2023 Autolus Therapeutics plc Earnings Call

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Operator: Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics call to discuss the full year 2023 financial results and business updates. At this time, all participants are in listen-only mode.

Hello, ladies and gentlemen, and welcome to the auto.

<unk> call to discuss the full year 'twenty three financial results and business updates at this time all participants are in listen only mode. After the Speakers' remarks, there'll be a question and answer session to ask a question at that time. Please press star one one on your Touchtone telephone.

Operator: After the speaker's remarks, there will be a question and answer session. To ask a question at that time, please press star 11 on your touchtone telephone. As a reminder, this conference call is being recorded. I would like to turn the conference over to your host, Olivia Manser. Please do so.

This conference call is being recorded.

I would like to turn the conference over to your host Olivia Mansour. Please go ahead.

Olivia Manser: Thank you. Thanks, Michelle. Good morning or good afternoon, everyone.

Thanks, Michele good morning, Olga afternoon, everyone. Thanks for joining us on today's call with me odd Christian Igen, our Chief Executive Officer, and Rob Belsky, Our Chief Financial Officer.

Christian Martin Itin: So we provided at ASH actually the totality of the data, and we believe that is important because that actually reflects the continuum of tumor burden and risk categories that physicians are facing when dealing with adult ALL patients, and in that regard, represents a proper cross-section of the patient population. And obviously, as you may remember, and we'll talk about a bit in further detail in the upcoming slides, obviously, we've shown very significant, very meaningful clinical activity combined with an excellent safety profile across all of these categories of risk in the patients treated with FELIX. What we also did was we provided an update on patients where we do actually have longer follow-up, and these come from the old CAR-19 study as well as the FELIX1B study.

So on slide two before we begin I'd just like to remind you that during today's call. We will make statements related to our business to afford 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 limited to statements regarding the stages 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.

Is any of them today.

Assume no obligation to update any such forward looking statements for a discussion of the material risks and uncertainties that could affect our actual results. Please refer to the risks identified in today's press release, and our SEC filings available on the Investor section of our website.

Christian Martin Itin: In fact, the patients that we had actually in that analysis had more than three years of median follow-up, and that gives us a very good understanding of what to expect longer term in terms of outcomes from the study, and we'll briefly talk about that as well in the next part of the presentation. Now, what's absolutely critical in this space is your ability to deliver product. And that's certainly been the most challenging part.

On slide three you'll see the agenda as usual Christian will provide an overview of our operational highlight Rob will then discuss the financial results before Christian will complete without coming milestones. He played in remarks, and we will then take questions.

Christian.

Thanks, Olivier and welcome everybody to our full year update obviously, it's been a very successful year for us.

And we're going to go through the accomplishments.

Christian Martin Itin: And if we think about the path that we've taken with OBSEL, with the company, it is to establish our own capability of delivering product. And obviously, at the core of that is the nucleus facility, which is located here in the UK in Stevenage. And what we managed to do during the course of last year was really get that facility, not just get the build finalized, but also take the facility into operation, qualify, and fully validate the facility. And all of that data, obviously, is key data that actually did flow into the BLA filing. Just as a reminder, from the time point when we actually broke ground for this facility, which is a four-story industrial build, a greenfield build, we took exactly 24 months to actually get the facility fully validated, everything written up, and into the BLA for the BLA filing. Overall, in terms of generating all the reports and the data sets, it was 22.

During the course of last year, particularly with our lead program or B cell on the following slide, but what we'd like to start out with is obviously the important transactions that we've been able to complete in February this year.

Obviously post the reporting period.

Obviously, the two transactions we conducted.

One was the strategic collaboration with biotech.

Which I think sets us up in a very interesting and attractive way going forward with a very strong partner and I think a lot of opportunity to realize synergies between the two companies.

D.

Focus of this collaboration.

Has it been sort of in three key platforms that we have developed the first one is providing access to bear on page two our manufacturing platform are obviously at the core of that being the new players manufacturing facility. But also offers of course, all the systems surrounding the product supply platform.

Secondly, the commercial platform that that we've been setting up and obviously are in the midst of preparing the company for a potential launch at the end of this year for <unk>, Oh should assistance, we set off to procedures. The presence of the centers we're building out.

Christian Martin Itin: So that's an exceptionally short period of time, and it required us to frankly take very different approaches from the build, the design, the build, but then also the operational model to be able to achieve. So what we also have, obviously, since reported is that we just went through the full inspection cycle with the MHRA. One of the prerequisites that you have if you operate with manufacturing facilities in Europe or in the UK is that you actually do need licenses for those facilities to supply product, not just for clinical trials or for supply within the country but also to be able to export product.

All obviously can be leveraged beyond Cisco b cell and I think theres significant opportunity there.

For additional programs to serve be served through that platform.

And then also obviously the.

Access to two of our product candidates, our Ottawa 'twenty, two and almost six Mg per.

I'm a co development co commercialization.

Actions that we have granted to do both of those programs.

And I think will allow us to accelerate some of our pipeline programs.

Christian Martin Itin: So if we think about US patients, obviously, we're also exporting the final produced product here in the UK to the US, and that actually required a specific license. So we have obtained this license, and they're now in a position that we have fulfilled the first major step here to get the facility in a position where it can actually support patients from the UK. Now, the second, obviously, key step is obviously the regulatory review, coming in that we're in the midst of the process. We filed the BLA at the end of last year, and during the course of November, we got the filing accepted for review by the FDA with a PDUFA date of November 16 this year.

Obviously looking forward to the collaboration here with our partner.

We've also have additional support to launch.

To expand <unk> into additional indications.

And so between all of those components.

We're looking at in upfront.

Contribution of 200 million through an equity investment and $50 million in cash from biotech and then an additional 582 million and for the option exercise at milestone payments.

This obviously is a key transaction for us I think with a very attractive partner that has a very similar view on how are we going to approach oncology. What the challenges are the opportunities are and we're really excited to working with the home Tech.

If opportunities in products going forward.

What we also did in parallel or right in sequence to.

Christian Martin Itin: Meanwhile, we've actually filed with the European Medicines Agency an MAA, and with that, they now have filings in the two major jurisdictions from a commercial perspective for this product. We're also going to be in conversation with the MHRA on the approach here to a registration path, and that's going to be the third jurisdiction we're looking to actually get the product approved as well. When we look in terms of commercial readiness, obviously one of the key activities that you have to involve is not only, you know, creating awareness for the product, which is mostly the medical affairs team's job to drive that, but also to make sure that we're in a position to deliver the product. And for that, obviously, the centers need to be accredited.

Executing the agreement with Val Tex.

Is to run a <unk>.

Financing transaction, which has yielded gross proceeds of an additional $350 million. So between the two transactions and a year end cash position of $240 million, we're looking at.

Year, beginning of the year cash position on a pro forma basis of around 800 million plus.

Which obviously sets us up in a very strong position to execute the plans that we have discussed with you leading up to these transactions as well.

Moving to slide number five.

I'd like to do on this slide is really kind of highlight some of the key activities that we've been engaged in with Ob sell during the course of last year, but also have progressed.

Christian Martin Itin: We're in the midst of the process of getting centers ready for commercial use of the product, and those activities are all on track with an expectation that we will have 30 centers ready at the time of launch for ready-to-use OVCell once approval is issued. So those are kind of the key updates that we ran through from an ob-cell perspective during the course of last year. I was in a very heavy lift to get to a place where we had both the clinical data as well as the manufacturing capability. Now, the focus this year is obviously to drive through the regulatory process and prepare the organization for launch.

In the first quarter now as well in 2024 first of all we've given obviously two key updates.

During the course of last year on the Felix data for Ob cell.

Providing the first data.

Presentation at Astro, which was focused on the morphological cohort or the Felix study this.

This included about 94 patients that we reported on and we presented the overall outcome of the study. We then data actually at the ash at the Ash time point.

December early December last year is to look at the entire Felix study, which included two additional cohorts one cohort with patients that have minimal residual disease or less than 5% tumor burden at times inclusion and also patients that have isolated extra medullary disease, which is a patient group that typically gets excluded from clinic.

Christian Martin Itin: Moving to slide number six, when we look beyond the OBCell opportunity within ALL, as we had indicated, we also are going to be moving into the autoimmune segment. And in fact, the first study is open for enrollment, and it's called the Carlisle study. What is important about where we are with the program is obviously that we're setting up and setting up. We're basing our program on the very strong foundation that we have built for OBCell in the adult ALL setting, which gives us a lot of safety data and gives us, obviously, the regulatory packages, which are absolutely relevant. It gives us commercial supply capability and presence in the centers.

Trials due to the challenging nature of the disease and the very high bar and challenges to actually get meaningful results. In these patients. So were provided at ash actually the totality of the data and we believe that is important because that actually reflects the continuum of tumor burden and risk.

Or is that physicians are facing when dealing with adult <unk> patients and in that regard reflect a proper.

Cross section after patient population and obviously as you may remember and we'll talk about it a bit in further detail in upcoming slides, obviously, they've shown very significant very meaningful clinical activity with combined with an excellent safety profile across all of these categories of risk.

Christian Martin Itin: These points, we believe, are very critical to be able to deliver effectively in the autoimmune settings. And obviously, what we have shown over the last several years is that we have an exceptional profile from both an activity and a safety perspective with OBCell. Looking at programs beyond OBCell, we did an update on two programs.

The patients treated in Felix study.

But we also did is we provided an update on Ah patients, where we do actually have longer follow up in these come from the old car 19 study as well as the Felix <unk> study in fact between the patients that we had actually in that analysis had more than three years of median follow up and that gives us a very good understanding of what do you expect long.

Term in terms of outcomes from this study and <unk> will briefly talk about that as well indeed, becoming part of the presentation.

Christian Martin Itin: We updated on Auto-8 in an oral presentation of the McCarty study at ASH, where we could show very high levels of clinical activity and, we believe, very nice cellular dynamics that we were seeing beyond just the clinical activity, but also cellular dynamics of the product. It looked very interesting and seemed to benefit from the dual targeting approach that we're choosing. And we've chosen for Auto-8 here, targeting both BCMA and CD19. And then the Auto-6 NG study in neuroblastoma, the McNetto study, also is open for enrollment as of the end of last year. So that's actually very nice progress on those products, not on this slide.

Now it was absolutely critical in this space is your ability to deliver products and that certainly being the most challenging part and if we think about the path that we've taken with <unk> with the company is to establish our own capability of delivering product and obviously at the core of that is the nuclear facility.

Which is located here in the U K in Stevenage and what we were what we manage to do during the course of last year is really get that facility not just get.

Get a final.

<unk> finalized, but also taken <unk> taken the facility into operation qualify and fully validate facility and all of that data. Obviously is key data that actually did flow into the BLA filing just as a reminder, from the time point when we actually broke ground for this facility, which is a four storey industrial build.

Christian Martin Itin: We also published the pediatric ALL data from Auto-122 in the journal BLOOD, also in the September timeframe last year. Moving to slide number seven and looking at some of the organizational changes that we ran through, first of all, I'd like to congratulate Chris Williams as well as Alex Strix on their promotions.

Greenfield build.

We took exactly 24 months to actually get.

The facility fully validated everything written up and into the BLA to the BLA filing.

Overall in terms of generating all the reports and the data sets. It was 22 months. So thats, an exceptionally short period of time and it required us to frankly.

Take very different approaches from the belt the design to build but then also the operational model to be able to achieve this.

Christian Martin Itin: Chris obviously has been instrumental in the various transactions that we have done over the years and, obviously, most recently, the BioNTech transaction. And Chris has been promoted to Chief Business Officer, and Alex Strix has been promoted to Senior Vice President for Legal Affairs, and will obviously continue as the General Counsel of the company. We also have a transition within the executive team. Edgar Braendle will step down as chief development officer to pursue other opportunities.

What we also have obviously since reported his staff.

We just went through the full inspection cycle with the NHRA one of the prerequisites that you have if you operate with manufacturing facilities in Europe or in the U K is that you actually do need licensees for those facilities to supply product not just for clinical trials or for supply within the car.

Christian Martin Itin: Edgar will continue to advise the company through the regulatory process for the BLA and MMA through the completion and approval of these and getting to approvals in those two processes. And, obviously, we'd like to thank Edgar for a fantastic job. Edgar joined in the middle of 21, right at the start of phase two of the pivotal sections at Felix. Obviously, a very challenging starting point, he managed with the team to get the study obviously conducted to a very successful outcome as well as obviously then translate, in record time, this data set as well as the data set coming from Dave's team on the manufacturing side into the BLA filing, the MMA filing, which was an enormous achievement in a very So, fantastic outcome, a lot of gratitude there, and we wish Edgar well with his next endeavor. And what we're internally, we'll have Miranda Neville take over from Edgar.

Country, but also to be able to export product. So if we think about the U S.

Patients obviously were also exporting back to the U S before the final.

<unk> products here in the U K and that actually required a specific license. So we have obtained this license and they're now actually in a position that we have fulfilled the first major step here.

To get to the facility.

In a position where it can actually support.

<unk>.

Patients.

From the U K now the second obviously, a key step is obviously the regulatory review.

Coming.

We're in the midst of the process off.

We filed the BLA at the end of last year and that during the course of November we got by mid January.

The filing accepted for review by the FDA with a producer date of November 16 this year.

Meanwhile, we also actually have filed with the European Medicines agency.

<unk>.

The MAA.

And with that the OCC has now filings into the two major jurisdictions.

Christian Martin Itin: She's running the OB cell program and has been for quite a while, and she will also continue to run the development team. So we have a nice level of continuity and drive forward. As we go through the course of this year, we will obviously expand our team even more into the autoimmune segment. And there will certainly be announcements during the course of this year with sort of the build-out of the development team in that direction as well. And finally, we have strengthened our board of directors. We had two recent appointments. Liz Leiderman joined us as well as Rob Asleby.

From a commercial perspective for this product, we're also going to be in conversation with the NHRA on the approach here to a registration path and that's going to be the third jurisdiction, we're looking to actually get the product approved as well.

When we look in terms of the commercial readiness is obviously one of the key activities that you have to involve in is not only creating awareness for the product, which is mostly the medical affairs teams job to drive that but also to make sure that we're in a position to.

To deliver the product and for that obviously that centers need to be accredited we're in the midst of the process of getting our centers ready.

Christian Martin Itin: Both of them obviously bring very significant levels of experience, Liz obviously with a strong financial and transactions background and Bob with a very strong background in commercializations both on the oncology side, on the CAR T side, but also on the rheumatology side. So very relevant backgrounds, and very significant opportunities for contributions as we go forward. And also, we're excited to have both of them now on the board of directors. Now, with that, I'd like to move to slide number nine and just briefly remind you, obviously, of the unique mechanism of action at the heart of the features that we see in the clinical properties we see with ob-cell. And this is all about driving a product that can physiologically engage with targets, which means it can engage rapidly, it can deliver the kill, and it can then disengage rapidly as well so that you do not have over-activation And as a consequence, you'll maximize, on the one hand, the activity because the product and the cells get recycled back into action much more quickly, so you actually have more active agents available at any given point in time.

For commercial use of the product.

And those activities are all on track with an expectation that we won't have 30 centers ready at the time of launch for our ready to use or B cell launch and approval is in.

So those are kind of the key updates that we ran through from an <unk> perspective. During the course of last year I would say a very heavy lift.

To get to a place where we have both the clinical data as well as the <unk>.

Manufacturing capability. The focus this year is obviously to drive through the regulatory process and prepare the organization for launch.

Moving to slide number six.

When we look beyond the <unk> opportunity within the P&L as we had indicated we also are going to be moving into the <unk> segment and in fact, the first study is open for enrollment as coal to Carlyle's study.

As important about it where we are with the programming is obviously that we're setting up and setting.

Spacing our program on the very strong foundation that we have built.

For <unk> in the adult setting, which gives us a lot of safety data. It gives us obviously, the regulatory packages, which are absolute development. It gives us to commercial supply capability and presence in the centers. These points. We believe are very critical to be able to deliver effectively in the <unk>.

Christian Martin Itin: But also, you avoid the toxicity that is seen with over-activation of the T cells, and obviously, is at the core of the reduced cytokine release syndrome, and in general, as well, the immunological toxicities related to neurological toxicities are usually referred to as IK. So the feature that's at the core is this very different way of engaging the target antigen. And obviously, as you remember, this has resulted in a very different profile for the product. What I'd like to do on the next slide, which is going to be slide 11, is really talk about a few aspects of the FELIX study that we presented in terms of a pooled analysis at the ASH meeting at the end of last year. I think what's important here is to understand, and I sort of already alluded to that when I was briefly talking about the time point when Edgar actually joined us, we conducted this study in the midst of the pandemic. And that is important because, obviously, we're dealing here with patients that are highly immune compromised, patients that are at very high risk of infection. In fact, many of these patients do pass away as a consequence of sepsis, in general, as a major cause of death.

Immune settings, and obviously, what we have shown over the last several years is that we have an exceptional profile.

From both an activity and a safety perspective with Ob sale.

Looking at programs beyond the Ob sale, we did update on two programs we updated.

Auto eight at an oral presentation.

Mccarthy study at Ash, where we could show very high levels of clinical activity and we believe very nice.

Salary dynamics that we're seeing beyond just the clinical activity, but also sell a dynamics of the product it looks very interesting and seem to benefit from the dual targeting approach that we're choosing and we've chosen for auto <unk> targeting both the CMA and CD 19, and then the <unk> <unk> study in Europe <unk> Neto study also.

It's open for enrollment as of the end of last year. So thats actually very nice progress on those program production not on this slide we also published a pediatric ALLL data from Ottawa 22 in the Journal plant also in the September timeframe last year.

Moving to slide number seven and looking at some of the organizational changes that we ran through the <unk>.

First of all.

Thanks to congratulate.

Chris Williams, as well as Alex tweaks to their promotions.

Christian Martin Itin: And as you can imagine, being in the midst of the pandemic with travel restrictions and lots of concerns around safety for patients, this has been a really challenging study to conduct. And in essence, what resulted is actually a study that is pretty much a real world study that we conducted here. Now, what is also important to understand is that as you're operating in this type of environment, you also have to make sure that the way that physicians can manage patients gives them a very significant level of or degree of freedom to frankly make the right choices and deal with the circumstances and challenges that they may also have experienced at their respective sites during that period.

<unk>, obviously has been instrumental in the various transactions that we have done over the years and obviously most recently at the <unk> transaction and Chris has been promoted to Chief business Officer, and Alex tricks.

Been promoted to senior Vice President legal affairs.

And obviously continue to ask the general counsel of the company.

We also have a transition within the executive team, Andrew Bradley will step down as Chief development officer to pursue other opportunities.

We will continue to advise the company through the regulatory process for the BLA and MAA through the completion and approval of these of these and getting to approvals and those two processes and obviously, we'd like to thank Ed for the fantastic job Edgar joined in the Middle of 'twenty, one right at the start of phase III of the pivotal sex.

Christian Martin Itin: One of the key aspects there is actually bridging therapy. Most clinical studies conducted in space actually do restrict the type of bridging therapy you can use, which is the therapy between collection of the cells and actually dosing of the cells and by restricting those, therapeutic options for bridging therapy. Obviously, it helps you, you know, select the patients that can manage with, you know, a certain type of bridging therapy. But at the same time, if you imagine this situation in the midst of the pandemic, it also would have been very, very challenging if we had actually basically put that in place.

So the <unk> study.

Obviously, a very challenging starting point manage too with the team to get the study obviously.

Conducted two very successful outcome as well as obviously then translate it in record time this data set as well as the dataset coming from days team on the manufacturing side into the into the BLA filing of the MAA filing which is an enormous achievement.

In a very very limited amount of time, so a fantastic outcome Lauder gratitude their entire wish after when all with his next endeavor and what we're internally will have Miranda naval take over from <unk> and are running the Ob cell program and has been for quite a while and she will also continue throughout.

Christian Martin Itin: So, different from studies in the past, we actually allowed any type of bridging therapy other than BlinCyto, so CD19 targeting T cell engager, but any other therapeutic actually was allowed in the bridging therapy. And we did that because we needed to make sure the physicians had every possibility to manage the patients given the unforeseen nature and the challenges that many of these institutions were facing, and with that, actually, making sure you could keep the patients safe and properly manage the patients. So that's a key element, and of course, what that also means is that the data we're seeing is very much a reflection of the real-world setting.

The development team. So we have a nice level of continuity and.

And drive forward as we go through the course of this year, we will obviously expand also our team.

More also into the autoimmune segment.

And there will be certainly announcements during the course of this year.

That said that the build out of the development team in that direction as well and finally, we have strengthened.

Our board of directors and we have two recent appointments.

The latest <unk> joined us as well as Ralph Bob it'll be.

Both of them, obviously, bringing very significant level of experience.

Obviously with a strong financial transactions background, and Bob with a very strong <unk>.

Christian Martin Itin: The same is true always in terms of the types of patients included. I mentioned that before, whether you have a very low disease burden, or you have an extremely high disease burden, or you have disease in areas outside of the bone marrow where the disease tends to be very challenging to manage. In all of those cases, the patients are present, and you need to understand actually what the product does in those patients. One of the strengths of the FELIX study is that it actually provides data for all of these risk categories and with that gives valuable information to physicians on what to expect with a particular patient and manifestation of the disease in that patient.

Ground in commercialization.

Both.

On the oncology side on the car T side, but also.

On the on the rheumatology side so very.

Relevant backgrounds very significant opportunity for contributions as we go forward and we're excited to have both of them.

Part of the board of directors.

Now with that I'd like to move to slide number nine and just briefly remind you obviously off the unique mechanism of action at the heart of the features that we see in the clinical properties, we see with Ob cell and this is all about driving a product that can physiologically engage with target cells, which means it can engage rapidly.

Christian Martin Itin: Slide number 12, we did actually look at sort of the change in disease burden in these patients as we are comparing the disease burden at screening versus the disease burden at lymphodepletion. And of course, this is an impact of what you see here, also of bridging therapy. And what's quite remarkable is that at every level of tumor burden averaging, you get to every other level of tumor burden at lymphodepletion. So you can go from a very low tumor burden of less than 5%, being in minimal residual disease, you can go all the way up to 75% tumor burden, but also the reverse. You can have more than 75 tumor burden at screening, and you can go below five at Wimford Application.

It can deliver the kill and they can then disengage rapidly as well so that you do not have over activation of the car T cell in the processing as a consequence, you will maximize on the one hand the activity because the recycle their product and the sales get recycled back into action much more quickly JF actually more active agent.

Available at any given point in time, but also you avoid the toxicity that is seen with over activation of the T cells and obviously is at the core for the reduced cytokine release syndrome.

And in general and as well the Hematological tax.

Toxicities related to neurological toxicities are usually referred to as icons. So.

In the feature of that is at the core is very different way of engaging the target antigen and obviously as you remember has resulted in very different profile for the product.

Christian Martin Itin: And it shows the variability of the disease and the dynamic nature of this disease and the impact of actual bridging therapy here for these patients. What was very striking to us, and this is what's summarized on the next two slides, is when we then actually look at the outcome of these patients dependent on the level of tumor burden at lymphodepletion. And what's quite striking when you look on slide number 13 is that going from the top line in blue where you have below 5% tumor burden to the middle line in green, which is between 5% and 75% tumor burden, to the red line, which is above 75% tumor burden of lymphoplesia, you see there's a profound impact on the event-free survival as you would expect because there's obviously very different amounts of tumor cells that have to be removed in these patients to drive out.

I would like to do on the next slide which is going to be slide 11.

Israeli talk about a few aspects of the <unk> study that we have presented in terms of the pooled analysis at the Ash meeting at the end of last year.

I think what's important here is to understand enel sort of already alluded to that one that was briefly talking about the time point of an editor accident joined US. We conducted this study in the midst of the pandemic.

And that is important because obviously we are dealing here with patients are highly immune compromised.

<unk> set a very high risk of infection. In fact, many of these patients do pass away as a consequence of sepsis in general.

As a major cause of death, and as you can imagine being in the midst of the pandemic with travel restrictions and lots of concerns around the safety for patients.

This has been a really challenging study to new doctrine in essence, which resulted in is actually a study that is pretty much a real world study that we conducted here.

What is also important to understand is that as you are.

Christian Martin Itin: Now, we see very clear differentiation, but remarkably, patients that are below 75% tumor burden tend to actually reach a plateau on the EFS, which is very encouraging when you think about the potential for long-term outcomes in these patients. Now, if we go to slide number 14, we also see an impact on tumor burden on the actual adverse event profile, particularly with regard to immunological toxicities.

Operating in this type of an environment you also have to actually make sure that.

The way that the physicians can manage their patients gives them a very significant level or degree of freedom to frankly make the right choices and deal with the circumstances and challenges that they may also have experienced at their respective sites during that period.

One of the key aspects there is actually the bridging therapy. Most clinical studies conducted in this space actually do restrict the type of bridging therapy, you can use which is a therapy between collection.

Christian Martin Itin: And what you can see on the left-hand side is a view of cytokine release syndrome and ICANs in all patients. And you can see we had a very attractive profile having high-grade CRS in 2% of the patients and high-grade ICANs in 7% of the patients, which is very low.

Collection of the sales and actually dosing up to sales.

And by restricting those.

Therapeutic options for the bridging therapy, obviously it helps you.

Select the patients that have can manage with a certain type of bridging therapy, but at the same time, if you imagine the situation in the midst of the pandemic. It also would have been very very challenging if we had actually.

Christian Martin Itin: This is lower even than what was observed in these types of patients with a product like. Now, when we look at the CRS by the BLAST count, the level of tumor burden at the time of lymphodepletion, you can see that there is clearly quite an interesting behavior here. Overall, as tumor burden increases, we see an increase in overall adverse events with cytokine release syndrome of any grade going from 47% to 88%. However, we do see that consistently across the board, the high-grade percentage for cytokine release syndrome is low. It's in the 3% to 4% range between 5% and close to 100% tumor burden. But in patients that have mineral residual disease, we actually have not observed any high-grade cytokine release syndrome in these patients.

Basically put that in place so different from studies in the past we actually allowed.

The type of reaching other than <unk>, CD 19 targeting T cell engagement, but any other therapeutic actually was allowed in the bridging therapy.

And we did do that because we needed to make sure that physicians had every possibility to manage the patients given the unforeseen nature and the challenges that many of these institutions are facing and that actually making sure you can keep the patient safe and properly manage their patients. So that's a key element and of course with <unk>.

It also means is that the data we're seeing is very much a reflection of the real world setting. The same is true obviously in terms of the types of patients included I mentioned that before where we have very low disease burden or you have extremely high disease burden already have disease in areas outside of the bone marrow where.

Christian Martin Itin: Now, very similar when we look at ICANNs. First of all, I think it's important to realize that the overall level of ICANNs is relatively low, also compared to other T-cell engaging or CAR-T approaches. But what we also do see here is the same picture that as tumor burden at lymphodepletion increases, we do see an increase in overall ICANS levels in these patients, going from 8% to 43%. But even in the extreme high tumor burden patients who have more than 75% tumor burden, the high-grade ICANS is at 15%, which is comparable to a T-cell engagement. Now, what's also important, and this goes back to the view that we had on the CRS, if we look at patients that have less than 5% tumor burden, we do not observe high-grade ICAMS in these patients. In fact, the overall ICAMS level is very low, with 8% overall.

The disease tends to be very challenging to manage and all of those cases is where the patients present and you need to understand actually what the product comes in those patients and one of the strengths of the Felix study is it actually provides data for all of these risk categories and with that gives valuable information to the physicians on what to expect.

With a particular patient and manifestation of the disease in that patient.

Slide number 12, we did actually look at sort of the change in disease burden in these patients as we are comparing the disease burden at screening versus the disease burden that link for depletion and of course. This has an impact what you see here also of bridging therapy.

And what's quite remarkable is that from Andrey.

Our level of tumor burden at bridging youll get to every other level of tumor burden at living for depletion. So it can go from very low tumor burden of less than 5% being in minimal residual disease. You can go all the way up to 75% tumor burden, but he also the reverse who can have more than 75% tumor burden that screen.

Christian Martin Itin: So it points to an impact of tumor burden at lymphodepletion both on the outcome from a clinical activity perspective, both from an ORR perspective, as well as from the EFS perspective, but we also see very clear differentiation with regard to immunological toxicity and the risk of these patients experiencing immunological toxicity as a consequence of the therapy. So this gives you an ability to anticipate for the physicians and plan accordingly for these patients. Moving to the sort of sentinel view based on the Olcar-19 and the Felix Phase 1B data, and this is going to get us to slide 16.

<unk> actually you can go below 5% at Wynn for depletion and it shows the variability of the disease and the dynamic nature of this disease and the impact of.

Off of.

Actually we're bridging therapy here for these patients is very striking to us and this is what summarized.

The next two slides is when we then actually look at the outcome of these patients depending on the level of tumor burden at limb for depletion.

What's quite striking when you look on slide number 13.

Is that going from top at the top line in Blue, where you have the low 5% tumor burden to the middle line and Green, which is between 5% and 75% tumor burden to the Red line, which is above 75% tumor burden of living for depletion you see there is a profound impact on the event free survival as you would expect.

Christian Martin Itin: And so what we're looking at here on the left-hand side is event-free survival, and we do see that event-free survival, with or without censoring for stem cell transplantation, gives us a plateau that's somewhere in the range of 35 to close to 45 percent here. And that obviously gives us a very attractive proposition because it suggests that, indeed, a significant proportion of the patients manage to get into long-term remission. In these patients, you can see the longest observation time we have with these patients is 60 months or five years.

Because there is obviously a very different amounts of tumor cells that have to be removed in these patients and to drive outcome.

We see very clear differentiation, but remarkably.

<unk> stat or.

Below 75% tumor burden.

Tend to actually reach a plateau on the FES, which is very encouraging when you think about the potential for long term outcomes in these patients.

Now if we go to slide number 14, we also see an impact on the tumor burden on the actual adverse event profile, particularly with regards to Hematological toxicities and what you can see on the left hand side is a view on the cytokine.

Christian Martin Itin: When we look at the median overall survival, or just the overall survival curve per se, what you do see, the median obviously gets crossed at around 16 months, but the actual story is that the fact that we see a tail building, and we have around 40% of the patients that are in, that are surviving, and it looks like the curve, as we've seen at the EFS, is stabilizing, suggesting that, indeed, we have long-term benefit for a proportion of the patients, which is very encouraging, and something that, unfortunately, we have not been able to see with other therapeutic modalities in the past in this syndication, and in this, at this stage of the, Moving to slide 17, this is just a slightly different look where you just look at SWIM plots here and you see the corollary as well as we just looked at obviously depicted in the slide. Now, if we look at the commercial launch readiness, which is sort of the obviously the key activity that we're engaged in during the course of this year, while we're working with the agencies through the review process for the product. Obviously, we have just updated you on the fact that we had this week that we got the MHRA inspection and approval for the nucleus facility, and we filed the MAA in Europe as well. We expect to file an MAA in the UK with the MHRA as well.

Released syndrome, and <unk> in all patients and you can see we had a very attractive.

Attractive profile, having high grade Crs in 2% of the patients and high grade icons and 7% of the patients. This is very low this is lower even than what was observed in these types of patients with a product like print cycle now.

Now when we look at the Crs.

Crs by the blast count the level of tumor burden at the time of linked depletion you can see that there is clearly quite a.

And interesting behavior, we see overall ASP.

Asked tumor burden increases we see an increase.

In the overall adverse events with cytokine release syndrome of any great going from 47% to 88%. However.

However, we do see that consistently across the board the high grade percentage off for cytokine release syndrome is low it seems.

The 3% to 4% range between five and close to 100% tumor burden, but in patients that have mineral residual disease, we actually have not observed any high grade cytokine release syndrome in these patients now.

Very similar when we look at icons first of all I think it's important to realize that the overall level of icons is relatively low.

Also compared to other T cell engaging <unk>.

<unk> car T approaches, but what we also do see here is the same picture that asked tumor burden at length for depletion increases we do see an increase in overall <unk>.

Christian Martin Itin: Timing is still to be defined, but it's going to be as soon as we can. And then, obviously, we have the FDA PDUFA date on November 16. So, this sets us up for very significant, very tangible progress through the course of this year for OBCell and also planned data updates for OBCell and additional follow-up data on the FELIX study in the mid-year section, so the ASCO EHA time frame, and then also at the end of the year. So when we then think about sort of the possibility and the opportunities for expanding OB Cell into additional indications, there's sort of two fundamental One is to move more broadly into the oncology arena with different forms of B cell malignancies, and alternatively, also look at the opportunity in autoimmune disease, where we know that the driving factor for those autoimmune diseases are autoreactive antibodies, obviously driven by B cells, and the corresponding plasma.

<unk> levels in these patients.

Going from 8% to 43%, but even in the extreme high tumor burden patients have more than 75% tumor burden. The high grade ICANN is at 15%, which is comparable to a T cell engagement.

No.

It's also important and this goes back to also the view that we had on the Crs. If we looked at patients that have less than 5% tumor burden, we do not observe high grade icons in these patients we track. The overall icon that is very low with 8% overall, so it points to an impact of tumor burden ethylene for the patient.

<unk>.

The.

Outcome from a clinical activity perspective, both on our.

Perspective, as well as on the Etfs perspective, but also see very clear differentiation with regards to immunological toxicity.

The risk of these patients experiencing neurological toxicity as a consequence of the therapy.

So it just gives you actually and ability to anticipate for the physicians and plan accordingly for these patients.

Christian Martin Itin: From this perspective, obviously when we think about the life-cycle management for OB cell, it goes into two directions. There's OB cell itself, and then obviously Auto-122, which is the dual targeting approach that we explored in pediatric patients, which gives us opportunity, particularly in those indications where we have established loss of CD19 antigen as a right of escape, and that's certainly shown in ALL. It's clearly shown in BCL.

Moving to the.

We exited the Sentinel.

Based on the old car 19 at Felix Phase one data and this is going to get us to slide 16.

And so what we're looking at here on the left hand side as Steve and free survival and we do see that the event free survival with or without censoring for stem cell transplant or it gives us a plateau that's somewhere in the range of 35 to close to 45% here and that obviously gives us a very attractive.

Proposition because it suggest that indeed, a significant proportion of the patients manage to get into a long term remission. In these patients you can see the longest.

Christian Martin Itin: So those are very clear directions for that type of product, and with Auto-8, a combination of BCMA targeting with CD19, I would say that gives us an option for both moving towards the multimyeloma segment or related diseases, as well as plasma cell and B cell-mediated autoimmune diseases. Now, I did mention on slide earlier and here on slide 22 that we have opened the CAR-LAB study, and we're enrolling patients. This is really a dose confirmation study, and as a backdrop, I think it's important to understand that the product that is sort of referenced and really has opened up the opportunity for CD19 CAR-T products in autoimmune disease at the University of Erlangen, which is a study that was done by Georg Schett and Andreas Mackensen, actually is, comes from a product that was initially set up for patients with pediatric ALL. The product has a lot of similarities in its structure if you look at the chimeric antigen receptor with chimeria and brianzi, although it is a different manufacturing process compared to both of those commercial products.

Our longest observations with time, we have with these patients is it 60 months or five years.

When we look at the median overall survival or it's just the overall survival curve per se. What do you do see the median obviously gets crossed at around 16 months, but the actual story is the fact that we see a tail building and we have around 40% of the patients.

That are.

<unk> that are surviving and it looks like the curve as we've seen in DFS is stabilizing suggesting that indeed, we have long term benefit for a proportion of the patients which is very encouraging and something that unfortunately, we have not been able to see with other therapeutic modalities in the past in this indication and in this at this stage.

Of the disease.

Moving to slide 17. This is just a slightly different look where you just look at swim plots.

And you see the corollary as well as we just looked at obviously depicted in a slightly different way.

Now if we look at the commercial launch readiness, which is sort of the also the key activity that we're engaged in during the course of this year, while we're working with the agency through the review process for the product.

Obviously, we have just updated you on the fact that we had this week that we got the.

NHRA.

Inspection and approval of the nuclear the nuclear facility.

Christian Martin Itin: The properties of the product are actually quite well known, and it has allowed us to actually compare our pediatric data to the pediatric data that was obtained at the University of Erlangen. And we do see a very nice match in terms of the overall data, as we had seen with Kymriah, as you may remember, in the CARPAL study. So very high levels of molecular CRs, comparable, superimposable, very similar levels of long-term outcomes, and very comparable levels of long-term persistence. The product in Erlangen is a long-term persisting CAR-T product that in pediatric patients also has persistence of two to three years or longer. Very similar to what we've seen with Obicel.

And we filed the MAA in Europe as well, we expect to file an MAA in the UK with the NHRA as well the timing is still to be defined but it's going to be as soon as we can.

And then obviously, we have the FDA produce up to eight.

On November 16, so this sets us up for very significant very tangible upstream progress through the course of this year for Ob cell and also planned data updates from four O b cell and additional follow up data on the Felix study.

The midyear sections of the <unk>.

Im frame and then also.

At the end of the year at Ash.

So when we then think about sort of the possibility and the opportunities for expanding <unk> into additional indications there's sort of two fundamental passed we can think about one is to move more broadly into the oncology arena with different forms of B cell malignancies, and Alternatively also.

Christian Martin Itin: And, of course, as we have seen with Kymriah before, obviously, the safety profile that we have with Obicel is obviously better because of a different way of engaging the CD19 antigen. And all of this is done at the exact same dose level that was used with OBCell in the pediatric studies, which is 1 million cells per kilogram. So we know that our profile is absolutely overlapping in actual clinical data in pediatric ALL patients with the product that was actually ultimately then used in the autoimmune patients in airline. Now the additional point I think here is that because we obviously know what the dose is and we have a lot of safety data obviously from our product at that level, what we're doing now is moving the product into a single dose rather than actually having or a fixed dose rather than having a weight- Obviously, here in autoimmune diseases, we're dealing with typically young adults or adults in general. And so we can actually pick a fixed dose, which simplifies the operation at the clinical center, and it reduces any possible dosing errors that, you know, could happen as a consequence of a variable dosing regimen.

Look at the opportunity in autoimmune disease, where we know that the driving factor for those auto autoimmune diseases are auto reactive antibodies, obviously, driven by b cells and a corresponding plasma cells.

In this from this approach perspective, obviously, when we think about the.

Lifecycle management for Ob sell it goes into two directions, Theres Ob cell itself and then obviously Ottawa 'twenty, two which is the dual targeting approach that we explored in pediatric patients, which gives us opportunity, particularly in those indications where we have established.

Loss of CD 19 antigen as a right of escape and has certainly shown in Alex clearly shown in the Bcl.

So theres, a very clear kind of directions for that type of product and with auto eight combination of CMA targeting with CD 19.

And I would say that gives us an option for both moving towards.

The multi myeloma segment or <unk>.

Related diseases as well as.

Plasma cell and B cell mediated autoimmune diseases.

We did I did mention on slide.

Early on here on slide 22 that we have opened the Carlyle study. We're enrolling patients. This is really a dose confirmation study and as a backdrop I think it's important to understand that the product that is sort of restaurants and really has opened up the opportunity for CD 19 car T products in autoimmune disease.

Christian Martin Itin: So we're exploring, therefore, and confirming the fixed dose here at 50 million cells in six patients. And with that, we believe we're actually well set to then take the next step and move this product forward and towards a pivotal. So this is a quick update on the study and what we're intending to do with it. But also, I think the reference to how it compares, how it sort of relates to the original data that was generated in the field, I think it is important also to understand that we do not have to speculate whether our profile of our product is appropriate for these patients. We know it's exactly the same profile.

At the University of Erlangen, which was a study that was done by Eric Shaff Andreas Makinson actually is comes from a product that was initially set up for patients with pediatric AML.

And the product has a lot of similarity in its structure. If you look at the <unk> antigen receptor with Kim Ryan and P&C as a different manufacturing process compared to both of those commercial products the.

The properties of the product actually are quite well known and has allowed us to actually compare arrow pediatric data to the pediatric data that was obtained at the University of Erlangen and we do see a very nice man.

Match in terms of the overall data as we have seen with Kim Ryan as you may remember for the.

Robert F. Dolski: So when we then look into other pipeline programs and technologies, obviously, you'll remember there are a number of programs that are ongoing, and we keep on, we'll keep updating you on these programs as they progress in their early clinical studies, particularly Auto 6 and G, Auto 9 will also be transitioning into a clinical study as well during the course of this year. So with that, I'd like to hand over the financial results to Robert. Thanks, Christian. And I'm going to be on slide 26, the financial summary. Good morning or good afternoon, to everyone.

The <unk> study, so very high levels of molecular Crs comparable superimposed will.

Very similar levels of long term outcome very comparable levels of long term persistence. So the product and are long and is a long term persisting car T product, which in pediatric patients also have persistence of two to three years or longer very similar to what we've seen with Obi cell and of course as we have seen with <unk> before.

Obviously, the safety profile that we have with Ob cell, obviously is better because of a different way of engaging with CD 19 antigen.

All of this is done at the exact same dose level that was used.

With Ob sell in this in the pediatric studies, which is 1 million cells per kilogram. So we know that our profile is absolutely overlapping on actual clinical data in pediatric allo patients with the product that was actually ultimately then used in the autoimmune patients an airline now.

Robert F. Dolski: It's my pleasure to review our financial results for the full year 2023. Our Cash and Cash Equivalents at December 31st, 2023 totaled $239.6 million, as compared to $382.4 million at December 31, 2022. Our total operating expenses, net for the year ended December 31, 2023 were $179.7 million, as compared to $143.4 million for the same period in 2020.

The additional point I think here is to have because we obviously know what the doses and we have a lot of safety data, obviously from our product at that level. What we're doing now is moving the product into a single dose rather than actually have a fixed dose rather than having a weight based dosing, which is 1 million cells per kilogram, which you have to do with children because.

The wide range of body size that you actually have between one year olds and young adults.

Obviously here in autoimmune diseases, we're dealing with typically with young adults or adults in general.

So we can actually pick your fixed dose and which simplifies the operation at the clinical center and it reduces any possible dosing errors.

Robert F. Dolski: Our research and development expenses increased from $117.4 million to $130.5 million for the year ended December 31st, 2023, compared to the same period in 2022. This change was primarily due to increases in operating costs related to the company's new manufacturing facility, contract contractual milestone payments, and headcount related costs as well as a decrease in our UK reimbursable R&D tax claim through the UK small and medium size enterprises. These were partly offset by decreases in clinical and manufacturing costs associated with the OBSELP clinical program. Please note that in prior years, Autolus reported the R&D tax credits as income tax benefits on a statement of operation. The company has revised its financial presentation, including the prior years, and will now present such tax credits as a reduction in R&D and development expense.

That.

It could happen as a consequence of the variable dosing dosing regimen.

So we're exploring therefore are confirming the fixed dose here at 50 million cells.

In <unk> patients.

With that we believe we are actually well set to then take the next step and move this product forward and towards a pivotal study.

So this is.

A quick update on the study and we're intending to do with it but also I think I think the reference to how it tax how it sort of.

Relates to the original data that was generated in field I think is important.

Also to understand that we do not have to speculate whether our profile of our product is appropriate for these patients. We know it's exactly the same profile from an efficacy perspective.

So when we then look into other pipeline programs and technologies, obviously Youll remember there is a number of programs that are ongoing and we keep on and we'll keep updating you on these programs as they progress in their early clinical studies, particularly obviously also at six <unk>.

Auto nine which will be transitioning into a clinical study as well during the course of this year.

Robert F. Dolski: As a result, the income tax benefit has been reduced by $19.5 million and $24.6 million for the years ending December 31, 2023 and 2022, respectively, with the corresponding reductions in research and development expenses and total operating. Moving on to general administration, our expenses increased from $31.9 million to $46.7 million for the year ended December 31st, 2020, compared to the same period in 2020. This increase was primarily due to an increase in general administrative headcount. Reporting the overall growth of the business, primarily related to pre-commercialization activities. Our net loss attributed to ordinary shareholders was $208.4 million for the year ended December 31st, 2023, compared to $148.8 million for the same period in 2020.

So with that I'd like to hand over for the financial results drop.

Thanks, Christian and I am going to be on slide 26, the financial summary.

Good morning, or good afternoon to everyone. It's my pleasure to review our financial results for the full year 2023.

Our cash and cash equivalents at December 31.

2023 totaled $239 6 million.

As compared to $382 4 million at December 31, 2022.

Our total operating expenses net for the year ended December 31, two.

23, or $179 7 million.

As compared to $143 4 million for the same period in 2022.

Our research and development expenses increased from $117 4 million to $135 million for.

For the year ended December 31, 2023 compared to the same period in 2022.

This change was primarily due to increases in operating costs related to the company's new manufacturing facility.

Robert F. Dolski: Autolus estimates that with its current cash and cash equivalents, and proceeds received from the Strategic Alliance with BioNTech and our equity financing, we are well capitalized to drive the full launch and commercialization of OBCell in relapsed refractory adult ALL as well as advance our pipeline development plans, which include providing runway to data in our first pivotal study of OBCell in autoimmune disease. I'll now hand things back to Christian to wrap things up with a brief outlook on expected miles. Christian.

Contract contractual milestone payments and head count related costs as well as a decrease in our U K Reimbursable R&D tax credits claimed through the U K small and medium sized entity scheme.

These were partly offset by decreases in clinical and manufacturing costs associated with the <unk> clinical program.

Please note in prior years <unk> reported the R&D tax credits as income tax benefits on our statement of operations. The company has revised its financial presentation.

Including the prior years, and we will now present, such tax credits as a reduction in R&D and development expense.

Christian Martin Itin: Thanks, Rob. So, a quick look at slide 28 on the plant news flow. Obviously, clearly, a significant focus on ob-cell delivery. First, on data, as I mentioned, we're planning to update at the ASCO EHA and ASH this year. This is going to be sort of the June and December time frames. We're planning to submit to the UK MHRA a marketing authorization application in the second half of this

As a result income tax benefit has reduced by $19 5 million and $24 6 million for the year ending December 31, 2023, and 2022, respectively.

With a corresponding reductions in research and development expenses in total operating expenses.

Moving onto general admin, our expenses increased from $31 9 million to $46 7 million for the year ended December 31, 2023 compared to the same period in 2022.

Christian Martin Itin: We know, obviously, our PDUFA target action date, November 16, this year, and we plan to show the first data from our SLE phase one study towards the end of this year. In addition, obviously, there will be updates on auto aid expected for the end of this year, as well as opportunities, certainly, for publications during the course of this year on a number of our programs. So this is kind of a quick update on the plant news flow. And in terms of summary, going to slide 30, obviously, we're in a very strong position with the company. We've been executing very consistently during the entirety of the last two years.

This increase was primarily due to an increase in general administrative head count supporting the overall growth of the business primarily related to pre commercialization activities.

Our net loss attributable to ordinary shareholders was $208 4 million for the year ended December 31 2023.

Compared to $148 8 million for the same period in 2022.

Auto loss estimates that with its current cash and cash equivalents and proceeds received from the strategic alliance with biotech and our equity financing, we are well capitalized to drive the full launch and commercialization of.

Christian Martin Itin: We've continued on this exact same pace into 2024, and we continue to do so. We have a strong cash position in the business. As indicated, Performa, we sort of started the year with north of 800 million in the bank between the year-end cash, the BioNTech transaction, and the equity race that we conducted at the beginning of February.

<unk> cel in relapsed refractory adult ALLL as.

As well as advance our pipeline and development plans, which includes providing runway to data in our first pivotal study of Ob sell in autoimmune disease.

I'll now hand things back to Christian to wrap up with a brief outlook unexpected milestones Christian.

Christian Martin Itin: And obviously, this gives us a very strong base to not only drive our lead program forward onto the market and through the launch, but also expand the opportunity beyond. In addition to the opportunity to expand from a pipeline perspective, also through the options granted to BioNTech. I think when we think about the capabilities we've built, we are obviously in a very good position with regard to our commercial manufacturing capabilities. That's been an enormous lift over the course of the last years.

So a quick look on slide 28 on the plant news flow, obviously, clearly a significant focus on Ob cell delivery first on data as I mentioned, we're planning to update at the <unk> and Ash. This year. This is going to be sort of the June and December time frames.

We're planning to submit to the UK.

NHRA.

Marketing authorization application in the second half of this year, we know I will say our <unk> target action date of November 16 this year.

Christian Martin Itin: It was also a very significant investment that we conducted during that period. Those costs are obviously going down because a lot of the capital expense-related costs are obviously behind us. With that, we see a shift of expense moving from the set-up costs for the facility completion of the pivotal study in ALL moving over to launch-related and launch preparation-related costs. That's the key swing that we'll see as we go through the course of this year.

And we plan to show that first data from our <unk> phase one study.

Towards the end of this year. In addition, obviously there will be updates on our auto rate expected for the end of this year as well as opportunities certainly for publications. During the course of this year on a number of our programs.

So this is kind of a quick update on the plant news flow and in terms of summary going to slide 30.

Christian Martin Itin: I think we have significant opportunity with the pipeline and also with OBCL to expand from an indication perspective and also from an overall product opportunity perspective. So overall, I think we're in a great spot. I think a great outlook for this year, and we're looking forward to taking your questions. Thank you. Thank you. If you would like to ask a question, please press star 1. If your question has been answered and you would like to remove yourself from the queue, please press star 11 again. Our first question comes from James Shin with Deutsche Bank. Your line is open. Hi, good morning guys. Can you hear me?

Obviously, we're in a very strong position with the company we've been executing.

Very consistently during the entirety of the last two years with continued on this exact same pace.

Into 2024, and we continue to do so.

We have a strong cash position with the business as indicated perform are we sort of started the year with.

North of $800 million in the bank.

The yearend cash the biotech transaction and the equity raise and that we conducted at the beginning of February.

Obviously this gives us a very strong base to not only drive our lead program forward.

James John Shin: I'm on a bus. I apologize if there's any background noise. No worries. Loud and clear. Bye, James. Hi Christian.

Onto the market and through the launch but also expand the opportunity beyond in addition to obviously the opportunity to expand from a pipeline perspective also.

Christian Martin Itin: Question on the MHRA approval. Does their inspection have any overlap with the FDA or EMA or any other upcoming inspections? And then I have a follow-up on Obacel for lupus and ALL. Right. So the MHRA inspection and license are a prerequisite for us as a company to be able to export, whether this is going to be to the US or to the EU.

Through the options granted to biotech.

I think when we think about the capabilities we've built.

Sure.

In a very good position with regards to <unk>.

Commercial manufacturing capabilities.

It's been an enormous lift over the last of course of the last years. It was also very significant investments that we have conducted during that period, obviously those costs.

Christian Martin Itin: So it is independent and separate from a US FDA perspective, but it is linked to the European, to the European filing. In fact, it is a prerequisite for the European filing. It's actually the fact that the facility has to actually have a certificate from and has a certificate from the MHRA to be even able to file with the European agency. So that's obviously where it's directly linked, is to the European side, and it is a necessity for the U.S. side, but independent of the FDIC. Are there any like overlapping metrics from the MHR inspections with FDA inspections by chance? Well, first of all, obviously, the fundamentals are the same, and this is all around, you know, the GMP, GMP manufacturer, and the guidelines associated with GMP manufacturing. So the basis for the inspection and the basis for the review is the same basis, so there's no difference there, but there are two independent bodies that actually do their independent reviews, whereas in Europe, the European agency relies on the MHRAs.

They are going down because a lot of the capital expense related cost is obviously.

Are behind Us and.

And with that we see sort of a shift of expense moving from.

The setup cost for the facility completion of the pivotal study in ALLL moving over to launch related launch preparation related costs. So thats sort of the key swing that we'll see as we go through the course of this year and I think we have significant opportunity with the pipeline and also where that would be sell to expand from an indication.

For perspective, and also from an overall product opportunity perspective. So overall I think we are in.

In a great spot I think great I'd look for this year and we're looking forward to taking your questions. Thank you.

Thank you if you'd like to ask a question. Please press star one one maybe.

Your question has been answered and you'd like to remove yourself from the queue. Please press star one again.

Our first question comes from James Sheehan with Deutsche Bank. Your line is open.

Hi, Good morning, guys can you hear me I'm on a bus I apologize if I did any of that.

Ground level.

No very slight unclear right James.

Hi Christian.

Question on the MH <unk> approval does their inspections have any overlap with the FDA PMA or any other upcoming inspection and then I have a follow up on almost all for lupus and AOR.

Christian Martin Itin: And then, as you prepare for Oberstdorf's ALL launch, you know, a lot of the on-calls you'll be spoken to will focus on quality products in a timely manner, given the dire condition of the patient. And, you know, if you look at some of the peer cell therapy launches, there have been some hiccups. What is Autolus doing to make sure, or what have they learned from these peer launches to avoid some of these pitfalls? Yeah, I mean, it's absolutely a relevant question.

Right. So so the image array inspection and license is a prerequisite for us as a company to be able to export whether this is going to be to the U S or to the EU.

It is independent and separate from a U S FDA perspective.

But it is linked to the European.

The European filing in fact, it is a prerequisite for the European filing.

Christian Martin Itin: And in fact, when we talk to physicians in our ad boards, you know, the top question coming back with a top point coming back is, you know, we need access to product. And so the ability to get access to product, to get slots, to get the product in time is absolutely critical. And it's a reflection of some of the challenges that the centers experienced with prior launches. So we spent a lot of time, obviously, optimizing our systems, minimizing the turnaround time. We'll be, in terms of bank delivery time, at around 16 days at the time of launch.

It's actually the fact that the facility has to actually have.

A certificate from and.

Has a certificate from the NHRA to be.

And to file with the European Agency. So that's obviously, where it's directly linked to the European side and it is a necessity for the U S side, but independent of.

The FDA review of the facility.

Are there is there any like overlapping metrics.

Two questions with FDA inspections by chance.

Well first of all I would say the fundamentals are the same and this is all around the GMP GMP manufacturer and the guidelines associated with GMP manufacturing so the basis for the inspection the basis for our review is the same basis.

Christian Martin Itin: And we're also going to do, obviously, full runs from each one of the centers through the entire chain to ensure that from every center, actually, the flow and the processes are fully operational before launch. Before we get to launch. So there's going to be not only the processes have been adjusted, they have been simplified, but also a whole bunch of dummy runs from all of those centers to ensure that, indeed, all aspects of that journey are fully vetted and fully tested for each individual. And then finally, on Carlisle, have you looked at any of the first six patients, and then what are the gating factors to get those subsequent six patients? So we haven't actually been guided on dosing or not dosing.

So theres no difference there.

But there are two independent bodies that actually do the independent reviews.

In Europe, the European agency relies on <unk> revenues.

Understood.

Then as you prepare for <unk>.

Well, Rob I'll caution you spoke to.

Sean.

The product and the <unk>.

Given the buyer.

Condition of the patient.

If you look at the peer yourself Watson.

What is all of the things mature or what have you learned from the co ops to avoid pitfall.

Yes, I mean, it's it's absolutely a relevant question and in fact, when we talk to.

Physicians in Iraq or at the top the top.

Question coming back or the top point coming back is.

We need access to product.

And so the ability to get access to product to get slots to get the product in time is absolutely critical and it's a reflection of some of the challenges that percentages experience with prior launches. So we spend a lot of time, obviously optimizing our systems minimizing the turnaround time will be in terms of bank delivery time at around 16 data.

Christian Martin Itin: The study is open, and it's enrolling patients now. The study itself is not a dose escalation study, so we don't have DLT periods. And we're not limited by the typical phase one dose finding studies, which sort of have to go through review processes in between. So we have an ability to actually enroll all of these six patients as they become available, but we don't have limitations in the study design that would sort of actually gate or slow down the process. I appreciate it. I'll yield to the floor.

Time of launch.

And we're also going to do obviously full rounds from each one of the centers through the entire.

The entire chain to ensure that from every center actually the flow and the.

The processes are fully operational.

Before launch before we're getting to launch so theres going to be not only the processes have been adjusted that simplifies that also is going to be a whole bunch of Dolby problems.

All of our centers to ensure that indeed, all aspects of that.

James John Shin: Thanks a lot, James. I appreciate it. Thank you. Our next question comes from Asthika Goonewardene with CHUIS. Your line is open.

Of that journey are fully vetted.

So the test sets for each individual centers.

Karina Rabayeva: Hi guys, this is Karina for Asthika. Thanks for taking the time to answer the question. So I had a question on the Felix update of ASCO. Besides the longer follow-up, what new data can we expect in this presentation? And also, will it be able to paint a clear picture of what OBCEL can do in terms of a favorable impact on patient outcomes without the need for transplantation? So in terms of the, thanks Karina, in terms of the... Felix study and what we're expecting to do. Obviously, there is quite a significant level of information within the Felix study that we haven't actually, you know, really worked through or presented yet. You know, the impact of bridging in more detail; what are the components that matter there.

I appreciate that and then finally on Carlile.

Have you looked at any of that.

The first application.

And then what are the gating factors to get there.

Sick patient.

So we haven't guided actually on dosing or not those that Saudi is open it's enrolling.

The study itself is not a dose escalation study so we don't have DLP periods.

And we're not limited by the typical phase one dose.

Those five big studies, which sort of have to go through a review process of inventory that we have an ability to actually enroll all of the six patients as they become available.

But we don't have limitations from a study design that would sort of actually gates or slowdown in the process.

I appreciate it I'll yield the floor. Thank.

Thank you.

Thanks, a lot James I appreciate it.

Thank you. Our next question comes from Africa Moon Warden with Jefferies. Your line is open.

Hi, guys. This is great enough for us to go ahead.

Christian Martin Itin: There are other components as well, obviously longer follow-up as well, and there's other risk factors and risk categories that you actually start to see as you go through the data that I think are very helpful and I think very informative. So there's going to be additional sub-analyses, a longer-term view, but also additional sub-analyses that we're going to be presenting through the course of this year. So that's the first part.

Taking the question.

Had a question on the helix update of Africa.

Besides the longer follow up data can we expect in this presentation and also will it be able to paint a clear picture of what.

So Ken.

In terms of that impact.

For patient outcomes without the need for transplant.

So in terms of the thanks Karina.

In terms of the.

Christian Martin Itin: The second part is that we've also been looking at the impact of transplantation. That's certainly also an area that we're planning to sort of report on as we go through the course of this year. Also, an interesting question there is, do we think it is actually, does it look like it's actually improving outcomes, or do we actually have a different type of outcome here? And those are questions we're evaluating, and we'll certainly be reporting as we go through the course of this year. If not at ASCO, then certainly at... And the data presentations for Iha and Ash later on are just an encore of the ASCO presentation. The presentations are somewhat related, but the abstracts are not identical between the two. They may share some of the data, but in terms of the focus, it's like... Okay, got it. Thank you so much.

CLEC study of what we're expecting to do obviously, there is a quite a significant level of inflammation within Felix study that we haven't actually really.

<unk> worked through or presented yet.

The impact of of breaching in more detail what are the components that matter. There there are other components as well as the longer follow up as well and there is other risk factors and risk categories that you actually saw.

To see as we go through the data that I think are very helpful and I think very informative so theres going to be additional sub analysis longer term view, but also additional sub analysis that we're going to be it won't be presenting through the course of this year.

So that's the first part the second part is actually we're also.

I have been looking at the impact of transplantation that certainly also an area that we're planning to sort of report on as we go through the course of this year.

Interesting question. There is do we think it is actually it doesn't look that good it's actually improving the outcomes or do we actually have a different a different type of outcome here and those are questions. We're evaluating and we'll certainly are reporting as we go through the course of this year if not at <unk> certainly at Ash.

Perfect and then data presentations for <unk> acetate on encore of the ask of presentation.

Karina Rabayeva: Thanks a lot, Karina. Thank you. Our next question comes from Gil Blum. Natum & Co. Hey, good morning and good afternoon.

The presentations.

Some are related but there is no that enters the abstracts are not identical between the two they may share some of the data but in terms of the focus is slightly different.

Gil Joseph Blum: Thanks for taking our question. So, a first question kind of focusing on the bridging aspects of the study; this is something that has also recently come up in the advisory committee. It looks like Bridging had a pretty significant impact on patient survival even before you got there for treatment. And in many ways, maybe the fact that you, you know, allow physicians to pick their own bridges may have actually assisted you here. How can you offer... Is there like a study to be done here? It's a really good question.

Okay got it. Thank you so much thanks locked arena.

Thank you. Our next question comes from Gil Blum.

With Needham <unk> Company your line is open.

Hey, good morning, and good afternoon, and thanks for taking our questions.

Our first question kind of focusing on bridging aspects study. This is something that has also recently come up at the Advisory Committee materials for <unk>.

<unk> correctly.

It looked like <unk> had a pretty.

Importantly impact.

Impact on patient survival, even before you got there.

Christian Martin Itin: I think, first of all, the situation is obviously a bit different between multiple myeloma and ALL. In multiple myeloma, the progression of the disease is much less rampant, much less significant in terms of the speed of deterioration as you would have in ALL. ALL obviously can go, as you've seen, you have patients go from mineral residual disease to more than 75% tumor burden. I mean, that gives you a sense of the explosiveness of the disease. So bridging is obviously something that you have to do in these patients. Otherwise, the tumor burden actually gets overwhelming and, in itself, becomes a limitation in these patients.

Treatment and many ways, maybe the fact that you.

<unk>.

Positioned to take their bridging may.

May have actually assess the queue here.

And how can you optimize friction is there like a study to be done here.

It's a really good question I think first of all.

The situation is obviously a bit different between all of the model, but also a L. L.

Milo mouse or progression of disease is much less rampant much less significant in terms of the speed of deterioration as you would have an ALLL ALLL. Obviously it can go as you have seen patients go from minimal residual disease to more than 75% tumor burden.

That gives you a sense of the explosives explosiveness of the disease. So bridging US is always is something that you have to do in these patients otherwise the tumor burden actually gets overwhelming and in of itself becomes a limitation for these patients, but as you could see the impact.

Christian Martin Itin: But as you can see, also, the impact can be that you either see no impact whatsoever, and the patients just go straight over, stays above 75%. Certainly, you would call this refractory as a very functional determination, but you also may have patients that actually transiently may actually have a significant decrease in tumor burden between enrollment and the actual dosing. And that does have an impact in the sense that the level of tumor burden and lymph depletion, so right before you're dosing, obviously seems to actually have quite a significant impact on outcome. And this is the data that we have shown, and we just walked through it a little earlier. So that is absolutely true. That is what you will see.

It can be that you either have no see no impact whatsoever on the patient's Cisco straight overstay is about 75%.

Certainly you recall that is refractory and very functional as a very functional determination.

But he also may have.

<unk> stat actually transiently may actually have a significant decrease in tumor burden.

Between enrolment and the.

And the actual dosing and that does have an impact in the sense that the level of tumor burden at link for depletion.

So right before you are dosing seems to actually have quite a significant impact on <unk>. This is the data that we have shown which is walk through a little earlier. So that is absolutely true that is what we do see and it seems better correlated than actually the tumor burden at the.

Christian Martin Itin: And it seems better correlated than actually the tumor burden at the time of screening or inclusion because that obviously is somewhat arbitrary. It just happens to be when you actually see the patient, and determine the level of tumor burden, and that could obviously be at any level in the relapse. And so at the time of bridging, obviously, that gives you much more relevant data. It's part of the therapy, and it's always been part of the therapy in ALL, even when you look at other therapies. At times, if you have very excessive tumor burden, you would actually first intervene with a short course of chemotherapy to push down tumor burden before you dose.

At the time of screening our inclusion because that obviously is somewhat arbitrary it just happens to be when you actually see the patient determined the level of tumor burden and that's obviously it could be at any at any level.

In the relapse.

So.

At the time of reaching I would say that gives you a much more relevant information, it's part of the therapy and its always been part of the therapy and even though when you look at other therapies at times. If you have that access of tumor burden do it actually first intervene.

Is that a short course of chemotherapy pushed Andrew.

Christian Martin Itin: It's one of the things we have done during clinical development. It certainly was important not only to improve or have a chance of success with that approach, but also to reduce the risk of very severe adverse events. So it is an integral part, and what we certainly will do is, over time, probably look at different types of bridging and whether we might actually see differences there.

So one of the things we have done inside the development and construction. It was important to also not only.

Improve or have a chance for outcome.

And with that approach, but also to reduce the risk for very severe adverse events.

So it is it is an integral part and we're certainly we will do is over time.

Probably look at different types of reaching and whether we might actually see differences. There. So that's certainly part of the analysis. We're also still running.

Gil Joseph Blum: So that's certainly part of the analysis we're also still running. Through the trial, it may actually pose opportunities for also potentially investigating a sponsored study. Okay, and switching to autoimmunity, you mentioned that there are a lot of similarities. Oberstel and the German IST said that there are a couple of other companies out there who also have very similar programs to the German IST. Where would you say is a differentiator between your program and other programs? What do you think is your key?

Through the trial actually posts.

I think opportunities for also potentially investigator sponsored study of the industry.

Okay.

Switching to Autoimmunity, you mentioned that there are a lot of similarities between <unk> and I'm. The chairman of the asset there are a couple of other companies out. There also have very similar programs to determine a nice day.

What would you say is a differentiator between air program and other programs. What do you think of your key advantage.

Christian Martin Itin: Well, the first thing I think is interesting is that it's not, I think, is that we can make a statement about our product as it stands. How that may compare to others, I think, is very difficult because, for the most part, we don't have data to compare. But we do have data to compare our product to the product that was used in Erlangen, and that is relevant because it gives us a very clear understanding of the features that that product in Erlangen had versus ours, and with that, predictability for us. And I think that is relevant. And I think what we do see, also compared to the airline program, as we have seen prior in the pediatric ALL patients, if one compared the CARPAL study to the ELIANA study from a safety perspective, there's a very significant difference there where none of the kids actually experience high-grade CRS compared to 47%. We had a pair of patients with high-grade COS in the Ileana study.

Well the first thing I think which is interesting is that it's not I think is that we can make a statement to our product as it stands.

How would that may compare to others I think is very difficult because for the most part we don't have data to compare to but.

But we do have data to compare our products to the product that was used in Arizona and that is relevant because that gives us a very clear understanding of the features that data product and airlines had versus ours and with that the predictability for outcome.

I think that is relevant and I think what we do see also compared to the airline program is.

As we have seen prior.

In the pediatric <unk> patients if we compare the cartel study to the Eliana study from a safety perspective, there's a very significant difference there where we had none of the kids actually experienced high grade Crs.

Compared to 47% payout.

Patients with high grade Crs in the Eliana study versus studies were conducted within a very short period of time actually overlapping each other as well so same environment same way of treating patients managing safety et cetera. So we do know that we have a quite a significant difference there in that different dose that was observed was observable when comparing to.

Christian Martin Itin: Most studies were conducted within a very short period of time, actually overlapping each other as well. So, the same environment, the same way of treating patients and managing safety, etc. So we do know that we have quite a significant difference there, and that difference also was observed and was observable when comparing to the program that was running in the pediatric patients, which obviously, you know, was prior to the work that we all know about on the All right, and maybe our last one on this topic. So most discussions that we've had on the use of self-therapy in autoimmune diseases suggest that only a relatively small window piece of literature needed I mean, I guess that's one hypothesis that is out there, but I'm sure you have a different view on that. Yeah, I mean, it's interesting.

The program that was running an airline on the pediatric patients, which obviously.

What's sort of prior to the work that we all know about.

On the audience side.

Alright.

And maybe a last one on this topic. So most discussions that we've had.

On the use of cell therapy in autoimmune diseases.

But only a relatively small window.

Based on our pleasure Nida to quote unquote resets.

The immune system.

I mean, I guess, that's one kind of hypothesis that is out there but.

I'm sure you have.

Christian Martin Itin: There are obviously a lot of hypotheses. And that sort of gets me back to actually what we know for. And so, what we know works is a product that is a long-lasting product in pediatric ALL when used in autoimmune patients, which have a very active immune system. Persistence, of course, is Dan in Highly Being Compromised Pediatric Illness, where you do see that that product with that type of properties gives us the type of outcome received. To suggest that a product that wouldn't actually be active in pediatric ALL would be able to get a significant outcome in immune patients is, I think, a postulate you can set up, but certainly, there's no data that would support that.

A different view on that.

Yes, I mean, its interesting theres, obviously a lot of hypotheses.

And that's what gets me back to actually what we know works and so what we know works is a product that is a long persisting product in pediatric AML when used in autoimmune patients, which have a very active immune system as a consequence, the persistence of course, it's shorter.

Then in highly immune compromised pediatric patients.

That you do see that that product with that type of properties gives us the type of outcome proceeding.

You suggested a product that wouldn't actually be active in pediatric AML.

Look be able to do the guest a significant outcome.

Of the immune patients I think is a possibility can set up but certainly there is no data that would support that at this point. So what we know is that a long persisting car T program gives you the right outcome that we were looking for we know our product has exactly those properties.

Christian Martin Itin: So what we know is that a long-term CAR T program gives you the right outcome that we were looking for. We know our product has exactly those. And I think everything else, you know, people will have to actually run trials and actually figure that out, but it is not, I think, very easily understandable why you would make that correlation if you start with a product that may not be really active or substantially active and then conclude that it would still work in autoimmune disease. It may, but I think at this point, it's sort of a statement in the absence.

And I think everything else people will have to actually run trials and actually figure that out but it is not I think there is.

Italy understandable for why you would make that correlation.

If you start with a product that is not where it may not be really active or substantially active in pediatric allo and then conclude that it would still work.

It may but I think at this point, it's subject to stay under the absence of data.

Gil Joseph Blum: All right, thanks for taking... Thanks a lot, Gil. Thank you. Our next question comes from Eric Yeung with William Blair. Your line is open. Hi, Eric Goone, for Matt Phipps.

Alright, thanks for taking our questions.

Lockout.

Thank you. Our next question comes from Erik Young with William Blair. Your line is open.

Yes.

Yes.

Hi, Eric on for Matt Phipps.

Eric Y Yeung: I was wondering, firstly, with the additional cash on the balance sheet, how you're thinking about obucelle development other than FOMA indications, and if you plan on enrolling any additional patients within NHL or CLL? Thanks, Eric. So we are currently looking at quite a range of indications, and we're sort of looking at where we want to actually put our bets. And we're clear we're going to have at least one pivotal study in autoimmune, and we're looking whether there would be a second autoimmune pivotal study or whether we're going to be running an oncology study in one of the non-Hodgkin's indications. And that's currently under evaluation. That's not yet decided.

Wondering firstly with the additional cash on the balance sheet.

Was wondering how youre thinking about Ob cell development other than film indication and if you plan on enrolling any additional patients with NHL or CLO.

Thanks, Eric for joining.

So we're currently looking at quite a range of indications.

We're sort of looking at where we wanted to actually put their beds and we're clear we're going to have at least one pivotal study in autoimmune.

And we're looking whether whether there is whether it would be a second autoimmune pivotal study or whether we're going to be running a.

Ecology study and one of the non Hodgkin's dedications and Thats currently actually under a renovation that's not yet decided.

Christian Martin Itin: But we're probably going to generate some additional data also for OBCell in the non-Hodgkin's indications to sort of round out the experience that we have. Great, and then just one additional question. So I know you've had to do next-generation sequencing on patients for enrollment in Auto IV and Auto V, and that paper you guys published in the blood journal, Cancer, on TRPC1 and 2 staining, I was wondering if that paper could be supportive of a potential companion diagnostic for Auto IV and V? It's a really good question. And that's obviously the reason why we've been working, you know, together with the parties you mentioned in the paper, that obviously, if you can move away from NGS and go to an antibody that you can actually use, and with classical staining, that obviously would simplify the approach and probably also accelerate it, because obviously, if you go with NGS, you actually need to have a sequence, you need to have the right primers, e It's not trivial.

But we're probably going to generate some additional data.

Also for Ob sale in Danone in Hodgkin's.

I'll now turn the indications to sit around the experience that we have made so far.

Great and then just an additional question.

So I know you've had to do next generation sequencing on patients for enrollment in auto Horne five and that paper you guys publish in the flood journal cancer on the TRP seem wanted to sustaining I was wondering if you think that paper could be supportive of a potential companion diagnostic for auto horn.

It's a really good question.

Obviously, the reason why we've been working together.

Together with the parties you had on the paper.

That obviously, if you can move away from Ngls and go to a.

An antibody that you can actually use with classical staining that obviously it would simplify the approach and probably also accelerated because obviously, we should go with mgs you'd actually.

Good to have a sequence of the right privacy et cetera specific.

And then actually run the analysis it is not trivial.

Christian Martin Itin: This could be easier, and it also would actually allow you to include these staining procedures in a more standard panel of stains that you'd be using to characterize tubers. It may actually lead to already a determination of TRBC status in patients ahead of even having them included in a therapeutic approach. But have it, like you have CD19 and other markers, the standard markers to analyze, actually move also in that direction. And, of course, as you point out, it gives you the opportunity for companion diagnostics based on staining. Great, thank you. Thanks a lot, Eric. Thank you. Our next question comes from Yanan Zhu with Wells Fargo. Your line is open.

This could be easier and it also would actually allow you to.

Include these.

<unk> staining procedures and a more standard.

Panel offstage that you'd be using to characterize tumors that may actually lead to.

Already a determination of <unk> status.

In patients ahead of even having.

Basic include them in a in a therapeutic approach, but have it like you have CD 19 at other markers of standup markers to analyze have them actually move also in that direction and of course as you point out. It gives you the opportunity for.

For companion diagnostic based on that answer any procedures.

Okay.

Great. Thank you. Thanks.

Thanks, a lot Eric.

Thank you. Our next question comes from Liana <unk> with Wells Fargo. Your line is open.

Yanan Zhu: Great, thanks for taking our questions. First on SLE, I know you mentioned you're not guiding for dosing or not dosing. I'm curious about the level of interest at your first clinical site and also, you know, regarding your guidance for data late 2024, I was wondering about the number of patients at the time of readout and the duration of follow-up. Do you have a minimal, kind of a powerful duration of follow-up? Thanks. Thanks, Yanan, and thanks for joining us.

Great. Thanks for taking our questions first of all S. L E.

I know you mentioned youre not guiding for dosing or not building.

I am curious about the level of interest at your fresh clinical site.

Also.

Regarding your guidance for data late 2024.

I was wondering about.

The number of patients at the time of readout and the duration of follow up do you have a minimal kind of a powerful duration of follow up thanks.

Thanks, Shannon and thanks for joining.

Christian Martin Itin: So, first of all, the study we're conducting in the UK... In the UK, there are actually no competing studies for these types of patients, so that puts us in a good position and one where we think we actually have an interesting standout feature around the study and opportunity for patients. In terms of data and the year, we obviously are expecting that we can involve the six patients and be able to report on those six patients. How much follow-up we'll have on them, I think that's premature to sort of point out. But the goal would be to actually have the cohort involved and then report on the data. Great, thanks for those colors!

So first of all the study we're conducting.

In the UK and Spain.

In the UK there are actually no competing studies.

For these types of patients so that puts us in a good position.

One way, we think actually we have a obviously a very sort of <unk>.

Adjusting standout.

Feature of this study and the opportunity for patients.

In terms of data end of the year we.

Are expecting that we can enroll the.

Six patients and theoretical to report on those six patients how much follow up we will have all of them I think that's premature to sort of point to.

The goal will be to actually have the cohort enrolled and then report on data from that cohort.

Great Thanks for that.

Those colors.

Yanan Zhu: On Felix, I was wondering for the mid-year data update, would the data be a pooled analysis, or would it be the pivotal cohort? Also, since you commented on your real-world breakthrough therapy strategy, I was wondering, does that have any implications for FDA review? Thanks. Yeah, really good question.

Our Phoenix wondering for the midyear data update.

The data.

A pooled analysis or would it be.

Pivotal cohort.

Also.

<unk> commented on.

Your real world braking therapy strategy.

I was wondering does that have.

Any implications for FDA review.

Thanks.

Christian Martin Itin: So, in terms of the data updates, obviously, as indicated, we're looking in particular at different risk groups within the data set, so that's going to be a key focus. And I think we're going to be, obviously, the general update will be likely across the entire study, because from a physician's perspective, that outlook is actually what's really relevant, because that reflects the patients that you would actually see in actual practice. And so we're probably going to report on that as a reference point, referencing back to the ASH data. Um, the bridging itself, obviously, is relevant in the sense that the analysis that you can run it sort of in two different ways, and different agencies take different positions on it.

Yes really good question so.

In terms of the data updates obviously as I indicated we're looking in particular at.

Different risk groups.

Within the data set so thats going to be a key focus.

And I think we're going to be obviously, the general update will be likely across the entire study because from a.

Physician's perspective that outlook is actually what's really relevant because that reflects the patients that you would actually see an actual practice and so we're probably going to report on that as a reference point referencing back to the.

The ash data.

The bridging itself obviously is is.

Relevant in the sense that the analysis that.

You can run.

Two different ways.

Different agencies take different positions on it you have to look at the at the analysis based on the tumor burden that screening, which is basically frankly, the time point, where any physician can look at the at the patients and you focus on patients that have more than 5% tumor burden those of the morphological patients thats the intent to treat.

Yanan Zhu: You either look at the analysis based on the tumor burden and screening, which is basically, frankly, the time point where any physician can look at the patients, and you focus on the patients that have more than 5% tumor burden. Those are the morphological patients. That's the intended, That's certainly the position or the primary focus you'll see with the European Agency as regards the primary view, which is to the physician's view. This is when the physician can make a decision. Okay, this is the patient that gets included. What is the outcome related to this? And then there, when you look at the review process for Blindsight and, as well as for Ticardus, the focus the FDA has is more on the patients that actually have 5% tumor burden at the time point of dosing. And so that would be 5% ad limpha depletion, and it would be that category of patient, which is the primary group for assessment. So there are differences and some different views that are taken in terms of analyzing data, and it really depends on the agency.

That's certainly the position or the primary focus you'll see.

The European agency as of the primary primary view, which is to the physician's view. This is where the physician can make a decision. Okay. This is the patient that gets included what is yet to come related to that.

And then when you look at the review process for <unk>.

Sure.

As well as for harvest the focus of the FDA is more of the patients that actually have.

5% tumor burden at the time point.

<unk>.

Of dosing.

And so that would be 5% admin for depletion and it won't be that category patient, which are the primary group for assessment. So there are differences in some different views that are taken in terms of analyzing data.

Christian Martin Itin: But that's the fundamental difference between what we're seeing based on prior review history. Great, great. I appreciate the cover. Thank you. So long. Thank you. Our next question comes from Kelly Shea with Jeffrey's. Your line is, Hi, this is Dev on behalf of Kelly, for taking our.

And it really depends on the agency, but that's the fundamental difference on what we're seeing based on prior review history.

In space.

Appreciate the color. Thank you.

Thanks, a lot.

Alright.

We have no more.

Please go ahead. Our next question comes from Kelly <unk> with Jefferies. Your line is open.

Hi, This is Dave on for Kelly and thank you for taking our question I have couple of question one.

Kelly Shea: I have a couple of questions. One is, did you do the analysis? Can you talk about what kind of patient baseline you are thinking about enrolling in your study for Data Presentation? Are you thinking of presenting it at a medical conference? Yeah, so when we look at the patients that we're enrolling in the study, we're enrolling patients that have, obviously are lupus patients that have, have or do not have kidney involvement. So both manifestations we do see, we do have patients and have that done in the airline study that will have at least one organ involvement in these patients. So it very much tracks alongside what you have seen and read about in the publications from the airline.

You did analysis on.

B cell engine, gentlemen, product, which is similar could you talk about what kind of patient baseline.

Thinking about enrolling in the study and data presentation, I, just thinking of presenting attacks.

Medical conference.

Yes.

When we look at the patients that we're enrolling in the study, but we're growing patients did have I'll say, our nuclear stations that have.

Or do not have kidney involvement so both manifestations. We do see we do have patients has that started in the <unk>.

Your line study that we'll have at least one organ involvement.

In these patients so it's very much tracks alongside what you have seen and read about in the publications from the airlines.

Christian Martin Itin: So it's a very comparable patient population, in terms of inclusion and exclusion criteria. The plan would be for us to see that we can first aid, Great, thank you. Thank you. Thank you. Our next question comes from Jacob Mekhael with KB. Hi there, and thanks for taking my question. I have a few, that's okay.

That's a very comparable patient population that we're enrolling.

In terms of inclusion exclusion criteria.

The plan would be for us to see that we can have.

First data at one of the medical conferences at the end of the year, so that would be the plan.

Great. Thank you. Thank you very much.

Thank you. Our next question comes from Jacob <unk> with KBC Securities. Your line is open.

Hi, there and thanks for taking my question I have a team thats okay.

Jacob Mekhael: First, I have a question on the option agreement with BioNTech on Auto-122 and Auto-6NG. What do you need to show or reach with those programs to trigger an opt-in from BioNTech? That's my first question. And then, perhaps more of a broad question on autoimmunity here, given the larger patient population we're talking about, from your point of view, what needs to happen in the CAR T ecosystem to ensure that, if approved, those treatments, or there is enough capacity in the ecosystem to ensure that those patients have access to those treatments. Thank you. Thanks, Jacob. I think these are two very good questions.

First I have a question on the option agreement by impact on Ultra $1 22, and <unk>, what do you need to show rate for that program to trigger and obtained from biotech.

My first question and then perhaps more of a broad question on auto immunity here given the larger patient population, we're talking about from your point of view what needs to happen in the car T ecosystem to ensure that if approved this treatment.

There is enough capacity in the ecosystem to ensure that patients have access to those treatment. Thank you.

Thanks, Jacob I think two very good questions. So first of all with regards to the option agreements on the <unk> 22 in order to <unk> deck.

Christian Martin Itin: So first of all, with regard to the option agreements on Auto 1.22 and Auto 6 NG, the option agreement is structured such that the options have to be exercised before we start our pivotal studies with those programs. So it's actually triggered by progression, and it's not defined by a defined outcome or a defined level of activity. It's the actual decision to move forward into pivotal studies, so that's the latest high point for the exercise. It can happen before, but that's the latest high point.

The option agreement is structured such that the options have to exercise before we start our pivotal studies with those programs. So it's actually triggered by progression that's not defined by a defined outcome or a defined set of level of activity. It's the actual decision to move forward into pivotal study. So that's.

The latest time point for the exercise it could happen before but thats the latest time point.

Christian Martin Itin: So that's the option exercise question. In terms of breadth with regard to autoimmune indications, I think the first observation is that we expect that the initial application for CAR-T will really be in what you would often refer to as the more refractory type of population in those indications. So that's intrinsically a relatively small part of the overall autoimmune indication that you'd be looking at. So if you have the overall lupus population, you may look at a few hundred thousand patients, but actually, what we expect to go in and to sort of be amenable to a CAR-T approach, that may be in the few thousand. So it is a smaller subset.

So that's the sort of the option exercise question.

In terms of the breadth with regards to autoimmune indications I think the first observation is that we expect that.

The initial application for car T will really be in there.

We refer to as the more refractory type of population in those indications. So that's intrinsically a smaller relatively small part of the overall.

The overall autoimmune indications that if you're looking at so if you have the overall Lucas.

Population you may look at a few hundred thousand patients, but actually will be expect to go in and just sort of be amenable for a car T approach that maybe in the few thousands. So it is a smaller subset and we expect that to be true also with some of the other indications so from that perspective moving into this disease.

Christian Martin Itin: And we expect that to be true also with some of the other indications. So from that perspective, and moving into these disease settings, we would expect that capacity and the ability to serve are doable and will be there. One of the questions will be, ultimately, with some of the other indications, how broad you would actually be able to go into these indications and have an adequate value proposition for these patients, and I think that's something we still need to learn about how far into these earlier stages or less severe stages of disease it is sensible to actually bring in a therapy like CAR T therapy. And I think that's something we'll be frank about that we still The initial position, we believe, is very well served by the current types of infrastructures.

<unk>, we would expect that capacity actually have the ability to serve.

It's doable it will be there.

One of the questions will be ultimately with some of the other indications is however, all you would actually be able to go into these indications and have an adequate value proposition.

For these patients and I think thats something were still need to learn how far.

Into these earlier stages or less severe stages of disease.

Is it sensible to actually.

Rig in a therapy like the car T therapy, and I think that's something we'll be we'll be frankly, we still need to figure out that we need to generate data in the field to get a better understanding of sort of where the right place and have brought that position can be the initial positioning we believe is variable cervical.

With the current types of infrastructures that technologies.

Jacob Mekhael: All right, thank you very much. Thank you, I appreciate it. Thank you. That's all the time we have for questions.

Alright, Thank you very much.

Thank you appreciate it.

That's all the time, we have for questions ill turn the call back over to Christian that Tim for closing remarks.

Christian Martin Itin: I'll turn the call back over to Christian Itin for closing remarks. Well, thank you very much for joining today. Obviously, great to have an opportunity to really review, I think, all the progress we've been able to make through the course of last year and into this year. A lot more to come this year.

Well, thank you very much for joining today.

Great.

We have an opportunity to really review I think all of the progress we've been able to go through the course of last year and into this year a lot more to come. This year. We appreciate the continued support and interest and wish you all.

Operator: We appreciate the continued support and interest and wish you all a great upcoming period and look forward to connecting in person again. Thank you. Thank you for your participation. This does conclude the program. You may now disconnect. Everyone, have a great day.

Great upcoming periods and looking forward to connecting in person again. Thank you.

Thank you for your participation. This does conclude the program you may now disconnect everyone have a great day.

Yes.

Yeah.

Okay.

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