BioCardia, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead, Miranda. 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. 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 reports on Form 10-K filed with the SEC on March 24, 2026, and in our subsequently filed quarterly reports on Form 10-Q.

The content of this call contains time-sensitive information that is accurate only as of today, August 12, 2026. 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 proceed. Thank you, Miranda, and good afternoon to everyone on the call.

The highlights of this second quarter have been the positive outcomes of three important meetings with regulatory agencies in Japan and the U.S. on the approvability of our CardiAMP cell therapy for the treatment of ischemic heart failure and on the approvability of our Helix transendocardial delivery catheter, which we use in our therapeutic programs. Let's take each of these in turn. In May, we announced that Japan's Pharmaceuticals and Medical Devices Agency, or PMDA, provided the Consultation Record of Advice, which supports our advancing to Shonin pre-market regulatory submission for approval of the CardiAMP cell therapy. PMDA noted that the positive outcomes seen in our CardiAMP trials were credible. We have remaining questions to address before and as part of the submission for regulatory approval for this therapy.

Specifically, PMDA requested BioCardia demonstrate that enrolled patients were on guideline-directed medical therapy and not eligible for revascularization procedures, both of which were required per the CardiAMP Heart Failure trial clinical protocol. They also requested additional details for each incidence of all-cause death, heart transplantation, or left ventricular assist device implantation. PMDA also provided guidelines and requested an initial proposal for further developing the post-marketing study with details on center selection, physician selection, training, and outcomes to be assessed. BioCardia believes these requests will be addressed to PMDA satisfaction and the post-marketing study to be developed together with PMDA and Japanese medical societies will be straightforward. In addition to answering these questions in great detail, BioCardia is preparing for the Shonin regulatory submission in Japan next quarter.

We are working to complete the electronic trial master file, conduct third-party Japanese Good Clinical Practice audits to PMDA standards, and structure clinical research data in accordance with CDISC standards, which support data consistency, traceability, and regulatory compliance. We are reviewing extensive product documentation internally and expect to soon sign an agreement with a designated marketing authorization holder, or DMAH, to help finalize the submission as they will act as the local regulatory representative to enable BioCardia sales of CardiAMP cell therapy in Japan. Our expected initial indication will be for approximately 20,000 patients in Japan, with approval approximately 12 months after we complete our Shonin submission. During this period, we would expect to be educating physicians and finalizing the details of the post-marketing study and its logistics so that we are ready to begin at all centers as soon as reimbursement has been established.

Reimbursement in Japan follows Shonin approval and will be determined based on discussions with the Ministry of Health, Labour, and Welfare. In Japan, another cell therapy for the same indication was approved in March of this year and has received confirmation that they have been approved for reimbursement in July at JPY 326,000 per treatment. This underscores the need recognized in Japan for such a therapy. That cardiac cell therapy is now a real market in Japan, and that CardiAMP cell therapy has potential to be an enormously valuable therapy. While these two cell therapies are different, we believe the minimally invasive delivery and autologous nature of CardiAMP, coupled with its greater clinical experience, will be attractive to both physicians and their patients.

With approval and reimbursement, we would expect adoption to be relatively rapid in the post-marketing study with world-class physician leaders whom have already been generous in their support of our efforts. Although our initial approval is only expected to be for 20,000 patients in Japan, we note that there are approximately 300,000 patients in Japan with ischemic heart failure today. Japan's world-class interventional cardiologists perform 250,000 cardiac catheterization interventions per year. Our enhancing both physician and patient success in the post-marketing study, where there will be reimbursement, is likely to result in a significant business that has a very positive impact on patients and society in Japan. Shonin approval of CardiAMP cell therapy, which includes the Helix biotherapeutic delivery catheter, may also help other developers of cardiac biologic therapy in Japan.

It is worth noting that the two publicly traded peer companies in Japan advancing cardiac cell therapies each have market capitalizations of approximately JPY 250 million. To our knowledge, BioCardia has performed more than 20 times as many clinical procedures as both of these firms combined. Each is pursuing a different catheter delivery approach, but we do feel we could be a valuable partner if we have not entered into an exclusive development agreement with a competitive party. We also have important issued patents on delivery in Japan. in June, we announced the results of our second significant regulatory discussion, our Q-Sub meeting with FDA's Center for Biologics Evaluation and Research. The meeting minutes from FDA confirmed that the ongoing CardiAMP Heart Failure II trial may support pre-market approval for market clearance.

This was significant as previously the FDA had not provided the support that one trial should be sufficient for approval for this large clinical indication. FDA said the data was interesting, and the message we are hearing is that the CardiAMP Heart Failure II trial is viewed as a confirmatory trial. There were no questions on safety or on delivery in the meeting, and our sense is that for the agency, the confirmatory trial is all about the efficacy of the study. We are expected to have additional discussions with the agency on the outcome measures in the study, in particular around the third tier of the composite outcome of quality of life. We continue to actively enroll in the CardiAMP Heart Failure II trial to take this study to completion as our confirmatory phase III study. Four clinical sites have enrolled in the study and are actively recruiting patients.

Three additional patients are expected to qualify for the study this month, and two are scheduled for their procedures this month. There have been no safety issues of which management is aware. The rate of enrollment here is driven primarily by resources deployed, and we are actively onboarding additional centers. in May, we had our third regulatory interaction on the de novo pre-submission with FDA for the Helix transendocardial delivery catheter system. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents. FDA's preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the de novo pathway.

However, we still don't have the formal meeting minutes from this meeting, which were expected June 12th. We did hear from FDA this morning by email that confirms our understanding, and FDA has said that they would have the formal minutes sent to us soon. Our assessment is that the Helix transendocardial delivery catheter system has the best safety, efficiency, and ease of use of any catheter of its kind. It takes years to generate this level of data, which we have for more than a dozen clinical trials with approximately 500 patients. We feel it is unlikely that another transendocardial delivery system will be able to have this amount of data within the next five years. This catheter has been previously CE marked and approved for market release in Europe.