Good morning, everyone, and thank you for joining us for the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference. My name is Emily Bodner, and I'm an equity research analyst at H.C. Wainwright. I'm pleased to introduce Christian Aiton, Chief Executive Officer of Autolist Therapeutics. Maybe to begin, Christian, for those who are newer to the Autolist story, can you walk us through your CAR-T technology platform and your lead asset, OBCIL or OCATCIL commercially, which is currently approved for B-cell acute lymphoblastic leukemia.

Well, thanks, Emily, for the invitation. Pleasure to be here. The focus that we had when we started the company was to come up with a CAR T-cell therapy that allows you to sort of mimic the physiological way and how T-cells actually do attack and recognize cells and take them out. And that physiological engagement is a very short one. the livers to kill, and then a rapid dissociation of the cells and allowing basically the CAR T cell to recycle and go back into action very quickly. On the safety side, what that also does, it actually minimizes the overactivation or the activation of the T cell. And that has a benefit because it avoids high cytokine release syndrome, but it also can avoid other immunological types of toxicities like the neurological toxicities that we've seen in the field across all of the CD19 programs. So the focus with that as a focus, we designed a product that actually has those properties. And basically it's a product that has a fast off rate and which that allows us to disengage after the kill has been delivered. And that really allowed us to create a very differentiated profile that we then actually applied in the field of acute leukemia. And that's obviously where we got our first approval based on the Felix study. And it really gives us a very safe, but also a very, very active product and with a very important long-term outcomes that we can actually see in those patients.

Awesome. And maybe going forward with that, you gave the guidance for the year of revenues of $120,000 to $135 million, what kind of gave you confidence that you could achieve this goal in 2026? And what steps have you been taking to ensure that you're achieving the quarterly growth?

Right. So when we launched the product at the beginning of 2025, we did $74 million in revenue for the first year of launch. And as we're sort of launching the product, we had, independent of the company, data collected from the commercial patients by the Rocker Consortium. And that data got presented first at the first data cut at ASH, and then a second data cut at the tandem meeting in February this year. The relevance is that basically what we see in the data cut that was presented at the tandem meeting in February was that about 60% of the commercial patients were actually included in that database and that translated gave us obviously a very important set of information about the actual real world performance of the product and what we're seeing is that the product tracks extremely well compared to the approval study to the Felix study and in in when we look at safety and we look at efficacy actually it looks like we have a somewhat better safety profile and we may actually see even more activity from an efficacy perspective. On safety, we have seen that none of the patients experienced high-grade cytokine release syndrome, and only 3% of patients experienced higher-grade neurological toxicity, which is very low. This is different from any other CD19-targeted therapy in the space. In addition, we also saw that the complete remission rate, whether the CR or CRI, actually was above 90% in these patients. So a remarkable combination of very good safety tolerability with that very manageable product together with a very good outcome. And what was also important is we started to see that the product, when we looked at the patient composition, that we were seeing that the product got used in patients that were very difficult to treat, older patients. So we had seen a higher median age compared to other products in the space. We also have seen that patients with a worse ECOG status were actually included compared even to the clinical trials. So we could see that that very difficult 3D population was actually included in treatment and tells you something about the confidence level that the physicians have in the product and their ability to actually manage it. On the other hand, we also saw that about a third of the patients had a very low disease burden at time of inclusion, clearly being driven by the observation and the experience from our pivotal study that patients that have low disease burden tend to have very good long-term outcomes. So we saw kind of the branching at both ends. And so coming off that meeting, we had a lot of very positive momentum and that translated obviously in a lot of patients being registered and manufactured for. And we believe that actually that puts us in a very strong trajectory for the rest of the year. We're also seeing very continuously, a very continuous increase in prescribing physicians. As we're looking through these now for six quarters of the launch, we see very nice straight up line on physicians using the product. And that also gives us a lot of confidence that indeed we have the right dynamic with the product. And then maybe the final metric, we did actually mention or guide that we would expect about 80 centers to be onboarded by the end of the year. We're approaching 80 now by the mid-year point already. So all of those parameters really point to the fact that we're on good track to hitting the guidance that we've given.

All right, makes sense. You also recently launched Ocatzel in the UK, obviously a bit of a smaller market and probably won't be as significant in 2026, but how do you kind of think about the opportunity in the UK longer term and also other ex-US countries?

Right, so the UK was obviously important for us because it's the home market for the company. Product got invented here and also developed to quite an extent. So we have a very good level of awareness within the UK and was one of the few products that actually was deemed cost-efficient for the National Health Service and also was taken up directly into routine commissioning. So that gives us a very strong position to launch from, and we did start the launch at the beginning of the year. Population-wise, the UK is about 20% of the US. It's about 70 million people. The US, about 350 million. So you have the same kind of epidemiology that we have in the U.S. So in terms of the actual numbers of patients, it's just the ratio is the same that we're seeing in the U.S. So you have obviously about a fifth of the patients. One of the things which is attractive with the U.K. is that once the system decides to actually take on the product, there is actually a central decision-making process for patients to get access to CAR-T. Once that decision is taken, the physicians choose the product that they want to actually use then for the patients. But that actually, in terms of early adoption and adoption in general, actually is helpful. And we've seen that the level of use actually seemed to sort of be on a, compared also to also looking at other CAR-T launches, seems to be somewhat accelerated in terms of the adoption rate compared to the U.S. because it has this element of a more centralized assessment. Ultimately, obviously, the patient numbers are limited by the size of the population in the country. So in that sense, it is relevant and obviously gives us an added group of patients to add to the U.S. patients. With regards to Europe, we obviously have an approval in Europe, and we continue conversations with the various healthcare systems. Obviously, one of the things that we're are clearly very mindful about is that, you know, a launch in the EU has to or in EU countries has to make economic sense. And we're only going to launch actually where that is, where we can actually confirm that, indeed, there is a good economic case to do that. And so this is where the or the nature of the conversations that we're having.

Makes sense. I think it's pretty clear that OCADCEL is likely the third line kind of therapy of choice for BALL. How do you think about expanding the opportunity beyond the third line, whether that's into different indications or earlier lines of treatment in BALL or, I guess, other oncology settings? Right.

So what we're seeing with our cats, when you look at the label, the label actually doesn't separate by line. It is relapsed or refractory patients. So as of frontline relapse, once you actually relapse from frontline, you know, the patients are eligible for treatment in the second line and onwards. What we're actually seeing is a very significant level of interest by some of the key physicians in the field to explore the use of the product in the frontline setting. And the idea there is to actually look at an abbreviated frontline treatment with a definitive consolidation using Ocadsel. And the backdrop to that is that typical frontline treatment is 18 to 36 months, combinations of high-dose chemotherapies, together with immunologically active products like Blencital, as well as potentially inotuzumab, depending on the center and the type of patient. And then, obviously, depending whether you have Philadelphia or chromosome positivity or not, also, obviously, would have TKIs. And so, the idea is, however, that obviously that very long current standard of care comes with a lot of toxicity, and you have a not insignificant amount of treatment-related mortality that goes along with that. So shortening the exposure to this toxicity and getting to an early definitive treatment is obviously hugely attractive from a patient perspective to sort of actually have a much more compact treatment, but it may also actually avoid some of the toxicities that tend to build up over time as you continue to actually exposed the patients to toxicity in the therapies. And so those studies obviously are quite attractive. We have currently two studies that are ongoing and are looking at slightly different subsets of patients in the frontline setting. And there is a third study that is about to get started in Europe as well. And between the three studies, we basically have the full range of patients that you could expect in the frontline setting. And with that, actually generate a pretty substantial data set between those three studies. We expect that probably earliest data, I would expect by the end of 27, out of the initial, the first study that was up and running. And we expect, obviously, then more data to come over time. What we have seen in the past is that in acute leukemia that those types of studies quite often did actually find the way into the NCCN guidelines. And with that actually basically was including the frontline therapy for other therapeutics in the past as in a recommended form. And once the therapies were recommended it in that frontline setting, there was also an ability to actually get reimbursement for What the pharmaceutical companies obviously could not do is they couldn't actually promote and classically market the product in the frontline setting. But from a physician perspective, it was a possibility to actually treat patients and get reimbursement for patients at that earlier stage in the disease. In general, we believe that is a significant opportunity for growth. And we're also obviously are looking into potentially also considering a frontline study at some point in time. But for the time being, it's the ISTs that are underway. And I think we'll provide early information about the utility of the product in that setting.

Sure. Makes sense. And you also have the pediatric trial catalyst that's ongoing and that's reading out next year. What does the increase in market opportunity look like with the pediatric setting and how much of an additional investment would you have to make from kind of your current sales, manufacturing, et cetera, capabilities?

Right. So actually, the pediatric population fits extremely well with the adult activities that we have ongoing. And in essence, allows us to go instead from 18 years onwards, basically, it goes from zero to, you know, through the entire age range. And that's actually what a label would allow us to do is really get the full range of patients that actually would be treatable with the product. When we look at the centers, the centers have a certain level of overlap between the adults and the pediatric patients. But there is also specific centers that actually are specialized in pediatric oncology that are separate from the treatment centers that are adults. So there are a few additional, there's a number of additional centers that we'll need to add and onboard. That's going to be an activity we're certainly engaging, but obviously with the benefit of having established a very efficient approach here and obviously have the team to do that. From a manufacturing perspective, the added volume that we expect from pediatric patients actually is very easily fit within the current infrastructure. When we look at the overall population on just a relapsed refractory setting in total, we're looking up to, in the U.S., up to maybe maximally about 1,000 patients. that is starting to be impacted by some of the early or some of the results that we've seen in the consolidation that was coming out about a year ago. And so we expect that to sort of contract somewhat and we expect it to be in the 500 plus range of patients that are in that group. And that's going to be kind of the key population that we're going to be active in. There is obviously one other product that's active in that population. And so, it's going to be certainly a competitive environment for us to enter into. But what we do see with the product, and we've shared the phase one date at the end of last year at ASH, is that we have very significant levels of clinical activity. We're above 90% complete remission rate in the patients with a good safety profile. So, we believe that this is an attractive offering for physicians and patients.

Yeah, makes sense. Maybe moving beyond the oncology indications, as you're also looking into several autoimmune indications, maybe starting with lupus nephritis, which is the one that's currently in a pivotal trial, what are some of the evidence that you've generated from the earlier Carlyle trial that gave you confidence to kind of advance into the pivotal luminous study?

So what we've seen from the Carlisle trial, where we treated basically a refractory type of population with lupus, when we look at the patients, the majority of the patients we had in our trial were patients that had lupus nephritis. And in fact, all the patients that were reported on last year actually were lupus nephritis patients. They all had very significant slediye scores. So they had very significant, not just kidney manifestation, but overall manifestation of disease. We had a median that was somewhere in the range of between 17 and 19. So it's a very significant level of slediye scores that we had in these patients. And we saw massive improvements. When we look at it from a Doris response perspective, this is actually reducing the SLEDI scores all the way down, but then also getting the use of steroids to a level that was considered kind of physiological levels of steroids, so five milligram daily dose. And what that basically showed is that we had more than 80% of the patients achieve that the Doris response, which was quite remarkable. We also saw that out of the LM patients that we had 60% of the patients actually show a complete renal remission as well. So both of that actually showed very strong levels of activity. And we'll provide an update by the end of this year. And we expect to have obviously additional patients. We included patients that were adolescent and treated those. And we have a few more patients that we treated along the way. And then obviously longer-term follow-up, which is really critical to understand the longer-term outcome in these patients. We also started to see that indeed, we could properly reset the B-cell compartment, get basically complete removal of the B-cells. And then once the CAR T-cells were cleared, you would actually see the B-cells come back from an initially naive state, gradually differentiating, but not showing any signs of autoimmunity coming back.

With the Lumina trial, the primary endpoint, which you discussed briefly, is complete renal remission. What do you think is kind of the bar for success there?

We did communicate that the success rate was at 40% complete remission rate. And that is still at the level that, you know, the regulators felt were the right hurdle to take. It's in essence, you know, two times the activity level that you would get with a calcineurin inhibitor, as an example.

Excellent. And in terms of durability with the updated Carlisle data later this year, what do you think is kind of an appropriate duration of complete remission or DORIS responses?

I think what you want to see is that these patients actually are stabilized over time. And, you know, that you basically see that all the various components you had in the slediye spores actually are down to, you know, very low level. There's an element, depending on the level of renal damage, that you might actually still have an element of score in slediye. But really keep it low and actually sustained over time. And that's really what the objective is. And that's what we're observing, obviously, and we'll report on. But clearly, the fundamental difference that we see with this type of a therapy is it is a fundamentally different outcome from any other therapy that we have actually currently in the space. There's no therapy that gives you that level of depth of response and a sustained level of response going forward. And that's really what's at the heart of the therapy.

Yeah, I guess going along with that and kind of the growing landscape in LN and lupus in general, I guess, like, are there any advantages that you think being a commercial company already kind of helps to bring to the table?

So there's certainly a few elements here. There's one fundamental element, which is in the product profile, and that's kind of the immunological adverse events that obviously could be triggered by the therapy itself. And obviously, having demonstrated in acute leukemia in hundreds of patients that we do have a very manageable product, and in fact, not seeing any forms of neurological toxicity in these patients is obviously important. Other programs have started to see neurological toxicities, and clearly that is a kind of a type of toxicity that is not easy to manage and certainly would be a concern. We don't have that, so we have replicated the type of properties and features that we've seen in the oncology side. When we then look from an ability and maturity perspective, obviously it's an approved product. It obviously has a very substantial amount of data around it. It is commercially available. So there is a manufacturing base to it. We obviously have very high manufacturing success rates, even in acute leukemia. All of that obviously is very, very helpful in order to actually be able to provide a high quality product to the market. And then obviously the commercial presence, as I mentioned, we're going to be in more than 80 centers by the end of this year, obviously gives us already a strong footprint to actually build on, including all the infrastructure to actually manage this type of a product. So it's a big advantage because there's a lot of complexity in that. And it's always a complexity that we have not only actually established, but we have already been have a few years ability to perfect it before the launch of an autoimmune indication.

And you also have your phase one MS data readout from the Bobcat trial that's coming later this year. I know you've said it's not an efficacy readout, but maybe just touch on what kind of translational biomarker data that you're kind of looking to see.

Right. So the Bobcat study is obviously in progressive MS. And what we're looking to see is obviously the impact of the CAR-T treatment in those patients. The fundamental hypothesis is that the drivers of the ongoing progression in these patients are B cells and plasmoblasts that are located behind the blood-brain barrier and with that inaccessible to conventional drugs. What obviously the CAR-T therapy allows you to do is you have a product because it's a cell that can actually migrate through the blood-brain barrier and very efficiently be active in the central nervous system. We have ample of evidence and proof of that from the acute leukemia setting where many patients have leukemia in their brain, in the CNS, and we can show that the product is highly active there, and including actually having demonstrated the presence of the product in CSF and so on. So what we're looking for is we're doing obviously a very stringent test. This is probably the most active product that can actually get across the blood-brain barrier and be active there. What we're fundamentally testing is the biological questions, which is, are those B cells and plasmoblasts truly the drivers for the disease? And so what we're looking at is, from a cell perspective, the presence of our product, the expansion in the periphery, the presence in the CSF, that's one prerequisite. The second is we're going to look at any signs for reduction of antibody fragments in the CSF. These could be oligoclonal bands or it could be light chain to observe. We're also going to look at neurofilaments, so the presence of neurofilaments as a marker for basically cell destruction of neuronal tissue and with that release of the neurofilaments. And then there's obviously imaging that goes on top of that. So there's quite a range. And then outside of all of that, obviously, you're scoring the EDSS score, the clinical score for these patients. And you will obviously follow that over time to see whether, indeed, what's happening with the actual disease itself and whether you see ongoing progression or whether you see stabilization in these patients.

Perfect. And obviously, we spoke about a lot of different programs and trials. So maybe just give us a summary of upcoming catalysts and milestones for the next 12 to 18 months.

Yep, happy to do that. So as we go towards the end of this year, we're going to have an update of the Carlyle study for our SLE patients, longer follow-up, larger data set, which was planned for the fourth quarter. We're also in the fourth quarter. We expect initial data from auto-8 in light-chain amyloidosis. Those are two key pieces. And then we expect to have additional data presented through the rocket consortium on the real world experience with a capsule in the U.S. As we go into next year, we expect to have then first data for the Bobcat study and progressive MS in the first quarter next year, and then obviously more data as we go through the course of the year, and then are expecting by the end of next year, the full data for the pivotal study for the catalyst study in pediatric ALL, which is sort of the next pivotal study readout. and then as we go into 28 by mid 28 we just expect to sort of reach the primary end point for the lumina study in lupus nephritis yep awesome thanks so much christian it's been great speaking with you uh thanks everyone for listening in