BioCardia, Inc.

Thanks, Jules, and good afternoon to everyone on the call. It has been only six weeks since our last call with the 2021 year-end results, and BioCardia continues to execute in its efforts to advance its meaningful pipeline of cell and cell-derived therapeutics to treat significant cardiovascular and pulmonary disease. The first quarter was significant for BioCardia, with progress in the development of both our autologous and allogeneic cell therapy platforms. Our primary focus is the enrollment in our clinical programs, which will be a continuing effort as the healthcare research systems across the United States recovers from COVID-19. Our efforts to complete the cardiac autologous cell therapy pivotal clinical trials for the indications of heart failure, or BCDL1, and chronic myocardial ischemia, or BCDL2, have had some nice milestones this quarter. We have already shared these in our last conference call, but it bears repeating that in this first quarter of 2022, our lead program in heart failure was granted FDA breakthrough designation, providing independent validation that our data to date is truly compelling. We had a successful data safety monitoring board review in our lead heart failure trial. We received Health Canada's no objection letter to expand the heart failure trial in Canada. We received a new CMS reimbursement code to support both pivotal cardiac cell therapy clinical trials. And we received a favorable opinion from the Office of the Inspector General of Health and Human Services, supporting our ability to cover patient co-payments in our heart failure trial. These were the result of efforts throughout 2021 and realized in the first quarter. For the first time, we have three cardiac heart failure trial procedures scheduled on the same day at three sites across the United States in the month ahead. We are working diligently to support our world-class clinical partners and complete enrollment in the cardiac trials as soon as possible. We are working with the goal of a 2023 completion of enrollment in the full 260 patient cardiac heart failure trial. and enrollment of the 100th patient in the CARDI-AMP chronic myocardial ischemia trial to enable its interim readout. We have just had our first consultation with Japan's Pharmaceutical and Medical Device Agency regarding registration of CARDI-AMP 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 CARDI-AMP cell therapy system in Japan, the United States, and the European Union. The meeting with Japan's PMDA went well. We are still on this pathway, aiming for approval of the cell therapy system in Japan based on our current data and planning for our second consultation where we will provide information and data that have been requested by Japan's Pharmaceutical and Medical Device Agency. Although Japan's population is declining, there are many patients in Japan with heart failure that we believe cardiac amp cell therapy can benefit. What is not well appreciated is that Japanese scientists have been central to this field of development that has led to the cardiac amp cell therapy. just as Japanese scientists have been central to the development of induced pluripotent stem cells for which they were awarded the Nobel Prize in Medicine. Now, I'd like to move to our two allogenic cell therapy product candidates based on our allogenic neurokinin-1 receptor-positive mesenchymal stem cell platform, which has progressed in the six weeks since our last call. Our program in heart failure, which we have designated as BCD03, targeted to the patients who have been excluded from our autologous program due to the nature of their cells, is completing what we believe is the last pharmacology and toxicology studies to enable IMD submission, targeted for acceptance by the FDA in 2022. Our program in patients recovering from acute respiratory distress syndrome, which we have designated BCD-04, has been approved by FDA this April to treat patients and we are targeting enrolling first patients as early as next quarter, Q3 2022. We have been invited to present our efforts at the second annual acute respiratory distress syndrome drug development symposium being held in July in Boston alongside leaders from peer companies developing MSCs for acute respiratory distress syndrome. In summary, we are advancing four therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and our allergenic 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 systems for cell gene and protein therapy candidates in the heart And third, monetizing our Avance transeptal introducer sheath product. I will now pass the call to David McClung, our CFO, who will provide some financial perspectives. David?

Thank you, Peter. The company ended the quarter with cash totaling $9.9 million, which together with the $1.5 million in proceeds from the ATM in April provide runway into the first quarter of 2023. Our research and development expenses increased by 22% to $2.2 million in the first quarter of 2022 due to increased spending in support of the cardiac heart failure trial. SG&A expenses of $1.2 million in the first quarter of 2022 is unchanged from Q1 2021. The company's net loss for the first quarter was $3.3 million compared to $3 million in the prior year. and net cash used in operations was 2.9 million in Q1 2021, compared to 1.9 million during the prior year's first quarter. The increase is due to the timing of payments from collaboration partners, coupled with the increased research and development expenses during the quarter. We're now ready to take questions. Operator?

Thank you. We will now begin the question and answer session. Should you wish to ask a question on today's call, you will need to press star then the number one on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing star then two. If you're using a speakerphone, we ask that you please pick up your handset before entering your request and speaking on the call. One moment please for the first question. Today's first question comes from Kumara Guru Raja with Brookline Capital Markets. Please go ahead.