BioCardia, Inc.

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia First Quarter 2024 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 1 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 Pato of BioCardia Investor Relations. Please go ahead, Miranda.

Thanks, Debbie. 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 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. 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 on March 27, 2024. The content of this call contains time-sensitive information that is accurate only as of today May 14th, 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 Dr. Peter Altman, BioCardio's president and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. This has been a big quarter for BioCardio, as our clinical investigators have presented positive results from each of our three ongoing autologous and allogeneic cell therapy clinical trials to treat ischemic heart failure and chronic myocardial ischemia. In this call, we will share an update on these product candidates in active clinical development. Our lead CARDI-AMP autologous cell therapy is targeted to treat ischemic heart failure of reduced ejection fraction, an enormous unmet clinical need. We now have results from three clinical trials, TABME, TAC-HIFT, and CARDIAMP-HF, with the CARDIAMP cells that support both the safety and therapeutic efficacy of these cells for patients having ischemic heart failure of reduced ejection fraction. Although we have seen positive signals of reduced mortality and reduced major adverse cardiac events in all patients treated in the most recent cardiac heart failure trial, the remarkable benefits in patients treated with elevated NT-ProBNP, a well-established biomarker of active heart failure, is where we are focused today. Results in these patients shared late in the first quarter show a remarkable 86% relative risk reduction in heart death equivalents and a 24% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events. Heart death equivalents include all-cause death, cardiac transplantation, and implantation of a left ventricular assist device to replace heart function. This is particularly exciting as therapies that are available today do not have a significant impact on mortality for these patients. And unfortunately, mortality for these patients is still approximately 50% at five years. Further, the recent interim results in these patients show all clinical outcomes favored cardiac cell therapy. including improved quality of life as measured using the Minnesota Living with Heart Failure questionnaire, reduction of NT pro BMP levels, greater six-minute walk test distance, and improved echocardiography parameters of left ventricular ejection fraction, left ventricular and systolic volume, and left ventricular and diastolic volume. Both the reduced heart death equivalence and improved quality of life outcomes demonstrated statistical significance favoring therapy in the patients with elevated NT-proBNP. Our goal is to have final results available for both scientific presentation and for regulatory submission in the fourth quarter of 2024. There is an enormous ongoing activity by the BioCardio team to monitor patients enrolled in this study, 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. The final results are expected to be provided to Japan's Pharmaceutical and Medical Device Agency as a key element of a submission for approval. Our previous consultations with Japan's Pharmaceutical and Medical Device Agency supported that if the data remains as good as it currently appears to be, At the final analysis, they are willing to consider approval based on this data without requiring an additional clinical trial in Japan. Subsequent interactions and consultations with Japan's pharmaceutical and medical device agency are expected. A post-marketing study is already in active discussion with world-class heart failure cardiology and interventional cardiology leaders in Japan who attended our last consultation with the agency. We are thankful for their involvement. The confirmatory CARDI-AMP Heart Failure II trial in the United States is focused on the patients with elevated NT-proBNP. The trial was approved by FDA in December, activated in February, and approved for reimbursement by Medicare in March. We estimate that the Medicare reimbursement reduces the cost of doing this study by more than $5 million. as we record payments from centers as a reduction in our R&D expense as these dollars are then paid back to centers to cover research costs for patient follow-up. This confirmatory trial has a greater than 90% power or statistical probability of success to meet the primary endpoint based on the CAR-DMP heart failure trial interim results. Our world-class executive steering committee and the distinguished cardiologists on our data safety monitoring board are continuing to support this program. We expect additional world-class heart failure clinicians to join our executive steering committee soon. We are actively working with our heart failure network and leaders in cardiology to enable this study to be fully enrolled in two years from the first patient enrolled, with results being available in three years. This is an aggressive goal. but we feel that the experience and data that we have will enable this to be achieved. We are actively onboarding sites, and this effort will accelerate in the months ahead. Our CARDI-AMP Cell Therapy Trial for Chronic Myocardial Ischemia, or BCDA-02, is a Phase III multicenter randomized double-blinded controlled study intended to include up to 343 patients at up to 40 sites. The company roll-in cohort results were presented in a call last month showing patients with refractory angina demonstrating an average 107-second increase in exercise tolerance and an 82% reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. Planning for the randomized phase continues based on these positive results. 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 allogeneic cell therapy for ischemic heart failure, or BCDA03, is a Phase I-II clinical trial program encompassing 69 patients. At the technology and heart failure therapeutics meeting in March, it was reported that there have been no adverse events in follow-up in the first low-dose cohort patient enrolled. The CARDI-ALO heart failure study is intended to build on three previous trials of mesenchymal stem cells in ischemic heart failure that we have co-sponsored at BioCardia. This is a precision medicine study as we are focusing this therapy for the first time on patients who have elevated NT-proBNP and elevated high-sensitivity C-reactive protein, a marker of inflammation that has been correlated with responsiveness to immunomodulatory mesenchymal stem cells in a significant previous study. We intend the phase two portion of the CARDI-ALLO 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. Our biotherapeutic delivery partnering business focuses on long-term partnerships where biocardia participates meaningfully in the value created. In March 2024, we announced a biotherapeutic delivery partnership with Stemcardia to advance Stemcardia's investigational pluripotent stem cell product candidate for the treatment of heart failure. initially through a Phase I-II clinical study. In May of 2024, biotherapeutic delivery partner CellProthera announced that they would have results this week at the European Society of Cardiology Heart Failure Meeting in Lisbon from their Phase I-II cell therapy study in post-myocardial infarction. Today, I am delighted to congratulate CellProthera on the positive clinical results they have just announced. In summary, with our three cardiovascular biotherapeutic clinical programs and our biotherapeutic delivery partnering, we have multiple pathways to succeed as a business and provide significant shareholder returns on investment. We are aiming for approval of a first therapy based on our lead program in Japan as early as 2025, which could be followed in the USA soon thereafter. I will now pass the call to David McClung, our CFO, who will review our Q1 2024 financial results. David?