Good afternoon, everyone, and thank you for joining the Jefferies Healthcare Conference 2025. My pleasure to welcome Christian Itin, CEO of Autolus today. Just a reminder, it will be a 20-minute presentation followed by five minutes of Q&A. Thank you. Thank you very much. Thanks for inviting us. Great to be back and fantastic to sort of see the activity sort of basically in competition with the ongoing launch. I appreciate you're all skipping lunch at some level, so thanks for joining. I'll be talking about where we stand with Autolus. We're focused on CAR-T cell therapies. We're a U.S. Nasdaq-listed company, so obviously look at our disclosures for the risk factors, etc. Where we are at this point in time, obviously we're focused very much on the launch of our lead asset, which is called Aucatzyl or OBE-cel. The product is being launched in the U.S. in patients with acute leukemia. This is the adult population. We also achieved approvals or received approvals in the U.K. and in Europe. We're in the process, obviously, of ramping up the launch. We have indicated at the beginning of the year that we're going to be in 60 centers active. We're now across that line, so we're in more than 60 centers active. We're looking to sort of really drive with the asset, not just in adult ALL, but also are driving into additional sets of indications. We've developed an end-to-end infrastructure, actually, for the supply of this product. The manufacturing facility is literally up the road here, about half an hour north of London, in a town called Stevenage, where we manufacture from. Our products start their journey at the clinical center in the U.S. The cells are collected there, get shipped fresh into the U.K. through Heathrow Airport, are manufactured here, tested, frozen, and actually sent back to the U.S. site to that particular patient where the cells came from. That full turnaround cycle actually works extremely well, with the facility being here in the U.K. One of the things that we learned through the pandemic while we were running our pivotal study is that actually the logistics through Heathrow and using long-range flights from the U.S. actually was more robust and more stable than we would have had with inter-U.S. flights, which typically, as we all know, particularly the second half of the day, become reasonably unreliable. It was quite remarkable. It's not something we expected, but something we actually learned that indeed being across the pond and having flights that actually have a preferred status and are typically going on time is a real advantage. We have several relationships with BioNTech, with Moderna, with BMS, and we're operating with a strong cash balance. Just a few words to Aucatzyl. Obviously, the product has a boxed warning, like all products that are looking at redirecting T- cells. There is obviously a significant level of disclosures around the safety profile of the product, and we'll talk more about that. The approval for Aucatzyl was based on a trial called the FELIX study, which was an open-label single-arm study, which had 127 patients actually enrolled into this trial. It is a very robust data set that we generated. We see two things that really stand out. One is a very high level of clinical activity in these patients. We have an overall remission rate of 77% in that study. We also had that very high level of activity matched with a very good and very well-manageable safety profile. When we look at these patients, we had 2% of the patients experience high-grade cytokine release syndrome and only 7% experiencing high-grade neurological adverse events. This is very different from any other product that was developed in the space with this type of a modality. It gives us an ability to really reach a large proportion of the patients, including elderly patients, which tended to be excluded from this type of an intensive therapy in the past. With that, just a few snapshots in terms of data. We're looking here at the data that we presented at EHA earlier this year. This is now based on 33 months of follow-up in this patient population. You can see here that indeed the product actually performs remarkably well. This is the overall survival curve that we're looking at. You can see there is a very nice plateau building, indicative that indeed we get a proportion of these patients into long-term remissions. Now, we can also look in terms of duration of response. We have now a median duration of response of 42 months, obviously giving us again that same picture that indeed a lot of the patients that actually achieve a response maintain the response over time, again giving us a very strong indication that with this product, as a single agent in this late stage of the disease, there's still a reasonable probability for long-term outcome. This is very different from what we've seen prior in the space. As some of you may know, I've been in this space and developing for quite a while. When we look at the launch, I think we're doing remarkably well. We've had just the Q3 numbers out. For the first nine months, we had $51 million in sales, which really gives us a very nice momentum. We also actually at this point have reached market leadership within the CAR-Ts that are sold for patients with acute leukemia. We are delivering, obviously, on all key aspects. I mentioned already the 60 centers that are authorized at this point. We have a very high manufacturing success rate. This has been a notorious challenge in the field because obviously we are manufacturing for each patient individually. Many of the launches had issues that products were out of specification. That is a problem for the physician. It is a problem for the patient, but it is also an economic problem because you do not get paid. Actually having a very high success rate is fundamentally important for the patient, but also important from an economic perspective. Obviously, when it comes to market access, the team's done a fantastic job making sure there's a high level of market access. In fact, we haven't actually had patients being turned down by insurers until now. This looks really positive. When we think about then the opportunity to expand the opportunity, there are several ways that we're looking at doing that. First of all, obviously, there's a lot of opportunity to grow the current indication where it stands. We see that we have about 15% of the patients that, or say 50% of market penetration before we launched our product from a CAR-T perspective. We're now in the centers we're active in at about 20%, which means there's a significant opportunity for growth within the indication we currently have the label for. That's a major focus for the company that we're engaged in. It basically requires two areas to focus on. One is the treating physicians, actually getting all the treating physicians at a center to actually use the product and use the product across the full range of the label. That is one key dimension. The other dimension is actually the awareness that the patients have for the product. Those are the key areas that we are going to be focusing on to really drive market share here. When we then think beyond that, the first element that we have here, and I will start bottom up, is that the investigators that have been associated with the program for a while are very keen to explore the utility of the product in a frontline setting. One of the fundamental challenges you have in acute leukemia is that these patients tend to get treated upfront with high-dose chemotherapy for a very extended period of time. We're talking 18-24 months. This is atrocious from a patient's perspective to think about what that does to you. Now, rather than actually continuing to do that and just extending that treatment, which is pretty much what we've been seeing over the last, frankly, 25-30 years happening, is to actually consider an option where you reduce the upfront amount of high-dose chemotherapy that you give and then go for looking to see whether you can actually do a definitive consolidation of the patients at an early stage into their treatment cycle and actually shorten the overall exposure. With that, avoiding over-treatment, avoiding the treatment-related adverse events that are occurring, but also the treatment-related mortality that we are seeing as you sort of see these extended therapies in these patients. In fact, we started to get an inkling for the importance of that in the ECOG-1910 study where Blincyto was added to the standard of care and just extended the therapy these patients received. Overall, the outcome was positive, but for the elderly patient, that actually was treading water. We had treatment-related mortality basically on the negative side, and we had the upside for being treated with Blincyto. Net-net, there was no benefit for the elderly patients. That shows you kind of where we start reaching the limits there. We need to change course. This is certainly one of the things that will be explored in the context and evaluated in the context of investigator-sponsored studies. What's also important that alongside the launch, what's happening, which is quite unusual, is that every patient in a 40-center consortium called the ROCCA Consortium, that every patient that receives Aucatzyl has actually been tracked. We actually have, as we're launching, simultaneous data collection of the real-world experience by the physician treating those patients. The first time we see a readout of that will be at ASH, and it's quite remarkable. The abstract is out, and there's going to be obviously more data coming. There will be updated data sets that will be presented as we go through the course of next year. It's very unusual to see that actually real-world collection alongside your product and the physicians talking about it and publishing about it. Obviously, the positive thing is very nicely replicating our clinical experience and remarkably differentiating to sort of the prior experience in the space. Now, moving beyond adult ALL, we're active in pediatrics. We're going to have data at ASH with the initial experience in pediatric patients, which include patients that are currently not eligible for CAR-T therapy. Those are patients with a high-risk profile. Based on the data, we have discussed an approach with the FDA to actually move towards a registrational package. That is based on actually including additional patients into this current study and with that going for a label that would also then actually expand from the adult population, which includes 18 years and older, now also would include now patients that are younger than 18 years. With that, get the full range of the patient. We also received an RMAT designation for that part of the product. The second area is really what we're doing on the autoimmune disease side. What's been quite astonishing when we look at the space is that we've seen some pretty remarkable data coming originally out of Germany, looking at getting a deep reset of the B-cell compartment and with that, a change of the course of autoimmune disease. The data were stunning because they actually were the first time that we could see that patients that are in very severe stage could actually transition to a state where they had no measurable disease. It looks like for many of these patients, that was sustained over time. We now have our own data that we've presented at ACR, and we're going to have an oral presentation at ASH that actually showed that behavior with very advanced patients and indeed be able to sort of get a very profound impact in these patients with a good safety profile. Based on that data, we're moving into the LUMINA study, which is a patient's population now, our patients that have lupus nephritis. These patients have very strong kidney manifestation of the disease. We're running a small study, which is designed for registration as well. This is a truly small study. It's about a 30-patient study. We're going to leverage, obviously, the safety data that we have from the product with all the oncology experience that we have that we can sort of use in this context as well. Aucatzyl or OBE-cel is actually the only product that is an approved product somewhere else that actually is being explored in autoimmune disease. I'm very excited about also the multiple sclerosis study. This is patients with progressive MS called the BOBCAT study. That study just started, but we have very significant demand on the patient side to get on the study, which has been very, very interesting to see. Looking to sort of expand and give us a broader indication space and really drive from there. Now, obviously, I already talked about why this matters in autoimmune disease. The mechanism, the safety, the depth of the reset of the compartment is important because what you want to get rid of are those B-cells that are autoreactive that are at the heart of driving these autoimmune diseases. Obviously, it gives us a very nice profile that we believe is nicely differentiated. This is just a few data points here. Obviously, the safety profile of the product in these patients is good. This is a small cohort of six patients. No high-grade CRS, no neurological toxicities, no significant infections. Very well tolerated from a patient's perspective, actually for most of these patients, frankly, not much to experience except that they start to actually feel amelioration of their symptoms fairly quickly. This is just a view here on some of the efficacy data on the left-hand upper side from your perspective. You see the SLEDAI scores. These are composite scores that look at the different manifestations of the disease. These are the different colors. The blue at the bottom is the kidney manifestation. What you see, the trend that we see fairly quickly, is that these patients are ameliorating. In fact, the manifestations outside the kidney manifestation actually disappear pretty much within a month in these patients. We see then, when we look at the other way of looking at the efficacy state, which is called the DORIS response, that the majority of these patients do get actually a DORIS response here, five out of six. We get, in terms of renal complete remissions, three out of six achieving that state in their very advanced stage of their disease. The opportunity is significant. Now, when we think about, of course, autoimmune diseases, some of those autoimmune diseases are truly large indications. We are not recommending using CAR-T for all of these patients. I think that wouldn't be the right way of thinking about it. What is important is that out of this large group of patients, there is actually a smaller group that has very advanced stage of disease with very significant impact in terms of their outlook, in terms of life expectancy, health economic impact, and so on. It is this smaller population which becomes refractory to standard of care, which is the population that we're targeting with our therapy. This is still about three times the size of ALL, just to give you one level of how we could think about this. Very significant opportunity for a very high medical need population. MS, quite similar again there. Obviously, it's the progressive forms of the disease. This is where our focus will be. Obviously, a much bigger opportunity, but also one obviously where we have to say at this point, we're in an exploratory study. This is frankly something that we need to actually prove that indeed we can actually get a differentiated outcome for these patients. But the medical need is very high, and so is the patient interest. Data that we actually are planning for the end of the year, obviously, there's quite a bit of data coming out at the ASH meeting. We're going to have several data sets, the two that I mentioned here, the pediatric data and the follow-up on the lupus data. But there is also an oral presentation where we compare the product features with long-term outcome, which is one of the oral presentations. Additional information related to the importance of the cells' persistence in oncology to drive long-term outcome as well. Obviously, we're starting up the pivotal study in lupus nephritis. There is a study also ongoing with a dual-targeting approach called AutoAid in light-chain amyloidosis patients as well. Those are just a few points. Where we are is we're obviously running through the launch. We've done well on all those aspects. I think we're moving well now into driving sort of the broader use of the product. The second is to sort of optimize the way we operate. We've obviously established now solid and stable production and supply. Now we are running through a process to really get efficient at it and to reduce cost per unit that we're actually producing. That's a big activity we're running. The third is we just went through is the opportunity to expand and create a pipeline in a product. Driving market share, improving margins, and expanding beyond ALL, that's the mission, and that's what we're engaged in. With that, I'm happy to take questions. In your reference patients, what's the percentage of patients who are having sufficient target expression of CD19? We haven't found to date patients that were not eligible for treatment. So the target expression was sufficient in all of these patients. The concern you're sort of what you're raising is obviously these patients can be exposed to Blincyto upfront, which is another CD19 targeting product. What we do know is that there are very small percentage of patients that might actually be selected out that could become target negative. And this also matches kind of the old experience that I've done when I still ran that program way back. So that was consistent, and it looks like this remains consistent. Yep? Concerning your cash position, do you have enough cash to run all the studies you are running currently? We're well positioned from a cash perspective to run the studies you've seen here. What that does not include is obviously getting the new indications launched. The launch cost actually would not be included, but the running of the studies is included in the cash position we have. With the uptake on your current product on the market, it's not enough to finance the next step of development? I think that is at this point, I think, remains to be seen. Obviously, we need to show that indeed we keep executing and we keep growing the market share. That is obviously what we are working on. We will need to see kind of what the trajectory will look like as we go through next year and 2027. Obviously, the start looks very positive, and I think we are on good track. You will see when you see the ROCCA data coming out that indeed the dynamic is not a surprise when you see the performance in the hands of the physicians. We are also obviously changing behavior. The physicians are actually changing what they are currently doing to a new therapeutic option. That takes a bit of time to develop. That's going to be an activity that we'll see impacting, I think, market share growth over the next two to three years for sure. All right. Any other questions? If not, then thank you very much for joining. Really appreciate it. Have a great day.