Earnings Call Transcript - BCDA Q2 2025

Operator, Operator

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia Second Quarter Financial Results and Business Update Conference call. 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 1 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 Benvenuti, Investor Relations

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 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. These 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.

Peter A. Altman, CEO

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 death and nonfatal MACE than the control group during the entire 24-month period of the CardiAMP Heart Failure study with a p-value of 0.17. And the composite endpoint of all-cause death, nonfatal 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 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. 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 Cardium system for market entry in Japan. In parallel, we have ongoing efforts towards requesting a meeting with the FDA 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 and chronic myocardial ischemia or BCDA-02, the roll-in 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 the 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. We continue to be focused on partnerships where our contributions to the successive 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 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. 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 the clarity on anticipated approvals ahead will enhance interest from 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 and 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. We believe this advantage underlies our positive cardiac 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. 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-01, our CardiAMP autologous cell therapy and heart failure. In the fourth quarter, we will aim to have the peer-reviewed manuscript accepted, meetings with Japan PMDA and 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 achieve as 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 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?

David McClung, CFO

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. We 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 United States 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 remained 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 months 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.

Operator, Operator

Our first question today comes from Joe Pantginis with H.C. Wainright.

Lander Egaña-Gorroño, Analyst

This is Lander on for Joe. So maybe, Peter, could you elaborate a little bit more on the expectations regarding PMDA reviewing CardiAMP for heart failure as a medical device. You talked a little bit about this 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?

Peter A. Altman, CEO

Thank you for the question, Lander. 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 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 is the standard consultation process with PMDA. And the current hurdle before us is the clinical consultation on the data and positioning of the therapy in the continuum of heart failure care. And so 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 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. 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 not from another individual. And 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 the point of care. And the value proposition here is it aligns completely with the cultural preferences of the Japanese. And then from a logistics and commercialization perspective, it fits neatly into the existing medical device distribution channels in Japan. So 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 United States, which is approximately 10% per year, 50% at 5 years. And so the way we see Cardium is 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 CardiAMP cell therapy. 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 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. So similar to those approaches, Japan PMDA has the ability to request post-marketing study of Cardium heart failure therapy and provide and secure additional data on both safety and efficacy in the Japanese population. 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. 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.

Lander Egaña-Gorroño, Analyst

Got it. That's very useful. And for the CardiAMP CMI program, the rolling core data that are anticipated in the fourth quarter, these are related to the primary endpoint results, right, at 6 months?

Peter A. Altman, CEO

Correct.

Operator, Operator

Our next question today comes from James Molloy at Alliance Global Partners.

James Francis Molloy, Analyst

In the fourth quarter, regarding regulatory meetings in Japan and the U.S., if we receive a favorable response, which I assume would be positive, when would we be able to proceed with the filing? Additionally, how would you evaluate other possible outcomes from those two meetings?

Peter A. Altman, CEO

Thank you for the question, Jim, and welcome to the call. To address the first part regarding Japan PMDA, if they accept our positioning for the CardiAMP cell therapy and find it reasonable, the meeting minutes could lead to addressing specific questions in our application for approval. This will initiate a series of necessary steps for the approval process, including thorough audits of our operations and clinical data. The process is similar for the FDA, including BIMO audits. We anticipate that achieving approval could take up to a year in either case. However, once that pathway is established, our confidence in success significantly improves. In Japan, we plan to work on reimbursement and distribution partnerships immediately if the meeting yields a positive outcome, which we hope for. For the FDA, we are pursuing a different timeline by submitting our Helix system for FDA approval first, based on comprehensive data, before engaging with them on the CardiAMP approval since Helix is integral to the system. The regulatory files for all three submissions contain largely the same information, and we will submit to the FDA first, then discuss CardiAMP Heart Failure with them. They are also reviewing annual reports and final data on CardiAMP Heart Failure. If we receive positive outcomes, we could be on the path toward approval in a significant market, although we anticipate some post-marketing requirements from both the FDA and PMDA. We acknowledge that we did not fulfill the primary endpoint, but the FDA has previously approved heart failure therapies based on subgroup analysis and required post-marketing studies. Some cases have involved confirmatory trials, and we already have one actively enrolling at multiple centers. If outcomes are negative, especially regarding Japan PMDA support due to resource issues, we will focus entirely on the U.S. market going forward. However, I remain optimistic about Japan. I believe the FDA will be receptive, especially given the current administration's interest. This is an autologous cell therapy with no residual material left behind, only the patient's own high-concentration cells, supported by robust data that is compelling for heart failure patients on guideline-directed medical therapy. We demonstrated a reduction in MACE over the trial duration with a p-value of 0.17, and the composite endpoint for patients with elevated NT-proBNP showed statistical significance. If we gain approval in Japan or the U.S., BioCardia will focus on patients receiving guideline-directed medical therapy who still exhibit evidence of active heart failure due to elevated biomarkers like NT-proBNP.

James Francis Molloy, Analyst

Maybe for the last question, could you provide some insight on the partnership environment? You mentioned it briefly in your prepared remarks. Would it be accurate to say that partnerships are essentially on hold until there's clarity regarding the FDA and the Japanese PMDA?

Peter A. Altman, CEO

I would firmly say that partnerships are not on hold. Regarding CardiAMP, it is indeed a crucial element and milestone for us. We are currently engaged in active discussions about our technology platforms. Specifically, we have ongoing dialogues with Helix and Morph. Additionally, CardiALLO has generated interest from individuals looking at other indications due to our capacity to manufacture cells with a small footprint. I believe CardiAMP is the focal point because of its value proposition. We have had active conversations regarding distribution partnerships in Japan, and those partners are informed and ready for the next important discussion. The nuances of reimbursement in Japan will also be crucial going forward. We see significant opportunities for success. The reimbursement we have established in the United States, which is $17,500 per procedure, is enticing for partnership discussions and should also attract attention from Japan's Ministry of Health, Labor and Welfare. Historically, the reimbursements for other CardiAMP therapies they have approved were nearly ten times that amount. We believe that presenting them with a reasonably priced therapy that includes autologous aspects will be beneficial. The potential partners we are engaging with for CardiAMP are primarily medical device distributors, as well as U.S. interventional cardiology groups in Japan that sell directly. These are additional parties we are actively exploring collaborations with.

Operator, Operator

Our next question today comes from Kumar Raja with Brookline Capital Markets.

Kumaraguru Raja, Analyst

So Peter, with regard to the meeting with the FDA, is this going to be a Type B meeting or a Type C meeting? And with regard to the HF II trials, 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.

Peter A. Altman, CEO

Thank you for the question, Kumar. It's great to have you on the call. Regarding the FDA, we have not yet determined the type of meeting. Keep in mind that CardiAMP has breakthrough designation. We are weighing the advantages and disadvantages of having a sprint discussion with them to obtain early feedback vs. considering another pathway. We will outline this in our annual report to the FDA. At the same time, we are working on the submission of a de novo 510(k) for the Helix system. The primary concern for the agency regarding risk appears to be our Helix system, which has substantial supportive data. I recently met with the Head of the devices at the FDA, and CBER has approved individuals to conduct clinical studies with Helix without prior communication with BioCardia, indicating they are quite comfortable with Helix. Our goal is to facilitate a productive discussion around the de novo 510(k). Once that is secured, we will engage on CardiAMP, mentioning that the cell processing platform has already been approved for diagnostic use. The Helix system is currently undergoing the de novo 510(k) process, and we seek your approval for the combination in this autologous cell therapy based on comprehensive clinical data from our three trials for heart failure patients, who presently have a 50% mortality rate over five years despite being on guideline-directed medical therapy with no other options available. What pathway could potentially allow us, with safety measures in the form of post-marketing studies, to provide patients access to this therapy and achieve the clinical outcomes demonstrated in our TABMMI trial, TACHFT trial, and our CardiAMP heart failure trial? That outlines our path forward. Did that address your first question adequately? Are you comfortable with that?

Kumaraguru Raja, Analyst

Yes, it does.

Peter A. Altman, CEO

We are currently making progress with CardiAMP Heart Failure II, which is led by the same team wrapping up CardiAMP Heart Failure I while preparing clinical study reports and managing regulatory activities for CardiAMP Heart Failure II. The new trial is an improved version of our previous CardiAMP Heart Failure trial, and the participants are aware of and excited about the data we’ve collected so far. At present, we have four centers actively enrolling patients, with a fifth center ready to start soon. We have treated a few patients already. A key aspect of this trial includes an extended lead-in time for treatment to monitor the Hawthorne effect, which indicates that a subject's behavior may change when they know they are being observed. Therefore, we observe the patients for a month before they undergo baseline measurements. It's crucial for us to ensure they adhere to their medication regimens and are as stable as possible during this observation period. After a month, they will complete their screening for the baseline measures and officially enter the trial. We've had a few patients treated, and there are some pictures of the initial cases on LinkedIn showcasing different physicians. This process is smoother now since we have prior experience. The main endpoint remains unchanged, with a p-value of 0.02 for patients who have elevated NT-proBNP levels, which will be above 500 picograms per ml for all participants. If anything, the process is becoming easier. We do not face the complications of COVID or other competing trials, and to our knowledge, this is currently the only large cell therapy trial in the U.S. We will continue to advance this trial, although it is a secondary priority compared to our regulatory submissions due to resource costs. We appreciate your patience as we finalize these submissions. If the FDA supports CardiAMP as a therapy, we may adjust the trial to potentially include an open-label registry that could either use historical controls or match them with data from our previous study. Regardless, having an active trial will help inform our future actions. Remember, CardiAMP HF II has the same Medicare reimbursement as our other two trials, so if it transitions to an open-label registry, it could progress quickly without imposing significant additional costs on BioCardia, given our established reimbursement framework.

Kumaraguru Raja, Analyst

Okay. Just one clarity with regard to the timelines. So by end of Q4, you will have clarity both from the PMDA as well as the FDA, that's the expectation?

Peter A. Altman, CEO

We will have clarity from PMDA, FDA is behind that because we're going to be submitting the de novo 510(k) for Helix first. So it's going to be close on the Helix, but soon thereafter.

Operator, Operator

And our next question comes from Chris W, an Investor.

Unidentified Analyst, Analyst

Peter, can you hear me?

Peter A. Altman, CEO

I can, Chris.

Unidentified Analyst, Analyst

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?

Peter A. Altman, CEO

So right now, that program we’re going to release that data. We are working on active conversations with respect to partnering. And my sense is, Chris, a lot of it depends on what happens with PMDA and FDA if PMDA gives us the signal that, yes, 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, we are seeing the same or better results than what was demonstrated in the Baxter Healthcare CD34 program. 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. So 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. And all of our patients on average are greater than the CD34 cell dosage achieved in the Baxter Healthcare trial. This is important because 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, we — 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 those — the therapy can actually be a very low-cost therapy. So 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 cost. 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? And then we can go in and process the cells at point of care with a relatively inexpensive approach so that our cost of goods can be literally less than 2% of what the cost of goods for the Baxter Healthcare program is. So yes, we’re very excited about BCDA-02. It’s just right now, it’s resources and prioritization. And so 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 then also the confirmatory trial. Those are our top priorities. But if we have more resources or if partnering steps up for that program, BCDA-02 is very well positioned to expand. And it’s a great program.

Unidentified Analyst, Analyst

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

Peter A. Altman, CEO

Yes. Please go ahead, Chris.

Unidentified Analyst, Analyst

So it sounds like there's some new data observations that were picked up, and you've submitted those from your prepared remarks. You've submitted those to the PMDA, will BioCardia be releasing or presenting that data to the public? Or is that just for regulatory submissions? 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 if you're able to explain in that regard.

Peter A. Altman, CEO

Yes, great questions. I appreciate them. When we presented our late-breaking clinical trial at the American College of Cardiology, we were under pressure to compile all the data for that presentation, and we successfully completed it. The data is thoroughly monitored and reliable, and we're proud of that achievement. However, it's important to note that there is a significant amount of data and observations involved. From my point of view, our understanding of the data improves over time. We are collaborating with our esteemed investigators to prepare a manuscript that highlights some of the nuances in the data for peer review and publication. While not everything will make it into the journal, we aim to include as much as possible. Regarding your question on financing, historically, we have utilized standard banking financing, which has posed some challenges. However, our last two financings resulted in very little dilution and were mostly assigned to long-term holders. Although the current markets do not reflect our progress, it is rare to find a company with pivotal trial data for a heart failure therapy available at our stock price, which I find concerning. Nevertheless, we have strong relationships and active partnering discussions ongoing, and we aim to secure financing that benefits all shareholders. We are taking this matter seriously and being cautious. Our recent use of the ATM showed that we've sold shares well above our recent average share price, and those shares were sold at the peak market value. I look forward to achieving profitability, as nobody on the management team or the Board likes dilution. We are trying to ensure that any deal we pursue supports our operations efficiently. Our burn rate is currently about $6 million annually, which is low for a company managing three trials and engaged in various discussions. We are being prudent with our resources and have secured reimbursement for our trials, which helps reduce our R&D expenses. While I cannot provide further details at this moment, we are reaching out to our network, and many are interested in investing in a company that not only has stable products like Morph and Helix but is also focused on obtaining near-term approvals for therapies. We are not just preparing for CardiAMP approval; we already have substantial progress on those dossiers. The next six months will be quite interesting for everyone involved. As shareholders in BioCardia, you are helping us advance a new therapy that could impact millions. The data is promising, and while it may not meet all our expectations, demonstrating additional benefits alongside guideline-directed medical care is commendable, and everyone involved should take pride in that achievement.

Operator, Operator

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

Peter A. Altman, CEO

I appreciate it, Rocco. Yes, 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. So on behalf of our hard-working team here at BioCardia, I thank you for your continued support. Have a great afternoon.

Operator, Operator

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.