Autolus Therapeutics plc

Hello, ladies and gentlemen, and welcome to the Autolist Therapeutics Second Quarter 2023 Financial Results Conference. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your host, Julia Wilson, Communications Consultant. Please go ahead.

Thank you, Corey. Good morning or good afternoon, everyone, and thank you for joining us to take part in today's call for Autolus' second quarter 2023 financial results and operational highlights. I am Julia Wilson, Communications Consultant for Autolus. With me today are Dr. Christian Knighton, our Chief Executive Officer, and Dr. Lucinda Crabtree, 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 safe harbor provisions of the Private Securities Litigation Form Act of 1995. These may include, but are not limited to, statements regarding the status of clinical trials and development and 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 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 in the investor section of our website. On slide three, you will see the agenda for today's call, which is as follows. Christian will provide an overview of our operational highlights for the second quarter of 2023. Lucinda will then discuss the company's second quarter 2023 financial results before Christian will conclude with upcoming milestones and any other concluding comments. Finally, we will, of course, welcome your questions. Over to you, Christian.

Thank you, Julia. Good morning to you all. Thank you for joining us. It's my pleasure to review our progress for the second quarter of 2023. Moving to slide four. We had a very productive second quarter with the ASCO and EHA data presentation of our pivotal Felix study as the highlight. OV-cell has shown an excellent profile in adult patients with relapsed refractory acute lymphoblastic leukemia. The ORR based on complete remissions with either complete or incomplete hematological recovery was 76% up from the interim analysis, which came in at 70%. The safety profile, which was remarkable with low levels of high-grade cytokine release syndrome and ICANNs, and the data tracked very well on persistence and duration of response with our prior all-CAR-19 study, where we have seen 35% of treated patients in long-term remissions without any need for additional anti-leukemia therapies. Next follow-up is planned for ASH with several OB-cell-related abstracts submitted to the organizers this week. Critical for the successful outcome of the Felix study was our robust product delivery platform with high manufacturing success rate, short range of delivery time, and high percentage of patients dosed with OV-cell. Key focus now is on the completion of the validation of the commercial manufacturing facility, which we call the nucleus. We're on track for a filing of a biologics license application with the FDA at the end of 2023, and a market authorization application with EMA in the first quarter of 2024. As the program is progressing towards the regulatory review, we're also actively preparing OBCEL for launch with critical activities underway in medical affairs, completion of value dossiers, and onboarding of clinical centers. On slide five, we have a short overview of the key pipeline progress. First, we continue to expand OBCEL, the OBCEL opportunity. In non-Hodgkin's lymphoma, in our old CAR-19 study, we demonstrated very high levels of metabolic complete remission rates in patients across B non-Hodgkin's lymphoma indications with an attractive high level of sustained CRs in DLBCL patients. We have also notably taken the decision to develop OB-cell in autoimmune disease, starting with a small phase one dose confirmation study in SLE patients, which we expect to start early in 2024. We believe the excellent safety and efficacy profile we have seen for OB-cell in ALL and non-Hodgkin's lymphoma patients will translate well into B-cell mediated autoimmune diseases and together with our established commercial manufacturing and delivery base plus attractive cogs will drive a well-differentiated expansion of the OB cell opportunity. Looking into OB cell lifecycle, the pediatric ALL CARPEL study with auto-122 was updated at the EBMT meeting in the second quarter and continues to show an impressive level of clinical activity and a very favorable safety profile. Also in the second quarter, we presented longer follow-up of the peripheral T-cell lymphoma patients treated with auto-4 showing complete remissions now sustained beyond one year. Finally, and also in collaboration with UCL, AutoAID is progressing well in the phase one multiple myeloma McCarty study with the first data plan for the end of the year. And finally, Auto6NG phase one study in neuroblastoma is expected to start in the third quarter. Turning to slide number six and to tell you a bit more about how we're strengthening the Autoless team. We had a very busy second quarter with great additions during the second quarter. I'd like to start out with Dr. Robert Janone, who joined our board as of directors in June. Rob brings to all of us a wealth of experience in the life science industry, having worked across a broad range of therapeutic areas and phases of development, including immunology programs at Jazz Pharmaceuticals, Immunomedics, AstraZeneca, and Merck and Company. Rob is a great addition to the board and brings, obviously, very relevant experience as we're going through the regulatory review process in the U.S. and elsewhere, and obviously is really instrumental in the further development and positioning of the product. In July, we announced that Rob Dolsky will be succeeding Lucinda Kraftin as chief financial officer. Rob has more than 20 years of a very diversified experience as a life science financial executive and joint autolist from Checkmate Pharmaceuticals. where he served as the CFO and was a key member of the team driving the sale of the company to Regeneron. Prior to that, Rob had key leadership roles and operational roles at Moderna, Human Genome Sciences, and Amgen. Rob is on the call with us today, and I'll ask him to give a quick introduction later in the call. At the same time as we announced Rob's appointment, we also announced that Dr. Veronica Hershberger had been appointed as Senior Vice President, Medical Affairs. Veronica joined all of us from Target Moon, a private Swiss oncology company where she served as the chief medical officer. She brings a long career in oncology development, medical affairs, and a long, remarkable level of experience across a wide range of products. During her time at AstraZeneca, Veronica was a global product leader for both Calquence and Levoxatig. And prior to that, she served as the global head of medical affairs for the hematology franchise at Roche. where she was also involved over the years in the development of a wide range of oncology programs. Finally, Miranda Neville was promoted to Senior Vice President, Project Management, heading up the OB-Cell program. Miranda served in various roles at Odalis, most recently as Vice President, Head of Program and Portfolio Management. Miranda has over 20 years of experience in project management, engineering, capital projects, and operations. Prior to leading the OB-Cell program, Miranda ran Odalis' commercial manufacturing capital product, delivering the nucleus facility in record time. Prior to OTALIS, Miranda supported several consulting projects for large biopharma companies as well as clinical stage gene therapy programs at companies like Human Genome Sciences and others. In particular, at Human Genome Sciences, Miranda led the BenLista program in SLE through the successful BLA and then obviously resulting regulatory approval and launch of the product. So we're expanding the team with a very experienced set of industry leaders. in their respective fields and obviously all of them are having a significant impact already and we continue a lot of contributions in the future With that I'd like to actually switch over to Obie cell and we're moving to slide number eight Here I will like to take the opportunity to really give you a quick update and summary of of the key data that we presented both at ASCO as well as at EHA from the Felix data. As you remember, the patients that we enrolled were relapsed refractory patients that had been extensively, gone through extensive lines of therapy prior to actually being eligible for this study. The primary endpoint we're looking for is overall response rate based on CRs and CRIs. And we're also looking at secondary endpoints that look at duration of response, event-free survival, as well as overall survival, and the ability to convert patients into an MRD negative status. Now, we have enrolled 112 patients in the study. We infused 94, so 84% of the patients involved were actually dosed with the product. And you can see in the slide also the difference between the involved and infused patients and kind of what the key characteristics were. Now, when we look at the baseline characteristics that are indicated, these are clearly a very advanced patient population. We have somewhat older patients. When you look at the average age in 50 years, they're somewhat above what we've seen in prior studies in relapsed refractory ALL, and certainly not an easy population. to work with. We see obviously well-balanced between gender, have the usual type of level of Philadelphia chromosome positive patients and prior types of therapies. I think what I'd like to point out at the bottom is obviously the patients did have high levels of tumor burden in their marrow, and also we had a significant proportion of patients that has extra medullary disease, which are known to be very difficult to treat and to manage. Moving to slide number 10, this is the overall response rate. As you can see, we had an overall response rate of 76%. 54% of the patients achieved a CR, 21% a CRI. And we have seen a very high level of patients achieving not just the complete remission, but also an MRD negative status with a sensitivity of 10 to the minus 4. Now, when we look at duration of response, obviously, this is still early in terms of follow-up. We have a median follow-up of 9.5 months. And you can see that the overall curve tracks very nicely with what we had expected and seen prior. But you can also see there's still a significant number of patients in the earlier part and the upper part of the curve, which tells you that there is still quite a bit of observation that we need for the study to actually for this curve to fully stabilize. At this point, 61% of the responders are in ongoing remission. Now, when we look on slide number 12 into sort of a bit more into sub-analyses of kind of what's driving or impacting the overall response rate, we do see obviously key drivers here. What I'd like to point out, as indicated before, patients that have extramedullary disease tend to have a poor outcome. as are patients that have very high levels of disease in the marrow. In fact, if you have patients that have more than 75% tuber burden in the marrow, you see a reduction of the overall response rate to the range of about 60%, whereas patients with disease burdens below 75% in the marrow and, in fact, any level below, we're in that range of somewhere between 80% and 85%. I think it's also worthwhile pointing out, and not a surprise, that obviously if you have patients that had a very significant number of prior lines of therapy, they tend to do less well than patients that had been less exposed to therapy before. And overall, obviously, some limited impact that we can see on either prior INO or prior blinotumor map therapy. However, those are always the overlapping, so from a confidence interval, not clearly differentiated. So with that, moving to the safety, as you can see on slide 13, quick summary on the immunological toxicity that we have observed. We looked, obviously, specifically for cytokine release syndrome and neurological toxicities as measured by ICANNs. And I think it's remarkable when you see overall that we have a remarkably safe product. On the overall CRS level, we had about 3% of patients that had experienced high-grade CRS. which is very low compared to any other, I think, therapeutic approach that utilizes T-cells, including Blincyto. When we look at the ICANs, we also see that the level of higher-grade ICANs is low at 7%, which is also below any of the other therapies that are redirecting T-cells. I think overall, we do see somewhat of an impact on tumor burden on ICANs, but we don't see much of a difference in terms of tumor burden on cytokine release syndrome. On ICANs, you can see that the patients that have more than 20% tumor burden, that the ICANs are elevated. We have about 10% of patients that have ICANs. If you're below 20%, you have a very low probability of experiencing high-grade ICANs. What was quite remarkable was that most of the patients that experienced the high-grade ICANs, which was a total of seven patients out of the 94, actually had more than a 75% tumor burden at the time of lymphoplethiation. So this is after bridging therapy and everything else you could do to contain the disease prior to dosing. They had still an excess of 75%. And that's the group of patients that actually have the highest risk, which also actually gives you very important information ahead of dosing the patient on what to expect and how to manage the patient going forward. And I think puts the physicians in control of this therapy, rather than basically finding themselves in a position where they're frankly being taken for a ride. Now, moving to slide 14. As you can see, one of the key parameters that we've been looking at is obviously the behavior of the T cells in the patient. And as you do remember, one of the unique properties that we have with OBSEL is that it is obviously a product that has a very unique design. The design allows us to get a very physiological engagement of the target cells, rapid recognition, rapid kill, and in a rapid disengagement after that kill has occurred, added ability for their cells to recycle back into action. But as they're cycling back into action again, they're not only actually continue in a serial killing mode, which actually is at much, much lower level of toxicity overall, they also actually get a very strong signal to proliferate. So one of the things that we do see across all of our patients is a massive expansion of the CAR T cells in vivo, which gives us this enormous peak that you see on the left-hand side on slide 14, which in fact matches very nicely the peak of expansion or total number of CAR T cells formed over time. That matches very nicely with what we have seen in our prior study, the old CAR-19 study. When we look at the area under the curve for the first 28 days, also very nicely matching. If you look at the half-life, very nicely matching our prior experience. And as we've seen with Olcar before, we do see a sustained level of CAR T cells over time. And this is important because as we go to slide 15, as a quick reminder of what the observation was in the Olcar 19 study, You can see on the right-hand side is that very similar behavior of rapid expansion, but then sustained levels of CAR T-cells over time. And you can see we look here up to four years in the old CAR-19 study. And we also did observe that all of the patients that had long-term remissions without any additional therapy, which are the patients at the top part on the swim plot on the left-hand side, all of those patients had sustained, persisting CAR T-cells. So we believe actually having seen a replication of the cellular properties in our Felix study, tracking what we have seen in the Olkar study gives us a high degree of confidence that we're on the right track in terms of a longer-term follow-up as well. Moving to the summary on slide 16, obviously we're very excited with the outcome that we have seen in this study. Remember, as a backdrop, this study was conducted through the peak of the pandemic We were not able to go onto the sites. Everything was done remotely. And as you can see, and it's also reflected in the patient population, we have a wide range of patients, patients with extraordinary risk factors, which actually normally wouldn't see recruited into studies like the Philae study. So we have a very much a real world patient population that we've treated here. And to see the outcome, both on efficacy as well as on safety to be so consistent with what we've seen before gives us a lot of confidence in the property of the product, but also with our ability, in our ability to deliver the product reliably at a high level of quality and in time for these patients, which is really critical. When we then look at the engraftment, that's what I just talked about, obviously we're tracking what we have seen in our prior experience with the program. And that obviously gives us a lot of confidence in the further analysis and follow-up of the study. Now, I'd like to spend just two or three minutes on manufacturing, moving to slide 18. And I just want to briefly talk about what are the critical success factors on product supply. The first is when you're dealing with patients with acute leukemia, you actually start with a very challenging starting field because many of these patients do not only have disease in their bone marrow, but also actually have disease that actually gets into the blood and basically leads to very high tumor burden also in the blood. So when you're collecting cells from the blood in a leukoparesis, you have patients where you have the predominant cells that you collect, up to 95% of the cells, can be leukemic cells. And as you can imagine, that's an incredibly difficult starting material because you have to first get rid of those cells before you can even think about manufacturing, which means that your manufacturing process has to be able to handle a wide range of very complex and challenging starting materials. So we spend a lot of time optimizing the manufacturing product process to actually achieve the level of robustness that is required for reliable product delivery here. The other aspect is that You need to have a very consistent turnaround time, which means you have a consistent production time. And then you need a consistent product release time, which is the analytics that leads you to a full batch record that allows you to release the product. That actually is a very, very important part if you take an overall turnaround times. And what actually allows us to actually be consistent and also manage our overall costs has to do with the fact that we're operating with a fully enclosed system that actually allows us to operate in a lower grade clean room environment than what you typically see in the space. And that actually leads to massive reduction in the time that it takes for people to get in and out of those particular rooms. So that's actually directly impacting costs. but it also has much less running cost involved. And it also simplifies the whole approach because it allows you to build on a level of semi-automation, which also reduces the actual handling steps substantially. And with that, increases robustness, but also decreases cost. Now, people are critical here. And I think we shouldn't underestimate the importance of the teams that you want to build here and the people you have to train. The people that actually operate in a facility like our manufacturing facility in Stevenage are not people you can hire at this point from the market. They do not actually exist. You have to actually train them. So actually creating a highly trained and motivated workforce is absolutely critical. And one of the key things that we have to do is actually establish a full-fledged training program to make sure that our operators are fully trained, fully capable, and skilled to deliver this type of an operation, this type of an outcome. And then the culture of continuous improvement is extremely important if you have processes that have a large number of steps that give you opportunity to improve, frankly, every single one of them. And that ultimately will translate not only in robustness, but also in increased efficiency and with that continued ability to decrease cost of goods over time, as well as reduce turnaround time. And then finally, the scale of the operation, you have to actually be able to deliver and serve the market that you're launching in. And that's been one of the critical issues that we've seen in the space is that the capacity available at launch was completely outstretched by the demand. And that creates a lot of problems, a lot of disappointment, and it's something that is really important to get right. This is why we chose to actually design a facility that allows us to actually treat two-thirds of all relapsed refractory patients in the U.S. and in Europe from the facility from which we launch or plan to launch the product. So those are important aspects. You also don't want to actually over-engineer or over-design the capacity, because if you go too high, you have too much excess capacity, you have a very significant adversarial impact on cost of goods. So with that, moving to slide 19, I already mentioned the whole a series of aspects that matter in terms of the actual product. We're working with the Miltoni Prodigy machines, which have proven to be extremely robust and reliable equipment and are really kind of the workhorse, frankly, on which we do the manufacture. You can see, actually, on the lower part of the chart, you see looking at the actual manufacturing success rate, the transduction efficiency, range of delivery time. And what we chose to do also as part of the presentation at ASCO and DHA to show frankly every single batch manufactured for the pill of the stuff. And that is important because this is an area where I think confidence in the manufacturing and the consistency is extremely important. That's why we chose to present the data in this quite unusual way in our field. Now, moving to slide 20, just a brief word on the manufacturing facility, the commercial manufacturing facility. We're well on track to run a complete evaluation of this facility. It was a very unusual project. We built this product or project in record time. We went from groundbreaking in November 21 to get the first clean room up and running in November 22, and we expect to file the BLA by the end of this year. So roughly from groundbreaking to BLA filing, a timeline of 24 months. And that includes all the build, the full validation of the facility, and getting all of that obviously into shape so that you can actually submit for registration. So it's been a remarkable project. There's a lot of different areas that we've done quite differently than what's normally done. But I think what it ultimately gets us to is it goes back to the team, the ability, the goal setting. But as you can see also on the right-hand side, what's really important is then actually to demonstrate that this type of facility can operate at high level of frequency and actually do that without breaking on either equipment, on the infrastructure, be it pressure, temperature, et cetera, or just on the flow of materials goods, and people through the facility. So what you see on the right hand side is actually a capacity challenge we conducted in the second quarter, where you see literally every one of the product sheet machines running in parallel at that point in time in the facility, which obviously leads us to maximal use, maximal amount of people in the room, maximal flow, pressure on flow, et cetera, of materials, goods, et cetera, through the facility, and really gives you the ability to pressure test identify where you have issues or stress in the system and then actually address that and keep improving from there. So it's been a very successful operations that we had. And the final part comment I'd like to make here is that obviously our range delivery time through all the challenges and logistics through the pandemic was 21 days. We expect that to go down to 16 days at launch. And that actually has to do with the commercial operating model that I'll mention on the next slide, but also on a set of release assays that actually allow us to accelerate and which were all implemented and were implemented as part of the pivotal study and will come to full effect at the time of launch. So preparing for commercial launch, going to slide 22, obviously there are a number of things that we need to sort of really focus on. One is obviously the data and the path to approval, which we have talked about already, expect to file a BLA application by the end of the year and then early next year for the European side manufacturing also needs to be ready needs to be all put together and in in particular when we then look into commercial side we need to obviously have a lot of work or ongoing on the medical affairs side working on the completion of the HDS dossiers and the central onboarding which are really core activities that you need to have in place and it has substantial amount of lead time But then obviously a focus in 2024 to really focus on the actual launch, prep, and execution, and also obviously considerations around commercializations in Europe. Now, one of the things that we did report on on slide 23 is the fact that we have selected Cardinal Health as our U.S. distribution partner. And that is important because actually it allows us to have some of the commercial infrastructure components to be supported and supplied by our partner. And that allows us to sort of focus our activities on the specific bespoke aspects of what we need to do so distribution obviously There's also important because the actual way on how these products move are not really moving technically with change of custody To a distributor and then all of work, but it goes directly ultimately from us to the center but there still has to be obviously an invoice generated there has to be a the center has to be checked and make sure that everything is fulfilled and also there has to be reporting to the government and those are areas where Cardinal will help us and will support us. Same is related to order to cash activities. But I think what's probably more from an operational and ultimately success perspective important is the depot model where we're going to be actually be able to ship products that are manufactured for patients in the U.S. and actually ship them before they're fully released, while they're still in our custody, moving physically from the UK to the US, get fully released in that time. And as soon as the full release is then, the product can then actually be moved from the depot to the center. And that obviously allows us some parallel processing, and that cuts time out of the range of delivery time, which is one of the key contributors to the reduction in range of delivery time that I pointed to in my prior slide. Now, when we look then on slide 24 and 25 is where do we go from here? Obviously, OBSEL in ALL is well on track. It's the primary focus of the company. But obviously, there is quite a lot of opportunity that we see for OBSEL, and we see it in several directions. What this slide summarizes is that the way we think about OBSEL is not just as a single product in ALL, but it is an actual opportunity to develop a franchise around OBSEL. And that is true for OB cell itself, but also from a lifecycle management perspective, actually leading into follow-on products. Two follow-on products are Auto-122, which is a dual-targeting approach, addressing the challenge of relapses driven by loss of significant antigen. And the second is a dual-targeting approach for multiple myeloma, possibly also for autoimmune disease. with an approach that has combined CD19 and with a very sensitive BCMA targeting chimeric antigen receptor. So what we've done basically here is we've taken the CD19 CAR, which we believe is the best-in-class CD19 CAR in the business, from Obicel, and we're combining it in those two additional products with CARs that are highly sensitive for CD22-expressing cells And in fact, tailored to actually give us activity against those cells that have very low levels of CD22 expression as well to make sure that we have a very efficient engagement on cells that even if they're trying to sort of down-modulate CD22 expression. Quite similarly, in multiple myeloma, many of the cells when you analyze patients, you do see that the expression of BCMA can be extremely low. It can be 10, 20, 30 receptors per cell. not thousands, but actually 10, 20, 30 receptors per cell. And that obviously requires a very sensitive meridatogen receptor to tackle those cells and make sure they can be efficiently recognized and taken out. So here the optimization also was on that side, similar to what we've done with the CD22 CAR. And we're combining both of those CARs with the CAR from OB-cell. And that gives us a very interesting set of products, and it gives us applications both on the hemato-oncology side, but also applications that we can choose on the other new slide as well where we're looking to sort of get rid of autoreactive B cell producing plasma cells. So moving to the next slide, this is slide 26. This is the slide you've seen before summarizing The non-Hodgkin's data published at the end of last year, we'll probably keep updating that data, obviously gives us a very high level of activity with OV-cell. And just as a reminder, obviously, in the non-Hodgkin setting, we're actually dosing patients with a single dose and do obviously have a very significant level of clinical activity. Almost all patients achieve metabolic CRs, in many of them sustained over an extended period of time. Very interesting, obviously, what we're seeing in DLD-CL, where we actually see sustained responses and no relapses so far, which is quite remarkable. And also what we're seeing is good levels of persistence also in non-Hodgkin's lymphoma, which is something that hasn't been quite as consistent across the field. The safety has been excellent in all of these indications, and we believe that the safety profile should allow OD cells to actually be used. respective indications as well. Moving to the next slide, slide 27, a quick word on the opportunity we see for OV-cells in autoimmune, beta-mediated autoimmune disease. Many of you have seen the really pioneering work by Georg Schett and Andreas Matheson from the University of Erlangen that was published, obviously, in several papers now that looked at utilizing a CD19 CAR approach in patients with refractory SLE. That's the initial study and then expanded into an additional set of related B-cell-mediated autoimmune diseases. The outcome was quite remarkable because what they basically observed is that the patient lost the autoreactive antibodies as well as clearly the underlying producing cells within a very short period of time. The antibodies typically got cleared within about a month and that clearance actually was sustained over time. So the patient did recover as a consequence of that removal of the autoreactive antibodies and went from very high composite scores to basically baseline. And these are refractory patients. So the outcome was very remarkable, very different from I think anything we've seen in the field based on monoclonal antibodies. I mentioned the fact that Miranda ran the Benlista program, so there's quite a bit of understanding within the company also of autoimmune diseases to the B-cell mediators. This is a different quality of outcome, and you've seen a number of companies start to look at that, et cetera. We believe we're actually extremely well positioned with our product because we obviously do have, as far as we can tell based on our data today, is that we have the safest and probably the most active CD19 CAR in the business. We also have a commercial manufacturing base, and we have an ability to deliver these products reliably and at attractive cost of goods. I think all of these components, I think, are incredibly important if you want to position a CD19 CAR program in ECHO, or any of the related diesel-mediated autoimmune procedures. We will start out with a dose confirmation study. We'll do that in SLE patients, and we will use that then as the basis to discuss the design of a pillable study with the agency. So that's where we are with the program. We expect to get started early next year in dosing patients, and we're really excited, obviously, about the opportunity here. Just as a quick reminder then on the two other programs that are beyond OVCEL in the franchise, I mentioned all the 122. looking to find a way to mitigate CD19-mediated, CD19-loss-mediated relapses. Obviously, we've tested this product, DOLA122, again, in patients that are ineligible for Cumbria, including patients that had actually relapsed after Cumbria therapy with CD19-negative disease, and we can show a very high level of clinical activity that gives us a good level of sustained activity as well as an excellent safety profile. So this product obviously is, I think, doing what we expect it to do and provide sort of an interesting opportunity for investment going forward. Auto8 is the program targeting multiple myeloma. Also, that program is in the clinic. We expect first aid at the end of the year. And clearly, it has a design principle that should allow us to get at these cells with a very low expression of BCMA, but also having the CD19 component and just you know, following, obviously, the conversation on autoimmunity and the fact that there are plasma cells that are CD90 positive. There is also a hypothesis that, in fact, those cells that are CD90 positive plasma cells are the driving cells in multiple myeloma. That's been a hypothesis that was postulated in, actually, the mid-'90s by Dr. Matsui and Tom Hopkins, and it's been one that's been going on for a while in the field, but we believe Also, with the data that we see now in SLE, there is a good chance that that actually has an ability to potentially give us sort of a deeper form of remission and also more sustained presence of the cells that is driven through the CD19 side. Now, finally, on the moving beyond OB cells, obviously, we provided an update at the Lugano-Oden-Koma meeting on ORO4. have seen an excellent continuation of the data. The key data, really, that we were interested in is to see whether the complete remissions that we were able to induce in these patients, whether it was sustained over time. And in fact, we have now two of those patients that have crossed one year, and that starts to give us a lot of confidence in the effect, the clinical effect and benefit that we can actually induce with the serotherapy and obviously There is more data that we're sort of working on that we're also looking to publish the data in a peer-reviewed journal as well. Now, moving just quickly to the pipeline slide on slide 32, obviously there is a significant amount of our programs. As you can see, we do in collaboration and work on the collaboration of UCL and sort of the broader generational program we're running, which has been a very successful collaboration. and also gives us an opportunity to really generate clinical data for future investment decisions so that when we actually are making decisions, what we're going to do beyond OB-Cell and beyond the initial indications really can be based on clinical data and doesn't have to be based on preclinical data, which we believe, unfortunately in this field, do not provide a lot of confidence in terms of the ability to translate the outcomes into patients. So with that, I would like to hand over to Lucy for the financial results.