BioCardia, Inc.

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardio 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 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 telephone keypad. To withdraw your question, please press star then 2. Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call. I would now like to turn the call over to Miranda Pito of BioCardia Investor Relations. Please go ahead, Miranda.

Thank you, Rocco. 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, 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 approval. 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 BioCardi'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, BioCardius President and CEO. Peter, please go ahead.

Thank you, Miranda. And good afternoon to everyone on the call. Myocardia'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 ischemia. All of our cell-based therapies involve local delivery of the therapeutic to the heart where we intend them to act locally. 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. Heart failure also impacts more than 5 million patients in the United States and is growing. In our lead cardiac cell therapy, the patient has 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 for heart failure with the cardiac cell therapy that lends support for both its safety and therapeutic efficacy for patients having ischemic heart failure of reduced ejection fraction. 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 cardiac heart failure trial presented scientifically earlier this month shows 37% relative risk reduction in heart death equivalents, 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 patients. 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-proBNP, a well-established biomarker of active heart failure and stress to the heart, the reduction in heart death equivalents were 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 follow-up shows improvements over controls, including an 86% relative risk reduction in mortality and a 24% relative risk reduction of non-fatal 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-proBNP levels, greater six-minute walk test distance, 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 equivalence and improved quality of life outcomes demonstrated statistical significance favoring therapy in this subset analysis. 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 CARDI-AMP Heart Failure Clinical Study in which both patients and evaluating physicians are blinded to the treatment group, 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. This final data on the patients already treated is expected to be provided to Japan 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. Subsequent interactions and consultations with Japan's pharmaceutical and medical device agency are expected. The confirmatory 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-proBNP levels greater than 500 picograms per milliliter at up to 40 centers in the United States. The primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, would be Tier 1, all-cause death, 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 cerebrovascular events, and Tier 3, change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months. The trial as designed has a greater than 90% power or statistical probability of success to meet the primary endpoint based on the CARDI-AMP 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 study. Our cardiac cell therapy trial for chronic myocardial ischemia, or BCD02, is a phase three multi-center randomized double-blinded control study intended to include up to 343 patients at up to 40 clinical sites. 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 cardiac autologous cell therapy. 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 the clinical costs. The company's cardi-allo or allogeneic cell therapy for ischemic heart failure where BCDAO3 is a phase 1-2 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 in 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 system, 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 NTproBNP 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 stem cells. Our strategy to advance our Cardiallo HF 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 II portion of the study to be performed in both the United States and in Japan, where it has 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 Transendocardial Biotherapeutic Delivery System is a therapeutic enabling platform for minimally invasive targeted delivery of biologic agents to the heart. 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. Two additional premier biotherapeutic delivery partnerships are expected in 2024. Our morph access 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 morph DNA steerable sheath introducers in a variety of sizes and lengths with clinical indications for use in the heart and peripheral vasculature. Myocardia 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. 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 in place. 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 two confirmatory study, and we will be working on a number of business development activities, which have potential to be impactful in our plans for staying listed on NASDAQ. I will now pass the call to David McClung, our CFO, who will review our Q3, Q4, 2023 financial results.