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.

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.

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 cardiac cell therapy for the treatment of heart failure in Japan and the approval of our Helix Transcendental Cardio 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 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 cardiac 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 cardiac 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 cardiac cell therapy for these patients in Japan. In our last quarter, we shared that we had remaining questions to address before the submission of cardiac 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 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 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 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 cardiac heart failure two trial to take this study to completion as our confirmatory phase three 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 FDA's potential approval of our Helix Transcendental Cardio 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 as final the minutes that we had provided without changes. We have recently filed a supplement de novo pre-submission to the FDA, which has been accepted. 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. 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 MorphDNA 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 cardiac 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 cardi-allo 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 intramyo-cardio delivery that is not well appreciated by many firms today. These possibilities are enhanced by the potential of hard 3D fusion imaging which we are working diligently with our respected partner, Cartek, 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 30th, 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 Cardi-AMP 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. 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.

We will now begin the question and answer session. To ask a question, you may press star then 1 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. And the first question today comes from James Molloy with Alliance Global Partners. Please go ahead.

Hello, this is Laura Ahn for Jim Molloy. Thank you for taking the questions and congrats on the progress this quarter. So on Cardi Amp, 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, you know, partnership 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, Cardi Amp 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 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 gonna be designed, the PMS study, in collaboration with the Pharmaceutical and Medical Devices Agency, but also with the three primary cardiovascular societies in Japan. And that's the Cardiovascular 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 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 in 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 Cardi Amp'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 are clinical efforts. Expanding beyond that is outside of our domain expertise. And so that's really where we need the partners. So the timing 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 partnering is going to be critical.

Great. Thank you for the info. Also, on the Heart Failure 2 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're going to have activated in total, as well as any updates on how patient enrollment is going on right now?

I don't know how many sites we're going to need in total. That's always hard to guess. Many of these trials, you know, bring on 60-plus sites, and that's pretty daunting for us to manage. You know, 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, you know, there's a lot that goes into these trials. So 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 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 cardiac heart failure, too, in the near term. But yeah, the study is going well. We have a couple of patients who are 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. 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.

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

I appreciate it, Laura. Thank you very much for your questions.

Again, if you have a question, please press star, then 1. 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.

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 count out there.

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