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spk04: Ladies and gentlemen, thank you for standing by. Good day and welcome to the BioCardio 2022 Third Quarter Conference Call. At this time, all participants are in a 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 telephone keypad. And to withdraw your question, please press star then two. Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through February 9th of 2022, excuse me, 2023. I would now like to turn the conference over to Jules Abraham of CoreIR, the company's investor relations firm. Please go ahead, sir.
spk02: Thank you, Chuck. Good afternoon, everyone, and thank you for participating in today's conference call. Joining me from Biocardia's leadership team today are Peter Altman, Ph.D., 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 or operational results, references to management's intentions, beliefs, projections, outlook, analyses, or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or 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 described in BioCardia's most recently filed periodic reports on Form 10-K, Form 10-Q, and the Form 8K filed with the SEC, and particularly the cautionary statements with it. The contents of this call contains time-sensitive information that is accurate only as of today, November 9, 2022. Except as required by law, BioCardio disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It's now my pleasure to turn the call over to Peter Altman, Ph.D., the company's president and CEO. Peter, please go ahead.
spk06: Thanks, Jules, and good afternoon to everyone on the call. We have had a great quarter. But before I get into the details, let's take a few moments to review what we are doing and why we are doing it. BioCardia's efforts are focused on advancing two cell therapy platforms, to treat significant unmet cardiovascular and pulmonary diseases. Specifically, ischemic heart failure, chronic myocardial ischemia, and acute respiratory distress. All of our cell-based therapies involve local delivery of the therapeutic cells to the heart or lungs where we intend them to act locally. In the heart, our own proprietary Helix minimally invasive delivery system, a third platform, is used to deliver the cells to target regions of damage. For the lungs, we intend to use intravenous delivery, which will result in the investigational cells being localized in the small blood vessels of the lungs. Local delivery of therapeutics to the target location where their action is desired maximizes their effective dosage within the tissues where delivered and minimizes potential negative effects remote from target tissues. Heart failure is the first problem we are going after. It is an enormous unmet need that affects more than 26 million people worldwide. The latest blockbuster drugs and pretty much the same indication we are going after don't have much of an impact on mortality. Patients in the published results of the pivotal trials for these new drugs have a cardiac mortality of roughly 7% and an all-cause mortality of 10% per year. regardless of whether they were treated or controlled patients. This data makes clear that heart failure is still a problem in great need of new therapeutic solutions. Our autologous mononuclear cell therapy platform, which we call cardiac cell therapy, is being advanced in two cardiac clinical indications. In preclinical studies, cardiac mononuclear cell therapy has been shown to release proteins locally within the tissue to facilitate cardiac recovery after heart damage with improvements in heart perfusion and contractile function. All known previous clinical studies, similar to the approach we are taking in our two lead cardiac cell therapy programs, have shown patient benefits on average. In some of these studies, including our own, the benefits have been remarkable. Our FDA breakthrough designation in ischemic heart failure validates this perspective. In granting this designation, the FDA looked through all of our clinical results, patient by patient, and agreed that cardiac cell therapy data to date shows it has promise to provide for more effective treatment for ischemic heart failure. Advancing this and our other therapeutic candidates is what we are all about. Our efforts to complete the cardiac autologous cell therapy pivotal clinical trials for the indications of heart failure, or BCDA01, and chronic myocardial ischemia, or BCDA02, remain our primary focus, with an estimated combined 1.6 million patients in a reachable U.S. market. The cardiac cell therapy heart failure trial, or BCDA01, is a Phase III 260-patient randomized controlled clinical study intended to provide the primary data to support safety and efficacy in pursuit of market clearance. We have enrolled 115 patients in this trial with a number of additional crossover patients. In August of 2022, the Independent Data Safety Monitoring Board completed a pre-specified data review, including a risk-benefit assessment, Following this review, the Data Safety Monitoring Board indicated that it had no significant concerns and recommended the study continue as designed. As part of this review, we looked at blinded results across more than 100 patients past the one-year primary endpoint, including treated and controlled patients in the trial. We were impressed that the survival rate one-year follow-up was greater and that observed in recent similar large pivotal trials in patients with heart failure with reduced ejection fraction. For study subjects followed through the key visit dates in this study, mean health outcomes across both treated and controlled patients was improved across multiple endpoints at all time points, including six-minute walk distance, which contributes to the primary composite endpoint. The Data Safety Monitoring Board recommended that the company, as sponsor, consider implementing an adaptive statistical analysis plan, which could enable an early readout for study treatment efficacy. An adaptive statistical analysis plan is one which attempts to determine the appropriate number of patients needed in a clinical study based on the data within the trial itself, as opposed to from a previous trial. This has the significant advantage of de-risking the trial from changes that have occurred in the current trial relative to previous trials. In reviewing the data during a data safety monitoring board meeting under an adaptive statistical analysis plan, the data monitoring board may be able to assess at certain points in the clinical trial how many patients should be enrolled in the trial to meet the primary endpoint in the trial. If a trial has already enrolled the number of patients expected to be required to show efficacy, then there is potential that the Data Safety Monitoring Board informs the sponsor that the trial enrollment might be stopped for expected success. Efforts are now underway to complete an adaptive statistical analysis plan for the cardiac heart failure trial, executive steering committee, and the FDA to review and comment on. In parallel, our clinical operations team, under the leadership of Debbie Holmes-Higgins, is working to ensure the clinical data that the Data Safety Monitoring Board would use in such an adaptive review of the study statistics is correct through extensive monitoring of the clinical data in collaboration with our clinical partners. This is often referred to as cleaning the data and is a significant effort. The next pre-specified formal Data Safety Monitoring Board review is anticipated in March 2023 And based on conversations the company has had with the intended developers of the Adaptive Statistical Analysis Plan and its respected regulatory consultants and our own efforts cleaning the data, the company believes it is likely to be able to have the Adaptive Statistical Analysis Plan in place for the next Data Safety Monitoring Board meeting. The specific details of any potential Adaptive Statistical Analysis Plan in combination with any modifications to the Data Safety Monitoring Board Charter will dictate what happens at this next and subsequent Data Safety Monitoring Board reviews. As the cardiac cell therapy trial in heart failure was over 90% powered for success based on the previous Phase II data, there is potential that the trial could meet its primary efficacy endpoint on the patients that have already been enrolled to date. However, when the Data Safety Monitoring Board next meets, they may recommend that the trial continue per plan, be stopped for safety, or be stopped for futility if the data does not support that achieving the primary endpoint is possible. This October, additional data came out at the Heart Failure Society of America annual meeting in the form of two-year data on the 10-patient rolling cohort. The data showed 100% survival and trends towards benefit across multiple endpoints, and further enhances our enthusiasm for this program. This October, we also updated our patient-facing website, www.cardiamp.com. This includes the elegant animation that details the trial overview discussed in our last quarterly call. I encourage everyone to view this website and watch the trial overview and the patient testimonials there. If you have friends or relatives suffering from heart failure, please pass along the website to them for them to learn about the CAR-DM cell therapy and opportunities to participate in the trial. Our second therapeutic program is for the same therapy for the treatment of chronic myocardial ischemia with refractory angina, or BCDAO2. The CAR-DM chronic myocardial ischemia trial is a phase three, multi-centered, randomized, double-blinded controlled study of up to 343 patients at up to 40 clinical sites. The Phase III Pivotal Trial is also designed to provide the primary support for the safety and efficacy of the cardiac cell therapy system for this indication. It uses many of the same novel aspects of the cardiac heart failure trial and is expected to leverage our experience and investment in the heart failure trial. This program benefits from the 2022 Center for Medicaid and Medicare Services, or CMS, reimbursement at up to $20,000 for treatment and control patients. The trial has been activated at two centers, and the company is working to activate additional centers. Early clinical data from the rolling cohort is showing safety with remarkable benefits in the primary endpoint of exercise tolerance time, and we are working to deliver data on this cohort in advance to the randomized cohort. As we have shared in July, we had our second consultation with Japan Pharmaceutical and Medical Device Agency regarding registration of cardiac cell therapy for ischemic heart failure. We are substantially ready today to submit the dossier with all details as requested, but may delay in order to obtain the support of one or more Japanese medical societies for cardiac cell therapy to support its approval and its reimbursement. This is under active discussion today with our regulatory and scientific advisors and one of our potential distribution partners. Japanese researchers established the building blocks for this therapy many years ago. The therapeutic approach we are pursuing was first studied in a preclinical model by physician scientists in Yokohama. This early work was performed in parallel to other Japanese vascular biology scientists, who identified important aspects of bone marrow-derived mononuclear cells and tissue repair. Their early efforts underlie our cardiac cell therapy, and we hope to be able to provide this therapy to the many in Japan who could benefit from it. Now I'd like to move to our two allogeneic cell therapy product candidates based on our allogeneic neurokinin-1 receptor-positive mesenchymal stem cell platform, which has also progressed in the last quarter. Our allogeneic MSC program in heart failure, which we have designated BCD03, is intended to include the patients who have been excluded from our autologous program due to the nature of their cells. We have completed the manufacturing validation runs and stability testing for the chemistry manufacturing control section of the IND. We have completed the preclinical pharmacology toxicology animal testing with no safety issues and with trends towards therapeutic benefits. It is my pleasure to share that the IND application for this program was filed with FDA CBER in early November 2022. The company anticipates FDA approval of the IND in December. Our allogeneic MSC program in patients recovering from acute respiratory distress syndrome, which we have designated BCD-04, was approved by FDA in April 2022 to treat patients. A first clinical study manufacturing run from our Sunnyvale facility has been completed. Cells are cryopreserved, awaiting final, longer lead time test data for lot release, hopefully this month, after which they may be shipped to centers for patients in the clinical study. This manufacturing run has potential to have sufficient cells to complete the entire Phase I portion of the Phase I-II trial as we achieve many doses with each batch. We are in late-stage onboarding of world-class clinical centers to perform the trial ahead. We are optimistic due to the longstanding promise of mesenchymal stem cells in lung repair and the unique clinical indication we have defined. We aim to address the need to reduce local and systemic inflammation after a patient is taken off respirator support with goals of accelerating recovery, enhancing survival, and reducing both relapse and rehospitalization. In summary, we are advancing four therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and our allogeneic cell therapy platforms. From these therapeutic development efforts, we now have four active business development initiatives. First is partnering our cardiac cell therapy platform internationally. Second is licensing out our clinical stage NK1R positive mesenchymal stem cell program for other clinical indications, which have shown promise with other mesenchymal stem cell preparations. Third is licensing our catheter-based biotherapeutic delivery systems for cell, gene, and protein therapy candidates to the heart, such as in the Blue Rock relationship we began last quarter. And fourth is monetizing our Avance transeptal introducer sheath product. I will now pass the call to David McClung, our CFO, who will provide some financial perspective. David?
spk07: Thank you, Peter. In the first three quarters of 2022, we had revenues of approximately $1.2 million on a net loss of $8.9 million, which compares favorably to the first three quarters of 2021, where we had revenues of $0.9 million with a net loss of $9.2 million. This increase in revenues and decrease in net loss is primarily due to the increased collaboration of revenues. I'd like to reiterate that the potential value of collaboration revenues is far greater than the dollars we receive when we enter incidents. Partnering programs provide additional pathways for BioCardia to participate in the upside of partner development programs. And the value, if we can help them be successful, should be meaningful for shareholders. Research and development expenses increased modestly, with $6.6 million reported in the nine-month period ending September 30, 2022, compared to $6.4 million in the nine months ended September 30th, 2021. SG&A expenses of $3.5 million for the nine months decreased from $3.7 million from the same period in 2021. The company ended the second quarter with cash totaling $6.7 million, which provides runway into the second quarter of 2023. To extend our runway, we are working on business development activities with a focus on non-dilutive financing. We're now ready to take questions. Operator?
spk04: Thank you. We will now begin the question and answer session. Should you wish to ask a question on today's call, you will need to press star, then one on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing the pound key. If you're using a speakerphone, please pick up your handset before entering your request and speaking on the call. In one moment, please, for the first question. The first question will come from Joe Pangenis with A.T. Wainwright. Please go ahead.
spk01: Hey, guys. Good afternoon. Thanks for taking the question. Peter, my first question is a bit multi-pronged, and I guess it's, I mean, it's housekeeping related, but it really goes into the weeds regarding the adaptive design plan that you're currently working on. So hopefully you can provide some more information. So I guess, you know, what are really the stage of the discussion now with the FDA you know, with regard to outstanding topics. That's number one. Is there, well, how would we consider the alpha spend around any of the adaptive components that you have here, especially if it's lower enrollment? And I guess it's really related there, you know, with regard to the outstanding topics with the FDA, you know, what else is on your, you know, wish list, excuse me, in getting this over the finish line with the FDA?
spk06: So, I can share with you that we are in the process. So, Joe, first off, thank you for the question. But to jump straight to the answer, the discussions with the FDA are still early. We have not yet had a Q-Sub meeting with them. We are in the process of preparing the submission with the appropriate detail that's really needed for them to understand it and wrap their heads around it. In this situation, you know, this is being recommended by the Data Safety Monitoring Board, and my sense is the agency will undoubtedly, you know, raise concerns about a smaller number of patients enrolled in the trial. But one of the advantages we have is, you know, the breakthrough designation from FDA that does give us the ability, I understand, to, if we need additional safety data for such a significant indication, to potentially capture that in a post-marketing scenario. We are working with two very prestigious groups who have actually cross-recommended one another. One is a world-class group in developing adaptive statistical analysis plans, and the other is a very high-profile regulatory consulting group that includes a number of former senior FDA directors. And so, we're pulling this team together and having regular meetings. But I guess the first thing is dialing in the adaptive statistical analysis plan in order to understand what the cost of alpha may be. But my sense is it's not going to be a significant cost of alpha here because our expectation is we're going to do a design that looks at, you know, the question of how how large should the trial be, not asking what are the results from the trial. And that changes the equation and makes it so that there's not an enormous alpha cost. So that's where we're at. This is a very active effort today. And I note in parallel to the regulatory and the statistics work, we have a significant ongoing effort to have all of the data cleaned so that at the next Data Safety Monitoring Board meeting, they're looking at very clean data so that we can rely upon the input that they provide on the other side of this. So, it's pretty exciting. But that said, as I shared in our comments, you know, there's no guarantees here. Fundamentally, this trial may just continue, and we are working diligently in ways to enhance enrollment in the trial, as well as enhance the experience of all the physicians participating in the trial.
spk01: Got it. No, those are all fair comments. I appreciate it. And then moving to sort of David's comments and even your list about business development goals, I guess I would ask it this way, and I would never ask you to predict timing. That's always a bad thing. But how would you describe the level of maturities of the list of those four different components of ongoing BD?
spk06: I would say that we've had significant discussions on all four of them. I would say that our focus right now is really on the first and the third of them, that is the OUS, CardiAmp, and the partnering on biotherapeutic delivery with others. We, in the last quarter, did enter into an arrangement with Blue Rock Therapeutics, and that is a time-limited option that they have that we may see some progress on in the year ahead. So, you know, there's, there's, this is, this is sort of the nuances of, of, of what we we've done historically. And remember previous, you know, to David's comments, the value of these partnerships, you know, we have a number of partners with significant data sets with our delivery system. And when you, when you're developing efforts, you know, those are, those are value propositions we have that could quickly grow into other value propositions ahead.
spk01: Got it, got it. And my last question, and thank you for bearing with me, if I just skip to the end of the pipeline for 04 and use of the allogeneic cells in our platform in ARDS, I guess maybe the broader concept of, look, the COVID landscape is dramatically changing, you know, it will still be sticking around based on, you know, the broad consensus. So I guess at this standpoint, status of COVID, if you will, you know, just the rationale of why, you know, doing the study at this standpoint, you know, and also while finances are important.
spk06: So the indication, so great question, Joe. The indication we're going after is patients essentially recovering from COVID. And there's actually a very significant gap there. There are right now really no therapies targeted for patients when they come off respirators. And so there's something out there that we've all heard about, you know, with chronic inflammation. A lot of folks will refer to it as long COVID, and that's not the indication per se that we're going after, but there are sustained inflammatory impact of COVID-induced ARDS. I also note that in other etiologies of acute respiratory distress or ARDS, there's also a gap in what happens to a patient at the tail end of being on respirator. And so there's a space where they don't have anything. And what we're doing is a relatively routine therapy. On the economic side, Joe, great question. So these trials, as they start with phase one, phase two, typically start with a dose escalation cohort with great care to protect the patient. And so there's not a significant number of centers that's going to be added to either of these trials. So basically, think of it as we're cleaning out all of the safety issues and optimizing the maximum tolerated dose for these two therapies, BC-03 and BC-04, with the expectation that it's not going to be a significant burn. We're manufacturing the cells ourselves here at Biocardia. For the ARDS effort, it has a very short endpoint for efficacy based on a lot of the other trials that have been out there. So we're feeling pretty good about the direction we're going, and I don't think it's going to substantially impact the burn rate for the phase one portion. As we move into later stage phase two portions, yes, the burn rate would increase significantly there. But that's something to be decided on in the future. Got it. Appreciate the color, Peter. Thanks a lot. No, appreciate the questions, Joe. Really appreciate being on the call.
spk04: Thank you. The next question will come from Michael Akunowicz with Maxim. Please go ahead.
spk05: Hey, Peter. Thank you for taking the questions. I wanted to see if you could provide a bit more color and kind of walk me through how you conducted the analyses on the blinded data, and then if you could just give us a bit more on how we should be interpreting that.
spk06: Yeah, so the blinded data, so a normal process for a data safety monitoring board review, Michael, is that you will receive an open session package that looks at all of the data on all of the patients. So it's aggregate data. So we are blinded to the data. We don't know whether one group is different from another group. But what stands out when we look at the data is that the patients are improved. And we're going after heart failure, which is a chronic condition. And in our phase two trial, the treated patients improved, but the control patients deteriorated over time, which is what you would expect. And, you know, it just sort of jumped out at us as we looked at the data. Now, I mentioned the animation of the trial at cardiamp.com. And even in that animation, we call out the fact that patients typically do better in a clinical trial. So we may just be seeing all of the patients together doing better in the clinical trial. But I note that the mortality rate is also significantly less than we would expect based on the related literature in the field. And again, we don't We don't have a way to compare it because we're blinded as to the patients which are in which group. And so this was the status of the data at the last DSMB. The DSMB recommended the adaptive statistical analysis plan in part because of slow enrollment during COVID. Typically, adaptive designs are used for trials that either are rolling slowly or have a very short end point. But we also have a significant number of patients past the primary endpoint. And so, coupled with that, we also have breakthrough designation. And so, you know, one of my great concerns, you know, even if we did have a wonderful ability to say we've already reached efficacy in the future before we completed the full enrollment in the trial, would be that, you know, in heart failure, since it's such a significant indication, you want to make sure that you've treated enough patients so that everybody has comfort with respect to safety. But our breakthrough designation gives us a pathway to collect that additional data on the other side of approval. So that's it at a high level. Have I addressed your question appropriately, Michael?
spk05: Yeah, you did. I'd just like to drill down a little bit deeper on one point in particular. When you're saying that you're You know, you saw a greater survival rate compared to other large pivotal trials. That's comparing aggregate data to the aggregate data from other similar pivotal trials? Is that the idea?
spk06: That's actually would be considered a fair assessment, Michael, because the trials that have been out there aren't really showing a reduction in mortality. And this is one of the topics that's a great discussion. at conferences such as Heart Failure Society of America, that the mortality problem is still out there. But actually, when I talk about the comparison, in order to be fair, and this is always dangerous when you're comparing apples to oranges, our trial to other trials that are out there, because they're not the same trials. They're not the exact same patients. They're not the exact same therapies. But what we're comparing it to is really the successful positive arm of the trial in, I think, you know, I'll call it out, the SGLT2i files that have just come out in New England Journal of Medicine. And we referenced that in a previous press release. So again, this is not an apples to apples comparison. It's an apples to oranges. And the things that we're doing are very different, but it's a striking reduction in mortality across an aggregate population for us. And so is that more in one group than the other? We don't know. But it's interesting. That's all I'm sharing.
spk05: All right. Thank you for that. And then just one more follow-up. I'd like to just see if you could touch on... how the biotherapeutic delivery platform benefits Blue Rock self-therapy candidate, what kind of attracted them to your particular platform, and then what sort of other therapeutics or indications could benefit from the device?
spk06: Yeah, so I can't comment on anything with respect to Blue Rock, but I can tell you that our Helix Transendocardial Biotherapeutic Delivery System, has a couple of advantages. First, it's the only intramyocardial delivery system I'm aware of that is in clinical use today. It is approved in Europe, although we don't sell it in Europe. We only partner it. And it also is, its safety profile, which has been in the published literature, is far superior to that of our previous competitors who have since left the arena, and that would be small companies such as Johnson & Johnson and Boston Scientific. I also note that its efficiency of delivery, which we believe is due to the stability of the helix in the myocardium and its stability enabling control over delivery, enhances really the retention in the heart tissue after delivery. multiple data sets on multiple different classes of therapies have shown. We have roughly three-fold the retention or three-fold the dosing with our delivery system that others have had with a simple straight needle intramyocardial approach. And so that's also helpful. So lastly is the ease of use of the system. We have no capital equipment involved in this product. And in the past, we had a number of larger entities that, you know, wanted to work with us primarily because of the absence of capital equipment that would slow their own sales cycle or their ability to train and work with physicians around the world. So, you know, those are really the key advantages. And I guess I would say the last thing is folks are going after indications. You know, BioCardia today is focused on heart failure, and chronic myocardial ischemia. We have a partner in Europe in CellProthera that's going after acute myocardial infarction or maybe subacute, you know, soon after myocardial infarction. And those are really the three big indications today. There is a fourth indication out there, which is heart failure with preserved ejection fraction. And it's one that we're eyeing with great interest. because a number of very sophisticated folks have made clear that if we're successful in ischemic heart failure and or chronic myocardial ischemia are two indications today that heart failure-preserved ejection fraction is also in great need. And because folks view preserved ejection fraction heart failure as due to microvascular disruption, there's potential to go in that direction as well. So those are really the four indications. that it would be used for. And, you know, amongst those four indications, it's the leading cause of death in the Western world. I can quote the CEO of Johnson & Johnson, who just recently bought a biomed for $16 billion. And, you know, he has said that all forms of heart disease wind up in heart failure. And they see the greatest opportunity for their efforts to in helping hearts recover. And frankly, we couldn't agree with them more. That's exactly where we are and what we're doing.
spk05: All right. Thank you, Peter. I really appreciate the additional insight. No, thank you, Michael.
spk06: Really appreciate the questions.
spk04: The next question will come from James Malloy with Alliance Global Partners. Please go ahead.
spk03: Hey, thanks for taking my questions. I had a question on the The O2 interim look we're anticipating here, the roll-in safety look first quarter 23, is that the 100 patients or is that a subset of 100 patients? And when will the 100-patient cohort out of the 343 be enrolled?
spk06: So we are working to complete enrollment in that next year. We are in the process currently. So, James, first off, thank you for the question. And it's a good eye. We are actually, so for that rolling cohort, we've already got patients enrolled. The results from that rolling cohort are probably not going to be available until Q1 next year. But the results are rather phenomenal in the patients that have been treated. And our expectation is we're still pushing hard to have that get to the full 100 patients by next year.
spk03: Again, in the rolling cohort.
spk06: I'm sorry?
spk03: How many patients are in the rolling cohort?
spk06: Right. The rolling cohort per protocol is 10 patients.
spk03: Okay. And you anticipate enrolling the remaining 100 in 23 with the data? When we anticipate potentially having data from the first 100 and then potentially the final 343rd patient in this trial?
spk06: Right. So, again, we've long said this. You're being very attentive here, Jim. We're expecting that the – so we've talked about an adaptive statistical analysis plan for BCD02, and that's part of the plan with the agency. The conversations there have focused on having that be a six-month follow-up endpoint, which the agency has approved. We are in the process. One of the things you do in a rolling cohort is you try and learn every way you can to potentially make the trial easier to perform and more likely to be successful before you roll it out. We're also in a situation where we have centers across the United States and actually now coming online across Canada that are all trained up for the heart failure program. It's the same logistics. It's the same training it's very much many of the same study reference documents that support both of these programs and so the idea is right now we're not doing this at centers that are actually I take that back we have centers that are active in the trial we're adding additional centers that are not active in the heart failure trial and then at some point we will probably expand it to all of the centers that are doing well in the heart failure program. But we're just not at that point yet. And these are the patients.
spk03: First hundred and 23, and it's a six-month follow-up. We should be looking for mid-24 for the first hundred data?
spk06: I would say it's going to take longer than that to get the data for efficacy. Six-month follow-up is correct, but it will take time to clean that data and prep and go through some stuff. So, you should probably add a year on the other side of the completion of enrollment.
spk03: Then on the BCA03, the IND filing here hopefully approved in December. The 04, IND was approved on April 12th with the expectation the trial would start in third quarter 22. That's now first quarter 23. Should we expect a similar, you know, three-quarter delay between the IND approval for 03 and the phase 1-2 trial for the BCDA 03?
spk06: Actually, no. We don't expect nearly the same. So, for BCDA 04, you know, the steps involved the clinical manufacturing of cells. And the cells were substantially manufactured in Q3, but there's a couple of elements in the manufacturing process that have long lead time to make sure that the cells are safe for patients. And we're still, even today, with clinical cells on ice awaiting one of those long lead time items. So all of that work on the cells we've manufactured today will benefit BCD-03 from BCD-04. I also note, Jim, BCD-03 will have the advantage of all the patients we've already identified in the BCD-01 program. So the idea is to take that to the patients that have been excluded from BCD-01. The decision process here at BioCardia is going to be very interesting because we could treat a large number of patients in BCDA03 if we weren't concerned about the focus on BCDA01 and other trajectory items. So right now, our focus is we're going to do the Roland cohort on BCDA03 probably pretty quickly, but we're going to assess where we're at before we launch into the phase two portion of that study, because that will be more expensive. And once you make a commitment to a phase of a study, as a sponsor, you need to have the responsibility to complete it. We have that nicely with BCDO 1 and 2 with the Medicare reimbursement. For BCDO 3, it won't benefit from that reimbursement. And so we need to be thoughtful before we move into the phase two program. Also, since it's the same physician's you know, we don't want to distract them from BCD01 significantly. Even though they're different patients, you know, having a patient working through the system does consume time in the cath lab, and physicians have a sense of, I'm treating patients in your trial, but, you know, we're right now prioritizing BCD01 over BCD03 by far. I know that's a lot of complicated, you know, James, a lot of interaction, but it's, I think, It's the value of the synergy we have with these programs because as a small company, we can manage all four of these programs at this stage.
spk03: Yeah, last question for David real quick. What's with reporting the nine-month data and not having the numbers for the quarter in the press release?
spk07: Can you say again, Jim?
spk03: Why don't you guys put your numbers for the third quarter into your press release instead of just sort of putting the nine-month reporting? It's atypical.
spk07: Well, we put the nine. I think the nine-month numbers are more meaningful, whereas we're trending now towards the end of the year versus the fluctuation of quarter to quarter. They're pretty flat. We could have shown both, and they're presented in the tables. Yeah, all the data is in the tables.
spk06: And our revenues are lumpy with partnerships. So do we have the greatest revenues we've ever had this year so far?
spk03: Okay, thank you.
spk06: No worries, James. Really appreciate it.
spk04: This concludes our question and answer session. I would like to turn the conference back over to Mr. Peter Oltman for any closing remarks. Please go ahead, sir.
spk06: Thank you, Chuck. I just want to thank all of you for participating in today's call and for your interest in biocardio. We look forward to sharing our continued progress. Thanks. Stay healthy, be kind, and have a wonderful day.
spk04: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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