Biocardia (NASDAQ:BCDA) Q1 2026 Earnings Call

0:00 Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia twenty twenty six First Quarter Financial Results and Business Update Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. 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.

0:46 A webcast replay of the call will be available approximately one hour after the end of the call.

0:53 I would now like to turn the call over to Miranda Peto of BioCardia, Relations. Please go ahead, 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, outlook, analyses and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies and obtaining regulatory approvals.

1:48 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 ks filed with the SEC on 03/24/2026. The content of this call contains time sensitive information that is accurate only as of today, 05/15/2026. 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.

2:33 It is now my pleasure to turn the call over to Doctor. Peter Altman, BioCardia's President and CEO. Peter, please go ahead. Doctor. Altman, this is the operator. Perhaps your line is muted. Thank you. Thank you, Miranda, and good afternoon to everyone on the call. We have had significant accomplishments this last quarter for our CARDI amp 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.

3:23 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 and the regulatory meetings that have been happening in parallel. This echocardiography data analyzed by the world class Echocor 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.

4:21 The CardioP heart failure echocardiography results showed compelling signals of enhanced heart function in the treated patients relative to the controlled 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.

5:10 In CARDI Amp 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 three 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.

6:01 And these benefits seen with CardiAmp cell therapy were in addition to those provided by the established therapy. This underlines that the CARDI Amp 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.

7:01 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 Shonen premarket application for approval in Japan, which we expect will take approximately seven 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.

7:53 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 premarket approval. FDA had no concerns on the safety of the cardiac 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 CARDI AMP HF2 trial to provide support for the premarket application.

8:45 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 this study. The four activated centers in the ongoing CardioM Heart Failure II study have continued to enroll patients. The trial is designed as a two fifty 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 CARDI AMP Shonen premarket application for approval in Japan and enrolling CardiAmp Heart Failure II are our top priorities.

9:35 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.

9:53 We have also completed the pre submission meeting with FDA on the approval of the Helix Transcendental Cardio 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.

10:14 FDA's preferred route of Helix approval was simultaneous with the approval of the CardioM 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 four catalysts detailed in our last call, having three positive regulatory interactions and are very pleased with the outcomes. For the second quarter of twenty twenty six, looking ahead, we expect to complete one or more transactions that will fund Japan PMDA submission for approval and the Cardium Heart Failure II trial. I will now pass the call to David McClung, our CFO, who will review our first quarter twenty twenty six financial results.

11:04 David? Thank you, Peter. Good afternoon, everyone. Here are the highlights of our financial results for the quarter ended 03/31/2026. Total expense decreased by $460,000 quarter over quarter to $2,300,000 in the first quarter of twenty twenty six compared to $2,700,000 in the same quarter of 2025. The primary driver of this change research and development expense decreased $295,000 to $1,200,000 in the first quarter of twenty twenty six versus $1,500,000 in the first quarter of twenty twenty five. 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 two trial and regulatory activities to advance CardiAmp in Japan.

11:58 Selling, general and administrative expenses decreased to $1,000,000 for the three months ended March 2026 as compared to $1,200,000 in the quarter ended March 2025, primarily due to lower professional service fees. Our net loss was $2,300,000 for the first quarter of twenty twenty six compared to $2,700,000 in Q1 twenty twenty five. Net cash used in operations was $1,700,000 for the first quarter of twenty twenty six compared to $1,600,000 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.

12:52 This concludes management's prepared comments. We're now ready to take questions from attendees.

13:31 Our first question today is from Jim Molloy with Alliance Global Partners. Please go ahead. Hello. This is Laura on for Jim Molloy. Thank you for taking our questions. So may you 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 shonen 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? Laura, thank you for the question. The dynamics in Japan, for submission are rather extensive. So we have already prepared a large stead document, which they've already been reviewing as part of this process, which is essentially a template for the actual submission.

14:21 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 seven months, I would expect.

15:10 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.

16:05 And our expectation is if things go as planned in roughly nineteen 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,

16:58 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 Therapeutic Society. 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. So that's the high level. If you have follow ups, Laura, that I didn't hit anything appropriately, welcome them. Yes. Thank you for the clarity. 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?

17:56 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 this 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 three hundred thousand patients in Japan with ischemic etiology heart failure who could be appropriate candidates. Initial market that will be much smaller than that. It will be very limited to what we call appropriate use conditions.

18:46 And we would expect it to be on the order of twenty thousand 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 $400,000,000 market.

19:39 Great. Thank you for taking the questions.

19:44 No problem. I appreciate them, Laura. 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.

20:11 Thank you, Gary. Our efforts advancing cell based therapies for ischemic heart failure are showing important benefits for patients to 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. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.