BioCardia Inc. Aktie

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.

And how does it look, you know, if you sell into this 20,000 patient market, $326,000, if that was the math right, opportunity, that's probably a little high. But if you sell $100 million,.

does the japanese partner the dmah do they sell that and then they then you get a royalty of that or no actually we yes so they they handle really fundamentally the regulatory and quality responsibilities we can actually go and sell in japan and work with um 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, you know, our plan is we will be the ones selling Cardiamp for the post-marketing study, which, you know, could be anywhere from, you know, a couple hundred patients to a thousand patients, and we're relatively agnostic to that because we're doing substantially the same thing in all information. And it'll be a great deal easier than what we're doing in cardi-amp trials in the United States because there's no control on them. Every patient's a treated patient, and some of the The research science that we've done behind the scenes will not be taking place in Japan. So it'll be much easier than what we're doing today, and it'll be relatively straightforward. Japan's not an enormous country geographically, so a small team can get around the country quite retroactively. And 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 side, of the table is their consultants helping them.

And 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. So 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, very strongly. So my sense is we'll work with PMDA and determine exactly how many centers will be in this post-marketing study. And 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 Cardiovascular Interventional Therapeutic Society and enabling physicians to conveniently, you know, be exposed to products and the data. And then by the time we have the approval and the reimbursement, all of those centers should be ready to go. And so we'll – the post-marketing study should happen relatively quickly.

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 the, percutaneous aortic valves. It's a new intervention for the interventionalists, but 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 interventionists on those procedures for those patients.

I think the adoption profile will be actually quite compelling. Great. And the final question for me, you do note that the CARDI-AMP HF2 trial, four sites enrolled in the study are actively recruiting, three additional patients supposed to go in this month. Any updates on, is it four centers total currently that are enrolling and any updates on how many patients have enrolled in the trial to date?.

Yes, we're 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're working through that process. And it's being done while our clinical team is addressing all of these issues for PMDA. So it was a great experience. We'll continue to accelerate over time, but really the main effort right now, milestone that we've got as our top priority is getting this PMDA submission in.

And it's happening. We also mentioned, and I mentioned in the call, that we're having conversations with the FDA on, you know, the primary outcome measure, you know, you know, the third tier in our composite. So we have three tiers, all cause mortality, um, you know, non-fatal cardiac mace. And then the third tier is quality of life. So that you, every patient contributes to the endpoint. And that third tier has had a lot of criticism in the scientific community in the last, um, six months. And the FDA has pushed back on that criticism. But, you know, there's 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. And so we're 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're also planning on streamlining the trial to really focus on that primary outcome measure, which will also enhance enrollment. And by not having the 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.

Thank you for taking the questions. I appreciate them, Jim. Be well.

Once again, if you would like to ask a question, please press star and then 1. Our next question comes from Deepankar Roy from Brookline Capital Markets. Please go ahead with your question.

Hi, good afternoon. Thanks for taking our questions. We had two questions. One about the PNDA's specific outstanding requests. So 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? Because we believe this could push the Q4 2026 Shorin submission timeline as well.

Right. So, this is, so with, so first, Deepak, 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 want. would like to see pretty ready to us. One of the nuances of it, I think one of the hardest things is on the guideline-directed medical therapy. So there are a couple of little things that we're chasing. So in our study, guideline-directed medical therapy, for those who work in heart failure, primarily means that they're on, today, the 4%. pillars of heart failure therapy care. And those four pillars you know, are four drugs that all patients should be on. In our trial, unless there's certain reasons one might not be on those medications.

So in our trial, we had better compliance than any of the other leading trials of the same era that we've looked at. So we definitely have great compliance, physician compliance to prescribing per the guideline directed medical therapy. So that's the first thing. Very comfortable there. The second thing is some of the patients, we don't have the exact details on why they weren't on guideline directed medical therapy. And that is data that we are collecting. I think it totals out of the... the 115 patients on the four drugs, I think there's a total of, uh, like eight patients or so or nine patients where they each have one drug each we have to to chase down because there's not the evidence in the record on exactly why they weren't on that we don't know that we need it we just know it's part of the pmda question so i think that's the only data that we don't already have in hand that we're that we're we're chasing down and we think it's relatively straightforward together. All right, thank you. No, no worries.

DMH selection. So what is the expected cost structure for the relationship? And would the short-term submission timeline depend on having that relationship before.

the submission can proceed. Tell me I understand the cost relationship. I'm missing... Can you repeat the question? The cost of having the DMH, DMAH. Oh, DMAH, yes, yes. I thought you said DMAH. So it's relatively straightforward. It's not a significant cost. It will be a, you know, the initial cost. So we already have a dossier that's pulled together that we've been developing with our regulatory consultants, and we'll separately be doing the good clinical practices on us with another group that our DMAH is close to. And so those two pieces will come together, and they're relatively straightforward.

Not expensive, and I don't expect any delays. We've already met face-to-face. Okay. And we have common friends, so I think it's relatively straightforward. So the shown in submission timeline would not be affected? I don't think it will be affected. We have, again, we have to complete the efforts to enable the good clinical practice audit. We've got to enable the PMDA to go through, you know, the answers to the questions that we've got and, you know, And then we need, we are preparing formal CDISC data as if we were doing an FDA submission for approval. And I think the CDIS data is probably the longest poll in the tent. It hasn't been asked for, but we think it's good just as we put a bow on Cardi-AMPHF with the idea that it is also going to support what we do for Cardi-AMPHF2. we're going to put it in that format.

So I think the CDISC format is the longest poll in the tent at present.

Thanks for taking our questions. No, I appreciate them, Dieter Karki.

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

Thank you, Jamie. So 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've just discussed for approval in Japan and the United States introduce potentially transformative milestones that are meaningful for patients. physicians who are caring for them, but also for our shareholders. So 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.

The conference has now concluded. We do thank you for attending today's presentation.

This live transcript is auto-generated without human intervention or review.

[Call has ended.]

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2026 First Quarter Financial Results and Business Update Conference Call. [Operator Instructions] 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 1 hour after the end of the call.

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

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.

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

It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Dr. 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 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?

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.

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

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?

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.

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?

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 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.

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.

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

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia Year-end 2025 Financial Results and Business Update Conference Call. [Operator Instructions] 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 the call.

I would now like to turn the conference over to Miranda Peto 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, 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 today, March 24, 2026.

The content of this call contains time-sensitive information that is accurate only as of today, March 24, 2026. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's mission is to develop and enhance therapies to treat cardiovascular disease. We are doing this today with 3 primary platforms, our CardiAMP, autologous minimally processed cell therapy, our CardiALLO allogeneic off-the-shelf mesenchymal cell therapy and our Helix transendocardial biotherapeutic delivery system, which is used by both our CardiAMP and CardiALLO cell therapy programs.

Our lead program remains the CardiAMP cell therapy for roughly 1 million patients in the United States and 150,000 patients in Japan with ischemic heart failure of reduced ejection fraction. These are patients who've had coronary disease may have had a heart attack and have subsequently developed heart failure characterized by a larger dilated heart that unfortunately pumps inefficiently.

Cardiac therapy includes CD34 and CD133 cells that have long been recognized as endothelial progenitor cells that promote new capillary formation. Preclinical data also provides support that these cells reduce fibrosis in the heart. Based on these mechanisms to effectively treat microvascular dysfunction, CardiAMP cell therapy is introducing a new therapeutic modality to the significant unmet need in ischemic heart failure that is primarily managed today by neurohormonal modulation.

The clinical outcomes with this approach have been excellent. We now have complete and final data from 3 clinical trials of the CardiAMP therapy with the latest results from our Phase III CardiAMP HF trial presented as a late-breaking clinical trial at the Technology and Heart Failure Therapeutics Meeting this month. The presentation was titled Autologous Cell Therapy may occur pathological ventricular remodeling in chronic ischemic heart failure of reduced ejection fraction patients selected for favorable cell characteristics.

The key takeaway from these new results is in this title. The Cardiac HF echocardiography clinical results, which measure heart chamber sizes over time, by a truly blinded world-class echocardiography core laboratory, show reductions in left ventricular volume disease when the heart ventricle is fully dilated with a p-value of 0.06 and when the heart is fully contracted with a p-value of 0.09.

For the prespecified subgroups of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful, greater than 20 milliliters per meter squared and 15 milliliters per meter squared, respectively, and statistically significant with a p-value of 0.02 and p of 0.01, respectively.

This echocardiographic data further supports our previous results of reduced fatal and nonfatal major adverse cardiac and cerebrovascular events and improve quality of life in the treated patients. They are similarly strongest in the prespecified subgroup of patients having elevated biomarkers of heart stress. When considered together with the significant reductions in left ventricular end systolic volume, and left ventricular end diastolic volume in the treatment group versus the control group, these results provide a basis for linking intramyocardial mononuclear cell therapy with suppression of pathological ventricular remodeling and beneficial clinical outcomes.

This trial result is also considered consistent with observations from other heart failure of reduced ejection fraction therapies showing an association between suppression of pathological ventricular remodeling and improvement in mortality. This data is consistent across all 3 of our clinical studies, which saw reduced major adverse cardiac and cerebrovascular events and improved heart function.

I also note that 2 of these trials were randomized, double-blinded clinical trials, which provide the greatest scientific rigor and the least investigator bias to study outcomes. This is the data we will soon be discussing with the Food and Drug Administration in the United States and which we have been discussing with Japan's Pharmaceutical and Medical Devices Agency or PMDA, regarding potential for approval with the rigorous post-marketing studies to collect further evidence with respect to both safety and efficacy. We expect to soon submit the Q-sub request on approvability of the CardiAMP system to FDA Center for Biologics Evaluation and Research, or CBER, based on the safety and compelling signals of patients benefits with elevated biomarkers of heart stress from our 3 clinical trials.

This discussion is expected to focus on our already FDA-approved CardiAMP cell process platform to extend existing labeling from in vitro diagnostic use to a therapeutic indication for ischemic heart failure of reduced ejection fraction. The dedicated Helix transendocardial delivery catheter has a presubmission actively under review by FDA Center for Devices and Radiological Health.

In Japan, we expect to soon have our formal clinical consultation to align with PMDA on the acceptability of the existing clinical data from our 3 trials to show -- to allow us to submit the CardiAMP system. If PMDA determines that existing clinical data is acceptable with respect to safety and efficacy, submission for Shonin approval would likely soon follow.

BioCardia is not alone in seeking approvals to provide therapeutic options to these patients and the physicians who care for them today. Japan has recently granted conditional approval to another allogeneic cell therapy for ischemic heart failure that involves the placement of sheets of cells on the surface of the heart in a surgical procedure. A U.S.-listed company has announced that they will be filing for a biological licensing application for their allogeneic cell therapy to also treat patients in a surgical setting. We expect a third company will also soon be applying for approval for surgically delivered cells. The need here is great, and we wish each of these peers and potential future delivery partners every success ahead.

In parallel to these efforts, to wrap up the CardiAMP HF trial and seek approvals based on this data, we have initiated the CardiAMP HF II confirmatory clinical study. CardiAMP HF II focuses on the patients who are the greatest responders in CardiAMP HF and applies all of our learnings with regard to endpoint and trial design. In October and November, University of Wisconsin at Madison and Henry Ford Health System in Detroit, Michigan and enrolled their first patients in CardiAMP HF II, respectively.

Emory University in Atlanta, Georgia has also been activated as a study site. With Morton Plant Mease in Clearwater, Florida, there are 4 centers actively enrolling in this study today. If FDA supports an earlier approval, there is potential the trial design will be modified and become our post-marketing registry. There is also potential the CardiAMP HF II trial may benefit from the previous trial and a shorter pathway to approval be identified. We will have clarity here soon. We have made progress on our CardiAMP cell therapy clinical program for chronic myocardial ischemia and for our CardiALLO allogeneic cell therapy for heart failure. The status of these efforts is in our earnings announcement today. There could be significant upside from these clinical efforts in the near term.

We have 4 catalysts before us in the next quarter. First, the FDA CardiAMP Heart Failure Q-submission for approval pathway under breakthrough designation has been drafted and is under legal review. We are targeting submission as soon as possible. Second, we have a formal clinical consultation scheduled with Japan PMDA on approvability of CardiAMP cell therapy. Third, we have an FDA substantive feedback meeting scheduled on approvability of our Helix transendocardial delivery system via the de novo pathway. And fourth, we have an abstract on CardiAMP and chronic myocardial ischemia that has been accepted for oral presentation at EuroPCR in May.

I will now pass the call to David McClung, our CFO, who will review our fourth quarter 2025 financial results. David?

Thank you, Peter. Good afternoon, everyone. I'll now provide an overview of our financial results for the year ended December 31, 2025.

Total expense accretes approximately 3% year-over-year to $8.3 million in 2025 and compared to $8.1 million in 2024. The primary driver of this change, research and development expense, increased to $5 million in 2025 compared to $4.4 million in 2024. The 13% increase was primarily due to the cost of closeout activities in the cardiac heart failure trial. Inception of enrollment in the CardiAMP HF II trial during the year and regulatory activities to advance CardiAMP in Japan. We anticipate R&D expenses will increase modestly in 2026 as we continue advancing our therapeutic candidates in both the United States and Japan.

Selling, general and administrative expenses decreased 10% in 2025 to $3.3 million as compared to $3.7 million in 2024, primarily due to lower professional fees coupled with reduced share-based compensation expense. We expect 2026 SG&A expenses to remain close to these 2025 levels.

Net loss increased modestly to $8.2 million in 2025 from $7.9 million in 2024. Net cash used in operations was approximately $7.5 million during the year into 2025. That's down from $7.9 million in 2024. The company ended the year with cash and cash equivalents totaling $2.5 million, very comparable to the $2.4 million as of December 31, 2024. We expect our cash burn will be relatively consistent in 2026, continuing our track record for carefully managing the use of resources and capital.

This concludes management's prepared remarks. We are happy now to take questions from attendees.

[Operator Instructions] And the first question will come from Joe Pantginis with H.C. Wainwright.

Hello, everyone. This is Lander on for Joe. We have a few. So let me start with the echo data presented at THT. So I wonder if you can provide some color on the p-values for the diastolic and systolic volumes in the complete population? And how do you think this data can support the narrative you're presenting to the PMDA?

Thank you for the question, and I really appreciate your eye on the Echo data. So this data is remarkably lovely data. And just -- I'll start off for everybody, typically, in these trials for all these therapies, very few companies have long-term truly blinded echo data. It's a very rare thing, and we have it in this trial. And the Core laboratory at Yale University is world-class. And so your question, Lander, was across all patients, the p-values are not statistically significant, but they're approaching it but to even see that kind of trend is wonderful.

So our expectation is that our approvals both in the United States and in Japan will not be for the full cohort, but will be for the subgroup with elevated NT-proBNP. And because those patients -- NT-proBNP is a marker that's released when the heart is under stress. And so when you have high stress in the heart, it continues to dilate. And so what we're seeing is that those patients who are decompensated and are continuing to dilate, the mononuclear cell therapy appears to stop that process. So that's what's exciting about this data.

So we see it across the full population with a p-value just above the key 0.05 threshold. But in the subgroup, we're looking at p-value of 0.02 and 0.1 for echo measures. And these are large magnitude changes that were presented at the THT conference.

Another value proposition above and beyond just talking to regulators with respect to this data, Lander, is this data is compelling to cardiologists who are trying to advance therapies for their patients and the patients that we have treated are on guideline-directed medical therapy. So the patients in this trial have already been advanced on everything that's available to them that's not extremely invasive and they still are dying at a rate of approximately 10% per year.

The big limit in heart failure is that nothing is changing mortality. And here, we're seeing a therapy that not only appears at a high level to be reducing mortality in MACE, but it's also showing these changes in left ventricular volumes that have a long history of being correlated with reduced mortality as well. So I think there'll be a lot of excited in the cardiology community, and that will translate into excellent enrollment in the CardiAMP Heart Failure II trial when we put our full weight behind it.

Perfect. That's helpful. Yes. And do you have an estimate of the CardiAMP submission to the FDA if everything goes according to plan? And how are you thinking about the potential requirements for post-marketing studies and their execution?

So for CardiAMP HF, we are -- as I shared in my remarks, we're imminently going to file for a discussion on approvable pathways. So they already have all of the data from the trial. We will be providing other analyses that have been done, but that's imminent. I expect the time line will be, because this has FDA breakthrough designation, it will be under a standard Sprint discussion, which I estimate is roughly a 45-day turnaround. And then the subsequent -- if they're supportive, it will take time for all of the details regarding a submission to be put forward.

And there's 2 approval pathways. Even though it is regulated by CBER, it is a device system. And so the approval pathway, again, CBER, the Center for Biologics Evaluation and Research. The device pathway has both the PMDA and the de novo pathway. And because of the safety profile we see with CardiAMP, it actually could go down the de novo pathway, which is really interesting. De novo is for devices that are safe. And there's no safety issues that I'm aware of right now with respect to CardiAMP. So if that's the door that's open and we decide to pursue it, it could be a very short time line. and relatively straightforward to secure approval. But if it's a PMA pathway, which has certain strategic advantages, it could be a little longer. The key question for FDA and for Japan PMDA, is this data acceptable for safety and efficacy for market release.

Now your second part of the question, Lander, was, how do you think about the post-marketing study post-marketing studies, you cannot have patients come in and not have an option to therapy can't truly randomize. So we would expect these to be relatively extensive studies on many hundreds of patients that we would follow over time, and we will be collecting long-term survival data potentially echo data, potentially biomarker data, it's something to be discussed with respect to the agency's guidance on this from each area.

Those measures I just identified are standard measures. So it wouldn't necessarily put an enormous undue burden on BioCardia, echo measures and NT-proBNP measures and understanding survival could be done relatively cost effectively in an open-label setting. So that's how we think about it. Clearly, it's a partnership with the regulatory bodies on their past experience and securing their support based on this data is really the focus.

Perfect. That makes sense. And you already talked about this a little bit, but how do you see CardiAMP HF competing or not with other cell therapies for heart failure that are currently in regulatory discussions?

So with respect to what I called the 4 pillars of therapy in heart failure are the patients that's guideline-directed medical therapy that's established. All of the patients in our CardiAMP HF and in our CardiAMP HF II trial are already on guideline direct to medical therapy. So it's not instead of but really it's in addition to, and we're seeing these benefits in addition to. With the newer cell therapies that are seeking approval in the United States, they're all surgical delivery so far. I believe that they've all expressed interest publicly on pursuing different approaches for minimally invasive delivery such as we are pursuing and we could be helpful to them there.

I see the competitive landscape as one where at the end of the day, I think CardiAMP will always remain one of the leading therapies because of how straightforward it is and how cost effective it will be. At the same time, this is the nature of waves of therapy development. There will ultimately be head-to-head trials for different therapies and it's good for patients if they have different therapeutic options and they're well studied.

My sense is from an efficacy perspective, I actually think the CardiAMP therapy is amongst the most robust therapeutic data that's out there. If you look at the magnitude of changes we're seeing compared to all of the pivotal trials for the guideline-directed medical therapy, the magnitudes are compelling. And so it's going to be interesting. I think the key thing is to continue to collect data for evidence of both safety and efficacy. And like all great therapies, things will evolve solely over time.

But I'm not concerned about the competitive issues. I think it's great for these patients that there's a number of folks pursuing therapies because the need here is enormous. In the United States, just in our indication, it's 1 million patients. So that's how we see it.

[Operator Instructions] The next question will come from James Molloy with Alliance Global Partners.

I was wondering if you could talk a little bit about the enrollment in the HF II trial. I know a few patients enrolled. Talk about sort of how the how that's building any anecdotal sort of stories from the enrollment, the challenges they're facing or maybe the challenges you are facing? And what's sort of the best centers best practices are using to sort of get folks into this HF II trial?

Yes. No, great question, Jim, and I really appreciate you being on the call. So if you actually look at our updated corporate presentation that we just came out a little while ago, we have pictures of 3 of clinical teams at these sites for CardiAMP HF II. And we put the pictures in there, first off, because it's really these centers that do all the work. But second, because you can see everybody's smiling after these procedures. And that's the signal of how well it's going as we're doing these procedures and also the relationships around doing this work.

Enrollment numbers right now, we haven't detailed, but we're starting this enrollment slowly because almost all of our clinical team is focused on the efforts, enormous efforts in taking a Phase III trial data set through for regulatory submission. But all of that is coming to a head. And the beauty of this effort is that, that data will be a primary driver in enrollment ahead. So our expectation is as soon as we complete these conversations with PMDA and FDA, we'll know whether or not the CardiAMP HF II trial should continue to be a randomized double-blind trial or should be migrated to a potentially open-label post-marketing study, and that impacts our efforts.

And second, if it stays a randomized trial, our team will have the strength of this data set which will help on the enrollment side. So we have quite a few sites that are interested in getting involved in the study. It's primarily a bandwidth and a resource basis for why that has not gone faster, but that will come soon ahead. So I hope that answers your question, Jim.

It does indeed. And then maybe moving over to the CMI. We're looking for the 6-month data here at the EuroPCR in Paris in May. What sort of good that equivalent, which should we be looking for as that data comes rolling out?

So I think that the data is as we've shared sort of a top line. I think you'll get more visibility into the physician and patient experience in that in that trial. And I think the interesting thing about the CMI trial is, right now, there's not a lot of options for patients with CMI. And the main value of -- we're right now not driving forward aggressively in enrolling the randomized portion of that trial, where we sort of put it on pause to focus on the heart failure program but from a business development perspective, it effectively doubles the market potential of CardiAMP HF. And so if we had resources, we could very easily advance the CardiAMP CMI trial all the way through its pivotal cohort. But those are some of the things that we're talking about in business development settings.

And how would you characterize the environment for potential partnerships currently?

That's a big question. Right now, there's a lot of folks focused on different things. I'll keep you posted. I think in the past, we've been rather forthcoming on all the conversations we have with respect to our various assets and platforms. And I think what will happen, Jim, is with the first cardiac cell therapy approved in Japan on the 19th of February. This is still pretty brand-new stuff for all of those folks in business development who we're used to looking at years of runway with cash flow, I think there will be great interest.

I think the interest in CardiAMP CMI will primarily be driven by the interest in CardiAMP HF. And my sense is with CardiAMP HF on a path to potential an early approval in the U.S. or in Japan, there will be great interest and support in CardiAMP CMI as well as in cardio.

This concludes our question-and-answer session. I would like to turn the conference back over to Peter Altman for any closing remarks.

Thank you, Nick. Our efforts advancing our cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. Our base plan remains to complete the confirmatory CardiAMP HF II trial while we engage with FDA and PMDA on potential near-term approvals. On behalf of our entire BioCardia team, I thank all shareholders for their continued support as you make our efforts possible. Thank you.

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

Good afternoon, and welcome to the BioCardia Third Quarter Financial Results and Business Update Conference Call. [Operator Instructions] 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 the call.

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

Thank you. 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 report on Form 10-K filed with the SEC on March 26, 2025, and in subsequently filed reports on Form 10-Q.

The content of this call contains time-sensitive information that is accurate only as of today, November 12, 2025. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. This has been another quarter of solid accomplishment for BioCardia as we have been working on regulatory submissions on the strength of our clinical data for CardiAMP cell therapy for the treatment of ischemic heart failure of reduced ejection fraction and for our Helix transendocardial delivery system as well as advancing the CardiAMP Heart Failure II clinical study.

Today, I will provide brief updates on our active clinical programs and progress on our Helix Biotherapeutic Delivery System and Heart3D Fusion Imaging. On BCDA-01, our CardiAMP autologous cell therapy to treat microvascular dysfunction for the treatment of ischemic heart failure, which has potential to help roughly 2 million ischemic heart failure patients with New York Heart Association Class II and III symptoms. Many of these patients have a prognosis worse than many cancers and few remaining options. This places a terrible burden on patients, their families and the health care system. The CardiAMP cell therapy selects patients based on the nature of their marrow cells, which are then harvested, processed and delivered to the heart in a single procedure. The CardiAMP system has received FDA breakthrough designation based on our clinical results, and we now have 3 remarkably consistent clinical trial results, demonstrating promise for the treatment of these patients. Even as we are actively enrolling in the confirmatory CardiAMP Heart Failure II clinical study, we are having discussions with the FDA and PMDA on the approvability of the CardiAMP system for these patients.

In this third quarter, we announced a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency, or PMDA. We have since responded to all questions from this meeting and anticipate our next consultation with PMDA soon, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan. Japan has a strong interest in heart failure therapies due to its aging population, the limited use of heart transplantation and left ventricular assist devices due in part to cultural issues and Japan's PMDA has approved other cell therapies, including for heart failure. Our CardiAMP cell processing platform is approved in Japan for orthopedic applications, which makes our Helix catheter system the only new product to be introduced with good performance in more than 400 clinical procedures. In parallel, we anticipate requesting a meeting with the FDA on the approvability of the FDA-designated breakthrough CardiAMP system based on our clinical data in the fourth quarter of 2025.

The CardiAMP Heart Failure II confirmatory Phase 3 250-patient randomized placebo-controlled trial is starting to accelerate now that staff is coming off the enormous effort of closing up the CardiAMP-HF study. Four centers are actively enrolling, 3 have randomized their first patients and additional centers are actively being onboarded. The CardiAMP HF II study uses a similar 3-tier composite primary outcome measure to the CardiAMP-HF study consisting of all-cause death, nonfatal major adverse cardiac events and a validated quality of life measure. In both our Phase II TAC-HFT Study and Phase 3 CardiAMP-HF study, both randomized double-blind, placebo-controlled studies. This CardiAMP HF II composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBN, who are the focus of the CardiAMP HF II study.

CardiAMP Heart Failure II trial advances include using the cell population analysis and screening to define treatment dose and improvements to the Helix system, including our FDA-approved Morph DNA steerable guide platform. These advances are expected to enable more patients to qualify for the therapy, enhance the ease of enrollment and improve physician control during the interventional cell therapy procedure.

CardiAMP HF II is supported by the Center for Medicare and Medicaid Services with reimbursement for both treated and controlled patients.

In addition to the potential for approvals based on existing data, we are pursuing pathways to fund this study to completion. BCDA-02 is our second indication for this therapy, the CardiAMP cell therapy in chronic myocardial ischemia. The top line primary outcomes from the open-label rolling cohort of the CardiAMP cell therapy in chronic myocardial ischemia trial show patients experienced increased exercise tolerance of an average of 80 seconds with an average of 82% reduction in angina episodes at the 6-month primary endpoint when compared to measurements prior to cell therapy treatment.

60% of the patients showed substantial improvements in both measures. The minimally invasive therapy was well tolerated with no treatment-emergent major adverse cardiac events. We are preparing results for scientific presentation and publication. The promise of these results suggest that the opportunity to positively impact patient lives may be double that of the ischemic heart failure indication we are pursuing as our lead program.

BCDA-03 is our second therapeutic platform, our CardiALLO allogeneic mesenchymal stem cell therapy. This off-the-shelf cell therapy is manufactured at BioCardia and is being advanced in the first prospective trial focused on inflammatory ischemic heart failure of reduced ejection fraction. We believe this program is well positioned for near-term nondilutive funding to complete the Phase I/II 39-patient trial. The results of this trial, if in line with our previous experience in the 30-patient dose escalation TRIDENT study are expected to enable submission for conditional approval in Japan. We expect clarity on the anticipated nondilutive funding in the first quarter of 2026.

On the Helix agent delivery front, we have completed an update to our master file for this delivery device, which supports our therapeutic agent programs and those of therapeutic agent partners. We are actively preparing a de novo 510(k) submission based on the strength of our clinical data. This Helix submission and anticipated approval of our low-risk agent delivery device should enhance support of regulatory agencies for the CardiAMP programs as the CardiAMP cell processing is already approved in the United States, the European Union and Japan for other indications.

Related to biotherapeutic delivery, in August, we announced our partnership to develop and commercialize Heart 3D fusion imaging for biotherapeutic delivery and cardiac biopsy with CART-Tech, a Netherlands company developing enhanced real-time fusion imaging solutions for interventional procedures. Together, we have already realized promising results for Heart 3D fusion imaging in animal studies using both MRI and CT imaging and intend to advance to the clinic in 2026. Looking forward, we have updated our milestones in our press release today. For BCDA-01, our CardiAMP autologous cell therapy in heart failure, we expect Japan PMDA clinical review in Q4, FDA meeting request on approvability also in Q4 and a manuscript published in Q1 with CardiAMP Heart Failure II enrollment continuing. For BCDA-02, CardiAMP autologous cell therapy in chronic myocardial ischemia, we are seeking peer-reviewed publication of the positive results in Q1 2025 -- 2026, excuse me. And for BCDA-03, CardiALLO allogeneic mesenchymal stem cell therapy in heart failure, we anticipate nondilutive funding coming together in the first quarter of 2026. For our Helix Biotherapeutic Delivery System, we anticipate FDA submission for approval in the fourth quarter of this year.

I will now pass the call to David McClung, our CFO, who will review our third quarter 2025 financial results. David?

Thanks, Peter, and good afternoon to everyone joining us.

For the third quarter of 2025, research and development expenses increased to $936,000 from $931,000 in the third quarter of 2024 and also increased to $3.8 million in the 9 months ended September 2025 from the $3.0 million in the 9 months ended September 2024. The increases were driven by the closeout for the CardiAMP Heart Failure study, including statistical data analysis and new enrollment in the subsequent CardiAMP Heart Failure II trial, coupled with regulatory activities in support of potential approvals. We anticipate R&D expenses will increase modestly in 2026 -- year-over-year -- sorry, 2025 year-over-year as we continue advancing our therapeutic candidates in the United States and in Japan.

Selling, general and administrative expenses decreased to $0.6 million in the third quarter of 2025 compared to $0.8 million for the third quarter of 2024, primarily due to lower compensation expense. Selling, general and administrative expenses decreased to $2.4 million during the 9 months ended September 25 as compared to $2.8 million for the 9 months ended September 2024, primarily due to lower professional service fees, coupled with lower share-based compensation expense. We expect 2025 SG&A expense to track close to the 2024 levels year-over-year.

Our net loss was $1.5 million for the 3 months ended September 2025 compared to $1.7 million for the 3 months ended September 2024, and it was $6.2 million for the 9 months ended September '25 compared to the $5.5 million for the 9 months ended September 2024. Net cash used in operations during the third quarter of 2025 decreased to $1.5 million compared to $1.7 million for the third quarter of the prior year. Net cash used in operations for the 9 months ended September 2025 decreased to $4.9 million as compared to $5.5 million for the 9 months ended September 2024.

The company ended the quarter with $5.3 million in cash, reflecting both the $6 million September financing and 304,000 shares of stock sold during the quarter under the company's ATM program. Cash currently on hand is expected to provide runway into the second quarter of 2026 without additional financing.

This concludes our prepared remarks. We're happy now to take questions from attendees.

[Operator Instructions] The first question comes from Joe Pantginis with H.C. Wainwright.

This is Lander on for Joe. So for the CardiAMP CMI data announced in September, could you please clarify, Peter, how many patients were part of this data set? And how are these results incremental to the initial 4 patient rolling cohort data presented in April last year?

Appreciate the question, Landon. The CardiAMP CMI data contains the 5 patients that have been enrolled at their primary endpoint out to 6 months. We have additional longer-term follow-up data. And the key takeaway is that the results in this open-label rolling cohort are pretty compelling relative to what has been out previously. It is a modest increase in data, but that rolling cohort is now completed, and we're wrapping it up for submission for publication.

Okay. Perfect. So you're wrapping it up with 5 patients total, right, for the rolling cohort, open-label?

Correct. Correct. And the CardiAMP CMI study benefits from the extensive clinical experience we have in the CardiAMP ischemic heart failure trials. Fundamentally, to advance in this indication, the rolling cohorts goal is fundamentally to see are there signals that we can observe that are compelling? Are there any safety issues that are not expected? And so the trial design is actually designed as a trial for approval with the rolling cohort. So we have updated the FDA on all the experience, and it is well positioned to go forward, although resources will have us focusing on the CardiAMP HF II program because we see it as much closer to market in the near term.

[Operator Instructions] The next question comes from James Molloy with Alliance Global Partners.

I was wondering if you could walk through -- I know you have 3 patients in 4 centers enrolling. Can you walk through any anecdotal stories on how recruitment is going and what the challenges or not challenges to get the patients in that trial that the docs are seeing out there?

Well, Jim, thank you for the question. The status of CardiAMP Heart Failure II is that it's coming along actually rather smoothly. The enrollment is easier in this trial because of our use of the cell population analysis to essentially set dosage where patients previously might have been excluded. The FDA has blessed an approach where we can modify the dosing in patients who had fewer cells available to essentially increase the dosing.

And so as far as challenges that we have, there's no real challenges. In fact, this is going to be relatively straightforward based on the experience we have. I think our fundamental challenge, Jim, is just resources and bandwidth. We are completing a Phase 3 trial, wrapping that data set up for a manuscript for the FDA and for the Japan PMDA. And so as I'm sure you can expect, all of the clinical data gets woven through that, and we have a relatively lean team. That same team is doing that work.

So that is being essentially closed up now. All those projects are pretty much all the work is done. And so as you've seen in recent weeks, centers will be treating their first patient and we'll be moving forward. We've actually treated more patients than you've alluded to. And the way this works for the patient, there is a delay in the time that a patient -- from the time that they are randomized -- or excuse me, from the time that they are screened until the time that they are actually complete the baseline measures because we have built into this trial something a delay actually to address the Hawthorne effect. And the Hawthorne effect is a process where as soon as a patient is observed, they begin to change their behavior. They -- if they're on meds and they haven't been taking them, they start taking their meds, for example.

And so as soon as a patient is consented for the trial, we do some preliminary measures to make sure they're likely to qualify. And then we essentially observe them for a month before we then advance them to care. So the patients that you're seeing treated in recent press releases and these centers getting started up have been in the queue for a very long time. And so you'll start seeing more patients coming through the queue. I think the challenges in enrollment are this is still a larger trial, it's 250 patients. We do benefit from Medicare reimbursement for both treatment and control patients. The trial is overpowered. And so I think what we'll see ahead as the team comes off these big initiatives we have to pursue pathways to approval in the United States based on the existing data and in Japan based on the existing data, this trial will be accelerating.

Of course, the conversations with Japan PMDA and with FDA may change some of our prioritizations here as well. So these are all interwoven into really a fundamental concept is that we have some really nice data -- the Phase I data, the Phase II data and the Phase 3 data are all consistent and support safety and benefit from our perspective. That is a shared perspective from other parties. Is it sufficient for us to actually secure an approval is to be determined. But that strength of that data underlines our enthusiasm for CardiAMP Heart Failure II as well as well as that of the physicians. So all of the physicians involved in CardiAMP Heart Failure I are continuing with CardiAMP Heart Failure II. And this is not just the Executive Steering Committee, but the physicians on the Data Safety Monitoring Board and the physicians on the Clinical Events Committee. So everybody was positive and supportive of this subsequent trial and is excited to see what the outcomes will be. The enrollment will come at pace. And just -- it's resource-driven primarily. There's no extra hurdles or unusual issues. In fact, I would say now that we've completed CardiAMP-HF I, the second trial is much, much easier for us to do.

My apologies, did I mishear on the prepared remarks that you said you had 4 centers enrolling and 3 of them had their first patients enrolled?

That's correct, but some of them have had more than 1 patient enrolled, Jim.

I'm sorry, what do you -- have said what the current count is?

We're not sharing current count as we go. We're just -- we will announce as each site does their first patient and just to basically to acknowledge the efforts to get there and to help them in with their communication to their colleagues and peers on enrollment, but we're not going to give a blow-by-blow this many patients this week, these many patients next week.

Understood. Makes sense. And then maybe last... You said in the first quarter, you guys were very sort of clear that you're going to complete a nondilutive funding in first quarter '26 for BCDA-03. Is there a partnership or something lined up that is expected to close first quarter '26?

Yes. So what we have is we actually have some federal grant funding, assuming the federal government opens up. And there are some nuances to it, but we've had some really interesting conversations with the NIH, and we're expecting the NIH to step up and fund this program because of -- not just because of their enthusiasm for the data in this clinical indication of these cells at this very high dosage we're delivering, but also because of some of the things that are under the hood, shall we say.

And so yes, so right now, I put that handicap on that. Nothing is guaranteed, but I put it as a high probability that will come through. And that program will be fully funded to go forward. Our team, it's what we do. And so it's basically going to be turning the crank, running another trial in parallel to CardiAMP HF II, but that trial will be fully funded.

The next question comes from Kumaraguru Raja with Brookline Capital Markets.

So I just needed some clarification with regard to the interactions with the Japanese regulatory authorities. So what are the next steps here that needs to be done before you can submit for approval in Japan here? And also with regard to the interactions -- positive interactions, any other additional color you can share, that would be great.

Absolutely. Well, I appreciate the question, Kumar. So where we're at right now, so the process in Japan is a series of consultations. And the key hurdle for us is a formal clinical consultation. And if -- we've been having preliminary clinical consultations, and they are fully apprised of the data. And so the process and what they're deciding is is the CardiAMP-HF clinical data in combination with the Phase II TAC-HFT clinical data in combination with the Phase I TABMMI data, is that sufficient for them to say that the clinical data is sufficient to support safety and efficacy in Japan for this population that right now really has no other option. And that's the key question.

So the clinical consultation is the challenge. We respect that the CardiAMP HF II trial is far from perfect, but there are some very strong signals in the data, particularly in the sickest of patients in greatest need of therapy. And so we are going to have that conversation with them. I would say 95% to 99% of the work with respect to these submissions and conversations are done. And so we're in a waiting mode currently.

With respect to the FDA, as I shared in my comments, they have all of the updated annual reports and details on the study. We have breakthrough designation, but we are going to be submitting the de novo 510(k) application for approval of the Helix system as a first step to get the agency comfortable that the Helix system on its own should be approved to basically eliminate a key bottleneck in the field of biotherapeutic delivery to the heart. And then come to them with CardiAMP.

Once they have received the submission for approval on the Helix system, we would like to engage them on this is an autologous cell therapy. If it was a homologous usage, there would be no regulatory approval required. The data we have is excellent. And yes, it's not perfect, but from a outcomes basis and a risk-benefit basis, it's actually quite remarkable.

And so we're going to have those conversations. I think that the potential in Japan is greater than the potential in the United States at this time. And if these conversations don't bear great fruit, we are full bore on CardiAMP Heart Failure II program. And the efforts that we've taken to prepare these submissions is substantially similar to the effort and its overlap with respect to the peer-reviewed manuscript that's in process. And so that is going to be a critical element for enhancing enrollment in the trial, as Jim Molloy just was touching on. So data drives enthusiasm. And we think the physicians who know the data are pretty jazz, but we need to get it out there more broadly to enhance referrals and beyond. So that's sort of the time line on those two efforts on CardiAMP.

Okay. That's great. With regard to the HF II, you said 4 clinical sites are on board. What are your expectations with regard to getting additional sites on board?

The additional sites on board, it's really a bandwidth issue on our side. There are -- there's also a slight challenge here that's a new element that's happening because of the reduction in some of the overhead funding that the federal government has put in place. A lot of clinical research sites are asking for quite a bit more for start-up costs and beyond. But because we've already been working at many of these sites, I don't expect that to be a significant issue for BioCardia.

So really, it's just our bandwidth moving through. There's going to be new contracting, there's going to be new budgeting, and that just takes staff time. And right now, some of that staff is working on closing out the regulatory submissions and making sure the manuscript is dialed in for submission. So we're not putting out numbers on the timing other than it's at least another year of enrollment in this trial.

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Peter Altman for any closing remarks.

Appreciate it, Drew. So we thank BioCardia investors who enable our efforts developing and enhancing therapies broadly for cardiovascular care. There is great promise for value creation from our therapeutic and biologic delivery development activities with potential transformative near-term catalysts from active regulatory and partnering discussions. On behalf of our entire team, I thank you for your continued support.

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