Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia First Quarter Financial Results and Business Update Conference Call. All participants will be in listen-only mode. [Operator Instructions]. After today's presentation, there will be an opportunity to ask questions. [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, Dave. 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 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 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, May 14, 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 and clarity on anticipated approvals ahead to enhance interest distribution partners and strategics.

For CardiALLO, cell therapy business development, our allogeneic cell therapy, we have the ability to manufacture our clinical-grade cells at a cost profile that we expect is likely less than all of our peers. We are also open to partnerships broadly in the many indications we are not currently pursuing.

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

Current partners realize that minimally invasive delivery not only enhances future commercialization, but it is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing operational costs by shortening timelines for 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 heart failure data and is due to the stability of the Helix in the beating heart and the self-healing helical pathway into the tissue. On the Morph front, the recent FDA approval has us open for business in a competitive, but real market.

Recently, the greater than $10 billion per year electrophysiology market, primarily focused on treating arrhythmias in the atria of the heart is expanded to treat arrhythmias in the ventricles of the heart where we deliver our cell therapies.

This is a more tortuous region of the heart to access and typically involves a 180-degree turn of the catheter system regardless which route of access is required. Trans-aorta or transmitral and down through the mitral valve.

Our Morph DNA design presents significant advantages in these orientations, which is exactly where it is being used today for our therapeutic procedures. Looking forward, we are working to complete the following important efforts for our therapeutic programs. One, submit CardiAMP HF results and request consultation with FDA and Japan PMDA.

Two, activate multiple sites in CardiAMP heart failure II and drive enrollment in this trial. For BCDA-02, we intend to deliver topline data in the rolling cohort. And lastly, for BCDA-03, we're going to complete the next dosing cohort ahead.

After the end of recent quarter, management chose to do a small financing at the market with minimum dilution to deliver on the milestones before us. We don't have a large burn rate as a company today. And this gives us greater flexibility as we choose the best pathways to fund value creation for our shareholders.

We have some large milestones expected very soon. I will now pass the call to Dave McClung, our CFO, who will review our first quarter '25 financial results.

David?.

Thank you, Peter. Good afternoon, everyone. I will now review highlights of our financial results for the quarter ended March 31, 2025. Total expenses increased by $396,000 quarter-over-quarter to $2.7 million in the first quarter of 2025 compared to $2.3 million in the same quarter of 2024.

The primary driver of this change, research and development expense increased $289,000 to $1.5 million in the first quarter of 2025 versus $1.2 million in the first quarter of 2024.

The increase relates to expenses incurred closing out and obtaining final data for the CardiAMP heart failure trial, coupled with the inception of enrollment in the new CardiAMP heart failure II trial during the first quarter of 2025.

We anticipate R&D expenses will increase modestly in 2025 as we continue advancing our therapeutic candidates in the United States and in Japan. Selling, general and administrative expenses increased modestly to $1.2 million for the three months ended March 2025 as compared to $1.1 million for the three months ended March 2024.

We expect 2025 SG&A expenses to track closely to these 2024 levels. Our net loss was $2.7 million in Q1 2025 compared to $2.3 in Q1 2024. Net cash used in operations was $1.6 million for the first quarter of 2025 comparable to the $1.5 million recognized in the same quarter in 2024.

The company ended the quarter with cash and cash equivalents totaling $949,000 before we did the modest financing and brought in some additional capital as Peter just mentioned. We will continue our track record for carefully managing the use of capital.

This concludes management's prepared comments, but we're happy now to take questions from attendees..

At this time, we will now begin the question-and-answer session. Our first question comes from Joe Pantginis with H.C. Wainwright. Please go ahead..

Hi, guys. Good afternoon. Thanks for taking the question. Peter, I'd like to start with, I mean, you mentioned business development a lot. So, I mean, I know it's obviously hard to or predict when deals may be consummated, but maybe can you discuss sort of the levels of maturity? And I'm sure it's wide ranging..

Wow. Yes. I think right now I would talk about our capabilities as opposed to the stage of a deal discussion. I've been in deal discussions where I thought the deal was going to be inked the next day and literally 18 months later, it wasn't done.

For example, the publicly traded company Care DX, which has a market cap of 1.8 billion, that financing took 18 months to close. And it takes a long time, even when you're in the final steps, but sometimes it can go quickly. I think the key takeaway is we have products that are established.

So, if we work up the value proposition, the more access pro product family is approved and being used in clinical cases today, both in our trials and in other physicians' hands. And I've guided folks to that this would be a long process as physicians gained experience and strategics became more interested.

We have a couple of active discussions ongoing with large cap strategics today around the more product opportunity. And again, the beauty of this is it's not an opportunity related to our core business necessarily. So, it's additional value from what investors might expect. And I did detail the cardiac electrophysiology market.

It's an enormous market that's growing at 30% per year and a technology like the Morph can help folks get to the location and do these procedures. So, it's a high value opportunity. Moving up the food chain on the Helix side, Joe, I'll walk through them. Helix is needed for biotherapeutic delivery partnering.

I noted in our corporate deck, you'll see there is one, a peer company that is seeking approval in Japan probably in the year ahead and that's Heartseed. And we wish them well and we like their strategy. They're cracking people's chests to deliver the cells intramyocardially. At some point in time, that's got to change.

I know that Novo Nordisk has said publicly that they're working on a catheter system. And we have a lot of intellectual property out there and we've done 500 cases and I think Helix is going to soon be approved. So, that's just one potential partner in the cell and gene therapy space in the heart.

On CardiALLO, we have a clinical data set now demonstrating safety in the heart, which is probably one of the most sensitive places to go. And we're having manufacturing relatively well dialed in.

Some really nice advances on how to manufacture these cells in a small footprint manufacturing that actually would enable us to do deals with other parties seeking to go after other clinical indications.

So, today we're focused on cardiac and pulmonary, but these same cells are being pursued or very similar cells are being pursued commercially at a price point of $800,000 per treatment by Mesoblast and by Helios in acute respiratory distress where we have approved IND in the United States.

So, there's many other indications for these cells out there and we're open for partnering with clinical grade cells with clinical data behind them. And then on the cardiac front, we are focused on the approval process in Japan. We've been having ongoing discussions with the regulators and with potential distributors now for a few years.

As we get closer to the door of, hey, this is going to be a product, who's going to distribute it? And by being reasonable and rational in the partnering, I think we'll see progress there. So, I can't give a specific timeline. I just think that investors should appreciate all four of these platforms are ready for deals today.

And they do line up with really significant opportunities. So, I guess that's where it's at. And you'll hear me continue to say this until as we ink deals and partners take some of the value that we've been investing in and grow it further..

Of course. I appreciate that. It surely sounds like you're very busy with it. So, good luck in bringing a deal forward. So, if we focus a little bit, obviously, I think maybe I'm overstating this, but the majority of people would be focused on the U.S. opportunities. But I think an unsung opportunity and focus is Japan. And you've talked a lot about this.

So, if Japan -- if the Japan PMDA allows you to submit the cardiac cell therapy system for the heart failure indication, after they review the clinical data, I mean, this is safe to assume that this is similar to the FDA accepting a BLA.

And what do you feel as the importance of that inflection point and how it might get to the market in Japan? Thanks..

Thank you, Joe. Joe, it's a great question. And I'm aligned with you. I do agree. It is the same thing as the FDA saying they'll accept the BLA. So, in Japan, they're extremely rigorous. They've gone through all of our data, I think, four times already. And there will be additional data review as we go into our clinical consultations.

But we're looking at roughly, I'd say, a six-month timeframe on the outside to have clarity on, are we going to be allowed to submit for approval? At that point, I view it as pretty sure that we're going to go through that approval process unless they find something fundamentally wrong with what we've done and what we’ve said.

And them allowing us to submit for approval also provides clarity for all of the distribution partners we're talking to. That puts it on a timeline for approval. And it becomes critical to then begin doing physician outreach and getting ready for how to train this, how to introduce this into a commercial channel.

And so it'll start slowly in Japan, but I do think that the value proposition for BioCardia is enormous. I know we have two peers in Japan. I mentioned Heartseed earlier and I have a lot of respect for Heartseed and their basic strategy. They have treated 10 patients.

And they have a market capitalization of about $350 million with open chest surgical delivery. There's another peer in Japan, Cuorips. They are delivering cells to the surface of the heart, again, through an open chest surgical procedure. I don't, I'm not a big fan of their strategy, I must say.

But their efforts they're going after approval in Japan based on eight patients treated total. And I know that it took them many, many years to get those eight patients, much as it took Heartseed many, many years to get their 10 patients.

Here we are with roughly 200 patients in the CardiAMP cell therapy trial, including two randomized placebo-controlled trials, minimally invasive delivery in autologous cell therapy.

And so them saying that they will accept our application in Japan, I think will help us close the gap in valuation between where BioCardia is today and where those companies are in terms of their valuation, if not even exceed their valuation over time, as folks become more aware of the differences in the therapy and the level of evidence in the safety profile and so on.

So, a long answer, Joe, but I think it's a great question and it's central to our strategy to get that PMDA submission in place..

No, that's fantastic. I appreciate that color, especially with the level of data relative to the comps. So, I appreciate all the color, Peter..

Thank you, Joe..

And the next question comes from Chris Stevens [ph], private investor..

Hello. Hi, Peter.

How are you?.

I'm doing well, Chris..

Great. My question pertains to the CardiAMP, the BCDA-01, the confirmatory trial. That's ongoing. That's starting up. You're enrolling patients in.

Can you kind of give some comments on how that would play into this other activity in which you're submitting to the FDA to see if there's a potential pathway to approval? So, it's kind of like you're running a trial, but at the same time, you're also submitting to the FDA for approval at the same time?.

Absolutely. That's a great question, Chris, and I appreciate it. And I know it may be a disconnect, but when you believe in your therapy, you're constantly going to be developing levels of evidence. And we know that we had a great clinical trial that we just reported, but it did not hit the primary.

And so, that does introduce really significant risks to the approval pathway ahead. And we have built this heart failure network in the United States in CardiAMP HF. The investigators have the data before them, which excites them. So, that will help us on enrollment ahead. And remember that CardiAMP-HF1 and HF2 are both reimbursed today by Medicare.

So, the cost to us in doing a second trial are not nearly as significant as it would be if we were not reimbursed by Medicare. And so, we're advancing that program. We will generate additional data. It's focusing in on the patients who are the greatest responders in CardiAMP HF. There are a couple other subtleties that we're weaving into the trial.

We are using our new Morph DNA platform in this trial. And I can tell you that the physician who did the first case sent me a text, a very short text that said, I love Morph DNA. So, just so you can appreciate how the physicians are responding to that.

We also have a strategy woven into CardiAMP Heart Failure II where the FDA has blessed our usage of the pre-procedure screening assay to change the dosing in the patients so that we can include more patients in CardiAMP Heart Failure II than we include in CardiAMP Heart Failure. And so, that's going to be a nice aspect of it.

And lastly, CardiAMP Heart Failure II will be using a very similar composite endpoint, which is the three-tier Finkelstein-Schoenfeld analysis. But instead of using six-minute walk in the third tier where we had some issues in CardiAMP-HF, we're going to be using a quality of life metric, a self-assessment question.

And the beauty of that change is that's not an assay or assessment, if you will, that is effort-based. You know, everybody will complete the same every time. And, you know, in CardiAMP-HF, we had patients fall out because, you know, they hurt their knee. And so, they couldn't do the six-minute walk distance.

So, it also avoids patient fallout for certain measures, which enhances the power of the trial. So, those are the big changes in CardiAMP-HFII. And it's active at three centers today. And there'll be news flow as it's expanded out to other centers. It does not have an adaptive statistical analysis plan.

And it's a 250-patient trial with one-to-one randomization. So, we're hopefully going to completely enroll it in 2 years..

Got you. Okay, that's great. That's good info. Just one follow-up, if I may. And I know this is very new.

But the tariffs, the best price policy or best nation price policy that just came out, is there anything in CardiAMP that would follow, anything within that treatment that would fall within any of this tariff concerns or even the best price policy that is being talked about just within the last day or two? I know it's very new..

No, no, I'm tracking. It's the most favored nation status that folks are in the United States….

There you go..

…based on most favored nation. And the answer to that is no today. So, right now, on the most favored nation, we are not actively selling CardiAMP outside the United States. We hope to be soon. If we do, we're actually hoping to benchmark it based on our current U.S. reimbursement. So, we're trying to turn that equation around, if you will.

We'd like others to be signing up to that U.S. pricing as well, and that may come into play. The tariffs is such a complicated landscape, and there's so much that we don't know. But for investors, I can share that we only have a few components that we use in our manufacturing here at BioCardia that are manufactured overseas.

We do some of our molding work outside the United States. Very low cost, not expected to have any impact to our business. Everything else we manufacture here in the United States. So, we manufacture the Morph product here at the facility I'm standing in.

We manufacture Helix in the facility I'm standing in, and we manufacture CARDI-AXO clinical cells in the facility I'm standing in here in Sunnyvale, California. The CardiAMP disposables are manufactured on a contract basis for us, but they're also manufactured in the continental United States.

And so, I don't expect tariffs to have an impact on what we might ultimately sell in the United States, but tariffs go both ways. And so, other countries applying tariffs broadly to medical products out of the United States could impact our reimbursement OUS, and the U.S. government saying they're only going to pay what others pay.

Who gets to pay the lowest is always a challenge, and I think that we are also involved in that discussion about what the pricing will be. And nicely, we price based on value. And so, in the CARDI-AXO therapy arena, there's been one reimbursed CARDI-AXO therapy at $124,000 U.S. per patient in Japan.

Now, I just shared we're trying to get the reimbursement that we have in the United States, which is closer to $20,000. We can have very large margins of $20,000, and frankly, I don't think any of the other CARDI-AXO therapy in development or even gene therapies in development are even considering a value pricing that low.

But for BioCardia, based on how we're doing CardiAMP, we actually think we can have greater than 90% margins at that price point. So, we think we can price on value, and we're not so concerned about those issues. But again, we're not as sophisticated as many of the folks on the street in Washington are on these issues.

We just -- we thought them through it a high-level one. Forgive the long-winded answer. I'm just trying to be very transparent on what our internal discussions have been..

No, that's great. I appreciate the info. All right. Thank you. Good luck..

Thank you..

And our next question comes from James Molloy with Alliance Global Partners. Please go ahead..

Hello. This is Laura Suriel on….

I'm sorry?.

Her line dropped..

Okay. No worries.

Why don't we wrap it here, Dave?.

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