BioCardia Q2 2026 Earnings Report

BioCardia EPS Results

• Actual EPS: -$0.13
• Consensus EPS: -$0.18
• Beat/Miss: Beat by +$0.05
• One Year Ago EPS: N/A

BioCardia Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

BioCardia Announcement Details

• Quarter: Q2 2026
• Date: 8/12/2026
• Time: After Market Closes
• Conference Call Date: Wednesday, August 12, 2026
• Conference Call Time: 4:30PM ET

BioCardia (NASDAQ:BCDA) is a clinical-stage biotechnology company dedicated to developing novel cell-based therapies for patients with cardiovascular disease. The company’s core focus lies in advancing regenerative medicine approaches that address both chronic heart failure and acute myocardial infarction. BioCardia leverages proprietary delivery technologies to optimize the targeted administration of therapeutic cells directly into the heart muscle.

The company’s flagship products include the Helix Transendocardial Delivery System and the CardiAMP Cell Therapy System. The Helix system is designed to facilitate precise, minimally invasive delivery of cells and biologics into viable myocardium. CardiAMP is an autologous bone marrow-derived progenitor cell therapy under investigation for its potential to improve cardiac function in patients with ischemic heart failure. Both platforms have secured investigational device exemptions from the U.S. Food and Drug Administration and are being evaluated in multi-center clinical trials.

Founded in the mid-2000s and headquartered in the San Francisco Bay Area, BioCardia has assembled a leadership team with deep expertise in interventional cardiology, regenerative medicine, and medical device development. Gary S. Margulies, M.D., serves as President and Chief Executive Officer, guiding the company’s clinical programs and strategic partnerships. BioCardia collaborates with academic medical centers and clinical research organizations across the United States to advance its pipeline and ultimately bring new therapeutic options to patients suffering from heart disease.

BioCardia Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Japan’s PMDA supported advancing CardiAMP toward a Shonin approval submission, which BioCardia expects to file in the fourth quarter of 2026. The company estimates an initial indication of roughly 20,000 patients, with approval potentially about 12 months after submission.
• Positive Sentiment: FDA feedback indicated that the ongoing CardiAMP Heart Failure II trial could serve as the confirmatory study supporting U.S. premarket approval, with no safety or delivery concerns raised. BioCardia is continuing enrollment and discussing how to define the quality-of-life component of the primary endpoint.
• Positive Sentiment: FDA also identified potential approval pathways for the Helix transendocardial delivery catheter, including simultaneous clearance with CardiAMP or a de novo route. Approval could strengthen BioCardia’s partnering opportunities and facilitate future cardiac biologic therapies.
• Negative Sentiment: Heart Failure II enrollment remains slow, with four active recruiting sites and no disclosed total enrollment; management said accelerating enrollment would require additional resources. The company may pursue modest financing to speed the program, creating potential dilution.
• Neutral Sentiment: BioCardia ended the quarter with $5.4 million in cash and said its runway extends into 2027, while raising $4.9 million through its at-the-market facility. Operating cash use was $1.7 million in the quarter, and management said available capital should fund the planned Japan submission.

Presentation

[Operator]

I would now like to turn the floor over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.

[Miranda Peto, Investor Relations Executive at BioCardia]

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.

[Miranda Peto, Investor Relations Executive at BioCardia]

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.

[Peter Altman, President and CEO at BioCardia]

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 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.

[Peter Altman, President and CEO at BioCardia]

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.

[Peter Altman, President and CEO at BioCardia]

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.

[Peter Altman, President and CEO at BioCardia]

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 $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.

[Peter Altman, President and CEO at BioCardia]

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.

[Peter Altman, President and CEO at BioCardia]

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. 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.

[Peter Altman, President and CEO at BioCardia]

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.

[Peter Altman, President and CEO at BioCardia]

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 DeNovo 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 DeNovo pathway.

[Peter Altman, President and CEO at BioCardia]

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.

[Peter Altman, President and CEO at BioCardia]

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 and centers, the DMAH is transferable, and the broader commercialization will be enhanced by an experienced team. Our expectation is that any deal has potential to include funding to advance CardiAMP for its second indication for chronic myocardial ischemia and our allogeneic CardiALLO 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.

[Peter Altman, President and CEO at BioCardia]

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 Heart3D Fusion Imaging, which we are working diligently with our respected partner, CART-Tech, to bring it 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 CardiAMP cell therapy. In parallel to the deals we are working to realize, a modest financing with long investors would accelerate the confirmatory CardiAMP Heart 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?

[David McClung, CFO at BioCardia]

Thank you, Peter, and good afternoon, everyone. I will now review the highlights of our financial results for the quarter and six months ended June 30, 2026. Net cash used in operations during the three months ended June 2026 was approximately $1.7 million, increased slightly from the $1.6 million used in the three months ended June 2025. Net cash used in operations for the six months ended June 2026 of $3.4 million increased slightly from the $3.3 million used in the six months ended 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 at-the-market facility at an average price of $1.22 per share.

[David McClung, CFO at BioCardia]

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 ended the quarter with cash and cash equivalents totaling $5.4 million, providing runway into 2027. 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 ended June 2026, total expense decreased $0.9 million to $3.9 million from $4.8 million.

[David McClung, CFO at BioCardia]

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. It decreased $0.8 million to $2.1 million for the six months ended June 2026, compared to $2.9 million for that same period in 2025. The decreases 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 continuing regulatory activities to advance CardiAMP in Japan. Selling, general and administrative expenses remained consistent at $0.7 million quarter-over-quarter. For the six-month period ended June 2026, SG&A decreased slightly to $1.8 million from $1.9 million for the six months ended June 2025.

[David McClung, CFO at BioCardia]

Our net loss was $1.6 million for the second quarter of 2026, compared to $2.0 million in the second quarter of 2025. For the six-month period ended 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 are now ready to take questions from attendees.

[Operator]

Ladies and gentlemen, at this time, we will begin the question-and-answer session. To ask a question, you may press star and then one on your touch pads. 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 two. At this time, we will pause momentarily to assemble the roster. Our first question today comes from Joe Pantginis from H.C. Wainwright. Please go ahead with your question.

[Joe Pantginis, Analyst at H.C. Wainwright]

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

[Peter Altman, President and CEO at BioCardia]

Well, hello, Dr. Pantginis. It's great to speak with you, Joe, and thank you for the question. The first element on this is the nuances for the DeNovo submission for Helix. We have some good clarity on how this has potential to be the first transendocardial biotherapeutic delivery catheter approved by FDA via the DeNovo route. Really, the only thing we need clarity on is them to say, yes, that's the tweak 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. They've found ways to do that with sort of a skirt around with other firms, with other routes of administrations historically.

[Peter Altman, President and CEO at BioCardia]

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. Our expectation 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. We have the data to support it and the experience to support it. So, it is a DeNovo, 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 transendocardial catheter, it's based on a design of active fixation pacing leads, which have been used in 1 million patients. Our data is second to none as published by independent parties.

[Peter Altman, President and CEO at BioCardia]

So, 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. I think 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 CardiAMP 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. So for all biologic interventions in cardiology. My expectation and hope is that the Helix will be the first such product.

[Peter Altman, President and CEO at BioCardia]

The downside of a DeNovo for BioCardia is that does enable others to then file a 510(k) referencing our DeNovo. But our expectation is they'll have to demonstrate some of the performance characteristics that we can demonstrate, so that it'll be a pretty significant barrier to entry still.

[Joe Pantginis, Analyst at H.C. Wainwright]

Got it. I appreciate that color a lot. Two more questions, if you don't mind, but going now to focus-

[Peter Altman, President and CEO at BioCardia]

Please. Welcome, Joe.

[Joe Pantginis, Analyst at H.C. Wainwright]

The first one is two-pronged. 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. The second part is, obviously, you mentioned important, I guess, derivative there with regard to ReHeart and the reimbursement that they're getting for about $326,000. I know it's hard to talk about comp sometimes, but maybe you could do a bit of a compare and contrast beyond what your prepared comments said.

[Peter Altman, President and CEO at BioCardia]

Sure. On the 20,000 patients, for the initial indication, 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. That's an advantage for our CardiALLO 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. The key thing to expand that 20,000 patients is to 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.

[Peter Altman, President and CEO at BioCardia]

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. Our sense is with 250,000 percutaneous coronary intervention procedures done per year. They have a very hungry interventional cardiology community for new therapies, and they have a very large patient population that has no real options. Our sense is that just by delivering a great experience in this post-marketing study, and beginning to educate the physicians that working with PMDA, the indication will expand in short order. On the second comment on the how does this play with respect to the reimbursement and what are the differences between CardiAMP and the other ReHeart therapy that is approved.

[Peter Altman, President and CEO at BioCardia]

Well, today, ReHeart requires surgical implantation, which means a patient's chest has to be opened up as if you were doing a coronary artery bypass procedure or a heart transplantation procedure. Then the cells are laid on the surface of the heart. Because they are not autologous, our expectation is that they will require chronic immunosuppression. Immunosuppression in these patients who have just had cardiac surgery can introduce other issues. Thirdly is what we are doing with our approach. The data we have is pretty robust, and their data, we have not seen their data, but my expectation is, they have a total of eight patients they have treated historically. I think going in there with our experience and our data become compelling. As we look at their reimbursement, that gives us a lot of room to have reasonable pricing.

[Peter Altman, President and CEO at BioCardia]

My sense is that our confidence that our pricing will be strong for BioCardia is there completely. If they are reimbursed at that level, that is great for them, and we wish their patients every positive. I think it presents an opportunity where they are educating, and they will be learning over the next year as we will be working through the regulatory process. I think on the other side of this, they will be a great peer company. We may also actually, Joe, be able to help them on delivery. I mentioned that they are pursuing a different delivery approach today, but we have a great depth of experience. They are a potential partner to us as well as arguably a competitor today with a different cell therapy approach. Our approach, interestingly, is an autologous mononuclear cell preparation.

[Peter Altman, President and CEO at BioCardia]

Theirs is an induced pluripotent stem cell preparation where the cells are intended to become cardiomyocytes. They do not speak of their mechanism of action as one of replacing heart cells, but rather of triggering an angiogenic response. There is still a lot that we are going to learn about them, and that they will learn about us ahead, and hopefully, the physician community as well. I am pretty confident that CardiAMP has a real role in Japan and can help quite a few patients.

[Joe Pantginis, Analyst at H.C. Wainwright]

Thank you, Peter, for that. Can you hear me?

[Peter Altman, President and CEO at BioCardia]

Yes, I can, Joe.

[Joe Pantginis, Analyst at H.C. Wainwright]

Perfect. My call actually dropped off. I was able to get back on real quick, so I heard your answers. I am glad it was still connected. 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.

[Peter Altman, President and CEO at BioCardia]

It is a great question, Joe. Great question. Japan is considered a first-world country, and I think we have said previously that their inspection of our facilities and their approval of CardiAMP carries weight in other countries around the world. 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. I think Japan has potential to be much bigger than it is, both in Japan, but also in rest of world. It is tied into some of the harmonization on the inspection work that has been done. I think it has great potential.

[Joe Pantginis, Analyst at H.C. Wainwright]

Thanks for the added color, Peter.

[Peter Altman, President and CEO at BioCardia]

Thank you, Joe. Appreciate the questions.

[Operator]

Our next question comes from James Molloy from Alliance Global Partners. Please go ahead with your question.

[James Molloy, Analyst at Alliance Global Partners]

Hey, guys. Good afternoon. Thank you for taking my questions. I wanted to follow up a little more on Joe Pantginis' question about Japan. Can you walk me through sort of how the Designated Marketing Authorization Holder, how that 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, DMAH is hoping to sign them soon. Is that partner, like, guaranteed to be signed, or what's sort of the next steps you anticipate there?

[Peter Altman, President and CEO at BioCardia]

So appreciate the question, James. Appreciate you being on the call. The DMAH, the Designated Marketing Authorization Holder, is a nuanced element of submission in Japan. 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 CardiAMP cell therapy in Japan. 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. It does not prevent us from doing distribution deals or licensing deals, more likely, for these therapies and enable others to advance them.

[Peter Altman, President and CEO at BioCardia]

It is a party that we have already met with, we are already talking about the specifics, and we are working on budgeting and contracts. But it is a party that BioCardia will pay to support us from a regulatory perspective. There will 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. Although we are not working with them yet today, 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 are going to be working with downstream.

[James Molloy, Analyst at Alliance Global Partners]

How does it look if you sell into this 20,000 patient market, $326,000, $6 billion, if I have the math right, opportunity. Maybe that is probably a little high. But if you sell $100 million, does the Japanese partner, the DMAH, do they sell that and then you get a royalty off that, or how does that work?

[Peter Altman, President and CEO at BioCardia]

No, actually. They handle really fundamentally the regulatory and quality responsibilities. We can actually go and sell in Japan and work with—So each and every hospital in Japan has a localized distributor. Even if you are a distributor of products, you still have to go through these localized distributors that take up to 10% of the total product value. But fundamentally, BioCardia, at present, our plan is we will be the ones selling CardiAMP for the post-marketing study, which could be anywhere from a couple hundred patients to 1,000 patients, and we are relatively agnostic to that because we are doing substantially the same thing in all instances. It will be a great deal easier than what we are doing in CardiAMP trials in the United States because there is no control arm.

[Peter Altman, President and CEO at BioCardia]

Every patient's a treated patient, and some of the research science that we've done behind the scenes will not be taking place in Japan. It will be much easier than what we're doing today. It will be relatively straightforward. Japan's not an enormous country geographically, so a small team can get around the country quite readily. We haven't figured out all the logistics and nuances of it yet. But in Japan, I've said previously that when we had our meeting with PMDA, we had a number of really distinguished, wonderful cardiologists in the room, both on our side of the table trying to help us, and on PMDA's side of the table as their consultants helping them. Everybody in the room wants to be involved in this post-marketing study, which is a huge advantage because there's real leadership in the Japanese cardiovascular community in that room.

[Peter Altman, President and CEO at BioCardia]

That's always the hardest part is to get the leadership support for advancing a program, and I think we've already got it very strongly. My sense is we'll work with PMDA and determine exactly how many centers will be in this post-marketing study. After the submission is in, we'll work with those centers to educate them and train them and get them experience and aware. We'll also be attending Japanese society meetings for both the Japanese Heart Failure Society and the Japanese Association of Cardiovascular Intervention and Therapeutics society, and enabling physicians to conveniently be exposed to products and the data. Then by the time we have the approval and the reimbursement, all of those centers should be ready to go. The post-marketing study should happen relatively quickly.

[Peter Altman, President and CEO at BioCardia]

I've said in our corporate presentation, or we've said in our corporate presentation that we expect the adoption profile to be roughly on par or superior to that of what it has been for percutaneous aortic valves. It's a new intervention for the interventionalists, but it's a therapy that treats a population. In fact, we may have an even more rapid adoption because I would describe our procedure as far more straightforward than the implantation of a valve percutaneously, and that the patient population doesn't have the option of surgical delivery, and there's no surgeons who are competing with the interventionalists on those procedures for those patients. I think the adoption profile will be actually quite compelling.

[James Molloy, Analyst at Alliance Global Partners]

Great. Final question from me. You do note that the CardiAMP HF II trial, four sites enrolled in the study, actively recruiting three additional patients, supposed to go in this month. Any updates on, is it four centers total currently that are enrolling? Any updates on how many patients have enrolled in the trial to date?

[Peter Altman, President and CEO at BioCardia]

We are not putting out the total number of patients. The enrollment is not going at blazing speeds. We have these four centers all actively enrolling, all have patients in the queue. We have conversations with a number of other centers who want to come on board, and we are working through that process. It is being done while our clinical team is addressing all of these issues for PMDA. It will continue to accelerate over time. But really the main effort right now, milestone that we have got as our top priority is getting this PMDA submission in. It is happening. We also mentioned, and I mentioned in the call, that we are having conversations with the FDA on the primary outcome measure.

[Peter Altman, President and CEO at BioCardia]

The third tier in our composite. We have three tiers, all-cause mortality, non-fatal cardiac MACE, and then the third tier is quality of life, so every patient contributes to the endpoint. That third tier has had a lot of criticism in the scientific community in the last six months. The FDA has pushed back on that criticism. But there are ways of handling data that are pretty sophisticated, and we know that the FDA knows more about how best to handle that endpoint than anybody else on the planet. We are going to be engaging with the FDA and hopefully get some guidance from them on exactly how to specify the use of that endpoint within our primary outcome measure. We are also planning on streamlining the trial to really focus on that primary outcome measure, which will also enhance enrollment.

[Peter Altman, President and CEO at BioCardia]

By not having all these other centers on board at this point, it just makes it easier for us to change these little nuances before we roll out more broadly.

[James Molloy, Analyst at Alliance Global Partners]

Thank you for taking the questions.

[Peter Altman, President and CEO at BioCardia]

I appreciate them, James. Be well.

[Operator]

Once again, if you would like to ask a question, please press star and then one. Our next question comes from Deepankar Roy from Brookline Capital Markets. Please go ahead with your question.

[Deepankar Roy, Analyst at Brookline Capital Markets]

Hi, good afternoon. Thanks for taking our questions. We had two questions, one about the PMDA's specific outstanding requests. The question is, how much incremental work would this require? Compiling this documentation, is this pulling data from already collected or would it require new source data verification? We believe this could push the Q4 2026 Shonin submission timeline as well.

[Peter Altman, President and CEO at BioCardia]

First, Deepankar, thank you for joining the call. I appreciate the question. The nuance here is we feel we've got all of the data that they would like to see pretty ready to us. One of the nuances of it, I think one of the hardest thing is on the guideline-directed medical therapy. There are a couple of little things that we're chasing. In our study, guideline-directed medical therapy, for those who work in heart failure, primarily means that they're on, today, the four pillars of heart failure therapy care. Those four pillars are four drugs that all patients should be on. In our trial, unless there's certain reasons one might not be on those medications, we had better compliance than any of the other leading trials of the same era that we've looked at.

[Peter Altman, President and CEO at BioCardia]

We definitely have great compliance, physician compliance to prescribing per the guideline-directed medical therapy. That is the first thing. Very comfortable there. The second thing is, some of the patients, we do not have the exact details on why they were not on guideline-directed medical therapy, and that is data that we are collecting. I think it totals out of the 115 patients on the four drugs. I think there is a total of like eight patients or so, or nine patients, where they each have one drug each, we have to chase down because there is not the evidence in the record on exactly why they were not on that. We do not know that we need it. We just know it is part of the PMDA question. I think that is the only data that we do not already have in hand that we are chasing down. We think it is relatively straightforward to gather.

[Deepankar Roy, Analyst at Brookline Capital Markets]

Thank you.

[Peter Altman, President and CEO at BioCardia]

No worries.

[Deepankar Roy, Analyst at Brookline Capital Markets]

My next question is on that DMAH selection. What is the expected cost structure for that relationship? Would the Shonin submission timeline depend on having that relationship before the submission can proceed?

[Peter Altman, President and CEO at BioCardia]

Tell me, I understand the cost relationship. I am missing. Can you repeat the question, Deepankar?

[Deepankar Roy, Analyst at Brookline Capital Markets]

The cost of having the DMAH.

[Peter Altman, President and CEO at BioCardia]

DMAH, yes. I thought you said DMAH. It is relatively straightforward. It is not a significant cost. We already have a dossier that is pulled together, that we have been developing with our regulatory consultants. We will separately be doing the Good Clinical Practice audit with another group, that our DMAH is close to. Those two pieces will come together, and they are relatively straightforward. Not expensive, and I do not expect any delays. We have already met face-to-face. We have common friends, so I think it is relatively straightforward.

[Deepankar Roy, Analyst at Brookline Capital Markets]

The Shonin submission timeline would not be affected?

[Peter Altman, President and CEO at BioCardia]

I don't think it will be affected. Again, we have to complete the efforts to enable the Good Clinical Practice audit. We've got to enable the PMDA to go through the answers to the questions that we've got. Then we are preparing formal CDISC data, as if we were doing an FDA submission for approval. I think the CDISC data is probably the longest pole in the tent. It hasn't been asked for, but we think it's good, just as we put a bow on CardiAMP HF with the idea that it is also going to support what we do for CardiAMP HF II. We're going to put it in that format. So I think the CDISC format is the longest pole in the tent at present.

[Deepankar Roy, Analyst at Brookline Capital Markets]

Right. Thanks for taking my questions.

[Peter Altman, President and CEO at BioCardia]

No, appreciate them, Deepankar. Thank you.

[Operator]

And with that being our final question, we will be turning the floor back over to Dr. Altman for any closing comments.

[Peter Altman, President and CEO at BioCardia]

Thank you, Jamie. For all on the call, our efforts advancing our cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. The positive regulatory interactions we have just discussed for approval in Japan and the United States introduce potentially transformative milestones that are meaningful for patients, the physicians who are caring for them, but also for our shareholders. On behalf of our entire BioCardia team, I thank all for their continued support. You make what we do possible, and I wish you all a great afternoon. Take care.

[Operator]

The conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your line.

Participants

Executives

• Miranda Peto, Investor Relations Executive
• Peter Altman, President and CEO
• David McClung, CFO

Analysts

• Joe Pantginis, Analyst at H.C. Wainwright
• James Molloy, Analyst at Alliance Global Partners
• Deepankar Roy, Analyst at Brookline Capital Markets