Good morning, everyone, and thank you for joining us for the H.C. Wainwright 4th Annual Cell Therapy Virtual Conference. My name is Emily Bodnar, and I'm an Equity Research Analyst at H.C. Wainwright. I'm pleased to introduce Christian Itin, Chief Executive Officer of Autolus Therapeutics. Maybe to begin, Christian, for those who are newer to the Autolus story, can you walk us through your CAR T technology platform and your lead asset, obe-cel or AUCATZYL 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 mimic the physiological way in how T-cells actually do attack and recognize cells and take them out. That physiological engagement is a very short one. It delivers to kill, then a rapid dissociation of the cells, 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. That has a benefit because it avoids cytokine release syndrome, 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. The focus with that, as a focus, we designed a product that actually has those properties, basically, it's a product that has a fast off rate which that allows us to disengage after the kill has been delivered. That really allowed us to create a very differentiated profile that we then actually applied in the field of acute leukemia. That's obviously where we got our first approval based on the FELIX study. It really gives us a very safe but also a very active product, with a very important long-term outcomes that we can actually see in those patients. Awesome. Maybe going forward with that, you gave the guidance for the year of revenues of $120 million-$135 million. What gave you confidence that you could achieve this goal in 2026, what steps have you been taking to ensure that you're achieving the quarterly growth? When we launched the product at the beginning of 2025, we did $74 million in revenue for the first year of launch. As we're launching the product, we had, independent of the company, data collected from the commercial patients by the ROCCA consortium, and that data got presented first at the first data cut at ASH, then a second data cut at the Tandem Meetings in February this year. The relevance is that basically what we see in the data cut that was presented at the Tandem Meetings in February was that about 60% of the commercial patients were actually included in that database. That translated, gave us obviously a very important set of information about the actual real-world performance of the product. What we're seeing is that the product tracks extremely well compared to the approval study, to the FELIX study. 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 a 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 and whether the CR or CRI actually was above 90% in these patients. A remarkable combination of very good safety tolerability with that, a very manageable product together with a very good outcome. 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 worse ECOG status were actually included compared to even to the clinical trial. We could see that that very difficult-to-treat 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 1/3 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. We saw the branching at both ends. 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. We believe that actually that puts us in a very strong trajectory for the rest of the year. We're also seeing 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. That also gives us a lot of confidence that indeed we have the right dynamic with the product. 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. All of those parameters really point to the fact that we're on good track to hitting the guidance that we've given. Perfect. Makes sense. You also recently launched AUCATZYL in the U.K., obviously a bit of a smaller market, and probably won't be as significant in 2026, but how do you think about the opportunity in the U.K. longer term and also other ex-U.S. countries? Right. The U.K. 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. That gives us a very good level of awareness within the U.K., 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. 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 U.K. is about 20% of the U.S. It's about 70 million people, the U.S. about 350 million. You have the same kind of epidemiology that we have in the U.S. In terms of the actual numbers of patients, it's just the ratio is the same that we're seeing in the U.S. You have obviously about 1/5 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. That actually, in terms of early adoption and adoption in general, actually is helpful. 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. 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 are clearly very mindful about is that a launch in the EU has to, or in EU countries, has to make economic sense. We are only going to launch actually where that is, where we can actually confirm that indeed there is a good economic case to do that. This is where the nature of the conversations that we are having. Makes sense. I think it is pretty clear that AUCATZYL likely the third-line kind of therapy of choice for B-ALL. How do you think about expanding the opportunity beyond the third line, whether that is into different indications or earlier lines of treatment in B-ALL or I guess other oncology settings? What we are seeing with AUCATZYL, when you look at the label, the label actually does not separate by line. It is relapsed or refractory patients. So as of frontline relapse, once you actually relapse from frontline, the patients are eligible for treatment who are second line and onwards. What we are 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. The idea there is to actually look at an abbreviated frontline treatment with a definitive consolidation using AUCATZYL. The backdrop to that is that typical frontline treatment is 18- 36 months, combinations of high-dose chemotherapies together with immunological active products like Blincyto, as well as potentially inotuzumab, depending on the center and the type of patient. Obviously, depending whether you have Philadelphia chromosome positivity or not, also obviously would have TKIs. 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. 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 expose the patients to toxicity in the therapies. Those studies obviously are quite attractive. We have currently two studies that are ongoing, are looking at slightly different subsets of patients in the frontline setting. There is a third study that is about to get started in Europe as well. Between the three studies, we basically have the full range of patients that you could expect in the frontline setting. 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 2027, out of the initial, the first study that was up and running, and we expect obviously more data to come over time. What we have seen in the past is that in acute leukemia, those types of studies quite often did actually find their way into the NCCN guidelines. With that actually, basically was including the frontline therapy for Autolus Therapeutics in the past, as in a recommended form. Once the therapies were recommended in that frontline setting, there is also an ability to actually get reimbursement for that. What the pharmaceutical companies obviously could not do is they couldn't actually promote, and classically market the product in the frontline setting. 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. We're also obviously are looking into potentially, also considering a frontline study at some point in time. For the time being, it's the ISTs that are underway, and I think will provide early information about the utility of the product in that setting. Perfect. Makes sense. You also have the pediatric trial CATULUS that's ongoing. 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 your current sales, manufacturing, et c, capabilities? Right. Actually, the pediatric population fits extremely well with the adult activities that we have ongoing. In essence, allows us to go instead from 18 years onwards, basically it goes from zero through the entire age range. 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. 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 engaged in, 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 the 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. We expect that to sort of contract somewhat, and we expect it to be in the 500+ range of patients that are in that group. That's going to be 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 there's going to be certainly a competitive environment for us to enter into. What we do see with the product, and we've shared the phase I data 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. We believe that this is an attractive offering for physicians and patients. Yep. 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 CARLYSLE trial, that gave you confidence to kind of advance into the pivotal LUMINA study? What we've seen from the CARLYSLE 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 we reported on last year actually were lupus nephritis patients. They all had very significant SLEDAI 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. It's a very significant level of SLEDAI 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 SLEDAI 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 of five milligram daily dose. 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 LN patients that we had, 60% of the patients actually show a complete renal remission as well. 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. 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 the bar for success there? We did communicate that the success rate was at 40% complete remission rate. Yeah. That is still at the level that the regulators felt were the right hurdle to take. Yeah. It's, in essence, two times the activity level that you would get with a calcineurin inhibitor as an example. Makes sense. In terms of durability with the updated CARLYSLE data later this year, what do you think is 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 that you basically see that all the various components that you had in the SLEDAI scores actually are down to 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 SLEDAI. Really keep it low and actually sustained over time, and that's really what the objective is. That's what we're observing, obviously, and what we'll report on. 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 the growing landscape in LN and lupus in general, I guess are there any advantages that you think being a commercial company already helps to bring to the table? There are certainly a few elements here. There's one fundamental element which is in the product profile, and that's the immunological adverse events that obviously could be triggered by the therapy itself. 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 type of toxicity that is not easy to manage and certainly would be a concern. We don't have that. We have replicated the type of properties and features that we've seen in the oncology side. When we look from an ability, a maturity perspective, obviously it's an approved product. It obviously has a very substantial amount of data around it. It is commercially available. 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 helpful in order to actually be able to provide a high-quality product to the market. 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. It's a big advantage because there's a lot of complexity in that, and it's obviously a complexity that we have not only actually established, but we have already have a few years' ability to perfect it before the launch of an autoimmune indication. Right. You also have your phase I 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 looking to see. Right. 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 plasmablasts 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, including actually having demonstrated the presence of the product in CSF and so on. What we're looking for is we're doing obviously a very stringent test. This is probably the most active product 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 plasmablasts truly the drivers for the disease? 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 the 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. There's obviously imaging that goes on top of that. There's quite a range. 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. 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- 18 months. Yeah, happy to do that. As we go towards the end of this year, we're going to have an update of the CARLYSLE study for our SLE patients, longer follow-up, larger data set, which is planned for the fourth quarter. We're also in the fourth quarter, expect initial data from AUTO8 in light chain amyloidosis. Those are two key pieces, and then we expect to have additional data presented through the ROCCA consortium on the real-world experience with AUCATZYL in the U.S. As we go into next year, we expect to have then first data for the BOBCAT study in progressive MS in the first quarter next year, and then obviously more data as we go through the course of the year. We are expecting by the end of next year the full data for the pivotal study for the CATULUS study in pediatric ALL, which is sort of the next pivotal study readout. As we go into 2028, by mid 2028, we just expect to reach the primary endpoint for the LUMINA study- Perfect. ...in lupus nephritis. Yep. Awesome. Thanks so much, Christian. It's been great speaking with you. Thanks everyone for listening in.