BioCardia Q1 2026 Earnings Call - Japan PMDA Clears Path for Shonin Approval on CardiAMP

Gary, Conference Call Operator: Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2026 first quarter financial results and business update conference call. I would now like to turn the call over to Miranda Peto of BioCardia Investor Relations.

Please go ahead, Miranda.

Miranda Peto, Investor Relations, BioCardia: Thank you very much. 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, outlooks, 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.

The content of this call contains time-sensitive information that is accurate only as of today, May 15th, 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 go ahead.

Gary, Conference Call Operator: Dr. Altman, this is the operator. Perhaps your line is muted.

Dr. Peter Altman, President and Chief Executive Officer, BioCardia: Thank you. Thank you, Miranda Peto. Good afternoon to everyone on the call. We have had significant accomplishments this last quarter for our CardiAMP cell therapy for the treatment of ischemic heart failure. This is a significant unmet clinical need for which we have FDA Breakthrough designation and Medicare reimbursement at $20,000 per treatment procedure today. I’m going to share these accomplishments as they happened. You can appreciate the dynamics of the recent developments. First, the blinded echocardiography data from the CardiAMP Heart Failure Trial presented at the Technology and Heart Failure Therapeutics Conference in Boston in early March was excellent. We described this data readout in our last call. It bears repeating as the clinical data underlies the value we are creating and the regulatory meetings that have been happening in parallel.

This echocardiography data, analyzed by the world-class Echocardiographic Core Laboratory at Yale University, is data which few, if any, advanced therapies for heart failure have in their trials, and it is long-term, truly blinded, contrast-enhanced echocardiography. The CardiAMP Heart Failure echocardiography results showed compelling signals of enhanced heart function in the treated patients relative to the control patients over time. More specifically, the heart volumes at both full heart relaxation and maximum heart contraction did not increase over time in the treated subjects, but did increase in the control subjects who did not receive therapy. Increased heart volumes is the normal course for these patients and results in the heart becoming more spherical and losing its pumping efficiency. Increased volumes have long been known to be correlated with poor long-term outcomes. In CardiAMP HF, the treated patients did not experience this negative remodeling.

In the subgroup having elevated biomarkers of heart stress, these heart function benefits for both full relaxation and full contraction were statistically significant and aligned with the 3 tiers of the composite outcome of, 1, living longer without heart replacement therapy such as LVAD or transplant. 2, having fewer major adverse events such as heart attacks, strokes, and hospitalizations. 3, having a better quality of life. This composite endpoint also achieved statistical significance. All of the patients were on maximum guideline-directed medical therapy. These benefits seen with CardiAMP cell therapy were in addition to those provided by the established therapy. This underlines that the CardiAMP cell therapy is likely driving a new mechanism of action of microvascular repair, promoting new capillary growth and reducing tissue fibrosis in the heart.

This is the data we have been discussing with Japan’s Pharmaceutical and Medical Devices Agency regarding potential for approval with a rigorous post-marketing study to collect further evidence with respect to both safety and efficacy. I am delighted today to share that in our formal clinical consultation with Japan’s Pharmaceutical and Medical Devices Agency, they have said that they are inclined to accept this data as the basis for regulatory submission and approval in Japan for an initial indication aligned closely with the trial results. They have noted that there is an unmet need in Japan that the CardiAMP cell therapy may address. In our 10-Q report today, we also detail that we have received the draft written advisory record from the agency. It is in alignment with this meeting.

BioCardia is already actively preparing for the formal Shonin pre-market application for approval in Japan, which we expect will take approximately 7 months to prepare and submit to the agency for review. We will provide additional updates on this timeline ahead. This is excellent news for patients, BioCardia, and our investors. We also completed a Q-Sub meeting with FDA Center for Biologics Evaluation and Research on this CardiAMP heart failure data. This discussion focused on our already FDA-approved CardiAMP cell processing platform to extend existing labeling from in vitro diagnostic indication to a therapeutic indication for ischemic heart failure of reduced ejection fraction. FDA made clear that they view the appropriate approval pathway is a pre-market approval. FDA had no concerns on the safety of the CardiAMP cell therapy, and the conversation focused on the efficacy results, which FDA found intriguing.

We discussed the potential of advancing to a pre-market application based on this data. FDA encouraged BioCardia to complete the ongoing CardiAMP HF II trial to provide support for the pre-market application. FDA did also agree to engage on certain elements of the study’s statistical analysis based on nuances of our composite endpoint and has provided other meaningful advice to BioCardia on this study. The four activated centers in the ongoing CardiAMP Heart Failure II study have continued to enroll patients. The trial is designed as a 250 patient study, where 160 patients are needed to have 80% power. We have additional centers interested in participating that we are onboarding and have plans to expand as fast as resources allow. Completing the CardiAMP Shonin pre-market application for approval in Japan and enrolling CardiAMP Heart Failure II are our top priorities.

Results also from our second clinical program of the CardiAMP cell therapy in chronic myocardial ischemia have been accepted for oral presentation next week at the prestigious EuroPCR meeting. We expect these results will be available on Wednesday. We have also completed the pre-submission meeting with FDA on the approval of the Helix transendocardial delivery system in recent weeks. FDA agreed that there are two pathways for Helix market and 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 as a standalone delivery system.

We have delivered now on all 4 catalysts detailed in our last call, having 3 positive regulatory interactions and are very pleased with the outcomes. For the second quarter of 2026, looking ahead, we expect to complete 1 or more transactions that will fund Japan PMDA submission for approval and the CardiAMP Heart Failure II trial. I will now pass the call to David McClung, our CFO, who will review our first quarter 2026 financial results. David?

David McClung, Chief Financial Officer, BioCardia: Thank you, Peter Altman. Good afternoon, everyone. Here are the highlights of our financial results for the quarter ended March 31st, 2026. Total expense decreased by $460,000 quarter-over-quarter to $2.3 million in the 1st quarter of 2026 compared to $2.7 million in the same quarter of 2025. The primary driver of this change, research and development expense, decreased $295,000 to $1.2 million in the 1st quarter of 2026 versus $1.5 million in the 1st quarter of 2025. The decrease relates primarily to the closeout of the CardiAMP Heart Failure Trial, partially offset by expenses for early enrollment in the CardiAMP Heart Failure II trial and regulatory activities to advance CardiAMP in Japan.

Selling general administrative expenses decreased to $1.0 million for the 3 months ended March 2026 as compared to $1.2 million in the quarter ended March 2025, primarily due to lower professional service fees. Our net loss was $2.3 million for the 1st quarter of 2026 compared to $2.7 million in Q1 2025. Net cash used in operations was $1.7 million for the 1st quarter of 2026 compared to $1.6 million in the same quarter in 2025, with the change relating primarily to the timing of supplier payments. The company ended the quarter with cash and cash equivalents totaling $951,000. We will continue to carefully manage our use of capital while still delivering our milestones and objectives. This concludes management’s prepared comments. We are now ready to take questions from attendees.

Gary, Conference Call Operator: At this time, we will now begin the question and answer session. To ask a question, you may press star then one on your touchpad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question today is from James Molloy with Alliance Global Partners. Please go ahead.

Laura, Analyst (on behalf of James Molloy), Alliance Global Partners: Hello, this is Laura on for James Molloy. Thank you for taking our questions. May you just provide a bit more insight into the regulatory process in Japan? What additional work do you think you might need to do alongside the Shonin application that you mentioned from now until submission this year? What’s the timing of when you’ll hear back from the agency after filing?

Dr. Peter Altman, President and Chief Executive Officer, BioCardia: Laura, thank you for the question. The dynamics in Japan for submission are rather extensive. We have already prepared a large STED document which they’ve already been reviewing as part of this process, which is essentially a template for the actual submission. The process ahead will involve auditing our clinical data, auditing our manufacturing, and literally going through every thread associated with the submission process. They have gone through the data here quite a bit already, so they’re pretty sophisticated on what we have. My expectation is it should go relatively straightforward. This was run under good clinical trial practices.

The submission itself, we have to do some pre-audit work on our own with Japan representatives that will hold our regulatory submission for us under BioCardia’s control. We will complete the submission in roughly 7 months, I would expect. The process after that is about a year-long review process similar to what’s done in the U.S. for a PMA, where they audit all of the data and the manufacturing and the sterility and all that goes into it. At the end of the day, we would expect to have approval. Just so everybody on the call is aware, you know, BioCardia, even though we’re a small company, we actually have roughly 100 FDA-cleared interventional products here in our Morph platform, and we’ve previously had products approved in Europe.

We have pretty good systems for quality and manufacturing in place, and I don’t expect any significant issues. The most significant issue was, of course, the clinical data. That is usually the case. Our expectation is if things go as planned in roughly 19 months, we’ll be approved and in the market in Japan. On the other side of that approval, there will be a post-marketing study. The post-marketing study is actually really important but also valuable for us. We will collect additional procedural safety data. We will establish sort of standard of care outcomes that we track, and this will be done in conjunction with the medical societies in Japan and with Japan’s Pharmaceuticals and Medical Devices Agency.

There will be reimbursement during that post-marketing study, it will be Think of it as an early marketing launch, we’ll be doing it under the auspices of all the leading societies in Japan and these societies are the Japanese Circulation Society, the Japanese Heart Failure Society, and the Japanese Association of Cardiovascular Intervention and Therapeutics. We had leadership from all of those attending our PMDA session and folks on both sides of the table in that session expressed interest in participating in that post-marketing study and were supportive of the efforts ahead. That’s the high level. If you have follow-ups, Laura, that I didn’t hit anything appropriately, I welcome them.

Laura, Analyst (on behalf of James Molloy), Alliance Global Partners: Yes. Thank you for the clarity. Yeah, just as a follow-up, may you just talk about more about the market opportunity in Japan? You mentioned how CardiAMP may cover an unmet medical need in the region. How may you see CardiAMP integrating into the treatment regimen in Japan?

Dr. Peter Altman, President and Chief Executive Officer, BioCardia: Right. By the way, Laura, there’s an enormous amount of work going through every single drug and therapy that’s approved in Japan and demonstrating that the standard of care there is almost identical to the standard of care here in the United States. There are subtle differences, but nothing that’s really meaningful from our perspective, but from the regulatory perspective, they are meaningful. The market opportunity, I think initially, you know, there’s roughly 300,000 patients in Japan with ischemic etiology heart failure who could be appropriate candidates. Initial market, though, will be much smaller than that. It will be very limited to what we call appropriate use conditions, and we would expect it to be on the order of 20,000 patients.

It’s also what we view as a reachable market, and we expect You know, historically in Japan, they have reimbursed a cardiac cell therapy that at a reimbursement of around $124,000 per procedure. Now, we don’t expect that level of reimbursement for what we do, ’cause one of the advantages of the CardiAMP cell therapy is it can be a cost-effective therapy. If we use the math of what is our reimbursement today in the U.S. and what is the expected indication we would have approval for in Japan, of 20,000 patients and the $20,000 reimbursement in the U.S., that becomes pretty quickly a $400 million market.

Laura, Analyst (on behalf of James Molloy), Alliance Global Partners: Great. Thank you for taking the questions.

Dr. Peter Altman, President and Chief Executive Officer, BioCardia: No problem. I appreciate them, Laura.

Gary, Conference Call Operator: Excuse me. Showing no further questions, this concludes our question and answer session. I would like to turn the conference back over to Peter Altman for any closing remarks.

Dr. Peter Altman, President and Chief Executive Officer, BioCardia: Thank you, Gary. Our efforts advancing cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. The positive regulatory interaction for approval in Japan is a transformative milestone, and we will continue to keep investors current on our progress towards submission and approval. On behalf of our entire BioCardia team, I thank all shareholders for their continued support as you make our efforts possible. Thank you very much.

Gary, Conference Call Operator: The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.