BioCardia, Inc.

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia year-end 2024 financial results and business update conference call. All participants will be in 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-tone 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 it's 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 Vito of BioCardia and Vesta Relations. 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. During this call, management will be making forward-looking statements, including statements that address BioCardio's expectations for future performance and operational results, references management's intentions, beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainty 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 BioCardio's report, on form 10-K filed with the SEC on March 26, 2025. The content of this contains time-sensitive information that is accurate only as of today, March 31st, 2025. 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, BioCardio's President and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. This morning, we announced the primary outcome data from the CARDI-AMP Heart Failure Trial, which was presented yesterday at the American College of Cardiology late-breaking clinical trial sessions in Chicago by Dr. Amish Raval of the University of Wisconsin at Madison, co-national principal investigator for the study. The slides for this presentation are now publicly available on our website. This data from 115 randomized ischemic heart failure patients treated with our lead therapeutic candidate, autologous cardiac cell therapy, or BCD01, is excellent and truly remarkable. To appreciate this, I would like to explain the outcome measure on this call. The endpoints in the CARDI-AMP HF clinical trial are composite endpoints in which patients are evaluated by outcome tiers in order of most important to least importance, and each patient is compared with every other patient to assess whether a patient is better than another in that tier. In the first tier of cardiac death equivalents, which includes all-cause death, heart transplantation, and implantation of a left ventricular assist device, the results demonstrated a greatly reduced mortality rate. This is wonderful to see in a clinical indication where no therapy today appears to be reducing mortality. In the second tier of major adverse cardiac cardiovascular events, which includes hospitalization for heart failure, stroke, and myocardial infarction, the results demonstrated meaningful reductions here as well. This is also excellent news as these events are the drivers for the enormous cost of heart failure care to society and to payers. In the third tier of the six-minute walk distance, we were not successful, and this offset the benefits in the first two tiers resulting in the primary endpoint not being met. An alternative third-tier component of quality of life, as measured by the Minnesota Living with Heart Failure questionnaire, which has been used as the third-tier component in other similar interventional heart failure therapies with this type of efficacy analysis, also favored therapy and showed meaningful trends approaching statistical significance with a p-value of 0.14. The FDA was aware we were doing this analysis before we looked at this final data. In clinical studies of heart failure, a reduced ejection fraction, most if not all other trials use elevated markers of heart stress such as NT-ProBNP as an inclusion criteria. When we applied this simple screen to our results, cardiac cell therapy has superior results on all three tiers for both outcome measures, reaching a p-value of 0.07 with six-minute walk in the third tier component and a p-value of 0.02 with quality of life in the third tier of the composite endpoint, reaching statistical significance. We are able to see these low p-values in this data because the changes in heart death equivalent and major adverse cardiac events are large. Results show a 47% relative risk reduction in heart death equivalents, a 16% relative risk reduction in major adverse cardiac events, a clinically meaningful 10.5 point improvement in quality of life score, and a 13.9 meter improvement in the six minute walk distance test. All of this out to two year follow up. Although we have not yet fully analyzed the echocardiography data, results are showing improved left ventricular ejection fraction, and perhaps more importantly, reduced heart volumes both at the end of contraction and the end of relaxation of the heart, suggesting positive heart remodeling. Lastly, we also noted reductions in cardiac arrhythmias in these patients that were treated. As the primary safety concern with cell therapy has historically been increased life-threatening arrhythmias, the strong trends toward reducing arrhythmias is a valuable signal for safety at minimum. When these results were presented at the American College of Cardiology, the discussant, Dr. Mary Walsh, a former president of the American College of Cardiology and a heart failure physician, congratulated Dr. Raval and shared her perspective that the very patients being treated in the cardiac heart failure study are in great need for therapies such as cell therapy, and that these patients have an interest in these therapies in her own practice. She congratulated Dr. Raval on the level of compliance shown to guideline-directed medical therapy in CardiAMP-HF. Dr. Walsh challenged Dr. Raval on how rigorous the blinding of the patients was in the study that resulted in the quality of life benefit noted. Dr. Raval made clear that a very rigorous blind had been implemented in CardiAMP-HF, which satisfied Dr. Walsh. and which was also supported by the blinding questionnaire in the study, whose results you can see in the presentation on our website. The market reaction this morning to these results is a bit of a surprise. If you review our previous reports and earnings calls, you will see that these results are exactly what we hoped we would have. We have long known that this trial would not meet its primary end point. potentially due to the six-minute walk test distance in the healthier patients who did not have elevated markers of heart stress in this study, and are delighted, actually, that the two-year outcomes are so strong across all patients and able to reach statistical significance in the patients having elevated markers of heart stress, or NT pro-BMP elevation. The win ratio is greater than 2.0, where we clearly win on the most important Tier 1 and Tier 2 assessments show that two patients in the treated group are doing better for every one patient, which may be the same or worse than in the control group. This data is meaningful for biocardia on two critical levels. First, we have a very rigorous data set for the cardiac cell therapy now that strongly supports the ongoing cardiac heart failure 2 trial, which utilizes quality of life in the third tier of the composite endpoints and requires patients to have elevated markers of heart stress. The p-value of 0.02 seen in this group says the CARDI-AMP HF2 trial is well overpowered and likely to be successful. Second, the benefits observed for patients on guideline-directed medical therapy seen in this study are compelling, particularly for patients with elevated markers of heart stress where there was statistical significance. This outcome is in line with our hopes for this data as discussed with regulatory authorities. We look forward to sharing the CARDI-AMP HF two-year data with the Food and Drug Administration and Japan's Pharmaceutical and Medical Device Agency soon to align on the pathways that could make it available for physicians and their patients. These regulatory leaders, similar to the distinguished Dr. Mary Walsh, are aware that these patients with ischemic heart failure of reduced ejection fraction are in great need, which is one of the reasons FDA granted cardiac cell therapy a breakthrough device designation, intended for indications in great need of new therapies. Knowing of this great need, these agencies approve therapies based on risk-benefit analyses from rigorous good clinical practice studies such as CardiAmp HF. These agencies know that for medical device implants, safety results over time can arise due to a host of issues related to fatigue, device erosion, and immunological response, among many others. These agencies also know that safety issues, such as drug toxicities, can present over time due to drug compartmentalization and the long history of difficult patient compliance to medications. These agencies will also know that these potential long-term medical device implant and drug safety issues do not exist for cardiac cell therapy for heart failure. After the one-time cardiac cell therapy procedure, there is nothing left behind other than high concentrations of a patient's own cells in their heart tissue, where these cells naturally home when there is an injury to the heart. Our discussions with the regulatory agencies will be around the evidence we have for safety, and efficacy of the cardiac cell therapy from this very rigorous clinical study in light of the very real patient need that exists and in light of other therapies that may be approved for these patients. The regulatory authorities are also aware that cardiac cell processing system has been previously approved in the United States and Japan for other indications, and our Helix delivery system has been approved previously in Europe. The CAR-DEM heart failure two trial is active and consenting patients. We expect significant news flow ahead as we progress in this study and parallel to the ongoing regulatory discussions. Beyond this lead therapeutic autologous cell therapy program in heart failure, we have also made progress this quarter in other programs. This quarter, final data from the last rolling cohort patient in the Cardi-AMP Cell Therapy and Chronic Myocardial Ischemia Trial, or BCD-02, is being collected and will be prepared for scientific presentation and publication. This entire program benefits from the scientific support from Cardi-AMP-HF. We have also completed enrollment in the low-dose cohort in our cardi-allo-allogeneic mesenchymal stem cell therapy in ischemic heart failure, or BCD-03. and are actively scheduling the data safety monitoring board review of the outcomes for this off-the-shelf therapy. On the Helix biotherapeutic delivery partnering front, we have no updates to share at this time on current and future partners. We continue to be focused on partnerships where our contributions to the success of partners will reward our shareholders. One element of the Helix delivery system is a proprietary FDA-approved MorphDNA steerable introducer platform. We are continuing to detail its advantages to physicians and partners who may benefit from these products. We do not expect significant revenues in the near term, but do expect to have news a year as we make progress. On the business development front, we understand that partnering can create meaningful value for shareholders with respect to each of our four platforms, Cardi Amp, Cardi Allo, Helix, and MorphDNAs. For cardiac cell therapy business development, we expect the final data from cardiac heart failure one trial, which we now have, will enhance interest by distribution partners and strategics. It is noteworthy that interventional therapies for heart failure are receiving more and more attention because there are many patients who remain symptomatic even on state of the art guideline directed medical therapy. For cardi allo cell therapy business development, our allogeneic cell therapy We have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease. I note that FDA has approved a first mesenchymal stem cell therapy by a peer company in 2025, which has a treatment price of $800,000 for a course of four treatments. And another peer company appears to soon expect conditional approval for a mesenchymal stem cell therapy in Japan to treat acute respiratory distress where we also have an approved IND at Biocardia. These peer company successes may enhance our partnering discussions around our clinical stage allogeneic mesenchymal stem cell therapy platform. For our Helix biotherapeutic delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products, and support capabilities remain active in discussion. Current partners realize that minimally invasive delivery not only enhances future commercialization, but is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their therapeutic development. Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery and the enhanced pharmacokinetics with our Helix system, supported by data from many groups. We believe this advantage underlies our positive cardiac HF data and is due to the stability of the helix and the beating heart and the self-sealing helical pathway into the tissue. On the more front, the recent FDA approval has us open for business in a competitive but real market. Physician usage is the first step toward any distribution or commercial partnership. MorphDNA was used as the steerable platform in the recent cardiallo low-dose cohort patient and more procedures are expected ahead. Looking forward, we are working to complete the following important efforts for our therapeutic programs. First, to submit CAR-DMHF results and request consultation with FDA and Japan PMDA. Second, to activate multiple sites in CAR-DMHF2 and drive enrollment. Third, for BCD02 to deliver top line data in the rolling cohort. And for BCD03, complete the DSMB review in the Cardiallo HF low-dose cohort. I will now pass the call to David McClung, our CFO, who will review our fourth quarter 2024 financial results. David. Thank you, Peter.