Q3 2022 BioCardia Inc Earnings Call
Ladies and gentlemen, thank you for standing by good day and welcome to the bio cardiac 2022 third quarter conference call. At this time all participants are in a listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.
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After the end of the call through February 9th 2022, excuse me 2023, I would now like to turn the conference over to Jules Abraham of core I or the company's Investor Relations firm. Please go ahead Sir.
Thank you Chuck and good afternoon, everyone and thank you for participating in today's conference call.
Joining me from bio cardiac leadership team today are Peter Hoffman 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 myocardial expectations for future performance or operational results references to management's intentions beliefs projections outlook analyses for our 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 myocardial Smith.
He filed periodic reports on Form 10-K Form 10-Q, and the form 8-K filed with form 8-K filed with the SEC and particularly the cautionary statements with that.
The contents of this call contains time sensitive information that is.
Accurate only as of today November nine 2022, except as required by law myocardial 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 Peter O N P. H E. A company who's the company's President and CEO . Peter Please go ahead.
Thanks, Joel and good afternoon to everyone on the Paul.
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.
Myocardial efforts are focused on advancing to 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 involved multiple 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.
So 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 <unk> therapeutics to the target location, where their action is desired maximizes their effective dosage within the tissues were delivered and minimize the potential negative effects remote from target tissues.
Heart failure is the first problem we're going after.
It is an enormous unmet need that affects more than 26 million people worldwide.
Our latest blockbuster drugs and pretty much the same indication we're going after.
Not 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 a control 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 to 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.
And some of these studies, including our own the benefits have been remarkable.
Our FDA breakthrough designation in ischemic heart failure validates this perspective.
And granted this designation the FDA look through all of our clinical results patient by patient and agreed the 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're all about.
Our efforts to complete the cardiac autologous cell therapy pivotal clinical trials for the indications of heart failure, or <unk> and chronic myocardial ischemia or BCA owe to remain our primary focus with an estimated.
At a combined $1 6 million patients in a reachable U S market.
The cardiac cell therapy heart failure trial or <unk> is a phase III 260 patient randomized controlled clinical study intended to provide 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 passed the one year primary endpoint, including treated and control patients.
In the trial.
We were impressed that the survival rate one year follow up was greater than 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 control 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 adapter statistical analysis plan, which could enable an early readout for study treatment efficacy.
And 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 Derisking 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.
A trial has already enrolled the number of patients expected to be required to show efficacy.
There is potential that the data safety monitoring board and forms the sponsor at the <unk>.
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 with Debbie homes Hagen is working to ensure the clinical data.
That the data safety monitoring board would use in such an adaptive review. 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 March 2023, and based on conversations that company has had with the intended developers of the adapter 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 charges 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 two 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 Dietz. They may recommended the trial continue per plan, we stopped for a stop.
Stop for safety or be stopped for futility and the data does not support that achieving the primary endpoint as possible.
Yeah.
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 fate, our patient facing website www Dot Hardy amp dot com. This.
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 cardiome cell therapy and opportunities to participate in the trial.
Our second therapeutic program is the same therapy for the treatment of chronic myocardial ischemia with refractory angina or bcl two.
The cardiac chronic myocardial ischemia trial as a phase III multicenter 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 $20000 for treatment and control patients.
The trial has been activated at two centers in 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's pharmaceutical and medical device agency regarding registration of cardiac cell therapy for ischemic heart failure.
We are substantially ready.
Good day 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 a 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 scientist 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 neuro kind of in one receptor positive message <unk> stem cell platform, which has also progressed.
Quarter.
Our allogeneic MSC program in heart failure, which we have designated <unk>. Three 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 in stability testing.
The chemistry manufacturing controls section of the IMD.
We have completed the preclinical pharmacology toxicology animal testing with no safety issues and with trends towards therapeutic benefit.
It is my pleasure to share that the IND application for this program was filed with FDA.
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 <unk> four was approved by FDA in April 2022 to treat patients.
Our first clinical study manufacturing run from our Sunnyvale facility has been completed.
Sales of Cryo preserve 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 sales to complete the entire phase one portion of the phase one two trial as we achieved many doses with each batch.
We are in late stage Onboarding, a world class clinical centers to perform the trial ahead.
We are optimistic due to the longstanding promise of mesenchymal stem cells and 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 has taken off respirator support.
With goals of accelerating recovery enhanced.
Enhancing survival and reducing both relapsed and re hospitalization.
In summary, we are advancing for therapeutic product candidates that address important unmet cardiac and pulmonary diseases based on our autologous and allogeneic cell therapy platforms.
From these therapeutic development efforts, we now have four active business development initiatives.
First is partnering or cardiac cell therapy platform internationally.
As licensing out our clinical stage NK, one our positive message Pamela stem cell program for other clinical indications, which have shown promise with other messing time will stem cell preparations.
Third is licensing our catheter based biotherapeutic delivery systems for Celgene, a protein therapy candidates to the heart such as in the Blue Rock relationship we began last quarter.
And fourth is monetizing our <unk> Trans septal introduced machine product.
I will now pass the call to David Mcclung, our CFO , who will provide some financial perspective, David 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 $5 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 revenues.
I'd like to reiterate the potential value of collaboration revenues is far greater than the dollars we receive when we enter into them.
Partnered programs provide additional pathways for biochar due 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 to $6 6 million reported in the nine month period, ending September 30 of 2022 compared to $6 4 million in the nine months ended September 32021.
SGA SG&A expenses were $3 5 million.
For the nine months decreased from three 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.
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.
Your question has been answered and wish to withdraw your request you may do so by pressing the pound key.
If youre using a speakerphone please pick up your handset before entering your request and speaking on the call and one moment. Please for the first question.
The first question will come from Joe <unk> with H C. Wainwright. Please go ahead.
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.
<unk> that you're currently working on so hopefully you can provide some more information so I guess.
What are the really the stage of the discussions now with the FDA with regard to outstanding topics that's number one.
Is there how would we consider the alpha spend around any alpha around any of the adaptive components that you have here, especially if it's lower enrollment and.
And I guess, it's really related there with regard to the outstanding topics with the FDA what else is on your wish.
A wishlist with wishlist excuse me in getting this over the finish line with the FDA.
So I can share with you that we are in the process.
First of all thank you for the question but.
Jump straight to the answer the <unk>.
Discussions with the FDA are still early we have not yet had Q sub meeting with them. We are in the process of preparing the.
The submission with the appropriate.
Detailed it's really needed for them to understand it and and wrap their heads around it but in this situation. This is being recommended by the data safety monitoring Board and my sense is the agency will undoubtedly.
<unk> raised concerns about a smaller number of patients enrolled in the trial, but one of the advantages. We have is the breakthrough designation from FDA.
Does give us the ability I understand too 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.
<unk> recommended one another one is a world class group 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.
Having regular meetings, but I guess the first thing is dialing in the adapter 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 where we're going to do a design that looks at the question of how.
How large should the trial be.
Not asking what are the results from the trial and that changes the equation that makes it so there's not an enormous alpha cost.
So that's where we're at this is a a very active effort today and I know in parallel to the regulatory and the statistics work.
We have a significant ongoing effort to have all of the data clean so that at the next data safety monitoring board meeting they are looking at very clean data.
So that we can rely upon the <unk>.
Put that they provide on the other side of this so it's pretty exciting.
But that said as I as I.
Shared in our comments there is no guarantees here fundamentally this trial may just continue.
And we are working diligently and ways to enhance enrollment.
The trial as well as enhance the experience of all the physicians participating in the trial.
Got it no those are all fair comments I appreciate it and then moving to sort of David's comments and your 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.
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 Oh U S.
<unk> and the.
Partnering on biotherapeutic delivery with others.
We in the last quarter did enter into an arrangement with <unk> therapeutics and and that is a a time limited option that they have that.
We may see some progress on in the year ahead.
So there's.
This is this is sort of the nuances.
Of of what we've done historically.
Historically remember previous to David's comments the value of these partnerships.
We have a number of partners with significant datasets with our delivery system and when you. When you are developing efforts. Those are those are value propositions, we have that could quickly grow into other value propositions.
Got it got it and then my last question and thank you for bearing with me if I just skip to the at the end of the pipeline for <unk>, four and use of the allogeneic cells or platform in <unk>.
Yes, I guess, maybe the broader concept I've looked at the Covid landscape is dramatically changing.
Still be sticking around based on the broad consensus so I guess at this stand or that this.
Status of Covid, if you will.
Just the rationale of why you know doing this study at this standpoint and also while finances are important.
So the indication so great question, Joe the integration indications, we're going after is patients essentially recovering from Covid and is actually a very significant gaps there.
Right now really no therapies targeted for patients when they come off respirator.
And so.
There is something out there that we've all heard about with chronic inflammation a lot of folks will refer to it as long COVID-19.
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.
Eddie allergies or acute respiratory distress or ards.
There is also a gap and 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 <unk>.
Dose escalation cohort with great care to protect the patient and so there is not a significant number of centers that is going to be added to either of these trials. So basically think of it as we're cleaning up all of the safety issues and optimizing the maximum tolerated dose for these two therapies <unk> and <unk>.
Zero four.
With the expectation thats not going to be a significant burn.
We're manufacturing the cells ourselves here of Biochar yet.
For the odds effort it has a very short.
Endpoint.
For efficacy based on a lot of the other trials that have been out there. So we were feeling pretty good about the direction, we're going and I don't I don't think it is going to substantially impact the burn rate for the phase one portion as we move into later stage phase II portions, yes, the burn rate would increase significantly that.
But that's something to be decided on in the future.
Got it I appreciate the color Peter Thanks, a lot.
No I appreciate the questions Joe really appreciate you being on the call. Thank you.
Okay.
The next question will come from Michael Accoona, which with Maxim. Please go ahead.
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.
Yeah.
Yes, so the blinded data so it's 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 with aggregate data.
We are blinded to the data, we don't know whether one.
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 are 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 it was just it was just sort of jumped out at us as we looked at the data now if you I mentioned that the.
The animation of the trial in cardiac dot com and even in that animation, we call out the fact that patients typically do better in a clinical trial.
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 fields and again, we don't we don't have a way to compare it.
Because we are blind to desktop the patients, which room, which group.
And so this was the status of.
The data at the last year's SMB, the DSM be recommended the adaptive statistical analysis plan in part because of slow enrollment during COVID-19.
Typically adaptive designs you used for trials with either rolling slowly or having very short endpoint.
But we also have a significant number of patients past the primary endpoint and so.
Coupled with that we.
We also have breakthrough designation and so.
One of my great concerns, 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 in hartsville. There 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.
Our pathway to collect that additional data on the other side of approval.
So that's it at a high level, if I have I addressed your question appropriately.
Appropriately Michael.
Yes, you did I'd, just like to drill down on.
A little bit deeper on one point in particular, when you're saying that you.
You saw a greater survival.
Right compared to other large pivotal trials, that's comparing aggregate data to the aggregate data from other similar pivotal trials that the idea.
That's actually I would be considered a fair assessment, Michael because the good trials that have been out there arent really showing a reduction in mortality and this is one of the topics that of <unk>.
Great discussion.
At <unk>.
Conferences, such as heart failure Society of America that the mortality problem is still out there, but actually when I when I talk about the comparison.
In order to be fair. This is always dangerous when you're comparing apples to oranges, our trial to other trials that are out there.
Because they are 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 I'll call. It up the <unk> II trials that have just come out in new England Journal of Medicine.
And we referenced that in our previous press release. So again this is not an apples to apples comparison isn't apples to oranges.
And the things that we're doing are very different but it's a it's a striking reduction.
In in mortality across an aggregate population for us and so you know.
Is that in more than one group than the other we don't know.
But it's interesting that's all I'm sure.
Alright. Thank you for that and then just one more one more follow up I'd like to just see if you could touch on.
How the biotherapeutic delivery platform benefits Blue rock cell 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.
Yes, so I can't comment on anything with respect to Blue rock.
But I can tell you that.
Our helix Trans endocardial biotherapeutic delivery system.
<unk> has a couple of advantages first it's the only interim myocardial 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 Ah.
And its safety profile, which has been in the published literature is far.
Far superior to that of our.
Previous competitors, who have since.
Left the arena and that would be small companies, such as Johnson, and Johnson and Boston scientific.
Also note that.
It's efficiency of delivery.
Which we believe is due to the stability of the the helix.
In the myocardium and its stability, enabling control over delivery enhances really the.
The retention in the heart tissue after delivery so multiple datasets on multiple different classes of therapies have shown we have.
Roughly three fold.
<unk> retention are threefold, the dosing with our delivery system that others have had with a simple straight needle inter myocardial approach and and so that's also helpful. So it's lastly is the ease of use of the system, we have no capital equipment involved in.
<unk>.
This product in the past, we had a number of larger entities that 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 those are really the key advantages and and I guess I would say the last thing is folks are going after indications biochar to you today is focused on heart failure and chronic myocardial ischemia.
We have a partner in Europe and sell pro there thats going after okay.
Myocardial infarction or maybe sub acute 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 who have made clear that if we're successful in ischemic heart failure and or chronic myocardial ischemia or two indications today that.
The preserved ejection fraction is also in great need and because folks view.
Zurve ejection fraction heart failure is due to micro vascular disruption.
There's potential to go in that direction as well so those are really the four indications.
It would be used for and.
Mongst those four indications.
It's the leading cause of death in the Western World I can quote the CEO of Johnson <unk> Johnson, who just recently bought a.
Biomed for.
For $16 billion.
And you know he.
He has said that all forms of heart disease windup in heart failure, and they see the greatest opportunity for their efforts in helping parts recover.
And frankly, we couldn't agree with him more that's exactly where we are and what we're doing.
Alright, Thank you Peter I really appreciate the additional insight.
Thank you Michael truly appreciate the questions.
Yeah.
The next question will come from James Molloy with Alliance Global Partners. Please go ahead.
Yes.
Hey, Thanks for taking my questions I.
I had a question on the.
<unk>.
Oh, two interim look we're anticipating here.
So if you look first quarter 'twenty three.
That the 100 patients or is that.
Subset of 100 patients and Wynwood 100 patient.
Cohort three.
343 be enrolled.
So.
We are working to complete enrollment in that next year. We are in the process. Currently so James first of all thank you for the question.
But 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 where our expectation is we're still pushing hard to have that.
Get to the 400 patients by next year.
So again in the wound cohort.
I'm sorry.
How many patients are in the rule and cohort you just figure reported on a rolling 12.
Right the rolling cohort per protocol is 10 patients.
Okay.
And then just enrolling the remaining 123 with the data when we get to sort of potentially having data from the first 100, and then essentially the final 343 patients in this trial.
Right. So so again, we've long said this is your very being very.
Attentive here Jim.
We're expecting that the debt the adapt so we've talked about and adaptive statistical analysis plan for <unk> 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 of one of the things you do in a rolling cohort as you try and learn every way you can 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. So it's the same logistics, it's the same.
Training is 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.
Okay.
I take that back we have centers that are active in the trial were 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 Patriots worth 123, and it's a six month follow up we should be looking for mid 'twenty four.
For the first 100 data.
I would say, it's going to it's going to take longer than that to get the data for efficacy.
Six months 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 that completion of enrollment.
And then on the BCD three.
Finally here hopefully approved in December .
Oh for 90 was approved.
April 12.
Your expectation.
The trial will start in third quarter to 42% of first quarter 'twenty three should we expect a similar three.
Three quarter.
The delay between the R&D approval for <unk>, three and the phase one two trial for <unk>.
See.
<unk> III.
Actually no we don't expect nearly the delay so for <unk> four.
The steps involved.
The clinical manufacturing of cells and the cells were substantially.
Manufactured in in Q3, but this long.
A couple of elements of the manufacturing process that have long lead time to make sure 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 three from BCD O four I also note Jim BCD three.
We'll have the advantage of all the patients we have already identified in.
The <unk> one program. So the idea is to take that to the patients that have been excluded from BCD one.
The decision process here at <unk> is going to be very interesting because we could treat a large number of patients in B C. D E O three.
If we werent concerned about you know the focus on <unk>, one and other trajectory items. So right now our focus is we are going to do the rolling cohort on B C. D O three probably pretty quickly, but we're we're going to have.
Assess where we're at before we launch into.
The phase two portion of that study because that will be more expensive and and once you make a commitment to a phase of the study as a sponsor you need to have the responsibility to complete it.
We have that nicely with BC their one and two with the Medicare reimbursement.
For <unk> three it won't benefit from that reimbursement.
And so we need to be thoughtful before we move into the phase II program.
So since it's the same physicians, we don't want to distract them from <unk> significantly.
Even though they are different patients.
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 we were right now prioritizing bcl one over BCD three by far.
I know, there's a lot of it.
James James is any of it.
Our action, but it's I think it's 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.
Okay last question for David Real quick.
As reported the nine months' data and not in the numbers for the quarter in the press release.
Can you say again Jim.
Why did you guys. Once you guys put in your numbers for the third quarter into your press release, instead of just sort of put in the nine months reporting atypical.
Oh well.
We put the nine.
The nine month numbers or more meaningful we're trending now towards the end of the year versus the fluctuation quarter to quarter, they're pretty plot, we could've shown both when they are presented in the tables.
Yeah, all of the data isn't getting the samples.
And if our revenues are lumpy with partnership so where do we have the greatest revenues we've ever had this year so far.
Okay. Thank you.
Nor is James.
Really appreciate it.
This concludes our question and answer session I would like to turn the conference back over to Mr. Peter <unk> for any closing remarks. Please go ahead Sir.
Thank you Chuck I just wanted to thank all of you for participating in today's call and for your interest in <unk>, We look forward to sharing our continued progress.
Thanks stay healthy be kind and have a wonderful day.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Okay.
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Yeah.
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