Q3 2024 Autolus Therapeutics PLC Earnings Call
Okay.
Speaker Change: Hello, Ladies and gentlemen, and welcome to the Altra list Therapeutics call to discuss its third quarter 'twenty 'twenty four financial results and business updates.
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Speaker Change: I would now like to turn the conference over to your host Olivia met Sir. Please go ahead.
Speaker Change: Thanks to send a good morning, or good afternoon, everyone and thanks for joining us on our Q3 'twenty 'twenty four quote today with me today, a doctor Christian <unk>, our Chief Executive Officer, Rob Dulski, Our Chief Financial Officer, and Chris Brown, Our Chief operating officer, I'm, sorry onto slide to our disclaimers as a reminder, during today's.
Speaker Change: Cool, we will make statements related to our business that forward looking under federal Securities laws on 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 or capsule or just manufacturing sales and marketing plans for oral capsule and creating potential.
Simon: Simon the nucleus the market potential for all cut so on the stages of clinical trials and development on the regulatory timelines. So I hope you saw in our other product candidates.
Simon: Shipments 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 on our S.
Simon: T SEC filings, which are both available on the investors section of our website.
Simon: On slide three we have the agenda as usual Christian is 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 my remarks and move on to Q&A as I mentioned, we have crisp on our Chief operating officer also available for Q&A today, so with that I will hand over to Christian.
Christian: Welcome everybody to our Q3 update obviously the big news has been the approval of a capsule which came in.
Christian: At the end of business day last week on Friday, Oh, it's a huge step for the company, but I think also a very important step with NDA and I'll feel providing patients with an additional option.
Christian: In the relapsed or refractory setting.
Christian: What was very interesting to see and I think important with regards to a capsule is that this is the first car T program. There 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.
Christian: With our low level of immunological toxicity and.
Christian: Together with the two reported guidance dosing that we have implemented for the program really provides a program that puts the position in control of the therapy, we believe thats going to be very important to expand the car T use.
Christian: AML indication so very excited about where we are obviously this has been a long journey and.
Christian: Fantastic to be here and as you can imagine.
Christian: A lot of activity at the company I would say to really get the program up and running and the product into the hands of physicians.
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 parties.
Speaker Change: Two actually.
Speaker Change: Deliver these types of therapies the car T therapies.
Speaker Change: 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.
Speaker Change: And authorized to be able to deliver this type of.
Speaker Change: After therapy.
Speaker Change: And that process is query involved it takes them a substantial amount of time in fact, we started the onboarding process of the centers.
Speaker Change: More than a year ago. We have currently about 60 centers are at various stages of the Onboarding process and 30 of those centers are ready to be activated now.
Speaker Change: This gives us an opportunity to really launch from a broad base. Those 30 centers actually reach about 60% of the patients in the U S with relapsed or refractory <unk>.
Speaker Change: Oh.
Speaker Change: As we go through the course of 2025, and we're going to add the additional 30 centers.
Speaker Change: With that that should be able to reach approximately 90% of the target population so very involved process.
Speaker Change: And obviously an area that requires not only obviously a lot of interaction training and support but also a series of systems that you have to be put in place to be able to deliver the product and support the centers appropriately.
Speaker Change: 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, our trader coal and as you note, we have decided or have decided to build our own <unk>.
Speaker Change: Actual manufacturing facility, which we call the nucleus are located here in Stevenage in the UK.
Speaker Change: This facility allows us to actually support the.
Speaker Change: Patients in this indication.
Speaker Change: The capacity that we have earmarked for the AML patients is approximately 2000 products a year that corresponds to about two thirds of the patients that are in the relapsed or refractory stage of their disease in the U S or in Europe.
Speaker Change: We also target a an attractive way 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 have conducted the pivotal study.
Through the pandemic and and also frankly built the facility through the pandemic, we have been able to pressure test pretty much every aspect of the of the product delivery.
Speaker Change: Right that we're going through whether this is logistics, where the basis sell handling where the basis.
Speaker Change: The actual manufacturing process itself.
Speaker Change: What's important to make this happen is that you have a very strong experienced and dedicated team to actually have a successful launch and the experience really comes from several 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 product.
Speaker Change: But we also have team members that have been in prior launches in the ALLL 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 our strong scientific communication, you've seen us present dobra series.
Speaker Change: Of medical conferences over the last 18 18 months until we see more data to come at the Ash meeting coming up within a few weeks' time and we are 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.
Speaker Change: Sharing the information on this important trial.
Speaker Change: We also have been focused very much as we were 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 site so that the same.
Speaker Change: Theres actually can focus on what they need to focus on which is treating the patients and we're taking obviously.
Speaker Change: The role and support to support both the centers are the reimbursement process as well as the patients.
Speaker Change: The overall process.
Speaker Change: We set.
Set the price for the product at $525000. This is based on very extensive.
Speaker Change: 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.
Speaker Change: With that I'd like to go to slide number six.
Speaker Change: 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.
Speaker Change: And that actually was being certainly where the vast majority of the organization was focused on.
Speaker Change: 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 <unk> in the U K.
Speaker Change: As we're working through the submissions that we have made to those two both of those authorities for Ob cell.
Speaker Change: We have also published or presented additional data from the Felix study one.
Speaker Change: Dataset was at the society for hematologic oncology, which was in August and where we're really looking at the rationale and the impact of the tumor burden guidance dosing.
Speaker Change: And then in October after the Q3 period. We also were presenting at the lymphoma leukemia, <unk> Myeloma Congress and.
Speaker Change: But we're really looking at what's the impact.
Speaker Change: <unk> stem cell transplant after Ob sell us.
Speaker Change: As well as the impact of reducing tumor burden prior to length of depletion on outcomes.
Speaker Change: Very important also on the operational side.
Speaker Change: Excellent new team member join US Mathias will ask the Chief Development Officer, and obviously, we continue to obviously.
Speaker Change: Expand both the commercial team as well as obviously driving the onboarding of the treatment centers.
Speaker Change: With that we're going to slide number seven.
Speaker Change: This is just a brief outlook of what we're planning to present at Ash. They are four abstracts that were selected for either poster or oral presentation.
Speaker Change: The first one is looking at the impact of the debt.
Speaker Change: <unk> offer emission.
Speaker Change: Outcome.
Speaker Change: Remember, we already looked at the impact the impact of persistence on outcome, which was the core theme.
For the presentation at Astro This year. This now looks at the other key aspect which is the.
Speaker Change: The ability to get very deep remissions and as Im sure Youre not you'll not be surprised obviously the opportunity to have both a deep molecular remission and putting long 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.
Speaker Change: The second question that we were looking at is really look at the impact of bridging therapies. Both the performance of Ob cell as well as the outcome that we're seeing.
Speaker Change: <unk> patients.
Speaker Change: The third area is looking at a very practical aspect.
Speaker Change: I'm, a clinical perspective, which is the healthcare resource utilization and costs associated with managing both cytokine release syndrome and icons. Those are obviously events that do require a lot of care a lot of oversight.
Speaker Change: Sure.
Speaker Change: Their respective patient and they tie resources.
Speaker Change: 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 <unk>.
Speaker Change: Obviously, having a product that has minimized both crs and icons.
Speaker Change: From a practical perspective as youre looking at it from a clinic perspective here.
Speaker Change: And then finally, we're looking at the impact.
Speaker Change: Outcomes and broader factors that are impacting outcomes that we're seeing in the patients we have obviously already talked about.
Speaker Change: Importance of the tumor burden add linked for depletion. This was a core focus of the ash presentation of 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 patients.
Speaker Change: That would actually give us a sense of how these patients will fare.
Speaker Change: And Ob cell therapy, so thats going to be one of the key questions that will be looked at in the fourth presentation.
Speaker Change: So that kind of wraps up my actual update for the quarter and I will now hand.
Speaker Change: Move over.
Speaker Change: Just a quick outlook on the activities with Ob sell 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 obese child not in isolation as an individual product solely focused on AML, but there were also I would say our.
Speaker Change: Looking to explore the broader utility of the program.
Speaker Change: See aware off that we're conducting.
Speaker Change: A study in pediatric patients with <unk>, but we're also conducting.
Speaker Change: Conducting a study in patients that are have a systemic.
Speaker Change: 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 sell we devised two additional programs at <unk> 22, a dual targeting approach is really designed to suit at <unk>.
Speaker Change: Sure the b cells, very deeply and minimize the ability.
Speaker Change: Either leukemia, <unk> lymphoma cells to escape recognition by the CD 19 receptor by having a second receptor presidency, a second antigen and weight that having an ability to minimize the chances for escape.
Speaker Change: This program as you May remember is part of the option agreement that we have with buy home Tech.
Speaker Change: Secondly, the order a program, which is also a dual targeting program looking at both CD 19 MPC MMA.
Speaker Change: And this program obviously, we've shown initial data in multiple myeloma patients, but we're also looking at for additional uses.
Speaker Change: That go beyond multiple myeloma for this program and we'll update you also as we go into.
Speaker Change: The first half of next year.
Speaker Change: And 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 heart, what type of impact and what level of impact can we see.
Speaker Change: Removing the b cell compartment deeply in particular, removing the CD 19 compartment, which also includes the plasma blasts and one of the areas that we certainly have been watching carefully as we went through the course of this year is.
Speaker Change: The range of patients that are being treated and the impacted you can see understanding there's going to be a tension between the inflammatory part of the process, which these therapies do impacts directly and the actual damage to the tissue actually may already have encountered the fibrosis.
Speaker Change: 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.
Speaker Change: Obviously for the various modalities as we go forward.
Speaker Change: From our own perspective, we're obviously.
Speaker Change: Very keen on based on this 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 a commercial manufacturing.
Speaker Change: <unk> 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 an ALLL. So we're looking forward to updating you on the.
Speaker Change: Phase one part of the systemic lupus program.
Speaker Change: With our first update towards the end of Q1, and then obviously longer term update in the second half of next year and also looking forward to 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.
Speaker Change: Off the ground and obviously, a fantastic place to be and really looking forward to seeing that we can have a real impact in.
Rob Dulski: The lives of those of the ALLL patients that we're looking to support here with that I'm actually moving to slide 11, and our parenting over to Rob.
Rob Dulski: 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.
Rob Dulski: So moving forward onto slide 12.
Rob Dulski: Our cash and cash equivalents at September 32024 totaled.
Rob Dulski: <unk> totaled $657 $1 million as compared to $239 6 million at the end of December 2023.
Rob Dulski: Total net operating expenses for the three months ended September 32024.
Rob Dulski: $67 9 million as compared to $42 9 million for the same period in 2023.
Rob Dulski: 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 32024, compared to that same period in 2023.
Rob Dulski: This change was primarily driven by increases in R&D employee salaries and related costs and.
Rob Dulski: <unk> <unk> clinical trial and manufacturing costs.
Rob Dulski: These were partially offset by a decrease in professional fees and general facility costs.
Rob Dulski: Moving on to our G&A.
Rob Dulski: General and administrative expenses increased from $10 6 million to $27 3 million for the first three months ending for.
Rob Dulski: For the three months ending September 32024, compared to that same period in 2023.
Rob Dulski: This increase was primarily due to salaries and other employment related costs, driven by increased headcount supporting pre commercialization and launch readiness activities.
Rob Dulski: And finally net loss was $82 1 million for the three months ended September 32024, compared to $45 8 million for the same period in 2023.
Rob Dulski: With the recent approval of our cattle in the U S. I'd also like to note two financial milestones that will be triggered in Q4.
Rob Dulski: As a result of the FDA approval <unk> will receive a $30 million milestone payment from Blackstone based on the terms of the Blackstone collaboration agreement.
Rob Dulski: In addition, the company will make a regulatory milestone payment of 10 million pounds Sterling.
Rob Dulski: In accordance with our U C L B license agreement.
Rob Dulski: Or both referred to in more detail under our subsequent events section of Form 10-Q for the third quarter.
Although this estimates that with its current cash and cash equivalents, we are well capitalized to drive the full launch and commercialization of Ob cell and relapsed refractory adult a L. L.
As well as to advance its pipeline plans, which include providing runway and data into the first pivotal study of Ob cell in autoimmune disease.
Christian: I'll now hand back to Christian to wrap up with a brief outlook unexpected milestones Christian.
Christian: Thanks, Rob as already discussed obviously the next key event is going to be the ash annual meeting.
Christian: At the beginning of December looking forward to obviously updating you on the four presentations that I walked you through before.
Christian: We're then obviously looking for initial data from the phase <unk> trial by the end of the first quarter.
And then have additional data from both the pediatric ALLL 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.
Christian: In a separate communication.
Speaker Change: With that I think we're at the point, where we're happy to take questions just Linda please start the Q&A.
Speaker Change: 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 one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please stand by while we compile the Q&A roster.
Speaker Change: Yeah.
Speaker Change: Our first question comes from James Chen at Deutsche Bank. Your line is open.
Hey, good morning, guys.
Speaker Change: Just a couple of questions is <unk> EU approval is still on track for mid 'twenty five or could this be slightly pulled forward and then secondly, looking ahead. There is some real world data showing to cordis can be administered in the outpatient setting and I noticed <unk> has a longer crs.
Speaker Change: Crs onset danine versus the cars a day five so will it be more favorable bolt to outpatient registration. Thank you.
Speaker Change: Hi, James first of all thanks for joining on the <unk> process. We are on track and we expect the timeline.
Speaker Change: Get us.
Speaker Change: To the middle of next year.
Speaker Change: 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 thats. The first I think the first observation.
Speaker Change: I think what's fundamentally is that the safety profile of Ob sell obviously allows you to manage this product with a lot less effort than I think many of the products that has sort of been.
Speaker Change: Generated in the past.
Speaker Change: And one of the.
Speaker Change: Opportunities is particularly for patients who have low disease burden that you can consider.
Speaker Change: Administrating this.
Speaker Change: This product in hospital outpatient setting.
Speaker Change: Obviously this is will require experienced like with any new therapy.
Speaker Change: Similar as it had.
Speaker Change: Back in the day for <unk>, but for other programs.
Speaker Change: And as I think the physicians and health care providers get more experienced with the product I think we're going to see more and more use.
Speaker Change: The hospital outpatient setting for these types of therapies and obviously the safety profile that we have with Ob cell sets it up in a remarkably good way.
Speaker Change: Two sort of actually it looked at this as a real opportunity.
Speaker Change: Our next question.
Speaker Change: Comes from Africa growing more gain extra list. Your line is open.
Speaker Change: Hi, This is <unk> I have two.
Speaker Change: Two questions first one is that the focus the label efficacy to patients with higher <unk>.
Speaker Change: Could you expand on the baseline characteristics that might suggest our default superior efficacy.
Speaker Change: And just like comparing it to FDA label it appears that patients in the study.
Speaker Change: A decade older and had higher incidence of extra medullary disease, how would you account for these differences.
Speaker Change: Second question is with your team achieving one of the highest transaction efficiencies in the industry at 72%.
Speaker Change: How are you maintaining a low out of spec rate in the commercial setting how confident are you in that.
Speaker Change: Thank you.
Speaker Change: Okay. Thanks for joining karina.
Speaker Change: So the first question was related to the activity and the activity also in patients with high disease burden, what we had shown.
Speaker Change: And the more detailed analysis that we had actually discussed at Astro 2023 was that patients that were below the 75% to avert Netherlands depletion.
Speaker Change: <unk>.
Speaker Change: <unk> that was in the range of 85% 86%.
So so clearly indicating that we do have a very high level of activity in patients that that level only when patients actually were at more than 75% to river AD Lim for depletion, which meant basically that these patients were bridging insensitive for refractory.
Speaker Change: That pool of patients you would see actually a drop in Dr or somewhere into the range of.
Speaker Change: 60% range. So so that's sort of the relationship between tumor burden and outcome one of the important elements that we had obviously done with this study is that we did not only confined to study to the morphological cohort of patients, but we added two additional cohorts bundle as a minimal residual disease cohort.
Speaker Change: And the other cohort.
Speaker Change: Were patients that had isolated extra medullary disease, which tend to actually be patients that are typically excluded from clinical trials, because they are notoriously difficult to treat.
Speaker Change: And that tends to perform actually play very poorly.
Speaker Change: Clinical trials.
Speaker Change: As you can see in our overall results and with obviously shown the data is also an integrated datasets as well we do see that the data actually looks good across all of these risk categories of patients.
Speaker Change: And I think that and including a wide range of age.
Speaker Change: We did have a median age of the study that was about 10 years older than what you would have picked up in other studies in the field before so.
Speaker Change: In 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 OSA all of the morphological cohort.
112 patients 11 patients actually passed away before there was any chance to actually dose, which is very unusual normally that's something you don't see you don't see patients actually passed away before you could trade. So it's a very very difficult population that we had in the trial.
Speaker Change: And with that obviously it gives us a lot of confidence both from an efficacy perspective.
Speaker Change: Is that the data is very very robust, but also from a safety perspective. So those are probably a few observation stay with regards to the Irish decorate Youre correct. We do have a very good level of.
Transaction.
Speaker Change: <unk> see that we see in our product.
Speaker Change: Versification, so really sets based on the clinical experience and the manufacturing experienced in our Gen <unk> clinical trials.
Speaker Change: And obviously those were obviously the goalposts that we're used to actually set the specification. So given that obviously, we have specifications that very nicely track our clinical.
Speaker Change: Performance and clinical data, we have a high degree of confidence that we're going to be very reliable.
Speaker Change: From a manufacturing perspective with lower interest rates.
Speaker Change: Our next question.
Speaker Change: Our next question comes from Matthew Phipps of William Blair. Your line is open.
Matthew Phipps: 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 talked about progressive investment maybe just anything else that you think can in general timing there.
Yes. So those are obviously, it's an area we're very actively.
Matthew Phipps: I've been looking into and Allstate are moving forward.
Matthew Phipps: I would hope that we are as we go through the course of the next year that we're going to see obviously additional trials go up.
Speaker Change: And we'll update update you as we go through the first quarter kind of what the trials are going to be activating at the time it Brad.
Speaker Change: But I'll say it very much.
Speaker Change: In front and center for the development organization.
Speaker Change: Advance our activities on the autoimmune side.
Speaker Change: And also push obviously, the currently ongoing trials as well.
Speaker Change: Thanks.
Speaker Change: Quick follow up as Youre looking to enrol the SLE trial do you feel that.
Speaker Change: The biggest gating factor is patient identification or finding capacity at the centers to conduct the upper end of the procedure.
Speaker Change: Yes, we don't see a capacity issue at the centers, we did see we had a.
Speaker Change: A slowdown in enrollment in the summer months, which tend to get a bit slower in Europe, but we're enrolling both in the U K, Spain, but as we're getting into September and then on forward actually the rate picks up nicely.
We don't think that there is actually a limitation there so.
Speaker Change: So we've actually seen very nice levels of engagement.
Speaker Change: A lot of it is also the physicians getting familiar.
Speaker Change: With the approach.
Speaker Change: The product.
Speaker Change: And we're seeing that actually starting to have an impact as well a positive impact.
Speaker Change: So that's I think where we are so we're very much back where we expect it to be and we don't.
Speaker Change: I think there are actually restrictions or limitations in terms of capacity at the centers.
Christian: Alright, Thanks Christian.
Matt: Thanks, a lot Matt.
Speaker Change: Our next question comes from Sebastian vendor shoot at BLK.
Speaker Change: I think thank you for taking my questions.
Speaker Change: First one is on.
Speaker Change: <unk> already on board and ready to be exit can you just clarify whether this onboarding also includes.
Speaker Change: <unk> own internal processes and that they can.
Speaker Change: Now directly order a cotton and then.
Speaker Change: Can you also provide some insight into how many of these centers have been Phoenix study and then on the SLE data can you provide some insights into how many patients and when they were enrolled.
Speaker Change: Over the past year.
Yes, so first off in terms of the centers. So there's sort of two it's a two stage process. The act the actual completion of the Onboarding.
Speaker Change: Is that 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 ahead of the producer or the actual approval date.
Speaker Change: But then once you have the label there is a number of steps that the centers have to go through this the final.
Speaker Change: Our final.
Speaker Change: Training that has to be done.
Speaker Change: From the company perspective, that's actually down very quickly and then the product now being obviously an approved product has to get onto the respective formularies within within the centers and b sort of integrated within the administrative processes at the centers and that.
Speaker Change: Can only be trigger it with a product having received approval before you 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.
Speaker Change: And once that's completed.
Speaker Change: The sensor is activated and then to set that can actually enroll.
Speaker Change: Enrolled its first patient.
Speaker Change: So.
Speaker Change: The process also like with any administrative process is extremely helpful.
Speaker Change: If there is an immediate needs to act.
Speaker Change: And obviously the need to act in many of these centers.
Speaker Change: We're going to be patients that actually are in need of therapy and their suit and are eligible for a car T therapy, and that's obviously, what's going to be a key driver to actually expedite.
Activation process centers. So that's kind of where we are so the 30 centers are going through that activation final steps.
Speaker Change: And we expect to a good number of them to be actually activate it very quickly and vendors.
Speaker Change: A small a certain amount of centers will take maybe a few weeks longer.
Speaker Change: But that process is already is running full steam in that.
Speaker Change: Our team has been all over this.
Speaker Change: This process to make sure we get the centers online as quickly as possible.
Speaker Change: And then the question related to the <unk> study obviously.
Speaker Change: The study got started up in the first half of the year, we indicated that we had enrolled the first patient in.
Speaker Change: Course of the second quarter, which meant that the patients are dosed.
Speaker Change: During the course of the second quarter and then most of the additional patients obviously were enrolled in the second half will be enrolled I'll say the second half of the year with enrollment is expected to be completed in the early part of Q1.
Okay, great. Thank you so much Christian.
Speaker Change: Thanks, a lot.
Our next question comes from Kelly She at Jefferies.
Speaker Change: Hi, This is jose.
Speaker Change: Kelly I just have two questions here. One is can you discuss any kind of feedback you're receiving from physicians regarding takata is this.
Speaker Change: <unk> from clinical trials.
Speaker Change: And what kind of implications on your launch projections and I have a follow up thanks.
Speaker Change: Yes.
Speaker Change: Yes, I think with the interactions that we're having with the with the physicians office has been very intense.
Speaker Change: Doc profile for Ob. So both has been very well received not only by those physicians were part of the <unk> sale.
Speaker Change: CLEC study.
Speaker Change: Which obviously were.
Speaker Change: Patients in the U S and 24 centers.
Speaker Change: But also obviously.
Speaker Change: A lot of the ALLL physicians that we have been speaking to over the last few months <unk> walk through the data 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 is a very much an appreciation.
Speaker Change: Of having a product that is easier to manage less success.
Speaker Change: With that.
Speaker Change: Is it can actually be much more easily integrated from a clinical practice perspective.
Speaker Change: And the handling perspective at the centers.
Speaker Change: I think that's going to be important I think thats also immediately experienced symbol for the physicians.
Speaker Change: And we believe will be a key driver for the uptake of the product, but also provide an opportunity to go into centers that are currently are not yet using car T.
Speaker Change: Old space and use it elsewhere and they will give us a L L.
Speaker Change: To actually have them expand.
Speaker Change: The offering for ALLL patients, including a car T product in the future. So so that's I think where a lot of that I think is resonating.
Speaker Change: Very encouraged with the feedback and we're looking forward to obviously additional interactions that we're going to it has leading up into ash and then obviously at asset sales.
Speaker Change: With the additional updates, which I think provide a lot of important information for treating physicians.
Speaker Change: Also forward decision, making on understanding the profile even more deeply.
Speaker Change: Thank you.
Speaker Change: Our next question is a follow up on the Sally.
Speaker Change: Can you give more colors.
Speaker Change: The patient numbers dose levels.
And what kind of data you're going to disclose park first quarter.
Speaker Change: The second half.
What kind of returns to a Sally Charles.
The safety data you thought in adult Anl.
Especially on your thoughts thank you.
Speaker Change: Yes so.
Speaker Change: The SLE trial that we have set up is really designed to confirm a fixed dose level of 50 million sales.
Speaker Change: The single dose.
Speaker Change: For SMA patients that's sort of the primary purpose.
Speaker Change: Enrolling six patients we have an ability to enroll additional patients over and above.
Speaker Change: The initial cohort of six patients.
Speaker Change: What were 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 the.
Speaker Change: Of this trial, we will have initial data.
Speaker Change: In Q1, which obviously gives us information about the initial behavior of the product.
Speaker Change: Actual activity.
Speaker Change: And what we were 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.
Speaker Change: These patients are doing well.
Start to recover.
Speaker Change: 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 T cell compartment. So those are the key parameters that we're going to be looking at that the differentiation between the earlier in the later time points for data release.
Speaker Change:
Speaker Change: In terms of the safety profile.
Obviously the fundamental.
Speaker Change: The difference that we're seeing with the product is.
Speaker Change: On the acute leukemia side and certainly in the safety profile that is immediately visible.
Speaker Change: And that is obviously also where the original program that was tested at the airline.
Speaker Change: Side, obviously, it was close to <unk> initially in.
Speaker Change: Given the accurate patients where the original data set came from safety data from it also was the experience that define the dose level that was used the patients that are managed at the age group was selected for compassionate use which is where a lot of the early data has been coming from.
Speaker Change: What we do know is today, 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.
Speaker Change: The right product with the right profile for these patients.
With regards to neurological toxicity, obviously, the neurological toxicity, we are seeing in adult patients.
Speaker Change: Patients is very low.
Speaker Change: But we also do see that when we move outside of ALLL.
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.
Speaker Change: Our next question comes from Gill at Needham <unk> Company.
Speaker Change: Hey, good morning.
Speaker Change: Congrats again on the approval just a quick one from us or can you remind us what your strategy is in Europe as it relates to our commercial rollout. Thank you.
Speaker Change: Yes.
In Europe, you have sort of a two stage type of process. One is the regulatory process, which is centralized.
Speaker Change: As to the European Agency <unk>.
Speaker Change: Once you actually go through that process and you receive an approval that's a regulatory approval for the entire EU, but didn't actually have to secure.
Speaker Change: The reimbursement in each one of the country's separately because the health care systems are different and they are separated from each other.
Speaker Change: And that means that you have a country by country launch.
Speaker Change: Typically you would look at Germany as sort of one of the first countries to launch it and then you would actually go from there.
Speaker Change: But it's a really on a country by country basis that you have to negotiate.
Speaker Change: <unk> access.
Speaker Change: And that's kind of the process that will be walking through and obviously as we go through we'll certainly keep you updated on the progress.
Speaker Change: The jurisdictions that we're choosing to go into but that's sort of the general approach that we take from our European launch perspective, it's a country by country.
Speaker Change: Approach that he will have to take to mitigate the product launched.
Speaker Change: Thank you Mr <unk>.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: <unk>.
Speaker Change: Okay.
Speaker Change: Alright.
Speaker Change: I think I think we can move on.
Speaker Change: Our last question comes from Jacob Macau at KBC Securities.
Jacob Macau: Hi, Thanks for taking my question I had a question about the phase one trial for <unk> in the pediatric allo setting I'm. Just curious if you can just give us your view.
Jacob Macau: On your potential differentiation compared to prior to that and how does this fit with your plans for <unk> 2022.
Jacob Macau: Which you previously also tested and the same thing and then I also have a follow up on the 16 day Vantiv release time, you've mentioned previously that there is potential for that to go even lower could you maybe quantify how low you could potentially go.
Speaker Change: So first of all thanks for joining Jack up the first question relates to the phase one study.
Speaker Change: In pediatric patients.
Speaker Change: The question and answer the two answers. The first one is when you aim to get an approval or a label for adult patients. In ALLL. You will also typically have an obligation to develop in children and showed yet activity at the profile of your product in children as well since the regulatory obligation would be negotiated.
Speaker Change: What that trial would look like with the regulators. This is true for the FDA is true for the European Agency, it's true for the MH array. So theres, an element, which is an obligation.
Speaker Change: It is there is the question is around the opportunity and differentiation.
I'd say at this point in time, there is a single product approved for children, which has obviously had a huge impact for for many children over the last eight years or so.
Speaker Change: But there's also I think important to actually have optionality for patients. So thats one of the physicians. So that's one of the elements that I think we're evaluating in pediatrics.
Speaker Change: To see whether indeed.
It makes sense to position.
Speaker Change: <unk> are also in the pediatric setting from a commercial perspective.
Speaker Change: One of the features that we obviously have with the product as a high level of consistency in the product.
Speaker Change: And obviously the data we have in the pediatric patients has been very attractive.
Speaker Change: Both from an activity persistence long term outcome as well as safety perspective.
Speaker Change: So that's an assessment that we're going to make once we have the full dataset.
Speaker Change: But I think there is likely also an opportunity there and we'll need to evaluate as we have more data from the study.
Speaker Change: We sort of see that opportunity versus <unk>.
Speaker Change: The other indications that we can go into.
Speaker Change: And then the second question was related to the vein to the release time of.
Speaker Change: 60 days.
Speaker Change: One of the key drivers that we have from a time perspective.
Speaker Change: Is actually the release process of testing the.
Speaker Change: <unk> part of the test actually relates to the stability testing.
Any any change in technology approach, who can take to simplify shorten.
Speaker Change: Our shortened the sterility test.
Speaker Change: Also have a major impact on the turnaround time with looking at anywhere from.
Speaker Change: Two to three days after appropriate five five day difference.
Speaker Change: The turnaround time, so it's a very significant has a very significant impact at the same time.
Speaker Change: You basically have to prove a negative.
Speaker Change: So in other words he has obviously very few events.
Speaker Change: Derivative items, because you're operating in in a clean room environment and highly controlled environment and so the.
Speaker Change: The technical challenges to demonstrate the negative and Thats also why this will take some time away some of the additional technology, we're evaluating two.
Speaker Change: We have sufficient data to statistically actually demonstrate that indeed.
Speaker Change: Shorter approach at times approach.
Speaker Change: Would actually give you the right level of outcome compared to the standard plate based testing, which is sort of the standard methodology that ease of use of the space.
Speaker Change: Okay. Thank you.
Speaker Change: I think we lost you there Jacob.
Speaker Change: Can you hear me.
Speaker Change: Yes Jacob.
Speaker Change: Now you're back yes.
Speaker Change: Sorry, My line of somebody coming up I, just wanted to hear about your.
Speaker Change: Spectation on your SG&A and R&D costs in 2025.
Speaker Change: Okay Brook, I think Thats one for you.
Brook: Yes, Hi, Jacob Thanks for the question.
Brook: We haven't given formal guidance in terms of expense and runway into 2025, if you look.
Brook: Certainly at the quarter over quarter changes for this year.
Brook: You see.
Brook: Especially on the SG&A side a ramp.
Brook: I noted in the.
Brook: <unk>.
Brook: In the remarks really driven by the build out of the commercial team and the launch readiness activities.
Brook: That team in general in the U S.
Brook: It's fairly established as we kind of exit Q3 going into Q4.
Brook: Recall, there are second wave of centers that are going to be coming in.
Brook: 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.
Brook: But for the most part the team is fairly established as we kind of end the year here.
Speaker Change: Okay. Thank you.
Speaker Change: This concludes the question answer session I would now like to turn it back to Christian for closing remarks.
Speaker Change: Okay.
Christian: Thanks, everyone at Lax launches Linda So first of all thanks, a lot for joining everybody. This is obviously a second call in a row. So appreciate you coming in and looking forward to seeing you at the ash hopefully at the at the upcoming conference.
Christian: I can only say that we're I would say usually excited kind of where we are.
Christian: Looking forward to.
Christian: Drive the 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 ended the year end 2025, thanks, a lot for joining and hopefully see you soon.
Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.