BioCardia - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 EPS was $(0.40) versus consensus of $(0.50), a beat of $0.10; revenue was $0 versus $0 consensus (in line). Sequentially, EPS improved from $(0.59) in Q1, driven by lower SG&A and modestly lower R&D. Consensus values marked with * were retrieved from S&P Global.
• Management highlighted near-term regulatory catalysts: Helix De Novo 510(k) submission targeted for Q3 2025, and CardiAMP HF clinical consultation with Japan PMDA mid‑Q4 2025; an FDA meeting request on CardiAMP is also planned for Q4 2025.
• Cash was $0.98M at quarter-end; $0.77M raised via ATM post-quarter, bringing cash to ~$1.1M and runway into October 2025; management also “anticipates a financing in September”.
• Operational momentum: CardiAMP HF II confirmatory trial now has four sites actively enrolling with a fifth coming; Henry Ford Health initiated enrollment in July.
• Business development: Exclusive Heart3D Fusion Imaging partnership with CART‑Tech announced on Aug 13, expected to enhance image-guided cardiac biotherapeutic delivery; Helix positioned as potentially the first approved transendocardial biotherapeutic delivery system in the U.S..

What Went Well and What Went Wrong

What Went Well

• EPS beat vs consensus: $(0.40) actual vs $(0.50)* expected, aided by lower SG&A and slightly lower R&D sequentially; Q2 SG&A $0.683M vs $1.196M in Q1, R&D $1.368M vs $1.530M in Q1.
• Clinical/regulatory progress: PMDA consultation expected mid Q4, FDA meeting request in Q4, and Helix De Novo 510(k) submission targeted for Q3; CEO: “Our Helix has potential to be the first approved transendocardial biotherapeutic delivery system in the United States”.
• Trial execution: CardiAMP HF II actively enrolling at four sites with a fifth imminent; Henry Ford Health initiated enrollment, reinforcing site momentum.

What Went Wrong

• Year-over-year net loss widened: $(2.049)M in Q2 2025 vs $(1.646)M in Q2 2024, reflecting higher R&D (CardiAMP HF closeout and HF II start-up).
• Cash remains constrained: $0.98M at 6/30; despite ATM proceeds, runway extends only into October and management signaled need for a September financing.
• No formal numeric revenue or margin guidance; company remains pre‑revenue with limited revenue visibility, and margins are not meaningful given zero collaboration revenue in Q2.

Transcript

Speaker 0

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia second quarter financial results and business 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.

Speaker 3

Thank you very much. Good afternoon and thank you all for participating in today's conference call. Joining me from BioCardia's leadership team are Dr. 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 26, 2025, and in subsequently filed reports on Form 10-Q.

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

Speaker 2

Thank you, Miranda, and good afternoon to everyone on the call. In our second quarter of 2025, we have been completing the CardiAmp Heart Failure Trial, 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 CardiAmp 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 CardiAmp Heart Failure Study, with a P-value of 0.17. The composite endpoint of all-cause death, non-fatal MACE, and quality of life was statistically significant in the subgroup of patients with elevated NT-proBNP, with a P-value of 0.02. 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 longstanding investors, this data is to your credit, as it provides objective evidence that together we have helped patients in a rigorous double-blind placebo procedure control trial. The CardiAmp Heart Failure Trial clinical package detailing this data has been provided to Japan’s Pharmaceutical and Medical Device Agency, or PMDA, and we hope to soon align on pathways to make this therapy available for physicians and their patients. 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. We expect two other cardiac cell therapies to be considered for approval by PMDA in the coming year, in addition to our CardiAmp cell therapy.

We view the sponsors of these other cell therapies as potential partners for our Helix biotherapeutic delivery system, which is supported by our experience and its use in clinical trials which 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 mid-Q4 2025. If the parties are aligned, this could enable BioCardia to submit for approval of the CardiAmp system for market entry in Japan. In parallel, we have ongoing efforts towards requesting a meeting with the U.S. Food and Drug Administration on the approvability of the FDA-designated breakthrough CardiAmp system based on this clinical data, also in the fourth quarter of 2025.

We are continuing to gather evidence to support the therapy as well, and the CardiAmp Heart Failure II trial is actively enrolling patients at four clinical sites, with the fifth to be activated in a few weeks' time. Our second program, the CardiAmp Cell Therapy in Chronic Myocardial Ischemia, or BCDA-02, the rolling cohort final data for scientific presentation and publication is ahead. The data to date has been excellent, and we have no more details to share until that data is publicly available. In Q2 2025, we had a successful data safety monitoring board review of the safety outcomes in the low-dose cohort in our CardiALLO allogeneic mesenchymal stem cell therapy in ischemic heart failure, or BCDA-03, our third program. 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 de novo 510(k) pathway based on the strength of our clinical data. Our Helix has potential to be the first approved transendocardial biotherapeutic delivery system in the U.S. 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. 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. 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. The DNA technology design prevents whip in this catheter, which we developed in 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. On the business development front, we believe partnering can create meaningful value for shareholders with respect to each of our four platforms: CardiAmp, Cardiallo, Helix, and Morph DNA. For CardiAmp cell therapy business development, we expect that clarity on anticipated approvals ahead will enhance interest by distribution partners and strategics.

For Cardiallo 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. 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. 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. Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery.

We believe this advantage underlies our positive CardiAmp 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. On the Morph 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 that has potential to be valuable for all of our product offerings and partnering efforts. Looking forward, we have updated our milestones in our press release today that are reflected in our updated corporate presentation available on our website. For BCDA-02, our CardiAmp autologous cell therapy in heart failure, in the fourth quarter, we will aim to have the peer-reviewed manuscript accepted, meetings with Japan’s Pharmaceutical and Medical Device Agency (PMDA) and U.S.

Food and Drug Administration (FDA) on approvability based on current data as we also enroll in CardiAmp Heart Failure II. For BCDA-02, CardiAmp autologous cell therapy in 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. For BCDA-03, Cardiallo allogeneic mesenchymal stem cell therapy in heart failure, we are projecting non-dilutive funding coming 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. This is the current quarter. We also anticipate a financing in September that 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 and while also doing well.

I will now pass the call to David McClung, our CFO, who will review our second quarter 2025 financial results. David?

Speaker 1

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. Research and development expenses increased to approximately $1.4 million for the three months ended June 2025, from approximately $0.8 million in the three months ended June 2024, and increased to approximately $2.9 million in the six months ended June 2025 from the six months ended June 2024. The increases are driven by closeout activities, including data analysis for the CardiAmp Heart Failure Trial and enrollment in the subsequent CardiAmp Heart Failure II Trial, 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 U.S. and in Japan.

Selling, general and administrative expenses decreased to approximately $0.7 million in the three months ended June 2025 compared to approximately $0.9 million for the three months ended June 2024, 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 ended June 2025 as compared to $1.9 million, the same amount in the six months ended June 2024. 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, and was approximately $4.8 million for the six months ended June 2025 compared to approximately $3.9 million for the six months ended June 2024.

With the increases in research and development expenses, net cash used in operations similarly increased. Net cash used in operations during the three months ended June 2025 increased $300,000 to approximately $1.6 million compared to approximately $1.3 million for the three months ended June 2024. Net cash used in operations for the six-month period ended June 2025 was approximately $3.3 million as compared to $2.8 million for the six months ended June 2024. 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 $2.59 per share, 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.

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 0

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. 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 the question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question today comes from Joe Pantginis with HC Wainwright. Please go ahead.

Speaker 6

Hello, everyone. This is Lan Deron for Joe. Thanks for taking our questions. Peter, could you elaborate a little bit more on the expectations regarding Japan’s Pharmaceutical and Medical Device Agency (PMDA) reviewing CardiAmp for heart failure as a medical device? You talked a little bit about it on 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 2

Thank you for the question, Landa. 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 CardiAmp cell therapy system has nothing that is left behind in the patient, such as a stent or a hip or a heart valve, for example. The nuances here are the standard consultation process with PMDA, and the current hurdle before us is a clinical consultation on the data and positioning of the therapy in the continuum of heart failure care. 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 U.S. 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. That last is something I'd like to comment on a little. In Japan, because of the culture of the wholeness of the individual, there's not a great adoption of transplanted organs because it's from another individual. I share that because it's important relative to CardiAmp because CardiAmp is an autologous cell therapy. It is the patient's own cells delivered in a straightforward procedure with processing at point of care. The value proposition here is it aligns completely with the cultural preferences of the Japanese. From a logistics and commercialization perspective, it fits neatly into the existing medical device distribution channels in Japan. We have already had conversations around distribution partnerships.

Should we be fortunate and have PMDA align on the acceptability of CardiAmp, 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. Patients are dying at the same rates they are in the U.S., which is approximately 10% per year, 50% at five years. The way we see CardiAmp 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 deaths, 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 CardiAmp cell therapy.

I note that under the regenerative medicine pathway, other companies such as Helios for pulmonary acute respiratory distress and by Terumo for their HeartSheet product historically, they've been able to achieve conditional approvals based on a small number of patients showing preliminary signs of safety and efficacy and following up those early studies with post-marketing studies in their conditional period. Similar to those approaches, Japan’s Pharmaceutical and Medical Device Agency (PMDA) has the ability to request post-marketing study of CardiAmp heart failure therapy and provide and secure additional data on both safety and efficacy in the Japanese population. That's sort of a high-level snapshot. I could probably talk for hours about the nuances between regulatory approval in Japan and the U.S. 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 6

Got it. Thank you. That's very useful. For the CardiAmp CMI program, the rolling cohort data that are anticipated in the fourth quarter, these are related to the primary endpoint results, right, at six months?

Speaker 2

Correct.

Speaker 6

Okay. Perfect. Thank you. Thanks.

Speaker 2

No worries. 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 the definitive final rolling cohort data for that population.

Speaker 6

Awesome. Thanks again. Thank you.

Speaker 2

Thank you for the question, Lana.

Speaker 0

Our next question today comes from James Malloy at Alliance Global Partners. Please go ahead.

Speaker 4

Hey, guys. Thanks for taking my questions. On the fourth quarter, Japanese and U.S. regulatory meetings, if you know, if you get the sort of the best response, which I presume would be, yeah, go ahead and file, what would the timing look like on that? What sort of how would you game out other potential outcomes to come out of those two separate meetings?

Speaker 2

Jim, thank you for the question and welcome to the call. The first part of the question, what if things go well? Let's just focus on Japan’s Pharmaceutical and Medical Device Agency (PMDA). If they accept our positioning for the CardiAmp cell therapy and they agree that this makes sense, the meeting minutes could potentially end with, you know, address the following questions in your application for approval. Then there's a whole series of steps that are required for that approval process, including detailed audits of our operations, our clinical data, and so on. It's a similar pathway for the U.S. Food and Drug Administration (FDA) with the BIMO audits and what have you. Our expectation is for either case, that process would take as much as a year to achieve.

The nice thing, though, is once that pathway has been opened, your confidence in success is far greater than it is at this juncture. The nuance of this in Japan is that, you know, we will be working on both reimbursement and on a distribution partner as soon as this, if this meeting comes out to be positive on the other side, as we hope it is. With FDA, there's a slightly different timeline we're pursuing in that we are submitting our Helix biotherapeutic delivery system for FDA approval based on the totality of data, in advance to submitting and engaging with them on the CardiAmp approval because the Helix is part and parcel of the system. All of the work that goes into the regulatory files for all three of these submissions is substantially the same information.

That will be going in first to FDA, and then we will be engaging them on CardiAmp heart failure. They also are receiving annual reports and the final data on CardiAmp heart failure as well. If things go well, we'll be on a pathway towards approval in an enormous market. We would expect some post-marketing requirements for both the FDA and PMDA. We recognize that we did not hit the primary endpoint, but the FDA has approved previous heart failure therapies based on subgroup analysis and required post-marketing studies. 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. We're advancing the therapy.

If things don't go our way, as you describe it, and they say it's a negative, we're continuing full bore here in the U.S. I think that if Japan’s Pharmaceutical and Medical Device Agency (PMDA) is not supportive because of resources and what have you, we would be completely focused on the U.S. going forward. That's where we've done most of our trial work to date. I'm actually very optimistic with respect to Japan ahead. I think the U.S. Food and Drug Administration (FDA) will be open to this. I don't think there's a better time in the administration than today with respect to the interest in, you know, this is an autologous cell therapy, right? 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.

Patients on guideline-directed medical therapy using all of the latest drugs that are available, we were able to demonstrate reduction in major adverse cardiac events (MACE) over the entire course of the trial and a P-value of 0.17. We're also able to demonstrate that the composite endpoint in the patients with elevated NT-proBNP was statistically significant. If we do get, you know, an approval in Japan or in the U.S., BioCardia would not seek it across all the patients. We would be seeking it 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 4

Maybe final question then. Thank you for that. The partnership environment, now you touched on it briefly in your prepared remarks. Would it be fair to say partnerships are more or less on hold until clarity on the FDA and the Japan’s Pharmaceutical and Medical Device Agency?

Speaker 2

I would say a resounding no to partnerships being on hold. For CardiAmp, I would say yes. That's a key element and milestone. We have very active discussions today around our technology platforms. Primarily, we have active dialogue and relationship with Helix, active dialogue and relationship with Morph, and even Cardiallo has had interest for folks going after other indications because of our ability to manufacture cells with a small footprint. I think CardiAmp, the main event, because of the value proposition there, we have had discussions and have active conversations with partners for distribution in Japan. They're plugged in and they're aware. This next conversation is the big deal. I think that the nuance of reimbursement in Japan is also going to be important ahead. We think that there's great opportunities for us to be successful. We think that the reimbursement we already have in the U.S.

at $17,500 per procedure is compelling for that partnering activity. 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. Our sense is we come to them with a more reasonably priced therapy that also interweaves the autologous aspects of it. The folks we're talking to, Jim, there on partnering for CardiAmp are fundamentally medical device distributors. There are a number of cardiovascular products. There are also U.S. interventional cardiology groups in Japan who sell direct. Those would be other folks that we would be actively talking to.

Speaker 4

Great. Thank you for taking the questions.

Speaker 2

No, thanks for it, Jim. Be well. Have a great day.

Speaker 0

Our next question today comes from Kumar Raja with Recline Capital Markets. Please go ahead.

Speaker 7

Thanks for taking my questions. Peter, with regard to the meeting with the U.S. Food and Drug Administration (FDA), is this going to be a Type B meeting or a Type C meeting? With regard to the HF2 trial, where do you stand with regard to the screening? Maybe you can highlight how the screening is going and when we can expect the patients to come on board and be treated.

Speaker 2

Right now, Kumar, thank you for the question. Great question. Delighted to have you on the call. With respect to the FDA, we haven't decided what the type of meeting is. Remember, this CardiAmp has FDA breakthrough designation. We're contemplating the pros and cons of having a sprint discussion with them on this issue to help get early feedback, versus doing another pathway. We're teeing this up in our annual report for the FDA. In parallel, we're working on the submission of a de novo 510(k) for the Helix biotherapeutic delivery system. The idea here is that the only thing I think the agency would be concerned with on the risk side is our Helix system, which has extensive data that's highly supportive of it. In fact, I ran into Brand Zuckerberg, who is the head of the devices at FDA.

They actually, at CBER, have blessed folks to do clinical studies with Helix without even talking to BioCardia. They're actually supposed to get a letter of reference. They're very comfortable with Helix, is our sense. The idea is to secure the discussion process around the de novo 510(k). Once that's in, then engage on CardiAmp and be able to say, with respect to CardiAmp, you've already approved the cell processing platform for use in processing diagnostics. The Helix system is under a de novo 510(k) process. 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 for these heart failure patients, which currently have a rate of mortality of 50% at every five years. They're already on guideline-directed medical therapy. 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 and achieve the clinical results we've demonstrated in our TAVMI trial, our TACF trial, and now also in our CardiAmp heart failure trial? That's sort of the pathway there ahead. Your second question, Kumar, and did that answer the first question? Are you comfortable with that?

Speaker 6

Yeah, it does. Thank you.

Speaker 2

All right. The second question of where are we at in CardiAmp Heart Failure II? CardiAmp Heart Failure II, it's the same team that is closing out CardiAmp Heart Failure I, preparing the clinical study reports, and involved in the regulatory activities that is also supporting CardiAmp Heart Failure II. Nicely, CardiAmp Heart Failure II is a modification of what we had done in CardiAmp Heart Failure trial. The folks who participated are aware of the data and pretty jazzed about the data that we ultimately have from CardiAmp Heart Failure. Right now, we've got four centers that are actively enrolling. We have a fifth center that's about to begin. We've treated a few patients so far. 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 in these patients.

For those who aren't real familiar with clinical study design, the Hawthorne effect is the fact that when you start to observe a subject, their behavior changes. We're observing the patients for a month before they go through their baseline measures. They know they're in the trial. We work on them to get them compliant to their medications. We get them as stable as we can possibly get them for a whole month, and then they go through the screening for the baseline measures and enter into the trial. We've treated a few patients. I think if you look on LinkedIn, there's a couple of pictures of first cases with different physicians. This is much easier to do because it's something that we've already been through. Fewer bumps in the road this time. The primary endpoint is the endpoint.

We have a P-value of 0.02 in the patients with elevated NT-proBNP. All patients in this trial will have elevated NT-proBNP of greater than 500 picograms per ml. It's, if anything, getting easier. 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 U.S. at this point in time. We'll be marshaling it forward. It's a secondary priority to getting these regulatory submissions in place. Just because of the cost of resources and our team, bear with us as we close out the regulatory submissions. There is potential if the U.S.

Food and Drug Administration decides to get supportive of CardiAmp as a therapy, that we would modify the trial and could conceivably make it an open label registry, in which case, maybe with a historical control, maybe we match it to the controls we have from our own study. Either way, there's lots of things by having that active trial, it feeds back into what we might do ahead. Remember, CardiAmp HF2 has the same Medicare reimbursement as our other two trials. If it was converted to an open label registry, not only would it go very quickly, but there wouldn't be any significant sudden cost to BioCardia because we have the reimbursement in place.

Speaker 7

Okay. Just one clarity with regard to the timeline. By end of Q4, you will have clarity both from the PMDA as well as the FDA. That's the expectation?

Speaker 2

Japan’s Pharmaceutical and Medical Device Agency. The U.S. Food and Drug Administration is behind that because we're going to be submitting the de novo 510(k) for Helix biotherapeutic delivery system first. It's going to be close on the Helix, but soon thereafter.

Speaker 7

Okay, great. Thanks so much.

Speaker 2

No worries. I appreciate the questions, Kumar.

Speaker 0

Thank you. Our next question comes from Chris W, an investor. Please go ahead.

Speaker 2

Hi, Peter, can you hear me?

Speaker 5

I can. Hi, Chris.

Speaker 2

Hey, there. A couple of questions. For BCDA-02, you are preparing to release or present data. What are your expectations following the data readout for that trial?

Speaker 5

Right now, that program, we're going to release that data. We are working on active conversations with respect to partnering. You know, my sense is, Chris, a lot of it depends on what happens with PMDA and FDA. 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-02 program. There are competitive programs to BCDA-02, but if you look at our corporate presentation, which was just updated today and available on our website, it compares the outcomes in BCDA-02. This is the CardiAmp cell therapy for patients in refractory angina as a function of chronic myocardial ischemia. You know, we are seeing the same or better results than what was demonstrated in the Baxter Healthcare CD34 program.

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. We have published previously at the European Society of Cardiology Heart Failure the CD34 dosages we have in CardiAmp cell therapy in the CardiAmp Heart Failure trial. All of 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 $50,000 to $60,000, whereas in our hands, by bringing it to point of care and processing the cells in the fashion we do and improving the efficiency of delivery and creating the 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. Instead of doing what Baxter did, which was to take the cells and remotely process them and bring them back to the center, which has enormous costs, 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.

Do you have the appropriate cells on board with a very inexpensive diagnostic?" Then we can 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. Yes, we're very excited about BCDA-02. Right now, it's resources and prioritization. The top priority is still BCDA-01. The top priorities for BCDA-01 are the regulatory submission discussions, where we have a number of board members who are very enthusiastic, and also the confirmatory trial. Those are our top priorities. If we have more resources or if partnering steps up for that program, BCDA-02 is very well positioned to expand. It's a great program.

Speaker 2

That's great. One more, if I can.

Speaker 5

Yes.

Speaker 2

Go ahead, Chris.

Speaker 5

It sounds like there are some new data observations that were picked up. You've submitted those from your prepared remarks. You've submitted those to the Japan’s Pharmaceutical and Medical Device Agency (PMDA). Will BioCardia be releasing or presenting that data to the public, or is that just for regulatory submissions? 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 if you're able to share anything in that regard.

Speaker 2

Absolutely. Yeah, absolutely.

Speaker 5

Thank you.

Speaker 2

Great questions. These are great questions, and I appreciate them. When we had the late-breaking clinical trial presentation at the American College of Cardiology, which, by the way, was a great honor that they gave us a late-breaking clinical trial, we're very thankful to the leadership at the American College of Cardiology for that. We were scrambling to pull all the data together in time for that presentation, and we got it done. The data is all monitored. It's good data. You can hang your hat on it. We're very proud that we got that done. As I'm sure you know, there's an enormous amount of data and observations here. 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.

We are working with our distinguished investigators to pull together a manuscript based on this awareness of some of these nuances of the data, 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 some things that just don't make it into the journal that are more appropriate in the regulatory dynamic. 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. That's sort of the response on that comment. As regards to your question on the financing, right now, look at how we financed historically. Yes, we have had times where we've done a standard banking financing, and we've had some challenges with it.

The last two financings we've done have been very little dilution. They've been assigned to long holders for the most part, and since then, we've had some phenomenal things come together. The markets are not reflecting where we're at. I don't know there's anywhere else in the world you can buy stock in a company that has what is pivotal trial data for a heart failure therapy, an enormous opportunity before regulators for the price of stocks going for today. That embarrasses me. At the same time, we have a lot of good relationships. We have a lot of active partnering discussions. We're doing our best to pull together a financing that is a positive for all shareholders. We take this very seriously, 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 the shares we've sold are well above the average share price that we've had of late. Those are straight common shares with no bells and whistles and discounts. They're at the peak of the market. I got to tell you, Chris, I can't wait till we get to profitability because I, the management team, and the board, nobody likes dilution. 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. If you look at the burn rate that David has detailed, we are very, we're trying to be what I think of as wisely frugal. With that, we don't waste money on things that don't make enormous sense.

We've secured a reimbursement for our trials, which winds up reducing our R&D expense. Right now, our annual burn rate is on the order of $6 million, a company that's pushing through three trials and has all these active partnering discussions. 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. 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. It's not like we're saying we're going to apply for approval for CardiAmp and prepare the dossiers. Those dossiers are already in substantially.

I think it's going to be a really interesting next six months for everybody who's here. Those who are shareholders in BioCardia, you're helping us to do this. You're helping us to advance a new therapy that has the potential to impact millions. I think that the data is excellent. It's not all we want it to be, but when you're treating patients on guideline-directed medical care, they're already being optimally managed, and you're able to show a benefit in addition to it, not instead of it, that's a great thing. It's something that everybody involved should be proud of. Thank you for that. I appreciate that info. Good luck on the upcoming meetings.

Speaker 5

All right. I appreciate it, Chris.

Speaker 0

Thank you. Dr. Altman, that closes the question and answer session. I'd like to turn the call back over to you, sir, for any closing remarks.

Speaker 2

Appreciate it, Rocco. I guess I would just reiterate what I detailed for Chris, that supporting BioCardia as an investor, you are also responsible for the benefits delivered to patients in the CardiAmp Heart Failure trial. 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 CardiAmp system and Helix approvals. On behalf of our hardworking team here at BioCardia, I thank you for your continued support. Have a great afternoon.

Speaker 0

Thank you. That concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.