Good morning, everyone, and thank you for joining us at the final day of the Needham Healthcare Conference. My name is Gil Blum, and I am a senior biotech analyst here at Needham & Company, and I cover the immuno-oncology space. It is my pleasure to have with me this morning Christian Itin, the CEO of Autolus. Now, as a reminder, any viewers who are watching through our conference portal are able to submit questions via the Ask a Question box below the video feed window. So, Christian, with that, maybe we can discuss a bit of recent developments and ongoing setup. For those who are unfamiliar, just remind us of Autolus's main mission and differentiating features as it relates to autologous CAR-Ts.
Well, first of all, thanks a lot for inviting us, and thanks for taking the time for this fireside. At Autolus, we're obviously focused on the delivery of autologous CAR-T programs, predominantly. That's the primary focus. The lead program that we're working on is called obe-cel. It's a CD19 CAR-T program that has an ability to engage target cells in a way that's very physiological. And with that, we avoid the high degree of immunological toxicity that we've seen with some of the earlier programs in the space. Technically, the way we do that is by having a binder that has a very fast, very fast on rate, which gives a specificity combined with a very fast off rate. So it's a very different molecular design on the binder.
Other than that, the product looks very similar to the products that you may have been familiar with or that are currently on the market. The product went through a series of clinical studies, initially in pediatric patients with acute leukemia, followed by adult patients with acute leukemia, as well as non-Hodgkin's lymphoma patients. Those were all kind of earlier phase 1 type of trials. They all very consistently gave us a very high level of clinical activity and minimal levels of immunological toxicity. And that obviously is a very attractive balance because it gets us to what the real promise of all of these therapies is, which is a very high level of outcome, including a proportion of patients that even in a refractory setting actually have a chance to become patients that achieve long-term remission.
And at the same time, obviously do that in a way that really allows you to manage and control the therapy and for the physicians to be in control of it. We then actually transitioned into a pivotal study, conducted that throughout the pandemic. It's called the FELIX study. And what that did was, obviously, as one of our physicians who looked at the data said, this was a courageous study because, as you can remember, the pandemic was a challenging period for patients that had a highly immune compromised immune system, which is certainly true for acute lymphoblastic leukemia patients who are both from a disease perspective, but then also from the therapies that they receive, highly immune compromised. But the other aspect, of course, is also that the centers went through pretty traumatic periods.
A lot of them actually had to shut down at one point or another during the conduct of the trial. A huge concern around usage of ICUs. And you can imagine a product that actually avoids that to the largest extent possible. Obviously, that was a product that was quite attractive for the physicians during that period. But it also was a pressure test in all sorts of ways, a pressure test for the safety because obviously a lot of these patients were in really poor condition when they finally got to the clinical study. But also a pressure test every aspect from product supply, with a lot of their transatlantic flights being down to as low as 5% of normal, as well as obviously on the operating side within the hospitals themselves where there's a lot of turnover of staff, a lot of challenges that they were facing.
So it's a real-world setting and actually conducting a pivotal study that has sort of real-world characters, actually unusual. And in this type of an indication, certainly something that hasn't been done in a long, long while. The good thing is the data that we actually got out of the study absolutely smack on with what we had seen prior to the pandemic. So the safety profile held up very nicely, exactly where we expected it to be. And it also looks, as we had seen in the adult patients during our first study, the ALLCAR19 study, where we have now more than five years of follow-up, that indeed a proportion of patients appears to actually get into long-term remission. So far the curves look very, very similar, and we'll obviously keep tracking these curves very carefully on event-free survival, duration of response, and so on.
But it is indicative that indeed we may actually have also a proportion, even in these very challenging environments that we conducted the study in, that actually will have managed to get a long-term outcome. And I think that's going to be one of the key objectives going forward, really substantiating that, follow these patients over time. But that's incredibly encouraging because that's frankly something that we haven't been able to do in this field, not for the adult patients. We could do it for kids, but we could not do it for adults. And that's actually where I think there's a lot of excitement. And obviously we're getting ready to, both from a manufacturing as well as from a commercial perspective, to be in a position, once the approval is through, to actually launch the product with the first launch expected for the US.
Before we dive into additional clinical results, can we discuss the recent financing events in the company, including the strategic partnership with BioNTech, and how the company is positioned ahead of a potential launch next year?
Yeah. Yeah, that was obviously one of the key things that we had to sort of navigate as we're getting through the course of last year and into the beginning of this year, is that obviously we're moving steadily forward on getting the product ready for filing and ready for commercialization, which included actually setting up our own manufacturing site for commercial supply, getting fully characterized, done that actually from groundbreaking to BLA filing with the full data set in 24 months, which is certainly an industry record. And obviously preparing for launch, which is quite a heavy lift because every one of the centers you're going to go into needs to be onboarded, requires to get the systems on.
It's about a year investment that you have for each center, a lot of work for the company, but also a lot of work for the centers to do to sort of get ready. So it's quite a heavy lift. So one of the key things that we had to solve for is make sure that we're adequately funded to be able to go through the launch, but also go through the launch and to profitability with the product. And so when we were starting the conversation with BioNTech, that was kind of the goal on our side, is to be able to do that and at the same time, obviously, having an ability to continue to invest in obe-cel going forward as our lead asset. And so the conversation that we had with BioNTech and the deal structure that we created was really around several platforms we developed.
Where the conversation started was actually on the manufacturing side. It was triggered on our side because we're developing, obviously, and setting up the commercial manufacturing side. We had 2,000 products a year earmarked for obe-cel, which gives us about a coverage of two-thirds of all relapsed refractory patients in the U.S. and in Europe. We actually had another 1,000 patients' worth of capacity in the facility that was not yet built out, but was ready to actually to sort of set in motion. There was extra capacity available. From BioNTech's side, they were getting to a very interesting point with the course of last year, actually getting a very good feel for the leading CAR-T programs that there indeed is actually quite an unusual profile with that product, and getting to the point where you have to make decisions about your pivotal study.
As soon as you get to that point, you need to lock down your manufacturing process. You need to actually get ready for commercial manufacture and get the infrastructure available. A lot of these questions kind of popped up, and it was basically getting to the point where it required investment. That's actually where we started talking and leveraging and realizing there was actually real benefit from leveraging the foundational investments that we have made in both the manufacturing as well as the commercial side, systems, etc., to leverage that for a larger number of products and a larger number of patients. There's an enormous amount of synergy you can actually generate just by having, with a given cost of infrastructure, more products run through. Obviously, your cost of goods go down.
And similarly, for the hospitals, actually, if you actually have onboarded a particular set of systems, you have more products run through those. That's actually much easier for the next product to onboard because a lot of the key pieces are already in place, your IT security checks and what have you not. There's a lot of work goes into that and training as well. And to be able to actually leverage that actually reduces cost, reduces work for the centers as well, and clearly has a very clear-cut rationale from an economic perspective as well. And so this is what we've been basically when we started the conversation with realizing, okay, there's a real opportunity, and the extra capacity we have would actually be very supportive to actually support the supply for the launch of BioNTech's lead CAR-T program.
We structured all of the relationships in that agreement as options. This is an option that BioNTech has to get that access and structure that we set in place to make the decisions around it. That's the first aspect and the first part of the deal. The second part of the deal was actually on the product platform. As you remember, there are multiple programs that we have running through that actually have already interesting clinical data. Two of those programs we selected to put into the arrangement. One is AUTO1/22. It's a dual targeting program targeting B-cell malignancies, particularly interesting to look at indications like large cell lymphoma. Second program is AUTO6NG, which is a solid tumor program for one of the key pediatric solid tumors, which is neuroblastoma.
Both programs are structured in a way where the option exercise is ahead of the start of a pivotal study, leads to co-funding, as well as then to co-commercialization and a profit share. It is somewhat asymmetrical with slightly more on our side, but with very meaningful contributions from our partner and an ability really to leverage also their infrastructure that they're building up for their particular ADC side on the solid tumor side. There's a lot of commercial infrastructure that is being put in place on BioNTech's side as well that I think is going to be very interesting for some of those programs. The third or fourth platform, if you wish, is really around technology. That is around the various ways in how we actually can engineer cells and change their properties. We've got about 80 patent families all in on the prosecution.
So it's a very important part of the work that we've done over the last close to 10 years now. Now, a key application of this technology is not only for autologous CAR-T products, but it can be used for different types of approaches, including in vivo approaches. And that's an area that BioNTech has been very interested in for a long period of time. In fact, it's the reason why there was a lot of the technology in place for mRNA-based delivery, which obviously resulted ultimately in Comirnaty and the COVID vaccine program. But it was not the reason why actually the technology was there. The technology was there, BioNTech, because there was an application worked on for oncology. And this is actually a key area of focus for BioNTech, and I'm sure will continue to be a key area of focus going forward.
A lot of our technology interfaces very nicely with that. So the structure, because it's all set as options or mostly set as options in the arrangement, then financially was an investment of $200 million, $50 million in cash, and then about $580 million in milestones and in various shapes or forms, option exercises, milestones, and so on for regulatory and development milestones. So that's the structure of the deal. What this allowed us, when you look at the upfront component of the package, that capital is what we identified we needed also to actually launch obe-cel and reach profitability with the program. So that's what it basically that deal actually and the financial part of the deal would actually address. The second aspect is that we then actually leveraged that into a financing, which added another $350 million.
So we added $600 million beginning of February to the balance sheet, which pro forma gave us a sort of a start of the year of $800 million, give or take, at the start of the year. So a very strong balance sheet, really, which we believe was really important because we're going into launch, and you can't starve your way to launch. There's no way to do that. You've got to do what you've got to do. You've got to do it right. And so that actually allows us to do the right things and really drive this launch effectively with obe-cel. But it also gives us flexibility to actually consider one or two additional indications to take them to a label.
That actually, I think, is the flexibility that we have within the cash runway that we have and the capital that we have in the business at this point. So a very attractive point, but also I think a very attractive partner for us, actually very similar roots, very similar way of thinking about oncology. And certainly a lot of excitement, I think, for I think a lot of things that we can do going forward, which I think will not be limited to what I just explained to you. So I think there's a lot of opportunity there.
All right. Very helpful. I do want to go back to the data in obe-cel and ALL. Maybe a short recap of the FELIX data that was presented to Needham. One thing we do get from investors quite often is how do those results compare to existing CAR-Ts in the space, let's say, to Kymriah?
Yeah. So the overall profile that we have seen with the product is that we have an overall response rate somewhere in the range of 70%, 75%, 78%, depending on how you cut the data and how you look at it. The interesting thing is that what we're seeing is, and this is what I indicated before, that we look at the event-free survival as well as duration of response. The data, that first presentation we made was in ASCO last year. We then followed up with ASH with good six months of additional follow-up. And what we started to see, that it looked like we're starting to see a tail building on event-free survival at ASCO last year. At ASH, I think that started to look quite a bit more stable.
It started to actually be in the range of, give or take, 40%, 35%-40%. But of course, still a substantial proportion of the patients with follow-up that was not quite long enough to really be certain that indeed the tail actually would be fully stable. So as we're going through the course of this year, we have two more data updates we expect, one middle of the year, one at the end of the year, which will give us another 6-12 months of follow-up. And I think with that, we'll start to give us a very clear view on whether indeed that tail is actually what we're stabilizing.
If it is, then actually the data would look very, very comparable to what we've seen in our initial data set in the old CAR study where we have now more than 5 years of follow-up and 35% of the patients in long-term remission without any subsequent therapy. And that's important, actually being in a position where you basically get a single CAR-T therapy, and then that's it. And you've got years of life afterwards. That's the goal. And if indeed we can replicate that, I think that would be a huge aspect, which clearly is different from any of the other programs that have been evaluated in adult patients with ALL. The response rate is in that bracket. And what we're seeing is, and when you look at response rate, is that up to about 75% tumor burden at lymphodepletion.
So still very, very significant mass of tumor. We're operating in, give or take, 85% ORR. And it's only actually when you get to this extremely high level of tumor burden between 75% and 100% tumor burden in the marrow. That is where the ORR actually starts to drop somewhat. And that gives us that average overall across the entire population of about 75%-76%. But it is very, very much a function of the fact that obviously we had a substantial proportion of the patients with very, very high tumor burden. So that's one of the consequences of certainly the situation we were in, but also gives us a lot of confidence in the data.
One of the things that we've done with this study is we did not only look at the patients that had morphological disease, so at inclusion, 5%-100% tumor burden. We also looked at a proportion of the patients that had disease burden that was below 5%, minimal residual disease. Then we also looked at a group of patients that had so-called isolated extramedullary disease. In other words, the disease has morphed to a point, a mutated point where it could actually take hold in another tissue and grow out in that tissue. It's in essence a gain of function for the disease and tends to be very difficult to treat.
When you look at the data, we have a representation across the entire range of tumor burden in these patients and across the entire risk factors that you can find in these patients. That's ultimately actually where the strength of the data is. Combining that with the consistent safety profile that we've seen across these various risk areas and risk scenarios for these patients has been extremely encouraging. That's why we think actually sort of we see the resonance that we're having with the treating physicians who look at the data because they do actually see their patients that they see in their daily practice represented in the data. There's an ability to link the data to the real-world setting that they're dealing with. That's often a problem in clinical trials.
A lot of clinical trials, particularly in this field, are highly selected and highly cherry-picked the patients to sort of manage a certain outcome. Now, even if we would have wanted to do that, we couldn't do that because in the pandemic, we literally couldn't go to the centers. Nobody could be physically there. There's just no way you could actually influence the study in this way, which ended up being a real asset in the study because it gives us this very rich data set. Also given that the size of the study is substantially bigger than what was done in the past, gives us also, I think, a very robust way of understanding what the profile of the product in the real-life setting is.
So I do want to speak to some of those items, specifically your learnings around disease burden at infusion as being a predictor of outcome. In a real-world setting, does that help you better manage those patients? How would you envision your product being used more wisely? Is that a good way to point it out?
I think, let me take a step back and maybe look at this in a slightly different way. One of the challenges, and I'll go back to a prior life quickly just to illustrate it, but one of the challenges is that you need to understand what to expect. In the prior life, when I developed Blincyto, the problem we had initially when we discovered neurological toxicity, which was something nobody had seen, and we had just no idea what hit us, physicians didn't know what hit them. It just happened at random. It looked like it was complete random. The problem was that if it is a situation where you think things are happening at random, you're basically taken on for a ride. You just don't know. You prepare yourself for everything could happen.
There's just really nothing you can really help you make decisions, resource allocation, et cetera, that you might be doing or precautions you might be taking. So it's a very difficult point. The core to actually get Blincyto ultimately developed and developable was to actually move it from a situation where it was unpredictable to a situation where the outcome was predictable. This was around dosing and the continuous IV infusion that we were using was a key part of that to make it predictable. But actually moving to that point where you knew what was happening and you knew what you could do, and you had a set of tools, one was steroids, one was step-up dosing, and was a step up in the dose, those were the tools put in place to navigate that.
For the physicians to see, "Okay, this happens, then I can do these two things." But it gives you an ability to control, to anticipate, to predict. And with that, it gives you actually confidence. Now, what the product actually allows us to do with obe-cel is actually also to go from a place where, remember, there are two programs that failed in adult ALL because of toxicity because it couldn't be controlled. There's a CAR-T product which has a very significant level of toxicity, certainly in the real-world setting, and a challenge because of that to manage. To get to a place where you actually know what to expect, that is really valuable. You dose, you observe, you can adjust. So that's one thing in terms of the dosing and the way we developed that.
But to your point, to be able to actually even start predicting what's going to happen to the patient with a high probability before you dose is really valuable. And that was one of the key things that we actually found when we analyzed the data is that the level of tumor burden that we have at time of lymphodepletion, so before we actually start any treatment of the patient or preparation for the patient for infusion, actually gave us very clear indication of what level of adverse events to expect. It also starts to actually give us a sense for outcome because we did see quite an interesting impact on event-free survival. So if you have low tumor burden, at lymphodepletion, you have a very high probability for long-term outcome because event-free survival is at 70%-80% level.
Your risk of adverse events is very immunological adverse events is very low. There's no high-grade CRS. There's no ICANS. And then if you're between 5%-75%, actually you have a slightly elevated level of CRS. So you've got 2%-3% of high-grade CRS you could expect. So 2%-3% or 2 or 3 patients out of 100 that could experience that. And you may have somewhere in the range of 3%-4% high-grade ICANS you could expect. And typically, overlapping patients with high-grade CRS are more likely to also have overlapping with the high-grade ICANS. But it gives you a pretty good view on that. And it also still gives you patients that actually have long-term outcomes. And you see event-free survival stabilizing, at least based on the data that we had at ASH and the level of follow-up.
But if you have very high levels of tumor burden, you know, on the one hand, that the patients have a higher level of adverse events with regards to CRS and ICANS actually at the overall level of Blincyto, so it's still remarkably good. And these are the worst patients with obe-cel. That's sort of the corollary if you look at the data. But also, you do see that these patients tend not to fully stabilize. So you need to also think about potential subsequent therapy, et cetera, in this patient group because they clearly have not stabilized. But they're also notoriously, frankly, the most difficult patients to treat because their immune system is completely shot. And just the sheer number of tumor cells you have, the probability game just makes it very, very difficult to achieve a long-term outcome.
Clearly, by definition, if you have that high level of tumor burden at lymphodepletion, it meant that the chemotherapy or agents that the patient might have received before lymphodepletion were not able to control that. So it's refractory by definition. And that's sort of what that basically tells you in that analysis. But understanding what to expect and then have a set of tools in hand to control and stay in control of the therapy and control of the patient is fundamental. And that is actually what I believe we managed to achieve with obe-cel, very similar to what I managed to achieve with my old team with Blincyto 15 years ago.
I do want to spend a minute on the bridging therapy as it relates to the way the FELIX study was conducted. Do we have good reason to believe that bridging would be better optimized now that we don't have a pandemic?
So first of all, we're looking into that quite intently in terms of bridging therapy and sort of the potential for outcome, et cetera. I think we have to understand in the pandemic, one of the things that we did, and this is also why this is very much a real-world study, the way we had to set it up is the physicians were free in their choices to bridge except they couldn't use Blincyto. That was the only thing they couldn't use. They could use everything else. And that's important because some of the studies in the past have been highly selective of bridging therapies or modalities that were highly artificial. They were actually not used in the space.
All of that is basically geared to sort of have basically what it allows you to do is actually select and push a certain patient selection because only certain patients you'll be able to control with those types of therapies. So it's a way to skew data and it's a way to skew the study. Well, we're in the pandemic. We couldn't do that. Also from an ethical perspective, how would you actually have told a treating physician to be limited in the choices of bridging when you know maybe there's hospital shutdown or there's an issue with the patient, there's an issue in the environment, a lockdown, maybe an issue on logistics, what have you not? There's all sorts of things that were quite obvious could go wrong. So the physicians needed maximal ability to control the patient.
And so this is why we allowed, frankly, any form of bridging, which is frankly what in the real world happens. Physicians are using what they know works, and they adjust it to the patient accordingly. And so one of the things we're looking at now is we're looking at the impact of bridging and whether there's something we can learn from certain ways of bridging and whether that actually whether we see individual types of bridging that might actually have are correlated with outcome or not. And that's one of the things that is currently ongoing and certainly an interesting aspect of the program.
Okay. Another interesting point that came out from the study is it looked like outcomes in patients that were going to transplant post-obe-cel actually looked sometimes worse than standalone obe-cel. Do you expect this trend to hold? And what sort of follow-up would be required to support such a conclusion?
Well, first of all, that's an area we're looking into very carefully because it's been quite a debate actually because today, the only way with any therapy outside of obe-cel to get a longer-term outcome in relapsed refractory patients with ALL is actually to do a transplant. There's no other therapy that gives you any tail or any buildup of durability that is meaningful as a single agent or as an individual therapy. So typically, what you do is in those settings is you try to go to an MRD-negative state and then transplant. Now, if I do that with Blincyto, if I do it after Inotuzumab, if I do it after high-dose chemo, obviously, that activity is sort of confined. It had happened. It's done. And then I transplant, and then I get whatever the benefit of the transplant is.
The problem with a product like obe-cel is that the product isn't done. Our product persists for very significant periods of time. We see in this patient's 2, 3 years out, we see persisting CAR-T cells. And it may even be correlated with outcome. That's one of the key things we're looking at and we'll update on during the course of this year. But the problem is if you take one of those patients that, yes, is MRD-negative, and now actually I'm going to prepare that patient for transplant, I'm going to wipe out all the T cells, the CAR-T cells in that patient, and then I'm going to come in with a CAR-T. So I lose the ability to control the leukemia with the CAR-T. So that's a very tricky trade-off.
And that's why one of the questions, as you point out, is that we're looking into is whether that's actually beneficial or whether actually it may not make a difference or it may be actually even a negative. And that's something we're looking at, but we need a certain amount of follow-up. We obviously may get a first glimpse maybe towards the middle of the year, but certainly, I think, a much more definitive view by the end of the year. But that's certainly a very interesting aspect of the program. And it's different if you had a product that doesn't persist. Then you're in the camp of BLIN or Inotuzumab, et cetera, because there's nothing you lose by doing the transplant, so it's truly additive. But in the case of obe-cel, there's a risk that it isn't.
So one of the early points for the benefit of obe-cel is potential to administer in the community setting. Now that we're kind of getting closer to approval, are there ways that you can manage those? You kind of alluded to it, but are there ways to parse patients based on their disease burden so you can treat at least some of them in the community?
Right. So that's an interesting question. There are sort of few layers. The first one is that in order to deliver a CAR T therapy, you need an accredited center. So that is, per definition, not what often would be converted to as community. That's not what that is. It's still a specialized center to be able to deliver it because you need that accreditation. That's the first observation. The second is, I would say, it makes a huge difference in terms of the resource use at those institutions and also for the patient is whether the therapy has to be delivered inside the hospital as a classical inpatient being on the ward and being cared for at the ward. That's the inpatient setting. Or whether you're what we often refer to as a hospital outpatient setting, which is more the ambulatory setting of a comprehensive cancer center.
A lot of infusions are happening with antibodies and chemo and so on. And we do believe that indeed, patients that have low tumor burden and that in overall reasonable condition, I would say if they have a lot of comorbidities, that may be different, but if they're in reasonable condition, there's an opportunity to consider treating these patients in the hospital outpatient setting. And there's a high degree of interest from the treating physicians to do that and to do that also on the commercial side. And predictability, obviously, is a key aspect here. So overall tumor burden at screening is important. But then you have that second checkpoint. Before you do the lymphodepletion, you can still make a decision. Is the condition okay to actually and everything stable? And you can do the hospital outpatient route.
Or you realize, okay, this doesn't quite look right, and the patient may have some issues that are popping up. Then you actually have a choice. But it's going to be a choice based on information and actual data that the physicians can then take. But there's a high degree of interest to actually treat these patients in the hospital outpatient setting. This is also, by the way, on how a lot of the patients with Blincyto are being managed in the hospital outpatient setting. This is what we had done years ago, even for early-stage studies there, but very much driven by the nature of the patient and the condition the patient was in.
Okay. I would like to spend some of the last minutes we have here on the potential uses for obe-cel and autoimmune disease. And not to belabor the Schett data, we all know that looked great. But what gives you confidence that obe-cel has good potential here?
Yeah. Well, the first thing is that it's important to understand where the Schett data comes from. And it comes from a pediatric ALL program. So that program was actually designed for pediatric ALL. It has a receptor very similar to Kymriah, Breyanzi, different manufacturing process. So there is actually pediatric ALL data. Part of that was shown back at ASH 2021. Our data and their data in pediatric ALL is highly superimposable with the exception of safety. Our product is substantially safer. But overall, in terms of the basic properties, molecular CR rate, longer-term outcomes, persistence, very, very similar. Now, that is important because everything we know that worked is based on that profile. Okay. That's where our fundamental confidence comes from, that our product actually has the right properties. Knowing that we have a safer product, obviously, matters a lot in this patient population.
So that's where that comes from. The second aspect, I think, is it's not only that the outcomes are superimposable. They're given at the exact same dose. We're dosing Obe-cel at the exact same level. So also, we're not running a dose-finding study. We know our product backwards. What we need to do is, and what we're doing is, we're converting it to a fixed dose. Pediatric patients, you can have the youngest patients we've ever treated was nine months old. That's five kilos. You can have a 16-year-old at 100 kilos. So you need adjustment because in the pediatric setting. With adult patients, you don't. And so that allows you to actually convert to a fixed dose. And what we're currently doing is we're running 50 million cells as a dose in six patients. And that's what we're going to do to confirm the dose to fixed dose.
In parallel, we're developing the pivotal study design, the regulatory interactions with a goal to be able to kick off a pivotal study somewhere in the range of the end of this year, early part of next year.
There are quite a few autologous CAR-Ts being developed specifically in lupus nephritis. I do want to focus on Kyverna and Cabaletta assets because they are probably the most similar to the Schett asset given his involvement there. We're just trying to understand better what is the key differentiator between these assets and between your asset?
Well, the first observation is, obviously, we know how we're differentiating from the data that actually was generated and the CAR that was generated. And that is very much on safety. And that's absolutely relevant in this population. The second aspect that I think is important to understand is that the way that you have to deliver these therapies, whether it's autologous or allogeneic, doesn't actually matter. You have to go through an accredited center. In other words, your product has to be present and integrated into a CAR T center. Now, the advantage we have of having a hemato-oncology program that actually is relevant for hemato-oncologists who are the people running CAR T centers. And actually, we're planning to have 30 centers commercially onboarded by the end of the year and about 60, give or take, middle of next year.
That puts us in a totally different perspective and a ballpark because the product is there. There's experience with the product from the hemato-oncology side. Now, we need to make the relationship between the rheumatology department and the physician and the hemato-oncologist. That's relatively straightforward to do. That's what we need to do. If you have just an autoimmune program, it actually is quite difficult to get onboarded because you don't have much of a proposition for those CAR T centers. You're not solving anything that these hemato-oncologists care for and the patients that they need to care for. And it is a lot of work for the centers to take you on. I think it may explain in part the long startup time for a lot of these studies, et cetera. So that's one aspect. The second aspect is we have, obviously, a very sizable safety database.
So when I'm talking about a safety profile, I'm not talking about a speculative one. I'm talking about a large program with a wide range of patients, a lot of them in horrible condition. So we have a lot of confidence and understanding on our product. The product is obviously fully developed. The BLA is under review. There is a commercial manufacturing base actually existing. And that is important in two ways. The first is it takes quite a bit of time and capital to set that up. That's one thing. It is complex to do. If you don't do it, kind of difficult to actually be economically viable. If you have CDMOs working for you on that, that's very, very tricky to actually get economically viable. So those are kind of quite tricky considerations.
But then when you think about it from any future filings, obviously, we can leverage the filing we have with the product, including the safety data, and add to that. It's not a de novo filing. It's not a completely new program. A lot of it will have already been extensively reviewed, including the facility inspected and reviewed for quite a while. So we believe it puts us in a very strong position because it's the only product that will actually have sort of a commercial presence in hemato-oncology that is also going into the autoimmune setting. And it has actually established mature infrastructure around it, which is both the cost, the risk, and the time component.
That's actually why we think we're in an interesting spot here, just frankly, because we did actually have to go through the pain of getting these things set up for the hemato-oncology side first.
If I were to summarize it, you would say there are operational advantages that.
Well, the product advantages may very well be, but we don't know anything about their products. So I can speculate. But I only can compare to the Schett program that I can compare to because we know exactly what we're looking at. Any of the other programs, we don't know. And I think it'll take time to understand how these products perform and how they perform also vis-à-vis Novartis's program and BMS's program, who obviously have infrastructure and, like us, have an ability to execute.
Okay. And maybe as a last point there, because this is a question that comes up a lot, what do you consider the initial market potential for obe-cel and autoimmune disease? I know everyone speaks of SLE, and SLE is a large market. But at the end of the day, not everyone's going to get lymphodepletion here. So I'd love to hear your assumptions.
Yeah. Actually, the lymphodepletion is not the argument here. The argument is different. The argument is these types of therapies are relatively expensive. And there's a limit to which you can go in terms of still having economic viability. And I think what that does is that actually makes these types of therapies attractive given that there's a high probability for long-term outcome for patients with very severe form or refractory form of disease. So we're not talking about the 300,000, 400,000 patients that you have on an incidence base and just the prevalence on the early-stage mild forms of disease. That's not what we're talking about. We're talking about those patients that are very heavily impacted by the disease and are basically not able to function within society in a normal way. They cannot have, if it's women, they cannot have kids. They cannot work.
People cannot actually go to university, get training, et cetera. It is pretty horrible, actually. The impact is huge because this could be decades of life that they may still get to, but without actually being able to function in a reasonable way. Being able to get that reset, that is very valuable. And I think that's where you have, I think, an attractive health economic perspective. You may be able to push that into the realms of the antibody combinations. And I think you could still argue that case. But if I start at that most inner circle, you're probably talking, give or take, 3,000 patients. If you actually then go into that more severe post-one or two antibodies, but still sort of antibody-eligible population, that would probably be a factor of three, maybe five, on top of that, so 10,000-15,000.
And beyond that, actually, it's very much a question of what's sort of the price elasticity? How much price is still reasonable to be carried from a society perspective and a payer's perspective versus the outcome? And there are ways to think about that. There is still actually quite into the earlier stage, still sensible because there is a huge amount of lost income over time, et cetera, you could sort of calculate. But it gets a lot more tricky. And so when we look at it, the initial proportion of patients we're looking at is in that 3,000, maybe 10,000 patient range. But that's certainly kind of the initial part that we're looking at. I don't think it's going to be substantially bigger initially. But it's also in those patients where the patients do go through chemotherapy.
They go through pretty intense courses of cyclophosphamide, much beyond what you would use actually in a lymphodepletion regimen, as well as many other antimalarials or what have you not, which are a lot of side effects, very challenging, with very limited outcomes. So that's sort of what that is. And if you can get those patients to a place where you can avoid even steroid use in these patients, which tend to be used at very high levels, one of the reasons why there is a high degree of diabetes building up and what have you not, you can get to that place where you can get rid of those things, including the high-dose steroids. I think you make a huge difference to these patients. And that's really what we're hoping to see with this type of an approach.
All right. We are a bit post-time. Again, I'd like to thank you, Christian, for attending today.
Thank you very much. Thanks for having us.