Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the BioCardia Third Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [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 one hour after the end of the call. I would now like to turn the floor 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 product 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 27, 2024, and in subsequently filed Form 10-Qs. The content of this call contains time-sensitive information that is accurate only as of today, November 13, 2024. 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. BioCardia continues to advance our targeted cellular precision medicines for cardiovascular disease. Our clinical stage cell-based therapies are targeted and we are delivering our therapeutic candidates locally to the target tissues where they are most needed and with a precision medicine perspective for specific patients that may benefit, identified by biomarkers. These biomarkers characterize a patient’s disease state, and in the case of our autologous CardiAMP mononuclear cell therapies, the potential of the patient’s own cells for providing therapeutic benefits. Our lead autologous CardiAMP cell therapy for the treatment of heart failure, which has been granted Food and Drug Administration breakthrough designation and is reimbursed by the Center for Medicare and Medicaid Services, is being studied today in two active clinical trials. The mechanism of action of CardiAMP cell therapy is viewed as microvascular repair by promoting increased capillary density and reduced fibrosis in the heart tissue where these cells are delivered, both of which have been demonstrated in preclinical studies. CardiAMP cell therapy is a one-time treatment in which the patients who qualify based on the critical selection criteria have their own mononuclear cells aspirated and delivered to the heart in high concentrations in a single minimally invasive catheter-based procedure. The procedure avoids the need for cardiac surgery to deliver the cells and no immunosuppression is required to prevent rejection of a patient’s own cells. I will now provide detail on the status of our two CardiAMP cell therapy trials for the treatment of heart failure. The CardiAMP Heart Failure I trial is a randomized placebo procedure-controlled study on 115 patients with 10 additional role in subjects. We will soon have final data where patients will have a minimum of one year and a maximum of two-year follow-up…

Thank you, Peter, and good afternoon, everyone. In September, we closed our $7.2 million public offering, bringing us into compliance with NASDAQ’s listing requirements. This extends our runway past our expected results in the pivotal CardiAMP Heart Failure trial in Q1 2025. Total expenses decreased 41% quarter-over-quarter to $1.8 million in Q3 2024, compared to $3.0 million in Q3 2023. Research and development expenses decreased to $931,000 during the third quarter of 2024, compared to $1.9 million for the third quarter of 2023, primarily due to the completion of enrollment in the CardiAMP Heart Failure I trial coupled with related reductions in clinical and supporting functional expenses. We expect R&D expenses to increase modestly as the CardiAMP Heart Failure II trial ramps up beginning in the fourth quarter of 2024. As Peter mentioned, the CardiAMP cell therapy for the treatment of heart failure qualifies for Medicare coverage, with covered costs including patient screening, the investigational CardiAMP cell therapy system, the procedure and the clinical follow-up at $17,000 for both the treatment and the control arms. This substantially reduces the expense of accelerating enrollment in the CardiAMP Heart Failure II trial. Selling, general and administrative expenses decreased to $825,000 for the three months ended September 2024, down from $1.1 million from the same period in 2023, primarily due to the reductions in personnel expenses. We expect SG&A expenses to remain close to the current run rate. BioCardia’s net loss decreased to $1.7 million for the third quarter of 2024, down from $2.6 million in the prior year’s third quarter, primarily due to those reductions in R&D and SG&A expense. Net cash used in operation for the third quarter of 2024 totaled $2.6 million, compared to $2.4 million in the third quarter of 2023. The increase is due to our settling of trade payables and accrued liabilities following the closing of the $7.2 million public offering in September. For perspective, cash flows for the nine months ended September 2024 were $5.5 million. That’s $2.6 million less than the same nine-month period in 2023. We expect our cash burn will increase moderately over the coming year, continuing our track record of operating efficiently and carefully managing the use of capital. This concludes management’s prepared comments, but we’re happy to take now questions from attendees.

[Operator Instructions] And our first question today comes from Joe Pantginis from H.C. Wainwright. Please go ahead with your question.

Hey, everybody. Good afternoon. Thanks for taking the questions. So, Peter, I want to start at the back end of your prepared comments, if you don’t mind. You gave a lot of great details around Morph DNA, and I guess, what are your potential options other than, individual partnerships or company partnerships or broader partnerships or even monetizing the entire program? What are your options that you’re looking at?

Well, Dr. Pantginis, thank you for the question. It is a good question. So Morph DNA is a product that we realize because we recognize the advantages it provides for all of our procedures on the cardiac cell therapy side and with partners using Helix, and it’s an elegant, durable introducer sheath platform. The market here is actually quite large. I’m actually aware of one hospital, a single hospital in the United States that uses 250,000 units of this type per year for one clinical indication of transeptal access for performing atrial fibrillation procedures. So it’s a quite large market opportunity across the Board. It’s very competitive in the electrophysiology space. In the last year in the electrophysiology space, primarily we saw Medtronic buy a company for roughly $100 million. We saw Boston Scientific buy a company with other assets for crossing the heart wall for $1.2 billion based on these steerable introducer assets. We’re earlier in the commercial pathway here, but we have a very compelling technology advantage to those other catheter systems and that our Morph DNA has a rotating tendon element that goes down the length of the catheter, which you can see in the product brochure that’s available on our website. And what that does is it eliminates whip when using this device in a patient’s heart or in their vasculature. And whip is the tendency for the catheter to be stable in one position but unstable in another position so that it jumps to the stable position. And so that technical advantage is one of the things that we’re going to be proving out. If you look at the brochure on our website, there’s what we call the naked man, an anatomical model of all the different places that this can be used in the…

Absolutely. Yeah. No. There were very, very helpful details and I appreciate all the options that you have. So if you don’t mind, I’d like to switch gears to your ex-U.S. efforts regarding CardiAMP and wanting to get sort of a general concept regarding the process and timing in Japan. And then just curious, because I’ve seen other examples for cellular therapies. I mean, since you have breakthrough therapy in the U.S., I believe the designation or similar designation in Japan is called Sakigake status. And I’m just curious if you were looking for that as well.

So, yeah, great question on Japan and I know who you’re thinking of, what you think was Sakigake status. And Sakigake is named after one of their first satellites. So we’ve had great interactions with Japan PMDA and with the FDA here in the United States. In Japan, the process ahead is we have our next clinical consultation scheduled for this month with PMDA, Pharmaceutical and Medical Device Agency in Japan. And in that consultation, we’re talking about the desire that we have to provide our data based on what to them are foreign trials, i.e. our trials in the United States and Japan. And my sense is they’re pretty supportive of that at present. We’re answering a number of questions that they raised in our clinical consultation in November of last year and detailed in written minutes in December of last year. And many of those questions tie into our CardiAMP Heart Failure data. Quite a few of the questions end with the statement of, please address this in your application for approval or your submission for approval. And that’s really where we’d like to get to. So it’s really a couple step process here. The first step is this next consultation is to tee up the clinical consultation. And it is a significant hurdle if they say, yes, we would like you to come in for a formal clinical consultation to review your data, which was really the second to last step before they say, yes, you can submit for approval and so that is a really big hurdle. So the next significant hurdle there is, will they allow us to submit and have a clinical consultation? So we will submit all of the data from CardiAMP Heart Failure I and engage with them on that data and…

Really helpful, again, and I appreciate the clarification on Sakigake. If you would indulge me, one last question. When you look at the cellular therapy space, regenerative medicine and all that, there’s always good, bad or ugly, a lot of investment and this goes for many different therapeutic approaches or technology approaches. Basket thinking, all cells are alike or in different indications, or what have you. So you referenced in your prepared comments an upcoming PDUFA date, and of course, this is for Mesoblast and for GvHD. So I’m just curious, I know it’s difficult to talk about, say, competitor products or what have you on calls like this, but can you point to any similarities or differences in your cells that can help, if they have a positive outcome, for a positive basket approach?

Yeah. So if you go back to an earnings call we had probably, gosh, over a year ago, two years ago, I was asked the question of what did I think of Mesoblast’s chance as a panel in their indication for pediatric graft versus host disease. And I was a big supporter. I was surprised that the panel did not approve it at that time or the agency didn’t. I think panel supported, the agency didn’t, because graft versus host disease is, one of the most significant, worst ways to die out there. That said, their cells in that indication are very similar to the cells that we are advancing. That program was initially begun by Osiris Therapeutics many years ago. BioCardia has worked with Osiris many years ago. So we’re very familiar with. These are allogenetic, culture-expanded, bone marrow derived, mesenchymal stem cells. Now, mesenchymal stem cells are characterized by the process, because each manufacturing process can be slightly different. But fundamentally, we’re delivering very similar cells. And so their success in their PDUFA meeting ahead is likely to significantly enhance interest in partners around both their programs and other indications, but also our clinical-grade cells for those, many of those same indications. So I think it’s a real opportunity that we have this ready. We have FDA-approved INDs for both an inner-tissue cardiac delivery, but also for an intravenous delivery for our PulmALLO project. So my sense is their success, rising tide lifts all boats, will enhance interest in our allogeneic platform as well.

Excellent. Peter, thank you very much for all the details and looking forward to the upcoming CardiAMP I data.

I appreciate it, Joe. Thank you so much for the questions.

Our next question comes from Kumar Raja from Brookline Capital Markets. Please go ahead with your question.

Good afternoon and thanks for taking my questions. First, with regard to the protocol amendment in the CardiAMP II trial, what percentage of patients would fit this profile and how were similar patients who had, like, similar nature of cells, how were they treated in the CardiAMP I trial?

Great question, Kumar. So I call that amendment approval, I call it the $20 million amendment here at BioCardia because of how significantly it’s going to change, how easy it is to enroll patients in the trial. Previously, if a patient didn’t meet the pre-specified cell population analysis criteria, they were excluded from the trial. Now, we took measures throughout the trial, and in our analysis of the CardiAMP Heart Failure cell population analysis data for both the patients who didn’t make it into the trial and the patients who did make it into the trial, we saw that there was a large portion of the patients that were just really under the threshold, within, say, 35% of the threshold. And so we went to the agency and we presented a plan whereby for those patients, to help ensure that they have potential to reach the target dosage, instead of excluding them, we are going to give them 35% more deliveries. So currently, we treat patients with 10 dosages around damage and infarct sites. For those patients that are in a class that doesn’t meet the full cell population analysis score, those that fall below but are greater than 65% will then be targeted with the 10 dosages, plus an additional five dosages to get them to the optimal target dosing. And so we’re pretty excited about this. It has -- we’re not detailing the exact numbers and all the details and changes yet because, again, we don’t yet have final data in the trial. But our expectation is that, we will still exclude patients based on not having appropriate cells for therapy. But my expectation, and I should say our expectation of the team, is that about 85% of the patients will pass that threshold and a number of them will wind up having 15 deliveries to get to the target dosage versus the 10. So this is truly personalized medicine, where we’re assessing a patient’s own autologous tissue, looking at it for its composition and then developing a treatment plan, which now has three arms. One arm is, I’m sorry, your cells don’t qualify you for treatment. The other arm is, yes, your cells qualify you for treatment. And the third arm is, your cells qualify you for treatment, but because of the nature of your cells, we’re going to provide an additional five dosages. So that’s what we’re rolling out now and all the paperwork’s been implemented here at BioCardia. We have IRB approval. The full CardiAMP Heart Failure trial, Heart Failure II trial, will incorporate that element.

That’s great. That’s very helpful. And with regard to Japan, what would be your commercialization strategy? Are you looking for partners there or what is the plan there?

Absolutely. So in Japan, my expectation is that we will partner in Japan. And when and how we partner will depend upon the progress ahead. We have a world-class group of folks and we have world-class physicians involved. The first step post-approval is expected to be really a post-marketing study to enhance awareness, to develop additional data. So that first year, think of it as a slow rollout. In Japan, distribution’s a little different than it is here in the States. Each and every hospital sort of has a transitionary distributor for these types of products that takes essentially 10% of the value proposition and manages the interaction within the hospital. There are other distributors who then sell into those distributors. And there are some larger players in Japan where we have active conversations on what we’re doing with this therapy and how it might fit into their commercial efforts and we continue to have these conversations. I think in Japan, being able to be approved without a clinical trial is viewed as quite valuable because clinical trials in Japan are notoriously expensive and take a very, very long time. I’ll do a cross-question comment here. I believe that the program that Dr. Pantginis was referring to was one that had Sakigake, but it couldn’t complete enrollment just because clinical trial enrollment in Japan is quite difficult. And so by getting approval without that requirement, I think it enables us to move forward. So, in addition, I’ll share with you that in Japan today, there are two other companies who have asserted publicly that they’re going to be applying for approval based on a total of 10 patients treated in a surgically-based cell therapy for heart failure, which requires chronic immunosuppression. And the advantages we bring to the table in not requiring those things, i.e., minimally invasive access, no immunosuppression, is a really compelling advantage for physicians, as well as for patients. And so my sense is on the other side of approval, there will be a lot of interest in this therapy. So determining exactly how to distribute it is TBD, but there’s lots of conversations ongoing. And the PMDA saying, yes, you can apply for approval, that will turn on a lot of green lights. So we’ll take it from there.

Great. Thank you.

Thank you, Kumar. Appreciate the question.

And ladies and gentlemen, at this time, I would like to end today’s question-and-answer session and turn the floor back over to Peter Altman for any closing remarks.

Thank you, Jamie. I thank everyone who has helped our mission to develop and enhance therapies to treat cardiovascular disease. Investors should know that we have potential to achieve enormous success with their support and that our market capitalization today presents a remarkable investment opportunity and a company with many ways to win that is able to do great things on modest capital. We expect to deliver a rewarding end to 2024 and an incredible 2025 if we are successful in our efforts. Have a great afternoon and thank you for your continued interest and support of BioCardia.

Ladies and gentlemen, with that, we’ll conclude today’s conference call and presentation. We do thank you for joining. You may now disconnect your lines.