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spk11: Hello, ladies and gentlemen, and welcome to the Altalist Therapeutics call to discuss this third quarter 2024 financial results and business updates. 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Olivia Mansour. Please go ahead.
spk01: Thanks, Jacinda. Good morning or good afternoon, everyone, and thanks for joining us on our Q3 2024 call today. With me today are Dr. Christian Eiten, our Chief Executive Officer, Rob Dolski, our Chief Financial Officer, and Chris Van, our Chief Operating Officer. So on to slide two, our disclaimers. As a reminder, 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 expected timing for the commercial launch of Orcatzel, Autoless manufacturing sales and marketing plans for Orcatzel, including potential refinements at the Nucleus, the market potential for Orcaxel and the status of clinical trials and development and or regulatory timelines for Obicel 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 on 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, which are both available on the investor section of our website. So on slide three, we have the agenda. As usual, Christian's going to give you an overview of our operational highlights. Rob will discuss the financial results, and we will then conclude with upcoming milestones and closing remarks and move on to Q&A. As I mentioned, we have Chris Fan, our Chief Operating Officer, also available for Q&A today. So with that, I will hand over to Christian.
spk08: Welcome, everybody, to our Q3 update. Obviously, the big news has been the approval of a capsule, which came in at the end of business day last week on Friday. Obviously, a huge step for the company, but I think also a very important step within the ALL field, providing patients with an additional option in the relapsed or refractory setting. What was very interesting to see and I think important with regards to a capsule is that this is the first CAR T program that was actually approved without a requirement for a REMS program by the FDA. And I believe this is obviously linked to the unusual mechanism of action that we have to combine the high level of activity together with a low level of immunological toxicity and in a together with the Tumor-verted guidance dosing that we have implemented for the program really provides a program that puts the physician in control of the therapy. We believe that's going to be very important to expand the CAR T use in the ALL indication. So, very excited about where we are. Obviously, this has been a long journey and, you know, fantastic to be here and, as you can imagine, a lot of activity at the company, obviously, to really get the program off and running and the product into the hands of physicians as we go through the next few weeks. So with that, I'd like to move to slide number five and just talk about some of the key elements that really drive the launch and are critical for the success of the launch. The first part is to actually deliver these types of therapies, the CAR-T therapies, you require actually quite a number of elements that have to be in place. The first one is that the centers obviously have to be ready and authorized to be able to deliver this type of a therapy. And that process is very involved. It takes a substantial amount of time. In fact, we started the onboarding process of the centers more than a year ago. We have currently about 60 centers at various stages of the onboarding process. and 30 of those centers are ready to be activated now. This gives us an opportunity to really launch from a broad base. Those 30 centers actually reach about 60 percent of the patients in the U.S. with relapsed or refractory ALL. As we go through the course of 2025, then, we're going to add the additional 30 centers, and with that, should be able to reach approximately 90 percent of the target population. So very involved process and obviously an area that requires not only obviously a lot of interaction, training, and support, but also a series of systems that have to be put in place to be able to deliver the product and support the centers appropriately. Now the other aspect, which is very important of course for CAR T therapies is that we have a personalized therapy. And so the manufacturing process, the reliability around it, the robustness of that manufacturing as well as the turnaround time are critical. And as you know, we have decided or had decided to build our own commercial manufacturing facility, which we call the nucleus located here in Stevenage in the UK. And this facility allows us to actually support the patients in this indication. The capacity that we have earmarked for the ALL patients is approximately 2,000 products a year. That will correspond to about two-thirds of the patients that are in the relapsed or refractory stage of their disease in the US or in Europe. We also target an attractive vein to release time of 16 days, which will obviously be improved over time, but it gives us a very robust platform to work from. And as we had conducted the pivotal study through the pandemic and also, frankly, built the facility through the pandemic, we have been able to pressure test pretty much every aspect of the product delivery route that we're going through, whether this is logistics, whether this is cell handling, whether this is the actual manufacturing process itself. Now, what's important to make this happen is that you have a very strong, experienced, dedicated team to actually have a successful launch. And the experience really comes from several sides. On the one hand, on the commercial team side, we have A lot of our team members who have actually in the past launched CAR-T products, but we also have team members that have been in prior launches in the ALL field, which gives us both a CAR-T experience within the team as well as an indication experience and relationships to the centers, which are very important. We're building on a strong scientific communication. You've seen us present over a series of medical conferences over the last 18 months, and obviously more data to come at the ASH meeting coming up within a few weeks' time. And we're also gearing up to obviously presenting and publishing the results in a peer-reviewed journal as well, which I think will be a next important step on sharing the information of this important trial. We also have been focused very much as we're setting up our systems and thought through the processes and how we engage with the centers to ensure that the way the centers can engage with us is as simple and straightforward as possible, moving as much work away from the center onto our side so that the centers actually can focus on what they need to focus on, which is treating the patients. And we're taking, obviously, the role and support to support both the centers, the reimbursement process, as well as the patients in the overall process. We've set the price for the product at $525,000. This is based on very extensive work on the value of the product, the clinical evidence, the differentiated safety profile, and also making sure that it is a price level that actually would allow us and allow the product to achieve broad coverage, and with that, access for patients. With that, I'd like to go to slide number six. On slide number six, just a few points of additional updates of activities that happened during the third quarter. Obviously, as you can imagine, the primary focus in the third quarter was really to get launch ready. And that actually has been certainly where the vast majority of the organization was focused on. Now, while we were doing that, obviously with a focus to launching in the U.S., we were also heavily engaged in the interactions with the regulatory authorities in Europe as well as the MHRA in the U.K. as we're working through the submissions that we have made to both of those authorities for OVCEL. We've also published or presented additional data from the FELIX study. One data set was at the Society for Hematologic Oncology, which was in August, and where we were really looking at the rationale and the impact of the tumor burden guided dosing. And then in October after the Q3 period, we also were presenting at the Lymphoma Leukemia Myeloma Congress And what we're really looking at was the impact of stem cell transplant after OB cell use, as well as the impact of reducing tumor burden prior to lymphodepletion on outcomes. Now, very important also on the operational side, I had an excellent new team member join us, Matthias Will, as the Chief Development Officer. And obviously, we continue to obviously expand both the commercial team as well as obviously driving the onboarding of the treatment centers. With that, we're going to slide number seven. This is just a brief outlook of what we're planning to present at ASH. There are four abstracts that were selected for either poster or oral presentation. The first one is looking at the impact of the depth of remission on outcome. You remember we already looked at the impact of persistence on outcome, which was the core theme for the presentation at ASCO this year. This now looks at the other key aspect, which is the ability to get very deep remissions. And as I'm sure you'll not be surprised, obviously the opportunity to have both a deep molecular remission and putting long-term pressure on the leukemia, we believe both of those are relevant to induce long-term outcomes in this very challenging patient population. The second question that we're looking at is really look at the impact of bridging therapies on both the performance of OB cell as well as the outcome that we're seeing for patients. The third area is looking at a very practical aspect from a clinical perspective, which is the healthcare resource utilization and costs associated with managing both cytokine belief syndrome and ICANNs. Those are obviously events that do require a lot of care, a lot of oversight for the respective patient. And they tie resources. And certainly for some of those events can tie resources for quite long periods of time. And we're looking at that impact and the impact of obviously having a product that has minimized both CRS and ICANNs from a practical perspective as you're looking at it from a clinic perspective here. And then finally, we're looking at the impact on outcomes and what are factors that are impacting outcomes that we're seeing in the patients. We have obviously already talked about the importance of the tumor burden and lymphodepletion. This was a core focus of the ASH presentation last year in 2023. What we're now looking at is actually whether there are any parameters that we can actually identify upfront at the time of screening the patient. that would actually give us a sense of how this patient will fare on an OB cell therapy. So that's going to be one of the key questions that will be looked at in the fourth presentation. So that kind of wraps up my actual update for the quarter, and I will now actually move over to just a quick outlook on the activities with OB cell moving to slide number nine. This is a slide that you've seen before, and it just highlights the fact that we're obviously are developing OB-GEL not in isolation as an individual product solely focused on ALL, but that we're also obviously are looking to explore the broader utility of the program. You're obviously aware of that we're conducting a study in pediatric patients with ALL, but we're also conducting a study in patients that are has systemic lupus, and that study is obviously ongoing as well. We're looking to broaden those activities as we go through the course of next year. And building on the properties that we have seen with OB cell, we devised two additional programs, OTO-122, a dual targeting approach. It's really designed to sort of capture the B cells very deeply and minimize the ability of either leukemic or lymphoma cells to escape recognition by the CD19 receptor by having a second receptor present, seeing a second antigen, and with that having an ability to minimize the chances for escape. This program, as you may remember, is part of the option agreement that we have with BioNTech. Secondly, the AutoA program, which is also a dual targeting program looking at both CD19 and BCMA. And this program, obviously, we've shown initial data in multiple myeloma patients, but we're also looking for additional uses that go beyond multiple myeloma for this program, and we'll update you also as we go into the first half of next year. Finally, just on slide number 10, obviously we're just ahead of the ACR meeting, which will take place in just a few days now. And we're obviously going to look for a lot of the updates that we're seeing in the field of what type of impact and what level of impact can we see removing the B cell compartment deeply, in particular removing the CD19 compartment, which also includes the And one of the areas that we certainly have been watching carefully as we went through the course of this year is the range of patients that are being treated and the impact that you can see, understanding there's going to be a tension between the inflammatory part of the process, which these therapies do impact directly, and the actual damage that the tissue actually may already have encountered, the fibrosis that patients may already have picked up. which obviously is the second component of the disease. And we're looking at the relationship between those two, and we're looking at the various outcomes, obviously, for the various modalities as we go forward. From our own perspective, we're obviously very keen on this approach. We think the product has a unique positioning in the space, also now with the approval for the product, but also having now commercial manufacturing available to the product, which is certainly a standalone feature at this point in time in the field, and building obviously on the excellent safety profile that we've seen in what certainly is the most challenging disease population to work with in ALL. So, we're looking forward to updating you on the phase one part of the systemic lupus program. with a first update towards the end of Q1 and then obviously a longer term update in the second half of next year. And also looking forward to sort of talking to you about the broadening of our activities from an indication perspective as well, which we're really excited about. But today is the focus on the approval, the focus on getting the launch off the ground and obviously a fantastic place to be and really looking forward to seeing that we can have a real impact in the lives of the ALL patients that we're looking to support here. With that, I'm actually moving to slide 11, and I'm handing over to Rob.
spk10: Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the third quarter of 2024. So moving forward onto slide 12, Our cash and cash equivalents at September 30th, 2024 totaled $657.1 million as compared to $239.6 million at the end of December 2023. Total net operating expenses for the three months ending September 30th, 2024 were $67.9 million as compared to $42.9 million for the same period in 2023. Breaking that down for our research and development expenses, these increased from $32.3 million to $40.3 million for the three months ending September 30, 2024, compared to that same period in 2023. This change was primarily driven by increases in R&D employee salaries and related costs and OB cell clinical trial and manufacturing costs. These were partially offset by a decrease in professional fees and general facility costs. Moving on to our G&A, general administrative expenses increased from $10.6 million to $27.3 million for the three months ending September 30, 2024, compared to that same period in 2023. This increase was primarily due to salaries and other employment-related costs, driven by increased headcounts supporting pre-commercialization and launch readiness activities. And finally, net loss was $82.1 million for the three months ended September 30, 2024, compared to $45.8 million for the same period in 2023. With the recent approval of Alcatel in the U.S., I'd also like to note two financial milestones that will be triggered in Q4. As a result of the FDA approval, Autolus will receive a $30 million milestone payment from Blackstone based on the terms of the Blackstone Collaboration Agreement. In addition, the company will make a regulatory milestone payment of 10 million pounds sterling in accordance with our UCLB license agreement. These are both referred to in more detail under our subsequent events section of Form 10-Q for the third quarter. AutoList estimates that with its current cash and cash equivalents, we are well-capitalized to drive the full launch and commercialization of ObieCell in relapsed refractory adult ALL, as well as to advance its pipeline plans, which include providing runway and data into the first pivotal study of ObieCell in autoimmune disease. I'll now hand back to Christian to wrap up with a brief outlook on expected milestones. Christian?
spk08: Thanks, Rob. As already discussed, obviously the next key event is going to be the ASH annual meeting at the beginning of December. Looking forward to obviously updating you on the four presentations that I walked you through before. We're then obviously looking for initial data from the Phase I SLE trial by the end of the first quarter. and then have additional data from both the pediatric ALL as well as the longer-term observation of the phase one patients in the second half of the year. We're obviously looking forward to adding additional clinical activity as we go through the course of the year, and we'll update you in a separate communication. With that, I think we're at the point where we're happy to take questions. Jacinda, please start the Q&A.
spk11: Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from James Shen at Deutsche Bank. Your line is open.
spk04: Hey, good morning, guys. Just a couple questions. Is Obacil's EU approval still on track for mid-25, or could this be slightly pulled forward? And then secondly, looking ahead, there's some real-world data showing Tocardis can be administered in the outpatient setting, and I noticed Obacil has a longer CRS onset, like day 9 versus Tocardis at day 5. So wouldn't it be more favorable to outpatient administration? Thank you.
spk08: Hi, James. First of all, thanks for joining on the EU process. We're on track and we expect the timeline to get us into the middle of next year. And as well as when we look at the UK timing, we expect to be that very similar in terms of the overall time point for hopefully an approval in both of those jurisdictions. So that's the first, I think, the first observation. I think what's fundamental is that the safety profile of Obicel obviously allows you to manage this product with a lot less effort than I think many of the products that have sort of been generated in the past. And one of the opportunities is particularly for patients that have low disease burden that you can consider administrating this product in a hospital outpatient setting. Now, obviously, this will require experience, like with any new therapy, similar as it had back in the day for Blinzaito and had for other programs. And as I think the physicians and the healthcare providers get more experience with the product, I think we're going to see more and more use in a hospital outpatient setting for these types of therapies. And obviously, the safety profile that we have with Obicel sets it up in a remarkably good way to sort of actually look at this as a real opportunity.
spk11: Our next question comes from Astika Goonwardane at Truist. Your line is open.
spk03: Hi, this is Karina for Astika. I have two questions. First one is, the FDA focused the labels efficacy to patients with higher blast counts. Could you expand on the baseline characteristics that might suggest OB-SOL superior efficacy? And just like comparing the two FDA labels, it appears that patients in the TELIC study were a decade older and had higher incidence of extra metabolic disease. How would you account for these differences? And second question is, with your team achieving one of the highest reduction efficiencies in the industry at 72%, how are you maintaining a low out-of-spec rate in the commercial setting? How confident are you in this? Thank you.
spk08: Okay, thanks for joining, Karina. So the first question was related to the activity and the activity also in patients with high disease burden What we had shown in the more detailed analyses that we had actually discussed at ASCO 2023 was that patients that were below the 75% tumor burden of lymphodepletion reached a ORR that was in the range of 85%, 86%. So clearly indicating that we do have a very high level of activity in patients at that level. only when patients actually had more than 75% tumor burden and lymphodepletion, which meant basically that these patients were bridging in sensitive or refractory. That pool of patients, you would see actually a drop in the ORR somewhere into the range of the 60% range. So that's sort of the relationship between tumor burden and outcomes. One of the important elements that we had obviously done with this study is that we did not only confine the study to the morphological cohort of patients, but we added two additional cohorts. One was a minimal residual disease cohort, and the other cohort were patients that had isolated extramedullary disease, which tend to actually be patients that are typically excluded from clinical trials because they're notoriously difficult to treat. and they tend to perform actually very poorly on clinical trials. As you can see in our overall results, and we've obviously shown the data as also an integrated data set as well, we do see that the data actually looks good across all these risk categories of patients. And I think that including a wide range of age, we did have a median age in the study that was about 10 years older than what he would have picked up in other studies in the field before. So in and of itself indicating a very challenging population and further highlighted by the fact that, as you can see when you look at the label, that obviously on the morphological cohort out of 112 patients, 11 patients actually passed away before there was any chance to actually dose them, which is very unusual. Normally that's something you don't see. You don't see patients actually pass away before you could treat. So it's a very, very difficult population that we had in the trial. And with that, obviously, it gives us a lot of confidence, both from an efficacy perspective, that the data is very, very robust, but also from a safety perspective. So those are probably a few observations there. With regards to the iris spec rate, you're correct. We do have a very good level of transaction efficiency that we see in our product. Specifications are really set based on the clinical experience and the manufacturing experience you had during clinical trials. And obviously, those were obviously the goalposts that were used to actually set the specifications. So given that, obviously, we have specifications that very nicely track our clinical performance and clinical data, we have a high degree of confidence that we're going to be very reliable from a manufacturing perspective with low-end spec rates.
spk11: Our next question comes from Matthew Phipps at William Blair. Your line is open.
spk06: Hi, Chris. Thanks for taking my call. I was wondering if you had any general timelines or thoughts around opening up baskets for additional autoimmune indications. I know you've talked about progressive MS, but maybe just anything else that you're thinking in general timing there.
spk08: Yeah, so those are obviously an area we're very actively looking into and obviously are moving forward. I would hope that as we go through the course of next year that we're going to see, obviously, additional trials go up. And we'll obviously update you as we go through the first quarter, kind of what trials are that we're going to be activating and the time at random. But obviously, very much in front and center for the development organization to sort of advance our activities on the autoimmune side and also push obviously the currently ongoing trials as well.
spk06: Thanks. And just one quick follow-up. As you're looking to enroll this SLE trial, do you feel that the biggest gating factor is patient identification or finding capacity at the centers to conduct the procedures?
spk08: Yeah, we don't see a capacity issue at the centers. We had a slowdown in enrollment in the summer months, which tend to get a bit slower in Europe. We were enrolling both in the UK and in Spain. But as we're getting into September and then on forward, actually the rate picked up nicely. And we don't think that there is actually a limitation there. So we've actually seen very nice levels of engagement. A lot of it is also the physicians getting familiar with the approach and the product, and we're seeing that actually starting to have an impact as well, a positive impact. So that's, I think, where we are. So we're very much back where we expect it to be, and we don't think there are actually restrictions or limitations in terms of capacity at the centers.
spk06: Great. Thanks, Christian.
spk08: Thanks a lot, Matt.
spk11: Our next question comes from Sebastian Vanderschoot at VLK.
spk05: Hi, team. Thank you for taking my questions. First one is on the 30 centers that are already onboarded and ready to be activated. Can you just clarify whether this onboarding also includes the center's own internal processes and that they can now directly order a cut seal? And then can you also provide some insight into how many of these centers have been involved in the Felix study? And then on the SLE data, can you provide some insights into how many patients and when they were enrolled over the past year?
spk08: Thank you. Yes. So first off, in terms of the centers, so it's a two-stage process, the actual completion of the onboarding. There is a large amount of the activities that you can actually do before you actually have your label in place. And those activities were all completed for these 30 centers ahead of the PDUFA or the actual approval date. But then once you have the label, there is a number of steps that the centers have to go through. There's a final training that has to be done. from the company perspective, that's actually done very quickly. And then the product now being obviously an approved product has to get onto the respective formularies within the centers and be sort of integrated within the administrative processes at the centers. And that can only be triggered with a product having received approval before and you cannot actually also do those steps. So the process actually that we're talking about now is really those final administrative processes that have to be completed at the level of the center. And once that's completed, the center is activated, and then the center can actually enroll its first patient. So the process also, like with any administrative process, is extremely helpful if there is an immediate need to activate And obviously the need to act in many of these centers are going to be patients that actually are in need of therapy and are eligible for a CAR T therapy. And that's obviously what's going to be a key driver to actually expedite the activation process at the centers. So that's kind of where we are. So the 30 centers are going through that activation, final steps. And we expect a good number of them to be actually activated very quickly. And then there's a A certain amount of centers will take maybe a few weeks longer, but that process is already running full steam, and our team has been all over this process to make sure we get these centers online as quickly as possible. And then the question related to the SLE study. The study got started up in the first half of the year. We indicated that we had enrolled the first patient in the course of the second quarter, which meant that the patient got dosed during the course of the second quarter. And then most of the additional patients obviously were enrolled in the second half and will be enrolled also in the second half of the year with enrollment expected to be completed in the early part of Q1.
spk05: Okay, great. Thank you so much, Christian.
spk08: Thanks a lot.
spk11: Our next question comes from Kelly Shee at Jefferies.
spk02: Hi, this is Hanfei Fu on for Kelly. I just have two questions here. One is, can you discuss any kind of feedback you're receiving from physicians regarding tachyotis via OB cell from clinical trial clearance and what kind of implications on your launch projection? And I have a follow-up. Thanks.
spk08: Yeah, I think with the interactions that we're having with the physicians obviously has been very intense. The product profile for Obicel has been very well received, not only by those physicians who were part of the Obicel Felix study, which obviously were physicians in the US in 24 centers. but also obviously a lot of the ALL physicians that we have been speaking to over the last few months and also work through the data, a key activity that the medical affairs team has been engaged in. So it's very good reception for the product. I think there is an appreciation of the differentiation of the profile. I think there's very much an appreciation of having a product that is easier to manage, less toxicity, and with that, can actually be much more easily integrated from a clinical practice perspective and a handling perspective at the centers. I think that's going to be important. I think that's also immediately experienceable for the physicians, and we believe will be a key to whatever for the uptake of the product, but also provide an opportunity to go into centers that are currently are not yet using CAR-T and the ALL space. They use it elsewhere, but may not yet use it in ALL to actually have them expand the offering for ALL patients, including a CAR-T product in the future. So that's, I think, where a lot of that, I think, is resonating and very encouraged with the feedback. And we're looking forward to, obviously, additional interactions that we're going to have leading up into ASH and then, obviously, at ASH itself, with the additional updates, which I think provide a lot of important information for treating physicians, also for decision-making and understanding the profile even more deeply.
spk02: Thank you. And my next question is a follow-up on the SLE. Can you give more colors on the patient numbers, dose levels, and what kind of data you're going to disclose in the first quarter versus the second half? and what kind of read-throughs to SLE trials from the safety data you got in adult ENL, especially on the NeuroTox? Thank you.
spk08: Yeah, so the SLE trial that we have set up is really designed to confirm a fixed dose level of 50 million cells as a single dose. for SLE patients. That's sort of the primary purpose. We're enrolling six patients. We have an ability to enroll additional patients over and above, but the initial cohort is six patients. What we're looking to in this cohort is obviously we're looking for the impact on the inflammatory component of the process. That's the primary purpose of this trial. We will have initial data in Q1, which also gives us information about the initial behavior of the product, initial activity, and what we're going to get in the second half of the year is the longer-term follow-up, which we believe will be important to understand also how these patients are doing once the B cells start to recover, which is sort of at the back end of the treatment and one of the key things to sort of understand whether indeed there was a proper reset of the B cell compartment. So those are the key parameters that we're going to be looking at and the differentiation between the earlier and the later kind of point for data release. In terms of the safety profile, obviously the fundamental difference that we're seeing with the product is on the acute leukemia side, it's certainly in the safety profile that it's immediately visible. And that is obviously also where the original program that was tested at the Erlangen site obviously was close to Kymriah, was initially given in pediatric patients where the original data set came from and safety data came from. It also was the experience that defined the dose level that was used, the patients that were managed, and the age group that was selected for compassionate use, which is where a lot of the early data has been coming from. What we do know is that our product obviously stacks up very, very well from a safety perspective against that program. And that gives us a lot of confidence that indeed we have the right product with the right profile for these patients. With regards to neurological toxicity, obviously the neurological toxicity we're seeing in adult patients as well as in pediatric patients is very low. But we also do see that when we move outside of ALL, and go into non-Hodgkin's lymphoma, we have no neurological toxicity observed in those patients. And that gives us, again, a lot of confidence that, indeed, the product has a very good profile for this patient population.
spk11: Our next question comes from Jill Blow at Needham & Company.
spk09: Hey, good morning, and congrats again on the approval. Just a quick one from us. Can you remind us what your strategy is in Europe as it relates to commercial rollout? Thank you.
spk08: Yeah. In Europe, you have sort of a two-stage type of process. One is the regulatory process, which is centralized and goes to the European agency. Once you actually go through that process and you receive an approval, that's a regulatory approval for the entire EU. But you then actually have to secure the reimbursement in each one of the countries separately because the healthcare systems are different and they're separated from each other. And that means that you have a country-by-country launch. Typically, you would look at Germany as sort of one of the first countries to launch in, and then you would actually go from there. But it's really on a country-by-country basis that you have to negotiate a reimbursement and access. And that's kind of the process that we'll be walking through. And obviously, as we go through, we'll certainly keep you updated on the progress and on the jurisdictions that we're choosing to go into. But that's sort of the general approach that you take from a European launch perspective. So it's a country-by-country approach that you will have to take to really get the product launched. Thank you. Just a question. Okay. Chris? All right. I think we can move on.
spk11: Our last question comes from Jacob McHale at KVC Securities.
spk07: Hi there, and thanks for taking my question. I had a question about the Phase 1 trial for OB-Cell in the pediatric ALL setting. I'm just curious if you can just give us your view on your potential differentiation compared to prior there. And how does this sit with your plans for also one 2022, which you previously also tested in the same setting? And then I also have a follow-up on the 16-day vein to release time. You've mentioned previously that there's potential for that to go even lower. Could you maybe quantify how low you could potentially go?
spk08: So first off, thanks for joining, Jacob. The first question relates to the phase one study in pediatric patients. The question has two answers. The first one is when you aim to get an approval or a label for adult patients in ALL, you will also typically have an obligation to develop in children and show the activity and the profile of your product in children as well. So there's a regulatory obligation, and you negotiate what that trial would look like with the regulators. This is true for the FDA. It's true for the European agency. It's true for the MHRA. So there is an element which is an obligation. The second is, the question is around the opportunity and differentiation. Obviously at this point in time, there's a single product approved for children, which obviously has had a huge impact for many children over the last eight years or so. But there's also, I think, important to actually have optionality for patients. So that's one of the, and physicians. So that's one of the elements that I think we're evaluating in pediatrics to see whether indeed it makes sense to position an OB cell also in the pediatric setting from a commercial perspective. One of the features that we obviously have with the product is a high level of consistency in the product. And obviously the data that we have with the pediatric patients has been very attractive, both from an activity, persistent, long-term outcome, as well as safety perspective. So that's an assessment that we're gonna make once we have the full data set in. But I think there is likely also an opportunity there and we'll need to evaluate as we have more data from the study on how we sort of see that opportunity versus frankly other indications that we can go into. And then the second question was related to the vented release time of 16 days. One of the key drivers that we have from a time perspective is actually the release process of the testing. The longest part of the test actually relates to the sterility testing. And any change in technology approach you can take to simplify, shorten, or shorten the sterility test. would also have a major impact on the turnaround time. We're looking at anywhere from two to three days up to probably a five-day difference in the turnaround time. So it's a very significant impact. At the same time, you basically have to prove a negative. In other words, you have obviously very few events, sterility events, because you're operating in a clean room environment, a highly controlled environment. And so the technical challenge is to demonstrate the negative, and that's also why this will take some time with some of the additional technology we're evaluating to have sufficient data to statistically actually demonstrate that indeed a shorter approach, a timed approach, would actually give you the right level of outcome compared to the standard plate-based testing, which is sort of the standard methodology that is still used in the space.
spk07: OK, thank you.
spk08: I think we lost you there, Jacob.
spk07: Can you hear me now or not? Yes, Jacob.
spk08: Now we can. Yeah. Now you're back.
spk07: Yeah. Okay. Sorry. My line was probably cutting off. I just wanted to hear about your expectations on your SG&A and R&D costs in 2025. Okay.
spk08: Rob, I think that's one for you.
spk10: Yeah. Hi, Jacob. Thanks for the question. We haven't given formal guidance in terms of expense and runway into 2025. If you look certainly at the quarter over quarter changes for this year, you see, you know, especially on the SG&A side, a ramp noted in the remarks really driven by the build out of the commercial team and the launch readiness activities. That team in general in the U.S., you know, is fairly established as we kind of exit Q3 going into Q4. Recall there are a second wave of centers that are going to be coming in as well next week or next year growing from the 30 to 60. So there are some modest growth that goes along with that continued expansion. But for the most part, the team is fairly established as we kind of end the year here.
spk07: Okay, thank you.
spk11: This concludes the question and answer session. I would now like to turn it back to Christian for closing remarks.
spk08: Thanks, everyone. Thanks a lot, Jacinda. First of all, thanks a lot for joining everybody. This is obviously the second call in a row, so I appreciate you coming in. Looking forward to seeing you at ASH, hopefully, at the upcoming conference. And I can only say that we're obviously hugely excited kind of where we are. Looking forward to obviously drive a launch with as much enthusiasm and energy that we can muster. And I think we're going to be in for a very attractive, very interesting end of the year and 2025. Thanks a lot for joining and hopefully see you soon.
spk11: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
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