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Date

Nov. 12, 2025 at 4:30 p.m. ET

Call participants

  • President and Chief Executive Officer — Peter Altman
  • Chief Financial Officer — David McClung
  • Investor Relations — Miranda Peto

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Takeaways

  • R&D Expenses -- $936,000 for the quarter, up from $931,000, and $3,800,000 for the first nine months, up from $3,000,000, driven by closing out CARDIAMP Heart Failure I and new enrollment in CARDIAMP Heart Failure II.
  • SG&A Expenses -- Fell to $600,000 from $800,000 for the quarter and to $2,400,000 from $2,800,000 over nine months, attributed to lower compensation and professional services costs.
  • Net Loss -- $1,500,000 for the quarter versus $1,700,000 prior-year; $6,200,000 for nine months compared to $5,500,000 prior-year.
  • Net Cash Used in Operations -- Dropped to $1,500,000 for the quarter from $1,700,000 and to $4,900,000 YTD from $5,500,000.
  • Quarter-End Cash Balance -- $5,300,000, reflecting $6,000,000 September financing and 304,000 shares via ATM sales.
  • Cash Runway -- Cash on hand is expected "to provide runway into 2026 without additional financing."
  • CARDIAMP Cell Therapy — Regulatory Progress -- Received FDA breakthrough device designation; positive preliminary consultation with Japan's PMDA and pending next consultation with potential for market approval submission in Japan.
  • CARDIAMP HF2 Clinical Trial -- Confirmatory Phase III trial enrolling at four centers, with three centers having randomized first patients and more sites onboarding.
  • CARDIAMP CMI Cohort Results -- In the open-label rolling cohort (n=5), patients saw an average 80-second increase in exercise tolerance, 82% mean reduction in angina episodes at six months, and 60% showed substantial improvement in both; no treatment-emergent major adverse cardiac events observed.
  • CARDIALLO Allogeneic MSC Program -- Phase I/II study advancing in inflammatory ischemic heart failure, manufacturing completed in-house, and company expects clarity on non-dilutive funding in 2026.
  • Helix Delivery System -- Clinical data supporting an anticipated FDA submission for device approval in Q4.
  • Upcoming Milestones -- Anticipated Japan PMDA review, FDA breakthrough designation meeting request, and continued enrollment for HF2; peer-reviewed manuscript and publications in process for primary trials.
  • CMI Study Update -- Rolling cohort finished enrollment (n=5), with data being wrapped for peer-reviewed submission.
  • HF2 Site Enrollment -- New centers face onboarding delays primarily due to internal bandwidth and administrative contracting, not external hurdles.
  • Medicare Reimbursement -- CARDIAMP HF2 trial costs covered for both treated and control patients, supporting trial logistics.

Summary

The company highlighted active regulatory engagement with both the FDA and Japan’s PMDA, setting the stage for possible approval submissions in multiple geographies. Clinical trial data across both lead and secondary indications showed consistent signals of efficacy and safety, supporting ongoing regulatory strategies. Management confirmed operational runway into 2026 with recent financing, while updates to its Helix delivery platform and ongoing partnering targets add to multiple potential near-term catalysts.

  • Management stated the CardiAMP HF2 trial is "overpowered," indicating recruitment strategies and endpoint measures could support strong statistical outcomes.
  • President and CEO Altman said, "So all of the physicians involved in cardiac heart failure one are continuing with cardiac heart failure two. 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," underlining trial continuity and physician engagement.
  • Peter Altman expects, "clarity on the anticipated non-dilutive funding in 2026," for its allogeneic program, and referenced pursuit of NIH grants to fully fund this trial.
  • The Helix system has completed a master file update, with a de novo 510(k) submission to the FDA planned to enable further progress in therapeutic agent delivery.

Industry glossary

  • PMDA: Japan’s Pharmaceuticals and Medical Devices Agency, regulatory authority for drug and device approvals.
  • NT-proBNP: N-terminal pro b-type natriuretic peptide, a heart failure biomarker used to stratify patient risk and efficacy endpoints in clinical trials.
  • Allogeneic MSC: Mesenchymal stem cells derived from a donor, enabling off-the-shelf therapeutic use versus autologous (self-derived) cells.
  • ATM program: At-the-market share offering program allowing companies to issue shares incrementally to raise capital.
  • De novo 510(k): A regulatory submission pathway for novel, low- to moderate-risk medical devices not previously classified by the FDA.

Full Conference Call Transcript

Operator: Good afternoon, and welcome to the BioCardia Third Quarter Financial Results and Business Update Conference Call. All participants will be in listen-only mode. After today's presentation, 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.

Miranda Peto: 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 from those statements and other factors that may cause actual results to differ materially.

For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10-Ks filed with the SEC on 03/26/2025, 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, 11/12/2025. 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.

Peter Altman: 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 cardiac 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 cardiac Heart Failure II clinical study. Today, I will provide brief updates on our active clinical programs and progress on our Helix delivery system and heart 3D fusion imaging.

On BCDA-one, our CARDI Amp autologous cell therapy to treat microvascular dysfunction for the treatment of ischemic heart failure, which has potential to help roughly two 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 healthcare 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 cardiac heart failure two 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 2025. The Cardio Amp Heart Failure II confirmatory Phase III 250 patient randomized placebo-controlled trial is starting to accelerate now. Staff is coming off the enormous effort of closing up the CardioM HF study. Four centers are actively enrolling, three have randomized their first patients, and additional centers are actively being onboarded. The CARDI AMP HF2 study uses a similar three-tier composite primary outcome measure to the CardioM HF study consisting of all-cause death, non-fatal major adverse cardiac events, and a validated quality of life measure.

In both our Phase two TAKHIFT study and Phase three CARDIAP HF study, both randomized double-blind placebo-controlled studies, this CARDI M HF2 composite efficacy endpoint was achieved with statistical significance in the patients with elevated NT proBNP, who are the focus of the CARDI AMP HF2 study.

David McClung: CARDI AMP heart failure two trial advances include using the cell population analysis at screening to define treatment dose and improvements to the Helix system, including our FDA-approved morphDNA 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. CardioMF HF2 is supported by the Center for Medicare and Medicaid Services with reimbursement for both treated and control patients. In addition to the potential for approvals based on existing data, we are pursuing pathways to fund this study to completion. BCDO2 is our second indication for this therapy. The CARDI amp cell therapy in chronic myocardial ischemia.

The top-line primary outcomes from the open-label cohort rolling cohort of the cardiac cell therapy and chronic myocardial ischemia trial show patients experienced increased exercise tolerance of an average of eighty seconds, an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. Sixty percent 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 suggests 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-three is our second therapeutic platform. Our CARDI allo 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 non-dilutive funding to complete the Phase one-two 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 non-dilutive funding in 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 05/10 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 CAR 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 BCD01, our cardiac 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 cardiac heart failure two enrollment continuing.

For BCDO2, cardiac autologous self-therapy in chronic myocardial ischemia, we are seeking peer-reviewed publication of the positive results in Q1 2025, 2026, excuse me, and for BCDO3, cardio allogeneic mesenchymal stem cell therapy in heart failure, we anticipate non-dilutive funding coming together in 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?

David McClung: Thanks, Peter, and good afternoon to everyone joining us. For the third quarter 2025, research and development expenses increased to $936,000 from $931,000 in 2024. And also increased to $3,800,000 in the nine months ended September 2025 from the $3,000,000 in the nine months ended September 2024. The increases were driven by closeout for the cardiac heart failure study, including statistical data analysis and new enrollment in the subsequent cardiamp heart failure two trial, coupled with regulatory activities in support of potential approvals. We anticipate R&D expenses will increase modestly in 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 $600,000 in 2025 compared to $800,000 for 2024, primarily due to lower compensation expense. Selling, general, and administrative expenses decreased to $2,400,000 during the nine months ended September 25, as compared to $2,800,000 for the nine months ended September 2024, primarily due to lower professional services 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 $1,500,000 for the three months ended September 2025 compared to $1,700,000 for the three months ended September 2024. And it was $6,200,000 for the nine months ended September 25 compared to the $5,500,000 for the nine months ended September 2024.

Net cash used in operations during the third quarter 2025 decreased to $1,500,000 compared to 1.7 for the third quarter of the prior year. Net cash used in operations for the nine months ended September 2025 decreased to $4,900,000 as compared to 5,500,000.0 for the nine months ended September 2024. The company ended the quarter with $5,300,000 in cash, reflecting both the $6,000,000 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 2026 without additional financing. This concludes our prepared remarks. We're happy now to take questions from attendees.

Operator: At this time, we will begin the question and answer session. The first question comes from Joe Pantginis with H. C. Wainwright. Please go ahead.

Lander Egaña-Gorroño: Hello, everyone. This is Lander on for Joe. Thanks for the updates and thanks for taking our questions. So for the CardiAmp CMI data announced in September, could you please clarify, Peter, how many patients were part of this dataset? How are these results incremental to the initial four patient rolling cohort data presented in April? Thank you.

Peter Altman: Appreciate the question, Lander. The cardiac 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 roll of report is now completed. And we're wrapping it up for submission for publication.

Lander Egaña-Gorroño: Okay, perfect. So you're wrapping it up with five patients, right, for the rolling cohort, open label? Correct.

Peter Altman: Correct. And the cardiac 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 cohort's 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 cardiac HF2 program because we see it as much closer to market in the near term.

Lander Egaña-Gorroño: Perfect. Thank you very much. This is helpful. Thanks.

Peter Altman: Appreciate the question. Thank you.

Operator: The next question comes from James Molloy with Alliance Global Partners. Please go ahead.

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

Peter Altman: Well, Jim, thank you for the question. The status of CardiAmp Heart Failure two 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 III 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 and that same team is doing that work. So that is being essentially closed up now. All those projects, 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 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, excuse me, from time that they are screened until the time that they are actually complete the baseline measures because we've built into this trial something a delay actually to address the Hawthorne effect. The Hawthorne effect is a process where as soon as a patient is observed they begin to change their behavior. 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 in these centers getting start 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 that 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. Phase one data, the Phase two data and the Phase three 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 Cardi M Heart Failure II as well, as well as that of the physicians.

So all of the physicians involved in cardiac heart failure one are continuing with cardiac heart failure two. 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 a pace. And it's 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 one, the second trial is much, much easier for us to do.

James Francis Molloy: 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?

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

James Francis Molloy: I'm sorry, is do you have the, did you said what the current count is?

Peter Altman: 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, this many patients next week.

James Francis Molloy: Understood. Makes sense. And then maybe last for worries. You said in the first quarter, you guys are very sort of clear that you're could is that you're to complete a non-dilutive funding first quarter 2026 for BCDA03. Is there a partnership or something lined up that is expected to close first quarter 2026? Yes,

Peter Altman: 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 have 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 the handicap on that. Nothing's 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 CARDI AMP HF2 that trial will be fully funded.

James Francis Molloy: Great. Thank you very much for taking the questions.

Peter Altman: I appreciate the time, Jim. Thank you.

Operator: The next question comes from Kumar Guru Raja with Brookline Capital Markets. Please go ahead.

Kumaraguru Raja: Thanks for taking my questions. So I just need 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 here. And also with regard to the interactions positive interactions, any other additional color you can share, that would be great.

Peter Altman: Absolutely. Well, 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 two TAKHIFT clinical data in combination with the Phase one TABME 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 cardiac HF2 trial is far from perfect. But there are some very strong signals in the data, particularly in the sickest of patients and greatest need of therapy. And so we are going to have that conversation with them. I would say ninety five percent to ninety nine percent 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 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 05/10 application for approval of the Helix system. As a first step to get the agency comfortable that 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, would be no regulatory approval required. The data we have is excellent. And yes, it's not perfect.

But from an 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, data we are full bore on Cardi M Heart Failure II program. And the efforts that we've taken to prepare these submissions is substantially similar to the effort and it's 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 drives enthusiasm and we think, the physicians who know the data are pretty jazzed but, we need to get it out there more broadly to enhance referrals and beyond. That's sort of the timeline on those two efforts on Cardium.

Kumaraguru Raja: Okay. That's great. With regard to the HF2, you said four clinical sites are on board. What are your expectation with regard to getting additional sites on board? Thank you.

Peter Altman: The additional sites onboard, it's really a bandwidth issue on our side. 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 startup costs and beyond. But because we've already been working at many of these sites, don't expect that to be a significant issue for BioCardia. So really it's just our bandwidth moving through the 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, I we're not putting out numbers on the timing other than it's at least another year of enrollment in this trial.

Kumaraguru Raja: Okay. Great. Thank you.

Peter Altman: Appreciate Kumar. Thank you for the question.

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

Peter Altman: Appreciate it, Drew. So we thank BioCardia investors who enable our efforts developing enhancing therapies broadly for cardiovascular care. There's 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.

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