Good afternoon. I'm Sam Semenkow, Senior Biotech Analyst here at Citi, and today it's my pleasure to be hosting Cabaletta Bio for a fireside chat at Citi's Global Healthcare Conference. I'm joined today by President, CEO, and Co-founder Steve Nichtberger, CMO David Chang, and Chief Commercial Officer Steve Gavel. Steven, David, and Steve, thank you so much for being here today.
Thank you.
Thanks.
Steven, why don't you kick off the session for us with just a little bit of introduction to Cabaletta? I'm wondering, at a high level, the overall strategy you have for developing and commercializing Rese-cel, and then we'll dive in much further.
Excellent. So thanks, first of all, Sam, for having us here. Maybe a good place to start is at the beginning, right? When we brought Rese-cel into the company and prioritized its development, it was on the thought that what we had seen from Professor Schett and the academics was going to really redefine the treatment of autoimmune diseases. We replicated the design of our product to really come as close as possible to the design of the product that was used in those academic studies, and we dosed in a weight-adjusted manner to replicate those clinical data. Fast forward from our IND filing in 2023 to now the end of 2025, we have multiple diseases that have now fully enrolled and, in some cases, completed the phase 1/2 portion of our development program, the RESET Clinical Trial P rogram.
Most recently, at ACR, we presented data on patients who had been treated with the RESET- Myositis Trial. We had presented data on patients who had been treated with a single dose of Rese-cel on a weight-adjusted basis with preconditioning, and at 16 weeks after they were dosed, four out of the four patients who reached that endpoint in terms of follow-up had hit what is the aligned primary endpoint for our pivotal myositis program, which is on track to initiate enrollment imminently. That is very inspiring for us, and we saw in the dermatomyositis, which is about 70% of the myositis population, we saw a really nice durable effect out even beyond a year at this point.
That data in myositis from ACR, combined with data from scleroderma patients where lung function is actually improving, the interstitial lung disease actually improving for the first time ever, really groundbreaking data on top of the improvements in skin that seem to be relentlessly continuing with follow-up, combined with our lupus program and the early data there, again, really important achievement of DORIS remission or objective renal response in all the patients that we're following. This combination of outcomes, and then finally the Pemphigus vulgaris study in which we took away the preconditioning and we asked, can Rese-cel by itself, we thought at a higher dose, give us the same level of activity in an autoimmune population? The answer to that question was presented just prior to the ACR meeting at another medical conference, and we saw profound acute activity.
Now it's a question of, at the starting dose that we are using, do we have durability? Or, as we hypothesize, will we need a higher dose without preconditioning to get a durable treatment effect? So we're moving that now into our lupus program, and we expect to be able to generate data in 2026. So to bring us up to date now where we are today, ACR was a defining moment for the field. For those who were there, you'll recognize immediately that CAR-T in autoimmunity was the story of ACR this year, and the rheumatology community has really hit a tipping point where they all understand how important and how transformative this therapy can be and are starting to ask, how can I become involved?
That's all terrific, and it's a necessary next step, as well as defining not only ourselves, but Bristol and Novartis and the others in the field together have really defined that this is going to be a drug category that transforms healthcare. Many of the other categories of drug that are going after CD19 have also presented data and, in summary, made it clear that they are not going to achieve the level of gold standard activity and safety that is now being presented by the category of drugs in the autologous CAR-T space.
So as we go into 2026, we're really excited to have initiation of the myositis pivotal trial, which has been aligned with FDA as recently as their review of our protocol a few months ago, to have the alignment on scleroderma that we will have achieved or not, the lupus alignment that we will have achieved or not, all by the end of this year, which to us means by JPMorgan, and the Pemphigus and lupus data without preconditioning in 2026.
On top of that, the myasthenia gravis program and the clarity of alignment with FDA in the first half of the year, all of it transitioning into a commercial perspective, which we can't wait to share with the investment community and with others because autoimmune CAR-T has a fundamentally different and fundamentally better financial profile for the company and for the institutions that would administer our therapy on an outpatient basis in a much healthier younger population than we've seen in cancer. But I'll leave that for the discussion today.
Oh, that's an excellent intro, and there's a lot to dig in there. Thank you for that. I would argue, though, that ACR, that excitement has been building over several years. It's been wonderful to see that grow. But David, I want to maybe ask you to maybe elaborate on one of the points that Steven made just about the safety profile of Rese-cel and how that just compares across the autologous CD19 CAR-T field for autoimmune indications broadly. How do you guys stack up versus some of the other competitors?
Yeah. So when we looked at our own data from the RESET studies, we are seeing probably approximately one-third of the patients developing CRS, almost all of them grade 1 CRS, which actually, compared to oncology, of course, is tremendously lower. Obviously, we can't comment on other CAR-T therapies that are autologous, but we've looked at the data, and generally, those numbers do appear to be much higher than the 33% CRS rate. So I think one of the potential differentiating features that is beginning to emerge is the safety profile, potentially related to dosing, using a weight-based dosing. And obviously, from using the backbone of a 4-1BB co-stimulatory domain, it's certainly been working to our advantage as well.
Right. And I think that's a good segue to maybe ask Steve a question just about how that safety profile, and Steven alluded to it, allows you to potentially do outpatient dosing. What does that look like in reality, or how do you envision it?
Yeah, thank you for the question. Yeah, it's a very important aspect of this. As Steven was talking about earlier, if you compare and contrast what's been going on historically with prior CAR-T therapy, specifically around cancer, a number of hospitals have been actually trying to move some of their patients into the outpatient setting for a number of different reasons. One of the reasons is just there's only so much basically space within these hospitals, whether it be in the ICU or just regular beds to monitor these patients and/or staff to monitor these folks. So there's been a press to move folks just naturally out of the hospital just because of capacity concerns. The second thing, which I think is a very important issue, and I think it's something that we should talk about, is the payment aspect, right?
So as Steven mentioned, autoimmune patients that we are going to be treating are much younger than historically what I've seen in other CAR-T therapies that I've launched, where these folks are basically being insured through private insurers. That's a dramatic difference. When you look historically back at prior CAR-T therapies for the treatment of cancer, where roughly 70%-80% of all patients treated with CAR-T were being treated inpatient and under the Medicare DRG system. And if you ask any administrator in the United States, they will tell you that that was very problematic because, in essence, what was happening for many of them is that that aggregated payment model was insufficient given the price of the CAR-T therapies, as well as the other costs associated with inpatient stays. So that was a problem.
It's one of the reasons why so many hospitals were looking to move outside the hospital. The rate limiter was the toxicity profile, right? So even though those two drivers were in place that was causing a lot of pressure within institutions and for providers, and they knew the outlet was going to outpatient, but the tox profile was the rate limiter to do that. They were trying to do that back in the day with CD19s, and they were seeing very acute CRSs. And what was happening is they would administer these products to these patients that were so sick, they would spike an immediate fever within a day or two, and they could not, they couldn't fundamentally do that. I think where I'm going to go, it's a roundabout way to answer your question, but I think it's an important one.
I think the Carvykti program was really the first proof of concept where, because of Carvykti's delayed CRS, that now hospitals were successfully able to administer in a clinic in the hospital and then monitor in the outpatient setting and then get out of this DRG payment mechanism that was in place. It was the first time they were able to do that. So hats off to my old team, back at Legend and Janssen, for assisting hospitals with that and educating folks on how to keep patients safe. The interesting features I see with the Rese-cel program is you see, from a CRS perspective, first of all, a much lower CRS profile, much less patients actually getting CRS, and those patients that did get CRS, it was very moderate.
So it's a very different-looking patient in terms of, and maybe David could talk about from a biological perspective why that is. But the fact of the matter is we do not see nearly the CRS, and the onset, ironically, for this program is also delayed. We see a median onset about seven days. So anyways, hopefully that answers a large part of your question.
It does, and it's great to have you joining Cabaletta right now at this particular junction of the company's journey. And you mentioned your experience with Carvykti and facilitating that launch. I'm wondering, there's a lot of learnings from oncology that I think you can draw to autoimmune, but perhaps some unique aspects. How are you going to help navigate it to make it a successful launch for Cabaletta?
Yeah, we talked about outpatient being a very important component of it. What we haven't talked about, and again, this is, again, pressures within the systems for providers is you see really spiked out-of-spec rates. You see, unfortunately, these patients who have late-stage cancer with really poor T cells, and so that was very difficult for many manufacturers to properly make proper drug product within specification, and that led to delays in manufacturing, and unfortunately, many patients never were treated because their disease progressed. So we do not see that. One of the things that caught my eye with this particular program is the lack of out-of-spec rates because I'm so used to seeing them, and you saw, I think it was on 60 patients dosed and treated, we see about 1% or less, for sure, less than 10%.
So it's a very small number in terms of, and it makes sense that it would be so low in a patient population like this. But in terms of, I think your question in terms of other lessons learned, I mean, there are just some facts that it's understood. What I didn't mention, though, is gets back to the economics here, is most manufacturers in that setting running out-of-spec, that out-of-spec drug product was manufactured. Unfortunately, there was a fair amount of cost incurred by the manufacturer, and that product was actually dosed off-label. By definition, that is not something that the manufacturer could actually charge or bill for. So that's a really, it's great for a patient, don't get me wrong, that's an important piece. The patient needs that product.
But unfortunately, from the drug manufacturer with a lot of out-of-spec, that's a lot of cost that you're incurring without any mechanism to recoup that. So I think that's an important piece.
Just to clarify, we've had one patient who was out-of-spec out of the 60-plus patients that we've manufactured dose for at this point from three different manufacturing facilities.
And David, maybe you can speak to that. That's just the healthier T cells that you are.
So we're looking at patient population who have pretty healthy bone marrows and able to generate B and T cells that are generally healthy.
Right. And so all of that is really good headwinds. And I wanted to mention that you said to me that the Myositis Pivotal study is outpatient, which is really sort of going to help drive that as a potential future label, potentially on label for Myositis for Rese-cel.
So a couple of comments. The first, our Pivotal program, we believe, is the only Pivotal program where outpatient therapy is possible in regards to the design of the protocol and the implementation of the infusion. And that is something that FDA has reviewed as recently, as I said, in August, our actual protocol. It turns out outpatient therapy doesn't require that it be in the label. In fact, FDA has historically been silent on where you should administer therapy. The hospitals and the administrators determine, the physicians determine where to administer therapy when the patient is younger, when the patient is healthier, when there are no complications. In two-thirds of the patients you treat, there's not even any CRS. In 95% of patients, if you have any CRS, it's grade 1. There's a couple of patients that have had grade 2 on Rese-cel.
In 95% of patients, you don't have any ICANS. So you've got this really excellent safety profile. Maybe it's due to the fully human binder we use. Maybe it's due to the 4-1BB. Maybe it's due to the dosing regimen, which is the only company that we know of that is using the same dosing regimen as Schett, which is a weight-adjusted dosing. Whatever the reason, the drug is really quite safe so far and relative to both cancer and the peers that we have in the autologous CAR-T autoimmune space. So that permits the outpatient therapy. It is not required in the clinical study that you treat outpatient, but it is our intention.
If we don't have sufficient numbers of patients that the hospital has chosen to treat outpatient in the pivotal study, which is 14 patients as aligned with FDA on the design and so forth, we will go ahead and treat patients outpatient in a separate protocol with the intention to publish that before we launch. So the data will be there to see that it's safe to administer the drug on an outpatient basis.
Right. Okay, that's very helpful. And then, I mean, this incentivizes perhaps the utilization of Rese-cel if you have such a high percentage of the population that could potentially be treated outpatient. Steve, could you just talk about capacity and how we might be able to get a sufficient number of autoimmune patients dosed on a commercial cadence that would be advantageous for you? I'm wondering, is there an apheresis sort of bottleneck? Is there a manufacturing bottleneck? Is there anywhere in the chain that you can that might cause capacity constraints?
Yeah, no, thank you. It's an important question because if you just do a postmortem, honestly, across all these CAR-T drugs, the two common threads are payment around reimbursement, right? Because the population that's being treated is an older population. And the second piece, as you hit on it, is manufacturing, right? And unfortunately, I've been involved in a couple of programs that ran into that very issue, right? I think more have had that issue than have not. I think the one probably who has not, out of all of us who have launched, has been the folks at Kite. I think they did a great job. And so one of the things, and this is, again, something that was attractive to me, given I've gone through some of that, is the approach that Cabaletta is taking in terms of ensuring supply when we launch.
One of the interesting things, and it's very problematic commercially, is you are turning on a market in phases because you have a limited supply to meet demand. That is not our intention here at all. We'll be launching through CDMOs. Lonza will be our first CDMO on deck. We will have another on deck at launch. Steven, feel free if you want to get into some of that. Downstream, and I'll let you maybe get into the Cellares play later. I think it's a very important topic because, again, to your point about lessons learned, we do not want to be constrained at launch in terms of our supply. We will not be constrained.
It's one of the things that what I was really interested in seeing is if you look again historically back at prior launches and turning on the market over time, which is very choppy. It's very problematic for patients, as you could imagine. We'll be launching roughly in 77 sites. That's a large, relatively speaking, a very large commercial footprint. We'll be leveraging the footprint that David and his team put in place, and we will be running full on. That's the intention here in terms of making sure the product's available at all those sites. I don't know if we'll have them all certified at day one because we'll probably over time be turning that on for sure, but the intention is that we will not be short supplied.
So a couple of comments. Bottlenecks, there are now a lot of CAR-T or cell therapy products in the marketplace, and all of those large and well-resourced companies are pushing to expand the number of apheresis sites, to expand the number of inpatient beds, to try and go outpatient with therapy. We just so happen to have a product that leverages everything that they have set up, right? If Carvykti, under Steve's leadership commercially from launch until the end of last year, had not created the outpatient framework for treatment, we wouldn't be able to walk into this discussion talking about the probabilities being so high that outpatient therapy is going to be how Rese-cel is largely administered. We wouldn't have the wisdom to understand that it's even possible. And frankly, we don't have the resources to create that infrastructure.
But we do have both the wisdom sitting to my right and both intention and resources to go after utilizing the outpatient processes, protocols, and infrastructure with a drug that rightfully has very high value in the marketplace, we believe, through displacement of routine annual therapies, each of which might cost $250,000 or $500,000 a year in a world where until now, CAR-T therapy has been seen as a very expensive therapy. Why? Because it's $500,000 plus the cost of administering and taking care of the inpatient and everything else. But when we compare that in autoimmunity to the $440,000 drugs that are going to be launching in the next couple of years, to the $250,000 a year IVIG cost, even if you're a large payer, that's the cost, and others that are launching somewhere in that range, these are annual therapies.
If that's the context, the value of Rese-cel to keep 85% of patients free of any further drug therapy after one infusion is a compelling value proposition that provides a real window of opportunity to create a financially sustainable CAR-T infusion center, not one that is constantly losing financially with every patient treated on an inpatient basis. The stars are aligned for the patients to really benefit. The doctors we see, and frankly, the doctors and the patients are seeing the results. We're seeing enrollment that is faster, frankly, than we want it to be, honestly, because I want to put these patients into our Pivotal program, and we're continuing to enroll. We're not going to turn patients away because we have a position with the clinical sites that is really privileged. The doctors know how to use our drug. They like to use it.
The patients want it, and we're going to continue to use the product as they would like to use it. I don't think that we're going to run into barriers to utilization through the apheresis limitations. I think that's okay for the moment. I do think a year or two after launch with others coming into the market, that will be an issue. We have a program to get rid of the apheresis and replace it with whole blood. We purposely put that lower in the priority than eliminating lymphodepletion because in the 600 doctors we've interviewed, the message was very clear. Efficacy, efficacy, efficacy is my top priority. It has to be durable, reliable, and it has to be really complete. It has to make my patient into a non-patient. That's number one. Number two, it's got to be safe.
Number three, if you can get rid of lymphodepletion, that's a real advantage. And then below that is everything else. And at the bottom of the everything else list is get rid of apheresis. So from our point of view, and actually, I'm sorry, even below that is turnaround time. What they care about more than turnaround time in autoimmunity is reliable delivery of the drug on the day you told me it was going to be here. And that's something that we can do very well. So there's a whole host of commercial opportunity discussions that we really are looking forward to having as we come into 2026 because the CAR-T assumptions that have been really seared into the minds of all investors for the last decade simply are yesterday's CAR-T.
As we look towards Rese-cel's future with very straightforward and clear objective assessment of what the Excel spreadsheet looks like, we are really thrilled with the opportunity that it can create for both patients, the providers, the payers, and our investors.
Two, I think, important follow-ups from that, Steven. So first is, have you had any payer conversations just talking about what they would be willing to accept in broad terms, price-wise, as an offset for the high cost of many of these drugs in addition to all of the other healthcare costs? And then just two for David. The lymphodepletion piece, I mean, you're already doing work there, and I'd love to hear a little bit more of that, but the lymphodepletion piece, I think, puts a lot of physicians that we talk to when we do our checks. That is a little bit of a hold-up. And while I recognize the CRS is very safe, how over time can you get physicians to, or what is the severity that you need to have to really offset the benefit risk for lymphodepletion before you're able to potentially remove it?
Yeah, yeah. So the question about lymphodepletion and patient reluctance, I think a key factor there is just a concern that they're getting a very aggressive chemotherapeutic agent, right? Cytoxan and fludarabine. Some may have actually gotten cyclophosphamide, but in maybe lower doses, but only for really bad, severe cases. But for the patient population, such as young women who are concerned about ovarian failure related to cyclophosphamide, which represents the lupus patient population quite well, that creates a hindrance. And there have been patients who have been reluctant to receive CAR-T therapy because of the preconditioning regimen, and many of whom have also asked for the ability to preserve the ovaries for future, even though they're only getting a single dose of cyclophosphamide. I think the fear is real and that that is always a toxic reality.
So I think when we think about that, if we can get this to work, you overcome some of the barriers related to patient fear, not to mention physician fears as well. Rheumatologists who have never heard of fludarabine, except by the oncologist talking to them, that these patients need to get that. So there's patient fear, there's physician fears, but there's also convenience factor as well. And I think one thing that we didn't really talk about is if a patient has gotten preconditioning regimen and they get CRS grade one, day five, seven, eight, 10, they're neutropenic fever. They're all readmitted to the hospital, right? Because you're concerned that they could have sepsis. So there's readmission concerns that drive up costs for these patients who have fludarabine cyclophosphamide that's causing lymphopenia and neutropenia. Whereas if they did not get that, they're no longer neutropenic, they may have fever.
That could be potentially managed as an outpatient.
Two other points. In the no preconditioning program, we chose lupus because that is where young women, young men of childbearing age are most prominently positioned. And it is, we think, the most compelling value opportunity for patients if it can work in that population. Not to mention, it helps us leapfrog to the very front of the pack of 35 companies that have an IND cleared for the treatment of lupus right now with a cellular therapy. So that's, I think, the first point. The second point I want to make is of the approximately 80 patients, I really, we frankly don't track it as closely now because it matters less. And it continues to be very rapid enrollment across the program.
But of the 80 patients, I can think of one patient out of the 80 we've enrolled who said to their doctor, "I'd prefer not to use preconditioning. I'm going to wait until it's available without preconditioning." All of the other 79, let's say, are, I would argue, not complaining about in 85% of those cases, having complete resolution with durability so far. And in the 15% or so in our program and across the industry who don't have a complete response that is durable, I want to be clear, these are not failures. These are patients who are no longer on three to five medicines, who have in almost every case much more modest disease. And this is not just Rese-cel data. This is everybody's data in autologous CAR-T.
The patients, I would bet, will be grateful that they met the drug, the CAR-T, the autologous CAR-T, because they have a more mild form of the disease they used to have. Now, we need more follow-up to see where they go and if they get worse, but it's perfectly reasonable to think that the B cells have been eliminated if it's dosed properly with a good drug, that the B cells are no longer causing short-lived antibody, short-lived plasma cells to secrete antibodies, but that instead the long-lived plasma cells, which have apparently less capacity to secrete those antibodies, are causing some simmering disease. And that might be just a component of a curative, if you will, a functionally curative paradigm that autologous CAR-T seems to be able to achieve. So there are complete responders who have durability. There are complete responders who don't have durability.
There are partial responders who have durability, and there are partial responders who don't. And then there's a very rare case of the non-responder who actually doesn't improve after the single dose, so thinking about it in now a more advanced way because we have a lot more data, we have hundreds of patients now dosed, I think makes a big difference to how we think about the cost, if you will, of lymphodepletion and whether or not I want to incur that cost, if you will, knowing that on the other side of this, it's highly likely that I am going to have a far better life without my disease than I used to have with it.
And part of that, I imagine, is going to be educational efforts as well as you're launching. And sort of to that point, Steve, maybe we could just talk about a little bit of the competition that might be coming from other modalities. I'm thinking bispecifics. I'm thinking maybe in vivo CAR-T down the road. They're not your near-term problem, but potentially. But how do you think about the value proposition here? And maybe you can pull for some of your learnings from the myeloma space as well.
Yeah, it's funny. It's like a repeat for me in terms of bispecifics. When we were launching other CAR-Ts for multiple myeloma, we were getting a lot of questions from investors at the time, exactly the questions that you're asking right now in terms of bispecifics. At the end of the day, jury's still out in this space, obviously, but one thing that's been very consistent in terms of the efficacy profile of CAR-T therapies is very strong, and I would assume we'll see how the data looks, of course, but I think we're going to beat bispecifics. Honestly, my focus here, being first out in myositis, is ensuring that we have the best possible outcome for that patient as well as the provider. I think you kind of take care of what you can control.
Like we've been talking about today, is ensuring that the sites, those patients, everyone involved in this particular product has the best experience they could possibly have, not only with the product, but also the service around the product and the delivery of it. To Steven's point, the predictability, because that has been a big letdown, quite frankly, in the past. A lot of people have left CAR-T with a really bad taste in their mouth because of the experiences they had, mostly around manufacturing. We'll ensure that that doesn't happen. We will, I guess, say there's a lot of great learnings of what not to do in this space.
And I can't tell you how happy I am given the patient population that we're going to be managing right now, as opposed to some late-line cancer patients where it was a very emotional launch for everybody involved because of very rapid turnaround requirements, et cetera, et cetera, that we're fortunate not to have to be managing through with this particular launch.
One question I get sometimes from investors is, will you need a partner to actually achieve this? Or conversely, how do you compete against a large pharma competitor? Any thoughts? Because you're outlining a very good strategy. It sounds like you're going to go on your own, but I'd love to hear if that's accurate.
Want me to go? I'm happy to take it.
I can tell you what my point of view.
I'll start off and let Steve guide it. So look, here we are at the end of 2025. We have more sites across the U.S. in the Rese-cel program than any other company. We were told that we couldn't do that, that we couldn't possibly compete with large companies, that there's no way, it's too expensive, it's too hard, there's no way it could happen. It has happened, right? We have as large a footprint in the U.S. as anybody. Large clinical footprint predicts commercial success. If there is a partnership that can form that can be valuable for the depth and breadth of our treatment of patients, valuable for the investors that have invested in our company, we're not going to hesitate to pursue that partnership.
But we also are thrilled, truly thrilled at the opportunity to do something that no CAR-T company has ever done, which is deliver really healthy profit margins even from the earliest days of commercialization because outpatient therapy can be reimbursed in full without a loss being incurred at the site, just based on the Medicare approach to reimbursement. And most of our patients aren't even in that paradigm. They are commercial, unlike cancer. So we believe that we can price for the value that we deliver.
I'm not going to opine on our price point, but I am going to say that when people tell us that CAR-T at $500,000 is so expensive, it can't possibly be used in large numbers of autoimmune patients, I would ask that you take a look at the FcRn category where price points are between $200,000 and $500,000 per year per patient for relative to CAR-T, autologous CAR-T data, modest treatment outcomes, and that has delivered billions of dollars of sales across many autoimmune indications. Now imagine if at some reasonable price point relative to that, you never have to spend another dollar on drugs for that patient's disease. I think that's a compelling value proposition for everybody in the healthcare ecosystem. And we're going to find out very soon, right? So we'll file our BLA in 2027. We'll launch either in 2027 or 2028.
And our launch is being designed with Steve at the head. And I want to be clear, when I was looking for our commercial lead, I wanted the person who built the outpatient opportunity for CAR-T. And when I spoke with references for Steve at J&J, at Legend, I came to understand that Legend is the one who essentially launched and built the infrastructure that was required to make the Carvykti product a success. And it was a shared experience over the lifecycle of that drug that made it as big as it is. But the idea that you could launch as a small company and do it really successfully, that's something that he's done before. So he is the perfect person to lead the effort at Cabaletta, and we'll backfill him with many others who have done it before.
That ability to look at sites, which is what we're doing right now, looking at our 77 clinical sites, asking who among them routinely treats outpatients, who among them has a protocol that's very comfortable for their hospital, who among them has many myositis patients in their clinic and outpatient therapy as their opportunity. Good. Those are the first sites that we're going to launch in. So it's going to be a very focused effort with a very directed and purposeful intention to get high uptake, early days from a focused group of centers, and then go out from there over time. So we absolutely can do this. We can do it alone.
We can do it in partnership, but we're going to do it profitably, and we're going to do it in a way that the manufacturing scalability for the first time ever in autologous CAR-T experience, we could have the opportunity to scale at levels that nobody has seen before. Why is that? We have a partnership with a company called Cellares. You'll be hearing a lot more about Cellares in 2026, I believe. Cellares is a company that we've partnered with over the past two or three years to come to the point where we are now imminently filing an IND. We'll be the first company in the world to file an IND using the Cellares fully automated, fully closed manufacturing system for autologous CAR-T. Let me say that again. No human hands need to touch the apheresis product after it's put into the Cell Shuttle.
The next time that human hands are touching that product is when it's in a bag on its way from the machine to the patient. That will have a dramatic impact on the predictability of our cost of goods. It'll have a dramatic impact on the scalability. In a room that is no bigger than two clean rooms, I can have no people involved. I can have hundreds of product, patient product batches run with efficiency that nobody has ever seen. I can imagine that Cabaletta can support scale that goes into the many, many thousands of patients independently, with our only cost being the variable cost associated with a batch that we need to deliver to a patient. We don't have to build big factories. We don't have to have massive head count.
It's a very efficient, fundamental frame shift from what recently honestly seems like it died, which is CAR-T version 1.0, where everybody has abandoned that commercial model now. Those who are doing it are doing it as well as possible, generating as much as they can. But there's a new day for CAR-T that is enabled by outpatient therapy and much more efficient cost and approach to manufacturing that could be fully automated. And we'll have our initial clinical data with the Cellares product in patients in the first half of next year, and that will help define our scalability.
I think we can compete alone or in partnership, but most of all, we're going to deliver product to patients and give them the benefit of Rese-cel, which is really the only reason we all are working at the company and why we keep pushing ahead in spite of the many doubts that we've faced for years.
Yeah, I mean, I don't know how you beat that. First of all, thanks for the comments. Appreciate that. The go-to-market model, it's not you don't necessarily need huge scale and huge reach when you launch CAR-T drugs because obviously the majority of the infusions are in the inpatient setting. I say the majority because you're seeing now outpatient, pure outpatient CAR-T given now. It was just, I saw an announcement earlier in the year where US Oncology now is actually doing this type of work in their clinics, which is great for patients because that's giving you now full breadth and reach to get out. So the proof of concept is now proven. So we intend to do this, and like you said, we could clearly do this on our own.
I believe we should be doing that on our own, quite frankly, because it's very doable because of the commercial footprint being what it is within our hospitals, as well as what you really haven't talked about is that referral network into our hospitals, right? So that'll be the buildout we'll be involved with. But when you do couple those together, this isn't some massive scale buildout. It's something that's very doable, Steve had mentioned, for a company of our size.
That's great to hear. So in the last 45 seconds or so, I mean, I could ask many more questions. This could be another 40 minutes. But I just want to give you an opportunity, perhaps Steven, to share any closing remarks and anything that you haven't yet emphasized that you really want investors to understand.
Autologous CAR-T as a category has proven itself to be safe for use in autoimmune patients, highly durably, reliably, completely effective in a way that distinguishes it from every other category in terms of just a data assessment of what has come to market, what is available. That opportunity to begin curing patients commercially in a way that is both scalable and profitable, different from any historic CAR-T autologous efforts, is coming very quickly, right? In 2027, we'll file the BLA, launch 2027 or 2028. The opportunity to deliver that is going to rely on sufficient funding for the company to be able to bring it to patients.
We are urging every investor that we have met with, and there's a lot of them in the past few days because there's increasing interest based on the data and based on the emergence of our regulatory alignment, to build an Excel spreadsheet, to actually look at the model and revisit the questions that caused you to never want to be involved in another autologous CAR-T company. I think this is the moment to do that because early 2026, we're going to see the ability to scale based on the data we generate with Cellares. We're going to see whether or not outpatient therapy is going to be a viable approach with autoimmune patients. And if those things are true, then the pricing and reimbursement model falls into place, and this becomes a compelling investment opportunity, in our opinion.
Our job is to make sure we communicate what we intend to do and help investors understand what we expect to happen in the marketplace.
That's excellent. Well, thank you so much. This has been a wonderful conversation. Thank you for joining me, and great.
Thank you, Sam.
Thank you, Sam. Appreciate it.