Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia Year-End 2024 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..

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. The content of this call contains time-sensitive information that is accurate only as of today, March 31, 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..

CardiAMP, CardiALLO, Helix and Morph DNA. For CardiAMP cell therapy business development, we expect the final data from CardiAMP Heart Failure I trial, which we now have will enhance interest by distribution partners and strategics.

It is noteworthy that interventional therapies for heart failure are receiving more and more attention because there are many patients who remain symptomatic even on state-of-the-art guideline-directed medical therapy.

For CardiALLO cell therapy business development, our allogeneic cell therapy, we have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease.

I note that FDA has approved a first mesenchymal stem cell therapy by a peer company in 2025, which has a treatment price of $800,000 for a course of 4 treatments.

And another peer company appears to soon expect conditional approval for mesenchymal stem cell therapy in Japan to treat acute respiratory distress, where we also have an approved IND at BioCardia. These peer company successes may enhance our partnering discussions around our clinical stage allogeneic mesenchymal stem cell therapy platform.

For our Helix Biotherapeutic delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products and support capabilities remain active in discussions.

Current partners realize that minimally invasive delivery not only enhances future commercialization, but is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening time lines for their therapeutic development.

Lastly, partner therapeutics are expected to benefit enormously from our threefold efficiency of delivery and the enhanced pharmacokinetics with our Helix system supported by data from many groups.

We believe this advantage underlies our positive CardiAMP-HF data and is due to the stability of the Helix in the beating heart and the self-sealing helical pathway into the tissue. On the Morph front, the recent FDA approval has us open for business in a competitive but real market.

Physician usage is the first step toward any distribution or commercial partnership. Morph DNA was used in the - as the steerable platform in the recent CardiALLO low-dose cohort patient and more procedures are expected ahead. Looking forward, we are working to complete the following important efforts for our therapeutic programs.

First, to submit CardiAMP-HF results and request consultation with FDA and Japan PMDA. Second, to activate multiple sites in CardiAMP-HF2 and drive enrollment. Third, for BCD-02 to deliver top line data in the rolling cohort and for BCD-03, complete the DSMB review in the CardiALLO-HF low-dose cohort.

I will now pass the call to David McClung, our CFO, who will review our fourth quarter 2024 financial results.

David?.

Thank you, Peter. Good afternoon, everyone. I'll now provide a brief overview of our financial results for the year ended December 31, 2024. Total expense decreased 35% year-over-year to $8.1 million in 2024 compared to $12.1 million in 2023.

The primary driver of this change, research and development expense decreased to $4.4 million in 2024 compared to $7.7 million in 2023. This 43% decrease was due to reduced cost and expense following the completion of the CardiAMP Heart Failure trial.

We anticipate R&D expenses will increase modestly in 2025 as we continue advancing our therapeutic candidates, both here in the United States and Japan.

Selling, general and administrative expenses decreased 16% in 2024 to $3.7 million as compared to $4.4 million in 2023, primarily due to realignment of personnel and cost reductions following the completion of the CardiAMP Heart Failure trial. We expect 2025 SG&A expenses to remain close to our 2024 levels.

Our net loss decreased to $7.9 million in 2024, down $11.6 million, down from $11.6 million in 2023. And our net cash used in operations was approximately $8 million during the year ended 2024 compared to approximately $10.0 million in 2023. The 20% decrease is primarily due to the reductions in R&D expenses that we talked about.

The company ended the year with cash and cash equivalents totaling $2.4 [ph] million. We expect our cash burn will increase moderately in 2025, continuing our track record for carefully managing the use of resources and capital. This concludes management's prepared comments. We're happy now to take any questions from attendees..

At this time, we will now begin the question-and-answer session [Operator Instructions] And our first question will come from Joe Pantginis with H.C. Wainwright. Please go ahead..

Hey, guys. Good afternoon. Thanks for taking the questions. So Peter, before I ask about the data, I was just curious on the back end of your comments, if you could provide a little more color on your PMDA discussions in Japan..

We met with PMDA. So first, Joe, thanks for the question. And we met with PMDA in, gosh, November. So they have been asking us for we want to see the 2-year data. We now have 2-year data. 2-year data looks even better than it did before.

So that's why we're a little bit surprised by the market reaction today because we've all known for a very long time that the key element of this trial is looking at what other signals are we seeing that support where we're going ahead with CardiAMP Heart Failure II. Worst case, this is a really nice Phase II trial is my perspective.

Best case, there is potential for conditional approval in Japan or even a full approval in Japan. So that's where we're knocking..

Got it. No, that's helpful. And then, okay, so more to the data now. When you look at how the study went per se and that the DSMB said about the 6-minute walk test potentially impacting the outcomes and what have you. So the data are very nice that you announced at ACC.

So just curious, any discussion around subsequent to the stopping of the study, any subsequent therapies that you can talk to or that patients went on that could have potentially impacted the data read? I'm assuming not really just based on how severe these patients are..

Yeah. No. So all these patients are already on guideline-directed medical therapy. And actually, Dr. Walsh at the session there's a slide showing that the guideline-directed medical therapy, it was congratulatory. It's actually - our investigators did a really nice job of making sure everyone was on stable guideline-directed medical therapy.

And that contributes to slowing of enrollment because heart failure physicians will alter medication when they see patients. And only when they finally have stabilized the patient said, okay, I've done the best I can, then this patient can advance to CardiAMP cell therapy.

So there are no other medications out there other than the ones that are currently under the guidelines. So - and in addition, as we look at the trial results, we actually - we have an extensive biorepository.

So we'll actually be able to interrogate patient samples and look at things in the future such as viral load with COVID, drug trough levels of sacubitril/valsartan and SGL-T2I. And so there's other things that we may learn going downstream. I mean this is a very rigorous study.

And yeah, no patients that I'm aware had subsequent therapies other than what they received in CardiAMP. I think the Dr. Walsh's question of Dr. Raval during the presentation at ACC, focusing in on, wow, those are good results.

How do you know that you - that quality of life is real? Were the patients truly blinded? And the discussion there was, yes, indeed, they were. We had formal scripts for each and every site.

Patients had headphones on and very much didn't know whether or not that they were being treated or not because all patients, as you all should know, were actually catheterized. The only thing that the control patients did not receive was the intramyocardial injections. And so the data is good.

So of course, when the data is really good, you challenge that and Dr. Raval had a very robust answer for that third tier in the quality of life front. So yeah, I think the data is a solid data set. It's something that we can all be proud of. We missed the primary endpoint. We've known that for a year..

Yeah, absolutely. And but it's good to have followed the patients to give you a more robust picture.

And so specifically, when you look at some of the demographics, I wanted to see if I can just get a little more color about the NTproBNP population and how well balanced they were between the 2 arms because it really appears that that's going to be an important marker going forward..

Yeah. Actually, so the balance of that essentially, it's roughly the same threshold. I think about half the patients in both groups had the elevated NTproBNP. So that's a key element. About half the patients cleared that threshold, and we will be doing it.

NTproBNP is a prespecified parameter that will be a covariant that we'll have to do covariate analysis on a head. And so along with some other parameters, so we'll be doing that work and hopefully seeing some more details there..

Got it. And my last question, and thank you for indulging me is I just wanted to get a sense about the durability and the improvements that you were talking about. I want to make sure I'm reading them correctly.

So when you look at the relative risk reductions in heart death equivalents, the difference that you're seeing between 20 and 24 months and the durability because I just want to make sure I'm reading it correctly with regard to the numbers. I think at 20 months, it was an 86% reduction and for the relative risk reductions in heart death equivalents.

And I can't tell, it appears it dropped off, but still very meaningful. I just want to make sure I understand I'm reading it correctly..

Yeah. So I mean the - so you are - so that the benefit here is essentially what we're seeing is not just the benefit in the heart death equivalent, but it's across all of the endpoints where we can actually achieve a p-value. So the way I have folks think about this is the endpoints here are these composites with these 3 tiers.

And the mere fact that we can have all 3 of these tiers go the same way at 2 years follow-up is a great signal. One of the difficulties of these sort of win ratio type analysis is sometimes others will lose on mortality or they'll lose on MACE, but they'll win on a less important tier such as quality of life or the 6-minute walk distance.

And I think one of the strengths of the data, Joe, is that we win on all 3 tiers at that long-term follow-up endpoint. And the mere fact that we have a p-value in 115 randomized patients, 125 total patient heart failure trial in the NTproBNP population, what everybody else treats, and they usually have to enroll thousands of patients.

I mean, 8,000 patients is not a small heart failure trial. And so these are really strong signals. These are really compelling signals. And the fact that they're still there at 2 years is what we view as the robustness of the data, not necessarily comparing the dynamic at one time point for one component of the endpoint to that at a later time point.

But we'll detail all of the numbers on absolute survival, absolute reduction in MACE, relative risk reduction in MACE and so on ahead. So that's sort of the thought process.

I also just - while we're on this, I should share for everybody, the interim data was based on unmonitored data with patients - many of them had some long-term follow-up, but we have enrolled additional patients since then as well.

So because the DSMB allowed us to clear out the queue of patients who had already been prescreened and treat them, which is a nice signal for safety.

But - so this data, a lot of things may have changed since we presented it and the fact that it's still - when I say robust, I'm saying that it's at 2 years that we're able to see these endpoints, not necessarily comparing it to the interim analysis on potentially different data points because it hadn't been monitored and source data verified..

Got it. Thanks for all the details, Peter..

No. Appreciate all the questions, Joe. Great questions. And I'm sorry I wasn't clear on them up front..

No worries..

Our next question will come from Kumar Raja with Brookline Capital Markets. Please go ahead..

Thanks for taking my questions and congratulations on the data.

So first, with regard to sharing the 2-year data with the FDA, what is the expected time line for that? And how do you think that's going to impact the CardiAMP -2 trial? And what has been the feedback in terms of the physicians? Do you think that the enrollment in the 2 trial will ramp up following this 24-month data?.

Yes. So first, with the conversations with respect to the FDA. This was truly a late-breaking clinical trial. We kept folks posted as we were freezing the data and pulling things together. So we are going to pull together the data and have a meeting with the agency. Our interaction with the agency has been excellent.

Historically, as everybody on this call likely knows, things are very different at the FDA these days.

And so I don't expect there to be difficulties with the agency, but there may be some creative approaches here that they see based on the strength of our data, the fact that we've got FDA breakthrough designation, the fact that there are really no real safety issues other than the procedural issues, which are all addressable.

So I feel pretty good about these are going to be interesting conversations ahead. Now your question on how will this impact CardiAMP Heart Failure 2. So that trial is already approved. It's already been activated. We have a number of centers that are in the final strokes of activation that are world-class centers.

And so I don't think it's going to impact it in the short term significantly, but I did mention the covariate analysis. We have a very large data set that we're looking at, and there may be a number of things that we learned that we take forward in the CardiAMP Heart Failure too.

One thing we took forward from CardiAMP Heart Failure 1 to CardiAMP Heart Failure 2 is our awareness that our cell population analysis, there was a number of patients that just barely missed the eligibility to participate in the trial.

And I think in the previous quarter, I detailed that the conversations with the FDA have allowed us to modify the treatment plan for patients who are in a certain window on the cell population analysis so they can still receive the same minimum target dose, but we don't necessarily need to exclude them from the trial.

So that's going to be something that we already have in place with the agency, and we'll be taking that forward. Other interactions with the agency are expected as we get through some of this covariate analysis.

There's been a lot of folks out there Kumar that have been suggesting that we go after an adaptive trial design again, but there's other leaders who said, look, you have a shot to see a mortality benefit that's statistically significant in this small trial.

We're not even the latest, greatest drugs have really demonstrated much, at least particularly not in real-world practice. So we may not do that, but it's - these are going to be part of the discussion with the agency. And they're very supportive of adaptive designs. We have a lot of data that will support where we're going with this.

And on enrollment, which is sort of the second piece of your question, I do think that this -- the change to enable us to target dosage or personalized dosage based on the cell potency assay or cell population analysis, if you will, will enable us to not exclude nearly as many patients.

I think we'll move from an exclusion profile of around - I think it's around 35% for that down to about 15% for that. I also think that the data we have is compelling. And I think physicians will look at our chart on the MACE events and see, wow, that's great across the board. Which side do you want your patients in.

And so I think that will contribute to this. And I think other things and other learnings we have will also contribute to our ability to enroll more quickly as well as selecting the sites that were the best performers in CardiAMP Heart Failure 1. So all of that will feed into enrollment..

Okay. Great. And you already met with the PMDA in November. And now you have the 2-year data. What are the next steps here? And what kind of time lines can we expect with regard to the interactions with the PMDA? Thank you..

Yes. No, it's a great question, Kumar. So we met with them in November. They've already invited the next conversation in November. So we - the time line here is are pulling together the appropriate submission package for them with the data in advance of requesting a consultation.

And then the other parameter is they're scheduling that meeting and consultation. So I just flew back from Chicago this morning. We just got the data out. We don't have exactly the time line with the regulatory advisers we have to pull together that package.

I mean if the package is as lean as the ACC presentation, which it very well could be, we could be requesting something in short order. But I think it's going to be far more substantive than that. They're very rigorous and detailed oriented, and we've had great interactions with them as well as the FDA.

And our expectation is we want to put the best foot forward with them and detail everything we possibly can to minimize the questions. Our goal at the end of the day is for their questions to end with the clause. Please address this in your application for approval. Those are the questions we want to have at the end of our ultimate consultation.

There'll probably be more than one consultation ahead, one probably to understand the clinical data and another one to follow up and probe in different areas and make sure that we've looked at some of the sensitivities that they're interested in. And we'll see.

This is - we respect that we don't have a grand slam home run data set that says, yes, this will absolutely be approved tomorrow. But this is a really nice data set, everybody. And - and I'm proud of the team and the clinicians and the patients who contributed to it.

So yes, we'll detail as we do, Kumar, when we have had the consultation and the time lines ahead as we get closer. But it's - the first step is to prepare the package and submit it. That's in our court. The next step is for them to look at their schedule. It could be as short as 3 weeks from that request or as long as 8 weeks. And so we'll see.

My expectation is it will be on the shorter end for both our preparing the package and for them scheduling a meeting..

Okay, great. Thanks so much..

No, appreciate the questions. Really do..

Our next question will come from James F. Molloy with Alliance Global Partners. Please go ahead..

Hey, guys. Good afternoon. Thank you very much for taking my questions.

I'm looking at the Heart Failure II trial and sort of the positive trends and on the first 2 things, the positive outcomes, how does that inform what you should be looking - what we should be looking for in Heart Failure II trial in the elevated subgroup? And what sort of - what will be the most positive outcome in this group from what you've seen in the Heart Failure I trial to translate in Heart Failure II?.

Well, Jim, I appreciate the call, and that's sort of one of the fundamental reasons I'm jazzed about this. So - the primary endpoint in CardiAMP Heart Failure II is the same composite endpoint structure, we have a p-value of 0.02 in CardiAMP Heart Failure I.

In addition, the subgroup that we looked at in CardiAMP Heart Failure that had that p-value is the subgroup, which is already in the FDA-approved protocol for CardiAMP Heart Failure II.

So my goal is to deliver that same result, which is an endpoint of all-cause cardiac death equivalent, major adverse cardiac events in the second tier and then quality of life in the third tier. And to put this into context, the company V-Wave had a late-breaking clinical trial at the American College of Cardiology last year.

That was their endpoint in their trial. They had an elevated NTproBNP much higher than what we are having in this subgroup. And I don't think that they came close to hitting their endpoint, but they were also acquired by J&J for $1.4 billion soon thereafter. So there is interest in these therapies, and this is good data.

So we'll see where this goes ahead. But now that we have this final data and it's out and it's public, we can discuss it and share it, and it's on our website, and I invite questions both in this call, but also after this call. We'll take questions from Investor Relations.

If these things we haven't addressed, we can address them in the manuscripts or in future calls.

So does that answer your question, Jim?.

It sure does. I appreciate that.

And what's the next cut point or interim look we should anticipate for HF2?.

HF2 is still early. The thing you should ask for HF 2 is what is the enrollment - what is the month-by-month enrollment? What's happening? How are sites being onboarded and so on and so forth. So - and we're working through that.

Some of the latest things that have happened with research funding in the United States have had an interesting repercussion on clinical sites in the United States. So we do intend to bring the wonderful team we had in Canada back online. And we may also seek to advance CardiAMP Heart Failure II in Europe. So stay tuned.

There's going to be a lot that goes on. Now that much of this project on Heart Failure I has been completed, there'll be a lot more momentum on CardiAMP Heart Failure II ahead..

Okay. Thank you very much for taking the questions..

I appreciate, Jim, you have a wonderful day..

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

Thank you, Wyatt. So I just want to have everybody be aware that we're developing therapies here at BioCardia. And the results released this morning show we have a strong signal of a sustained benefit with no safety concerns in our lead therapeutic candidate for an enormous unmet clinical need.

I respect investor desire to be approved and commercial as soon as possible, and we are doing the good work to get us there. The data today was actually good data. And hopefully, we'll see that to the finish line. I thank everybody for their continued support, and I wish you a great day ahead. Thank you very much..

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