BioCardia (BCDA) Q3 2026 Earnings Call Transcript

DATE

Thursday, Nov. 12, 2026

CALL PARTICIPANTS

• Investor Relations - Miranda Benvenuti
• President and Chief Executive Officer - Peter Altman
• Chief Financial Officer - David McClung

TAKEAWAYS

• Net Loss -- $1.8 million for the third quarter, compared to $1.8 million in the third quarter of 2025.
• Net Loss Per Share -- $0.12, compared to $0.24 in the third quarter of 2025, reflecting a higher weighted-average share count.
• Cash and Cash Equivalents -- $2.2 million as of Sept. 30, 2026, which management indicated provides a runway into 2027.
• Research and Development Expenses -- $1.2 million for the quarter, an increase from $936,000 in the prior year due to regulatory work in Japan and trial enrollment.
• Selling, General and Administrative Expenses -- $600,000, representing a moderate increase from $552,000 in the third quarter of 2025.
• Net Cash Used in Operating Activities -- $1.7 million for the quarter, consistent with the amount used in the same period of 2025.
• Japan Target Indication -- 20,000 patients for the initial clinical indication of CardiAMP cell therapy, with approval anticipated 12 months after Shonin submission.
• Japan Ischemic Heart Failure Patients -- 300,000 patients suffering from the condition today, according to management estimates.
• Helix Delivery System Data Set -- 12 clinical trials involving approximately 500 patients, supporting the pending regulatory submission.
• Helix FDA Review Target -- 150 review days under medical device user fee amendments guidelines, targeting a mid-2027 approval.
• CardiAMP HF II Clinical Sites -- 11 total centers, consisting of four active sites and seven additional centers currently in the onboarding process.
• Japan Cardiac Procedures -- 250,000 cardiac catheter interventions performed annually by interventional cardiologists in Japan.
• Post-Marketing Study Scale -- 200 patients to be treated in a real-world setting to evaluate safety and long-term survival.
• Nine-Month Operating Loss -- $5.7 million for the first nine months of 2026, compared to $6.3 million in the same period of 2025.
• Nine-Month Research and Development Expenses -- $3.4 million, a decrease from $3.8 million in the prior year period following the completion of a previous trial.
• Gene Therapy Collaboration Leads -- four separate conversations regarding gene therapy partnerships held within the 72 hours preceding the call.
• Helix FDA Feedback Timeline -- six weeks, the period within which management expects to receive feedback on its de novo presubmission.
• Reimbursement Benchmark -- $300,000 per treatment, representing the reimbursement rate for a recently approved cell therapy in Japan for similar indications.

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RISKS

• Altman stated, "A primary risk of this time line is if our product documentation does not meet a requisite standard and we need to repeat testing of some sort," noting no deficiencies have been identified to date.

SUMMARY

BioCardia, Inc. (NASDAQ:BCDA) reported a focus on regulatory milestones for its lead therapeutic and delivery platforms in Japan and the United States. Management indicated that all remaining questions from Japan's Pharmaceuticals and Medical Devices Agency have been addressed, allowing the company to proceed toward a Shonin submission for its CardiAMP cell therapy. In the United States, the company is pursuing a de novo approval pathway for the Helix delivery system, supported by clinical data from approximately 500 patients across 12 trials. Financial results for the quarter showed a stable operational cash burn, with research and development investments directed toward advancing these regulatory filings and expanding clinical trial site enrollment.

• Management indicated that the CardiAMP cell therapy aligns with Japanese cultural preferences for autologous treatments over organ transplantation. CEO Altman stated, "Delivering a patient's own cells resonates with Japanese culture that has historically avoided the transplantation of organs."
• The company has engaged a designated marketing authorization holder as the required local regulatory representative to manage the Shonin submission and subsequent sales in Japan.
• Management noted that the Helix transendocardial delivery system is being positioned as a potential development platform for partners focused on gene-based cardiac therapies.
• BioCardia is collaborating with partner CART-Tech to advance the Heart3D fusion imaging platform, which integrates three-dimensional anatomical models with real-time X-ray imaging.
• The CardiAMP Heart Failure II trial is supported by Medicare reimbursement, with management noting a total annual burn rate of approximately $6 million.

INDUSTRY GLOSSARY

• Autologous: A medical procedure or therapy in which the donor and recipient are the same person, utilizing the patient's own cells.
• CardiAMP: BioCardia's lead autologous cell therapy system designed to treat heart failure and chronic myocardial ischemia.
• DMAH: Designated Marketing Authorization Holder; the local regulatory representative required for foreign companies to sell medical products in Japan.
• Heart3D: A fusion imaging platform that combines anatomical heart models with X-ray imaging to assist in cardiac interventions.
• Helix: A biotherapeutic delivery system used to administer treatments directly into the heart muscle via a catheter.
• Ischemic Heart Failure: A condition where the heart muscle is weakened due to reduced blood flow caused by narrowed or blocked arteries.
• MDUFA: Medical Device User Fee Amendments; federal regulations that authorize the FDA to collect fees from medical device manufacturers to fund the review process.
• PMDA: Pharmaceuticals and Medical Devices Agency; the Japanese government organization responsible for reviewing drugs and medical devices.
• Shonin: The standard regulatory application for medical device or pharmaceutical approval in Japan.

Full Conference Call Transcript

Operator: Good day, and welcome to the BioCardia Q3 2026 Financial Results and Corporate 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 1 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 Benvenuti: 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 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: 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 followed 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 need for opening the patient's chest surgically to deliver the cells. We expect to be able to discharge the patients 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 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 time line 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 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, Labor and Welfare and subsequent reimbursement has been established. 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. are 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 United States, we continue to actively enroll the CardiAMP Heart Failure II Trial to take the study to completion as our confirmatory Phase III study. our clinical sites have enrolled in this 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 7 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 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 waiting the FDA minutes from our May 2026 meeting.

Soon after our Q2 earnings call in August, the FDA accepted this final the minutes that we had provided without changes. We have recently filed a supplement de novo presubmission to the FDA, which has been accepted. We expect to hear from the FDA on this presubmission 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 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 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 Imaging platform. Our business development falls into 2 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. 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 4 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?

David McClung: Thank you, Peter, and good afternoon, everyone. Let's review the highlights of our financial results for the quarter and 9 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 III 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, and 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're now ready to take questions from attendees.

Operator: [Operator Instructions] And the first question today comes from James Molloy with Alliance Global Partners.

Laura Suriel-Suarez: This is Laura on for Jim Molloy. 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 partnership discussions that you might be having within Japan?

Peter Altman: Thank you, Laura. I 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 Japan's Pharmaceutical Medical Device 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, 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, Labor 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 Pharmaceutical and Medical Devices Agency, but also with the 3 primary cardiovascular societies in Japan. And 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 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 CardiAMP 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 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 to partner. So 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. 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 partnering is going to be critical.

Laura Suriel-Suarez: Great. And also on the Heart Failure II trial, you mentioned that you have 4 active sites right now and 7 more sites that are being onboarded. So how many clinical trial sites do you think you're going to have activated in total and as well as any updates on how patient enrollment is going on right now?

Peter Altman: Yes. So we have -- so 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-plus 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. So 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. So right now, we have 4 sites. The next 7 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 United States.

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. The primary focus is getting the regulatory approvals for CardiAMP in Japan and for Helix in the United States. And that does involve folks on our clinical team, preparing the clinical records and going through the good clinical practices audits and all that. So 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. So I expect some really nice news to share on CardiAMP Heart Failure II in the near term. But yes, the study is going well.

We have a couple of patients we're hopefully going to be randomizing this week ahead. And yes, it's just -- it's a week by week with these 4 sites, and they're all working hard. So 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.

Operator: [Operator Instructions] 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: 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.

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