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Good day everyone, and welcome to Autolus Therapeutics first quarter 2026 financial results conference call. At this time, all participants are in a listen-only mode. After the presentation, there will be a question and answer session. To ask a question, you will need to press star one one on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the call over to the Executive Director of Investor Relations, Amanda Cray. Please go ahead.

Thank you, Carmen. Good morning or good afternoon, everyone, thank you for joining us on today's call. With me, our Chief Executive Officer, Dr. Christian Itin, and Chief Financial Officer, Rob Dolski. I'd like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding status of the ongoing commercial launch of AUCATZYL in the U.S. and U.K., Autolus manufacturing, sales and marketing plans for AUCATZYL, the market potential for AUCATZYL, and the status of clinical trials, development and/or regulatory timelines and market opportunities for obe-cel.

These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the investors section of our website. On slide 3, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We'll take questions. With that, I will turn it over to Christian.

Thanks, Amanda, and welcome everyone to our first quarter update. Moving to slide number 4, we had a very good first quarter, and we see nice traction building both in the U.S. and obviously in our early launch in the U.K. as well. In Q1, we had $26.2 million in revenue booked, and we do see a very nice penetration and deepening with the positive physician experience that was highlighted at the Tandem Meetings as part of the Cell Therapy Consortium presentation. Where we had approximately 60% of our commercial patients represented in that data set, and we had discussed the data at the full year update, which was given a few weeks ago and also was further analyzed and reviewed in the context of a KOL call we did in the early part of April.

When we look into the U.K., we do see very good start in the U.K. We have more than 10 centers already active. We're going very strong in the U.K. with regards to not only center onboarding, but also start to see early patients come in and actually become treated under the NHS access program. When we look into the 2026 overall outlook, we do see that we have a very nice continued momentum. We're currently from a perspective of U.S. centers already at around 73 centers and we're increasing beyond 80 centers by the end of the year. Our full year guidance is unchanged at $120 million-$135 million.

For the first time this quarter, we did see a shift to positive gross margin, which is important because obviously this is one of the key metrics that we're looking at during the course of this year, to start to actually see that the overall commercial base and our ability to ultimately drive a proper cash flow into the company, increase over time. First time positive gross margin, and obviously a lot of that impacted by, on the one hand, an increase in volume, but also operational improvements that we made to the overall operation of the company, but in particular, the operation of the manufacturing plant that we're running. This is where we are with regards to the overview from a commercial perspective for obe-cel.

Very good dynamic, and we believe very strong momentum as we go into Q2. With that, we're going to slide number 5. I would like to start on the right-hand side and just briefly talk about the journey that we're on with regards to moving the product to a place where indeed we have a profitable ALL business. The foundation was really laid during the first year of launch, and what we had to establish during that first year of launch is consistent and high-quality product supply and services so that we have a strong foundation, we serve our patients properly, and we can generate very strong outcomes in these patients.

You've seen all of that actually presented as part of the Cell Therapy Consortium's experience, which had more than actually almost all patients that were intended to be treated actually received treatment. We also did see that that treatment actually translated into a very positive safety profile with no high-grade CRS, only 3% high-grade ICANS, and more than 90% overall response rate in the patients. A remarkable outcome in the hands of the physicians in the real-world setting. We're also starting to see that we're already starting to see branching out of the patient pool into patients that actually are older, have more comorbidities, typically tend to be considered difficult to treat.

That's one expansion that we've seen, but also an expansion into patients that have a very limited tumor burden, and with that, obviously, what we have seen in our prior studies certainly have a good opportunity to sort of get a more pronounced benefit over time. We've seen an expansion already in terms of the patient pools. That is very important because based on that behavior, as well as the good safety profile, we do expect that that forms a very strong foundation, and we see that translate actually already in the first few months in 2026.

The second stage now, as soon as we actually had established consistent high-quality product supply and services, that is actually when we switched gears and really started to drive optimization, improve efficiency, as well as at the same time, obviously, increase the volumes that actually were driving through the overall operation. With that, have an ability to actually get our overall costs down for the products. We expect at the peak ALL business to be around 65%-70% gross profit margin, which gives us a very healthy business for the ALL side of AUCATZYL. The optimization we ran through obviously also was not just an optimization in processes, but also with that, obviously, we have run through a reduction in force at the company of 13%.

We also at the same time have driven up the efficiency that we're running within the operation. You'll see that in a very simple metric. We expect to produce twice as much product this year compared to last year with overall staffing that is at or below the levels that we had last year. That gives us a very clear understanding of why indeed these gross margins are moving into the positive and will continue to improve as we go through the course of this year. Overall, as once the one-time effect of the restructuring is taken care of, you'll see that pass through, Rob will talk to that briefly, we expect for 2027 a net impact of a savings of $15 million on an annualized basis.

When we look onto the development side and leveraging the exceptional profile that we now not only are seeing in clinical trials, but see it translated also in the real-world setting, we're obviously building on that set of properties into a range of additional indications. The first one, clearly to extend the treatment from the adult population into the pediatric population. We'll have the phase II expansion of the CATULUS study ongoing. Data is expected towards the end of 2027, and we have aligned with the FDA on the protocol design and support for potential registration.

The second study, obviously that is progressing well, we expect actually data during additional data towards the end of this year is the CARLYSLE study, where we have added additional patients, and we're also will have substantial more follow-up in that patient population. I think that will give us a very good understanding of the type of benefit that indeed obe-cel can induce in indications now beyond oncology, in this case, in a refractory form of lupus, systemic lupus. The next study that is actively enrolling is the LUMINA study, which is in lupus nephritis. This is the phase II study where we have agreement with the agency to based on this study aim for a registration in refractory lupus nephritis.

The study is active in certain countries in Europe as well as the U.S. We're expecting data from this study in 2028. Finally, the study that will get us into neurological diseases is the progressive multiple sclerosis study that we're conducting, which is the BOBCAT study. This study is continuing to enroll, and we expect initial data at the end of this year and then full data during the course of next year.

When we look a bit more broadly, we also obviously will have additional data collection through the Cell Therapy Consortium, which is actually continuing to collect information from patients treated with commercial product and actually starting to look at quite a range of questions related to the performance of the product and the properties of the product with a clear view from the real-world setting. In addition, this was also part of the KOL call that I referenced before, we're seeing investigator-sponsored studies starting that actually are looking at the use of obe-cel in a frontline consolidation setting, which is ultimately aiming to explore whether indeed an abbreviated frontline treatment might be possible. We're obviously very interested to see how the product performs in those settings.

We expect our investigators to report in upcoming conferences on their studies. With that, I'm at the end of the introductory remarks, and I will hand over now to Rob for the financial results.

Thanks, Christian. Good morning or good afternoon to everyone. It's my pleasure to review our financial results for the first quarter of 2026. I'll be referring to slide 8 in the presentation. Total net product revenue for the first quarter of 2026 was $26.2 million, compared with $9 million in the first quarter of 2025. This quarter reflects sales in the U.S. and our first quarter in the U.K. market, though given it is early in the launch, contribution from the U.K. was minimal. As Christian noted, we're pleased to shift to a positive gross margin during the quarter with $1.6 million, compared to losses in prior quarters in 2025. With the combination of increasing product revenue and our cost reduction initiatives that Christian mentioned that are underway, we expect the margin expansion to continue as we move forward.

Underlying that gross margin, cost of sales in the first quarter totaled GBP 24.6 million. That's compared to GBP 18 million for the same period in 2025. The increase primarily reflects costs related to higher AUCATZYL sales period over period. Our research and development expenses decreased to GBP 21.2 million for the first quarter of 2026 from GBP 26.7 million during the same period in 2025. This change was primarily due to a decrease in development activities, including clinical trial and clinical manufacturing supply costs, as well as capacity mobilization costs, mostly all related to obe-cel. Our selling, general, and administrative expenses increased to GBP 39.9 million for the first quarter of 2026, compared to GBP 29.5 million in the same period of 2025.

This increase was primarily due to salaries, other employment-related costs, and professional fees supporting commercialization activities in both the U.S. and U.K. In addition, this quarter also included one-time termination-related expenses related to the operational efficiency and cost reduction initiative that we announced last month in April. Loss from operations for the 3 months ending March 31st, 2026 was GBP 59.5 million, as compared to GBP 65.2 million for the same period in 2025. Finally, net loss was GBP 71.6 million for the 3 months ending March 31st, 2026, compared to GBP 72 or GBP 70.2 million for the same period in 2025. Our cash equivalents in marketable securities at March 31st, 2026 totaled GBP 229.4 million as compared to GBP 300.7 million at December 31st, 2025.

This decrease was primarily driven by net cash used in our operating activities. As Christian noted, we are reiterating financial guidance issued in January that we expect between $120 million and $135 million in AUCATZYL net product revenue in 2026, including contribution from both the U.S. and U.K. markets. Finally, based on our current operating plans, including anticipated AUCATZYL net revenues, we expect that current and projected cash equivalents, and marketable securities will be sufficient to fund our operations into Q4 2027. I'll now hand back to Christian to wrap up with a brief outlook on expected milestones. Christian.

Thanks, Rob. When we look at towards the end of this year, we have updates from 3 of our programs. We have the longer-term follow-up from the CARLYSLE study. We have initial clinical data from the BOBCAT phase I in progressive MS, and we expect to have initial clinical data from the ALARIC phase I study. That's the AUTO8 trial in light chain amyloidosis, which we're collaborating on with UCL also by year-end of this year. Full data expected for the BOBCAT study during the course of 2027. The pediatric phase II data readout is expected for year-end 2027. The LUMINA phase II data in lupus nephritis is expected in 2028. Those are the key updates and key milestones. With that, we're opening up to questions.

Thank you. As a reminder, to ask a question, simply press star one one to get in the queue. One moment for our first question. It comes from Gil Blum with Needham & Company. Please proceed.

Good morning, everyone, and thanks for taking our questions, and co-congrats on the progress. You're saying you're seeing some level of market expansion, older patients, maybe a bit, you know, patients for consolidation, that sort of thing. It didn't seem to change the guidance for this year. I'd appreciate your commentary on that, and then I have a follow-up.

Yeah. First of all, thanks a lot for joining, Gil. The dynamic we're seeing in the market is very positive. I want to see the dynamic obviously play out into the full aspect as we go through the course of the year. The guidance at this point, we believe is reasonable, and frankly no reason for us to change the guidance at this point. Also we'll keep monitoring the development, and if indeed we see a different trajectory, we obviously will update the market.

Thank you. Very helpful. As it relates to the LUMINA study, we just saw another registrational study come up again in lupus nephritis, kind of like in a similar line of therapy. Are you guys seeing any potential challenges in enrollment? I mean, it is a little crowded. Thank you.

Thanks, Gil. The population we're going after is a proper refractory population that are post the standard of care, which is based on B-cell depleting antibodies, as well as calcineurin inhibitors. That's a pool that's currently not served by the standard of care. You behold that. The trial size that we need to recruit is very limited. We're looking at a 30-patient trial. From that perspective, and also given that we're running the study both in the U.S. and outside the U.S., we believe we're in a good position to enroll the study. We're not worried about that.

Excellent. Maybe a last one on the multiple sclerosis. Can you remind us what level of data you think you may have in 2026?

The BOBCAT study, first of all, it's a dose escalation study, so we're starting at 100 million, and we have an ability to go further up. That's the basic design of the study. We expect to have initial information on the behavior obviously of the product with regards to safety, but also the cellular dynamics that we're seeing, which is important. You want to understand the ability of the product to expand in the periphery, but also look at the presence of the product in the CSF, obviously on the other side of the blood-brain barrier.

Then certainly we'll record the various types of markers that we have available here that actually monitor both either the inflammation, inflammatory state of the disease, as well as potential damage to tissue that you can monitor both with biochemical markers as well as with imaging. We'll have early data in terms of the behavior. Then I think as we look into next year, I think we start to have more data points that look at the actual disease scores and the ability, obviously, and frankly, any potential impact on disease scores going forward.

For that, you wanna have several data points and a longer observation time to make sure you're not actually monitoring potential placebo effects or other types of impact that you might have, given that part of those assessments are either physician or patient reported. Hard measures for this year, mostly on the actual behavior and safety, behavior from a pharmacodynamic perspective and pharmacokinetic markers, but also, then as we go into next year, looking into the actual disease scores themselves.

Thank you for taking our questions.

Thank you.

Thank you. Our next question comes from Simon Baker with Rothschild & Co Redburn. Please proceed.

Thanks so much for taking my questions. Two if I may please. Christian, I just wondered if you could give us a little bit more detail on the mechanics of the U.K. rollout. As I believe there are 20 CAR T centers that in principle could administer AUCATZYL. What's the cadence for rolling those out in terms of getting centers on board? How does this compare with the experience in the U.S.? Any color on that would be helpful. Then on the R&D expense, it was lower than expected in the quarter because of clinical trial activity. I just wondered if you could give us any more color on the evolution of R&D spend as the year goes on. Thanks so much.

Okay. Thank you. Thanks a lot for joining. With regards to the U.K. rollout, we actually see a dynamic that we think is at least as quick as what we saw in the initial phase in the U.S. It might actually be quicker. One of the things that is positive about the U.K. system is that the decision whether or not a patient would actually go on a CAR T therapy or not is actually centrally, essentially made, which actually accelerates decision-making. That's actually a benefit of the way that is organized rather than individual center by center, physician by physician decision that is normal in other healthcare systems.

There are elements actually that are allowing us to probably move even a bit faster than we were able to do in the U.S., and we see very positive dynamic, very positive messaging also right from the NHS. NHS gave, you know, there were interviews held at on television in the U.K., et cetera. There was quite a lot of presentations and work that the NHS itself did, actually, frankly, increasing the awareness of the product and the opportunity for this new treatment modality for patients.

I think from an awareness perspective, as well as from a drive perspective that we see in the center base and then the initial decision-making process or the internal decision-making process base, it will be in going through a single body to take the decisions, I think is actually very helpful, and we expect a good rollout here in the U.K. With regards to R&D expense, I think I'll start and then I'll hand over to Rob. I think what's important on the R&D expense, obviously there is some changes as we see our activity with regards to clinical trials. There, you know, as you transition from one trial phase to another trial phase, that usually, you know, slows down a little bit the involvement in that process. There can be some fluctuations.

Also if we look back into last year, obviously there was still quite a lot of work that was ongoing related to the longer term follow-up of the FELIX study. That actually, that work will be reduced over time as we're sort of obviously ramping up some of the other clinical activities. There are quite, you know, important trade-offs there that we have on actual clinical trial activity. The other area is really the mobilization of additional capacity at The Nucleus, which we're obviously kinda taking on as we're sort of ramping now the demand in the U.S. We also had some activity still ongoing during the course of last year. Those activities will substantially be reduced or are pretty much coming to a stop.

We actually have now an ability to obviously we'll have it, certain of those activities which are also R&D-related costs, as you mobilize the activity, will start to obviously be reduced, while at the same time we start increasing obviously our clinical trial costs. We expect all in all that there's gonna be very helpful trade-offs and also will keep overall that R&D expense at a fairly steady level. Rob, do you want to add anything?

I mean, the only additional thing I can add, Simon, I think Christian covered it really well. Another example I'd throw out there certainly was our pediatric study where it was at a stage where we had that kind of first cohort enrolled and was still active at sites. That was part of the data presentation that happened at the end of last year. In terms of getting this next wave up and going, where we're more in kind of a valley, and now we're in the enrollment for the expansion cohort. Certainly, as we start treating more patients, both in the clinical programs, even on some of the investigator sponsored trials that we have out there that Christian's mentioned, you will see more clinical supply-related costs that will come in.

This is going to kind of move, you know, kind of up and down a little bit. We are not projecting any significant add of infrastructure, et cetera, on the R&D side.

Great. Very helpful. Thanks so much.

Thank you.

Thank you. One moment for our next question. That comes from Salim Syed with Mizuho. Please proceed.

Great. Good morning, guys. Congrats on the quarter. Just one for us on the data that we're expecting this year, Christian, Rob. It sounds like for the MS, the more important data set's gonna be coming in 2027. I don't know if you sort of interpret the same way for ALARIC. I'm just trying to balance how important do you guys deem these data sets coming at year-end? Are we expected to get any sort of bogey or how you guys are deeming what is a successful outcome on these year-end measures? I'm just trying to balance that with just the cash runway here before Q 2027. Thank you.

Yeah. When we look at the nature of the MS study, obviously we're collecting data points on disease score. In order to actually get, I think, a good sense of the trajectory of the disease score, you need to have a certain amount of observation period. We obviously collect the data. We'll have an initial view on that. To actually make a strong statement about the trajectory that you'll see after, you know, a few months is probably not sufficient. I know there's a temptation to do that, and there's certainly, we see that sometimes in the market that that's being done.

We believe with those types of data points, you actually want to have a little further out, a view, and with that, I think get more stable data. On the ALARIC study, I think what we do have is, certainly initial good understanding of the level of activity we have in this disease setting. We haven't actually reported on that before. I think that should give us a good feel for the level of activity that we're seeing, and the impact we're seeing in these patients. I think that's certainly gonna be a data point that we're obviously, I think will be very helpful and will certainly from a read-out perspective, I think will certainly be interpretable, in a clear way.

The other aspect I think is also getting back to the MS program. I think one of the things to sort of be clear about is that the importance here is on the one hand, in the short for the data point at the end of the year, is the ability to demonstrate that indeed the product actually can be, you know, give us a safe product profile in these patients, which I think is very important for these patients. Also then actually have be able to actually show that indeed the product is active in the, in the CSF and with that in the central nervous system.

I think that actually is a key piece of the information and really goes to the foundation of the rationale for using the cell-based product because that allows us to actually get across the blood-brain barrier and with that have an ability for activity. Just as a reminder for some of you, if you haven't actually been able to listen to the KOL call, Lori Muffly did present one of her patients that had explosive ALL or filled up bone marrow, the disease strongly and frankly intruding into the brain and into the CSF. Frankly, putting pressure onto the spine directly leading to the patient becoming paraplegic.

What she described is that she treated the patient with obe-cel, which she thought was the only treatment she could give the patient that would be actually safe enough. What she was seeing is that the patient, within 28 days, had actually the leukemia taken care of MRD negative in the periphery, but also obviously clearance in the CNS and the patient actually recovered mobility and control over her body. That tells you a lot about the ability of the product to cross the blood-brain barrier, to be very active and remove CD19 positive cells, in this case, obviously leukemic cells in the brain, to a point where indeed there is massive improvement that could be seen in the patient.

That's really at the heart of the feature, which is unique to this type of a therapy, and that's really what we're building on for the BOBCAT study in progressive MS.

Okay. Got it. Thanks, Christian.

One moment for our next question. It comes from the line of James Shin with Deutsche Bank. Please proceed.

Hey, good morning, team. Thank you for the question. I appreciate obe-cel achieving positive gross margins this quarter. Intending obe-cel's top line growth and, you know, with the risk in place, could we see Autolus becoming profitable on a company level basis by, say, late 2027? Second question, between Besponsa and Blincyto, is Blincyto the main bridge before patients receive obe-cel? Does the bridging then duration tend to align with obe-cel's manufacturing turnaround time? Thank you.

Thanks, James. Very good question. The first related to kind of the trajectory for the ALL business. What we're projecting for the ALL business is that we're going to cross the line to profitability in the ALL business in 2028. Whether or not the company will actually be profitable at that point also depends on the reinvestment rate that we'll have in the upcoming one and a half years towards that time point. That's going to be the key driver, whether or not we're going to be, you know, can be profitable as a company or not by that time point. As an ALL business, we expect to cross that line in 2028.

With regards to the bridging therapies that are employed for obe-cel, typically you would use for bridging either chemotherapy or inotuzumab or Besponsa. You would not use Blincyto. The reason for Blincyto is this is when a treatment, when you start it should go for, it's basically a continuous IV infusion for four weeks, which is actually longer than the manufacturing turnaround time for these patients, and that actually wouldn't make sense. We don't actually see the use of Blincyto for bridging in with our product. It's mostly driven by chemotherapy and/or inotuzumab.

We continue to the next question. It comes from Matthew Phipps with William Blair. Please proceed.

Thanks for taking my questions. I guess could you maybe characterize a little bit of the growth that you've seen this quarter? Is it from greater utilization at current centers? You know, you mentioned expansion to older patients. Or is it mainly expansion into new centers? I guess what percent of the market do you think you'll have covered when you reach the 80 centers by the end of this year? Thank you.

Thanks, Matt. When we look at the growth, we see that actually, given that we already have 73 centers on, and when you compare to beginning of the year, we were at about 65. The majority obviously comes from the centers that were already active. That's where you see the repeat use and you see that build up. The new centers obviously gradually build on, but their initial activity is gonna be limited. There's gonna be 1 or 2 patients, initial experience gained, that eventually translates further. We see a lot of good positive momentum out of the centers.

One of the metrics we're looking at is also not just the centers themselves, because when you look into the centers, what you do see initially is that typically it's a small number of physicians that might actually use product. What you really wanna do is you want to see actually the group of physicians using the product increase per center. One of the metrics we're looking at is obviously the physicians that are actually using the product, and we actually see very nice progression in terms of the numbers of physicians using the product and have actually dosed a patient. We kinda track that as one of the key metrics, and you clearly see that dynamic. For the most part, that expansion actually is within the centers we're already active in, and we're starting to see broader adoption.

That's really how ultimately you will build market share. It's the use of the product by most of the physicians at each given center across the range of the indication of the label. That gives you really the ability to grow that market share. Overall, we do believe we see very good dynamic in terms of increasing the market share, obviously, as we're going forward. Based on just our guidance, you would expect that we would have a substantial increase in the overall market share that we're projecting obviously for 2026, and that's the guidance we have reiterated.

One moment for our next question, please. It comes from Emily Bodnar with H.C. Wainwright. Please proceed.

Hi, thanks for taking the questions. Maybe a follow-up from the prior question. Can you kind of comment on what contribution U.K. revenue had on growth in the first quarter and how you're kind of expecting that to play out for the remainder of 2026? Maybe on the data update for SLE and LN later this year, if you can kind of talk about what level of durability you're hoping to see in the updated data, and also response rates for the 100 million dose. Thanks.

All right. Thanks a lot, Emily. Thanks for joining. For the U.K. sales, given that the U.K. is obviously a fraction of the size of the U.S., we decided not to actually break out U.K. sales numbers. Certainly initially in the launch because it frankly doesn't make much sense. It is too early in the process. We expect to break it out likely towards the end of the year. For the first quarter, that doesn't actually make much sense at this point because obviously a lot of the patients would roll in. You start to produce initial products, then you start to actually see the momentum translated into the actual sales numbers.

With regards to the LN update, obviously we have patients that will have about 12 months or more follow-up in terms of the initial cohort. I think that is going to be very meaningful because it tells us a lot about not just the initial safety and the initial reset, but then also how the B cell compartment sort of reconstitutes over time. With that then also, the ability to see sustained response in these patients going forward, which is one of the key elements and metrics that we're looking at. Obviously for the other patients, which include higher dose cohort, as well as adolescent patients, we're obviously going to have a limited follow-up.

That's going to be mostly around the initial response, the safety, the initial response, and you know, initial kind of recovery of the B cell compartment. Obviously, that will have a limited follow-up compared to what we will have for the first cohort, where we're going to be certainly beyond the year of follow-up.

Great. Thank you.

Thanks, Emily.

One moment for our next question. That comes from Jacob Mekhael with KBC Securities. Please proceed.

Hi there, thanks for taking my questions. I have a few, if I may. First of all, just on the gross margin, you mentioned in one of the slides earlier that you expect it to be 65%-70% at peak. Curious, do you plan to provide peak sales guidance at some point in the future? When would be the right time to do that in your view? That's the first one. Maybe I have a follow-up on the, on your agreement with Cellares Corp for the manufacturing. Is there a timeline by which you need to have a formal agreement in order to incorporate that into the new manufacturing process for the clinical program in autoimmune?

All right. Well, first, thanks for joining, Jacob. First, with regards to the gross margin reference and peak sales, I think what we have been pointing out with regards to the overall opportunity in the relapsed refractory setting in the U.S. is that we have approximately 1,600-1,800 patients. We have seen certainly with other agents before that you can get with a good profile up to about 60% penetration, which we expect, or market share, which we expect kind of the upper end of the range is in the relapsed refractory setting. That's kind of where we are and I think where we sort of see the opportunity.

I think to guide towards, you know, a more formal peak sales, I think that's premature at this point in time. I think it gives you a good understanding of kind of the overall size of the market and the overall opportunity that we're sort of identifying for the product. With regards to the Cellares timing, we're in the midst of a feasibility study. We want to understand where the product actually produced on that technology platform versus the platform we're using at The Nucleus today, how the products compare. That's a key analysis that we're running. That's what we're really going to be focusing on this year. If that data turns out positive, that's when I think the timing, the time point to actually take the next steps.

In terms of being in time, we believe that the key area where I think that technology I think could be attractive to us is if we're sort of getting to a step change in the need for product. We believe that that step change certainly could come from an indication like progressive MS. I think that's sort of where we're looking to sort of actually work through and make sure that we have an option there that would allow us to actually scale production in a, in a, in a reasonable and economical way as well. That's sort of where the frankly, the elements that are being connected.

For this year, it's really around making sure we get the clear data from the feasibility, and our understanding that, whether this, the quality of the product we're getting actually is comparable.

Okay. Thank you.

Thank you.

Thank you. Our next question comes from Roger Song with Jefferies. Please proceed.

Hi. Good morning. This is Fiona on for Roger. Thanks for taking our questions. Just a couple from us. On the AUCATZYL revenue, how should we think about the near term and long term growth driver and any active measures you're taking to further deepen the penetration in the U.S. versus ex-U.S. dynamics? Just another one. Understanding that you're gonna switch to a positive gross margin from this quarter, do you see any further optimization needed moving forward? Do you want to see the impact of the cost reduction play out? Thank you.

Thanks a lot, Fiona. First on with regards to the revenue drivers, clearly there's two key elements here. There's getting to, you know, a large percentage of the patients that you or the market you can cover in terms of access, patient access to centers. We believe that we're in this 80 plus center range. We're getting to, certainly in the range of 80% of the patients that we can actually cover from that perspective, which I also believe is an add-on answer to what Matt was asking as well before.

What really drives the ability for the drive the market share up, and this is in any jurisdiction that you're active in, is really getting the physicians, at a given center to use the product consistently, gain experience and gain confidence. With that, starting to use the product in the first place for typically, a limited number of patients, which is sort of typically patients they think they cannot serve with the standard of care that they have experience with. Gain experience with the product. Then actually, start to apply the product much more widely across the full range of the label. We've seen that play out actually during clinical trials, we see it play out also now in the, in the, in the marketplace as well.

That is really what drives ultimate the market share, is the conviction of the physicians that this product, actually allows you to treat a wide range of patients. Again, Lori Muffly made these types of comments actually also at the call that we had organized. What she was talking about is the ability to actually have an option with a CAR T that irrespective of modality, actually gives you a safe way of treating patients and actually allows her to treat patients she would not have even considered treating before. That was actually not a differentiation between CAR T products, but across the range of product options and modalities that she has available.

That's kind of an expression of that level of confidence, and I think that is where we see, I think the biggest growth is for physicians to get to that place. That's also where the ultimate decision-making resides is obviously with the physician. The patient receives the product once. It's a one-time experience for the patient. It's a repeat experience for the physicians, and that's what's really, what's your foundation and what's really driving this. This is true whether this is in the U.S. or it's in the U.K. or elsewhere. With regards to the opportunity to sort of expand beyond the U.S., obviously, we're active in the U.K. at this point. We continue conversations in Europe, and we're navigating, market access and MSN topics in Europe, and obviously, we need to make sure we get to reasonable places there.

At this point, we're not guiding for European sales. We're obviously approved. We continue those conversations, and we'll certainly, once we actually are, you know, get through market access in first European countries, we'll obviously inform everyone on that. This is an ongoing process, and they're certainly somewhat delicate also with the policy changes that we see across the board that we need to take into account.

Very helpful. Thank you.

With regards to optimization. The final question I think you had was on optimization. Actually, optimization, certainly from a manufacturing process, is a continuous process. It's not just a one-off. We made some very significant changes in our operating model that are now implemented, and we continue to improve as we go through literally every step along the way of the manufacturing process. What we're really aiming for is to make sure that the hours of work that go in to produce every single product can be minimized. It's really a drive to minimize the work spent per product. At the same time, obviously, we want to reduce the overall contribution from the fixed cost, and that particular aspect is driven by the volume of products you run through the facility.

Those are the two key metrics that actually are driving ultimately your cost down per product. One is the total volume, and with that, the reduction of the fixed cost allocation and then also a reduction of a reduced number of work hours per product. That's really what we're driving at, and we'll see a very significant steady impact as we go over the upcoming probably two years.

Thank you, Christian.

Thank you.

Thank you. Our last question comes from Shyam Kotadia with Goldman Sachs. Please proceed.

Thank you for taking my question. Just 2 from my end. On the gross margin that reached positive this quarter, how should we think about that cadence for the rest of this year? Should we expect a steady improvement? What is your target gross margin, I guess, for full year 2026? Also on that peak margin you mentioned, when are you expecting to reach that? That's the first one on gross margin. Then the second one on multiple sclerosis. I know it's early, but just wanted to see if you guys could provide any color on your commercialization plan there. Are you planning to go at this yourself, or would you look to a partner or in-license for this indication? Thank you.

Thank you very much. With regards to the gross margin, we expect to actually see continuous improvement of the gross margin as we go through the course of this year. We obviously have implemented significant improvements in the operating model in the first few months this year. They will start to actually have impact in terms of the cost as we get through the remainder of the year. I think we'll see sort of an increased impact over time. At the same time, we'll see obviously, and we expect an increase in terms of the volume of product that we're running through the facility as well. Those two parameters will actually be supportive to really see a continuous improvement of the gross margin.

We haven't given guidance on where we expect to be by the end of this year. We're obviously It's a metric that we continuously will report, and I think you'll start to get a good understanding and feel for the dynamic as we go through the next few quarters. That's the first part of the question. The second is, when do we expect peak typically to get through to peak sales in indications like ALL, that's probably taken between 4 and 5 years.

The main impact that you will see from a gross margin perspective is likely gonna be somewhat earlier because if you get to a certain level of volume of product you run through the facility, the amount of improvement you get on the fixed cost contribution obviously becomes limited. You're running an asymptotic line. Obviously, the big gains that we expect on productivity and with that reduction of labor cost, is expected to happen actually during the course of this year. Then there may individual elements where we might actually introduce particular improvements on technology that can actually then lead again to a step change.

Those will not be, those obviously will take time and will not be in a straight line, but obviously will then give us sort of individual discrete steps that we expect to see. For the time being, I think most of it is really just the actual improvement on the work hours and the impact of the changes in the operating model, which will likely have the single biggest contribution that will be made through that. There are a number of much smaller initiatives that over time will add to that. With regards to the MS commercialization question. What we're seeing in MS is obviously a population of patients. First of all, it's a much larger population.

They're much more distributed. They're also, it's also a patient group that's extremely motivated, and we see that also even in the conduct of the clinical study. We see even a different dynamic, even to acute leukemia, where you know this is a disease that can actually and quite likely may kill you. There's just still actually a higher degree, I think of in, I think of dynamic that we're seeing with MS patients. That is sort of one side of the equation. There's the sheer volume question in terms of if you have some product that actually impacts these patients, it's a very substantial patient population.

From that perspective, it does make sense to consider, certainly a commercial approach where you would operate in collaboration with a partner, and that is certainly one of the areas that we are exploring.

Thank you.

Okay. Thank you very much.

Thank you. This concludes our Q&A session for today.

Very good.

Thank you so much.

Thanks, everybody, and have a great Q2. We're looking forward to keeping you updated at the various conferences during the quarter. Thank you.

Thank you for participating in today's conference. This concludes the program, and you may now disconnect.

Good day, and thank you for standing by. Welcome to the Autolus Fourth Quarter 2025 and Full Year 2025 Financial Results Conference Call. [Operator Instructions] Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Amanda Cray, Executive Director of Investor Relations. Please go ahead.

Thank you, Kevin. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me are Chief Executive Officer, Dr. Christian Itin; and Chief Financial Officer, Rob Dolski. On Slide 2, I'd like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding status of the ongoing commercial launch of AUCATZYL in the U.S. and U.K., Autolus manufacturing, sales and marketing plans for AUCATZYL, the market potential for AUCATZYL and the status of clinical trials, development and/or regulatory time lines and market opportunities for obe-cel and our other product candidates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the Investors section of our website. On Slide 3, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We'll then take questions. With that, I'll turn it over to Christian.

Thank you, Amanda, and welcome, everyone, to our Q4 and full year update. As we have communicated in January, we had a very good first year of launch with AUCATZYL in the U.S. with $74.3 million in revenue recognized in 2025. By the end of 2025, we had 67 centers activated and are building on positive physician feedback and reliable high-quality product delivery for our second year. We are reiterating our guidance for 2026 with net revenue of $120 million to $135 million, a shift to positive gross margins in 2026 and increasing our commercial footprint, targeting more than 80 activated centers by end of 2026. Regarding gross margins, larger volumes will drive down fixed costs and improvements in the operating model will reduce variable cost per batch. By the end of 2025, we had also achieved regulatory approvals in the EU and in the U.K. and achieved market access in the U.K. and have initiated the launch at the very beginning of this year. On Slide 5, alongside the launch in the U.S., the ROCCA Consortium, which stands for real-world outcomes collaborative of CAR T in Adult ALL, collected data from all patients treated with AUCATZYL within participating institutions. Overall, 96 patients were apheresed. Of those, 91 actually achieved the infusions. And 5 patients did not receive an infusion due to medical reasons, either due to progressive disease or a combination of progressive disease and infection or a lineage switch of the disease and loss of CD19. Of the 91 patients that received the dosing, both infusions were received in all of those patients. And by the time of the analysis at the beginning of this year, 84 patients were evaluable for a day 28 assessment for response. The median follow-up is obviously relatively short because this was the first year of launch. So the median follow-up was 137 days from first CAR T cell infusion. Moving to Slide #6. What we're seeing in terms of the outcomes, we're looking here at both the outcome of the ROCCA Consortium in the real-world setting, and we actually juxtapose our prior clinical trial experience in the FELIX study. What is worthwhile realizing that the 96 patients that were actually collected in the database approximate about 60% of the U.S. commercial patients that were treated during the course of the first year of launch. When we look in terms of the patient population, we do see that we see a wide range of age with a median age of about 50 years comparable to what we had in FELIX and a very wide range, including patients that were very much on the elderly side already. Now what was very encouraging was to also see that when moving to the real-world setting that we actually were able to maintain the safety profile that we have seen with AUCATZYL or obe-cel in the FELIX study. So the real-world observation was from a CRS perspective, from a cytokine release syndrome perspective, is that about 59% of the patients had a cytokine release syndrome of Grade 1 or Grade 2, but no patient experienced a Grade 3 or higher cytokine release syndrome. Similarly, when we're looking in the -- on to the ICANS side, we had 17% of the patients that experienced Grade 1 or Grade 2 ICANS and only 3% experienced Grade 3 ICANS in this -- in the real-world setting. When you then look at the -- and compare that to the FELIX experience, you do see that, that actually does translate very well. We had in FELIX on CRS, a slightly higher level overall of cytokine release syndrome observed. And we also had a small proportion of 2% of the patients with high-grade cytokine release syndrome. And similarly, on the neurological toxicity side on the ICANS, we had in the FELIX study, 23% of the patients experiencing ICANS and about 7% experienced high-grade ICANS. So overall, a very nice reproduction of our clinical experience now in the actual real-world setting. Now when we look at the efficacy side, obviously, this is early data. So the -- what was available is the tumor assessment at day 28. Further data may become available at later time points, but that is what so far has been analyzed and what was presented at the ASGCT meeting in an oral presentation this year in Salt Lake City. What you see is, again, on the left-hand side, the data from the real-world setting. And you can see that overall, we have about 92% overall complete remission rate in the real-world setting, which actually is quite similar to what we've seen overall from a picture perspective with the mature FELIX data at 3 months, and it looks somewhat improved over the day 28 assessment in the FELIX study. But this, again, is a very nice, I think, confirmation of the data and the observations we had in our clinical trial now in a real-world setting and in patients that were obviously now treated in the normal standard of care environment that obviously at times can differ from clinical trial environments. So what is important is, obviously, the data is very nicely aligned with what we have prior observed. Very nicely corroborating the data that we have presented in the past. But what we also do see in the patient population that there is also a wider range of patients included from a tumor burden perspective, as you would expect in the real-world setting, where once you have evidence of disease coming back, you wouldn't wait treating the patient until the patient had high disease burden, but you would intervene at an earlier time point. It's reflective of the actual standard of care that we're seeing in the disease setting. So very encouraging observation of the first year. I think for us, quite a remarkable coincidence that indeed it was -- the Consortium was ready to collect the data practically from day 1 that we were able to make product available. And with that, get a real-time view of the performance of the product, both from a manufacturing, from a supply perspective, but also from an outcomes perspective. So with that, I'd like to move to Slide #7. And just a brief word on the overall activities that we have, in particularly around obe-cel oral capsule. Obviously, we have now a very strong foundation in the Adult ALL segment with our first label and the product in the market and performing well in the market. And we're now obviously building on that to actually broaden the utility of the product across a range of additional indications. And obviously, one of the first indications that is natural -- it's very natural to add is actually to aim for an ability to offer the product across the entire age range within acute leukemia. And hence, we started the work on the CATULUS study, and I'll briefly show you the data in the upcoming 2 slides. But what we're doing with the CATULUS data is really looking to actually get a data set that allows us to also get to a label for pediatric patients. We had started with a Phase 1 data set, which was presented at ASH just at the end of last year. And based on that data and discussions with the agency, we agreed on a path to expand the study and with that expanded study should have the data as a pivotal study to support a future label in this particular pediatric population. The second study that obviously we've been very active in, and we also reported data on at the end of last year, first at ACR and then in an oral presentation at ASH is the first experience that we gained in the autoimmune setting, and this is in systemic lupus with very advanced patients. It's the CARLYSLE study. This is a Phase 1 study where we evaluated the activity of the product and the safety of the product in this group of patients. And we have reported initial data based on that data and also interaction with the agency, we designed then the LUMINA study, which is focusing on lupus nephritis patients that are advanced patients, and we're in the process of actually enrolling that study. So that study is off the ground and running. And we expect data in 2028 for the lupus nephritis population. We have alignment with the FDA on the design and also as the design as a pivotal study to get us to enable the approval of the product if the data obviously can be generated. In addition, we're looking at progressive MS as sort of an exploratory study. That's a Phase 1 study called the BOBCAT study, which is currently enrolling. We treated the first patient in October last year. So that's enrolling, and we expect to have full data for this Phase 1 experience during the course of 2027 and hope to have early data by the end of this year to get a first view. Overall, when you look at the flow from the pivotal study perspective, the pediatric ALL study, we expect to have data by the end of 2027. The LUMINA study, again, pivotal data in '28. And in '26, we expect, obviously, a longer-term update and data update from the CARLYSLE study, which is planned for the end of the year. Now in addition, there are additional opportunities that we see with the products that we actually have obviously, on the one hand, a continuation of data collection that we expect to see from the ROCCA Consortium and sort of more of that experience being frankly, collected and analyzed in their hands. And then on the other hand, there is a substantial interest for investigator-sponsored studies with a particular focus on the opportunity in frontline patients to see whether you could actually develop a definitive consolidation and have data in that -- from that -- in that space to see whether indeed there is activity in that early setting as well. So there's quite a lot of interest, obviously, to explore a broader opportunity base here for the product. And also when we look at our internal studies, I think a very nice news flow as we go through '26 and '27 into '28 with very meaningful data updates and hopefully, data sets that will enable a broadening of the opportunity commercially as well for the product. With that, I would like to actually, on the next 2 slides, briefly summarize the data that was presented at the ASH conference for the pediatric experience. These are all relapsed/refractory patients. And I would like to start on Slide #8 with just a brief view on the safety data as it was presented at ASH. And what you can see when you go through the safety data set is you see this is consistent with what we have seen in the adult population in terms of immunological toxicity infection risk as well as neutropenia, which is very well characterized in this population. When we then go to Slide #9, what you can see here is a swim plot. First, I think, to observe is that, in fact, almost all patients managed to actually achieve a complete remission, either a CR or CRi. Overall, we do see that it was a CR/CRi level at the 95% level and the CR level in just around 91% of the patients. So clearly confirming the very high level of activity, consistent, obviously, with what we're seeing in the adult population as well. And we start to see a good duration of responses, as you sort of see the swim plot here in front of you. Obviously, the follow-up is still relatively early in this population. We have a median follow-up of 8.8 months. With that, I'd like to just briefly look on Slide #10 on how we're actually moving forward on the pediatric side. So we have decided to add an additional 30 patients for the Phase 2 portion of the study. It's an international study. So we have centers in the U.S., U.K. and in Spain active. We have developed the approach in collaboration with the Children's Oncology Group, the key group for pediatric oncology in the U.S. And in terms of the age range, we include patients between 0 and 18 years of age. You remember that our label in the U.S. is 18 years and older. And we have stipulated a minimum body weight, to 6 kilogram. Remember, the way we dose in pediatric patients with a single infusion with 1 million cells per kilogram. In terms of the population that we're including, obviously, these are relapsed/refractory patients, and we have a particular focus on the patients that have in the first line, a high-risk relapse and that -- first -- sorry, first line high-risk relapse population, which is actually populations currently excluded from access to CAR T therapy. I want to make sure there's an opportunity also for those patients to benefit from CAR T therapy. And hence, we're including that population in addition to obviously the broader range of relapsed/refractory patients. So this is where we are on the pediatric ALL side. As I mentioned, we expect to have data by the end of 2027. Moving to Slide 11 and the advanced SLE population that we have studied in the CARLYSLE study. We have determined the recommended Phase 2 dose in that study, which is a 50 million single infusion after the dose. When we look at the patient population that we have in the Phase 1, it was patients that had to the large extent, significantly impaired kidney function as well as quite a wide range of additional manifestations of autoimmune disease that you would actually then see represented in the SLEDAI-2K disease scores. And in fact, we're having overall a population with very high levels of disease scores, which obviously represent a very challenging to patient population. We have now 11.4 months of follow-up in the 50 million cell dose cohort. We achieved in 5 out of 6 of those patients, a DORIS response, achieved in 3 of 6 a complete renal remission. The product was overall well tolerated. We saw no ICANS and we had no high-grade CRS in these patients. And we start to get a good feel for some of the key biomarkers. And just to give you just a quick snapshot on the data, if you go to Slide #12. This is actually from the actual ASH presentation and starting on the left-hand upper side, the summary of the safety data. Obviously, the key there is overall very good, very well tolerated product and minimal immunological toxicity that we have picked up in the form of CRS and ICANS. Below that, you see the SLEDAI scores. You see in different colors, the different manifestations of autoimmune disease that are shown on the legend on the right-hand side of that panel. And you can see that these patients do improve over time. The blue color that you see is actually the renal scores in these patients. And obviously, some of these patients already had very advanced, very challenging disease. If we go to the right upper panel, you do see kind of a depiction of the DORIS remissions. And you see that 5 of the 6 patients actually converted into a DORIS response. The DORIS response actually looks at both the manifestation of the disease as you would actually have it depicted in the SLEDI score. So you need to have the SLEDI score improvement. But you also want to see that the patients are getting down to low levels of corticosteroids of no more than 5 milligrams per day or less. And so it is both a measure, obviously, of the improvement overall, but also the fact that, that is now a state that the patients are in where they get what's typically referred to as physiological levels of steroids. Now at the bottom on the right-hand side, we see basically took a look at both the persistence and the recovery of the B cell compartment. When we look at persistence, we do see that the median persistence is 3 months for the product. And when we look at the time to recovery, the median time to recovery for the B cells, we see that is at 6 months. We've seen very deep remission, a reset, a naive state after the B cells start to reappear and then obviously, over time, differentiation of these cells from there on forward. But this is clearly a deep cut and a nice sequence of loss of persistence followed by recurrence of B cells, as you would expect from a mechanism of action perspective. When we then go to Slide 13, this is a quick look at the way that we are developing in lupus nephritis. We've obviously done the CARLYSLE study. We selected the dose. We actually also have included now in the CARLYSLE study and report at the end of the year also teenagers, patients 12 years and older and include that population as well because we believe it's a particular medical need and quite often a very aggressive course of the disease in these teenagers and young adults. Based on this data, we're moving or have moved into the LUMINA study, which is a single-arm, 30-patients study in patients that have gone through B cell depleting antibodies. And Calcineurin inhibitors failed on both and are now basically outside the approved standard of care in this -- for that stage of the disease. The study is enrolling, and we're actually are active in the U.S., in the U.K., in Spain, and we're likely going to add 1 or 2 additional countries on top. When we then think forward, obviously, there is an opportunity once you actually create a foothold in the indication to then think about the ability to broadening the use of the product in a wider set of patients, and that's going to be sort of the second step once we sort of achieved our first approval in the indication. We expect data for the LUMINA study, as indicated in 2028. And then finally, on Slide 14, just as a reminder, the progressive MS study that we're conducting in the BOBCAT study. And obviously here, really what we're looking at is both the safety or obviously, the safety profile on the one hand, the clinical impact from a disease score perspective as well as a range of biomarkers and imaging measures to understand the activity of the product in these patients and obviously, depending on outcome, we'll move from there. So with that, we're getting to the financial results section, and I'm handing over to Rob.

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the fourth quarter of 2025, and I'll be referring to the information on Slide 16. Before diving into the specific numbers, I would like to note a refinement to the accounting treatment related to our product revenue and cost of goods sold that are reflected in the results that we'll discuss today. Importantly, this change has no material impact on our existing or anticipated AUCATZYL revenue and has a practical benefit of better aligning the timing of revenue and cost of sales. On a full year 2025 basis and moving forward, we plan to recognize both the full value of product sales and the associated cost of goods sold upon confirmation of the second dose administration for AUCATZYL. From a revenue perspective, this means we will no longer recognize a 50-50 split across the first and second dose confirmations. This also eliminates the previous deferred revenue accounting and earlier cost of goods recognition associated with those deferred revenues. The accounting for personalized cell therapy products is an emerging area. And during our year-end reported review process, we and our auditor concluded on this refined position within the accounting standards and again, with no material impact on the financial statements. Now on to the results. Net product revenue for the fourth quarter of 2025 was $23.3 million, bringing us to a total of $74.3 million for the first full year of AUCATZYL sales. I'll also note that we also recorded a $1 million license revenue component in Q4 2025, related to the achievement of a clinical milestone under our license and option agreement with Moderna. Combined, this gives you the $24.3 million in total revenue for the fourth quarter. Cost of sales in the fourth quarter totaled $25.3 million, and that's compared to $11.4 million for the same period in 2024. This change was primarily driven by having a full quarter of sales in 2025 and having only a partial quarter of commercial manufacturing activity expense recognition upon FDA approval back in November of 2024. Additionally, cost of sales in Q4 2025 includes canceled orders in the period, patient access program product, inventory reserves or write-offs, third-party royalties for certain technology licenses. As discussed on our full year guidance, we expect to shift to positive gross margin this year based on increasing patient volume, improving overall plant utilization, together with executing on operational efficiencies. Moving on, our research and development expense was $35.6 million for the fourth quarter of 2025. That compared to $30.8 million during the same period in 2024. This change was primarily driven by an increase in research and development activities, including some of our new clinical trial start-up and a reduction in the period-over-period U.K. R&D tax credit. This was partially offset by commercial manufacturing-related employee and infrastructure costs that have now shifted to cost of sales and inventory. Our selling, general and administrative expenses increased to $35.8 million for the fourth quarter of 2025 compared to $33.7 million in the same period in 2024. This increase was primarily due to salaries and other employee-related costs, driven by the increased headcount supporting the commercialization activities. Our loss from operations for the 3 months ended December 31, 2025, was $72.5 million as compared to $75.9 million for the same period in '24. And finally, net loss was $90.3 million for the 3 months ending December 31, 2025, compared to $27.6 million for the same period in '24. Our cash, cash equivalents and marketable securities at December 31, 2025, totaled $300.7 million.

Hello, Rob? Rob are you still there? SP1 Pardon me, Amanda, can you hear me?

This is Christian. I can hear you.

Okay. Looks like we might have just lost Rob. . [Technical Difficulty].

Okay. I think I'm going to take over.

Sorry about that.

Are you back? Okay.

Okay. I'm going to pick up on the -- our cash and cash equivalents and marketable securities at the end of '25 totaled $300.7 million as compared to $588 million at the end of December 2024. That decrease was primarily driven by net cash used in operating activities and impacted by a delayed receipt of approximately $18.6 million related to the 2023 R&D tax credit that we are expecting from the U.K. HMRC. As Christian noted, we are reiterating financial guidance issued in January that we expect between $120 million and $135 million in AUCATZYL net product revenue in 2026. This includes contribution from both the U.S. and U.K. markets. Finally, based on our current operating plans, including anticipated AUCATZYL net revenues, we expect that current and projected cash, cash equivalents and marketable securities will be sufficient to fund our operations into Q4 2027. I'll now hand back to Christian to wrap up with a brief outlook on expected milestones. Christian?

Thanks, Rob. All right. So going to Slide 18, upcoming milestones. We're actually just about 2 weeks away from a Virtual KOL Event that will be focused on acute leukemia and the opportunity there. I'll talk a little bit more on the next slide about that. We then actually have -- if you look into '26, we expect towards the end of the year, longer-term follow-up from the CARLYSLE Phase 1 trial. We also expect first data from our AUTO8 program in collaboration with UCL on light chain amyloidosis. Name of the trial is ALARIC and early data from the BOBCAT Phase 1 trial in progressive MS. The full data for BOBCAT is then expecting during the course of 2027. And we also, by the year-end of '27, expect the full Phase 2 data for the CATULUS study, which obviously is designed as a pivotal study. And then the second pivotal study, the LUMINA study in lupus nephritis is expected to read out in 2028. So with that, just a quick look on Slide 19, the event that we're planning for April 8. We got a great group of speakers who will talk through the landscape and the opportunity. It starts with Dr. Jae Park from Memorial Sloan Kettering, who will talk about the Adult ALL treatment landscape and unmet medical need. Dr. Lori Muffly from Stanford will talk through the ROCCA real world experience with AUCATZYL. Dr. Elias Jabbour from MD Anderson will look at the opportunity in the earlier lines of treatment in ALL and particularly through the lens of investigator-sponsored trials. And then we will get to the pediatric population with Dr. Michael Pulsipher from Utah University Huntsman, who will look at the medical need in the pediatric patients and the initial data that we have from the CATULUS study. The event, obviously, is going to be webcast and also will be recorded. And we're looking forward to hopefully many of you being able to join us, a great group of speakers, and I think a very nice direct feedback and sense for where the disease setting is and where the opportunities are and also, obviously, their perception of how AUCATZYL fits into this landscape. With that, just to finish and to wrap up, the focus for 2026, clearly drive market share for a AUCATZYL, improve the gross margins for the product and expand the utility of obe-cel with the clinical trial programs, development programs that we have ongoing that are designed to give us overall a broader range of indications ultimately to be able to serve with obe-cel. With that, I think we're at the end of the prepared remarks, and we're happy to take questions.

[Operator Instructions] Our first question comes from James Shin with Deutsche Bank.

I have a couple. For the 2026 guide of $120 million to $135 million, Christian, can you -- or Rob, can you guys help us with how much might come from U.K. and other ex-U.S. regions? Secondly, what's the latest on more EU adoption or reimbursement for AUCATZYL? And then Christian, given we're pretty much through 1Q '26, can you shed any light on how AUCATZYL uptake has trended?

Yes. Well, first of all, thanks a lot for joining, James. So with regards to the U.K. guidance, as Rob said, this includes both the U.S. as well as the U.K. We're not planning to break that out. Obviously, we're early on in the launch. The U.K. is a substantially smaller country than the U.S. and much smaller population. So we're going to be actually presenting the data in the aggregate. And we do not expect a major contribution yet from the U.K. given that this is obviously very early in the process. So at this point, I think too early to tell and probably too early and frankly, too early to break out. With regards to other EU countries, we do not expect in 2026 any contributions from other -- from EU countries. As you remember, we have an approval in the EU, and we're actually in conversation with market access authorities in Europe to see whether there's appropriate path here for us to take. I think what is very clear for us is that obviously, we need to be able to enter a market in a way that actually is economically sensible. And different from maybe some of the larger players, we cannot afford actually taking a loss doing that. So we're in the process of evaluating, and we certainly will keep you updated as we learn more and we get a better understanding of the dynamics here. But for 2026, we are not actually guiding to any revenue coming outside of the U.S. and U.K. And with regards to Q1, obviously, we're not going to break out individual quarters. We've given you the full year guidance as we had actually at the beginning of the year and now reiterated. I think in overall, when you look during the course of last year, what we certainly saw were elements of seasonality that we're picking up. And certainly, in the -- as you sort of go through in the summer with vacation periods that is clearly visible as well as kind of the year-end holidays do have an impact on patients, particularly those patients that are -- have an ability to, frankly, buy some time or bridge some time and obviously are interested to sort of spend time with their families, particularly over Christmas, New Year's. So there's elements there that we see over the years. But overall, we're not going to give, I think, any sort of particular guidance per quarter because, frankly, there's too much variability in those numbers, but we're confident on the aggregate for the full year.

Our next question comes from Gil Blum with Needham & Company.

So very nice ROCCA results. Do you think this is going to influence physician behavior? Is this sufficiently socialized? I mean feedback that we've gotten is most physicians already view AUCATZYL as a preferred therapeutic?

Thanks for joining, Gil. Obviously, we're very pleased with the observation, the real-world observation. And I think what's important to understand in this disease setting is that, obviously, this is an incidence-driven disease. It's a onetime therapy. And so what's really at the core of your ability to actually build market share is the continued buildup of confidence, experience and confidence that the treating physicians have. So that's a critical component in that, obviously, the ROCCA data, which is the physician's own data, obviously, is very important. Now we have to understand when we look into kind of the physician groups that actually are treating ALL patients, this is not just the transplanters or CAR T therapists that actually are treating ALL patients, but the wide range of hemato-oncologists who are treating them and particularly in the frontline and early relapse setting. So there's a lot of work that we do to sort of expand, obviously, the adoption of the product across the range of stem cell transplanters and CAR T therapists, but also increase the awareness within the group of those physicians that tend to do the frontline therapy. So those are kind of the key dimensions that we're working on. And obviously, the data is very important because this is their own data, their own experience in many of the centers for many of the centers that are very relevant for the treatment of ALL patients. So we think the data is very important, but there is a substantial amount of work that we have ahead of us to sort of go from a market penetration that is probably somewhere around the 10% range to really start driving that towards the levels of penetration that we're seeing with Blincyto, which is what we believe actually the actual potential would look like.

And are there any insights you can provide on how the LUMINA enrollment is going?

So the LUMINA study, as I indicated, is taking place in several countries. We started out in the U.K. and obviously building on the initial experience from the CARLYSLE study. So that is starting to get -- I think, to start to gain good momentum. We're in the process of adding U.S. centers, and we expect U.S. centers to come online in the upcoming quarter. And with that, I think we're going to start to see, I think, a very nice sort of development in the disease setting and in the enrollment characteristics. So far, we're seeing kind of what we had expected to see in the indication and then seeing the type of flow of patients consistent with what our expectations were.

All right. And one last one for Rob. So now that we're recognizing revenues and costs on the second dose, how should we view patients only receive one dose?

Yes. Thanks for the question, Gil. So maybe just as a reminder on that, I mean, if you go back to the experience in the clinical study or even commercial experience last year, we're talking about a relatively small number of situations in patients. So they don't get the second dose. So the cutoff will be certainly, if there's a first dose towards the end of a quarter, that patient may still get the second dose, that revenue won't be recognized. But if they get the second dose in the second -- in the next period would be recognized then. If the patient only ever gets the first dose, that's going to be a situation where there's a number of factors that will feed in, depending on the type of patient in terms of the split CMS reimbursement or credits according to the trade policy that may apply. But eventually, what will happen there is we will wait until cash receipt to recognize that revenue on that individual patient. Whether it's a full reimbursement or a 50% reimbursement, it really depends on the patient characteristics.

Our next question comes from Salim Syed with Mizuho.

Congrats on the progress. Just one for us on cadence of catalysts for this year. So I know we're getting a lot of data here at the year-end of '26. But a lot of these trials like BOBCAT, LUMINA, et cetera, I think even ALARIC are all open-label studies with -- I presume you're going to be looking at data through the course of the year. Is there any potential here on these studies for potential early disclosure? And can you just remind us specifically on BOBCAT, the intervals that you'll be measuring disability progression?

Yes. Really good question. Thanks for joining us. With regards to CATULUS the -- on the CARLYSLE study, obviously, we have presented sort of the baseline data at the end of last year. So what the next real question for that study is really kind of the longer-term outcome in these patients and obviously also the additional experience in the adolescent patients. We don't think we're going to make sense to actually to piecemeal that data. I think you want to give a proper update with a comprehensive review of the data, which is what we're planning to do. With regards to the ALARIC study, so that's the first data cut we're going to do in that study. Obviously, you want to have enough patients and also from a dose level perspective, have enough experience to actually look at the data and understand kind of what the impact of the treatment is. With regards to BOBCAT, one of the key things that obviously you'd like to understand is, on the one hand, the pharmacodynamic markers that you can look at and some of the imaging markers. But you also want to obviously see whether there is actually any sign of clinical activity eventually, and that will actually take time to build. So in a way, it's tempting to look very early, but the thing is you will not actually have any understanding whether or not there is a clinical -- anything you could link to a clinical outcome. And I think ultimately, that's ultimately what we would like to do is to be able to sort of make these connections. But even if you look at the pharmacodynamic markers, you need a certain number of data points that you collect, so you understand what trends are to actually get a good sense of what it is you're looking at. The individual data points, I think, are tricky, particularly early on and can be misleading. So we're not planning to actually come early with data from BOBCAT that doesn't make sense because I think the data probably would be not interpretable as much as we can get excited about individual patients and individual observations. So we're planning to come towards the year-end, but we're not expecting to come earlier than that because I don't think it's helpful.

Okay. And same on LUMINA, I presume there'd be no potential early disclosure here that's open label.

Well, it's open label, but it's also a pivotal study. So the thing you don't want to do is you don't want to actually start to put information out that may actually impact the trial itself. And that's particularly tricky in single-arm studies and open-label studies. So that's something you absolutely would not do. And remember, we didn't do -- we didn't do that with the FELIX study either. Because you start to risk actually the integrity of the study.

Our next question comes from Matt Phipps with William Blair.

On the progressive MS study, you were kind of hitting on this, but just, I guess, a follow-up. Stanford recently presented data on 6 patients at ACTRIMS. And a couple of patients maybe saw some improvements by 6 months in ES scores and CSF oligoclonal bands. I guess any thoughts on this data and then how that makes you think about what you could present at BOBCAT later this year? And then for AUTO8 and AL amyloidosis, similarly, I mean, cilta-cel has shown very high response rates in that setting. What do you think the CD19 aspect of AUTO8 gets you as far as differentiation from cilta-cel?

Yes. Very good questions. Thanks, Matt. So with regards to the data that was presented at ACTRIMS from the Stanford team, I think overall, encouraging data. They're showing certain correlations between pharmacodynamic markers, and there's early observations on the disease score in these patients. The challenge, and this is goes back to the answer I gave to Salim before, the challenge is that obviously part of those disease scores also include patient assessment and physician assessment, which obviously can be more subjective. And that actually creates some of the challenges in the interpretability of that data, particularly if you look at it early on. Overall, what you look -- what you'd like to see is probably some congruence between pharmacodynamic activity and some early indication of activity. And we think that stage, we're probably going to reach sometime next year in '27 with a longer-term follow-up and more stability in the data. I think early on, you'd be looking more at some of the pharmacodynamic markers and general presence and product properties, persistence, presence of the product in CSS, those types of assessments that you'd be looking at and then obviously, B-cell depletion data and so on. But I think in terms of going from there forward and sort of concluding whether or not you might actually have the type of clinical outcome, I think, would be premature in the early time point I think we get a better sense for that during the course of next year, but it takes a longer observation time to start to be able to have put some weight on that. What was encouraging with the Stanford data was it suggested that the patients did improve. But again, it's early data and it's early days, but definitely worthwhile, obviously, pursuing and frankly, figuring it out. And then with regards to the ALARIC data, so that's obviously light chain amyloidosis, predominantly a plasma cell disorder. And what we're looking at there is we're actually looking predominantly at the action of the BCMA component of the product. And then we're going to see whether or not the CD19 component adds to that or not. But the fundamental activity, we expect, obviously, very clearly to be driven by the BCMA either predominantly or maybe even exclusively.

Our next question comes from Roger Song with Jefferies.

This is [ Fiona ] up for Roger. Congrats on the quarter. So I understand that you will shift to a positive gross margin this year. And how should we think about the near-term on involvement of gross margin once it turns positive? And with your partnership with Soliris platform early this year, how quickly can this automated platform be integrated into your commercial supply chain? And what's the magnitude of cost reduction do you expect from this approach?

Yes. Very good questions. Thank you. So let me start out with just -- what we're doing in order to actually drive down overall production costs and also with that improve gross margins for the product. The 2 key areas. One is quite obvious, which is you run more products through the infrastructure. And with that, the fixed cost obviously can be broken down to a large number, a larger number of products. And with that, the contribution of fixed costs becomes reduced on a product per product basis. That's very straightforward. The second aspect, which is really critical, though, is that we're also doing a lot of work in optimizing the operating model that we have in our facility and really are optimizing every step along the way. And between those 2 elements, the optimization on the one hand and the higher level of volume through the facility, we actually can drive the cost down substantially over time. Overall, that is going to be the key trajectory we're going to be on and will be the key driver to get us to an economically attractive place. The Soliris opportunity is obviously one where we do a feasibility study to see what the comparability of the data between the 2 different manufacturing setups, which is from an operating setup slightly different. But obviously, the biology that you're running is the same biology in the 2 systems. For us, the particular interest is actually in -- for situations where we might actually have to scale substantially because of a new indication that we might be able to unlock that may require us to actually set up a substantially larger manufacturing capacity. And so the -- when we look at Solaris, this is much more an ability to scale to a substantially higher level of volume rather than actually to drive down costs. the primary focus is actually on the ability to scale. And the reason why we're looking into it is that we obviously do not know where the out where we're going to come out on some of the new indications, particularly also on MS, but assume a positive outcome in MS, that could actually drive substantial demand and substantial need to be able to stand up capacity. And that is sort of the context under which we're actually looking at this, and we're looking doing the feasibility work because we believe that could be an attractive way to actually scale and scale in an economical way. It doesn't actually take anything away from what we're doing at our own facility at the Nucleus facility, which is obviously really focused on delivering for the ALL patients and the smaller subsets of the autoimmune patients, which is what the facility is designed to support.

Our next question comes from Yanan Zhu with Wells Fargo.

Just maybe a follow-up to the primary MS study questions earlier. The study has 3 dose cohorts at the year-end readout, can you talk about how many dose cohorts could we expect and whether a signal of efficacy can be discerned from kind of dose response on some of the metrics? And if you could be a little more specific on powerful success, that would be very helpful. And I have a follow-up as well.

Okay. Thanks for joining Yanan and all really good questions. Obviously, this is an exploratory study, which means that we expect this is a study where we will actually learn quite a bit along the way. We've designed it as a dose escalation study. What we do know is that the product obviously does give us an ability to penetrate the blood-brain barrier and be active in the brain. We've seen that with acute leukemia patients with CNS involvement. We've seen it also in primary CNS lymphoma patients. So we know the product has the right properties. It has an ability to do that. What the sort of the appropriate dose level is, is something we're evaluating in this study. We started at 100 million cell dose. We have an ability to either step up or step down, both is possible. And obviously, one of the key things we're going to be looking at is the presence of CAR T cells in CSF as sort of a measure of the ability to actually cross the blood-brain barrier and going to the compartment that we know that systemically applied therapeutics typically cannot actually get to and typically cannot be active in. So that's where the mechanism helps a lot and gives us sort of a differentiation here. Now in terms of where -- what we're sort of working through is obviously working through the dose levels. We need to have with each one, I think, a reasonable level of follow-up. So by the end of the year, I think it would be really very early data from our initial dose cohort to get a feel for what that data might look like. And it will be, as I indicated, predominantly around the product properties in terms of expansion, the safety profile, obviously, the ability to sort of actually access the CSF -- and then I think, additional sort of typical pharmacodynamic markers, including B-cell depletion and so on. And then we're going to obviously record all the typical other parameters that you can record both biochemicals, imaging parameters. And we'll see whether there's any correlation between any of these parameters. I think it will be very -- it will be too early to actually understand where there are true connections and where there's a link to outcome. I think that is just not enough observation time. But we believe as we go through the course of next year that, that we start to get to a place where we actually have a longer observation time with that have an opportunity to start looking more at clinical impact and hopefully can put more emphasis, but also more trust in the data that we're collecting on the clinical side, just given the inherent variability that, that data can actually represent. So that's where we are. So it will be very -- an early peak, but then the much more relevant data during the course of 2027.

Great. That's super helpful. Then on the B-ALL launch for AUCATZYL, can you comment on whether there's any use in earlier line setting such as MRD-positive consolidation? And also, we see there is a Sloan Kettering ITT that just opened for MRD-negative consolidation. Can you share your thoughts on how that could be leveraged in expanding the opportunity?

Right. So in terms of the actual use, current use, what we're seeing is that -- and this was what was presented at the ASTCT meeting, and Laurie will talk more specifically to it. But what we're seeing is similar to what we've seen with other products in the relapsed/refractory setting that patients can be included that actually have mineral residual disease or low disease burden at the time of inclusion. They're still relapsed/refractory. So it's the same setting, but it's basically inclusion at a time when the disease hasn't actually grown quite to the level of morphological disease. So that we do see in the data, we see maybe about 1/3 of the patients, give or take, in that bucket, which is frankly what you would expect to see. This is the standard of care. This is the way these patients are being assessed and the intervention is done when you see when you have evidence of relapse. And as I mentioned, none of the physicians will wait for things to get worse for a patient when they already have evidence of the disease coming back. So we do see that, which is very expected in terms of the real-world setting. I don't think we have patients that actually are in a frontline MRD setting at this point. I don't think we do. But that's something that we'll need to sort of look at and sort of see more kind of data coming back from the Consortium to see whether indeed that might happen over time. It's not something that we expect to see for the time being. Now what you've picked up with the memorial entry in clinicaltrial.gov is a trial that's done in connection with other centers across the U.S. and there's a second study as well in the U.S. that are currently looking for as an investigator-sponsored studies where those investigators are interested in exploring the use of obe-cel in frontline patients that have gone through the initial frontline treatment and then actually have either evidence or no evidence of disease in the studies where it differ in terms of their designs in that regard to then do a consolidation, but do, in essence, have an ability and look at a population or patients that were treated not for the full extent of frontline treatment, which is like an 18-months treatment with quite a range of therapeutics and then at the end, put the CAR T, but rather actually look at an abbreviated initial therapy and aim for a definitive consolidation. That's the thought process that these investigators have sort of brought forward and what they're interested in looking at. And also it's an area we're very interested in. And from a fundamental perspective, certainly if you think about it from a patient perspective, would be desirable to find therapies that actually can actually reduce the overall treatment time and reduce the overall amount of toxicity that the patients do get exposed, particularly in the frontline treatment. So we understand that there could be real benefit in those settings. And I think we'll learn from those investigators experience, and we'll get a sense for the profile of the product in those patients.

Our next question comes from Emily Bodnar with H.C. Wainwright.

I guess how much additional follow-up and durability data should we expect from the CARSLYLE trial later this year for the 50 million and 100 million cell doses? And what are you kind of looking to see to gain additional confidence in the LUMINA trial?

Yes. Thanks a lot for joining, Emily. So the CARSLYLE study, I did mention we had 8.8 months of follow-up for the data cut at ASH. I would assume for that -- and that's the initial cohort of the 50 million cohort. I would assume we have 12 more months between 6 and 12 more months, depending when the exact data count happens. So we're looking at somewhere in the range of 1.5 years to close to -- well, probably around 1.5 years of follow-up for the 50 million cohort. And the 100 million cohort will probably be just under probably a year of follow-up at that point in time and probably half a year follow-up for the adolescent patients. So that's kind of the ballpark in terms of follow-up that we expect. And in terms of the LUMINA study, the difference with the LUMINA study is that the population is slightly different. In the CARSLYLE study, it was SLE patients with organ involvement. Happens to be that the vast majority of these SLE patients had pretty significant kidney damage and kidney involvement. So they had a lupus nephritis component to their disease. What we're having here in the LUMINA study is more precisely defined the population and it's defined by the prior lines of treatment that the patients went through. In this -- in the LUMINA case, it's a CD20 or other B-cell depleting antibodies and calcineurin inhibitors being after those [ 2 lines ]. And at that point in time, you actually get sort of outside the approved therapeutics from a label perspective. And so it's more defined, it's more defined population. And then there's obviously a range of kidney -- level of kidney damage and a requirement for the inflammatory process to be ongoing. So indeed, this type of an approach has an ability to improve the outcome. So it's a different definition of the patients. Obviously, very similar overall properties, but it's a different way of defining the patient population as the basis to then actually have a definable primary endpoint that would be interpretable from a pivotal perspective.

Ladies and gentlemen, we've reached the conclusion of the Q&A portion of today's conference. I'd like to turn the call back to Christian for any further remarks.

Well, first of all, thanks, everybody, for joining. We're looking forward to hopefully seeing or hearing from most of you on April 8 when we have the KOLs talk to us about the ALL disease setting of the opportunities. And obviously, after that, it's not far out, and we're going to be meeting again for the Q1. So thank you very much for joining today, and I wish you all a good time.

Thank you, ladies and gentlemen. This does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.