BioCardia Q3 2026 Earnings Results & Report

BioCardia EPS Results

• Actual EPS: -$0.12
• Consensus EPS: -$0.13
• Beat/Miss: Beat by +$0.01
• One Year Ago EPS: N/A
• EPS Beat Rate: 6 of last 8 quarters

BioCardia Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

BioCardia (NASDAQ:BCDA) is a biotechnology company focused on developing regenerative cell therapies and delivery systems for the treatment of cardiovascular diseases. The company’s programs are designed to address conditions in which damaged or poorly functioning heart tissue may benefit from cellular therapy.

BioCardia’s principal product candidates include CardiAMP Cell Therapy, an autologous treatment that uses a patient’s own bone marrow-derived cells, and CardiALLO Cell Therapy, an investigational allogeneic therapy based on mesenchymal precursor cells from a donor source. The company also develops specialized catheter-based systems intended to deliver cell therapies to targeted areas of the heart.

Founded in 2002 and headquartered in Sunnyvale, California, BioCardia conducts clinical development activities in the United States and has worked with research and clinical partners internationally. The company is led by Peter Altman, Ph.D., who serves as president and chief executive officer.

BioCardia Q3 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: BioCardia said it has resolved the remaining questions to Japan’s PMDA’s satisfaction and is preparing a Shonin submission for CardiAMP with its local marketing authorization holder. The company expects approval about 12 months after submission, though it cautioned that documentation or testing requirements could affect the timeline.
• Neutral Sentiment: The FDA has accepted BioCardia’s supplemental De Novo pre-submission for the Helix delivery catheter, with feedback expected within six weeks. If the agency supports the pathway, BioCardia aims to submit in Q1 2027 and anticipates a mid-2027 decision; otherwise, further discussions may be needed.
• Neutral Sentiment: CardiAMP Heart Failure II has four active recruiting sites, with seven more being onboarded, but management described enrollment as progressing gradually and did not provide enrollment totals. The company said its near-term focus is on regulatory work in Japan and the U.S.
• Negative Sentiment: BioCardia ended Q3 with $2.2 million in cash and said its runway extends into 2027. Q3 operating cash use was $1.7 million and net loss was $1.8 million, leaving limited cash on hand relative to its ongoing development efforts.
• Neutral Sentiment: The company is discussing potential licensing partnerships for CardiAMP in Japan and collaborations involving its delivery technologies, including gene therapy. These discussions remain early, with no agreements announced; management expects to lead the initial Japanese post-marketing study, potentially involving about 200 patients.

Presentation

[Operator]

Good day, and welcome to The BioCardia Q3 2026 Financial Results and Corporate Update Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchscreen or keypad. To withdraw your question, please press star then two. 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, Investor Relations Executive at BioCardia]

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.

[Miranda Peto, Investor Relations Executive at BioCardia]

The content of this call contains time-sensitive 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 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, President and CEO at BioCardia]

Thank you, Miranda, and good afternoon to everyone on the call. The highlights of this second 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 CardiAMP Cell Therapy for the treatment of ischemic heart failure follow 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.

[Peter Altman, President and CEO at BioCardia]

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 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.

[Peter Altman, President and CEO at BioCardia]

We have answered all of these questions to Japan's Pharmaceuticals and Medical Devices Agency satisfaction, and we are proceeding to Shonin 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.

[Peter Altman, President and CEO at BioCardia]

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 towards 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.

[Peter Altman, President and CEO at BioCardia]

Although our initial approval is only expected to be for 20,000 patients in Japan, we note 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. Our 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 CardiAMP cell therapy, which includes the Helix biotherapeutic delivery catheter, may also help other developers of cardiac biologic therapy in Japan. In the U.S., we continue to actively enroll the CardiAMP Heart Failure II trial to take this study to completion as our confirmatory phase III study. Four clinical sites have enrolled in the study and are actively recruiting patients.

[Peter Altman, President and CEO at BioCardia]

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 FDA's potential approval of our Helix Transendocardial Delivery Catheter System in the U.S. 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 waiting 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 supplemental De Novo pre-submission to the FDA, which has been accepted.

[Peter Altman, President and CEO at BioCardia]

We expect to hear from the FDA on this pre-submission in the next six 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 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.

[Peter Altman, President and CEO at BioCardia]

In addition to the role of the investigational Helix platform for our own therapeutic development activities, Helix has 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 DNA navigation platform and our investigational Heart3D Fusion 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.

[Peter Altman, President and CEO at BioCardia]

A deal has 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.

[Peter Altman, President and CEO at BioCardia]

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?

[David McClung, CFO at BioCardia]

Thank you, Peter, and good afternoon, everyone. Let's review the highlights for 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.

[David McClung, CFO at BioCardia]

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 remain 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 now ready to take questions from attendees.

[Operator]

We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today comes from James Molloy with Alliance Global Partners. Please go ahead.

[Laura Suriel, Analyst at Alliance Global Partners]

Hello, this is Laura on for Jim Molloy. Thank you for taking the questions, and congrats on the progress this quarter. 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 partnership discussions that you might be having within Japan?

[Peter Altman, President and CEO at BioCardia]

Thank you, Laura. Appreciate you being on the call, and I appreciate the question. To reiterate, CardiAMP Heart Failure launch, post-marketing study, and partnering. On the launch, right now, we would expect, we're preparing essentially the post-marketing study will be that launch. It's actually a nice structure, primarily because in Japan, all of the KOLs want to be involved in these studies. 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 Japan's Pharmaceuticals and Medical Devices Agency, everybody in the room wants to participate in this post-marketing study, which we're delighted by. Our expectation is the launch will be that post-marketing study.

[Peter Altman, President and CEO at BioCardia]

The way we're thinking about it today, and we don't know if this will be possible, but 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 recruiting patients as soon as we have Actually, not recruiting, just treating patients as soon as we have the ultimate reimbursement from Ministry of Health, Labour, and Welfare. 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. 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.

[Peter Altman, President and CEO at BioCardia]

That's the Cardiovascular, the Circulation Society, the Heart Failure Society, and the Cardiovascular Interventional Therapeutics Society. We had representatives from all of those societies in leadership roles attend our PMDA session for our clinical consultation. 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. 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 CardiAMP Cell Therapy, because we're going after very similar indications.

[Peter Altman, President and CEO at BioCardia]

Partners have recognized the differences here. The conversations have included historically standard distribution models, but we are 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 is a commitment that we have made to PMDA. They want us there transferring this knowledge and experience in Japan. At the same time, we will have a partner that we are teaching and working with who ultimately will be in charge of the expansion of this. Partners recognize that it is not just Japan. Japan is a first-world country, a very rigorous regulatory approval process. I note that CardiAMP's approval is an approval. It is not a conditional approval like our peer. Because it is an approval, it will have potential for rest of world distribution structures.

[Peter Altman, President and CEO at BioCardia]

We are still early in this process. We have talked to some really incredible companies, and we are excited about what is coming ahead. I look forward to sharing more as it evolves, but our sense is, just so everybody appreciates it, that we can do this post-marketing study because it sort of comes with the territory of the approval. It is part of the approval process, and it is what we do today in our clinical efforts. Expanding beyond that is outside of our domain expertise, and that is really where we need the partner. The timing will be something that depends on partner interest, our experience, the approval, and also the board's thoughts on what options we have before us. There is nothing that is going to delay our initial post-marketing study, because we are going to be the ones with boots on the ground making that happen.

[Peter Altman, President and CEO at BioCardia]

The question is the expansion beyond that. That is really where the partner is going to be critical.

[Laura Suriel, Analyst at Alliance Global Partners]

Great. Thank you for the info. Also on the CardiAMP Heart Failure II trial, you mentioned that you have four active sites right now and seven more sites that are being onboarded. How many clinical trial sites do you think you are going to have activated in total, as well as any updates on how patient enrollment is going on right now?

[Peter Altman, President and CEO at BioCardia]

Yeah, I don't know how many sites we're going to need in total. That's always hard to guess. Many of these trials bring on 60+ sites, and that's pretty daunting for us to manage. Keep in mind that our annual burn rate, as David said, is just over $6 million. We're running a phase III trial. Yes, we have Medicare reimbursement in this trial, but there's a lot that goes into these trials. Right now, we have four sites. The next seven sites are incredible, and we've got some things that we're doing to truly enhance enrollment. That could be the totality of the sites in the U.S. And we're just working through it slowly. We haven't updated on the enrollment numbers just because that's not the primary focus right now.

[Peter Altman, President and CEO at BioCardia]

The primary focus is getting the regulatory approvals for CardiAMP in Japan and for Helix in the U.S., and that does involve folks on our clinical team preparing the clinical records and going through the good clinical practices audits and all that. I try to make them have one primary priority, which we're all aligned on, and then the enrollment will happen on the other side of it. I expect some really nice news to share on CardiAMP Heart Failure II in the near term. But yeah, the study's going well. We have a couple patients we're hopefully going to be randomizing this week ahead, and yeah, it's a week by week with these four sites, and they're all working hard. I'm sorry that's not as detailed as you'd like, but that's sort of what we've chosen to do as we go forward.

[Laura Suriel, Analyst at Alliance Global Partners]

I appreciate the insights. Thank you for taking the questions.

[Peter Altman, President and CEO at BioCardia]

I appreciate, Laura. Thank you very much for your question.

[Operator]

Again, if you have a question, please press star, then one.

[Operator]

Seeing no further questions, 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, President and CEO at BioCardia]

I thank everyone for being on the call today. Even as the main driver of significant value is approval in Japan, our next news will likely be on the Helix feedback from FDA in a few weeks and a gene therapy partnership with both Helix and Heart3D. I hope all will stay with us and hold the course ahead. You enable everything we do to help patients. Thank you, and be kind out there.

[Operator]

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

Participants

Executives

• Miranda Peto, Investor Relations Executive
• Peter Altman, President and CEO
• David McClung, CFO

Analysts

• Laura Suriel, Analyst at Alliance Global Partners