BioCardia, Inc. (BCDA) Earnings Call Transcript

Thank you. Good day everyone and welcome to the Biocardia Q2 2026 Financial Results and Corporate Update Conference Call. All participants will be 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 and then 1 on your touch tone telephones. or keypads. To withdraw your question, you may press star and then 2. 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 today's conference. I would now like to turn the floor over to Miranda Pato of Biocardia Investor Relations. 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. statements, including statements that address biocardius expectations for future performance and operational results, references to management's intention, beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approval. 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 report on Form 10-K filed with the SEC on March 24, 2026 and in our subsequently filed courtier reports on Form 10-Q. The contents of this call contain is 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. 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 United States on the approvability of our cardiac cell therapy for the treatment of ischemic heart failure and the and on the approvability of our Helix Transcendental Cardio Delivery Catheter, which we use in our therapeutic programs. Let's take each of these in turn. In May, we announced that Japan's Pharmaceutical and Medical Device Agency, or PMDA, provided the consultation record of advice, which supports our advancing to Shonan pre-market regulatory submission for approval of the cardiac cell therapy. PMDA noted that the positive outcomes seen in our CAR-D-AMP 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 BioCardio demonstrate that enrolled patients were on guideline-directed medical therapy and not eligible for revascularization procedures. both of which were required per the CARDI-AMP 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 a 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, BioCard 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 general. Japan. Our expected initial indication will be for approximately 20,000 patients in Japan. with approval approximately 12 months after we complete our shown in 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 Shonan approval and will be determined based on discussions with the Ministry of Health, Labor, 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 $326,000 per treatment. This underscores the need recognized in Japan for such a therapy. The cardiac cell therapy is now a real market in Japan, and the cardiac 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 Cardi-AMP 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 who 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 We know 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. are 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. Shown in approval of cardiac 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 $250 million. And 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 Cardi-Amp Heart Failure II trial may support premarket approval for market clearance. 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 CARDI-AMP Heart Failure 2 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 CAR-D-AMP Hard Failure 2 trial to take this study to completion as our confirmatory phase 3 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 Transcendental Cardio 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 cardiac 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. confirms our understanding and FDA has said that they would have the formal minutes sent to us soon. Our assessment is that the Helix Transcendental Cardio 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 Transcendental Cardio 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. The key value propositions for the FDA approval of Helix are enhanced partnering for biocardia around Helix and simpler regulatory submissions for therapeutic approvals, including our cardiamp cell therapy and heart failure. On the business development front, we have active conversations in the Asia Pacific region on our cardiovascular therapeutics. While BioCardia fully expects to have boots on the ground in Japan for the post-marketing study, as we transfer all of our experience to Japanese physician centers, the DMAH is transferable, and the broader commercialization will be enhanced by an experienced team. Thank you. Our expectation is that any deal has potential to include funding to advance Cardi-AMP for its second indication for chronic myocardial ischemia and our allogeneic cardi-allo cell therapy for inflammatory heart failure to market clearance as well. Such a deal would enhance our efforts in the United States on all three of these programs. Business development on biotherapeutic delivery is also active. We believe we can help many of those in development, particularly for gene-based therapy. There is a great deal more possible with intramyocardial delivery that is not well appreciated by many firms today. These possibilities are enhanced by the potential of heart 3D fusion imaging, which we are working diligently with our respected partner, CarTech, to bring to the clinic and to the market as soon as possible. Today, we believe we have the capital to complete the significant and potentially transformative milestone of PMDA submission of CAR-D-AMP cell therapy. And parallel to the deals we are working to realize, a modest financing with long investors would accelerate the confirmatory Cardiamp Act Card Failure II program. With that, I will now pass the call to David McClung, our CFO, who will review our second quarter 2026 financial results. David? Thank you.

Thank you, Peter, and good afternoon, everyone. I'll now review the highlights of our financial results for the quarter and six months into June 30th, 2026. Cash used in operations during the three months into June 2026 was approximately 1.7 million, increased slightly from the 1.6 million used in the three months into June 2025. Net cash used in operations for the six months into June 2026 of 3.4 million increased slightly from the 3.3 million used in the six months into June 2025. These small increases are primarily due to the timing of supplier payments. During the second quarter, BioCardia raised net proceeds of approximately $4.9 million under our eight at the market facility at an average price of $1.22 per share. Funding from this facility has a lower cost of capital than traditional financing vehicles and does not involve the issuance of stock warrants or other dilutive securities. The company entered the quarter with cash and cash equivalents totaling $5.4 million, providing runway into 2027. As we ended the quarter with 2.7 million in equity, which we believe keeps us compliant now with NASDAQ listing standards. Total expense decreased by 0.4 million quarter over quarter. to 1.6 million in the second quarter of 2026 compared to 2.1 million in the same quarter of 2025. For the six months into June 2026, total expense decreased 0.9 million to 3.9 million from 4.8 million. The primary driver of these changes, research and development expense decreased 0.5 million to 0.9 million in the second quarter of 2026 compared to 1.4 million in the second quarter of 2025. And it decreased 0.8 million to 2.1 million for the six months ended June 2026 compared to 2027. to 2.9 million for that same period in 2025. The decreases relates primarily to the closeout of the CAR-D-AMP heart failure trial, partially offset by expenses for early enrollment in the CAR-D-AMP heart failure two trial and continuing regulatory activities to advance CAR-D-AMP in Japan. Selling general and administrative expenses remain consistent at 0.7 million quarter over quarter. For the six-month period into June 2026, SG&A decreased slightly to 1.8 million from 1.9 million for the six months into June 2025. Our net loss was $1.6 million for the second quarter of 2026 compared to $2.0 million in the second quarter of 2025. The six month period into June 2026, our net loss was 3.9 million compared to 4.9 million for that period in 2025. The June SEC proposal to eliminate the baby shelf limitation that constrains access to registered offerings and ATM programs for smaller companies is expected to be beneficial for BioCardia when implemented. It would be great if this were available to BioCardia in Q1 2027. This concludes management's prepared comments, and we're now ready to take questions from attendees.

Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then 1 on your touchpads. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys. If at any time your question has been addressed, you would like to withdraw your question, you may press star and 2. At this time we will pause momentarily to assemble the roster. Our first question today comes from Joe Pantagenis from HC Wainwright. Please go ahead with your question.

Hey guys, good afternoon. Thanks for taking the questions. So Peter, a couple things, I guess spanning geographies. Let me go backwards with regard to your prepared comments. So with regard to the pending FDA minutes, obviously, you know, we'll wait to see what they say, but what would you say are the key points that are outstanding?.

Well, hello, Dr. Pantagenis. It's great to speak with you, Joe, and thank you for the question. on this is the nuances for the de novo submission for Helix. So we have some good clarity on how this has potential to be the first transendocardial biotherapeutic delivery catheter approved by FDA via the de novo route. And really, the only thing we need clarity on is them to say, yes, that's the tweet. for submission. The key issue with FDA is they have a very challenging time approving a delivery system for a biologic for a clinical indication and a route of administration for which no therapeutic has yet been approved. And they've found ways to do that with sort of a skirt around with other firms, with other routes of administrations historically. Our conversation with them was approaching it head on, saying, look, this is what we're trying to do. This is what the data says. is that their internal processes are so rigid that we're going to have to also do a similar end around for our approval for this catheter system. and we have the data to support it and the experience to support it. So it is a de novo, so there is no other catheter approved with this route of administration. But for those on the call who may not be entirely familiar with the Helix TransCycler, transendocardial catheter, it's based on a design of active fixation pacing leads, which have been used in a million patients. Our data is second to none as published by independent parties. So... I've also, you know, we've raised with the agency that there are many folks who are pursuing routes of administration for their therapeutic development. that either makes no sense or is driven by the great desire to not have an investigational delivery platform woven into their efforts. And so I think we can... the agency appreciates the value proposition of enabling approval of Helix. As I said in my prepared comments, their first choice would be approval with the CAR-D-AMP cell therapy. That's easy for them. That's straightforward for them. But I think they also recognize that by not having an approved delivery system, they're basically hampering the whole field of development. And so for all biologic interventions in cardiology. And my expectation and hope is that the Helix will be the first The downside of a de novo for biocardia is that does enable others to then file a 510k referencing our de novo but our expectation is they'll have to demonstrate some of the performance characteristics that we can demonstrate and so that will be a pretty significant barrier to entry still.

Got it. No, I appreciate that color a lot. So two more questions, if you don't mind, but going now to focus. Please. Welcome, Joe. Hey. If you get approval in Japan, you said the initial target market is about 20,000 patients. What efforts or what kind of components would be considered? to expand that market, number one. And the second part is, obviously you mentioned important I guess, derivative there with regard to ReHart and the the reimbursement that they're getting for about $326,000. I know it's hard to talk about comps sometimes, but maybe you could do a bit of a compare-contrast beyond what your prepared comments said.

Sure. So, on the 20,000 patients for the initial I think the way that is expanded is by success in this post-marketing study. In Japan today, the patients that we will be treating truly have few options. They don't do a lot of heart transplantation in Japan because they don't like the concept of – implantation of other people's organs in another patient. And that's an advantage for our call against cell therapy. But it also means that left ventricular assist devices, which is an implanted device, also has some reservations by the patient community there. So the key thing to expand that 20,000 patients is have this post-marketing study go as smoothly as possible to have the physician experience be akin to what it is today in the united states And we think we can deliver that. So that's – as we go to Japan, PMDA has said they want us to stay with this program as it advances. And we will definitely be involved as this post-marketing study is initiated and performed. But our sense is – with 250,000 percutaneous coronary intervention procedures done per year. They have a very hungry interventional cardiology team community for new therapies, and they have a very large patient population that has no real options. And so our sense is that just by delivering a great experience in this post-marketing study and beginning to educate the physicians that we're working with PMDA, the indication will expand in short order. And on the second comment on how does this play with respect to the reimbursement, and what are the differences between Cardi-Amp and the other Re-Heart therapy that's approved, Well, today, REHEART requires surgical implantation, which means that patient's chest has to be opened up as if you were doing a coronary artery bypass procedure or a heart transplantation procedure. And then the cells are laid on the surface of the heart. Because they are not autologous, you know, our expectation is that they will require chronic immunosuppression. and immunosuppression in these patients who have just had cardiac surgery, can introduce other issues. Thirdly is what we're doing with our approach. You know, the data we have is pretty robust, and their data, you know, we haven't seen their data, but my expectation is they have a total of eight patients they've treated historically. So I think going in there with our experience and our data become compelling. And so as we look at their reimbursement, you know, that gives us a lot of room to have reasonable pricing. And my sense is that our confidence that our pricing will be strong for BioCardia is there completely. If they're reimbursed at that level, that's great for them and I wish their patients every positive. But I think it presents an opportunity where they're educating and they'll be learning over the next year as we will be working through the regulatory process. And I think, think on the other side of this, you know, they will be, you know, a great peer company. We may also actually, Joe, be able to help them on delivery. I mentioned that they're pursuing a different delivery approach today, but, you know, we have a great depth of experience. And so, you They are a potential partner to us as well as arguably a competitor today with a different philosophy. therapy approach. Our approach, interestingly, is an autologous mononuclear cell preparation. Theirs is an induced pluripotent stem cell preparation where the cells are intended to become cardiomyocytes, but they don't speak of their mechanism of action as one of replacing heart cells, but rather of triggering an angiogenic response. So there's still a lot that we're going to learn about them and that they'll learn about us ahead and hopefully the physician community as well. But I'm pretty confident that CardiAmp has a real role in Japan and can help quite a few patients.

Thank you, Peter, for that. Can you hear me? Yes, I can, Joe. Oh, perfect. My call actually dropped off. I was able to get back on real quick, so I heard your answers. I'm glad it was still connected. So my last question is regard to Japan, but more, I guess, expanding the concept. If you do get approved in Japan, plus all the discussions and data that you have with Japan, how that might be applicable to additional geographies?.

It's a great question, Joe. Great question. So, Japan is considered a first world country. And I think we've said previously that, you know, their inspection of our facilities and their approval of Cardi Amp carries weight in other countries around the world. So we have already had conversations around potential relationships in Brazil and United Arab Emirates, and those would arguably follow after – we were successful with an approval in Japan. So I think Japan has potential to be much bigger than it is both in Japan, but also in rest of world. And it's tied into some of the harmonization on the inspection work that's been done but yes i think it has great potential Thanks for the added color, Peter. Thank you, Joe. Appreciate the questions.

Our next question comes from James Molloy from.

Allianz Global Partners, please go ahead with your question. Hey guys, good afternoon. Thank you for taking my questions. I want to follow up a little more on Joey Pan's question about Japan. Can you walk me through sort of how the designated marketing authorization holder, how their partnership works? Is it like a traditional partnership you would have with a partner in any other geography where they sell you get a royalty? Can you break down how that will work? And is that partner, I think you say in there, credit marks, hoping to sign them soon. Is that partner guaranteed to be signed? Or what sort of the next steps should anticipate there?.

So, appreciate the question, Jim. Appreciate you being on the call. The DMAH, the designated marketing authorization holder, is a nuanced element of submission in Japan. So, in this situation, this is actually a party that we contract with who essentially works for biocardia to represent all of the regulatory and quality issues associated with the cardiac cell therapy in Japan. This is, you know, when you do a distribution deal or a partnership in Japan, oftentimes partners will want to own the authorization. They will want to be the marketing authorization holder because it becomes harder to transfer. But when you have a designated marketing authorization, holder, it is completely transferable. So it does not prevent us from doing distribution deals or licensing deals more likely for these therapies and enable others to advance them. And it's a party that we've already met with, we're already talking about the specifics and we're working on budgeting and contracts, but it is a party that BioCardia will pay to support us from a regulatory perspective. And there'll be other parties that are involved on doing the good clinical practice audit of our information to support them so that they have a great deal of confidence as they help us pull together our dossier for the submission. that they will know that their related entities have done this work. And although we are not working with them yet today, you know, they are plugged into this. group that we are working with in Japan today. So through that, we have a good relationship and a high confidence that we have the right people that we're going to be working with downstream.