BioCardia, Inc. (BCDA) Earnings Call Transcript & Summary

Good day, and welcome to the BioCardia Q3 2026 Financial Results and Corporate Update Conference Call. [Operator Instructions] Participants are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. The webcast replay of the call will be available approximately 1 hour after the end of the call. I would now like to turn the call over to Miranda Peto of BioCardia Investor Relations. 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 24, 2026, and in our subsequently filed quarterly reports on Form 10-Q. The content of this call contains timesensitive information that is accurate only as of today, November 12, 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 the 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. The highlights of this quarter have been the continued progress on the approval of CardiAMP Cell Therapy for the treatment of heart failure in Japan and the approval of our Helix Transendocardial Delivery Catheter System in the United States. I would like to focus a little time on each of these regulatory initiatives to detail where we are at, the risks, and our anticipated successful outcomes. Our efforts to seek approval in Japan for our cardiac cell therapy for the treatment of ischemic heart failure show Japan's leadership supporting these therapies, as they have recognized the potential for meaningful impact to treat heart failure. They have recently approved and reimbursed a cell therapy in Japan for patients with heart failure. Our CardiAMP cell therapy may have advantages over what has been approved in that it is autologous and requires no immunosuppression. Delivering a patient's own cells resonates with Japanese culture that has historically avoided the transplantation of organs. Further, our CardiAMP cell therapy procedure is performed using minimally invasive catheter delivery without the need for opening the patient's chest surgically to deliver the cells. We expect to be able to discharge the patient soon after the procedure on the same day. The patient need is great, and we look forward to real-world assessment of the CardiAMP cell therapy for these patients in Japan. In our last quarter, we shared that we had remaining questions to address before the submission of CardiAMP cell therapy for regulatory approval in Japan. We have answered all of these questions to Japan's Pharmaceuticals and Medical Devices Agency satisfaction, and we are proceeding to submission with our designated marketing authorization holder. Our designated marketing authorization holder will prepare and submit the Shonin application and act as the local regulatory representative to enable BioCardia sales of CardiAMP cell therapy in Japan. Our work with them is also supported by additional preparatory consultancies that we have engaged. The timing of this is fluid, but it looks like most tasks will be completed in the coming months. A primary risk of this timeline is if our product documentation does not meet a requisite standard and we need to repeat testing of some sort. No deficiencies have yet been identified by BioCardia. However, as we work with our designated marketing authorization holder, we may identify areas where they may request additional work. We have been getting ready for some time preparing for this. Our team recently completed a recertification audit to the international standard that sets requirements for a quality management system specifically tailored for our industry. Our team has also taken steps to revalidate our product sterilization process with an eye toward Japanese regulations. The expected initial clinical indication in Japan will be for approximately 20,000 patients, with approval expected 12 months after we complete our Shonin submission. During this period, we would expect to be training physicians and finalizing the details of the post-marketing study and its logistics so that we are ready to begin at all centers as soon as approval by the Ministry of Health, Labour and Welfare and subsequent reimbursement has been established. Although our initial approval is only expected to be for 20,000 patients in Japan, we know that there are approximately 300,000 patients in Japan with ischemic heart failure today. Japan's world-class interventional cardiologists perform 250,000 cardiac catheter interventions per year. Enhancing both physician and patient success after approval in the post-marketing study, where there will be reimbursement, is likely to result in a significant business that has a very positive impact on patients and society in Japan. Japan's approval of cardiac cell therapy, which includes the Helix Biotherapeutic Delivery Catheter, may also help other developers of cardiac biologic therapy in Japan. In the United States, we continue to actively enroll the CardiAMP Heart Failure II trial to take this study to completion as our confirmatory Phase 3 study. Four clinical sites have enrolled in the study and are actively recruiting patients. There have been no safety issues of which management is aware. The rate of enrollment here is driven primarily by resources deployed, and we are actively onboarding an additional seven world-class centers. We expect to have additional exciting news here. The second significant regulatory milestone in the near term is related to the FDA's potential approval of our Helix Transendocardial Delivery System in the United States. There is significant data on this delivery platform, with data from a dozen clinical trials with approximately 500 patients. In our last quarter, we shared we were awaiting the FDA minutes from our May 2026 meeting. Soon after our Q2 earnings call in August, the FDA accepted as final the minutes that we had provided without changes. We have recently filed a supplement, a novel pre-submission to the FDA, which has been accepted. We expect to hear from the FDA on this pre-submission in the next 6 weeks. If the FDA supports the De Novo approval pathway for Helix, we expect to complete the De Novo submission in the first quarter of 2027, with approval in mid-2027 if the FDA meets its official target goal of 150 review days under the Medical Device User Fee Amendments guidelines. If the FDA does not support the De Novo approval pathway, there will be additional discussions ahead. We firmly believe that there is every reason for the Helix to be approved and intend to work with the agency to make this happen. In addition to the role of the investigational Helix platform for our own therapeutic development activities, Helix has the potential to become the leading development platform for biologic therapies to treat heart disease, as it provides efficient delivery and control for these investigational agents to the heart. We have enhancements to Helix that will impact our investigational cardiac therapies as well as those of partners. This includes our FDA-cleared Morph navigation platform and our investigational Heart3D imaging platform. Our business development falls into two separate efforts primarily. The first is on the therapeutic front, driven by the interest in CardiAMP cell therapy. Conversations here of interest are around our cardiovascular portfolio. Deals have potential to include our entire cardiovascular pipeline, including CardiAMP for its second indication of chronic myocardial ischemia, and our allogeneic CardiALLO cell therapy for inflammatory heart failure, both of which are well positioned with clinical data and a pathway to market clearance. BioCardia is fully committed to the post-marketing study launch in Japan with our expertise, but we do recognize the value that a partner has for long-term growth in Japan and the Asia-Pacific region. Business development on biotherapeutic delivery is also active. We believe we can help many of those in development, particularly for gene-based therapies. In the last 72 hours, we've had conversations on four separate gene therapy collaborations. Under confidentiality, we are helping partners appreciate what is possible with our delivery technologies. There is a great deal more possible with intramyocardial delivery that is not well appreciated by many firms today. These possibilities are enhanced by the potential of Heart3D fusion imaging, which we are working diligently with our respected partner, CART-Tech, to bring to the clinic and to the market as soon as possible. I will now pass the call to David McClung, our CFO, who will review our third quarter 2026 financial results. David?

Thank you, Peter, and good afternoon, everyone. Let's review the highlights of our financial results for the quarter and nine months ended September 30, 2026. Net cash used in operations during Q3 2026 was approximately $1.7 million, in line with the $1.7 million used in Q3 2025. Net cash used in operations for Q3 2026 year-to-date increased modestly to $5.1 million from $4.9 million in the same period in 2025. We ended the quarter with cash and cash equivalents totaling $2.2 million, providing runway into 2027. R&D expenses increased to $1.2 million in Q3 2026 compared to $0.9 million in Q3 2025, partially due to increased expenses from regulatory work to advance CardiAMP in Japan and from expenses to support enrollment in the CardiAMP Heart Failure II trial. R&D expenses decreased to $3.4 million in Q3 year-to-date 2026 as compared to $3.8 million in Q3 year-to-date 2025, primarily due to the completion of the CardiAMP heart failure trial. SG&A expenses increased moderately to $0.6 million in Q3 2026 as compared to $0.55 million in Q3 2025. SG&A expenses remained consistent at $2.4 million in Q3 year-to-date 2026 versus Q3 year-to-date 2025. Our net loss was $1.8 million in Q3 2026 compared to $1.5 million in Q3 2025. Our net loss decreased to $5.7 million in the Q3 year-to-date 2026 compared to $6.2 million in Q3 year-to-date 2025, primarily due to lower R&D expenses. This concludes management's prepared remarks. We are ready to take questions from attendees.

We will now begin the question and answer session. [Operator Instructions] And the first question today comes from James Molloy with Alliance Global Partners. Please go ahead.

Hello, this is Laura on for Jim Molloy. Thank you for taking the questions and congrats on the progress this quarter. So on CardiAMP, maybe you just talk a bit more about what a launch in Japan could look like and some of the logistics behind getting the post-marketing study started? Also, what might the study design look like, as well as any updates on partner discussions that you might be having within Japan?

Thank you, Laura. Appreciate you being on the call and I appreciate the question. So to reiterate, CardiAMP heart failure launch, post-marketing study, and partnering. So on the launch, right now, we would expect we're preparing essentially the post-marketing study will be that launch. And it's actually a nice structure primarily because in Japan, all of the KOLs want to be involved in these studies. And so what happens is you wind up leading from a leadership perspective in your initial commercial activities. We said previously in our last PMDA discussion where we had leadership that we've been collaborating with as well as leadership that's been collaborating with the Pharmaceuticals and Medical Devices Agency, everybody in the room wants to participate in this post-marketing study, which we're delighted by. And so our expectation is the launch will be that post-marketing study. The way we're thinking about it today, and we don't know if this will be possible, is that we'll aim to have, let's say, 20 centers up and running and trained and ready to go and be able to begin treating patients as soon as we have the ultimate reimbursement from the Ministry of Health, Labour and Welfare. And the PMS study, the way I'd think about it is it could be on the order of 200 patients treated real-world, primarily focused on safety outcomes from the procedure, but also looking longer term on how are these patients surviving relative to historical controls? And so that's going to be designed, the PMS study, in collaboration with the Pharmaceuticals and Medical Devices Agency, but also with the three primary cardiovascular societies in Japan. And that's the Japanese Circulation Society, the Heart Failure Society, and the Japanese Association of Cardiovascular Intervention and Therapeutics. We had representatives from all of those societies and leadership roles attend our PMDA session for our clinical consultation. And we are hopeful that the enthusiasm will continue as we go downstream. On the partnering side, the nature of this is intriguing because there's already a therapy that's just been approved in Japan and now has reimbursement at over 300,000 per treatment. And it's a different therapy with a different mechanism of action potentially, but it will be an interesting benchmark for what we're advancing for cardiac cell therapy because we're going after very similar indications. Partners have recognized the differences here. And so the conversations have included historically standard distribution models, but we're really looking at conversations with larger players to do a licensing framework whereby we would still be there with boots on the ground for the entire post-marketing study. And that's a commitment that we've made to PMDA. They want us there transferring this knowledge and experience in Japan. But at the same time, we'll have a partner that we're teaching and working with who ultimately will be in charge of the expansion of this. And partners recognize that it's not just Japan. Japan is a first-world country, a very rigorous regulatory approval process. And I note that CardiAMP's approval is an approval. It's not a conditional approval like our peer. And so because it is an approval, it will have potential for rest-of-world distribution structures. And so we're still early in this process. We've talked to some really incredible companies, and we are excited about what is coming ahead. So I look forward to sharing more as it evolves. But our sense is, just so everybody appreciates it, that we can do this process post-marketing study because it sort of comes with the territory of the approval. It's part of the approval process and it's what we do today in our clinical efforts. Expanding beyond that is outside of our domain expertise. And so that's really where we need the partners. So the transaction will be something that depends on partner interests, our experience, the approval, and also the board's thoughts on what options we have before us. But there's nothing that's going to delay our initial post-marketing study because we are going to be the ones with boots on the ground making that happen. The question is the expansion beyond that. That's really where the partner is going to be critical.