlanta, Georgia has also been activated as a study site. With Morton Plant Meese 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 the CAR-DM HF2 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 cardiac 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. First, the FDA cardiac 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. Second, we have a formal clinical consultation scheduled with Japan PMDA on approvability of cardiac cell therapy. Third, First, we have an FDA substantive feedback meeting scheduled on approvability of our Helix Transfrontal Cardio Delivery System via the de novo pathway. 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.