BioCardia, Inc.

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the BioCardia third quarter 2024 financial results and business update conference call. At this time, all participants are in a listen-only mode. If 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 and then one using a touch-tone telephone. To draw your questions, you may press star and 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 floor over to Miranda Pato of Biocardia Investor Relations. Please go ahead, Miranda.

Thank you. 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 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 approvals. Fast, 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, and in subsequently filed Form 10-Qs. The content of this call contains time-sensitive information that is accurate only as of today, November 13, 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, BioCardia's president and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. BioCardia continues to advance our targeted cellular precision medicines for cardiovascular disease. Our clinical stage cell-based therapies are targeted in that we are delivering our therapeutic candidates locally to the target tissues where they are most needed and with a precision medicine perspective for specific patients that may benefit, identified by biomarkers. These biomarkers characterize a patient's disease state, and in the case of our autologous cardiac mononuclear cell therapies, the potential of the patient's own cells for providing therapeutic benefit. Our lead autologous cardiac cell therapy for the treatment of heart failure, which has been granted Food and Drug Administration breakthrough designation and is reimbursed by the Center for Medicare and Medicaid Services, is being studied today in two active clinical trials. The mechanism of action of cardiac cell therapy is viewed as microvascular repair by promoting increased capillary density and reduced fibrosis in the heart tissue where these cells are delivered, both of which have been demonstrated in preclinical studies. Cardiamp cell therapy is a one-time treatment in which the patients who qualify based on the critical selection criteria have their own mononuclear cells aspirated and delivered to the heart in high concentrations in a single minimally invasive catheter-based procedure. The procedure avoids the need for cardiac surgery to deliver the cells, and no immunosuppression is required to prevent rejection of a patient's own cells. I will now provide detail on the status of our two CARDI-AMP cell therapy trials for the treatment of heart failure. The CARDI-AMP Heart Failure 1 trial is a randomized placebo procedure-controlled study on 115 patients with 10 additional role and subjects. We will soon have final data where patients will have a minimum of one year and a maximum of two-year follow-up of the outcome measures, with approximately 92% of the patients not lost a follow-up, having two-year follow-up results. Only 4% of patients have been lost a follow-up in this study. We are conservatively optimistic that results anticipated for release in Q1 2025 will be similar to results seen in the interim review last year. This interim review data showed trends of improved survival, reduced major adverse cardiac events, and improved quality of life in those who received therapy. Final cardiac heart failure one results expected in Q1 2025 will be based on data that has had source data verification completed and will include an additional 13 randomized patients, and patients with an additional year of follow-up outcome measures. These CARDI-AMP Heart Failure 1 trial results are enormously important, as the data from this trial is intended to provide support for future product approvals and commercialization of the CARDI-AMP cell therapy in the United States and Japan. As we work to deliver these results from the 125 patients enrolled in the CARDI-AMP Heart Failure 1 trial, we are advancing a second confirmatory clinical study in the CARDI-AMP Heart Failure 2 trial. The CARDI-AMP Heart Failure 2 trial is a 250-patient pivotal study at up to 40 centers. It advances the same therapeutic approach and focuses on the remarkable benefits seen in patients treated with elevated NT-proBNP, a well-established biomarker of active heart failure. The FDA recently approved an important protocol amendment to personalize treatment plans in this therapy based on the cardiac cell population analysis, expected to considerably increase the number of patients eligible for the trial. Simply put, the protocol amendment enables patients who would previously fall short of treatment requirements due to the nature of their cells to receive a higher dosage of cells. Multiple consented patients are in the screening queue today, and study sites are being actively onboarded. Enrollment in the CARDI-AMP Heart Failure 2 trial is expected to be significantly enhanced because of the positive data and experience from the CARDI-AMP Heart Failure 1 trial. Additionally, efforts we have taken to streamline the clinical study, implement the treatment planning approach that enables more patients to be eligible based on the nature of their cells, and leverage the enormous experience in the broader CARDI-AMP clinical team are all expected to enhance trial enrollment. Beyond our lead autologous cell therapy program in heart failure, which I've just detailed, we have also made progress this quarter in other programs. This quarter, the last rolling cohort patient in the CARDI-AMP Cell Therapy and Chronic Myocardial Ischemia Trial, or BCD02, was enrolled. which means the primary six-month follow-up endpoint for all patients in this study cohort will be reached in Q1 2025. We have also secured FDA and IRB approval to enroll patients in our cardiallo-allogeneic mesenchymal stem cell therapy in ischemic heart failure, or BCDA03, without requiring them to have been excluded from the cardiac heart failure trial. We expect the last low-dose cohort patient to be enrolled this quarter in the single center dose escalation phase 1-2 study. 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 long-term partnerships where our contributions to the success of partners will reward our shareholders. One element of the Helix delivery system is our proprietary MorphDNA steerable introducer platform. This MorphDNA product family design has performed well for our CARDI-AMP and CARDI-ALO procedures and has potential to enhance many other clinical procedures as a commercial product with a broader product family configuration. We received FDA approval for this product family this past quarter. The product is intended to provide a pathway through which medical instruments such as balloon dilation catheters, guide wires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart. The clearance covers an array of 16 products in lengths of 30, 45, 71, and 90 centimeters in five, six, seven, and eight French introducer sheet equivalent diameters. Marketing materials are currently available on the company's website in preparation for commercial release of the initial products. We are reaching out to senior management at other companies who don't have these products to support their own interventional procedures and inviting their sales teams to be aware of the MorphDNA products. We will also soon be reaching out to many leaders in interventional cardiology, cardiac electrophysiology, vascular surgery, and interventional radiology to obtain first-in-man procedures on the many applications of this elegant enabling commercial platform. We do not expect any significant revenues in the near term, but do expect to have news here ahead as we make progress. On the business development front, We have active partnering discussions with potential to be meaningful for our business with respect to all four of our platforms, CardiAmp, Cardialo, Helix, and MorphDNA. For CardiAmp cell therapy business development, we expect the final data from CardiAmp Heart Failure 1 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 business development, our allogeneic cell therapy currently in the clinic for heart failure, we have extensive clinical experience from three trials. We've had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease. I note that the FDA has set a prescription drug user fee act date of January 7th, 2025 for a peer company with very similar cells and another indication whose anticipated success will likely enhance our partnering discussions around our clinical stage allogeneic 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 discussions. Current partners realize that minimally invasive delivery not only enhances future commercialization, but it 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 threefold efficiency of delivery and the enhanced pharmacokinetics with our Helix system, supported by data from many groups. We believe this advantage is due to the stability of the Helix in the beating heart and the self-sealing helical pathway into the tissue. We encourage all partners to perform pharmacokinetic studies, including a surgical delivery control so they will have their own data supporting what we have seen. 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 towards any distribution or commercial partnership. In summary, we have delivered five of the six milestones detailed in our last conference call. We had expected to treat the first patients in cardiac heart failure two trial and begin demonstrating that we can enroll in this trial quickly with our world-class clinical partners. Two hurricanes in Florida this quarter have had an impact on this goal, but patients are in the queue and this goal will be realized soon. We are working to complete the following before the end of this quarter, Q4, 2024. One, have a consultation with Japan PMDA and cardiac cell therapy. Two, complete data lock on the cardiac heart failure one trial data set. Three, begin treatments and activate an additional three centers in the cardiac heart failure two trial. Four, enroll the last low dose patient in the cardiallo heart failure trial. And five, put first commercial morph DNA products on the cell shelf and perform first procedures. I will now pass the call to David McClung, our CFO, who will review our third quarter 2024 financial results. David.