BioCardia, Inc.

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.

Thank you, Dave. 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, book 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 26, 2025, and in subsequently filed reports on Form 10-Q. The content of this call contains time-sensitive information that is accurate only as of today, May 14, 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, BioCardia's President and CEO. Peter, please go ahead.

Thank you, Miranda. And good afternoon to everyone on the call. In March of this year, the CARDI-AMP heart failure trial results demonstrated both safety and meaningful benefits of CARDI-AMP cell therapy for heart failure patients who still have elevated biomarkers of heart stress, despite being on maximal guideline-directed medical therapy. This therapy has potential to have a positive impact on the enormous unmet clinical need for approximately 1 million Americans with heart failure currently expected to have a 10% mortality per year. Our top priority this second quarter of 2025 is all about sharing this data with the Food and Drug Administration and Japan's Pharmaceutical and Medical Device Agency to align on pathways to make this therapy available for physicians and their patients, as well as sharing this data with the broader clinical community in more detail in the form of a peer-reviewed manuscript. We are also continuing to gather evidence to support the therapy, and the cardiac heart failure two trial is actively enrolling patients at three clinical sites. This trial has a similar design with some important changes intended to confirm the results we have from this therapy, and also result in enhanced enrollment. We expect this trial to be fully enrolled over the next two years, and have a primary readout when the last patient reaches their one-year follow-up endpoint. This past quarter, final data from the last Roland cohort patient in the cardiac cell therapy and chronic myocardial ischemia trial, or BCDA02, became available, and we are working towards both scientific presentation and publication of this data. We have also had a successful Data Safety Monitoring Board review of the safety outcomes in the low-dose cohort in our cardi allogeneic mesenchymal stem cell therapy in ischemic heart failure, or BCDA03. The absence of any adverse events in these very ill patients was great news to confirm for this off-the-shelf therapy. On the Helix Biotherapeutic Delivery partnering front, we are actively preparing for submission for approval of this product, which is expected to be valued by therapeutic partners. Helix has potential to be the first approved trans-endocardial biotherapeutic delivery system in the United States because of the CARDI-AMP heart failure data. 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 our proprietary FDA-approved MorphDNA steerable introducer platform. We are continuing to detail its advantages to physicians and partners who may benefit from these products. The largest market procedures are in cardiac electrophysiology for our transeptal avance product. But just yesterday, a procedure was detailed in the superior mesenteric artery, which would be a peripheral procedure. On the business development front, we believe partnering can create meaningful value for shareholders with respect to each of our four platforms, CardiAmp, Cardialo, Helix, and MorphDNA. For CardiAmp cell therapy business development, we expect the final data from CardiAmp part failure and clarity on anticipated approvals ahead to enhance interest by distribution partners and strategics. For cardi-allo cell therapy business development, our allogeneic cell therapy, we have the ability to manufacture our clinical grade cells at a cost profile that we expect is likely less than all of our peers. We are also open to partnerships broadly in the many indications we are not currently pursuing. For our Helix biotherapeutic delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience products and support capabilities remain in active discussions. 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 operational costs by shortening timelines for 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 heart failure data and is due to the stability of the Helix in the beating heart and the cell-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. Recently, the greater than $10 billion per year electrophysiology market primarily focused on treating arrhythmias in the atria of the heart is expanded to treat arrhythmias in the ventricles of the heart where we deliver our cell therapies. This is a more tortuous region of the heart to access and typically involves 180 degree turn of the catheter system regardless which route of access is required, trans-aorta or trans-mitral and down through the mitral valve. Our morphed DNA design presents significant advantages in these orientations, which is exactly where it is being used today for our therapeutic procedures. Looking forward, we are working to complete the following important efforts for our therapeutic programs. One, submit CARDI-AMP HF results and request consultation with FDA and Japan PMDA. Two, activate multiple sites in CARDI-AMP Heart Failure 2 and drive enrollment in this trial. For BCD02, we intend to deliver top-line data in the rolling cohort. And lastly, for BCD03, we're going to complete the next dosing cohort ahead. After the end of the recent quarter, management chose to do a small financing at the market with minimum dilution to deliver on the milestones before us. We don't have a large burn rate as a company today. And this gives us greater flexibility as we choose the best pathways to fund value creation for our shareholders. We have some large milestones expected very soon. I will now pass the call to David McClung, our CFO. we'll review our first quarter 2025 financial results. David.