BioCardia Inc (BCDA) 2025 Q3 法說會逐字稿

Good afternoon, and welcome to the BioCardia third-quarter financial results and business update conference call (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. 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 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, November 12, 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. This has been another quarter of solid accomplishment for BioCardia as we have been working on regulatory submissions on the strength of our clinical data for CardiAMP cell therapy for the treatment of ischemic heart failure of reduced ejection fraction and for our Helix transendocardial delivery system as well as advancing the CardiAMP Heart Failure II clinical study.

Today, I will provide brief updates on our active clinical programs and progress on our Helix Biotherapeutic Delivery System and Heart3D Fusion Imaging. On BCDA-01, our CardiAMP autologous cell therapy to treat microvascular dysfunction for the treatment of ischemic heart failure, which has potential to help roughly 2 million ischemic heart failure patients with New York Heart Association Class II and III symptoms.

Many of these patients have a prognosis worse than many cancers and few remaining options. This places a terrible burden on patients, their families and the health care system. The CardiAMP cell therapy selects patients based on the nature of their marrow cells, which are then harvested, processed and delivered to the heart in a single procedure.

The CardiAMP system has received FDA breakthrough designation based on our clinical results, and we now have three remarkably consistent clinical trial results, demonstrating promise for the treatment of these patients. Even as we are actively enrolling in the confirmatory CardiAMP Heart Failure II clinical study, we are having discussions with the FDA and PMDA on the approvability of the CardiAMP system for these patients.

In this third quarter, we announced a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency, or PMDA. We have since responded to all questions from this meeting and anticipate our next consultation with PMDA soon, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.

Japan has a strong interest in heart failure therapies due to its aging population, the limited use of heart transplantation and left ventricular assist devices due in part to cultural issues and Japan's PMDA has approved other cell therapies, including for heart failure.

Our CardiAMP cell processing platform is approved in Japan for orthopedic applications, which makes our Helix catheter system the only new product to be introduced with good performance in more than 400 clinical procedures. In parallel, we anticipate requesting a meeting with the FDA on the approvability of the FDA-designated breakthrough CardiAMP system based on our clinical data in the fourth quarter of 2025.

The CardiAMP Heart Failure II confirmatory Phase 3 250-patient randomized placebo-controlled trial is starting to accelerate now that staff is coming off the enormous effort of closing up the CardiAMP-HF study. Four centers are actively enrolling, three have randomized their first patients and additional centers are actively being onboarded.

The CardiAMP HF II study uses a similar 3-tier composite primary outcome measure to the CardiAMP-HF study consisting of all-cause death, nonfatal major adverse cardiac events and a validated quality of life measure. In both our Phase II TAC-HFT Study and Phase 3 CardiAMP-HF study, both randomized double-blind, placebo-controlled studies. This CardiAMP HF II composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBN, who are the focus of the CardiAMP HF II study.

CardiAMP Heart Failure II trial advances include using the cell population analysis and screening to define treatment dose and improvements to the Helix system, including our FDA-approved Morph DNA steerable guide platform. These advances are expected to enable more patients to qualify for the therapy, enhance the ease of enrollment and improve physician control during the interventional cell therapy procedure.

CardiAMP HF II is supported by the Center for Medicare and Medicaid Services with reimbursement for both treated and controlled patients. In addition to the potential for approvals based on existing data, we are pursuing pathways to fund this study to completion. BCDA-02 is our second indication for this therapy, the CardiAMP cell therapy in chronic myocardial ischemia.

The top line primary outcomes from the open-label rolling cohort of the CardiAMP cell therapy in chronic myocardial ischemia trial show patients experienced increased exercise tolerance of an average of 80 seconds with an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment.

60% of the patients showed substantial improvements in both measures. The minimally invasive therapy was well tolerated with no treatment-emergent major adverse cardiac events. We are preparing results for scientific presentation and publication. The promise of these results suggest that the opportunity to positively impact patient lives may be double that of the ischemic heart failure indication we are pursuing as our lead program.

BCDA-03 is our second therapeutic platform, our CardiALLO allogeneic mesenchymal stem cell therapy. This off-the-shelf cell therapy is manufactured at BioCardia and is being advanced in the first prospective trial focused on inflammatory ischemic heart failure of reduced ejection fraction. We believe this program is well positioned for near-term nondilutive funding to complete the Phase I/II 39-patient trial.

The results of this trial, if in line with our previous experience in the 30-patient dose escalation TRIDENT study are expected to enable submission for conditional approval in Japan. We expect clarity on the anticipated nondilutive funding in the first quarter of 2026.

On the Helix agent delivery front, we have completed an update to our master file for this delivery device, which supports our therapeutic agent programs and those of therapeutic agent partners. We are actively preparing a de novo 510(k) submission based on the strength of our clinical data.

This Helix submission and anticipated approval of our low-risk agent delivery device should enhance support of regulatory agencies for the CardiAMP programs as the CardiAMP cell processing is already approved in the United States, the European Union and Japan for other indications.

Related to biotherapeutic delivery, in August, we announced our partnership to develop and commercialize Heart 3D fusion imaging for biotherapeutic delivery and cardiac biopsy with CART-Tech, a Netherlands company developing enhanced real-time fusion imaging solutions for interventional procedures. Together, we have already realized promising results for Heart 3D fusion imaging in animal studies using both MRI and CT imaging and intend to advance to the clinic in 2026.

Looking forward, we have updated our milestones in our press release today. For BCDA-01, our CardiAMP autologous cell therapy in heart failure, we expect Japan PMDA clinical review in Q4, FDA meeting request on approvability also in Q4 and a manuscript published in Q1 with CardiAMP Heart Failure II enrollment continuing. For BCDA-02, CardiAMP autologous cell therapy in chronic myocardial ischemia, we are seeking peer-reviewed publication of the positive results in Q1 2025 -- 2026, excuse me.

And for BCDA-03, CardiALLO allogeneic mesenchymal stem cell therapy in heart failure, we anticipate nondilutive funding coming together in the first quarter of 2026. For our Helix Biotherapeutic Delivery System, we anticipate FDA submission for approval in the fourth quarter of this year.

I will now pass the call to David McClung, our CFO, who will review our third quarter 2025 financial results. David?

Thanks, Peter, and good afternoon to everyone joining us. For the third quarter of 2025, research and development expenses increased to $936,000 from $931,000 in the third quarter of 2024 and also increased to $3.8 million in the nine months ended September 2025 from the $3.0 million in the nine months ended September 2024.

The increases were driven by the closeout for the CardiAMP Heart Failure study, including statistical data analysis and new enrollment in the subsequent CardiAMP Heart Failure II trial, coupled with regulatory activities in support of potential approvals. We anticipate R&D expenses will increase modestly in 2026 -- year-over-year -- sorry, 2025 year-over-year as we continue advancing our therapeutic candidates in the United States and in Japan.

Selling, general and administrative expenses decreased to $0.6 million in the third quarter of 2025 compared to $0.8 million for the third quarter of 2024, primarily due to lower compensation expense. Selling, general and administrative expenses decreased to $2.4 million during the nine months ended September 25 as compared to $2.8 million for the nine months ended September 2024, primarily due to lower professional service fees, coupled with lower share-based compensation expense. We expect 2025 SG&A expense to track close to the 2024 levels year-over-year.

Our net loss was $1.5 million for the three months ended September 2025 compared to $1.7 million for the three months ended September 2024, and it was $6.2 million for the nine months ended September '25 compared to the $5.5 million for the nine months ended September 2024.

Net cash used in operations during the third quarter of 2025 decreased to $1.5 million compared to $1.7 million for the third quarter of the prior year. Net cash used in operations for the nine months ended September 2025 decreased to $4.9 million as compared to $5.5 million for the nine months ended September 2024.

The company ended the quarter with $5.3 million in cash, reflecting both the $6 million September financing and 304,000 shares of stock sold during the quarter under the company's ATM program. Cash currently on hand is expected to provide runway into the second quarter of 2026 without additional financing.

This concludes our prepared remarks. We're happy now to take questions from attendees.

(Operator Instructions)

Joe Pantginis, H.C. Wainwright.

Hello, everyone. This is Lander on for Joe. So for the CardiAMP CMI data announced in September, could you please clarify, Peter, how many patients were part of this data set? And how are these results incremental to the initial four patient rolling cohort data presented in April last year? Thank you.

Appreciate the question, Landon. The CardiAMP CMI data contains the five patients that have been enrolled at their primary endpoint out to six months. We have additional longer-term follow-up data. And the key takeaway is that the results in this open-label rolling cohort are pretty compelling relative to what has been out previously. It is a modest increase in data, but that rolling cohort is now completed, and we're wrapping it up for submission for publication.

Okay. Perfect. So you're wrapping it up with five patients total, right, for the rolling cohort, open-label?

Correct. Correct. And the CardiAMP CMI study benefits from the extensive clinical experience we have in the CardiAMP ischemic heart failure trials. Fundamentally, to advance in this indication, the rolling cohorts goal is fundamentally to see are there signals that we can observe that are compelling? Are there any safety issues that are not expected?

And so the trial design is actually designed as a trial for approval with the rolling cohort. So we have updated the FDA on all the experience, and it is well positioned to go forward, although resources will have us focusing on the CardiAMP HF II program because we see it as much closer to market in the near term.

Perfect thank you very much this is helpful.

Thanks. Appreciate the question.

Thank you.

James Molloy, Alliance Global Partners.

Hey guys, thank you very much for taking my questions. I was wondering if you could walk through -- I know you have three patients in four centers enrolling. Can you walk through any anecdotal stories on how recruitment is going and what the challenges or not challenges to get the patients in that trial that the docs are seeing out there?

Well, Jim, thank you for the question. The status of CardiAMP Heart Failure II is that it's coming along actually rather smoothly. The enrollment is easier in this trial because of our use of the cell population analysis to essentially set dosage where patients previously might have been excluded.

The FDA has blessed an approach where we can modify the dosing in patients who had fewer cells available to essentially increase the dosing. And so as far as challenges that we have, there's no real challenges. In fact, this is going to be relatively straightforward based on the experience we have.

I think our fundamental challenge, Jim, is just resources and bandwidth. We are completing a Phase 3 trial, wrapping that data set up for a manuscript for the FDA and for the Japan PMDA. And so as I'm sure you can expect, all of the clinical data gets woven through that, and we have a relatively lean team. That same team is doing that work.

So that is being essentially closed up now. All those projects are pretty much all the work is done. And so as you've seen in recent weeks, centers will be treating their first patient and we'll be moving forward. We've actually treated more patients than you've alluded to.

And the way this works for the patient, there is a delay in the time that a patient -- from the time that they are randomized -- or excuse me, from the time that they are screened until the time that they are actually complete the baseline measures because we have built into this trial something a delay actually to address the Hawthorne effect.

And the Hawthorne effect is a process where as soon as a patient is observed, they begin to change their behavior. They -- if they're on meds and they haven't been taking them, they start taking their meds, for example.

And so as soon as a patient is consented for the trial, we do some preliminary measures to make sure they're likely to qualify. And then we essentially observe them for a month before we then advance them to care. So the patients that you're seeing treated in recent press releases and these centers getting started up have been in the queue for a very long time. And so you'll start seeing more patients coming through the queue. I think the challenges in enrollment are this is still a larger trial, it's 250 patients.

We do benefit from Medicare reimbursement for both treatment and control patients. The trial is overpowered. And so I think what we'll see ahead as the team comes off these big initiatives we have to pursue pathways to approval in the United States based on the existing data and in Japan based on the existing data, this trial will be accelerating.

Of course, the conversations with Japan PMDA and with FDA may change some of our prioritizations here as well. So these are all interwoven into really a fundamental concept is that we have some really nice data -- the Phase I data, the Phase II data and the Phase 3 data are all consistent and support safety and benefit from our perspective.

That is a shared perspective from other parties. Is it sufficient for us to actually secure an approval is to be determined. But that strength of that data underlines our enthusiasm for CardiAMP Heart Failure II as well as well as that of the physicians.

So all of the physicians involved in CardiAMP Heart Failure I are continuing with CardiAMP Heart Failure II. And this is not just the Executive Steering Committee, but the physicians on the Data Safety Monitoring Board and the physicians on the Clinical Events Committee. So everybody was positive and supportive of this subsequent trial and is excited to see what the outcomes will be. The enrollment will come at pace. And just -- it's resource-driven primarily.

There's no extra hurdles or unusual issues. In fact, I would say now that we've completed CardiAMP-HF I, the second trial is much, much easier for us to do.

Thank you. My apologies, did I mishear on the prepared remarks that you said you had four centers enrolling and three of them had their first patients enrolled?

That's correct, but some of them have had more than one patient enrolled, Jim.

I'm sorry, what do you -- have said what the current count is?

We're not sharing current count as we go. We're just -- we will announce as each site does their first patient and just to basically to acknowledge the efforts to get there and to help them in with their communication to their colleagues and peers on enrollment, but we're not going to give a blow-by-blow this many patients this week, these many patients next week.

Understood. Makes sense. And then maybe last year you said in the first quarter, you guys were very sort of clear that you're going to complete a nondilutive funding in first quarter '26 for BCDA-03. Is there a partnership or something lined up that is expected to close first quarter '26?

Yes. So what we have is we actually have some federal grant funding, assuming the federal government opens up. And there are some nuances to it, but we've had some really interesting conversations with the NIH, and we're expecting the NIH to step up and fund this program because of -- not just because of their enthusiasm for the data in this clinical indication of these cells at this very high dosage we're delivering, but also because of some of the things that are under the hood, shall we say.

And so yes, so right now, I put that handicap on that. Nothing is guaranteed, but I put it as a high probability that will come through. And that program will be fully funded to go forward. Our team, it's what we do. And so it's basically going to be turning the crank, running another trial in parallel to CardiAMP HF II, but that trial will be fully funded.

Great. Thank you very much for taking the questions.

I appreciate the time, Jim. Thank you.

Kumaraguru Raja, Brookline Capital Markets.

Thanks for taking my questions. So I just needed some clarification with regard to the interactions with the Japanese regulatory authorities. So what are the next steps here that needs to be done before you can submit for approval in Japan here? And also with regard to the interactions -- positive interactions, any other additional color you can share, that would be great.

Absolutely. Well, I appreciate the question, Kumar. So where we're at right now, so the process in Japan is a series of consultations. And the key hurdle for us is a formal clinical consultation. And if -- we've been having preliminary clinical consultations, and they are fully apprised of the data.

And so the process and what they're deciding is is the CardiAMP-HF clinical data in combination with the Phase II TAC-HFT clinical data in combination with the Phase I TABMMI data, is that sufficient for them to say that the clinical data is sufficient to support safety and efficacy in Japan for this population that right now really has no other option. And that's the key question.

So the clinical consultation is the challenge. We respect that the CardiAMP HF II trial is far from perfect, but there are some very strong signals in the data, particularly in the sickest of patients in greatest need of therapy. And so we are going to have that conversation with them. I would say 95% to 99% of the work with respect to these submissions and conversations are done. And so we're in a waiting mode currently.

With respect to the FDA, as I shared in my comments, they have all of the updated annual reports and details on the study. We have breakthrough designation, but we are going to be submitting the de novo 510(k) application for approval of the Helix system as a first step to get the agency comfortable that the Helix system on its own should be approved to basically eliminate a key bottleneck in the field of biotherapeutic delivery to the heart. And then come to them with CardiAMP.

Once they have received the submission for approval on the Helix system, we would like to engage them on this is an autologous cell therapy. If it was a homologous usage, there would be no regulatory approval required. The data we have is excellent. And yes, it's not perfect, but from a outcomes basis and a risk-benefit basis, it's actually quite remarkable.

And so we're going to have those conversations. I think that the potential in Japan is greater than the potential in the United States at this time. And if these conversations don't bear great fruit, we are full bore on CardiAMP Heart Failure II program.

And the efforts that we've taken to prepare these submissions is substantially similar to the effort and its overlap with respect to the peer-reviewed manuscript that's in process. And so that is going to be a critical element for enhancing enrollment in the trial, as Jim Molloy just was touching on.

So data drives enthusiasm. And we think the physicians who know the data are pretty jazz, but we need to get it out there more broadly to enhance referrals and beyond. So that's sort of the time line on those two efforts on CardiAMP.

Okay. That's great. With regard to the HF II, you said four clinical sites are on board. What are your expectations with regard to getting additional sites on board? Thank you.

The additional sites on board, it's really a bandwidth issue on our side. There are -- there's also a slight challenge here that's a new element that's happening because of the reduction in some of the overhead funding that the federal government has put in place. A lot of clinical research sites are asking for quite a bit more for start-up costs and beyond. But because we've already been working at many of these sites, I don't expect that to be a significant issue for BioCardia.

So really, it's just our bandwidth moving through. There's going to be new contracting, there's going to be new budgeting, and that just takes staff time. And right now, some of that staff is working on closing out the regulatory submissions and making sure the manuscript is dialed in for submission. So we're not putting out numbers on the timing other than it's at least another year of enrollment in this trial.

Okay, great.

Thank you. Appreciate, Kumar.

Thank you for the question.

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

Appreciate it, Drew. So we thank BioCardia investors who enable our efforts developing and enhancing therapies broadly for cardiovascular care. There is great promise for value creation from our therapeutic and biologic delivery development activities with potential transformative near-term catalysts from active regulatory and partnering discussions. On behalf of our entire team, I thank you for your continued support.

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