BioCardia Inc (BCDA) 2025 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia firsIt quarter financial results and business update conference call. (Operator Instructions) Participants on 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 leadership team are: Peter Altman, President and Chief Executive Officer; and Dave 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 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 sequentially filed reports on Form 10-Q.

The content of this call contains 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.

Thank you, Miranda. Good afternoon to everyone on the call. In March of this year, the CardiAMP heart failure trial results demonstrated both safety and meaningful benefits of CardiAMP cell therapy for heart failure patients who still have elevated biomarkers of heart stress despite being on maximal guideline-directed medical therapy.

This therapy has potential to have a positive impact on the enormous unmet clinical need for approximately 1 million Americans with heart failure expected to have a 10% mortality per year. Our top priority this second quarter of 2025 and is all about sharing this data with the Food and Drug Administration and Japan's Pharmaceutical and Medical Device Agency to align on pathways to make this therapy available for physicians and their patients as well as sharing this data with the broader clinical community in more detail in the form of a pure manuscript.

We are also continuing to gather evidence to support the therapy and the CardiAMP heart failure II trial is actively enrolling patients at three clinical sites. This trial has a similar design with some important changes intended to confirm the resources we have from this therapy and also result in enhanced enrollment. We expect this trial to be fully enrolled over the next two years and have a primary readout when the last patient reaches their one-year follow-up endpoint.

This past quarter, final data from the last roll in cohort patient in the CardiAMP cell therapy and chronic myocardial ischemia trial or BCDA-02 became available, and we are working towards both scientific presentation and publication of this data. We have also had a successful Data Safety Monitoring Board review of the safety outcomes in the low-dose cohort in our CardiALLO allogeneic mesenchymal stem cell therapy in ischemic heart failure or BCDA-03.

The absence of any adverse events in these very ill patients was great news to confirm for this off-the-shelf therapy. On the Helix biotherapeutic delivery partnering front. We are actively preparing for submission for approval of this product, which is expected to be valued by therapeutic partners. Helix has potential to be the first approved transendocardial biotherapeutic delivery system in the United States because of the CardiAMP heart failure data.

We continue to be focused on partnerships where our contribution to the success of partners will reward our shareholders. One element of the Helix delivery system is our proprietary FDA-approved morph DNA steerable introducer platform. We are continuing to detail its advantages to physicians and partners who may benefit from these products.

The largest market procedures are in cardiac electrophysiology for our transseptal Avance product, but just yesterday, a procedure was detailed in the superior mesenteric artery, which would be a peripheral procedure. On the business development front, we believe partnering can create meaningful value for shareholders with respect to each of our four platforms. 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 by 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 wish to 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-sealing helical pathway into the tissue. On the more 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, transaorta 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 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 3 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, $2.7 million in Q1 2025 compared to $2.3 million 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.

(Operator Instructions) Joe Pantginis, HC Wainwright.

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 the levels of maturity. And I'm sure it's wide ranging.

Wow, yes, it -- 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 in the next day and literally 18-months later, it wasn't done. For example, the publicly-traded company, CareDx, which has a market cap of $1.8 billion. That financing took 18 months to close.

And it takes a long time, even in a final steps. But sometimes you 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 guided folks to that this would be a long process as physician in 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 it's -- 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 ecolectrophysiology market, it's an enormous market that's growing at 30% per year and the 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 (technical difficulty) Helix side Joe, we'll walk through. Helix is needed for biotherapeutic repartnering? 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 hard seat. And we wish him well and we like their strategy.

There cracking people's chests to deliver the cells intramyocardial. 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 had an 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 more sensitive places to go, and we're having manufacturing relatively well dialed in. We comped some really nice advances on how to manufacture these cells in a small foot of manufacturer 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 of $800,000 per treatment by Mesoblast and by Healios in acute respiratory distress where we 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 CardiAMP 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 color, it surely sounds like you're very busy with this. 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 US opportunities, but I think the -- an unsung opportunity and focus is Japan. And you've talked a lot about this.

So if the Japan PMDA allows you to submit the CardiAMP 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 of BLA. And what do you feel as the importance of that inflection point in how it might get to the market in Japan.

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 or 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 will start slowly in Japan, but I do think that the value proposition for BioCardia is enormous. I note we have two peers in Japan. I mentioned Heartseed earlier, and I have a lot of respect for Heartseed in 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, C-U-O-R-I-P-S.

They are delivering cells to the surface of the heart, again, through an open chest surgical procedure. I don't -- not a big fan of their strategy, I must -- but their efforts -- they're going after approval in Japan based on eight patients treated total. And I note that it took them many, many years to get those eight patients as 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 deliver 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 and 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.

Chris (technical difficulty), private investor.

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 is a potential pathway to approval. So it's kind of like you have -- 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 it's primary end point. And so that does introduce really significant risk on the approval pathway ahead.

And we have built this heart failure in the United States in CardiAMP, the investigators have the data before them, which excites them. So that will help us on enrollment ahead. And remember, the CardiAMP HF I and HF II, are both reimbursed today by Medicare. 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, and we will generate additional data. It's focusing in on the paper where the greatest responders in CardiAMP HF. There are a couple of 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 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 included 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 the very similar composite endpoint, which is the 3-tier Finkelstein Schonefeld 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-question.

And the beauty of that change is that's not an assay or assessment, if you will, that is effort-based. Everybody will complete the same every time. And CardiAMP HF, we had patients fall out because they hurt their need. 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 HF II, 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 1:1 randomization. So we're hopeful they'll completely enroll it in two 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 up. 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 that -- I know it's very new, but --

No, I'm tracking. It's the most favorite nation status that folks are based on most. And the answer to that is no today. So right now -- so 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 reimbursement. So we're trying to turn that equation around if you will.

We'd like other companies be signing up to that US 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 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 US.

And the US government is saying they're only going to pay what others pay. It's -- 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 cardiac cell therapy arena, there's been one reimbursed cardiac cell therapy at $124,000 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. And we can have very large margins at 20,000. And frankly, I don't think any of the other cardiac cell 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 at a high level. And forgive the long-winded answer, I'm just trying to be very transparent on what our internal discussions have been.

Laura Suriel, Alliance Global Partners.

This is Laura Suriel on --

I'm sorry?

Her line dropped.

Why don't we wrap it here, Dave?

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