BioCardia, Inc.

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 Pato 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 BioCardio'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 BioCardio's expectations for future performance and operational results, references to management's intentions, beliefs, projections, book 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, 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. And good afternoon to everyone on the call. In March of this year, the CARDI-AMP heart failure trial results demonstrated both safety and meaningful benefits of CARDI-AMP 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 currently expected to have a 10% mortality per year. Our top priority this second quarter of 2025 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 peer-reviewed manuscript. We are also continuing to gather evidence to support the therapy, and the cardiac heart failure two trial is actively enrolling patients at three clinical sites. This trial has a similar design with some important changes intended to confirm the results 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 Roland cohort patient in the cardiac cell therapy and chronic myocardial ischemia trial, or BCDA02, 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 cardi allogeneic mesenchymal stem cell therapy in ischemic heart failure, or BCDA03. 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 trans-endocardial biotherapeutic delivery system in the United States because of the CARDI-AMP heart failure data. We continue to be focused on partnerships where our contributions to the success of partners will reward our shareholders. One element of the Helix delivery system is our proprietary FDA-approved MorphDNA 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 transeptal 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, Cardialo, Helix, and MorphDNA. For CardiAmp cell therapy business development, we expect the final data from CardiAmp part failure and clarity on anticipated approvals ahead to enhance interest by distribution partners and strategics. For cardi-allo 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 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 three-fold efficiency of delivery and the enhanced pharmacokinetics with our Helix system supported by data from many groups. We believe this advantage underlies our positive cardiac heart failure data and is due to the stability of the Helix in the beating heart and the cell-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 180 degree turn of the catheter system regardless which route of access is required, trans-aorta or trans-mitral and down through the mitral valve. Our morphed 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 CARDI-AMP HF results and request consultation with FDA and Japan PMDA. Two, activate multiple sites in CARDI-AMP Heart Failure 2 and drive enrollment in this trial. For BCD02, we intend to deliver top-line data in the rolling cohort. And lastly, for BCD03, we're going to complete the next dosing cohort ahead. After the end of 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 David McClung, our CFO. we'll review our first quarter 2025 financial results. David.

Thank you, Peter. Good afternoon, everyone. I will now review highlights of our financial results for the quarter ended March 31st, 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 cardiac heart failure trial coupled with the inception of enrollment in the new cardiac heart failure two 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 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.

At this time, we will now begin the question and answer session. To ask a question, you may press star then one on your touchpad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star one, then star two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Joe Hansgenis with HC Wainwright. Please go ahead.

Hey, 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 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. Yeah. Um, it's, uh, 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, uh, and literally 18 months later, it wasn't done. For example, you know, the publicly traded company care DX, which has a market cap of 1.8 billion, that financing took 18 months to close. Um, 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, you know, the Morph Axis 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 all of them. Helix, you know, 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 HeartSeq. And we wish them well, and we like their strategy. They're cracking people's chests to deliver the cells intramyo-partially. 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 You know, 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 more sensitive places to go, and we're having manufacturing relatively well dialed in. We've come up with 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 the United States. acute respiratory distress where, you know, 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 cardiac front, you know, 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, you know, 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. No, I appreciate that, Colin. 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 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, you know, 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 time frame. on the outside to have clarity on, you know, 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 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, you know, 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, 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'm not a big fan of their strategy, I must say. But their efforts, you know, 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, much as it took Heartseed many, many years to get their 10 patients. Here we are with roughly 200 patients in the cardiac cell therapy trial. including two randomized placebo-controlled trials, minimally invasive delivery, and 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 BioCardi 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 appreciate all the color, Peter.

Thank you, Joe.

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

Hello. Hi, Peter. How are you? I'm doing well, Chris. Great. My question pertains to the BCDA01, 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, you know, we know that we had a great clinical trial that we just reported, but it did not hit its primary point. And so that does, you know, introduce really significant risks in the approval pathway ahead. And we have built this heart failure network in the United States in CARDI-AMP-HS. The investigators have the data before them. which, you know, excites them. So that will help us on a moment ahead. And remember the CAR-DF, 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 and we will generate additional data It's focusing in on the patients who are the greatest responders in cardiac HF. There are a couple other subtleties that we're weaving into the trial. We are using our new MorphDNA 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 MorphDNA. So just so you can appreciate how the physicians are responding to that. We also have a strategy woven into cardiac heart failure 2 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 cardiac heart failure 2 than we include in cardiac heart failure. And so that's going to be a nice aspect of it. And lastly, cardiac heart failure 2 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 questionnaire. 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 it 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 HF2. 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'll hopefully completely enroll it in two years.

Gotcha. 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 based on most favored nation status. And the answer to that is no today. So right now, so on the most favored nation, we are not actively selling Cardi Amp 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 would 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-Apso clinical cells in the facility I'm standing in here in Sunnyvale, California. The Cardi-Amp 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, you know, tariffs go both ways. And so, other countries, you know, applying tariffs broadly to, you know, medical products out of the United States, you know, could impact our reimbursement OUS. you know, the US government saying they're only going to pay what others pay. You know, it's, it's, you know, who gets to pay the lowest is always a challenge. And I think that, you know, 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 US per patient in, 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 cardiac cell therapy in development or even gene therapies in development are even considering a value of 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, uh, 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, you know, 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 Malloy with Alliance Global Partners. Please go ahead.

Hello, this is Laura Suriel.

I'm sorry? Her line dropped. Okay. No worries.

Why don't we wrap it here, Dave?

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