BioCardia, Inc. (NASDAQ:BCDA) Q4 2021 Earnings Conference Call March 29, 2022 4:30 AM ET
Company Participants
Jules Abraham – Investor Relations, CORE IR
Peter Altman – President & CEO
David McClung – CFO
Conference Call Participants
Kumar Raja – Brookline Capital Markets
Emanuela Branchetti – H.C. Wainwright & Co.
Michael Okunewitch – Maxim Group
James Molloy – Alliance Global Partners
Jason Kolbert – Dawson James
Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio should the corresponding text be unclear. The machine-assisted output provided is partly edited and is designed as a guide.
Operator
00:05 Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia 2021 Year-End Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] 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 June 29, 2022.
00:56 I would now like to turn the call over to Jules Abraham of CORE IR, the company’s Investor Relations firm. Please go ahead.
Jules Abraham
01:05 Thank you, Andrea. Good afternoon, everyone and thank you for participating in today’s conference call. Joining me today from BioCardia’s leadership team are Peter Altman Ph.D, President and Chief Executive Officer; and David McClung, the company’s Chief Financial Officer.
01:21 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, analysis or current expectations. Such factors include among others, the inherent uncertainties associated with developing new products or technologies and obtaining regulatory approvals.
01:47 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 Form 8-K filed with the SEC, particularly the cautionary statements in them. The content of this call contains time sensitive information as accurate only as of today, March 29, 2022, except as required by law BioCardia disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.
02:28 With that, 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.
Peter Altman
02:36 Thank you, Jules and good afternoon to everyone on the call. BioCardia continues to execute in its efforts to advance its meaningful pipeline of cell and cell derived therapeutics to treat significant cardiovascular and pulmonary diseases. 2021 was a big year for BioCardia’s team. We have progressed significantly in the development of all four of our therapeutic candidates, based on our autologous and allogeneic cell therapy platforms.
03:10 I’m going to touch on each of these core programs in term. First, our efforts to complete the CardiAMP autologous cell therapy pivotal clinical trials for the indications of heart failure or BCDA-01 and chronic myocardial ischemia or BCDA-02 have had some nice milestones. These include the receipt of an FDA breakthrough designation, successful Data Safety Monitoring Board reviews, and Health Canada No Objection Letter and the issuance of the new CMS reimbursement code to support both pivotal CardiAMP Cell Therapy clinical trials.
03:50 The FDA grant of breakthrough designation for the CardiAMP Cell Therapy System in heart failure is an enormous accomplishment that has been years in the making. This FDA breakthrough designation means that after the FDA performed an extensive review of all of the available patient by patient data. The agency made a formal assessment that the CardiAMP Cell Therapy has potential to be better than standard of care for patients with ischemic heart failure. Physicians that care for these patients, and the patients themselves can benefit from this independent review by the FDA, when they consider the CardiAMP Cell Therapy as an option.
04:33 Although, we have said that signals of patient safety and benefit are compelling all along, it has greatly to the credibility of the therapy for all involved that the FDA’s granting of Breakthrough Designation aligns with this perspective. It also shows that the FDA recognizes the current therapies haven’t addressed the enormous need that exist for these patients. The Breakthrough Designation results and are having significant advantages in our FDA interactions ahead, but most importantly, it is FDA saying that the autologous cell therapy we are advancing for these patients is important.
05:14 Although, the CardiAMP Cell Therapy Trials are covered by CMS, many private insurers don’t follow CMS’ lead. As a result, many patients with heart failure, who would qualify for our trial clinically have been excluded from receiving this FDA designated breakthrough cell therapy because of insurance. Although, the Breakthrough Designation may increase the frequency, the private insurers support covering the CardiAMP Cell Therapy, we have set out to solve this in three ways.
05:48 First, after significant sequential filings with both the biologics in the device group at Health Canada, the CardiAMP Cell Therapy in heart failure was issued in No Objection Letter. This letter allows the trials to advance in Canada where there are world-class sites we seek to bring into this trial. These clinical leaders are expected to help the program toward completion as BioCardia we paying for all patients enrolled without the logistical challenges with respect to private insurance reimbursement that exists in the United States.
06:21 Second, as sponsor we are now providing sites with CMS approved coverage of standard clinical costs for patients who is private insurer has declined to cover our investigational FDA designated breakthrough cell therapy for patients with heart failure. This can allow all patients to receive therapy regardless of insurance and is expected to double the number of eligible subjects in the trial in the United States. Third, we saw additional clarity from CMS in the form of a reimbursement code supporting both the treatment and control arm of the CardiAMP Cell Therapy procedures. CMS has issued such a new procedure code C9782 which applies to the CardiAMP Cell Therapy clinical trials in both indications.
07:18 We are thankful for the efforts of Health Canada FDA and CMS on these initiatives related to the CardiAMP Cell Therapy platform, which enhances the attractiveness of the trial and the therapy for centers, physicians and patients. In 2021 and 2022, we have had three Data Safety Monitoring Board reviews of the blinded CardiAMP Heart Failure Trial results. In all instances, the Data Safety Monitoring Board has said the trial should continue as planned. These initiatives and continued good data coupled with the weighing (ph) of COVID-19 at clinical sites throughout the country are operationally important for completion of the CardiAMP Autologous Cell Therapy trials in the United States and in Canada.
08:06 As a last item on the CardiAMP Cell Therapy, we have initiated a discussion with Japan’s Pharmaceutical and Medical Device Agency regarding registration of CardiAMP Cell Therapy based on the quality of our clinical data and the regulatory approvals that exist around all of the elements of the CardiAMP Cell Therapy System in Japan, The United States and the European Union.
08:31 Now, I’d like to move to our two allogeneic cell therapy product candidates both supported by our allogeneic Neurokinin-1 Receptor Positive culture expanded mesenchymal stem cell platform, which is progressed greatly over the last year. Our allogeneic Neurokinin-1 Receptor Positive culture expanded mesenchymal stem cell program in heart failure, which we have designated BCDA-03 is targeted to the patients who have been excluded from our lead program due to the nature of their cells. This program has completed the Chemistry Manufacturing and Controls validation and is completing additional pharmacology and toxicology study in animals.
09:14 Our allogeneic program on the same allogeneic Neurokinin-1 Receptor Positive culture expand mesenchymal stem cells in Acute Respiratory Distress Syndrome has also completed Chemistry Manufacturing and Controls validation, it’s pharmacology and toxicology studies and in March of this year, we submitted an IND to the FDA. We expect news in April from the FDA that this therapy may proceed to treat patients or will be placed on clinical hold with additional items to work through.
09:45 In summary, we are advancing four therapeutics cell therapy product candidates based on our autologous and our allogeneic platforms. The therapeutic delivery systems, we have created for our own programs are actively being used by partner programs and we believe that both patients and our shareholders will benefit from the success of our partners.
10:10 I will now pass the call to David McClung, our CFO, who will provide some financial perspectives. David?
David McClung
10:17 Thank you, Peter. Our financials show that we are disciplined and strategic in the use of capital. Revenue for the year ended December 31, 2021 totaled just over $1 million compared to $145,000 for the year ended December 31, 2020. $870,000 increase was primarily due to collaborations with corporate partners. This financial contribution helps to reduce our operating burn at each of these collaborations as the potential to [indiscernible] into a significant collaboration of the company.
10:50 The net loss for 2021 was $12.6 million compared to a net loss of $15 million in 2020. Net cash used in operation — at operating activities in 2021 was only $10.4 million compared to that cash used in 2020 of $12.4 million. This represents a decrease in overall spending for operations of approximately $2 million through the end of the year December 31, 2021 compared to December 31, 2020. And we ended 2021 with just under $13 million in cash and equivalents, which we anticipate a sufficient with our other planned activities to carry us through 2022.
11:34 We have also completed the transition of our laboratories and manufacturing to our new Sunnyvale facility, which has been designed to accommodate our clinical, commercial manufacturing and office needs for both our cell and cell derived therapies and our device delivery systems. Most of this transition and construction expenses rewarded (ph) in 2021 and with our new Sunnyvale lease, we have reduced annual facility expense by roughly $500,000 going forward, while significantly enhancing our facilities and capabilities.
12:07 The two deals, we entered into the 2021 with [indiscernible] our perspective, one of these has been extended and the other is ongoing. We look forward to continue expanding all of our collaborations, as our partners advance and their strategies alone.
12:24 I will now pass the call back to Peter for some final thoughts before we open the call to questions. Peter?
Peter Altman
12:30 Thank you, David. In closing, our team has worked hard in 2021. While in the middle of a pandemic we advanced all of our programs. Year-over-year, we increased our modest revenues by seven-fold and decreased our operating cash burn by 16%. We delivered on strategic initiatives to enhance our manufacturing capabilities and reduce cost. We invested in our team, our technology, and our relationships. We intend to complete the clinical trials before as with scientific rigor, prioritizing patient safety, and with speed as we believe there are enormous benefit these therapies can bring to patients and their families.
13:09 Our goals for 2022 includes significantly accelerating both autologous CardiAMP Cell Therapy clinical programs treating first patients with our allogeneic Neurokinin-1 Receptor Positive Mesenchymal Stem Cells Therapy and growing our partnering and commercial product revenues. We are targeting 2023 to complete enrollment in the heart failure trial and to have the chronic myocardial ischemia trial to reach enrollment to support planned adaptive readout.
13:39 We are now ready to take questions. Operator?
Question-and-Answer Session
Operator
13:46 At this time, we will open the call to questions. [Operator Instructions] And our first question comes from Kumar Raja of Brookline Capital Markets. Please go ahead.
Kumar Raja
14:33 Thanks for taking my questions and also congratulations on all the progress include the Breakthrough Device Designation. So first, with regard to the four sites in Canada, how soon do you think you will be able to start recruiting patients there? And in the U.S., what are you seeing in terms of the impact in terms of enrollment, how soon do you think we will get to the pace, which we had before the COVID pandemic started?
Peter Altman
15:11 Thank you, Kumar. Appreciate you joining the call and I appreciate the question. So first, on sites in Canada, how soon do we expect them to be activated enrolling? The Canadian team we have four different sites we’re working within Canada and we have been working with them throughout the entire back and forth with [indiscernible] Health Canada on both the device side at Health Canada and the biologics side. So I don’t think it’ll be very long for us to bring on all four sites in Canada. I think we — it will take some time after the approval for it to roll through administratively, but we’re talking a matter of a handful of weeks is how I would think about it.
15:59 With respect to — in the United States, the impact on enrollment, almost everything we’re doing is lined up to really try and reduce barriers for enrollment and the Breakthrough Designation that you noted that addresses, some of the concerns on cell therapy and the — there is criticism on cell therapies, because of other programs that have gone before and having the FDA go through our data and say, yes, this is a breakthrough therapy, the way you were doing it with the data that you have in these three clinical trials. They went through our phase 1, our phase 2 and all of the data we have in phase 3 as well as the reports from the Data Safety Monitoring Board. So when management of BioCardia says the data is good. The FDA has concurred to a degree.
16:54 And so I guess that’s my perspective on enrollment. We expect it to be coming online much more rapidly with some acceleration. We had a consent I can share today. And that’s really where it starts, the process for enrollment begins initially with patient being consented and after that they go through a series of tests. As we all know, we have this assay that we performed, the cell potency assay that essentially identifies the patients who are most likely to respond the therapy. Unfortunately that inclusion criteria results in us having 30% of those patients eliminated from the potential to be enrolled in the trial. And so the process for enrollment takes time to move through the inclusion-exclusion, but I can share with all in the call that COVID does appear to be waning (ph)across the nation, all of these regulatory elements that have come to us from FDA, CMS and Health Canada make this trial easier to perform, easier to enroll, enhance physician comfort, and enhanced patient comfort and the DSMB reviews further enhance physician comfort. So all of these pieces are coming together to really push these trials forward.
Kumar Raja
18:19 Thank you. And maybe you can talk a little bit about the next DSMB review and its expectations and I’ll get back in the line. Thank you.
Peter Altman
18:28 Thank you, Kumar. So the next DSMB review scheduled, I think for — I think the cusp of August-September, I don’t know exactly when the date is yet, but we will update folks when we have it. And keep in mind, the DSMB review, not only looks at all of the data of the treatment, but all of the follow-up data as well. And so we’re working towards, I think that review will hopefully have the increase enrollment we’re working towards as well as some significant follow-up on these patients.
18:59 And I’ll just throw it also, we have crossover patients now. We have seven crossover patients. Those are open label treatment. So we’re going to be able to share data with folks on our crossover patients as they reach the endpoints in their subsequent trial, if you will. So, next question.
Operator
19:26 Your next question comes from Emanuela Branchetti of H.C. Wainwright & Co. Please go ahead.
Emanuela Branchetti
19:34 Good afternoon, guys and thank you for taking my questions. I was wondering, Peter, can you give us a sense on how many patients did not access the trial because of the lack of insurance coverage you were mentioning?
Peter Altman
19:50 Yeah. So, our — I mean these are hard numbers to get at, Emanuela. Our expectation is, in this patient demographic approximately 50% of the patients are Medicare patients. In addition, the reimbursement that Medicare has put forth for us is typically followed by United and Aetna and they cover about 150 million lives in United States. So that’s a pretty significant group, but it also, when you’re at a center and you have to go and pre-qualify a patient for a therapy it becomes frustrating if they’re not United or Aetna, and the insurer denies them and so the elements that we’re putting together that will enhance that is first. We’re pointing out that, hey, this is available in Canada. Second, yeah, the reimbursement, we’re putting in place enables us to a sponsor to cover the decline cost of the insurers and that’s up from a CMS — it’s of an approach that CMS is blessed previously.
21:04 And then lastly, with the reimbursement code, we’re making it clear that we are able to that both the control arm and the treatment arm recovered. Those three pieces all go together address pretty much all the questions at any site has. So we’re hopeful that we’ll see these contribute to enrollment, but since it’s — where we are still going to see heavily Medicare patients and hopefully this will bring in the United and Aetna patients as well as other insurers who will follow this because of the breakthrough in part.
Emanuela Branchetti
21:36 Got it. Thank you. Yeah. Maybe staying on these subjects, you’re getting — it seems like you’re getting feedback from investigators from the site. Are there any other elements you’re working on to optimize the enrollment other than the one you just mentioned?
Peter Altman
22:00 There are — we have a policy in place that there is an opinion that just came out of the office of the Inspector General at health and human services related to our ability to cover the co-pays oof patients.
Emanuela Branchetti
22:18 Got it. And so…
Peter Altman
22:21 That’s more esoteric element, but we’ve hit this with a full court press address every single issue that we think acts as a barrier to enrollment in this trial. And I think most if not all of those barriers have been addressed, including the significant one of the waning of COVID.
Emanuela Branchetti
22:42 Yeah. No. Absolutely, and in fact, my other question was, these with around the COVID situation and if you can give us a sense of what you’re seeing in different centers and geography and geographies, if you could give us more color on how the COVID situation is waning?
Peter Altman
23:03 Sure. So folks there is two pieces to the COVID impacts clinical trials from our perspective. Remember, we only know our trials. And the first is, [indiscernible] can only do electric procedures for certain periods. Patients don’t want to go to centers. It’s all related to the potential for interactions around COVID. The second though is related to staffing. So a lot of folks got used to working from home, coordinator staffing at different centers has been problematic across the country. And so how we are seeing that change, there’s one leading center. It’s been very quiet for us for a very long time. They now have three patients in the queue.
23:47 Another center was very quiet and they just appeared on the radar screen and said, yes, they just approve the trial internally and they want to get into the trial. And so there’s other centers that we’re still bringing on board as well. So I think it’s happening as anybody on the call who has hired people know, the staffing process can take time, but I think that piece is evolving in our favor as well.
Emanuela Branchetti
24:11 Makes sense. Thank you. And my last question, the relevance of the potency assay as taken center stage recently as always be important obviously, but it’s taken recent center stage recently. I was wondering for cell therapies and I was wondering, if you can give us a sense of how much dialog have you had with the FDA regarding your potency assay?
Peter Altman
24:38 So our — this is a cell selection assay in which we are identifying a number of biomarkers that based on all of the data before support that the patients would have a high probability of benefiting. And so really, it’s an inclusion-exclusion criteria in our trial. We have called it a cell potency assay and it does relate to it, but it’s different from a cell potency assay under the state of the terms that the agency would look at. And so I think I know that cell potency assays are center stage for the agency with respect to many of the other advanced cell therapies out there. I think the things that we’re doing, we do have cell potency assay efforts that we’re looking at. We assess not only the viability of cells in each and every procedure, but also their ability to form colony forming units and that has been used in other studies in the past as potency assay as well.
25:41So I think in total, the selection diagnostic aspect and the things that we’re doing from a cell potency assay perspective support what our [indiscernible] are looking for, but fundamentally, this is a regulated as a device system. And so it’s probably not going to have the same criteria, because we can’t generate cell potency for a patient that’s already been treated. It’s something that we’re doing after the patient is treated in our core laboratories.
Emanuela Branchetti
26:15 Understood. Thank you very much.
Peter Altman
26:18 However — just one more step, Emanuela, but for our allogenic programs we absolutely will have a cell potency assay and it will be derived from some of the knowledge we have on our lead programs, and all of the work we’ve done on colony forming units with respect to these expanded mononuclear cells in the lead program, they also feed into what we’re doing on the Neurokinin-1 allogenic cells in programs 3 and 4.
Emanuela Branchetti
26:52 Understood. Thanks.
Peter Altman
26:57 Appreciate the question.
Operator
27:00 The next question comes from Michael Okunewitch of Maxim Group. Please go ahead.
Michael Okunewitch
27:07 Hey. Thanks for taking my question. So I guess first, I’d like to add something just in the context of Mesoblast discussions with regulators regarding their cell therapy in heart failure specifically with moving into ischemic and diabetic patients, but they saw the greatest benefit in subgroup analysis. Can this be viewed as validating of your targeting of ischemia heart failure patients with BCDA-01representing the right patient for a cell therapy product?
Peter Altman
27:44 Well, Michael, it’s — so first, I want to acknowledge that Mesoblast data at three-year follow-up in the New York Heart Association Class II patients and the ischemia cardiology as we’ve looked at the dataset that they’ve shared publicly. It’s good data. Now that’s exciting. That’s the signal, the stronger than any of the other pivotal trials we’ve seen from the latest heart failure therapies that are out there. That said, it is a different therapy than we are advancing and it uses a different delivery platform. However, the patients that they say responded greater in their trials does line up substantially with the patients we’re targeting in our trials. So they are focusing on New York Heart Association Class II, they’ve said going forward.
28:36 In our trial, I believe — I don’t know from how to say the numbers, but a large portion of the patients from New York Heart Association Class II that the delta between what they’re doing and what we’re doing as they required hospitalization in the six months prior to treatment and they required a high NT-proBNP level, which is a measure of the status of the heart failure and we don’t require either of those. So I think we’re leaning into patients who are less sick, which is what they’ve said they’re going to do going forward. And the reason we’ve believed in these patients all along is, the CardiAMP Cell Therapy is not an event driven trial. We’re not looking for the sickest of the sickest because we’re big believers that the art of clinical trial design is optimizing signal to noise. And we think in these New York Heart Association Class II patients and the threes that are not so significantly sick that they have high NT-proBNP and they recently had a MACE events such as a hospitalization are the right patients to go after. And so they are saying, yes, those are the patients they’re going to go after going forward. It’s too much though for us to rely on their data, because again they’re delivering a different cell therapy, they’re delivering it with a different delivery system, but it is an interim myocardial bone marrow derived cell therapy, which is what ours is. So there is — I’m trying to support kind of what you’re saying would also point to the limitations which are significant.
Michael Okunewitch
30:07 Yeah. No. Thank you. I appreciate the additional color. I’d also like to see if you could remind us of what the biomarkers and you’re cell selection potency assay are selecting for on a mechanistic level?
Peter Altman
30:26 So we’ve — so we have a number of biomarkers we’re looking at. The only one we detailed publicly as the CD34 cell counts. And this is a marker that’s been used in other clinical trials in the past. Just this past, in 2021, we presented data on the dosage we’re achieving in the current pivotal trial in heart failure and the dosage we’re able to achieve with the combination of the cell potency assay selecting patients with high CD34, the cell processing platform and its efficiency on only a 60CC marrow aspirate and the efficiency of delivery is actually higher than every major cell therapy trial that has shown signs of efficacy based on CD34 cells.
31:13 So I think it’s promising from that perspective. The mechanisms that folks look to on CD34 is one often of androgenesis and enhanced microvascular elements that may not be the only element it’s going on. I mean, again, we’re treating ischemic heart failure patients, means their disease is caused by Ischemia, but we are not treating actively Ischemic patients is our focus. And that’s an important delineation because we were the first group to say, we want Ischemia cardiology and heart failure and we don’t need for them to be actively Ischemia. Ischemic. So there is other mechanisms of action probably woven into this as well.
Michael Okunewitch
31:58 All right. Thank you. And then just one last one, with the addition of these Canadian trial sites coming online. Do you think that the different reimbursement environment could make that easier to enroll than the U.S. or given the developments with CNS, they should be about equally as it is?
Peter Altman
32:23 That’s a great — that’s a great question. We don’t know, is the answer. We started the process in Canada, in part because we know some great KOLs there, key opinion leaders, who’ve done enormous work in this space historically and been involved in other trials. But there was also an element that it becomes a test case without having the reimbursement issues. And so we will have to pay for everything in Canada. It’s not as expensive to do clinical trials in Canada, although, the paperwork of going through two separate agencies for the approval process was daunting. Our expectation is that Canada enables us to test that question without necessarily sacrificing the value proposition of our reimbursement for both trials in the United States.
33:22 And in addition to working on Health Canada, we were taking a belt and suspenders approach and we’ve worked through the nuances of what was causing sites some difficulties. And so we think that our friends at CMS have done — made good efforts to help us to get some of those issues resolved and we think that’s going to roll through the system well going forward. So it will be interesting to see the impact of these different elements. At the end of the day, we won’t be able to tease out exactly which element is resulting in the enhanced enrollment which site, but it’s a sign that we at BioCardia are constantly listening to our clinical sites and trying to understand what is the problem for them? How can we make this trial easier, provide more support for it from a scientific reimbursement perspective, while we also optimize the value propositions, we have of the Medicare reimbursement.
Michael Okunewitch
34:25 All right. Thank you very much. I appreciate you taking the time to answer my question.
Peter Altman
34:29 Thank you, Michael. I appreciate it.
Operator
34:36 The next question comes from James Molloy of Alliance Global Partners. Please go ahead.
James Molloy
34:43 Thank you for taking my questions. And thank you very much for the — all the insight and to the expectations on the trial. On 01 you guys gave a guidance for expectation for another DSMB here for — I think fourth quarter. Any thoughts or is there a way to get an idea of when you look the ramps trial given how enrollment is getting better with COVID can waning?
Peter Altman
35:07 Yes. So Jim, we’re targeting I think third quarter for the DSMB review in BCDA-01 which is the CardiAMP Cell Therapy for ischemic heart failure. And we’re targeting completing enrollment of that lead program in 2023. We’re also targeting completion of enrollment for the adaptive readout in the same therapy for the indication of Chronic Myocardial Ischemia in the same year. So 2023 is going to be a very big year for us. And I can’t provide any more specificity on it in that, we will find out, we will report out the enrollment as we go and — but as we budget things, we’re budgeting for success here. So we are pushing hard on the enrollment activities today and these are not the only things we’re doing the things that have happened in 2021 and subsequent to 2021 based on the efforts in 2021. There’s a lot going on to make this trial be completed as soon as possible.
James Molloy
36:13 Excellent. Then maybe how does the given environment has been obviously been a challenging environment first half of the year biotech across the board. Has the environment for potential acquisitions or partnerships changed gotten more or less active given what’s been going on with some of the stock’s really getting us dramatically low levels.
Peter Altman
36:37 All right. Jim, I can only speak to the business development activities that we have underway. And so, and those are not really tied into M&A, although, there is licensing on a couple of elements. So just I’ll recap them briefly. So one of the efforts we have ongoing is identifying a partner for CardiAMP outside the United States and specifically in Japan. That would be involved a partnership not an acquisition, and I can share that there is interest. In light of all the things that I’ve just shared that have been taking place. In our 10-K, we detailed that we are meeting with PMDA in the near future. And so we will be having conversations with them in parallel to having conversations with potential partners to help advance the CardiAMP Cell Therapy in Japan, where there is a million patients there with heart failure. It’s a great unmet need and I also note that the only cardiac cell therapy that’s approved that we’re aware of is in Japan and it has a reimbursement this is the HeartSheet by Terumo, it has a reimbursement and I think $124,000 again equivalent. So there is a support for regenerative medicine in Japan that also will hopefully put some wind behind the therapies we’re advancing. So that’s one.
38:08 The second level of partnering that we’re involved in is around our biotherapeutic delivery platform. So today, we actually feel we have the safest most efficient at delivery and easiest to use delivery system that’s appropriate for cell gene and protein delivered to the heart. And so we can — all of the things we’ve solved are available for partners. And so we’re trying to move more towards significant corporate partnerships. We would like to enable other significant entities to have their own delivery system, even though it would compete with us and potentially be cannibalistic, our perspective is that these therapies will ultimately compete and if our shareholders can benefit from both therapies, great. If patients can benefit from all that we’ve learned on delivery, great So that’s an area that we’re very active in today and that reflects the two deals we did in 2021.
39:15 And the last area is in actually monetizing assets that we’ve developed that don’t fit our core initiatives. And one of those assets is our AVANCE transseptal sheet, which is an FDA-cleared product. It’s based on technology that is elegant. We use it the technology in our, what we call our more DNA product, which is part of our biotherapeutic delivery systems, but the AVANCE addresses an existing market in the United States, it’s extremely competitive of around 500,000 procedures a year. And we’re having conversations around identifying a partner to monetize that with the idea that we will enable them to have that technology in that product and at the same time, the dollars will come in and feed some of the other initiatives here at BioCardia. And so those are really the three types of efforts we have. Of note, the international partnering and the AVANCE monetization activities, those can only be done with one partner, but the biotherapeutic delivery activities we can work with the number of partners. And we treat our partner information is strictly confidential, I think we have a very good relationship and reputation amongst our current and past partners. And sometimes programs don’t go forward. It has nothing to do with delivery. It’s often related to the therapy or funding for the therapy or other elements, but this programs wait to last year is still ongoing. And we’re optimistic that we’ll be doing some nice partnering in the year ahead.
James Molloy
41:05 Great. Thank you for taking the questions.
Peter Altman
41:08 Appreciate Jim.
Operator
41:10 The next question comes from Jason Kolbert of Dawson James. Please go ahead.
Jason Kolbert
41:17 Hi, Peter. Thank you. Most of my questions have been answered, but I’d like to talk a little bit about the endpoint of the trial. And can you help me understand kind of what the critical measures are associated. I think it’s Finkelstein-Schoenfeld hierarchical analysis. What are the key critical aspects there, and what other significant drugs have been approved using that endpoint?
Peter Altman
41:47 So Jason appreciate the question and it is a good one. The Finkelstein-Schoenfeld of 3-tier composite endpoint that we’re using in the trial is a hierarchical endpoints that includes mortality, major adverse cardiac events, and then functional capacity as measured by 6-minute walk. There have been a number of other heart failure programs that have been advanced with that as an endpoint. And I think more important than identifying a specific other drug that’s been approved, I would say, the FDA recommended this endpoint to us and specifically guided us to use this endpoint. And I may have shared in the past, but this endpoint, we had something that was a little bit more sophisticated from a statistics perspective, but the agency did us a great service in nudging us to the Finkelstein-Schoenfeld 3-tier because it’s something that clinicians understand, and what we had was something that was difficult to describe even though it was probably more sophisticated and substantially equivalent by moving it towards the Finkelstein-Schoenfeld we wind up with an endpoint that everybody understands and accepts, because the way it works is, is the therapy better for the patient. So if a patient dies, they’re in the worst rank.
43:01 We want patients to live first and foremost. If there is a MACE event, that’s the next rank. And, but if there is no, if there is no death and no MACE in a patient, how do you know whether they’re better or not? And the 3-tier of the functional capacity as measured by 6-minute walk is how this plays out? And the results we have so far are good. 6-minute walk is a non-trivial endpoint. It can be subject to manipulation by a clinical trial coordinator who is a cheering patient on one day and that’s cheering the patient on the next day. We’ve been very disciplined in rolling this out, working with leadership at NHLBI related to 6-minute walk a two week that’s from Heart, Lung, Blood Institute related to 6-minute walk.
44:02 And so our sense is we’re doing it is rigorously as we can do it and combined, it’s an endpoint that the FDA has effectively blessed by recommending it to us in the modification. And does that answer all your questions, because there is another element that I’d may be –
Jason Kolbert
44:20 Right. I’d like to just pick up on something you said, which is the data so far is pretty good. Can you expand upon that?
Peter Altman
44:28 Well, so I don’t — we don’t see any of the data in the blinded trial. But if you look at published results so far for our — are actually worse data in our Phase 1 where we had a 10% mortality rate at three years. And I know that’s 10% at three years, if you look at all of the data coming out of the very large drug trials. The mortality rates at three years are roughly 21%. I note that if you look at Mesoblast data in their Phase II, I think they are under a 10% mortality at three years. So there is — that’s in the New York Heart Association class II. So our data in Phase 2 as we had no patients lost that one-year follow up. And in the Phase 3, I can only share the one-year data that was published, but we have no patients lost in that rolling cohort of the Phase III trial.
Jason Kolbert
45:29 Okay. Sure. That makes sense, so it’s encouraging, that’s what you’re saying.
Peter Altman
45:34 Yeah. So again, these are very sick patients and the fact that they’re doing well in those metrics is great, but if you look at the other elements of those datasets. The Phase 1, we saw improvement in exercise tolerance. We saw improvement in heart function. Phase 2, we saw improvement in exercise tolerance. We saw improvement in heart function. Phase 3, we see improvement in exercise tolerance. We see improvement in Heart function. We see improvement in quality of life. It all holds together. So it’s not as if we have a dataset, it doesn’t include one element of those benefits and these data sets are complicated. So we’re hopeful, if we repeat the results, we had in Phase 2, we have potentially a new therapy for these patients. And these therapies that we’re advancing, it’s a one-time treatment of concentrating the patient’s own cells around the damaged tissue in the heart.
46:32 And so it’s from a safety perspective, at the end of the procedure, if you get the safety check at the end of the procedure, we feel very good at the end of the day. There is no, with normal drug trials compartmentalization and drugs look at localize in the adipose tissue and you can have toxicity events downstream with other device therapies where you have an implant. Implants can erode they can become infected. So we don’t have any of those long-term safety ramifications in what we’re doing in the CardiAMP Cell Therapy programs. There are procedural risks and again there are also risks for the cells that haven’t been fully adjudicated. This is not an approved therapy. But as we think about it, we think that the safety profile is pretty compelling.
Jason Kolbert
47:15 Thanks, Peter.
Peter Altman
47:18 Thank you, Jason. Appreciate you being on the call.
Operator
47:24 This concludes our question-and-answer session. I would like to turn the conference back over to Peter Altman for any closing remarks.
Peter Altman
47:31 Thank you, Andrea. I want to thank all of you participating on today’s call and for your interest in BioCardia. We look forward to sharing our continued progress. Thanks. Stay healthy, be kind and have a wonderful day.
Operator
47:51 The conference is now concluded. Thank you for attending today’s presentation and you may now disconnect.
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