BioCardia, Inc.

Ladies and gentlemen, thank you for standing by. Good day and welcome to the BioCardia 2022 second quarter 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 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 through August 24, 2022. I would now like to turn the conference over to Jules Abraham of CoreIR, the company's investor relations firm. Please go ahead.

Thank you, Kate. Good afternoon, everyone, and thank you for participating in today's conference call. Joining me from BioCardio's leadership team today 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 or operational results, references to management's intentions, beliefs, projections, outlooks, analyses, or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or 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 described in BioCardia's most recently filed periodic reports on Form 10-K, Form 10-Q, and form 8K files with the SEC, particularly the cautionary statements in them. The contents of this call contains time-sensitive information that is accurate only as of today, August 10, 2022. Except as required by law, BioCardia disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It's now my pleasure to turn the call over to Peter Altman, Ph.D., the company's president and CEO. Peter, please go ahead.

Thanks, Jules, and good afternoon to everyone on the call. We've had a great quarter, but before we get into the details, let's take a few moments to review what we are doing and why we are doing it. Myocardial efforts are focused on advancing two cell therapy platforms to treat significant unmet cardiovascular and pulmonary diseases. Specifically, ischemic heart failure, chronic myocardial ischemia, and acute respiratory distress. All of our cell-based therapies involve local delivery of the therapeutic to the heart or lungs where we intend them to act locally. In the heart, our proprietary Helix minimally invasive delivery system is used to deliver the cells to target regions of damage. For the lungs, we intend to use intravenous delivery, which will result in the investigational cells being localized in the small blood vessels of the lungs. Local delivery of therapeutics to the target location where their action is desired maximizes their effective dosage within the tissues where delivered and minimizes potential negative effects remote from the target tissues. Heart failure is the first problem we are going after. Heart failure is an enormous unmet need that affects more than 26 million people worldwide. The latest blockbuster drugs and pretty much the same indication we are going after don't have much of an impact on mortality. Patients in the published results of the pivotal trials for these new drugs have a mortality of roughly 7% per year regardless of whether they were treated or control patients. This data makes clear that heart failure is still a problem in great need of new therapeutic solutions. In preclinical studies, cardiac mononuclear cell therapy has been shown to release proteins locally within the tissue to facilitate cardiac recovery after heart damage with improvements in heart perfusion and contractile function. All known previous clinical studies, similar to the approach we are taking in our two lead cardiac cell therapy programs have shown patient benefits on average. In some of these studies, including our own, the benefits have been remarkable. Our FDA breakthrough designation in ischemic heart failure validates this perspective. In granting this designation, the FDA looked through all of our clinical results, patient by patient, and agreed that cardiac cell therapy data to date shows it has promised to provide for more effective treatment for ischemic heart failure. Advancing this and our other therapeutic candidates is what we are all about. Our efforts to complete the cardiac autologous cell therapy pivotal clinical trials for the indications of heart failure, or BCDAO1, and chronic myocardial ischemia, or BCDAO2, remain our primary focus. The lead heart failure program has 114 patients enrolled and 10 control patients have crossed over to receive therapy. Here today, we will only detail the new accomplishments towards completion of these studies. For both of these trials, the Center for Medicaid and Medicaid Services, or CMS, reimburses clinical sites for performing these procedures. In May of 2022, CMS increased the reimbursement up to $20,000 per patient procedure for both control and treated patients retroactive to April 1, 2022. This is important for our clinical partners as it enhances confidence that they will be paid at the level they seek for both treatment and control procedures and enhances the blinding of the trial as all patients should be coded identically with respectability. We have also been adding additional clinical sites and expanding the study. The first of four anticipated world-class sites in Canada was activated and is now enrolling in our heart failure trial. Canadian sites are critically important as a second approach to mitigate potential impact that the CMS reimbursement is causing a delay in enrollment. We are also working to provide additional educational materials for patients. including a simple but elegant animation of the cardiac heart failure trial, which is now live on our website and which we invite you to view on the site cell therapy clinical trials page. We anticipate submitting this animation to clinical sites as soon as other materials are also available for institutional review board approval, which is required for the materials to be shown to patients. Many patients are believed to not participate in the trial, because they want to receive the therapy and prefer to not have a 40% chance of being in the control arm. The animation explains why this randomization is important and makes it clear that should patients in the control arm wish to proceed to therapy after they complete the follow-up in the control arm, they may. To explain this further, a new patient testimonial is also now available on our website on the same cell therapy clinical trials web page, telling, quote, Tim's story, end quote. Tim was an ultramarathoner and developed heart disease in his 40s. Now in his 70s, he participated in the cardiac heart failure trial at the University of Wisconsin and was in the control group. After his two-year follow-up, he elected to receive therapy and is now in the treated group. We also anticipate submitting the video on Tim's story to clinical sites as soon as other materials are also available for institutional review board approval. These efforts to enable patients to be well-informed on the cardiac cell therapy heart failure study and to share their experiences with one another are continuing. We anticipate this will have a significant impact in the percentage of patients eligible who decide to participate in the CAR-D-AMP cell therapy trials. These efforts show we are working diligently to support our world-class clinical partners and complete enrollment in the CAR-D-AMP trials as soon as possible. We are working with the goal of a 2023 completion of enrollment in the full 260-patient CAR-D-AMP heart failure trial and enrollment of 100 patients in the CAR-D-AMP chronic myocardial ischemia trial to enable its interim readout. We have just had our second consultation with Japan's Pharmaceutical Medical Device Agency regarding registration of CAR-DM cell therapy. This consultation is based on the quality of our clinical data and the regulatory approvals that exist around all of the elements of the CAR-DM cell therapy system in Japan, the United States, and the European Union. For the second consultation, in addition to high-level analysis, we provided Japan's PMDA with all of our clinical data on a patient-by-patient basis from all of our trials. The second consultation meeting went well, and there were no questions on our existing clinical data sets provided. We are still on this pathway aiming for approval of the CAR-DAM cell therapy system in Japan based on our current data and planning for our next submission where we will provide much of the same data in a new format more details on our clinical protocols and preclinical testing, and provide written responses to questions from our last consultation. Japanese researchers established the building blocks for this therapy many years ago. The therapeutic approach we are pursuing was first studied in a preclinical model by physician scientists in Yokohama. This early work was performed in parallel to another Japanese vascular biology scientist who identified important aspects of bone marrow-derived mononuclear cells in tissue repair. Their early efforts underlie our cardiac cell therapy, and we hope to be able to provide this therapy to the many in Japan who could benefit from it. Now I'd like to move to our two allogeneic cell therapy product candidates based on our allogeneic neurokinin-1 receptor-positive mesenchymal stem cell platform, which has also progressed in this second quarter. Our allogeneic MSC program in heart failure, which we have designated as BCD03, is intended to include the patients who have been excluded from our autologous program due to the nature of their cells. This program has completed what we believe is the last pharmacology and toxicology studies to enable IND submission, targeted for acceptance in 2022. Much will depend on the final data which we expect soon. Our allogeneic MSC program in patients recovering from acute respiratory distress syndrome, which we have designated BCDL4, was approved by FDA in April to treat patients. This program is expected to have clinical cells available from our Sunnyvale production facility and a first clinical site activated this quarter. Our expectation is that enrollment will soon follow after we have final lot release testing of the cells. We are optimistic due to the longstanding promise of mesenchymal stem cells and lung repair and the unique clinical indication we have identified. We aim to address the need to reduce local and systemic inflammation after a patient is taken off respirator support with goals of accelerating recovery, enhancing survival, and reducing both relapse and hospitalization. In summary, we are advancing four therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and our allogeneic cell therapy platforms. From these therapeutic development efforts, we have three active business development initiatives. First is partnering our cardiac cell therapy platform internationally. Second is licensing our catheter-based biotherapeutic delivery system for cell, gene, and protein therapy candidates to the heart. And third, monetizing our Avance transeptal introducer sheet product. I will now pass the call to David McClung, our CFO, who will provide some financial perspective. David?