BioCardia, Inc. Q4 FY2025 earnings call

Biocardia's mission is to develop and enhance therapies to treat cardiovascular disease with three primary platforms: CARDI-AMP autologous minimally processed cell therapy, CARDI-ALO allogeneic off-the-shelf mesenchymal cell therapy, and Helix transendocardio-biotherapeutic delivery system. Lead program is CARDI-AMP cell therapy for ischemic heart failure patients. Have complete and final data from three clinical trials of CARDI-AMP therapy, including phase three CARDI-AMP HF trial with echocardiography data showing reductions in left ventricular volume disease. Initiated CARDI-AMP HF2 confirmatory clinical study. Progress on cardiac cell therapy clinical program for chronic myocardial ischemia and cardiallo-allogeneic cell therapy for heart failure. Four catalysts in next quarter: drafting FDA cardiac heart failure Q submission for approval pathway under breakthrough designation, formal clinical consultation with Japan PMDA on approvability of cardiac cell therapy, FDA substantive feedback meeting on Helix Transfrontal Cardio Delivery System via de novo pathway, and abstract on cardiamp and chronic myocardial ischemia accepted for oral presentation at EuroPCR in May. Total expense in 2025 was $8.3 million, research and development expense increased to $5 million, selling, general, and administrative expenses decreased to $3.3 million, net loss increased to $8.2 million, net cash used in operations was approximately $7.5 million, ended the year with cash and cash equivalents totaling $2.5 million

Expect cash burn to be relatively consistent in 2026, continuing to carefully manage use of resources and capital. Anticipate R&D expenses will increase modestly in 2026 as continuing to advance therapeutic candidates in US and Japan. SG&A expenses expected to remain close to 2025 levels

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

A: Thank you for the question. And I really appreciate your eye on the echo data. So this data is remarkably lovely data. So I'll start off for everybody. Typically in these trials, for all of these therapies, very few companies have long-term, truly blinded echo data. It's a very rare thing, and we have it in this trial. And the core laboratory at Yale University is world-class. And so your question, Landerone, was across all patients, the p-values are not statistically significant, but they're approaching it. But to even see that kind of trend is wonderful. So our expectation is that our approvals, both in the United States and internationally, in Japan will not be for the full cohort, but will be for the subgroup with elevated NT-proBNP. And because those patients, NT-proBNP is a marker that's released when the heart is under stress. And so when you have high stress in the heart, it continues to dilate. And so what we're seeing is that most patients who are decompensated and are continuing to dilate, the mononuclear cell therapy appears to stop that process. So that's what's exciting about this data. So we see it across the full population with a p-value just above the key 0.05 threshold. But in the subgroup, we're looking at p-value of 0.02 and 0.01 for echo measures. And these are large magnitude changes that were presented at the THT conference. Another value proposition above and beyond just talking to regulators with respect to this data on their own is this data is compelling to cardiologists who are trying to advance therapies for their patients. And the patients that we have treated are on guideline directed medical therapy. So the patients in this trial have already been advanced on everything that's available to them that's not extremely invasive. And they still are dying at a rate of approximately 10% per year. The big lament in heart failure is that nothing is changing mortality. And here we're seeing a therapy that not only appears at a high level to be reducing mortality in MACE, but it's also showing these changes in left ventricular volumes that have a long history of being correlated with reduced mortality as well. So I think there'll be a lot of excitement in the cardiology community, and that will translate into excellent enrollment in the CARDI-AMP Heart Failure 2 trial when we put our full weight behind it.

Q: And do you have an estimate of the CARDIAM submission to the FDA if everything goes according to plan? And how are you thinking about the potential requirements for post-marketing studies and their execution?

A: For CARDIAM-HF, we are, as I shared in my remarks, we're imminently going to file for a discussion on approvable pathways. So they already have all of the data from the trial. We will be providing other analyses that have been done, but that's imminent. I expect the timeline will be, because this has FDA breakthrough designation, it'll be under a standard sprint discussion, which I estimate is roughly a 45-day turnaround. And then the subsequent, you know, if they're supportive, it will take time for all of the details regarding a submission to be put forward. And there's two approval pathways. Even though this is regulated by CBER, it is a device system. And so the approval pathway, again, CBER, the Center for Biologics Evaluation Research, the device pathway has both the PMA and the de novo pathway. And because of the safety profile we see with CardiAmp, it actually could go down the de novo pathway. which is really interesting. De Novo is for devices that are safe. And there's no safety issues I'm aware of right now with respect to Cardia. So if that's the door that's open and we decide to pursue it, it could be a very short timeline and relatively straightforward to secure approval. But if it's a PMA pathway, which has certain strategic advantages, it could be a little longer. The key question for FDA and for Japan PMDA is, is this data acceptable for safety and efficacy for market release? Now, your second part of the question, Landa Rohn, was how do you think about the post-marketing study? So post-marketing studies, you cannot have patients come in and not have an option to therapy. You can't truly randomize. So we would expect these to be relatively extensive studies on many hundreds of patients that we would follow over time, and we would be collecting long-term survival data, potentially echo data, potentially biomarker data. It's something to be discussed with respect to the agency's guidance on this from each area. Those measures I just identified are standard measures, so it wouldn't necessarily put an enormous undue burden on biocardia, echo measures and NT-proBNP measures and understanding survival could be done relatively cost-effectively in an open-label setting. So that's how we think about it. Clearly, it's a partnership with the regulatory bodies on their past experience, and securing their support based on this data is really the focus.

Q: And you already talked about this a little bit, but how do you see cardiomepages competing or not with other cell therapies for heart failure that are currently in regulatory discussions?

A: With respect to what are called the four pillars of therapy in heart failure, the patients, that's guideline-directed medical therapy that's established, All of the patients in our CARDI-AMP HF and in our CARDI-AMP HF2 trial are already on guideline-directed medical therapy. So it's not instead of, but really it's in addition to, and we're seeing these benefits in addition to. With the newer cell therapies that are seeking approval in the United States, they're all surgical delivery so far. I believe that they've all expressed interest publicly on pursuing medical different approaches for minimally invasive delivery such as we are pursuing and we could be helpful to them there. I see the competitive landscape as one where at the end of the day, I think Cardiamp will always remain one of the leading therapies because of how straightforward it is and how cost effective it will be. At the same time, you know, this is the nature of waves of therapeutic development. There will ultimately be head-to-head trials for different therapies, and it's good for patients if they have different therapeutic options and they're well-studied. My sense is, from an efficacy perspective, I actually think the cardi-amp therapy is amongst the most robust therapeutic data that's out there. If you look at the magnitudes of changes we're seeing compared to all of the pivotal trials for the guideline directed medical therapy, the magnitudes are compelling. And so, you know, it's going to be interesting. I think the key thing is to continue to collect data for evidence of both safety and efficacy. And like all great therapies, you know, things will evolve slowly over time. But I'm not concerned about the competitive issues. I think it's great for these patients that there's a number of folks pursuing therapies because the need here is enormous. In the United States, just in our indication, it's a million patients. So that's how we see it.

Q: Hey, guys. Thank you for taking my questions. I was wondering if you could talk a little bit about the enrollment in the HF2 trial. I know you have a few patients enrolled. Talk about sort of how that's building, any anecdotal sort of stories from the enrollment, the challenges they're facing, or maybe the challenges you aren't facing, and what sort of the best centers, best practices are using to sort of get folks into this HF2 trial?

A: Yeah, no, great question, Jim, and I really appreciate you being on the call. So if you actually look at our updated corporate presentation that just came out a little while ago, we have pictures of three of the clinical teams at these sites for CARDI-AMP HF2. And we put the pictures in there, first off, because it's really these centers that do all the work. But second, because you can see everybody's smiling after these procedures. And that's a signal of how well it's going as we're doing these procedures and also the relationships around doing this work. Enrollment numbers right now, we haven't detailed, but we're starting this enrollment slowly because almost all of our clinical team is focused on the efforts, enormous efforts in taking a phase three trial data set, through for regulatory submission. But all of that is coming to a head. And the beauty of this effort is that that data will be a primary driver in enrollment ahead. So our expectation is as soon as we complete these conversations with PMDA and FDA, we'll know whether or not the CARDIAP-HF2 trial should continue to be a randomized double-blind trial or should be migrated to um a potentially open label post-marketing study and that impacts you know our efforts and second you know if it stays a randomized trial our team will have the the strength of this data set which will um help on the enrollment side so we have we have quite a few sites that are interested in getting involved in the study it's it's primarily a bandwidth and a resource uh basis for why that has not gone faster, but that will come soon ahead. So I hope that answers your question, Jim.

Q: And then moving over to the CMI, we're looking for the six-month data here at the EuroPCR in Paris in May. What sort of good, bad, equivocal, which would we be looking for as that data comes rolling out?

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

A: That's a big question. Right now there's a lot of folks focused on different things. I'll keep you posted. I think in the past we've been, you know, rather forthcoming on all the conversations we have with respect to our various assets and platforms. And I think what will happen, Jim, is – With it, the first cardiac cell therapy approved in Japan on the 19th of February. This is still pretty brand new stuff for all of those folks in business development who are used to looking at years of a runaway with cash flow. I think there will be great interest. I think the interest in Cardiamp CMI will primarily be driven by the interest in Cardiamp HF. And my sense is with CardiAmp HF on a path to potential an early approval in the U.S. or in Japan, there will be great interest and support in CardiAmp CMI as well as in Cardio.