BioCardia (BCDA) Q1 2026 Earnings Transcript

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Date

May 15, 2026, 4:30 p.m. ET

Call participants

• President and Chief Executive Officer — Peter Altman, Ph.D.
• Chief Financial Officer — David McClung

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Takeaways

• FDA Breakthrough Designation -- CardiAMP Cell Therapy for ischemic heart failure holds FDA breakthrough status and is reimbursed at $20,000 per procedure in the United States.
• Japan regulatory progress -- Japan's Pharmaceutical and Medical Devices Agency stated it is "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," supporting BioCardia (NASDAQ:BCDA)'s plan to file the Shonin premarket application within 7 months.
• Clinical efficacy -- The CardiAMP Heart Failure trial's blinded echocardiography assessment revealed that treated patients did not experience increases in left ventricular volumes over time, while control patients did; statistical significance was achieved in the subgroup with elevated biomarkers for both heart relaxation and contraction measures.
• Composite outcome -- In patients with elevated heart stress biomarkers, the composite endpoint (encompassing survival without LVAD/transplant, fewer major cardiac events, and better quality of life) reached statistical significance.
• FDA interaction -- The FDA viewed CardiAMP's data as "intriguing" and confirmed premarket approval as the appropriate pathway, citing no safety concerns and encouraging completion of the CardiAMP Heart Failure II trial; the agency also provided feedback on statistical endpoints.
• Ongoing trials -- CardiAMP Heart Failure II is enrolling at 4 activated sites, aiming for 250 patients in total and 160 required for 80% power, with additional sites in onboarding.
• Helix system approval path -- FDA discussed two approval routes for the Helix Transendocardial Delivery System, noting "no concerns on Helix safety data, device performance or compatibility," and suggesting the de novo pathway as a standalone option in a future pre-submission.
• Expenses -- Total expenses declined $460,000 quarter over quarter to $2.3 million, attributed mainly to lower R&D (-$295,000) and SG&A (-$200,000) spending; R&D changes reflect closeout of CardiAMP HF trial, with partial offset from CardiAMP HF II costs and Japan regulatory activities.
• Net loss -- Net loss for the quarter was $2.3 million, compared to $2.7 million for the same period in 2025.
• Operational cash use -- Net cash used in operations was $1.7 million, slightly above $1.6 million in the prior year, primarily tied to supplier payment timing.
• Liquidity -- The company closed the quarter with $951,000 in cash and cash equivalents.
• Near-term financing -- Management said, "we expect to complete one or more transactions that will fund Japan PMDA submission for approval and the CardiAMP Heart Failure II trial" in the second quarter.
• Japan market size -- Management estimated "roughly 300,000 patients in Japan with ischemic etiology heart failure," but expects the initial addressable market post-approval to be "on the order of 20,000 patients."
• Reimbursement comparison -- Japan previously reimbursed a different cardiac cell therapy at ~$124,000 per procedure; using the U.S. CardiAMP reimbursement rate of $20,000 per treatment and an initial Japanese cohort of 20,000 patients, management estimates a potential $400 million market opportunity.
• Post-marketing study requirement -- Post-approval in Japan will involve a "post-marketing study" with reimbursement, conducted with involvement of national cardiology societies and Japan's PMDA.

Summary

BioCardia (NASDAQ:BCDA) reported regulatory momentum in both Japan and the United States for its CardiAMP Cell Therapy as a result of positive clinical data and multiple constructive agency meetings. The company has begun preparations for Japan's Shonin submission, received agency endorsement to proceed, and mapped a timeline of approximately 19 months to potential commercialization in Japan. The ongoing CardiAMP Heart Failure II trial continues patient enrollment, supported by favorable FDA signals and updated feedback on the study's statistical endpoints. Expense management actions produced sequential declines in operational spending, while liquidity at quarter-end prompts stated intent to pursue new financing transactions in the near term. The initial Japan market access will be tied to well-defined indication limits and collaborative, reimbursed post-marketing surveillance.

• The Helix Transendocardial Delivery System may follow a de novo clearance pathway as a standalone device pending further FDA advice.
• BioCardia expects incremental catalysts from new data presentations at external cardiovascular conferences, as noted by the upcoming EuroPCR meeting reveal for chronic myocardial ischemia trial data.
• Japan's regulatory review will proceed under a process similar to the U.S. PMA framework, with a one-year review after application submission and agency inspection of BioCardia's quality and manufacturing systems.
• Management confirmed that additional participating sites for CardiAMP Heart Failure II will be added progressively as resources allow to accelerate study recruitment.

Industry glossary

• Shonin application: Japan's regulatory pathway for approval of new medical devices and therapies, submitted to the PMDA (Pharmaceutical and Medical Devices Agency).
• LVAD: Left ventricular assist device, a mechanical pump for patients with severe heart failure.
• De novo pathway: U.S. FDA approval process for novel medical devices lacking a predicate, allowing market access as Class I or II devices on review of safety and effectiveness.

Full Conference Call Transcript

Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

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

Peter Altman: Thank you. Thank you, Miranda, and 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 happen, so 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, but it bears repeating as the clinical data underlies the value we are creating in the regulatory meetings that have been happening in parallel. This echocardiography data analyzed by the world-class Echo 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 of 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: one, living longer without heart replacement therapy such as LVAD or transplant; two, having fewer major adverse events such as heart attacks, strokes and hospitalizations; and three, having a better quality of life. This composite endpoint also achieved statistical significance. All of the patients were on maximum guideline-directed medical therapy. And 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, and it is in alignment with this meeting. BioCardia is already actively preparing for the formal Shonin premarket 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 time line 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 as a premarket 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 premarket application based on this data. FDA encouraged BioCardia to complete the ongoing CardiAMP HF II trial to provide support for the premarket application.

FDA did also agree to engage on certain elements of the study statistical analysis based on nuances of our composite endpoint and has provided other meaningful advice to BioCardia on the study. The 4 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 premarket 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 2 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 presubmission incorporating agency advice could enable Helix approval via the de novo pathway as a stand-alone delivery system. We have delivered now on all 4 catalysts detailed on 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 one 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: Thank you, Peter. Good afternoon, everyone. Here are the highlights of our financial results for the quarter ended March 31, 2026. Total expense decreased by $460,000 quarter-over-quarter to $2.3 million in the first 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 first quarter of 2026 versus $1.5 million in the first 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 and 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 first quarter of 2026 compared to $2.7 million in Q1 2025. Net cash used in operations was $1.7 million for the first 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're now ready to take questions from attendees.

Operator: Our first question today is from Jim Molloy with Alliance Global Partners.

Laura Suriel: This is Laura on for Jim Molloy. So maybe just provide a bit more insight into the regulatory process in Japan? Like what additional work do you think you might need to do alongside the Shonin application that you mentioned from now until submission this year? And also, what's the timing of when you'll hear back from the agency after filing?

Peter Altman: Laura, thank you for the question. The dynamics in Japan for submission are rather extensive. So 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. But 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. And my expectation is it should go relatively straightforward. This was run under good clinical trial practices.

So 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. And then we will complete the submission in roughly 7 months, I would expect. And then the process after that is about a year-long review process similar to what's done in the United States for a PMA, where they audit all of the data and the manufacturing and the sterility and all that goes into it. And at the end of the day, we would expect to have approval.

Just so everybody on the call is aware, BioCardia, even though we're a small company, we actually have roughly 100 FDA-cleared interventional products here in our Morph platform, and we previously had products approved in Europe. So 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. And 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. And 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 Pharmaceutical and Medical Device Agency. There will be reimbursement during that post-marketing study. So it will be -- think of it as an early marketing launch, but we'll be doing it with -- under the auspices of all the leading societies in Japan. And these societies are the Japan Circulation Society, The Japan Heart Failure Society and the Cardiovascular Interventional Therapeutics Society.

We had leadership from all of those attending our PMDA session and folks on both sides of the table in that session express interest in participating in that post-marketing study, and we're supportive of the efforts ahead. So that's the high level. If you have follow-ups, Laura, that I didn't get anything appropriately, I welcome them.

Laura Suriel: Yes, just as a follow-up, maybe you just talk about more about the market opportunity in Japan. You mentioned how CardiAMP may cover an unmet medical need in the region. So how may you see CardiAMP integrating into the treatment regimen in Japan?

Peter Altman: Right. So this -- and by the way, Laura, there is an enormous amount of work going through every single drug and therapy that's approved in Japan and demonstrating that there's -- 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 that meaningful from our perspective. But from the regulatory perspective, they are meaningful. So the market opportunity, I think initially, 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. But it's also what we view as a reachable market. And we expect -- 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 because one of the advantages of the CardiAMP Cell Therapy is it can be a cost-effective therapy.

But if we use the math of what is our reimbursement today in the United States and what is the expected indication we would have approval for in Japan of 20,000 patients and the $20,000 reimbursement in the United States, that becomes pretty quickly a $400 million market.

Operator: [Operator Instructions] 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.

Peter Altman: 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.

Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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