Earnings Call Transcript - AUTL Q3 2023

Operator, Operator

Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics Third Quarter 2023 Financial Results Conference Call and Business Update. At this time, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your host, Julia Wilson. Please go ahead.

Julia Wilson, Communications Consultant

Thank you, and good morning or good afternoon, everyone, and thank you for joining us to take part in today's call for Autolus' third quarter 2023 financial results and business update. I'm Julia Wilson, Communications Consultant for Autolus. With me today are Dr. Christian Itin, our Chief Executive Officer; and Rob Dolski, our Chief Financial Officer. Before we begin, I would 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 the status of clinical trials and development and/or regulatory timelines for our product candidates and our expectations regarding our cash runway. 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 our SEC filings, both available on the Investors section of our website. On Slide 3, you will see the agenda for today's call, which is as follows: Christian will provide an overview of our operational highlights for the third quarter of 2023. Rob will then discuss the company's third quarter 2023 financial results, before Christian will conclude with upcoming milestones and closing remarks. Finally, we will, of course, welcome your questions. Over to you, Christian.

Christian Itin, CEO

Thank you, Julia, and good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the third quarter in 2023. Moving to Slide number 4. We'll give you here a quick summary of the progress we've made with obe-cel during the third quarter. Key focus has been on preparing the BLA filing, which is on track for a filing by the end of the year. Building on the data we presented at ASCO and EHA early in the year for our pivotal FELIX study in adult patients with relapsed/refractory acute lymphoblastic leukemia, we look forward to presenting longer follow-up and subgroup analysis at ASH in December. The ASH abstract embargo has just lifted, and we have an oral presentation giving longer follow-up data from the FELIX study on Saturday, December 9. In addition, we will, in a poster presentation, provide long-term follow-up data from our prior ALLCAR19 study. In the FELIX 1b study on both ALLCAR19 and FELIX 1b, we're approaching up to five years and up to three years of follow-up, respectively. I'd also like to highlight that before the end of the year, we'll be initiating a pediatric Phase 1 study of obe-cel to support our filing with the European Medicines Agency, which is expected to start in the first half of 2024. Critical for the successful outcome of the FELIX study was our robust product delivery platform with a high manufacturing success rate, short range to delivery time, and high percentage of patients dosed with obe-cel. During the third quarter, we successfully completed the process performance qualification at the Nucleus manufacturing facility set up for commercial supply and are on track to support a biologics license application with the FDA by the end of 2023. And a market authorization application with EMA in the first half of 2024. Importantly, we will be presenting more detail about the obe-cel manufacturing performance also at the ASH meeting in December as a part of a poster presentation. As the program is progressing through the regulatory review, we are actively preparing obe-cel for a potential U.S. launch with critical activities underway in medical affairs, completion of value dossiers, and onboarding of CAR T centers. Moving to Slide 5. Here is a quick overview of the pipeline progress during the third quarter. First, we continue to expand the obe-cel opportunity and we are progressing the development of obe-cel in autoimmune diseases, starting with a Phase 1 dose confirmation study in SLE patients, which we expect to start early in 2024. We held an analyst and investor event last week, where we discussed this in more detail and a replay of this presentation can be found on the Events section of the Autolus website. In summary, we believe that the excellent clinical profile we have seen for obe-cel will translate well into B cell-mediated autoimmune diseases. The differentiated mechanism of action, regulatory package, clinical validation in ALL, substantial safety database, and commercial manufacturing and delivery base will provide a differentiated opportunity for obe-cel in autoimmune disease. Data presented at ASH last year demonstrated the potential best-in-class profile of obe-cel, supported by the data observed from the ALLCAR extension study in B-cell non-Hodgkin's lymphoma. With continued high levels of clinical activity paired with an encouraging tolerability profile across diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. We expect to complete enrollment in the ALLCAR extension study by the end of the year and to publish the data in a peer-reviewed journal as well as update data at the upcoming ASH conference this year. Together with Dr. Sara Ghorashian from Great Ormond Street Hospital, we published the Phase 1 experience with AUTO1/22 in pediatric ALL patients in blood. The study showed that patients who were not eligible for commercial CAR T therapy showed a high level of clinical activity and good tolerability, with over 80% of patients achieving a molecular complete remission with no antigen negative relapses seen with a median follow-up of up to 8.7 months. Included also were patients who had relapsed after Kymriah therapy with CD19 negative disease. Our final pipeline updates continued during the quarter include AUTO8 and AUTO6NG, both in collaboration with UCL. AUTO8 is progressing well in the Phase 1 study in multiple myeloma patients called the MCARTY study, and I'll give you more information shortly on the anticipated study data at ASH. With AUTO6NG, we expect the first patient to be dosed in the neuroblastoma Phase 1 study by the end of the year. Moving to Slide number 6. As well as from there going straight to Slide number 7, focusing on obe-cel. As you remember, obe-cel has a unique mechanism of action. What's fundamentally different about our product candidate is that it has an ability to engage physiologically with the target cell. What this allows us is to actually have a product that can rapidly bind the target cell which delivers specificity paired with a fast off-rate for rapid disengagement from the target cell once the kill has been delivered. This unique engagement drives maximum activity while minimizing toxicity and is at the heart of the differentiated clinical profile we are observing for obe-cel in ALL, and we believe provides a great platform for future indication expansions in oncology and autoimmune diseases. Moving to Slide number 8. On this slide, you can see a summary of the FELIX data we presented at ASCO and EHA earlier this year. What we've characterized today is that what we continue to hear from KOLs as we share the FELIX data is that we enrolled this study and studied a patient population, our FELIX trial that is highly representative of a real-world clinical setting. Remember, we did this study during the pandemic, obviously, where patient flow was very challenging, particularly given the challenges with access to centers and many patients only being moved to centers when there was an absolute need for them to actually move to the next therapy. FELIX patients were refractory to multiple lines of therapy, including stem cell transplants and presented with a high disease burden with a median bone marrow blast of 50% at screening, and extramedullary disease was present in 19% of the patients. Despite this challenging population with high disease burden and lots of risk features overall older than studied in prior programs, obe-cel delivered complete responses in 76% of patients. And of those responders, 97% actually had deep MRD-negative responses. The tolerability is remarkable. obe-cel had 3% high-grade CRS as well as patients with ICANS, Grade 3 ICANS in the range of 7%. So both of these numbers are very low compared to any other trial conducted in this type of indication and allow for a very good level of control of these patients. Most of these events, particularly the higher-grade ICANS occurred in patients that had more than 75% tumor burden and lymphodepletion. And as you know, we will be providing a longer-term follow-up from this study as well as further subgroup analysis at the ASH meeting. Regarding the manufacturing process, irrespective of disease burden and adverse prognostic factors, the manufacturing was robust and reliable. The majority of patients for whom leukapheresis was achieved and a released product with a median vein to delivery time of 21 days, 84% of the enrolled patients were also dosed. CAR T cell engraftment and persistent results are consistent with our prior observations in the ALLCAR19 study, where we showed that all patients with long-term outcomes had also long-term persistent CAR T cells. Moving to Slide number 9. As I've mentioned, the ASH abstracts were released this morning and are available online via the ASH Conference platform, and we just would like to briefly highlight the presentations at the conference. We have had four abstracts accepted, two oral presentations, and two poster presentations. In an oral presentation on Saturday afternoon, December 9, Professor Claire Roddie will present the pooled safety and efficacy as well as longer follow-up data from the FELIX study, including subgroup analysis. Data from all patients treated in the FELIX study continue to demonstrate high rates of overall responses, CRS, and CRIs, and a very favorable safety profile. Additionally, data suggests better outcomes in the subgroup of patients with low leukemia burden at screening and lymphodepletion. Data presentation will be based on a median follow-up of approximately 15 months versus nine months at ASCO earlier this year. We look forward to sharing more details at the actual presentation. Second, in a poster presentation, we'll look in addition at data from a pooled analysis of relapsed/refractory adult ALL patients that were treated in the ALLCAR19 study, as well as the FELIX Phase 1b study. So this was the precursor of the running part of the study before we conducted the pivotal study. After a median follow-up of more than three years between those two studies, we approximately have 30% of patients that remain in remission without subsequent transplant or other anti-leukemia therapy, indicating that we have a proportion of patients that are likely to experience a long-term benefit. When we then look into the CLL and NHL cohorts of the ALLCAR19 extension study, we have there more than two years of follow-up at this point in time. The study also shows durable responses and a low incidence of serious infections as well as a very good overall safety profile, which gives us a strong rationale for moving over time into these additional disease settings. Continuing on with the obe-cel abstracts, we'll also be presenting data on our manufacturing capabilities in a poster presentation. Data gathered in the FELIX study successfully demonstrated the robust operability of obe-cel manufacturing. All apheresis starting materials were successfully processed despite the multitude of constraints posed by the COVID-19 pandemic, and many patients had very high levels of leukocytes and cancer cells collected in the leukapheresis. Further optimization improvements were made during the startup of the study, and increased reliability, consistency, and precision of the manufacturing process, as well as improved analytics, helped to minimize turnaround time and support the development of the Nucleus as well as our new obe-cel manufacturing facility. Shifting gears to our dual BCMA/CD19 targeting CAR T program, AUTO8, for multiple myeloma. In an oral presentation, we'll be sharing preliminary data from the ongoing Phase 1 MCARTY study at ASH. All patients treated achieved a response, and doses were well-tolerated with no ICANS or CRS larger than Grade 3 with a median follow-up of 4.5 months at the time of the abstract. With that, we're transitioning to Slide number 11, and we're looking at the preparation for commercial launch of obe-cel. As you can see on Slide number 11, we are well on track with the activities as we have laid out. Key, obviously, is getting the manufacturing supply all set up, which has progressed really well. I'll spend a little bit on the next slide on that as well. Remember, we designed this facility for capacity that will allow us to actually address and support two-thirds of the total market in the U.S. and Europe for relapsed/refractory ALL patients. So we have an initial capacity set for 2,000 batches a year. The full capacity of the facility actually exceeds that level. Secondly, obviously, we're working towards the filing of the BLA. The target is to get the filing in before year-end, and we're on track to deliver that important milestone for the program and the company. We will, as we go through the early part of next year, obviously, go through a set of inspections of the facility; we will certainly have one from the MHRA, which we expect in the early part of next year as well as in the context of a BLA review. Obviously, additional inspections are expected during that process. The filing for an EU registration is expected in the first half of next year and is also conducted under a prime designation similar to the RMAT designation that we have with the FDA. From a commercial perspective, there's been a significant amount of activity this year, particularly in the medical affairs side, where we also are very active, sharing the data, running medical education, etc. The second key area that we're working on is really working through the value proposition for the program and the value dossiers. So that's a key set of activity that we're well on track with and exactly where we expect to be at this point in time. And third, obviously, we have started the onboarding of clinical centers for obe-cel, which is a process that typically takes somewhere between about nine and probably 15 months depending on the center to actually get fully onboarded and registered. When we look into next year, obviously, we'll start to build up towards U.S. launch preparation, and that will be one of the key activities that we will seriously focus on in terms of buildup as we're after we have filed the BLA and we're in the review process of the application. So with that, we're moving to Slide number 12, and this is a brief overview of the Nucleus facility. As you remember, this is a very compact facility, quite unusual in its design. It has a total square footage of 70,000 square feet. It's a four-story building, industrial height. In order to actually get this building off the ground and operationally ready in a very short period of time, we have taken on an approach that built on or was based on a high degree of off-site building of the facility. In fact, we had about 70% of the facility built off-site, moved to the actual construction site, and they were actually assembled. By taking this approach and also using an unusual startup approach, we're actually able to go from November 8, 2021, when we broke ground, to the full qualification of the facility, which is complete at this point in time, all in less than two years. And if we look at the timing for the BLA filing, we’ve been just around two years from groundbreaking to a full package that is submitable in its complete form. So that’s an exceptionally fast process that we’re able to run through. It has a lot to do with the innovation that we’re applying to both the design as well as the build-up. And the facility design was not just chosen for the speed of setup, but also because it gives us an ability to replicate the facility with increased demand elsewhere and also be able to achieve that with relatively short timelines from decision-making to operational activity. That is going to be important because there’s a big impact on the risk profile of investments and the timing of investments. What you then see on the right-hand side is the actual inside of the initial operating suite. This suite is designed to deliver about 700 products a year. And what you see here is this suite actively operating at full capacity during the capacity challenge. The manufacturing process, as you remember, is highly automated and allows us to run a relatively large number of products in parallel within the same environment. In fact, what you see here is a picture that comes from the actual capacity challenge where we pushed the output of that particular clean room to its limits, with the key objective to demonstrate sustained control throughout that level of pressure and deliver high-quality products during this period. So a key aspect is obviously that this data goes into the BLA filing as well. When we look beyond the ALL opportunity – moving to Slide 14, what you see summarized on Slide 14 is basically the evolution of the obe-cel program as we see it currently. First of all, as you’ve seen, obe-cel, with its anchor indication in ALL, gives us a very unique product with an exceptional level of activity combined with a remarkable level of safety. And that creates a unique opportunity not only for the development of the product in patients with acute lymphoblastic leukemia but also for indication sets in non-Hodgkin’s lymphoma as well as in autoimmune diseases. So that’s the core opportunity we see with obe-cel. We’re active on all those fronts with the program. When we think about the next steps with the program and building on the unique features of the CD19 CAR that’s utilized in obe-cel, we've developed two next-stage products. One is AUTO1/22, that I mentioned before, which is a dual-targeting approach aimed at minimizing the risk of patients relapsing with CD19 negative disease, which is one of the major drivers for relapse in acute lymphoblastic leukemia, both in children and adults. This product gives us sort of a next leg up. It builds upon the unique properties of the CD19 targeting, utilizing the same CD19 CAR as obe-cel does but adds a highly potent CD22 CAR designed to recognize cells that express very low levels of CD22 on their surface, one of the known escape mechanisms for CD22. So this is the next generation program for obe-cel, aimed specifically at oncology indications. The second program, AUTO8, I mentioned before, we’re going to be presenting an oral presentation on the initial Phase 1 data generated together with our colleagues at UCL. This program also builds on the CD19 CAR from obe-cel and adds a highly potent BCMA CAR, optimized for recognizing very low levels of BCMA on the surface of target cells. This is a known challenge with BCMA targeting, as the target is selective but often expressed at copy numbers that are as low as 10 or 20 molecules on the cell surface for multiple myeloma cells. This creates some challenges in efficiently recognizing these cells and ensuring we can target all cells and not just the higher level expressing multiple myeloma or plasma cells. This program, as with AUTO1/22, is a dual-targeting program and opens up opportunities that could extend both to oncology and autoimmune sides. Depending on the development of the data, we’ll make decisions on which direction we think we’re going to take this program. Moving to Slide 15. This slide summarizes our current evaluation of the program. We believe we’re in a very good position, given our substantial amount of clinical validation, large dataset in an incredibly difficult-to-treat patient population, showing a best-in-class benefit-risk ratio across this indication, and a highly attractive profile in non-Hodgkin’s lymphoma settings. This gives us a lot of confidence around the product. In autoimmune diseases, you need to make a very deep cut into the B cell compartment. This is what we’ve demonstrated in all these patients, driving to show B cell aplasia. Strong clinical activity has been observed in these patients, combined with an exceptional safety profile, which matters significantly more in autoimmune disease than in oncology. We have generated a substantial safety database through our current development leading up to the imminent filing in patients with ALL. This safety data becomes particularly important considering that we have seen through the work done by Georg Schett and Andreas Mackensen, the potential for inducing deep responses in SLE patients. Initial patients treated with their own CD19 CAR T therapy have shown responses that are sustainable for at least one to two years. This level of activity creates interesting opportunities for the development path we can take in SLE, which is more aggressive and compact compared to standard trials used for various monoclonal antibodies in this space, requiring very large patient numbers to demonstrate effects. We believe this is an excellent strategic position for us, leveraging our current development data and significant de-risking on manufacturing, regulatory, and commercial fronts.

Rob Dolski, CFO

Thanks, Christian, and good morning or afternoon to everyone. It’s my pleasure to review our financial results for the third quarter ended September 30, 2023. Our cash and cash equivalents at September 30 totaled $256.4 million, compared to $382.4 million on December 31, 2022. Total operating expenses net for the three months ended September 30 were $47.8 million, compared to $43.5 million for the same period in 2022. Our research and development expenses decreased by $0.4 million to $37.2 million for the three months ended September 30 compared to the same period in 2022. This was primarily due to decreases in clinical trial and supply costs related to our obe-cel clinical program, and these were partially offset by increases in operating costs related to our new manufacturing facility, as well as salaries and employee-related costs driven by increased headcount. On the G&A side, general and administrative expenses increased by $2.4 million to $10.6 million for the three months ended September 30 compared to the same period in 2022. This increase was primarily due to salaries and other employee-related costs, driven by an increase in general administrative headcount supporting overall business growth, primarily related to pre-commercialization activities. Our net loss attributable to ordinary shareholders was $45.8 million for the three months ended September 30, 2023, compared to $42.8 million for the same period in 2022. Autolus estimates that our current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the company’s cash runway into 2025. Just as a reminder, in our projections, we do anticipate an R&D tax refund from the UK HMRC in Q4 of this year, and we would anticipate being eligible for a tax refund in a similar fashion next year as well.

Christian Itin, CEO

Thank you, Rob. And so we’re moving to Slide 21. This is a quick summary of the planned news flow. As you can see, there’s a lot of activity coming up towards the end of the year and into the early part of next year. As mentioned before, the big item of focus and clearly where most of the organization is working towards is getting the BLA filing in before the end of the year. We talked about the obe-cel FELIX data update as well as the updates around ALLCAR19 and the FELIX 1b study, which gives us longer-term information and I think a nice proxy for what to expect in terms of longer-term outcomes from the larger pivotal FELIX study. Then we’ll have the update on AUTO8, which is shaping up nicely and I think will provide an interesting look at the profile of that program. Then, as mentioned, we expect to start the AUTO6NG Phase 1 trial in children with neuroblastoma before the year-end. Importantly, as we go into early next year, we expect to keep the Phase 1 up and running and have the first patient in, early next year. Treating patients with autoimmune disease, particularly focusing on SLE in this initial study, the study is designed to confirm dosages, which will provide a basis for regulatory discussions around the pivotal study design. As indicated earlier, we expect to submit the filing in Europe, the MAA application with the European Agency, in the first half of next year. So a lot of activity in the upcoming months, and significant milestones for the company. We’re very well set up, and we have a great team building up on the commercial side that will position us strongly for the next steps once we’re through our regulatory interactions. A lot of good stuff ahead of us, and I look forward to connecting with many of you, probably at ASH, and I’m happy to take questions now.

Operator, Operator

Our first question comes from Matthew Phipps of William Blair. Your line is now open.

Matthew Phipps, Analyst

Hi. Thanks for taking my questions and all the updates. I guess first on ASH, will the obe-cel FELIX update provide sufficient follow-up to really show EFS curves? And then for AUTO8, another six IO patients - were those just from the BCMA alone CAR in cohort 1, or were some of those with cohort 2 that had CD19 as well? And how many patients do you expect from cohort 2 at ASH?

Christian Itin, CEO

Yes. Very good questions. Thanks for joining, Matt. So for the first question, are we expecting to update or present event-free survival data? The answer is yes, on the FELIX study. Regarding the AUTO8 program, what Matt was referring to is that we started the Phase 1 clinical study, dosing patients with the BCMA CAR alone, to establish the base profile for it, and then, after that was established, we added the CD19 CAR component to the product. We will have data on both patients with BCMA only and those with both CARs present. We’re likely looking at about 10 patients, maybe slightly above that.

Matthew Phipps, Analyst

And if I can ask just one other one on the autoimmune side again. Can you remind me if this was discussed last week? Is there a safety kind of DLT period in between patients where you have to wait a month before treating a subsequent patient?

Christian Itin, CEO

We would expect a gap between the initial patients and after you have initial data, which will allow for quicker enrollment. We have quite a good level of data on safety with the ALL population, so we should be able to enroll relatively quickly.

Matthew Phipps, Analyst

Great. Thanks for taking my questions.

Christian Itin, CEO

Thanks, Matt.

Operator, Operator

One moment for our next question. Our next question comes from the line of Dev Prasad of Jefferies. Your line is now open.

Dev Prasad, Analyst

Hi. Thank you for taking our question. This is Dev on for Kelly at Jefferies. I have a quick question on SLE. How do you think about cell persistence that can impact efficacy and safety in contrast to the oncology indications that we have seen so far?

Christian Itin, CEO

Hi, Dev. Very good question. As mentioned before, to achieve a deep cut into the compartment, you need to remove autoreactive precursor cells, memory cells, and autoreactive plasma cells. Therefore, persistence will be crucial to ensure effectiveness over time. What we’ve seen is that the program in Erlangen achieved a very deep response with CAR T cells lasting about six months. After that, the B cell compartment regenerates, but we do not see a recurrence of autoreactivity. Our product and the product used in Erlangen have shown similar behavior in terms of persistence, which is very encouraging.

Dev Prasad, Analyst

Thank you for taking our question.

Christian Itin, CEO

Thank you.

Operator, Operator

One moment for our next question. Our next question comes from the line of Gil Blum of Needham and Company. Your line is now open.

Gil Blum, Analyst

Good morning and good afternoon and thanks for taking our questions. A couple of items from us. For AUTO8, it looks like the data is intriguing, but it’s a crowded market with many assets going into it. What do you think is going to be a key differentiator, particularly on safety?

Christian Itin, CEO

Thanks, Gil, for joining. That's a very interesting question and one we've observed in the field's evolution. This product is designed for deep responses to achieve low levels of disease burden in these patients, much like we can measure minimal residual disease levels in multiple myeloma and ALL. The second aspect is the persistence of CAR T cells in multiple myeloma patients, which often doesn't last long. We aim to achieve longer-term persistence through the CD19 CAR component, providing some baseline activation for CAR T cells. Finally, we’re looking to target the CD19 positive early stage plasma cells to potentially treat driver cells of multiple myeloma. We want to see a high level of responses in these patients that deepen over time.

Gil Blum, Analyst

It also goes back to your comments during the SLE event. Why does the company believe that commercial-stage CAR T’s need to redo their production and conduct more studies to move into SLE despite having commercial assets?

Christian Itin, CEO

This is a very good question. We see that companies are changing their manufacturing processes significantly. For instance, moving from manual to highly automated manufacturing, which changes product properties. A new product means generating new clinical safety data. On top of that, the manufacturing setup becomes entirely different, requiring substantial investments to address these changes. Two of the companies in this space have made significant alterations that will necessitate additional clinical data and adjustments to commercial production infrastructure.

Gil Blum, Analyst

All right, thanks for taking my questions.

Christian Itin, CEO

Thanks a lot, Gil.

Operator, Operator

One moment for our next question. Our next question comes from the line of Yanan Zhu of Wells Fargo. Your line is now open.

Yanan Zhu, Analyst

Hi, thanks for taking our questions. I have a couple for the SLE and a couple for FELIX. Perhaps let's start with the SLE. I was wondering, Christian, you were talking about the benefit of us having the same product as your soon-to-be commercial product. Would that help reduce some of the safety database size requirements in your new indication? Is that something you've had preliminary agreements with the agencies on, or is that your general expectation? Also, I was wondering if you have any thoughts on Novartis' YTB323 abstracts at ACR regarding dose level early efficacy and safety, and how does that impact your confidence for obe-cel in SLE?

Christian Itin, CEO

Thanks, Yanan, for joining. Really good questions. So first off, on safety, yes, the general guidance from regulators indicates that safety databases can be smaller for the same product across indications. This isn't specific guidance, but a consistent expectation in regulatory discussions. Regarding the Novartis program, I think it looks good overall and encouraging. If they successfully replicate the data from Erlangen, that’s positive news. Their dosage is relatively low, consistent with our experience when achieving high activity at low levels. However, it’s a different product, so some differences will exist. Overall, this is encouraging as it shows that data can be replicated.

Yanan Zhu, Analyst

Great, thanks. On FELIX and the ASH update, will the data cutoff for the abstract be the same as the actual presentation? Also, I think we noted the median DOR is stated as not reached now, whereas there was a median DOR back at ASCO. Has the curve fluctuated with newer patients and longer follow-up?

Christian Itin, CEO

Yes, the data cut for ASH will give us an additional six months’ follow-up. The median follow-up at ASH is expected to be around 15 months, compared to nine months at ASCO. The initial data cut for the abstract might differ from the one presented at the conference. The observed variability comes from early data with many patients still in early curves, leading to fluctuations in the median.

Yanan Zhu, Analyst

Great, very helpful. Thank you, Christian.

Christian Itin, CEO

Thank you very much.

Operator, Operator

One moment for our next question. Our next question comes from the line of Karina Rabayeva of Truist. Your line is now open.

Karina Rabayeva, Analyst

Hi, this is Karina for Asthika. Congrats on the progress. I had a few questions on AUTO8. What kind of data can we expect at ASH? Will it include baseline characteristics and percentage of patients with EMD and other high-risk agnostic factors? I think you said it’s going to be eight patients worth of data at ASH. Can you confirm that?

Christian Itin, CEO

Yes, this is a Phase 1 study, so yes, we will review the included patients’ states and provide characteristics on them. We expect to be in the range of 10-plus patients, as mentioned.

Karina Rabayeva, Analyst

Okay. And will there be enough follow-up for six-month and nine-month PFS?

Christian Itin, CEO

There is some follow-up, but we need more patients and time to firm up those types of information.

Karina Rabayeva, Analyst

Okay, thank you.

Christian Itin, CEO

Thank you, Karina.

Operator, Operator

One moment for our next question. Our next question comes from the line of Simon Baker of Redburn Atlantic. Your line is now open.

Simon Baker, Analyst

Thank you for taking my questions. Two, if I may, please. Firstly, on SLE. You have an advantage over most competitors in terms of your safety database size and the suitability of your manufacturing process. Could you provide time estimates for this advantage or potential timelines on when we should consider pivotal trial starts and commercialization?

Christian Itin, CEO

Thanks, Simon. On the SLE side, it's a bit early to determine, but our plans include starting the dose confirmation next year, which we believe could lead to the pivotal study starting in the following year.

Simon Baker, Analyst

Regarding manufacturing capacity and the Nucleus facility, could you specify the validated capacity there?

Christian Itin, CEO

The facility has a modular setup for three clean rooms, each scaled for 700 products per year. We expect to launch out of the first clean room, giving us an initial capacity of 700. The other clean rooms will come online later, based on demand.

Simon Baker, Analyst

Thank you so much.

Christian Itin, CEO

Thank you, Simon.

Operator, Operator

This concludes our question-and-answer session. I would now like to turn it back to Christian Itin for closing remarks.

Christian Itin, CEO

Well, first of all, thanks for joining. Looking forward to seeing you at ASH with the additional data updates. For those of you who happen to be in London in mid-November, we're having a visit at the manufacturing facility. Please contact Susan Noonan if you're interested in joining us for that visit. It might provide insights into CAR T therapy and the necessities for launch. Thanks again for joining, and I appreciate your time. Speak to you soon.

Operator, Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.