Earnings Call Transcript - BCDA Q4 2025

Operator, Operator

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia Year-end 2025 Financial Results and Business Update Conference Call. 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 conference over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.

Miranda Benvenuti, Investor Relations

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 product 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 reports on Form 10-K filed with the SEC today, March 24, 2026. The content of this call contains time-sensitive information that is accurate only as of today, March 24, 2026. 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.

Peter Altman, CEO

Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's mission is to develop and enhance therapies to treat cardiovascular disease. We are doing this today with three primary platforms: our CardiAMP, autologous minimally processed cell therapy; our CardiALLO allogeneic off-the-shelf mesenchymal cell therapy; and our Helix transendocardial biotherapeutic delivery system, which is used by both our CardiAMP and CardiALLO cell therapy programs. Our lead program remains the CardiAMP cell therapy for roughly 1 million patients in the United States and 150,000 patients in Japan with ischemic heart failure of reduced ejection fraction. These are patients who've had coronary disease, may have had a heart attack, and have subsequently developed heart failure characterized by a larger dilated heart that unfortunately pumps inefficiently. Cardiac therapy includes CD34 and CD133 cells that have long been recognized as endothelial progenitor cells that promote new capillary formation. Preclinical data also provides support that these cells reduce fibrosis in the heart. Based on these mechanisms to effectively treat microvascular dysfunction, CardiAMP cell therapy is introducing a new therapeutic modality to the significant unmet need in ischemic heart failure that is primarily managed today by neurohormonal modulation. The clinical outcomes with this approach have been excellent. We now have complete and final data from three clinical trials of the CardiAMP therapy with the latest results from our Phase III CardiAMP HF trial presented as a late-breaking clinical trial at the Technology and Heart Failure Therapeutics Meeting this month. The presentation was titled 'Autologous Cell Therapy May Occur Pathological Ventricular Remodeling in Chronic Ischemic Heart Failure of Reduced Ejection Fraction Patients Selected for Favorable Cell Characteristics.' The key takeaway from these new results is in this title. The Cardiac HF echocardiography clinical results, which measure heart chamber sizes over time, by a truly blinded world-class echocardiography core laboratory, show reductions in left ventricular volume disease when the heart ventricle is fully dilated with a p-value of 0.06 and when the heart is fully contracted with a p-value of 0.09. For the prespecified subgroups of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful, greater than 20 milliliters per meter squared and 15 milliliters per meter squared, respectively, and statistically significant with a p-value of 0.02 and p-value of 0.01, respectively. This echocardiographic data further supports our previous results of reduced fatal and nonfatal major adverse cardiac and cerebrovascular events and improved quality of life in the treated patients. They are similarly strongest in the prespecified subgroup of patients having elevated biomarkers of heart stress. When considered together with the significant reductions in left ventricular end systolic volume, and left ventricular end diastolic volume in the treatment group versus the control group, these results provide a basis for linking intramyocardial mononuclear cell therapy with suppression of pathological ventricular remodeling and beneficial clinical outcomes. This trial result is also considered consistent with observations from other heart failure of reduced ejection fraction therapies showing an association between suppression of pathological ventricular remodeling and improvement in mortality. This data is consistent across all three of our clinical studies, which saw reduced major adverse cardiac and cerebrovascular events and improved heart function. I also note that two of these trials were randomized, double-blinded clinical trials, which provide the greatest scientific rigor and the least investigator bias to study outcomes. This is the data we will soon be discussing with the Food and Drug Administration in the United States and which we have been discussing with Japan's Pharmaceutical and Medical Devices Agency regarding potential for approval with the rigorous post-marketing studies to collect further evidence with respect to both safety and efficacy. We expect to soon submit the Q-sub request on approvability of the CardiAMP system to FDA Center for Biologics Evaluation and Research, based on the safety and compelling signals of patient benefits with elevated biomarkers of heart stress from our three clinical trials. This discussion is expected to focus on our already FDA-approved CardiAMP cell process platform to extend existing labeling from in vitro diagnostic use to a therapeutic indication for ischemic heart failure of reduced ejection fraction. The dedicated Helix transendocardial delivery catheter has a presubmission actively under review by FDA Center for Devices and Radiological Health. In Japan, we expect to soon have our formal clinical consultation to align with PMDA on the acceptability of the existing clinical data from our three trials to allow us to submit the CardiAMP system. If PMDA determines that existing clinical data is acceptable with respect to safety and efficacy, submission for Shonin approval would likely soon follow. BioCardia is not alone in seeking approvals to provide therapeutic options to these patients and the physicians who care for them today. Japan has recently granted conditional approval to another allogeneic cell therapy for ischemic heart failure that involves the placement of sheets of cells on the surface of the heart in a surgical procedure. A U.S.-listed company has announced that they will be filing for a biological licensing application for their allogeneic cell therapy to also treat patients in a surgical setting. We expect a third company will also soon be applying for approval for surgically delivered cells. The need here is great, and we wish each of these peers and potential future delivery partners every success ahead. In parallel to these efforts, to wrap up the CardiAMP HF trial and seek approvals based on this data, we have initiated the CardiAMP HF II confirmatory clinical study. CardiAMP HF II focuses on the patients who are the greatest responders in CardiAMP HF and applies all of our learnings regarding endpoint and trial design. In October and November, University of Wisconsin at Madison and Henry Ford Health System in Detroit, Michigan enrolled their first patients in CardiAMP HF II, respectively. Emory University in Atlanta, Georgia has also been activated as a study site. With Morton Plant Mease in Clearwater, Florida, there are four centers actively enrolling in this study today. If FDA supports an earlier approval, there is potential the trial design will be modified and become our post-marketing registry. There is also potential the CardiAMP HF II trial may benefit from the previous trial and a shorter pathway to approval may be identified. We will have clarity here soon. We have made progress on our CardiAMP cell therapy clinical program for chronic myocardial ischemia and for our CardiALLO allogeneic cell therapy for heart failure. The status of these efforts is in our earnings announcement today. There could be significant upside from these clinical efforts in the near term. We have four catalysts before us in the next quarter. First, the FDA CardiAMP Heart Failure Q-submission for approval pathway under breakthrough designation has been drafted and is under legal review. We are targeting submission as soon as possible. Second, we have a formal clinical consultation scheduled with Japan PMDA on approvability of CardiAMP cell therapy. Third, we have an FDA substantive feedback meeting scheduled on approvability of our Helix transendocardial delivery system via the de novo pathway. And fourth, we have an abstract on CardiAMP and chronic myocardial ischemia that has been accepted for oral presentation at EuroPCR in May.

David McClung, CFO

Thank you, Peter. Good afternoon, everyone. I'll now provide an overview of our financial results for the year ended December 31, 2025. Total expenses increased approximately 3% year-over-year to $8.3 million in 2025 compared to $8.1 million in 2024. The primary driver of this change, research and development expense, increased to $5 million in 2025 compared to $4.4 million in 2024. The 13% increase was primarily due to the cost of closeout activities in the cardiac heart failure trial, inception of enrollment in the CardiAMP HF II trial during the year, and regulatory activities to advance CardiAMP in Japan. We anticipate R&D expenses will increase modestly in 2026 as we continue advancing our therapeutic candidates in both the United States and Japan. Selling, general and administrative expenses decreased 10% in 2025 to $3.3 million compared to $3.7 million in 2024, primarily due to lower professional fees coupled with reduced share-based compensation expense. We expect 2026 SG&A expenses to remain close to these 2025 levels. Net loss increased modestly to $8.2 million in 2025 from $7.9 million in 2024. Net cash used in operations was approximately $7.5 million during 2025, down from $7.9 million in 2024. The company ended the year with cash and cash equivalents totaling $2.5 million, very comparable to the $2.4 million as of December 31, 2024. We expect our cash burn will be relatively consistent in 2026, continuing our track record for carefully managing the use of resources and capital. This concludes management's prepared remarks. We are happy now to take questions from attendees.

Operator, Operator

And the first question will come from Joe Pantginis with H.C. Wainwright.

Lander Egaña-Gorroño, Analyst

Hello, everyone. This is Lander on for Joe. 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 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?

Peter Altman, CEO

Thank you for the question, and I really appreciate your eye on the Echo data. So this data is remarkably good. And just to start off for everybody, typically, in these trials for all 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. The Core laboratory at Yale University is world-class. And so your question, Lander, 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 in Japan will not be for the full cohort, but will be for the subgroup with elevated NT-proBNP. This is a marker that's released when the heart is under stress. The patients we see 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-values of 0.02 and 0.1 for echo measures. 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, Lander, is this data is compelling to cardiologists who are trying to advance therapies for their patients. The patients we have treated are on guideline-directed medical therapy. So the patients in this trial have already been advanced on everything available to them that isn't extremely invasive, and they still are dying at a rate of approximately 10% per year. The big limit in heart failure is that nothing is changing mortality. 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. I think there'll be a lot of excitement in the cardiology community, and that translates into excellent enrollment in the CardiAMP Heart Failure II trial when we put our full weight behind it.

Lander Egaña-Gorroño, Analyst

Perfect. That's helpful. Yes. And do you have an estimate of the CardiAMP 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?

Peter Altman, CEO

For CardiAMP HF, we are, as I shared in my remarks, imminently going to file for a discussion on approvable pathways. 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 will be under a standard Sprint discussion, which I estimate is roughly a 45-day turnaround. If they’re supportive, it will take time for all of the details regarding a submission to be put forward. There are two approval pathways. Even though it is regulated by CBER, it is a device system. The approval pathway, again, CBER, the Center for Biologics Evaluation and Research, has both the PMDA and the de novo pathway. Because of the safety profile we see with CardiAMP, it could go down the de novo pathway, which is interesting. De novo is for devices that are safe. There are no safety issues that I'm aware of right now with respect to CardiAMP. If that's the door that's open and we pursue it, it could be a very short timeline and relatively straightforward to secure approval. However, if it's a PMA pathway, which has certain advantages, it could take a little longer. The key question for FDA and for Japan PMDA is whether this data is acceptable for safety and efficacy for market release. Regarding your second part of the question, post-marketing studies cannot have patients come in and not have an option for therapy; you can’t truly randomize. We would expect these to be relatively extensive studies on many hundreds of patients that we would follow over time. We will be collecting long-term survival data, potentially echo data, and potentially biomarker data. These measures are standard, and wouldn’t necessarily put an enormous undue burden on BioCardia. So that’s how we think about it. Clearly, it’s a partnership with the regulatory bodies to secure their support based on this data.

Lander Egaña-Gorroño, Analyst

Perfect. That makes sense. And you already talked about this a little bit, but how do you see CardiAMP HF competing or not with other cell therapies for heart failure that are currently in regulatory discussions?

Peter Altman, CEO

With respect to what I call the four pillars of therapy in heart failure, our patients are on guideline-directed medical therapy that is established. All of the patients in our CardiAMP HF and in our CardiAMP HF II 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. With the newer cell therapies that are seeking approval in the United States, they're all surgical delivery so far. I believe they've publicly expressed interest in pursuing different approaches for minimally invasive delivery, similar to our pursuits, 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 and cost-effective it is. At the same time, this is the nature of waves of therapy development. There will ultimately be head-to-head trials for different therapies, which is good for patients if they have different well-studied therapeutic options. From an efficacy perspective, I actually think CardiAMP therapy is amongst the most robust data out there. The magnitude of changes we’re seeing is compelling compared to all pivotal trials for guideline-directed medical therapy. The key is to continue collecting data for evidence of safety and efficacy, and things will evolve over time with no concerns about competitive issues. It’s great for patients to have several firms pursuing therapies because the need is enormous. In the United States, just in our indication, it’s 1 million patients.

Operator, Operator

The next question will come from James Molloy with Alliance Global Partners.

James Molloy, Analyst

I was wondering if you could talk a little bit about enrollment in the HF II trial. I know a few patients enrolled. Talk about how that's building, any anecdotal stories from the enrollment, the challenges they are facing or maybe the challenges you are facing? What sort of the best centers best practices are using to get folks into this HF II trial?

Peter Altman, CEO

Yes. Great question, Jim, and I really appreciate you being on the call. If you look at our updated corporate presentation that we just released, there are pictures of three clinical teams at these sites for CardiAMP HF II. We put those pictures in there, first off, because these centers do all the work, but second because you can see everybody's smiling after these procedures. That signals how well it's going as we’re doing these procedures and also the relationships around this work. Enrollment numbers right now, we haven’t detailed, but we are starting this enrollment slowly because almost all of our clinical team is focused on the enormous efforts in taking a Phase III trial data set through for regulatory submission. However, all of that is coming to a head. The beauty of this effort is that this data will drive enrollment ahead. As soon as we complete these conversations with PMDA and FDA, we’ll know whether or not the CardiAMP HF II trial should stay a randomized double-blind trial or migrate to a potentially open-label post-marketing study. If it stays a randomized trial, our team will have the strength of this data set which will help with enrollment. Several sites are interested in getting involved in the study. Our bandwidth is why it hasn't gone faster, but that will come soon. I hope that answers your question, Jim.

James Molloy, Analyst

It does indeed. And then maybe moving over to the CMI. We're looking for the 6-month data here at EuroPCR in Paris in May. What should we be looking for as that data comes rolling out?

Peter Altman, CEO

I think the data is as we’ve shared sort of top line. You’ll get more visibility into the physician and patient experience in that trial. The interesting thing about the CMI trial is right now, there aren't many options for patients with CMI. We’re not driving forward aggressively in enrolling the randomized portion of that trial now; we’ve put it on pause to focus on the heart failure program. However, from a business development perspective, it effectively doubles the market potential of CardiAMP HF. If we had resources, we could push the CardiAMP CMI trial all the way through its pivotal cohort. Those are some things we discuss in business development settings.

James Molloy, Analyst

And how would you characterize the environment for potential partnerships currently?

Peter Altman, CEO

That's a big question. Right now, there's a lot of folks focused on different things. I think in the past, we've been quite forthcoming on all the conversations we have regarding our various assets and platforms. I believe with the first cardiac cell therapy approved in Japan on the 19th of February, this is still pretty new for all the business development folks who are used to looking at years of runway with cash flow. I think there will be great interest. CardiAMP CMI's interest will primarily be driven by the interest in CardiAMP HF. My sense is that with CardiAMP HF on a path to potential early approval in the U.S. or Japan, there will be heightened interest and support in CardiAMP CMI.

Operator, Operator

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

Peter Altman, CEO

Thank you, Nick. Our efforts advancing our cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. Our base plan remains to complete the confirmatory CardiAMP HF II trial while we engage with the FDA and PMDA on potential near-term approvals. On behalf of our entire BioCardia team, I thank all shareholders for their continued support as you make our efforts possible. Thank you.

Operator, Operator

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