Q3 2024 BioCardia Inc Earnings Call
Speaker Change: Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the BioCardia third quarter 2024 financial results and business update conference call.
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Speaker Change: I would now like to turn the floor over to Miranda Pato of Biocardia Investor Relations. Please go ahead, Miranda.
Miranda Pato: Thank you. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardio's leadership team are Peter Altman, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer.
Miranda Pato: 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.
Miranda Pato: Such factors include, among others, the inherent uncertainties associated with developing new products and technologies and obtaining regulatory approvals.
Miranda Pato: Fast forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.
Miranda Pato: For more information about these risks, please refer to the Risk Factors and Cautionary Statements described in BioCardia's report on Form 10-K, filed with the SEC on March 27, 2024, and in subsequently filed Form 10-Q's.
Miranda Pato: The content of this call contains time-sensitive information that is accurate only as of today, November 13, 2024, except as required by law.
Speaker Change: 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, BioCardio's President and CEO. Peter, please go ahead.
Speaker Change: Thank you, Miranda, and good afternoon to everyone on the call.
Speaker Change: Biocardia continues to advance our targeted cellular precision medicines for cardiovascular disease.
Speaker Change: Our clinical stage cell-based therapies are targeted and that we are delivering our therapeutic candidates locally to the target tissues where they are most needed and with a precision medicine perspective for specific patients that may benefit identified by biomarkers.
Speaker Change: These biomarkers characterize a patient's disease state, and in the case of our autologous cardiac mononuclear cell therapies, the potential of the patient's own cells for providing therapeutic benefit.
Speaker Change: Our lead autologous cardiac cell therapy for the treatment of heart failure.
Speaker Change: which has been granted Food and Drug Administration Breakthrough Designation and is reimbursed by the Center for Medicare and Medicaid Services is being studied today in two active clinical trials.
Speaker Change: The mechanism of action of cardiac cell therapy is viewed as microvascular repair by promoting increased capillary density and reduced fibrosis in the heart tissue where these cells are delivered.
both of which have been demonstrated in preclinical studies.
Speaker Change: Cardiac cell therapy is a one-time treatment in which the patients who qualify based on the critical selection criteria have their own mononuclear cells
Speaker Change: aspirated and delivered to the heart in high concentrations in a single minimally invasive catheter based procedure.
Speaker Change: The procedure avoids the need for cardiac surgery to deliver the cells, and no immunosuppression is required to prevent rejection of a patient's own cells.
Speaker Change: I will now provide detail on the status of our two cardiac cell therapy trials for the treatment of heart failure.
Speaker Change: The CARDI-AMP Heart Failure I trial is a randomized placebo procedure controlled study on 115 patients with 10 additional rolling subjects.
Speaker Change: We will soon have final data where patients will have a minimum of 1 year and a maximum of 2 year follow-up of the outcome measures with approximately 92% of the patients not lost a follow-up having 2 year follow-up results.
Speaker Change: Only 4% of patients have been lost to follow-up in this study.
Speaker Change: We are conservatively optimistic that results anticipated for release in Q1 2025 will be similar to results seen in the interim review last year.
Speaker Change: This interim review data showed trends of improved survival, reduced major adverse cardiac events, and improved quality of life in those who received therapy.
final CARDI-AMP Heart Failure 1 results.
Speaker Change: expected in Q1 2025 will be based on data that has had source data verification completed and will include an additional 13 randomized patients and patients with an additional year of follow-up outcome measures.
Speaker Change: These CARDIAMP Heart Failure 1 trial results are enormously important as the data from this trial is intended to provide support for future product approvals and commercialization of the CARDIAMP cell therapy in the United States and Japan.
Speaker Change: As we work to deliver these results from the 125 patients enrolled in the CARDI-AMP Heart Failure 1 trial, we are advancing a second confirmatory clinical study in the CARDI-AMP Heart Failure 2 trial.
Speaker Change: The CARDIAC HEART FAILURE II trial is a 250 patient pivotal study at up to 40 centers.
Speaker Change: It advances the same therapeutic approach and focuses on the remarkable benefits seen in patients treated with elevated NT-proBNP, a well-established biomarker of active heart failure.
Speaker Change: The FDA recently approved an important protocol amendment to personalize treatment plans in this therapy based on the cardiac cell population analysis.
Speaker Change: expected to considerably increase the number of patients eligible for the trial.
Speaker Change: Simply put, the protocol amendment enables patients who would previously fall short of treatment requirements due to the nature of their cells to receive a higher dosage of cells.
Speaker Change: Multiple consented patients are in the screening queue today and study sites are being actively onboarded.
Speaker Change: Enrollment in the CARDIAC HEART FAILURE II trial is expected to be significantly enhanced because of the positive data and experience from the CARDIAC HEART FAILURE I trial.
Speaker Change: Additionally, efforts we have taken to treatment planning approach that enables more patients to be eligible based on the nature of their cells.
Speaker Change: and leverage the enormous experience in the broader Cardi-AMP clinical team are all expected to enhance trial enrollment.
Speaker Change: Beyond our lead autologous cell therapy program in heart failure, which I've just detailed, we have also made progress this quarter in other programs.
Speaker Change: This quarter, the last rolling cohort patient in the Cardiac Cell Therapy and Chronic Myocardial Ischemia trial, or BCD-02, was enrolled.
Speaker Change: which means the primary six-month follow-up endpoint for all patients in this study cohort will be reached in Q1 2025.
Speaker Change: We have also secured FDA and IRB approval to enroll patients in our CARDI-ALLO allogeneic mesenchymal stem cell therapy in ischemic heart failure, or BCDA-03, without requiring them to have been excluded from the CARDI-AMP heart failure trial.
Speaker Change: We expect the last low-dose cohort patient to be enrolled this quarter in the single-center dose escalation phase 1-2 study.
Speaker Change: 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 long-term partnerships where our contributions to the success of partners will reward our shareholders.
Speaker Change: One element of the Helix Delivery System is our proprietary MorphDNA steerable introducer platform.
Speaker Change: This Morph DNA product family design has performed well for our cardiac and cardiolo procedures and has potential to enhance many other clinical procedures as a commercial product with a broader product family configuration.
Speaker Change: We received FDA approval for this product family this past quarter.
Speaker Change: The product is intended to provide a pathway through which medical instruments such as balloon dilation catheters, guide wires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
Speaker Change: The clearance covers an array of 16 products in lengths of 30, 45, 71, and 90 centimeters in 5, 6, 7, and 8 French introducer sheet equivalent diameters.
Speaker Change: Marketing materials are currently available on the company's website in preparation for commercial release of the initial products.
Speaker Change: We are reaching out to senior management at other companies who don't have these products to support their own interventional procedures and inviting their sales teams to be aware of the morph DNA products.
Speaker Change: We will also soon be reaching out to many leaders in interventional cardiology, cardiac electrophysiology, vascular surgery, and interventional radiology.
Speaker Change: to obtain first-in-man procedures on the many applications of this elegant enabling commercial platform.
Speaker Change: We do not expect any significant revenues in the near term, but do expect to have news here ahead as we make progress.
Speaker Change: On the business development front, we have active partnering discussions with potential to be meaningful for our business with respect to all four of our platforms.
CARDI-AM, CARDI-ALLO, HELIX, and MorphDNA.
Speaker Change: For cardiac cell therapy business development, we expect the final data from cardiac heart failure one.
will enhance interest by distribution partners and strategics.
Speaker Change: 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.
and David Benvenuti.
Speaker Change: For cardi-allo business development, our allogeneic cell therapy currently in the clinic for heart failure. We have extensive clinical experience from three trials.
Speaker Change: We've had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease.
Speaker Change: I note that the FDA has set a Prescription Drug User Fee Act date.
Speaker Change: of January 7, 2025 for a peer company with very similar cells and another indication whose anticipated success will likely enhance our partnering discussions around our clinical stage allogeneic cell therapy platform.
Speaker Change: For our Helix biotherapeutic delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products, and support capabilities remain active in discussions.
Speaker Change: Current partners realize that minimally invasive delivery not only enhances future commercialization, but it is also seen as a critical means for clinical development.
Speaker Change: enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their therapeutic development.
Speaker Change: 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.
Speaker Change: We believe this advantage is due to the stability of the helix in the beating heart and the self-sealing helical pathway into the tissue.
Speaker Change: We encourage all partners to perform pharmacokinetic studies, including a surgical delivery control, so they will have their own data supporting what we have seen.
Speaker Change: 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 towards any distribution or commercial partnership.
Speaker Change: In summary, we have delivered five of the six milestones detailed in our last conference call.
Speaker Change: We had expected to treat the first patients in CARDIAMP Heart Failure II trial and begin demonstrating that we can enroll in this trial quickly with our world-class clinical partners.
Speaker Change: Two hurricanes in Florida this quarter have had an impact on this goal, but patients are in the queue and this goal will be realized soon.
Speaker Change: We are working to complete the following before the end of this quarter, Q4 2024.
Speaker Change: 1. Have a consultation with Japan PMDA and Cardi-Am cell therapy.
Speaker Change: 2. Complete data lock on the CARDI-AMP Heart Failure 1 trial data set.
Speaker Change: Three, begin treatments and activate an additional three centers in the CARDI-AMP Heart Failure II trial.
Speaker Change: 4. Enroll the last low-dose patient in the Cardiallo heart failure trial.
Speaker Change: And five, put first commercial morph DNA products on the shelf and perform first procedures.
Speaker Change: I will now pass the call to David McClung, our CFO, who will review our third quarter 2024 financial results. David.
All right.
Thank you, Peter, and good afternoon, everyone.
Speaker Change: In September, we closed our $7.2 million public offering, bringing us into compliance with NASDAQ's listing requirements. This extends our runway past our expected results in the pivotal cardiac heart failure trial in Q1 2025.
Speaker Change: Total expenses decreased 41% quarter over quarter to 1.8 million dollars in Q3 2024 compared to 3.0 million dollars in Q3 2030.
Speaker Change: Research and development expenses decreased to $931,000 during the third quarter of 2024, compared to $1.9 million for the third quarter of 2023, primarily due to the completion of enrollment in the CARDI-AMP Heart Failure I trial, coupled with related reductions in clinical and supporting function expenses.
Speaker Change: We expect R&D expenses to increase modestly as the CARDIAC HEART FAILURE II trial ramps up beginning in the fourth quarter of 2024.
Speaker Change: As Peter mentioned, the Cardiac Cell Therapy for the Treatment of Heart Failure qualifies for Medicare coverage.
Speaker Change: with covered costs including patient screening, the investigational cardiac cell therapy system, the procedure, and the clinical follow-up at $17,000 for both the treatment and the control arms.
Speaker Change: This substantially reduces the expense of accelerating enrollment in the CARDIAC Heart Failure II trial.
Speaker Change: Selling General and Administrative expenses decreased to $825,000 for the three months ended September 2024, down from $1.1 million from the same period in 2023, primarily due to the reductions in personnel expenses.
Speaker Change: We expect SG&A expenses to remain close to the current runway.
Thank you for your time.
Speaker Change: BioCardia's net loss decreased to $1.7 million for the third quarter 2024, down from $2.6 million in the prior year's third quarter, primarily to those reductions in R&D and SG&A expense.
Speaker Change: Net cash used in operation for the third quarter of 2024 totaled $2.6 million compared to $2.4 million in the third quarter of 2023.
Speaker Change: The increase is due to the settling of trade payables and accrued liabilities following the closing of the $7.2 million public offering in September.
Speaker Change: For perspective, cash flows for the nine months ended September 2024 were $5.5 million. That's $2.6 million less than the same nine-month period in 2023.
Speaker Change: We expect our cash burn will increase moderately over the coming year, continuing our track record of operating efficiently and carefully managing the use of capital.
Speaker Change: This concludes management's prepared comments, but we're happy to take now questions from attendees.
Speaker Change: Ladies and gentlemen, at this time we'll begin the question and answer session.
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Speaker Change: Once again, that is star and then one to join the question queue.
We'll pause momentarily to assemble the roster.
Speaker Change: And our first question today comes from Joe Pandigenous from H.C. Wainwright. Please go ahead with your question.
Speaker Change: Hey, everybody. Good afternoon. Thanks for taking the questions. So, Peter, I want to start at the back end of your prepared comments, if you don't mind. You gave a lot of great details around MorphDNA. And I guess, you know, what are your potential options other than, you know, individual partnerships or company partnerships or broader partnerships or even monetizing the entire program? What are your options that you're looking at?
Speaker Change: Well, Dr. Panchenis, thank you for the question. It is a good question. So MorphDNA is a product that we realized because we recognize the advantages it provides for all of our procedures on the cardiac cell therapy side and with partners using Helix. And it's an elegant, durable, introducer sheath platform.
The market here is actually quite large.
Speaker Change: I'm actually aware of one hospital, a single hospital in the United States.
Speaker Change: that uses 250,000 units of this type per year for one clinical indication of transeptal access for performing atrial fibrillation procedures.
Speaker Change: So it's a quite large market opportunity across the board. It's very competitive in the electrophysiology space.
In the last
You know, here in the electrophysiology space, primarily, we saw
Speaker Change: We saw Medtronic buy a company for roughly $100 million. We saw Boston Scientific buy a company with other assets for crossing the heart wall for $1.8 billion.
$2 billion based on these steerable introducer assets.
Speaker Change: We're earlier in the commercial pathway here, but we have a very compelling
Speaker Change: technology advantage to those other catheter systems and that our morph DNA has a rotating tendon element that goes down the length of the catheter which you can see in the product brochure that's available on our website.
Speaker Change: And what that does is it eliminates WHIP when using this device in a patient's heart or in their vasculature.
Speaker Change: And whip is the tendency for the catheter to be stable in one position but unstable in another position so that it jumps to the stable position.
Speaker Change: And so that technical advantage is one of the things that we're going to be proving out.
Speaker Change: If you look at the brochure on our website, there's what we call the naked man, an anatomical model of all the different places that this can be used in the clinic today based on the approvals we have and the configurations we have. We are going to be populating
Speaker Change: that image with case reports from world-leading physicians in the months ahead. And if there is a perception that this provides a compelling benefit for the physicians who use it, our options to answer your question, Joe,
Speaker Change: pathways where we can sell this business unit far more at present than we are to pathways where we would enter into a distribution agreement.
Speaker Change: and that's one of the reasons why today we've reached out to executives at companies that sell into these physician groups today to say, hey, our product's available.
Speaker Change: you right now are recommending potentially a product of your competitors and You could recommend a product of a company that if it resonates for you could be a potential tuck-in acquisition for you ahead
Speaker Change: So our plan right now is we're trying to demonstrate that the the physician utility over existing product and in parallel to developing analyses to either support expanding our
Speaker Change: manufacturing and commercial footprint, we'll also be exploring pathways where we can divest this business in a fashion that brings in significant non-dilutive capital.
Speaker Change: for our other efforts, which is our main focus. I note that any divestment that we would consider would have to guarantee that Biocardia retains
exclusive rights to this platform technology for biotherapeutic intervention.
Speaker Change: because it is a significant advantage that we have. And I note that the products, if you look at our website, we only offer this available in 90 centimeters length commercially.
Speaker Change: and yet our platform that we use in all of our procedures today is 110 centimeters in length.
Speaker Change: And that sort of puts a little barrier into there for anyone that wishes to use our commercial product for what we do on the cell therapy side.
Speaker Change: So, it's a long-winded answer, Joe. Forgive me, but we've had some good thoughts on it.
And it's under web. Absolutely. Yeah.
Speaker Change: Very, very helpful details and I appreciate all the options that you have. So if you don't mind, I'd like to switch gears to your ex-US efforts regarding CARDI-AMP and want to get sort of a general concept.
Speaker Change: regarding, you know, the process and timing in Japan, and then just curious because, you know, I've seen other examples for cellular therapies. I mean, since you have breakthrough therapy in the U.S., I believe the designation or
Speaker Change: A similar designation in Japan is called Sakigaki status and I'm just curious if you were looking for that as well.
Speaker Change: So, yeah, great question on Japan, and I know who you're thinking of with Sakagaki status. Sakagaki is named after one of their first satellites.
Speaker Change: So, we've had great interactions with Japan PMDA and with the FDA here in the United States. In Japan...
Speaker Change: The process ahead is we have our next clinical consultation scheduled for this month with PMDA, Pharmaceutical and Medical Device Agency in Japan. And in that consultation, you know, we're talking about the
Speaker Change: the desire that we have to provide our data based on what to them are foreign trials, i.e. our trials in the United States and Japan.
Speaker Change: And my sense is they're pretty supportive of that at present.
Speaker Change: were answering a number of questions that they raised in our clinical consultation in November of last year and detailed in written minutes in December of last year.
Speaker Change: And, you know, many of those questions tie into our CARDI-AMP heart failure data.
Speaker Change: Quite a few of the questions, you know, end with the statement of, please address this in your application for approval.
Speaker Change: or your submission for approval. And that's really where we'd like to get you. So it's really a couple step process here. The first step is this next consultation is to tee up the clinical consultation.
Speaker Change: and it is a significant hurdle if they say yes, we would like you to come in for a formal clinical consultation to review your data, which was really the second to last step before they say.
Speaker Change: Yes, you can submit for approval. And so that is a really big hurdle. So the next significant hurdle there is will they allow us to submit and have a clinical consultation?
Speaker Change: So we will submit all of the data from CARDI-AMP Heart Failure 1 and engage with them on that data and answer quite a few questions they have on how that fits into standard care in heart failure in Japan, which we've already addressed extensively.
Speaker Change: They're very detail-oriented but they've given us some pretty positive signals so far. And so our hope is that after that clinical consultation, our first hope is to get to a clinical consultation. That's a significant hurdle.
Speaker Change: In the clinical consultation expected in roughly Q1, or the submission in Q1, if they invite us to effectively apply for approval,
Speaker Change: That's a really big deal. That means we're on a pathway to approval in the not-too-distant future for a cell therapy in Japan in heart failure.
Speaker Change: And I note that you asked about Sakagaki. You know, Sakagaki is often tied into more the biologic therapies. And in Japan...
CARDI-AMP is going to be regulated as a device system.
Speaker Change: similar to the way it's regulated in the United States. They get into the cell-based therapy and the selection of patient elements, which are all biologic, but as the cells are manufactured in a device at the patient's bedside, it will be regulated as a device-based system.
Speaker Change: And that means that our approval, should we get it in Japan, would be a full approval.
Speaker Change: So, that's sort of the timeline ahead, so we are hopeful, very hopeful, early next year that we'll have the clinical consultation with Japan PMDA. And after that clinical consultation, in the minutes,
Speaker Change: that they provide from that clinical consultation, looking at the data from all three of our trials and answering all of the questions they've had heretofore, that all of the questions they ask us will end with, and please address this in your application for approval.
and appreciate the clarification on Sakagaki.
Speaker Change: When you look at the cellular therapy space the regenerative medicine and all that There's always you know good bad or ugly a lot of investment and this goes for many different Therapeutic approaches or technology approaches, you know basket thinking, you know All cells are alike or in different indications or what have you so you referenced in your prepared comments an upcoming PDUFA date And of course, this is for Mesoblasts and you know for GVHD, so I'm just curious. I know it's difficult to talk about You know say
Speaker Change: competitor products or what have you on calls like this but can you point to any similarities or differences in your cells that can help you know if they have a positive outcome you know for a positive basket approach?
Speaker Change: yeah so um so if you go back to an earnings call we had probably gosh
Speaker Change: over a year ago, two years ago, I was asked the question of what did I think of Mieselbosch's chances at panel.
in their indication for pediatric graft-versus-host disease.
are very similar to the cells that we are advancing.
Speaker Change: That program was initially begun by Osiris Therapeutics many years ago.
on BioCardia, his work with Osiris many years ago.
allogenetic, culture-expanded, bone marrow derived, mesenchymal stem cells.
Speaker Change: Now, mesenchymal stem cells are characterized by, you know, the process, because each manufacturing process can be slightly different. But fundamentally, we're delivering very similar cells.
And so, their success.
in their PDUFA meeting ahead.
is likely to significantly enhance interest.
in partners around
Speaker Change: both their programs and other indications, but also our clinical grade cells.
Speaker Change: for those, many of those same indications. So, I think it's a real opportunity that we have this ready. We have FDA-approved INDs for both an inner tissue cardiac delivery, but also for an intravenous delivery for our palm LO project.
Speaker Change: So my sense is their success, you know, rising tide lifts all boats, will enhance interest in our allogeneic platform as well.
Speaker Change: Excellent. Peter, thank you very much for all the details and looking forward to the upcoming CARDIAC-1 data.
Speaker Change: I appreciate it Joe. Thank you so much for the questions.
Thank you.
Speaker Change: Our next question comes from Kumar Raja from Brookline Capital Markets. Please go ahead with your question.
Speaker Change: Good afternoon and thanks for taking my questions. First with regard to the protocol amendment in the CARD EMP2 trial
Speaker Change: what percentage of patients would fit this profile and how were similar patients who had like, you know, similar nature of cells, how were they treated in the CARDI-MP1 trial?
Speaker Change: Great question, Kumar. So I call that amendment approval, I call it the 20 million dollar amendment here at BioGuardian because of how significantly it's going to change how easy it is to enroll patients in the trial. Previously, if a patient didn't meet the pre-specified cell population analysis criteria, they were excluded from the trial.
Speaker Change: Now, we took measures throughout the trial and in our analysis of the cardiac heart failure cell population analysis data for both patients who didn't make it into the trial and the patients who did make it into the trial.
Speaker Change: We saw that there was a large portion of the patients that were just really under the threshold, within, say, 35% of the threshold. And so we went...
Speaker Change: to the agency and we presented a plan whereby for those patients
Speaker Change: to help ensure that they have potential to reach the target dosage instead of excluding them.
Speaker Change: we are going to give them 35% more deliveries. So currently, we treat patients with 10 dosages around damage and infarct site. For those patients that are in a class that doesn't meet the full cell population analysis,
Speaker Change: score, those that fall below but are greater than 65% will then be targeted with the 10 dosages.
Speaker Change: plus an additional five dosages to get them to the optimal target dosing.
And so we're pretty excited about this.
Speaker Change: We're not detailing the exact numbers and all the details and changes yet, because again, we don't yet have final data in the trial, but our expectation is that
You know, we will still exclude patients.
Speaker Change: based on not having appropriate cells for therapy. But my expectation, and I should say our expectation of the team, is that about 85% of the patients will pass that threshold and a number of them
Speaker Change: will wind up having 15 deliveries to get to the target dosage versus the 10. So this is truly personalized medicine where we're assessing a patient's own autologous tissue.
Speaker Change: looking at it for its composition and then developing a treatment plan which now has three arms. One arm is, I'm sorry your cells don't qualify you for treatment.
The other arm is...
Speaker Change: Yes, your cells qualify you for treatment, and the third arm is your cells qualify you for treatment, but because of the nature of your cells, we're going to provide an additional five dosages. So that's what we're rolling out now, and all the paperwork's been implemented here at BioCardio. We have IRB approval. The full CardiAMP heart failure trial, heart failure 2 trial, will incorporate that element.
Speaker Change: That's great, that's very helpful. And with regard to Japan, what would be your commercialization strategy? Are you looking for partners there or what is the plan there?
Absolutely. So in Japan, my expectation is...
that we will partner in Japan.
and when and how we partner will depend upon...
Speaker Change: We have a world-class group of folks and we have world-class physicians involved.
Speaker Change: The first step post-approval is expected to be really a post-marketing study to enhance awareness to develop additional data. So that first year
Speaker Change: Think of it as a slow rollout. In Japan, distribution is a little different than it is here in the States. Each and every hospital sort of has a transitionary distributor for these types of products. It takes
Speaker Change: essentially 10% of the value proposition and manages the interaction within the hospital. There are other distributors who then sell into those distributors.
Speaker Change: and there are some larger players in Japan where we we have active conversations on what we're doing with this therapy and how it might fit into their commercial efforts and we continue to have these conversations.
Speaker Change: I think in Japan, being able to be approved without a clinical trial is viewed as quite valuable because clinical trials in Japan are notoriously expensive and take a very, very long time.
I, you know, I'll do a cross...
Speaker Change: question, comment here. I believe that the program that Dr. Panjenis was referring to
Speaker Change: was one that had Sakagaki, but it couldn't complete enrollment just because clinical trial enrollment in Japan is quite difficult.
Speaker Change: And so, by getting approval without that requirement, I think it enables us to move forward. So, in addition, I'll share with you that in Japan today...
There are two other companies...
Speaker Change: and a surgically-based cell therapy for heart failure, which requires chronic immunosuppression.
Speaker Change: and the advantages we bring to the table and not requiring those things, i.e. minimally invasive access, no immunosuppression, is a really compelling advantage for physicians as well as for patients.
Speaker Change: And so my sense is, on the other side of approval, there will be a lot of interest in this therapy.
Speaker Change: That will turn on a lot of green lights, so we'll take it from there.
Great, thank you.
Thank you, Kumar. Appreciate the question.
Speaker Change: And ladies and gentlemen at this time I would like to end today's question and answer session and turn the floor back over to Peter Altman for any closing remarks.
Thank you, Jamie.
Peter Altman: I thank everyone who has helped our mission to develop and enhance therapies to treat cardiovascular disease.
Speaker Change: Investors should know that we have potential to achieve enormous success with their support.
Speaker Change: and that our market capitalization today presents a remarkable investment opportunity and a company with many ways to win that is able to do great things on modest capital.
Speaker Change: We expect to deliver a rewarding end to 2024 and an incredible 2025 if we are successful in our efforts.
Speaker Change: Have a great afternoon and thank you for your continued interest and support of BioCardio.
Speaker Change: Ladies and gentlemen, with that we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.