BioCardia - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 was primarily a clinical/regulatory catalyst quarter: BioCardia presented two-year CardiAMP HF data with strong Tier 1 and Tier 2 benefits (mortality and MACE reductions), though the composite primary endpoint was not met due to 6-minute walk outcomes; management emphasized significance in the NT‑proBNP-elevated subgroup and plans FDA/PMDA consultations.
• Financially, Q4 revenue was $0 while net loss increased sequentially to $2.296M (derived from FY and 9M), reflecting continued operating investment into programs despite lower quarterly activity.
• Management guided to modest R&D increases and moderate cash burn growth in 2025, with SG&A near 2024 levels, and expects “significant news flow” from CardiAMP HF II site activations and enrollment.
• Versus Wall Street consensus, Q4 revenue missed (consensus $22,500 vs actual $0) while EPS beat (consensus -$0.625 vs actual -$0.25), with the ACC late-breaking presentation and regulatory pathway in Japan as key stock-reaction catalysts—management noted market response was “a bit of a surprise” despite data aligning with prior expectations.

What Went Well and What Went Wrong

What Went Well

• CardiAMP HF two-year data showed a 47% relative risk reduction in heart death equivalents and 16% reduction in major adverse cardiac events; quality of life improved meaningfully and six-minute walk improved modestly, with stronger statistical significance in NT‑proBNP-elevated patients (p=0.02 using QoL as Tier 3).
• Management reported signals of reduced arrhythmias and improved cardiac remodeling trends (LVEF and reduced volumes), supporting safety and potential efficacy in a high-need population; FDA Breakthrough Device designation provides a constructive regulatory context.
• PMDA invited the next consultation after submission of two-year data and indicated openness to sufficiency of CardiAMP HF and prior trials for registration; management views this as a potential pathway to Japanese approval without new local trials.
  • “This data readout has potential to significantly de-risk development… and may serve as the primary evidence to support product registration for market release.” — CEO Peter Altman.

What Went Wrong

• The composite primary endpoint was not met due to Tier 3 six-minute walk outcomes across the full trial population, although quality of life trends were favorable; management highlighted this non-success in Tier 3 as the offset.
• Q4 revenue was $0 and quarterly net loss increased sequentially to $2.296M despite year-over-year expense reductions, underscoring ongoing reliance on external financing and disciplined cash management amid low near-term commercialization revenue.
• Limited near-term revenue expected from Morph DNA and partnering activities; management acknowledged no significant revenue visibility yet, emphasizing clinical, regulatory, and partnering milestones over immediate monetization.

Transcript

Operator (participant)

Ladies and gentlemen, thank you for standing by. Good afternoon and Welcome to the BioCardia Year End 2024 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 touch-tone screen 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 it's 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.

Miranda Peto (Consultant and Head of Investor Relations)

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 uncertainty 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. The content of this call contains time-sensitive information that is accurate only as of today, March 31, 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.

Peter Altman (President and CEO)

Thank you, Miranda, and good afternoon to everyone on the call. This morning, we announced the primary outcome data from the CardiAMP Heart Failure Trial, which was presented yesterday at the American College of Cardiology Late-Breaking Clinical Trial Sessions in Chicago by Dr. Amish Raval of the University of Wisconsin at Madison, co-national principal investigator for the study. The slides for this presentation are now publicly available on our website. This data from 115 randomized ischemic Heart Failure patients treated with our lead therapeutic candidate, autologous CardiAMP cell therapy, or BCD01, is excellent and truly remarkable. To appreciate this, I would like to explain the outcome measure on this call.

The endpoints in the CardiAMP HF clinical trial are composite endpoints in which patients are evaluated by outcome tiers in order of most important to least importance, and each patient is compared with every other patient to assess whether a patient is better than another in that tier. In the first tier of cardiac death equivalents, which includes all-cause death, heart transplantation, and implantation of a left ventricular assist device, the results demonstrated a greatly reduced mortality rate. This is wonderful to see in a clinical indication where no therapy today appears to be reducing mortality. In the second tier of major adverse cardiovascular events, which includes hospitalization for Heart Failure, stroke, and myocardial infarction, the results demonstrated meaningful reductions here as well. This is also excellent news as these events are the drivers for the enormous cost of Heart Failure care to society and to payers.

In the third tier of the six-minute walk distance, we were not successful, and this offset the benefits in the first two tiers, resulting in the primary endpoint not being met. An alternative third-tier component of quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire, which has been used as the third-tier component in other similar interventional Heart Failure therapies with this type of efficacy analysis, also favored therapy and showed meaningful trends approaching statistical significance with a p-value of 0.14. The FDA was aware we were doing this analysis before we looked at this final data. In clinical studies of Heart Failure, a reduced ejection fraction, most, if not all, other trials use elevated markers of heart stress, such as NT-proBNP, as an inclusion criteria.

When we apply this simple screen to our results, CardiAMP cell therapy has superior results on all three tiers for both outcome measures, reaching a p-value of 0.07 with six-minute walk in the third-tier component and a p-value of 0.02 with quality of life in the third tier of the composite endpoint, reaching statistical significance. We are able to see these low p-values in this data because the changes in heart death equivalent and major adverse cardiac events are large. Results show a 47% relative risk reduction in heart death equivalents, a 16% relative risk reduction in major adverse cardiac events, a clinically meaningful 10.5-point improvement in quality of life score, and a 13.9-meter improvement in the six-minute walk distance test, all of this out to two-year follow-up.

Although we have not yet fully analyzed the echocardiography data, results are showing improved left ventricular ejection fraction and, perhaps more importantly, reduced heart volumes both at the end of contraction and the end of relaxation of the heart, suggesting positive heart remodeling. Lastly, we also noted reductions in cardiac arrhythmias in these patients that were treated. As the primary safety concern with cell therapy has historically been increased life-threatening arrhythmias, the strong trends toward reducing arrhythmias is a valuable signal for safety at minimum.

When these results were presented at the American College of Cardiology, the discussant, Dr. Mary Walsh, a former president of the American College of Cardiology and a Heart Failure physician, congratulated Dr. Raval and shared her perspective that the very patients being treated in the CardiAMP Heart Failure study are in great need for therapies such as cell therapy and that these patients have an interest in these therapies in her own practice. She congratulated Dr. Raval on the level of compliance shown to guideline-directed medical therapy in CardiAMP HF. Dr. Walsh challenged Dr. Raval on how rigorous the blinding of the patients was in this study that resulted in the quality of life benefit noted.

Dr. Raval made clear that a very rigorous blind had been implemented in CardiAMP HF, which satisfied Dr. Walsh and which was also supported by the blinding questionnaire in the study whose results you can see in the presentation on our website. The market reaction this morning to these results is a bit of a surprise. If you review our previous reports and earnings calls, you will see that these results are exactly what we hoped we would have. We have long known that this trial would not meet its primary endpoint, potentially due to the six-minute walk test distance in the healthier patients who did not have elevated markers of heart stress in this study. We are delighted, actually, that the two-year outcomes are so strong across all patients and able to reach statistical significance in the patients having elevated markers of heart stress or NT-proBNP elevation.

The win ratio is greater than 2.0, where we clearly win on the most important tier one and tier two assessments show that two patients in the treated group are doing better for every one patient, which may be the same or worse than in the control group. This data is meaningful for BioCardia on two critical levels. First, we have a very rigorous data set for the CardiAMP cell therapy now that strongly supports the ongoing CardiAMP Heart Failure II trial, which utilizes quality of life in the third tier of the composite endpoint and requires patients to have elevated markers of heart stress. The p-value of 0.02 seen in this group says the CardiAMP HF II trial is well overpowered and likely to be successful.

Second, the benefits observed for patients on guideline-directed medical therapy seen in this study are compelling, particularly for patients with elevated markers of heart stress, where there was statistical significance. This outcome is in line with our hopes for this data, as discussed with regulatory authorities. We look forward to sharing the CardiAMP HF two-year data with the Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency soon to align on the pathways that could make it available for physicians and their patients. These regulatory leaders, similar to the distinguished Dr. Mary Walsh, are aware that these patients with ischemic Heart Failure of reduced ejection fraction are in great need, which is one of the reasons FDA granted CardiAMP cell therapy a breakthrough device designation intended for indications in great need of new therapies.

Knowing of this great need, these agencies approve therapies based on risk-benefit analyses from rigorous good clinical practice studies such as CardiAMP HF. These agencies know that for medical device implants, safety results over time can arise due to a host of issues related to fatigue, device erosion, and immunological response, among many others. These agencies also know that safety issues such as drug toxicities can present over time due to drug compartmentalization and the long history of difficult patient compliance to medication. These agencies will also know that these potential long-term medical device implant and drug safety issues do not exist for CardiAMP cell therapy for Heart Failure. After the one-time CardiAMP cell therapy procedure, there is nothing left behind other than high concentrations of a patient's own cells in their heart tissue, where these cells naturally home when there is an injury to the heart.

Our discussions with the regulatory agencies will be around the evidence we have for safety and efficacy of the CardiAMP cell therapy from this very rigorous clinical study in light of the very real patient need that exists and in light of other therapies that may be approved for these patients. The regulatory authorities are also aware that CardiAMP Cell Processing System has been previously approved in the United States and Japan for other indications, and our Helix Delivery System has been approved previously in Europe. The CardiAMP Heart Failure II trial is active and consenting patients. We expect significant news flow ahead as we progress in this study in parallel to the ongoing regulatory discussions. Beyond this lead therapeutic autologous cell therapy program in Heart Failure, we have also made progress this quarter in other programs.

This quarter, final data from the last rolling cohort patient in the CardiAMP cell therapy and chronic myocardial ischemia trial, or BCD02, is being collected and will be prepared for scientific presentation and publication. This entire program benefits from the scientific support from CardiAMP HF. We have also completed enrollment in the low-dose cohort in our CardiALLO allogeneic mesenchymal stem cell therapy in ischemic Heart Failure, or BCD03, and are actively scheduling the Data Safety Monitoring Board review of the safety outcomes for this off-the-shelf therapy. On the Helix biotherapeutic delivery partnering front, we have no updates to share at this time on current and future partners. 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 a 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. We do not expect significant revenues in the near term, but do expect to have news flow as we make progress. On the business development front, we understand that 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 the final data from CardiAMP Heart Failure I trial, which we now have, will enhance interest by distribution partners and strategics.

It is noteworthy that interventional therapies for Heart Failure are receiving more and more attention because there are many patients who remain symptomatic even on state-of-the-art guideline-directed medical therapy. For CardiALLO cell therapy business development, our allogeneic cell therapy, we have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease. I note that FDA has approved a first mesenchymal stem cell therapy by a peer company in 2025, which has a treatment price of $800,000 for a course of four treatments. Another peer company appears to soon expect conditional approval for a mesenchymal stem cell therapy in Japan to treat acute respiratory distress, where we also have an approved IND at BioCardia.

These peer company successes may enhance our partnering discussions around our clinical stage allogeneic mesenchymal stem cell therapy platform. 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 threefold efficiency of delivery and the enhanced pharmacokinetics with our Helix system supported by data from many groups. We believe this advantage underlies our positive CardiAMP HF 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 more front, the recent FDA approval has us open for business in a competitive but real market. Physician usage is the first step toward any distribution or commercial partnership. Morph DNA was used as the steerable platform in the recent CardiALLO low-dose cohort patient, and more procedures are expected ahead. Looking forward, we are working to complete the following important efforts for our therapeutic programs. First, to submit CardiAMP HF results and request consultation with FDA and Japan PMDA. Second, to activate multiple sites in CardiAMP HF II and drive enrollment. Third, for BCD02 to deliver top-line data in the rolling cohort. And for BCD03, complete the DSMB review in the CardiALLO HF low-dose cohort. I will now pass the call to David McClung, our CFO, who will review our Q4 2024 Financial Results. David?

David McClung (CFO)

Thank you, Peter. Good afternoon, everyone. I'll now provide a brief overview of our financial results for the year ended December 31, 2024. Total expense decreased 35% year-over-year to $8.1 million in 2024 compared to $12.1 million in 2023. The primary driver of this change, research and development expense, decreased to $4.4 million in 2024 compared to $7.7 million in 2023. This 43% decrease was due to reduced cost and expense following the completion of the CardiAMP Heart Failure trial. We anticipate R&D expenses will increase modestly in 2025 as we continue advancing our therapeutic candidates both here in the United States and Japan.

Selling general and administrative expenses decreased 16% in 2024 to $3.7 million as compared to $4.4 million in 2023, primarily due to realignment of personnel and cost reductions following the completion of the CardiAMP Heart Failure trial. We expect 2025 SG&A expenses to remain close to our 2024 levels. Our net loss decreased to $7.9 million in 2024, down from $11.6 million in 2023. Our net cash used in operations was approximately $8 million during the year ended 2024 compared to approximately $10.0 million in 2023. The 20% decrease is primarily due to the reductions in R&D expenses that we talked about. The company ended the year with cash and cash equivalents totaling $2.4 million. We expect our cash burn will increase moderately in 2025, continuing our track record for carefully managing the use of resources and capital.

This concludes management's prepared comments. We're happy now to take any questions from attendees.

Miranda Peto (Consultant and Head of Investor Relations)

At this time, we will now begin the Q&A session. To ask a question, you may press star, then one, on your touch-tone pad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. Our first question will come from Joe Pantginis with H.C. Wainwright. Please go ahead.

Joseph Pantginis (Managing Director and Equity Research Analyst)

Hey, guys. Good afternoon. Thanks for taking the questions. Peter, before I ask about the data, I was just curious on the back end of your comments if you could provide a little more color on your PMDA discussions in Japan?

Peter Altman (President and CEO)

We met with PMDA so first, Joe, thanks for the question. We met with PMDA in, gosh, November. They have been asking us for we want to see the two-year data. We now have two-year data. Two-year data looks even better than it did before. Yeah, that's why we're a little bit surprised by the market reaction today because we've all known for a very long time that the key element of this trial is looking at what other signals are we seeing that support where we're going ahead with CardiAMP Heart Failure II. Worst case, this is a really nice phase two trial is my perspective. Best case, there is potential for conditional approval in Japan or even a full approval in Japan. That's where we're knocking.

Joseph Pantginis (Managing Director and Equity Research Analyst)

Got it. No, that's helpful. More to the data now. When you look at how the study went per se and that the DSMB said about the six-minute walk test potentially impacting the outcomes and what have you, the data are very nice that you announced at ACC. I'm just curious, any discussion around subsequent to the stopping of the study, any subsequent therapies that you can talk to or that patients went on that could have potentially impacted the data read? I'm assuming not really, just based on how severe these patients are.

Peter Altman (President and CEO)

Yeah. No, all these patients are already on guideline-directed medical therapy. Actually, Dr. Walsh at the session, there's a slide showing that the guideline-directed medical therapy was congratulatory. It's actually our investigators did a really nice job of making sure everyone was on stable guideline-directed medical therapy. That contributes to slowing of enrollment because Heart Failure physicians will alter medication when they see patients. Only when they finally have stabilized the patient and said, "Okay, I've done the best I can," then this patient can advance to CardiAMP cell therapy. There are no other medications out there other than the ones that are currently under the guidelines. In addition, as we look at the trial results, we have an extensive bio repository.

We will actually be able to interrogate patient samples and look at things in the future, such as viral load with COVID, drug trough levels of sacubitril/valsartan and SGLT2i. There are other things that we may learn going downstream. This is a very rigorous study. No patients that I'm aware had subsequent therapies other than what they received in CardiAMP. Dr. Walsh's question of Dr. Altman during the presentation at ACC focusing in on, "Wow, those are good results. How do you know that quality of life is real? Were the patients truly blinded?" The discussion there was, "Yes, indeed, they were." We had formal scripts for each and every site. Patients had headphones on and very much did not know whether or not they were being treated or not because all patients, as you all should know, were actually catheterized.

The only thing that the control patients did not receive was the intramyocardial injections. The data is good. Of course, when the data is really good, you challenge that. Dr. Altman had a very robust answer for that third tier on the quality of life front. The data is a solid data set. It's something that we can all be proud of. We missed the primary endpoint. We've known that for a year.

Joseph Pantginis (Managing Director and Equity Research Analyst)

Yeah, absolutely. It's good to have followed the patients to give you a more robust picture. Specifically, when you look at some of the demographics, I wanted to see if I can just get a little more color about the NT-proBNP population and how well balanced they were between the two arms because it really appears that that's going to be an important marker going forward.

Peter Altman (President and CEO)

Yeah, actually. The balance of that, essentially, it's roughly the same threshold. About half the patients in both groups had the elevated NT-proBNP. That's a key element. About half the patients cleared that threshold. We will be doing NT-proBNP as a pre-specified parameter that will be a covariate that we'll have to do covariate analysis on ahead. Along with some other parameters, we'll be doing that work and hopefully seeing some more details there.

Joseph Pantginis (Managing Director and Equity Research Analyst)

Got it. My last question, and thank you for indulging me, is I just wanted to get a sense about the durability and the improvements that you were talking about. I want to make sure I'm reading them correctly. When you look at the relative risk reductions in heart death equivalents, the difference that you're seeing between 20 and 24 months and the durability, I just want to make sure I'm reading it correctly with regard to the numbers. At 20 months, it was an 86% reduction for the relative risk reductions in heart death equivalents. I can't tell if it appears it dropped off, but still very meaningful. I just want to make sure I understand I'm reading it correctly.

Peter Altman (President and CEO)

Yeah. You are, so the benefit here is essentially what we're seeing is not just the benefit in the heart death equivalent, but it's across all of the endpoints where we can actually achieve a P value. The way I'd have folks think about this is the endpoints here are these composites with these three tiers. The mere fact that we can have all three of these tiers go the same way at two years follow-up is a great signal. One of the difficulties of these sort of win ratio type analyses is sometimes others will lose on mortality or they'll lose on MACE, but they'll win on a less important tier such as quality of life or the six-minute walk distance. one of the strengths of the data, Joe, is that we win on all three tiers at that long-term follow-up endpoint.

The mere fact that we have a P value in a 115 randomized patient, 125 total patient Heart Failure trial in the NT-proBNP population, what everybody else treats, and they usually have to enroll thousands of patients. 8,000 patients is not a small Heart Failure trial. These are really strong signals. These are really compelling signals. The fact that they're still there at two years is what we view as the robustness of the data, not necessarily comparing the dynamic at one time point for one component of the endpoint to that at a later time point. We will detail all the numbers on absolute survival, absolute reduction in MACE, relative risk reduction in MACE, and so on ahead. That is sort of the thought process. I also just, while we're on this, I should share for everybody, the interim data was based on unmonitored data with patients.

Many of them had some long-term follow-up, but we enrolled additional patients since then as well because the DSMB allowed us to clear out the queue of patients who had already been pre-screened and treat them, which is a nice signal for safety. This data, a lot of things may have changed since we presented it. The fact that it's still, when I say robust, I'm saying that it's at two years that we're able to see these endpoints, not necessarily comparing it to the interim analysis on potentially different data points because it hadn't been monitored and source data verified.

Joseph Pantginis (Managing Director and Equity Research Analyst)

Got it. Thanks for all the details, Peter.

Peter Altman (President and CEO)

No, appreciate all the questions, Joe. Great questions. I'm sorry I wasn't clear on them upfront.

Joseph Pantginis (Managing Director and Equity Research Analyst)

No worries.

Operator (participant)

Our next question will come from Kumaraguru Raja with Brookline Capital Markets. Please go ahead.

Kumaraguru Raja (Senior Biotechnology Analyst)

Thanks for taking my questions and congratulations on the data. First, with regard to sharing the two-year data with the FDA, what is the expected timeline for that? How do you think that's going to impact the CardiAMP two trials? What has been the feedback in terms of the physician? Do you think that the enrollment in the two trials will ramp up following this 24-month data?

Peter Altman (President and CEO)

Yeah. First, with the conversations with respect to the FDA, this was truly a late-breaking clinical trial. We kept folks posted as we were freezing the data and pulling things together. We are going to pull together the data and have a meeting with the agency. Our interaction with the agency has been excellent. Historically, as everybody on this call likely knows, things are very different at the FDA these days. I don't expect there to be difficulties with the agency, but there may be some creative approaches here that they see based on the strength of our data, the fact that we've got FDA breakthrough designation, the fact that there are really no real safety issues other than the procedural issues, which are all addressable. I feel pretty good about these are going to be interesting conversations ahead.

Now, your question on how will this impact CardiAMP Heart Failure II? That trial is already approved. It's already been activated. We have a number of centers that are in the final strokes of activation that are world-class centers. I don't think it's going to impact it in the short term significantly, but I did mention covariate analysis.We have a very large data set that we're looking at, and there may be a number of things that we learn that we take forward into CardiAMP Heart Failure II. One thing we took forward from CardiAMP Heart Failure I to CardiAMP Heart Failure II is our awareness that our cell population analysis, there was a number of patients that just barely missed the eligibility to participate in the trial.

In their previous quarter, I detailed that the conversations with the FDA have allowed us to modify the treatment plan for patients who are in a certain window on the cell population analysis so they can still receive the same minimum target dose, but we do not necessarily need to exclude them from the trial. That is going to be something that we already have in place with the agency, and we will be taking that forward. Other interactions with the agency are expected as we get through some of this covariate analysis. There's been a lot of folks out there, Kumar, that have been suggesting that we go after an adaptive trial design again, but there's other leaders who said, "Look, you have a shot to see a mortality benefit that's statistically significant in this small trial."

We're not even the latest greatest drugs that have really demonstrated much, at least particularly not in real-world practice. We may not do that, but these are going to be part of the discussion with the agency. They're very supportive of adaptive designs. We have a lot of data that will support where we're going with this. On enrollment, which is sort of the second piece of your question, I do think that the change to enable us to target dosage or personalized dosage based on the cell potency assay or cell population analysis, if you will, will enable us to not exclude nearly as many patients. We'll move from an exclusion profile of around 35% for that, down to about 15% for that.

I also think that the data we have is compelling. Physicians will look at our chart on the MACE events and see, "Wow, that's great across the board. Which side do you want your patients in?" that will contribute to this. Other things and other learnings we have will also contribute to our ability to enroll more quickly, as well as selecting the sites that were the best performers in CardiAMP Heart Failure I. All of that will feed into enrollment.

Kumaraguru Raja (Senior Biotechnology Analyst)

Okay. Great. You already met with the PMDA in November. Now you have the two-year data. What are the next steps here and what kind of timelines can we expect with regard to the interactions with the PMDA? Thank you.

Peter Altman (President and CEO)

Yep. No, it's a great question, Kumar. We met with them in November. They've already invited the next conversation in November. The timeline here is our pulling together the appropriate submission package for them with the data in advance of requesting a consultation. The other parameter is their scheduling that meeting and consultation. I just flew back from Chicago this morning. We just got the data out. We do not have exactly the timeline with the regulatory advisors. We have to pull together that package. If the package is as lean as the ACC presentation, which it very well could be, we could be requesting something in short order. It is going to be far more substantive than that. They are very rigorous and detail-oriented, and we have had great interactions with them as well as the FDA.

Our expectation is we want to put the best foot forward with them and detail everything we possibly can to minimize the questions. Our goal at the end of the day is for their questions to end with the clause, "Please address this in your application for approval." Those are the questions we want to have at the end of our ultimate consultation. There will probably be more than one consultation ahead, one probably to understand the clinical data and another one to follow up and probe in different areas and make sure that we have looked at some of the sensitivities that they are interested in.

We respect that we do not have a grand slam home run data set that says, "Yes, this will absolutely be approved tomorrow." This is a really nice data set, everybody. I am proud of the team and the clinicians and the patients who contributed to it. Yeah, we'll detail as we do, Kumar, when we have had the consultation and the timelines ahead as we get closer. The first step is to prepare the package and submit it. That's in our court. The next step is for them to look at their schedule. It could be as short as three weeks from that request or as long as eight weeks. We'll see. My expectation is it'll be on the shorter end for both our preparing the package and for them scheduling the meeting.

Kumaraguru Raja (Senior Biotechnology Analyst)

Okay. Great. Thanks so much.

Peter Altman (President and CEO)

No, appreciate the questions. Really do.

Operator (participant)

Our next question will come from James F. Molloy with Alliance Global Partners. Please go ahead.

James Molloy (Managing Director and Senior Equity Analyst)

Hey, guys. Good afternoon. Thank you very much for taking my questions. Looking at the Heart Failure II trial and sort of the positive trends and on the first two things, the positive outcomes, how does that inform what we should be looking for in Heart Failure II trial in the elevated subgroup? What would be the most positive outcome in this group from what you've seen in the Heart Failure I trial to translate in Heart Failure II?

Peter Altman (President and CEO)

James, I appreciate the call. That is sort of one of the fundamental reasons I'm jazzed about this. The primary endpoint in CardiAMP Heart Failure II is the same composite endpoint structure. We have a P value of 0.02 in CardiAMP Heart Failure I. In addition, the subgroup that we looked at in CardiAMP Heart Failure I that had that P value is the subgroup which is already in the FDA-approved protocol for CardiAMP Heart Failure II. My goal is to deliver that same result, which is an endpoint of all-cause cardiac death equivalent, major adverse cardiac events in the second tier, and then quality of life in the third tier. To put this into context, the company V-Wave had a late-breaking clinical trial at the American College of Cardiology last year.

That was their endpoint in their trial. They had an elevated NT-proBNP much higher than what we are having in this subgroup. I do not think that they came close to hitting their endpoint, but they were also acquired by Johnson & Johnson for $1.4 billion soon thereafter. There is interest in these therapies, and this is good data. We will see where this goes ahead. Now that we have this final data and it is out and it is public, we can discuss it and share it. It is on our website. I invite questions both in this call but also after this call. We'll take questions from investor relations if there are things we haven't addressed. We can address them in the manuscripts or in future calls. Does that answer your question, James?

James Molloy (Managing Director and Senior Equity Analyst)

It sure does.

Peter Altman (President and CEO)

No, I appreciate that.

James Molloy (Managing Director and Senior Equity Analyst)

What's the next cut point or interim look we should anticipate for HF2?

Peter Altman (President and CEO)

HF2 is still early. The thing you should ask for in HF2 is, "What is the enrollment? What is the month-by-month enrollment? What's happening? How are sites being onboarded?" and so on and so forth. We're working through that. Some of the latest things that have happened with research funding in the United States have had an interesting repercussion on clinical sites in the United States. We do intend to bring the wonderful team we had in Canada back online. We may also seek to advance CardiAMP Heart Failure II in Europe. Stay tuned. There is going to be a lot that goes on. Now that much of this project on Heart Failure I has been completed, there will be a lot more momentum on CardiAMP Heart Failure II ahead.

James Molloy (Managing Director and Senior Equity Analyst)

Thank you very much for taking the questions.

Peter Altman (President and CEO)

I appreciate it, Jim. You have a wonderful day.

This will conclude our Q&A session. I would like to turn the conference back over to Peter Altman for any closing remarks.

Thank you, Wyatt. I just want to have everybody be aware that we are developing therapies here at BioCardia. The results released this morning show we have a strong signal of a sustained benefit with no safety concerns in our lead therapeutic candidate for an enormous unmet clinical need. I respect investor desire to be approved and commercial as soon as possible, and we are doing the good work to get us there. The data today was actually good data. Hopefully, we'll see that to the finish line. I thank everybody for their continued support, and I wish you a great day ahead. Thank you very much.

Operator (participant)

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