BioCardia, Inc.

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia 2021 year-end 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 June 29, 2022. I would now like to turn the call over to Jules Abraham of CoreIR, the company's investor relations firm. Please go ahead.

Thank you, Andrea. Good afternoon, everyone, and thank you for participating in today's conference call. Joining me today from BioCardio's leadership team are Peter Altman, Ph.D., 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, outlook, 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 8-K, followed with the SEC, particularly the cautionary statement in them. The content of this call contains time-sensitive information that is accurate only as of today, March 29, 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. With that, it's now my pleasure to turn the call over to Peter Alton, Ph.D., the company's president and CEO. Peter, please go ahead.

Thank you, Jules, and good afternoon to everyone on the call. BioCardia continues to execute in its efforts to advance its meaningful pipeline of cell and cell-derived therapeutics to treat significant cardiovascular and pulmonary diseases. 2021 was a big year for BioCardia's team. We have progressed significantly in the development of all four of our therapeutic candidates based on our autologous and allogenic cell therapy platforms. I'm going to touch on each of these four programs in turn. First, our efforts to complete the CARDI-AMP autologous cell therapy pivotal clinical trials for the indications of heart failure, or BCD01, and chronic myocardial ischemia, or BCD02, have had some nice milestones. These include the receipt of an FDA breakthrough designation, successful data safety monitoring board reviews, a Health Canada no objection letter, and the issuance of a new CMS reimbursement code to support both pivotal cardiac cell therapy clinical trials. The FDA grant of breakthrough designation for the cardiac cell therapy system in heart failure is an enormous accomplishment that has been years in the making. This FDA breakthrough designation means that after the FDA performed an extensive review of all of the available patient-by-patient data, the agency made a formal assessment that the cardiac cell therapy has potential to be better than standard of care for patients with ischemic heart failure. Physicians that care for these patients and the patients themselves can benefit from this independent review by the FDA when they consider the cardiac cell therapy as an option. Although we have said that signals of patient safety and benefit are compelling all along, it adds greatly to the credibility of the therapy for all involved that the FDA's granting of breakthrough designation aligns with this perspective. It also shows that the FDA recognizes that current therapies haven't addressed the enormous need that exists for these patients. The breakthrough designation results in our having significant advantages in our FDA interactions ahead, but most importantly, it is FDA saying that the autologous cell therapy we are advancing for these patients is important. Although the cardiac cell therapy trials are covered by CMS, many private insurers don't follow CMS's lead. As a result, Many patients with heart failure who would qualify for our trial clinically have been excluded from receiving this FDA-designated breakthrough cell therapy because of insurance. Although the breakthrough designation may increase the frequency that private insurers support covering the cardiac cell therapy, we have set out to solve this in three ways. First, After significant sequential filings with both the biologics and the device group at Health Canada, the cardiac cell therapy and heart failure was issued a no-objection letter. This letter allows the trials to advance in Canada, where there are world-class sites we seek to bring into this trial. These clinical leaders are expected to help the program toward completion, as BioCardi will be paying for all patients enrolled without the logistical challenges with respect to private insurance reimbursement that exists in the United States. Second, as sponsor, we are now providing sites with CMS approved coverage of standard clinical costs for patients whose private insurer has declined to cover our investigational FDA designated breakthrough cell therapy for patients with heart failure. This can allow all patients to receive therapy regardless of insurance and is expected to double the number of eligible subjects in the trial in the United States. Third, we sought additional clarity from CMS in the form of a reimbursement code supporting both the treatment and control arm of the CARDI-AMP cell therapy procedure. CM has issued such a new procedure code, C9782, which applies to the CARDI-AMP cell therapy clinical trials. in both indications. We are thankful for the efforts of Health Canada, FDA, and CMS on these initiatives related to the cardiac cell therapy platform, which enhances the attractiveness of the trial and the therapy for centers, physicians, and patients. In 2021 and 2022, we have had three data safety monitoring board reviews of the blinded cardiac heart failure trial results. In all instances, the Data Safety Monitoring Board has said the trial should continue as planned. These initiatives and continued good data, coupled with the waning of COVID-19 at clinical sites throughout the country, are operationally important for completion of the CARDI-AMP autologous cell therapy trials in the United States and in Canada. As the last item on the CARDI-AMP cell therapy, we have initiated a discussion with Japan's Pharmaceutical and medical device agency regarding registration of CARDI-AMP cell therapy 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. Now I'd like to move to our two allogenic cell therapy product candidates, both supported by our allogenic neurokinin-1 receptor-positive culture-expanded mesenchymal stem cell platform, which has progressed greatly over the last year. Our allogenic neurokinin-1 receptor-positive culture-expanded mesenchymal stem cell program in heart failure, which we have designated as BCO3, is targeted to the patients who have been excluded from our lead program due to the nature of their cells. This program has completed the chemistry manufacturing controls validation, and is completing additional pharmacology and toxicology study in animals. Our allogenic program on the same neurokinin-1 receptor-positive cultured expanded mesenchymal cells in acute respiratory distress syndrome has also completed chemistry manufacturing controls validation. It's pharmacology and toxicology studies. And in March of this year, we submitted an IND to the FDA. We expect news. in April from the FDA that this therapy may proceed to treat patients or will be placed on clinical hold with additional items to work through. In summary, we are advancing four therapeutic cell therapy product candidates based on our autologous and our allogenic platforms. The therapeutic delivery systems we have created for our own programs are actively being used by partner programs, and we believe that both patients and our shareholders will benefit from the success of our partners. I will now pass the call to David McClung, our CFO, who will provide some financial perspectives. David. Thank you, Peter.