Q2 2025 BioCardia Inc Earnings Call

Speaker #3: Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to BioCardia's second quarter financial results and business update conference call. All participants will be in listen-only mode.

Speaker #3: Should you need assistance, please signal the conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.

Speaker #3: To ask a question, you may press star, then one on your touch screen or keypad. To adjourn your question, please press star, then two.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Please go ahead, Miranda.

Speaker #4: Thank ou very much. Good afternoon and thank you all 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.

Speaker #4: 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.

Speaker #4: Such factors include, among others, the inherent uncertainties associated with developing new products and technologies and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

Speaker #4: 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 26, 2025, and in subsequently filed reports on Form 10-Q.

Speaker #4: The content of this call contains time-sensitive information that is accurate only as of today, August 11, 2025. 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.

Speaker #4: It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Speaker #5: Thank you, Miranda. And good afternoon to yone on the call. In our second quarter of 2025, we have been completing the Cardian Heart Failure Trial.

Speaker #5: Whose primary outcomes were presented as a late-breaking clinical trial at the American College of Cardiology's annual scientific sessions on March 30, 2025. For study patients, all on stable guideline-directed medical therapy, the Cardian Heart Failure Treatment Group had a lower incidence of both all-cause deaths and non-fatal MACE than the control group during the entire 24-month period of the Cardian Heart Failure study.

Speaker #5: With a P value of 0.17. And the composite endpoint of all-cause death, non-fatal MACE, and quality life was statistically significant in the subgroup of patients with elevated NT-proBNP with a P value of 0.02.

Speaker #5: As we have reviewed the data, there have been additional compelling observations that we anticipate will be detailed in the upcoming peer-reviewed manuscript. For our long-standing investors, this data is to your credit, as it provides objective evidence that together we have helped patients in a rigorous double-blind placebo-controlled trial.

Speaker #5: The Cardian Heart Failure Trial Clinical Package detailing this data has been provided to Japan's pharmaceutical and medical device agencies, or PMDA, and we hope to soon align on pathways to make this therapy available for physicians and their patients.

Speaker #5: Japan has a strong interest in heart failure therapy. And Japan's PMDA has approved other cell therapies including for heart failure. Our own cell processing platform is also approved in Japan by our partner Zimmer Biomet for orthopedic applications, which makes our Helix catheter system the only truly new product to be introduced.

Speaker #5: We expect two other cardiac cell therapies to be considered for approval by PMDA in the coming year, in addition to our Cardian cell therapy. We view the sponsors of these other cell therapies as potential partners for our Helix biotherapeutic delivery system.

Speaker #5: Which is supported by our experience and its use in clinical trials that have enrolled more than 400 patients. It is expected that the in-person meeting on the clinical consultation with PMDA, requested in July of 2025, will take place in mid-Q4 2025.

Speaker #5: If the parties are aligned, this could enable BioCardia to submit for approval of the Cardian system for market entry in Japan. In parallel, we have ongoing efforts toward requesting a meeting with the FDA on the approval of the FDA-designated breakthrough Cardian system based on this clinical data, also in the fourth quarter of 2025.

Speaker #5: We are continuing to gather evidence to support the therapy as well. And the Cardian Heart Failure II trial is actively enrolling patients at four clinical sites with the fifth to be activated in a few weeks' time.

Speaker #5: Our second program, the Cardian cell therapy and chronic myocardial ischemia, or BCDO2, has the rolling cohort final data for scientific presentation and publication ahead.

Speaker #5: The data to date has been excellent and we have no more details to share until that data is publicly ailable. In Q2, 2025, we had a successful data safety monitoring board review of the safety outcomes in the low-dose cohort in our Cardialo allogeneic mesenchymal stem cell therapy and ischemic heart failure, or BCDO3, our third program.

Speaker #5: Management's assessment is that we have good potential of receiving non-dilutive funding for this program in Q1 2026. On the Helix biotherapeutic delivery partnering front, we are actively preparing for submission for approval of this product via the de novo 510(k) pathway based on the strength of our clinical data.

Speaker #5: Our Helix has potential to be the first approved transendocardial biotherapeutic delivery system in the United States. We remain interested in partnering this technology and providing support to the many other cell and gene therapy firms working to enhance the therapeutic options for patients with cardiovascular disease.

Speaker #5: We continue to be focused on partnerships where our contributions to the success of partners will reward our shareholders. One element of the Helix delivery system is our proprietary FDA-approved morph DNA steerable introducer platform.

Speaker #5: We are continuing to detail its advantages to physicians and partners who may benefit from these products. Our goal is to partner this product and its underlying technology for the enormous cardiac electrophysiology market for the mapping and ablation of both atrial and ventricular tachyarrhythmias.

Speaker #5: The DNA technology design prevents whip in this catheter, which we developed and value for all of our Helix procedures, and is expected to have even greater value for ventricular ablation procedures should they require advancing the steerable introducer sheath in the left ventricle of the heart.

Speaker #5: On the business development front, we believe partnering can create meaningful value for shareholders with respect to each of our four platforms: Cardian, Cardialo, Helix, and Morph DNA.

Speaker #5: For Cardian cell therapy business development, we expect the clarity on anticipated approvals ahead will enhance interest by distribution partners and strategics. For Cardialo cell therapy business development, our allogeneic cell therapy we have the ability to manufacture our clinical-grade cells at a cost profile that is likely less than that of all our peers.

Speaker #5: We are also open to partnerships broadly in the many indications we are not currently pursuing. For our Helix biotherapeutic delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience products and support capabilities remain active in discussions.

Speaker #5: Current partners realize that minimally invasive delivery not only enhances future commercialization but is also seen as a critical means for clinical development. Enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their therapeutic development.

Speaker #5: Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery. We believe this advantage underlies our positive Cardian heart failure data and is due to the stability of the Helix in the beating heart and the self-sealing helical pathway into the tissue.

Speaker #5: On the more front, partnering discussions are underway for the greater than $10 billion per year electrophysiology market described in my earlier comments. We expect to soon announce more details on the fusion imaging partnership we have entered into, which has the potential to be valuable for all of our product offerings and partnering efforts.

Speaker #5: Looking forward, we have updated our milestones in our press release today, which are reflected in our updated corporate presentation available on our website. For BCDO1, our Cardian autologous cell therapy for heart failure, in Q4, we will aim to have the peer-reviewed manuscript accepted.

Speaker #5: Meetings with Japan PMDA and FDA on approval based on current data as we also enroll in Cardian heart failure II. For BCDO2, Cardian autologous cell therapy and chronic myocardial ischemia, in the fourth quarter, we intend to deliver final top-line data from the rolling cohort and seek peer-reviewed publication of the results.

Speaker #5: For BCDO3, Cardialo allogeneic mesenchymal stem cell therapy, and heart failure, we are projecting non-dilutive funding to come together in the first quarter of 2026. For our Helix biotherapeutic delivery system, we anticipate FDA submission for approval in the third quarter of this year.

Speaker #5: This is the current quarter. We also anticipate a financing in September. We are working to have be a success for current shareholders. Insider investors have supported recent financings in 2025 as they recognize the great potential we have to be impactful for patients with cardiovascular disease.

Speaker #5: And while doing well, I will now pass the call to David McClung, our CFO, who will review our second quarter of 2025 financial results.

Speaker #5: David?

Speaker #6: Thank you, Peter. And good afternoon, everyone. I'd like to take a moment to review the highlights of our financial results for the quarter and the six months ended June 30, 2025.

Speaker #6: Research and development expenses increased to approximately $1.4 million for the three months into June 2025, from approximately $0.8 million in the three months into June 2024.

Speaker #6: And increased to approximately $2.9 million in the six months into June 2025, from the six months into June 2024. The increases are driven by a close-out activities inclusive, including data analysis for the Cardian heart failure trial and enrollment in the subsequent Cardian heart failure II trial.

Speaker #6: Coupled with regulatory activities in Japan. We anticipate R&D expenses will increase modestly in 2025 year over year, as we continue advancing our therapeutic candidates in the United States and in Japan.

Speaker #6: Selling, general, and administrative expenses decreased to approximately $0.7 million in the three months ending June 2025, compared to approximately $0.9 million for the three months ending June 2024.

Speaker #6: Primarily due to lower professional fees and share-based compensation expense. Selling general and administrative expenses remain consistent at approximately $1.9 million during the six-month period into June 2025, as compared to $1.9, the same amount in the six months into June 2024.

Speaker #6: We expect 2025 SG&A expenses to track close to the 2024 levels year over year. Our net loss was approximately $2.0 million for the three months ended June 2025, compared to approximately $1.6 million for the three months ended June 2024.

Speaker #6: And was approximately $4.8 million for the six months into June 2025, compared to approximately $3.9 million for the six months into June 2024. With the increases in research and development expenses, net cash used in operations similarly increased.

Speaker #6: Net cash used in operations during the three months into June 2025 increased $300,000 to approximately $1.6 million compared to approximately $1.3 million for the three months into June 2024.

Speaker #6: Net cash used in operations for the six-month period ending June 2025 was approximately $3.3 million, compared to $2.8 million for the six months ending June 2024.

Speaker #6: The company ended the quarter with cash and cash equivalents totaling $980,000. In the third quarter, we sold $769,000 in BioCardia common stock under our ATM facility at an average price of $259 per share.

Speaker #6: Bringing our current cash balance to approximately $1.1 million. This provides us with runway into October, exclusive of any additional capital from future business development or financings.

Speaker #6: We will work hard to continue our track record of efficient use of resources and optimizing the cost of capital. This concludes our prepared comments, and we're now happy to take questions from attendees.

Speaker #3: Thank you. At this time, we will now begin the question and answer session. To ask a question, you may press star then one on your touchpad.

Speaker #3: If you are using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw the question, please press star then two.

Speaker #3: At this time, we will pause momentarily to assemble our roster. And our first question today comes from Joe Pantingenis with HC Wainwright. Please go head.

Speaker #7: Hello, everyone. This is Landa Ron for Joe. Thanks for taking our estions. So maybe Peter, could you elaborate a little bit more on the expectations regarding PMDA reviewing Cardian for heart failure as a medical device?

Speaker #7: You talked a little bit about it in your last week's press release point of care therapies versus laboratory manufactured. What are the key differences in terms of regulatory reviews, timelines, and potential approval?

Speaker #5: Thank you for the estion, Landa. So fundamentally, the approval process is not dissimilar I think that it's viewed as actually a lower hurdle for a medical device approval, particularly as the Cardian cell therapy system has nothing that is left behind in the patient such as a a stent or a hip or a a heart valve, for example.

Speaker #5: The nuance here is the standard consultation process with PMDA. The current hurdle before us is, you know, a clinical consultation on the data and positioning of the therapy in the continuum of heart failure care.

Speaker #5: And so okay, what we have done is we have detailed for PMDA where this lies in the continuum of care. Currently, in Japan, the care is substantially equivalent to the care in the United States.

Speaker #5: With the same four pillars of medication, I think key differences in Japan are the utilization of left ventricular assist devices and the low use of heart transplantation for heart failure in Japan.

Speaker #5: And that last is something I'd like to comment on a little. In Japan, because of sort of the culture of the wholeness of the individual, there's not a great adoption of transplanted organs because it's it's not the it's from another individual.

Speaker #5: And I share that because it's important relative to Cardian because Cardian is an autologous cell therapy. It is a the patient's own cells delivered in a straightforward procedure with processing at point of care.

Speaker #5: And the value proposition here is it aligns completely with the cultural preferences of the Japanese and then from a a logistics and commercialization perspective, it fits neatly into the existing medical device distribution channels in Japan.

Speaker #5: So we have already had conversations around distribution partnerships. Should we be fortunate and have PMDA align on the acceptability of Cardian? I note today in Japan because they don't have heart transplantation, as a primary therapy because of that cultural sense of the wholeness of the individual, there's a huge need in heart failure.

Speaker #5: You know, patients are dying at the same rates they are in the United States, which is approximately, you know, 10% per year and 50% at five years.

Speaker #5: And so the way we see Cardian as a one-time therapy of delivering very high concentrations of a patient's own cells in and around damaged regions of the heart based on the results that we presented demonstrating reduced mortality, reduced all-cause death, reduced major adverse cardiac events, and improved quality of life, we do think that there's a very compelling argument to support the adoption of of Cardian cell therapy.

Speaker #5: I note that under the regenerative medicine pathway, other companies such as Helios for pulmonary acute respiratory distress and Terumo for their heart sheet product have historically been able to achieve conditional approvals based on a small number of patients showing preliminary signs of safety and efficacy.

Speaker #5: And following up those early studies with post-marketing studies in their conditional period. So similar to those approaches, you know, Japan PMDA has the ability to request post-marketing study of Cardian heart failure therapy and provide and secure additional data on both safety and efficacy in the Japanese population.

Speaker #5: So, that's sort of a high-level snapshot. I could probably talk for hours about the nuances between regulatory approval in Japan and the United States.

Speaker #5: I can tell you that the folks we've interacted with are extremely professional, highly detail-oriented, and we're pretty excited about the upcoming clinical consultation.

Speaker #8: Got it. Thank you. That's very useful. And for the Cardian CMI program, the rolling core data that are anticipated in fourth quarter, these are related to the primary endpoint results, right, at six months?

Speaker #5: Correct.

Speaker #8: Okay. Perfect. Perfect. Thank you. Thanks.

Speaker #5: No worries. No worries. And this data what is what this potential the timing here is just making sure we've got the data monitored and we're looking at you ow the the definitive final rolling cohort data for that that population.

Speaker #8: Awesome. Thanks again. Thank ou.

Speaker #5: Thank you for the question.

Speaker #8: Lana.

Speaker #3: Our next question today comes from James Maloy at Alliance Global Partners. Please go head.

Speaker #9: Hey, guys. anks for my questions. On the fourth quarter, Japanese and US regulatory meetings, if you know, if you get the sort of the response which I presume would be, yeah, go head and file.

Speaker #9: what would the timing look like on that? and then what sort of how would you game out other potential outcomes to come out of those two separate meetings?

Speaker #5: Well, Jim, thank you for the question. And welcome to the call. The first part of the question, what if things go well? Well, let's just focus on Japan PMDA.

Speaker #5: So if they accept our positioning for the Cardian cell therapy and they agree that this makes sense, then the meeting minutes could potentially end with you addressing the following questions.

Speaker #5: in your application for approval. then there's whole series of steps that are required for that approval process. including detailed audits of our operations, our our our clinical data and so on.

Speaker #5: And it's a similar pathway for the FDA with the BIMO audits and what have you. So our expectation is for either case that the process would take as much as a year to achieve.

Speaker #5: and so the the nice thing though is once that pathway has been opened your confidence in success is is is far greater than than it is at this juncture.

Speaker #5: the the nuance of this in Japan is that you know we're we will be working on both reimbursement and on distribution partner as soon as this if this meeting comes out to be positive on the other side as we as we hope it is.

Speaker #5: and and with FDA there's a slightly different timeline we're ursuing in that we're submitting our Helix system for FDA approval based on the totality of data in advance to to submitting and engaging with them on the Cardian approval because the Helix is part and parcel of the system.

Speaker #5: So all of the work that goes into the regulatory files for all three of these submissions is substantially the same information. so you know that will be going in first to FDA and then we will be engaging them on you ow Cardian heart failure.

Speaker #5: They also are receiving you know annual reports and the the final data on Cardian heart failure as well. so if things go well, we'll be on a pathway towards approval in an enormous market.

Speaker #5: We would expect some post-marketing requirements for both the FDA and PMDA. you know we recognize that you know we did not hit the primary endpoint but you know the FDA has approved previous heart failure therapies based on subgroup analysis and required post-marketing studies.

Speaker #5: In some cases, they've looked to a confirmatory trial, and we already have a confirmatory trial actively enrolling at four, and soon to be five, centers.

Speaker #5: So so we're we're advancing the therapy. If if things don't go our way as you describe it and that they're say it's a negative, we're continuing full bore here in the United States.

Speaker #5: I think that if Japan PMDA is not supportive, and because of resources and what have you, we would be completely focused on the United States going forward.

Speaker #5: but that's where we've done most of our our trial work to date. but I I'm ally very optimistic with respect to Japan ahead and I think the FDA will be open to this.

Speaker #5: I don't think there's a better time in the administration than today with respect to you ow the the interest in you know this is an autologous cell therapy, right?

Speaker #5: This is a minimally delivered autologous cell therapy. We leave nothing behind but the patient's own cells in high concentration and it's supported by very rigorous data that's quite compelling in heart failure and patients on guideline-directed medical therapy.

Speaker #5: Using all of the latest drugs that are available, we were able to demonstrate a reduction in MACE over the entire course of the trial, with a P value of 0.17.

Speaker #5: We're also able to demonstrate that the composite endpoint in the patients with elevated NT-proBNP, you know, was statistically significant. So, if we do get you an approval in Japan or in the United States, you know, BioCardia would not seek it across all the patients.

Speaker #5: We would be eking it out for those patients who are on guideline-directed medical therapy and still have evidence of active heart failure because of their elevated biomarkers for heart failure or NT-proBNP.

Speaker #3: That may be the final question then. Thank you for that. The partnership environment, now you touched on it briefly in your prepared remarks. It would be fair to say that partnerships are more or less on hold until clarity on the FDA and in the Japanese PDMA.

Speaker #5: So I would say a resounding no to partnerships being on hold. the for for Cardian, I would say yes. That's a key element and milestone.

Speaker #5: But you know we have very active discussions today around, you know, our technology platforms. And primarily, you know, we have an active dialogue and relationship with Helix, and an active dialogue and relationship with Morph.

Speaker #5: And even Cardialo has had interest from folks going after other indications because of our ability to manufacture cells with a small footprint. So I think Cardialo is the main event because of the value proposition there. We have had discussions and have active conversations with partners for distribution in Japan.

Speaker #5: And they're they're plugged in and they're they're aware. And so this next conversation is the big deal. I think that the the the nuance of reimbursement in Japan is also going to be important ahead.

Speaker #5: And so we think that there are great opportunities for us to be successful. We believe that the reimbursement we already have in the United States, at $17,500 per procedure, is compelling for that partnering activity.

Speaker #5: but we also think it's compelling for the Ministry of Health, Labor, and Welfare in Japan because the other cardiac therapies they've historically approved they provided a reimbursement that was almost 10 times that amount.

Speaker #5: So our sense is we we come to them with a more reasonably priced therapy that also interweaves the autologous aspects of it. And the folks we're talking to, Jim, there on partnering for Cardian, are are fundamentally medical device distributors.

Speaker #5: So the there are a number of cardiovascular products. There's also US interventional cardiology groups in Japan who sell direct and so those would be other folks that we would be actively talking to.

Speaker #3: Great. Thank you for taking the questions.

Speaker #5: No. Thanks, George. Jim, be well. Have a great day.

Speaker #3: And our next estion today comes from Kumar Raja with Recline Capital Markets. Please go ahead.

Speaker #10: Thanks for taking my questions. So Peter, with regard to the meeting with the FDA is this going to be a Type B meeting or a Type C meeting?

Speaker #10: And with regard to the HF2 trials, where do you stand with regard to the screening? Maybe ou can highlight you know how the screening is going and when we can expect the patients to come on board and be treated.

Speaker #5: So right , so Kumar, thank you for the question. Great question and delighted to have you on the call. with respect to the FDA, we haven't decided what the type of meeting is.

Speaker #5: So remember, this Cardian has FDA breakthrough designation. And so we're contemplating the pros and cons of having a Sprint discussion with them on this issue.

Speaker #5: to help get early feedback. versus doing another another pathway. And we're teeing this up in our annual report for for the FDA. in parallel, we're working on the submission of a de novo 510K for the Helix system.

Speaker #5: So the idea here is that you know the the only thing I think the agency would be concerned with respect to on the risk side is our Helix system, which has you ow extensive data that's highly supportive of it.

Speaker #5: fact, you know I ran into the Brand Zuckerberg, who is the you know the head of the devices at FDA and they actually at Sieber have blessed folks to do clinical studies with Helix without even talking to BioCardia.

Speaker #5: They're ally supposed to get a letter of of reference. They're very comfortable with Helix as our sense. so the idea is to secure the discussion process around the de novo 510K.

Speaker #5: And once that's in, then engage on Cardian and be le to say, with respect to Cardian, you've already approved the cell processing platform for use in processing diagnostics.

Speaker #5: The Helix system is under a de novo 510K process. we're we're interested in your approving the combination for this autologous cell therapy based on the totality of clinical data we have in these three trials.

Speaker #5: For these heart failure patients, which currently have a rate of mortality of 50% at every five years. And they're already on guideline-directed medical therapy.

Speaker #5: There are no other options for them today. Under what pathway can you enable us potentially with guardrails in the form of post-marketing studies enable patients to have access to this therapy?

Speaker #5: And achieve the clinical results we've demonstrated in our CADME trial, our TACIF trial, and now also in our Cardian heart failure trial? So that's sort of the pathway there ahead.

Speaker #5: And then your second question, Kumar, and did that answer the first question? Are you comfortable with that?

Speaker #10: Yeah. It does. Thank you.

Speaker #5: All right. Then the second question of where we at in Cardian heart failure two. Cardian heart failure two, so it's the same team that is closing out Cardian heart failure one preparing the clinical study reports and involved in the regulatory activities that is also supporting Cardian heart ilure two.

Speaker #5: Nicely, Cardiac heart failure two is a modification of what we had done in the Cardiac heart failure trial. And, you know, the folks who participated are aware of the data and pretty jazzed about the data that we ultimately have from Cardiac heart failure.

Speaker #5: So right now we've got four centers that are actively enrolling. We have a fifth center that's about to begin, and we've treated a few patients so far.

Speaker #5: One of the things that happens in this trial is that we have a longer lead-in time to treatment to look at the Hawthorne effect of these patients.

Speaker #5: And so for those who aren't real familiar with clinical study design, the Hawthorne effect is the the fact that when you start to observe a subject, their behavior changes.

Speaker #5: And so we're observing the patients for a month before they go through their baseline measures so they know they're in the trial. We work on them to get them compliant to their medications.

Speaker #5: We we get them as stable as we can possibly get them for a whole month and then they go through the screening for the the baseline measures and and enter into the trial.

Speaker #5: And we've treated a few patients. I think if you look on LinkedIn, there are a couple of pictures of our first cases with different physicians. You know, this is much easier to do because it's something that we've already been through.

Speaker #5: So fewer bumps in the road this time. The primary endpoint is the endpoint. We have a P value of 02 on in the patients with elevated NT-proBNP.

Speaker #5: And all patients in this trial will have elevated NT-proBNP at greater than 500 picograms per mL. So yeah, it's it's it's if anything, it's getting easier.

Speaker #5: And we don't have the burdens, Kumar, of COVID. We don't have the burdens of other really competing trials. To our knowledge, this is the only large cell therapy trial in the United States at this point in time.

Speaker #5: And and we'll be marshaling it forward. But it's it's a secondary priority to getting these regulatory submissions in place and just because of you know cost of resources and our team you know bear with us as we close out the regulatory submissions.

Speaker #5: And and there is potential if the FDA decides to get supportive of Cardian as a therapy that we would modify the trial and could conceivably make it a you know an open label registry in which case you know maybe with a historical control, maybe we match it to the controls we have from our own study.

Speaker #5: But either way, there's lots of things by having that active trial it feeds back into what we might do ahead. And remember, Cardian, HF2, has the same Medicare reimbursement as our other two trials.

Speaker #5: So, if it was converted to an open-label registry, not only would it go very quickly, but you know there wouldn't be any significant sudden cost to BioCardia because we have the reimbursement in place.

Speaker #10: Okay. Just one clarity with regard to the timelines. So by end of Q4, you will have a clarity both from the PMD as well as the FDA that the ectation?

Speaker #5: We will have clarity from PMDA FDA is behind that because we're going to be submitting the de novo 510K for Helix first. So it could it's going to be close on the Helix.

Speaker #5: But soon thereafter.

Speaker #10: Okay. Great. Thanks so much.

Speaker #5: No worries. I appreciate the questions, Kumar.

Speaker #3: Thank you. And our next question comes from Chris W. at Investor. Please go ahead.

Speaker #11: Hi. Peter, can you hear me?

Speaker #5: I can. Hi, Chris.

Speaker #11: Hey there. A couple of questions for BCDA. DAO2, you are preparing to release or present data. What are your expectations following the data readout for that trial?

Speaker #5: So right now, that program we're going release that data. We are working on active conversations with respect to partnering. And you know my sense is, Chris, a lot of it depends on what happens with PMDA and FDA.

Speaker #5: If PMDA gives us the signal that, "Yeah, we're going to be allowed to apply for approval," our reality changes. We will easily have relatively non-dilutive capital to accelerate the BCDA O2 program.

Speaker #5: there are competitive programs to BCDA O2. But if you look at our corporate presentation, which was just updated today and available on our website, it compares the outcomes in BCDA O2.

Speaker #5: This is the Cardian cell therapy for patients in refractory angina as a function of chronic myocardial chemia. you know we are seeing the same or better results than what was demonstrated in the Baxter healthcare CD34 program.

Speaker #5: And I think that's a really important historical data point to take into mind because the Baxter program it was stopped primarily because of the cost of the autologous therapy.

Speaker #5: So we have published previously at the European Society of Cardiology heart failure the CD34 dosages we have in Cardian cell therapy in the Cardian heart failure trial.

Speaker #5: And all of our on on our patients on average are greater than the CD34 cell dosage achieved in the Baxter healthcare trial. This is important because you know in Baxter, we could estimate that their cost of goods for their therapy was on the order of as much as 50 to 60 thousand dollars.

Speaker #5: Whereas in our hands, by bringing it to point of care and processing the cells in the fashion we do, we are improving the efficiency of delivery and creating a screening approach where we only treat patients who have the appropriate cells on board. We've dialed some things in so that the therapy can actually be a very low-cost therapy.

Speaker #5: So instead of doing what Baxter did, which was to take the cells, and remotely process them, and bring them back to the the center, which has enormous costs.

Speaker #5: And that's one of the big problems with autologous cell therapy. We have essentially taken the patient. We screen the patients and say, "We're selecting the patients.

Speaker #5: Do you have the appropriate cells on board with a very inexpensive diagnostic? And then can we go in and process the cells at point of care with a relatively inexpensive approach so that you know our cost of goods can be literally less than 2% of what the cost of goods for the Baxter Healthcare program is.

Speaker #5: So yeah, we're very excited about BCDA O2. It's just right now, you know it's resources and prioritization. And so top priority is still BCDA O1.

Speaker #5: The top priorities for BCDA O1 are the regulatory submission discussions where we have a number of board members who are very enthusiastic. And then you know also the confirmatory trial.

Speaker #5: Those are our top priorities. But if we have more resources or if partnering steps up for that program, BCDA 2 is very well positioned to expand.

Speaker #5: and it's a it's a great program.

Speaker #11: That's great. That's great. one more if I can.

Speaker #5: Yes.

Speaker #11: Go ahead, Chris.

Speaker #5: So it sounds like

Speaker #11: there are new there are some new data observations that were picked . And you've mitted those from your prepared remarks. You've submitted those to the PMDA.

Speaker #11: Will BioCardia be releasing or presenting that data to the public? Or is that just for regulatory submissions? And the and the second one, anything additional you might be able to share about a beneficial September raising event, how that would be beneficial to current shareholders?

Speaker #11: If you're able to share anything in regard.

Speaker #5: Absolutely. Yeah. No. Absolutely.

Speaker #11: Thank you.

Speaker #5: So so first question. No. Great questions. These are great questions. And I appreciate them. So so yeah. So when we had the late-breaking clinical trial presentation at the American College of Cardiology, which by the way is was a great honor that they gave us a late-breaking clinical trial and we're we're very thankful to the leadership at the American College of Cardiology for that.

Speaker #5: You know, we were scrambling to pull all data together in time for that presentation. And we got it done. The data's all monitored. It's good data.

Speaker #5: You can hang your hat on it. We're very proud that we got that done. But, as I'm sure you know, there's an enormous amount of data and observations here.

Speaker #5: And so you there's I can I can share from my perspective the data only gets better when you understand it more. that said, we need to make that the peer-reviewed perspective.

Speaker #5: And so we are working with our distinguished investigators to pull together a manuscript based on this awareness of some of these nuances of the data.

Speaker #5: and have this reviewed and published. So it'll be accessible for all. I can't say that everything we've seen will be in there. just because inherently there are things that you ow just don't make it into the journal that are more appropriate you know in the regulatory dynamic.

Speaker #5: But from my perspective, we hope to have as much in that peer-reviewed manuscript and potentially even a supplement as we can to share what we're seeing with respect to this data.

Speaker #5: So that's sort of a response on that comment. As regards to your question on the financing, so, you know, right now, I mean, look at how we finance historically.

Speaker #5: So yes, we have had times where we've won standard banking financing, and you know we've had some challenges with it. But you know, the two financings we've won have been very little dilution.

Speaker #5: They've been assigned to long holders for the most part. And and since then, we've had some phenomenal things come together. Now the markets are not reflecting where we're at.

Speaker #5: I don't know there's anywhere else in the world you can buy stock in a company that has a a what is pivotal trial data for a heart failure therapy, an enormous opportunity before regulators for the price of our stocks going for today.

Speaker #5: And that embarrasses me. but at the same time, you know we have a lot of good relationships. We have a lot of active partnering discussions.

Speaker #5: And so we're we're doing our best to pull together a financing that that you know is is a positive for all shareholders. we're take this very seriously.

Speaker #5: And we're trying to be as wise as we can about it. if you look at how we've utilized the ATM recently, you can see that we've you know the shares we've sold are you know well above the average share price that we've had of late.

Speaker #5: and those are you ow straight common shares with no bells and whistles and discounts. They're at the the peak of the market. so I I got to tell you, Chris, I can't wait till we get to profitability because you know I I and the management team and the board, nobody likes dilution.

Speaker #5: But we're trying to be as thoughtful as we can and bring together a deal to fund us. we keep our burn rate low so we don't need much capital.

Speaker #5: You know if you look at the burn rate that David has detailed, you ow we are very we're trying to be what I think of as wisely frugal.

Speaker #5: And so with that, we don't waste money on things that don't ake enormous sense. We've secured a reimbursement for our trials. We've winds reducing our R&D expense.

Speaker #5: So right now, you know our annual burn rate is on the order of $6 million for a company that's pushing through three trials.

Speaker #5: And has all these active partnering discussions. So I think it's going to be interesting. I can't tell you any more details around it than we are going to the folks that we know.

Speaker #5: We are detailing where we're at, and there's a lot of folks who are willing to bet on a company that not only has stable products under its belt with its Morph and its Helix, but is going after approvals for therapies in the near term.

Speaker #5: And though and it's not like we're saying we're going to apply for approval for Cardian and prepare the dossiers. Those dossiers are already in substantially.

Speaker #5: So I think it's going to be really interesting next six months for everybody who's here. And those who are shareholders in BioCardia, you know you're helping us to do this.

Speaker #5: You're ping us to advance a new therapy that has the potential to impact millions. And I think that the data is excellent. It's not all we want to be.

Speaker #5: But you know when you're ating patients on guideline-directed medical care, they're already being optimally managed. And you're able to show a benefit in addition to it.

Speaker #5: Not instead of it. That's a great thing. And it's ething that everybody involved should be proud .

Speaker #11: Well, thank you for that. I appreciate that info. Good luck on the upcoming meetings.

Speaker #5: All right. I appreciate it.

Speaker #3: Thank you. And Dr. Alma, that closes the question and answer session. So I'd like to turn the call back over to you, sir, for any closing remarks.

Speaker #5: Appreciate it, Rocco. Yeah. I I guess I would just reiterate what I I I detailed for Chris. That supporting BioCardia as an investor you are also responsible for the benefits delivered to patients in the Cardian heart failure trial.

Speaker #5: As investors in BioCardia, you have done good for others. Our focus today is to get around to delivering the increased value for our investors so that they can do well as we pursue the Cardian system and Helix approvals.

Speaker #5: So on behalf of our hardworking team here at BioCardia, I thank you for your continued support. Have a at afternoon.