Q3 2022 Autolus Therapeutics PLC Earnings Call

Okay.

Hello, ladies and gentlemen, and welcome.

Third quarter 2017.

And that's a result conference call as a reminder, this conference call is being recorded.

Now I'll turn the conference over to your host Olivia referenced director of Investor Relations. Please go ahead.

Hey, good morning.

Hum.

Joining us today.

That's cool.

Hum.

I like that.

The director of Investor Relations and with me on stage.

Christian heighten our Chief Executive Officer.

Listen the Crabtree, our Chief Financial Officer.

Before we begin I'd just like to remind you that during today's call. Our discussion will contain forward looking statements.

You can actually get familiar with our disclaimer slide that you've done.

Right.

And then turning to slide three you'll see the agenda for today is as follows.

Christian will provide an update of our operational highlights third quarter of 2022.

He will then discuss the company's financial results for Kristian will complete milestones and any other cost savings.

And finally of course, we welcome your questions.

To your question.

Thank you Olivia and good morning to you all and thank you for joining US. It's my pleasure to review our progress for the third quarter of 2022 moving to slide four.

Really pleased with our strategic and operational progress during the third quarter of 2022, which is highlighted over the next two slides.

Firstly, we remain on track to provide an update on our pivotal field trial in Q4, 2022, and we plan to present Felix Phase II data at a medical conference in the first half of 2023, most likely at Astro. We're also likely we're also looking forward to presenting longer follow up data from our ALLL patients can be old car 19 phase one trials.

At Ash and are planning a more in depth look at the patients.

Alright.

Looking forward to it.

Patients that we've treated with non Hodgkin's lymphoma.

Representing further data.

At the three phase one trials at Ash in December 1st.

Indicating that the old car 19 phase one extension study for Ob sell NBA NHL car Pallet study, which is also a phase one trial with only 122 pediatric allo and from our Libre T. One phase one trial of order forward peripheral T cell lymphoma. The abstracts are these data updates will be online later this morning, So we won't be discussing.

During this morning's call. In addition, the phase IV Mccarthy trial exploring auto eight in multiple myeloma.

Patient is progressing and the phase <unk> trial exploring <unk> is expected to start in the first half of 2023, turning to slide five we've made some great operational progress during the quarter and post period end.

We're very pleased to report a two technology deals in October 2022, which underscore the scientific capabilities and expertise at all of the lists we signed an agreement with Bristol Myers squibb, prompting them access to our proprietary <unk> rituximab induced safety switch for incorporation into a set of selected cell therapy programs in return for a loaded.

Low to mid single digit million dollars upfront payment with potential for near term option exercise fees and development milestones.

Plus royalties, but earn exercised an option on one of the proprietary behind us being developed against an undisclosed immuno oncology targets for the delivery of their message RNA Therapeutics and returned for a low single digit million dollars upfront payment as well as development and commercial milestone payments for each product successfully commercialized plus royalties on net sales of <unk>.

<unk> commercialized under the agreement.

The license option stems from the deal we signed with <unk> in August 2021.

We also continued to make progress in our manufacturing in CMC operations face amount of the build of our Stevenage facility is on track for transfer to <unk> before the end of the year to start the qualification and validation work facility and remains on track for good manufacturing practice operations commencing in the second half of 2023.

We're also on track with the CMC workflow and report generation for the CMC package plan to support a BLA submission to the FDA.

Cash and cash equivalents at the end of September were $163 1 million not including the R&D tax credits for HRC of $19 1 billion received in October .

Slide six with that let's talk about our primary focus our lead product <unk> on slide seven just to remind you <unk> has a unique mechanism of action and builds on a highly specific engagement of CD 19, coupled with a fast release from CD 19, once the <unk> has been initiated.

This fastest engagement is based on the fast off rate of the cat Binder and drives three key properties of Ob sale reduction of the <unk> cytokine release per target selling cantor, which in turn will reduce the amount of unit toxicity in the patients.

Reduced exhaustion of the car T cell and improved and grasp and overall persistence.

And those of you not familiar I refer you to a paper by Ceragon, Russia at nature Medicine published in 2019.

Moving to slide eight we show. This slide is a reminder, that there remains a very high unmet medical need for treatment of adult <unk> patients with approximately 8400, new cases diagnosed yearly.

On a worldwide basis in the last slide setting and.

Approximately 3000 of these cases reside in the U S in EU.

And whilst a combination chemotherapy <unk> been able to about 90% of the adult <unk> patients to achieve complete remission only about 30% to 40% will achieve longer term innovation. Once relapsed patients have a median overall survival of less than a year current approved therapies for adult patients our billing cycle and the card.

Both therapies are highly active but frequently followed by subsequent treatments for example, allogeneic stem cell transplants.

<unk> has a favorable safety profile with few patients experienced severe crs and icons, but with limitations on durability of effect and convenience due to the need for continuous IV infusion of <unk> four week treatment cycles. The.

Patients in morphological with morphological disease trading at 34 sides of the U S. The U K and Spain.

We're on track with our previous guidance unexpected provide the qualitative updated Q4, 2022, which we would expect to reference whether the primary endpoint has been neck.

We're planning on presenting data from the Felix study at a medical conference in each of 2023.

In order to maximize that it comes from the Felix trial in parallel were also assessing <unk>, an additional cohort of up to 50 patients and second or later complete remission.

Who have developed minimal residual disease. However, this additional cohort does not impact our plan filing timeline as the primary data will be based on the data from the morphological cohort.

Moving to slide 12 O.

<unk> sells unique profile means it could be applicable to a broad range of indications for consequently, valuating the product candidates outside of ALLL and vsel non hodgkins lymphoma indications.

An ongoing in an ongoing phase one clinical trial.

As we said before we have positive clinical readouts at the recent DHA Congress from the Phase one studies in <unk> lymphoma, and primary CNS lymphoma presented by way of the poster as well as an oral presentation of the first auto 122 faced bomb data in pediatric patients.

Cover the state of the upcoming slides.

As I said, we'll be presenting additional data ash in December this year with abstracts due to go online later today.

On slide 13, as a reminder, the academic Golkar 19 study has been extended at the basket study, where we are testing obi cell in the number of P cell malignancies. Today. It was treated 17 patients with Follicular <unk> lymphoma, and no patient experience high-grade Crs and non has any great of neurotoxicity.

The 17 patients dose 16 achieved metabolic complete remission 770.

Follicular lymphoma patients six or seven <unk> lymphoma patients and three of three not to sell it for locations.

We lost one patient to cover it and one mcl patient Laelaps 60.

16, 14 of the 16 patients that have responded remain in metabolic CR with a median follow up of 9.2 months the longest being 19.1 months as of the last reported data costs and the data continues to mature.

We've also started reading some tll patients and from the three patients that have reached initial evaluation as over the last day to cut off two went into molecular C. R. In the bone marrow that have some residual lymphadenopathy on C T scans.

We're looking forward to presenting additional patients and longer follow up data from this old car extension study.

December .

You Slide 14, we're also exploring overselling primary CNS lymphoma or academic Carousel study.

This is a type of aggressive visa lymphoma, but because of its anatomical location. It as a particular poor prognosis initial treatment is often intensive and outcomes for these patients tends to be poor.

On in the day that we presented the DHA, we didn't see high grade Crs two patients experience neurotoxicity, great three and four lump patient improved with steroids and Ah Kendra. The second patient had several neurological deficits consistent with progressive disease and didn't respond to stairway sent out of kindergarten.

Overall, you can see on the right hand side of this slide that despite these patients having no disease outside of the CNS and having had lots of <unk> treatment, we still see really nice expansion of <unk>, Bruce robot and we expect to provide more data from this study in 2023.

Moving to slide 15, our initial experience with obesity in children achieved high level of sustained Crs without experiencing high rates Harris.

Those children, who relapsed on it with after treating with <unk>.

Most of them had lost senior 19 expression on their leukemic cells at the time if relapse here, we're taking the next step in Obi cells life cycle with auto 122, a dual targeting product building and I hope you sell and adding a highly potent C. D 22 targeting <unk> receptor. The city 22 car was designed to be active against the <unk>.

With low levels of city 22 expressed on their surface.

The evaluated auto 122, and an extension of the Carp health study in children, who were ineligible for <unk>. The children either relapsed after receiving can Brian I could not be treated or they had extra meat already disease, a singular lesions in tissue without having disease in the bone marrow the normal location of leukemia.

This is a very challenging group of patients to treat at a 14 children forehead prior to Brian therapy, and three of them had lost C. D 19 expression seven kids had extra Madonna's ray disease.

Moving to slide 16.

There are presented of DHA and showed at nine of the 11 patients achieved a molecular CR on base 28.

Or the 122 as well manageable with no patients experiencing high-grade Crs no patient relapse with antigen loss and two of the CD 19 negative patients achieved a molecular C. R demonstrated the isolated activity of the CD 22 car, we're continuing to follow the patients and we will be presenting this data at ash.

The upcoming weeks.

Slide 17.

Moving straight to slide 18 on the pipeline there was a brief depiction of our broad cell programming tool kit. We have developed over the last few years and drove the deals with Pms and put it.

All in the technology is covered programming modules for targeting control shielding and enhancing khaki cell activity.

<unk>, we have more than 100 patent families covering these products and sell programming technologies recent illustrations of three technology applications were shown at <unk>. The annual meeting in May this year.

Each of one of our product candidates supplies, one or several of the technologies to maximize its impact on the specific cancer. It is designed to tackle.

Moving to slide 19.

This slide shows more of our next generation programs beyond <unk>.

Lifeline program, we're particularly excited about his auto for which is in phase one study and T cell lymphoma, I'll give you a refresh of the data we presented the DHA in just a minute.

<unk> moved into the clinic earlier this year in a phase one clinical study in patients with multiple myeloma.

And we are now dosing patients and also want to mention that our first started to a program Autistics energy HED too positive solid tumors will be moving into the clinic and the first half of next year.

Turning to slide 20.

We're actively exploring <unk> lymphoma, which is an aggressive disease with a very poor prognosis for patients.

Recall <unk> analyst call for a Dr. Horowitz from Department of Medicine Lymphoma Service Memorial Sloan Kettering Cancer Center talked about the majority of patients being either refractory or relapsing after initial treatment.

The standard of care is variable and often based on intensive chemotherapy treatments.

Median survival for patients with relapsed or refractory disease is less than six months.

<unk> disease that either express <unk> the T cell receptor better chain constant domain, one or two are expressed on more than 95% of all T cell lymphoma patients.

Only gamma Delta T cell or N K T cell derived lymphomas lack T cell receptor beta chain constant remains wanding too.

Four targets CIBC one it is the first product candidate to do so using next generation sequencing, we identify patients with Trp's Yvonne expressing <unk> lymphoma, and then <unk> positive patients are treated on the currently open order for study and in the future. We plan to open and studied targeting <unk> positive patients.

With all the five as well.

Four is designed to selectively kill lymphoma cells in a manner that we believe will preserve a portion of the patients normal healthy T cells to maintain immunity in that patient.

Turning to slide 21, we presented data DHA on the Liberal T. One study evaluating order foreign patients with diesel lymphoma.

We've seen encouraging activity in a favorable tolerability profile, indicating clinical proof of concept for the new approach for targeting piece of lymphoma.

Looking forward to presenting longer follow up at ash.

So with that we'd like to turn to slides twenty-three.

Manufacturing a cell therapies as complex and we've developed a great deal of skill and experience manufacturing products throughout the pandemic and for a range of products candidates. We're building a new manufacturing facility in Stevenage in the UK dislocation is about a mile away from our current clinical manufacturing operations at the cell and gene therapy for.

<unk> and will allow us to transition our entire operation, including our experienced staff to the new facility in an expeditious inefficient way, both maximize minimizing startup risks and costs for commercial supply.

As evidenced by our successful manufacturer of khaki.

Products for the pivotal study with centers across the U S and Europe location is well suited for global supply with easy access to several international airports, including loans mantra.

The new 70000 square foot facility.

We'll provide all the list with a capacity of approximately 2000 cell therapy batches, a year and with the ability to expand capacity.

Further when needed you can see on this slide a rendering of what the facility looks like once completed by the end of the year in the Middle you can see the actual facility a few weeks ago when the large preassembled HVAC units were lifted onto the roof.

I mentioned, our progress earlier phase of onto the built built project is scheduled to complete.

In the fourth quarter and the equipment installation that qualifications, but <unk> on track for G&P operations for the second half of next year.

Clinical supply operations. We currently operate with four shifts seven days a week Ah commercial manufacturing modal will continue with that pattern of a seven day a week.

Throughout the year.

So with that I would like to return to slide twenty-five and pass the call to the center for our third quarter of 2022 financial update Lucy.

Thanks, Christian and good morning, or good afternoon, everyone.

It's my pleasure to review our financial results for the third quarter to September 30th 2022.

We'll start with our cash position, which at September 30th 2019 totaled $163 $1 million.

This doesn't include a $19.1 million or detached credit we received from hatred nothing <unk>.

<unk>.

Which is also a cash I will.

Given the majority of I'll spend it in GBP, we actually hold a large portion of our cash has reported that should hopefully, 80% and Pam and <unk> in the U S D.

Net total operating expenses for the quarter with $43.5 million, which included license revenue income touching $2.4 million.

Which primarily resulted as a result of the vagina option exercise announced in October .

Research and development expenses increased by $5.3 million to $37.6 million guaranteed train. This was primarily to following an increase of $3.6 million in clinical amount of <unk>, primarily the 1980 cents and.

An increase of $2 million in salaries and unemployment connected costs maintenance driven by an increase in the number of employees engaged in research and development activities.

We also have largely increasingly 19 fees as we transition to the quarter offset by decreased cost and the appreciation is tiki.

General and administrative expenses remained stable O'neill.

Other <unk> income.

That extends income decreased to an extent at $3.7 million from an income of $1 million in the first three months after September 30th 2021.

The decrease of $4.7 billion is primarily due to the weakening at the <unk> setting relative to the lifestyle that exchange during the three month period.

Interest expense increased to $1.9 million in the quarter, which relates primarily to the liability related to <unk> agreement with <unk>.

Thank you ma'am.

Finally, net loss attributable to ordinary shareholders was $42.8 million per quarter.

<unk> and I need to get lost the ordinary <unk> <unk> <unk> <unk> <unk> <unk> <unk> <unk> 21.

We estimate the al-qaeda cash on hand.

Anticipated more things and developing painted from Blackburn extended the companies from my M. C 2024.

And now that as Christians give you a brief outlet unexpected <unk> Christian.

Thank you Lucy Slide 27 finally on next steps. We believe we have an exciting period ahead of <unk> with a summary shown on this slide.

The main focus of courses Obi cell and relapse refractory it all day a L patients with our initial update on this pivotal fiebig study coming before the end of the year and obviously the plan presentations.

At a medical conference in Middle of 2023 longer term follow up by will be then shown plan or a plan to be shown by the end of 2023 as well.

That the studies of obesity on the relapse refractory DNA challenge Tll in primary C. N S lymphoma are ongoing as well as our older 122 program and our <unk> program and we expect to have more data over the course of this year and next whilst we progress the others phase one.

Programs.

In our pipeline finally, as a result of our collaboration Blackstone in anticipation of the milestones we expect to receive during the relevant period, where <unk> cash round way unchanged and two 2024 for now happy to take questions.

Thank you.

At this time will conduct a question what's your session.

You can ask a question or I'm depressed 911.

I'll call them right now.

So our first question is gonna confirm miracle food.

Your line is now open.

Feeling kind of data disclosure yeah in the fourth quarter can you so to speak to you know, what we will see whether or not you know I'm I'm, assuming there will be some read on the primary endpoint response rates, but I'm curious about the secondary endpoints and again that the data M. I D.

Can I get a cohort that.

Rolling and then the other question I had it relates to the manufacturing where that process will need with respect to the hiring of the BLA and how you'll be able to <unk> for filing it'll be a lie.

Okay. Thanks, Laura Thanks for the questions, but first off what we're planning to do at the end of the year of the private update on the ceiling study will be high level update.

We'll be able to make a statement towards the primary endpoint of the study I do not believe that we'd be able to actually make comments pretty cautious secondary endpoints of this study that would be premature and you have already cohort <unk> and will continue to enroll.

Last year, but of course that cohort.

The key data that will go into orbit critical data that that was the for the <unk>.

So the focus is all the ceilings data data itself.

Will that be targeted to be showing Miller next year. If we said we target ask though.

And of course, you do remember that they were very strict disclosure rules if.

If you want <unk>.

Reduces the amount of information that we can share with enterprise planning for the end of the year.

Second question I think was related to the manufacturing setup and as we are indicated the commercial manufacturing site is on track to obviously go through all the qualifications validation work that needs to go into.

The.

Filing.

He's going to be in town for being targeted for the end of next year.

Alright, thank you.

Thank you.

Do we have another question.

Mmm just jump in I think family account and the next question was asked to get trashed, making your line should be open.

Hi, guys can you hear me okay.

Then.

Good afternoon.

Thanks for a couple of questions.

Let me just want to build on last question first.

Specifically disclosed in the press release, a number of maybe like the essentials the patient in remission.

And the primary endpoint can you. Please provide a number in the press release or is this something that doesn't want to hold back given how strict <unk> is uhm and then looking forward to the all coin 19 update beyond what machine Ash I'm, just curious to know how many more patient and follow up would you need to give it a <unk>.

Didn't initiate some pivotal studies based on any specific indications and not pivotal trial initiations continued can expect.

In 2023.

And then lastly, the listing here can you give us some direction on how R&D plus they're gonna move next year, given that Felix is winding down and majority <unk>.

<unk>. Thanks.

Alright, well, thanks, a lot Africa glad we managed to connect.

So the first question you asked was related to the talk of disclosure.

We can make so that the statements indicated won't be advised the primary endpoint according to the.

Study is the.

Overall relation right.

Which is based on the information and complete information with incomplete Hematological recovery.

<unk> the statements with regards to the point.

<unk> is difficult task, so we have to pass.

Actually be sure that indeed, the signal is truly of off the threshold that was set for for this.

For the study, which is hopefully basically in very simple terms basically getting up substantially.

The level, where the car standard of care type of basically.

What's coming up.

After visiting the reference point that gives you reference points.

<unk> I'll be out of the home that you're looking for that you have to be sure.

Substantially.

<unk> so.

So when are we going to be able to give it a specific number I don't think we're gonna be able to give a specific number without actually kind of crossing the line in terms of disclosures for the confidence that it'll be the statement arrived the primary endpoint based on projected on.

On the <unk>.

That will be the key to keep calling.

There with regards to the old car study, where this morning, I would say the non Hodgkin's indications in that study up we have been adding additional patients.

In the various cohort.

For those patients that we already have tree data, if I'm able to deal with restart to have meaningful long term follow up and I think we start to get a good feel for the program I think this gives us opportunity to move the program forward into into those applications.

Progress with a program overall.

The primary focus for 2023 will clearly be on the execution of the it all day and I Hope program and getting to pay program to be able to filing.

And also the additional activities around the.

L L indication, which with the primary focus.

Evaluating our options with regards to initiating a pivotal trial I think the data that we're starting to see.

Across his education I think is starting to shape up to a point where that decision in terms of picking the pivotal program that has the potential to go pivotal.

They call me to a point where in I would assume.

Yeah, we should have a good feel for which day does that we should actually be taking out of the various education.

And then it's gonna be inefficient, depending on the market conditions et cetera.

Sorry.

But for a basic data perspective, I think we have a lot of confidence in yoga profile of the product.

Pick the right timing for one hour next step here.

And then I think that'll be <unk> I think.

Okay.

Yeah, Hi, Thanks for the question and I'm.

I'm, hoping to get into specifics <unk> I mean, you know I think you can assume that and development.

It had it into 10 to 23.

Won't be at the same level.

<unk> and how would they.

As you can imagine what are the prices simply reviewing and he seems to talk to the company's normal budgetary process that you know I.

<unk> I will say that we send the numbers and every cell number of activities and such tried to treat related.

Hold on to that development rocket EM.

<unk> and as we anticipate and patient problematic et cetera.

Yeah, I I think you can safely assume it's about with a slightly at the sight Netflix <unk>.

Alright, thanks, so much guys.

Okay. Thanks I appreciate it.

Thank you and our next question comes from Matthew Phillips and you are now on the line.

Okay. Thanks for taking my questions and that's gonna call.

The Liberty one study with auto for do you think it ashville have any patients that were treated with the new manufacturing protocol.

Thanks for joining we started treating patients with a new protocol.

Not sure we're going to have data from that from those patients quite yet I think would be able to make some statements arrive the process change itself as the properties that were January .

But it's probably it's probably still premature to actually.

Data from patients.

Three days with a new political transition.

Transition as you May remember was made after the presentation.

When you go through the normal regulatory cycle from it but I didn't leave an awful lot of time before data cause Earplug Gash conference.

Got it it's interesting talking to you while the aspect of coming out of the real time here, what but when will auto five.

Get into clinics and what's beginning factors at this point.

I think what we're planning to do with all the five is good that program ready towards the towards the end of the year, we do <unk>.

Dating factor here is to transition uhm finalized basically the.

The CMC side of the process and we're going to be all today is asking some of the changes that were making for the oil for process willing to actually also include.

Five process before we get going on the program. So that's one of the key elements <unk>.

Flowing.

The.

Few early patients that thing called the impulses modify policies I think will be indicative of hotels, an awful lot of that transition.

Transition.

Vacations into it.

Program as well.

Okay, and then lastly, I guess just can you give us any updates on switching or moving to H B S. A.

For the diagnosis applications are the influx.

Unfortunately.

So so what we had indicated for the program that we have basically three ways to detect tumor cells.

What we're using in the clinical trial League baseball next time sequences.

Okay.

Ah well established methodology for court.

Diagnostic diagnosed me too.

Does take a bit of time and temperature at the right time and soon as alternatives to lose it I see we also they look at.

The.

Section by slow.

Both of those are always the antibody based that while I'm against the.

The nature of the average and typically in the <unk>.

Where you have biggest issue versus basically life, but.

In the case of the facts methodologies do work well and we're currently going through kind of a selection, which one we're gonna take forward.

They should actually have it made so.

So technology should just pay for it works well.

Top of the data right then.

Donald decision, which one.

Portal development actually that's not yet.

Alright, great thank transfer function.

Thanks, a lot man I appreciate it.

Thank you and our next call Alright next question will come from Jean Shin Your line should not be open.

Okay Gotcha any.

Oh.

Hey, James because here.

Great great. Thanks for clarifying on <unk> or 220 press release, when the whole day doesn't or at least the next year, though could you share what your view would be for a positive that data.

And are you going to be available at the conference or is that going to be.

Not that you talked about towards the end of the year.

So on M idea what to expect that that's more focus for the end of the year, because obviously what I understand.

Also someone to follow up in that cohort.

Four were continues to enrolled patients.

He called so the expectation is I think M. A D data on first data.

Next year, so there's a target.

With regards to add.

All secondary endpoint data or so we're going to be looking at various types of <unk>.

Data related to the secondary endpoints.

And we're probably going to look at.

Looking at the data.

Looked at a subset of the patients earlier in this study that may have longer fall off that give us some of it on the follow up.

Information finally look next year.

That you're referring to and including <unk> over time.

As well as obviously have increased survival. So we'll start <unk> clearly as we go through the course of the year, including a dash.

We're also gonna get additional information in terms of longer term follow up with you.

You May remember I smoke, we looked at the <unk> from the old card 1970.

You may remember that that <unk> basically.

Shows spilled drops until about 12 months of follow up on it then we saw a stabilization from 12 months before.

And so I think what we're going to look at your best data I think to get a.

<unk> longer term view on the data, we're probably going to have to cover to ask to really understand.

<unk> the longer term outlook.

For that actually looks like.

So that really early data, but I think in terms of actually getting a better understanding of.

More stability in the data book over to have to go into ash.

Mmm.

Understood have you disclose what MRP sensitivity here looking at for the quota is it turns on negative things by chance.

Well that is obviously one of those measures. We're gonna look at you know all.

All of those levels you can always the measure down to 10 to the minus six with the with the USA.

And we're certainly going to look at the at the drop old Olean that he can get to typically what he wants to see us at least.

Step reduction to actually call. It a response to the market respond specifically the way that was tunnels in the past using either flow or or P. C. R. So there is that that's one of the ladies and how you can look at it but it also you wanted to look at the absolute reduction and see whether there's any.

Different theories and potentially has come at nine depending on the total for that you're actually looking at.

Understood and if I may for just one more on Mccarty uhm.

Mccarty exclude require cell therapy.

But our patients allowed to have sailed by specifics such as the recently approved tech what's the matter.

I don't think we have excluded in that study.

The targeting of D C M a.

Obviously, what's already available with regards to the D. C. M. A targeting are agc's to be CMA, which are actually available in the market. So divisive <unk> coming available uhm and I would assume they're allowed at the point that correct place, where we haven't <unk> car T <unk>.

Carty.

We're conducting this study in the UK and in fact, there's no availability.

For these patients.

Carpeting therapies.

At this point.

It's more theoretical exclusion at this point I'm ready to come go pick up a practical inclusion haven't done country rescue sorry progresses.

Yeah, that's awesome man. Thank you.

Thank you.

Thank you and our next call. Our next question comes from <unk> and your line is now open.

Gil Your line is open.

Good morning, and good afternoon, just a couple of quick once from us.

Kind of as a follow up here.

What are you hoping are gonna be the differentiating features for auto it and <unk> given how crowded spaces.

Great to have young so differentiating features some things of what we're looking for.

In in a sort of a second generation approach a multiple myeloma.

I think that what we do know from the current products.

We're looking at <unk>, if we do get higher response rates.

And and all services have very meaningful durability. Thanks, what we've done what we see is still challenging.

Get out very high percentage off.

Uhm.

Disease.

<unk> in terms of the protection. So is there any sort of element there in terms of molecular responses are being a cheese for you could actually see differentiation can pick that up none of the standard response rate, but let me look at <unk>.

The second aspect is what we're seeing with all the product.

Clearly as much more of a challenge in multiple motto much actually January pulled off should have longer persisting products.

And the <unk>.

As well as the slowly progressing.

Challenging microenvironment with Ya.

Tomorrow.

That he could have pockets that actually where whereabouts basically survive and ultimately it was clearly essentials, we buy a significant amount of time with the current therapies.

Difficult appears difficult taxes switch it to the stage, where there is a high degree of confidence day, Andrew Longterm permission.

Thank you Wanna see very deep responses at the other aspect is you Wanna see indications for good levels of sustained persistent cough persisting product I think those are two features I think would be would be looking for.

I think they're very experienced occasion that we're starting to.

Features.

Oh, so the fundamental piece in terms of design that we put in on the D. C. M. A side is okay very.

<unk>.

Approach that allows us to target cells with very low expert.

That's it.

Expression levels.

Which is one of the fundamental challenges with the target.

Alright, Thank you for those details and maybe one last one.

On the auto for study or are you still are you enrolling additional patients with the Hypos right now.

Yeah, so revolting patients.

At the Oh, we had enrolled continued leftover the cord at the 450 level and with the event.

Through for the modify manufacturing process.

We took a step down.

225 until the first patients.

Initially dose at 225, and once you have an actual data and then back off escalated to 450.

But we haven't gone beyond 450 in terms of sell those.

Excellent. Thank you for taking my questions.

Thanks, a lot I appreciate it.

Thank you and our next question comes from Nick Habit. Your line is now open.

I think 10 years.

So I think I might've missed one I never thought for <unk>.

Yes. It is here online perfect Alright, just cassava ethnic conflict and thank you for taking my questions.

Just a couple of nights Festival <unk>.

<unk> could you just help us frame expectations, what we might expect in terms of patient numbers and what the key data points, we should be looking out for <unk> and then if possible would you be able to give us an idea of some of the key cause I'd element <unk> N J trial.

Yes, Thanks, a lot for joining lake with regards to the updated ask are the key focus Israeli on longer term follow up Oh <unk>.

<unk>.

The <unk> actually the a O L patient widowed detail as well or as I remember there was an additional six months are actually more than six months.

Since the last update was given all that cohorts. We will have it's kind of long term follow up on these patients.

So that's kind of.

The key focus with regards to obesity.

There are a few more patients on the non Hodgkin's cohorts, but the primary really think the primary vehicle you longer and longer term.

Where the guards to Ottawa 22 always have very early data for pediatric patients. So we have longer term philosophers really be important particularly.

We're.

To minimize or eliminate.

<unk> negatively lapses.

In these cases.

The data we have it <unk> I think indicative but of course, we didn't have that much for I'll tell the patients. So at least theoretically that might've state of <unk>. So if you pick it up target negative.

Rebound Susan.

A follow up I think is meaningful and they'll give us a good.

Additional.

Information on how to design purposes.

The program.

With regards to an order for as well.

Follow up is kind of the key piece there and then obviously some viewers with regards to the modify process and what it might do for the product going forward.

But the the critical piece that was the here is that we have limited follow up on the patient.

<unk> <unk>.

All the cities with the additional data <unk>.

We should get closer to one year.

I'd be happy if I'm here at home companies patient.

Meaningful.

Remember these patients typically passed away within the last six months at this stage of the disease.

And that we both in terms of the patient rolled into the site.

So those are some of the key expectations I think with regards to the to the trial.

That's great. Thank you very much Christian and did you have any data you can provide only or six Charles Yep sure. Thank you.

Via on the <unk>, we're planning to have.

We're introducing a number of.

<unk> new modules.

Two module feature of being in the hospital and visit cause this is easily active el seven type modules.

So that's a significant addition and where.

Working through kind of the exact.

Initial approach also with the.

With the regulators here in the UK.

So obviously have an approach that <unk> I will be going with the hospitals.

And then I'll be able to see that matches talk generating safety data first obviously is on trial and then also pushed those resolved.

Demonstrate it's safe to discharge actually broken.

Impact on the on the activity antitumor activity as well.

The details are still in part <expletive>.

Negotiating directly to do so I don't think I can get you a fine line of service.

Okay. Thank you very much thank you.

Thank you.

And we now have Kelly she now on the line.

Hi can you hear me okay.

Hi, Kelly.

<unk>.

Hi, this is clear.

So sorry, <unk> can you comment on patient baseline characteristics.

Patients.

Is it consistent with this one.

Just one day I just want the stage.

And also according to clinical chart dot com well enough to inclusion criteria.

[noise] screen patients slash by that five per cent flashing phone there 75 per cent share of ancient.

Part of that sounds frequently actually.

And 25 per cent of their patiently slash five per cent slashing from there so surely except lower response rate for Ah top line data.

Yeah Lastly.

<unk>. Thank you.

So with regards to inclusion exclusion criteria those are actually consistent between the <unk> the.

It takes two portion.

There are also largely consistent.

The.

Prior development business space, including theirs.

And the last four practices cause my thighs or for it to Congress.

So the the the.

<unk> a R R.

Very similar across the board of these trials.

And between societies wanted me in the face too.

The terms of patients.

Most of the patients that are part of the analysis that that will go into.

Our patients that have more than 5% tumor burden at the time of enrollment.

That is O T T.

He inclusion criteria.

<unk> and have less than five per cent to a burden can actually be enrolled into the second cohort that we're running which a patient and minimal residual disease.

But they are clearly differently.

Two different cohorts ever analyzed separately.

Terms of the <unk>.

<unk> responds standpoint, but you look at a primary and when you look at the the morphological cohort is complete permission information.

A patient with here in patients with <unk> with incomplete recovery.

Logical recovery.

To those measures always they are looking at going from a level of.

Last about 5% until level, 5%, which is a condition to me.

Just sort of.

Four when we get into the city or.

As a cohort of the minimal residual disease that are starting below 5% those patients are technically Oxford interest secret mission.

And what we're measuring with those patients in business does that <unk>.

Question.

Your last before.

You didn't actually can look after conversion.

Of these patients into a molecular complete remission.

Which actually provide additional with options are typically those tunnels.

Have you looked at the airports and minus four.

So those are kind of the day.

Between the two population there's no difference that we expect to have in terms of the actual patient directory states.

Compared to the same swampy and also when it comes to.

General composition of the patients.

Guards to prior lines with private therapies.

<unk> exposure to suicide that you don't expect to see that.

Got it.

Can you also share some details regarding your preference preparation off of each I'll launch on manufacturing plants.

The same patient.

You know Ain't available or ask you asking in clinical trials for.

And how what's the difference passed out at all.

Manufacturing success rate and advocacy.

So as soon as you actually have a group of patients that are about five per cent to reverse arrange can be quite.

Quite a bit so he can have patients with other just slightly.

Patients who are you know in the 95% branch of tumor burden in tomorrow.

<unk> can also vary in terms of the bank off the television and obnoxious as a matter of a vanilla Olson circulation. So there's a big variability you haven't been there. We believe that we have a very good representation across the entire board of those levels of tumor burden as well as levels of circulating leukemic cells in the trial.

That we didn't expect a child to actually be.

I said predicted for this truly.

Truly advanced stage of disease.

It would be very interesting to see.

Most of the outcome of some patients that have lowered disease burden.

And five per cent disease burden on there had been what residual disease and that's obviously the reason why we're running the second cohort.

And not the primary primary group of patients that I was able to advise the label for the call.

Okay. Thank you.

Thank you appreciate it.

Thank you and next question comes from Noah Eisenberg.

Hey, guys. This is Noah on for Eric Thanks for taking our questions. Just a couple of quick ones for us.

So could could you remind us does the <unk> use the same exact conditioning regimen as the.

Previous stays on trial for <unk> and then also.

How is enrollment progressing.

Parasol trial, and what can we expect and.

Data next year. Thanks.

Could you repeat which trial, whether it's enrollment question came.

Oh, Oh that Carousel trial Parasail trial, Okay, sorry, I couldn't I couldn't understand that okay.

Alright. So the first question is to pre conditioning regimen in fact, a precondition regimen that we're using is consistent which was which was used in the face while I'm b and consistent wages now typically used across across the industry and the various car T trials in terms of use.

<unk>.

If you've ever been in <unk>. So that is very consistent and slightly different from what we had any old car study, which was devastated study that started a few years before and was still closer to some of the original work in the stomach pain.

[noise] and then.

Carousel trial.

And then with regards to the carousel file relatively expected to have a balance somewhere between 10 and 12 patients devoted a total.

We expect to be able to provide an off day that during the course of the next year I'm, probably more towards the main living here.

Okay, great. Thank you.

Thank you.

And that was our final question I'd like to now turn it back to Christian for closing remarks, alright, well. Thank you very much well. Thanks, everybody for joining today is obviously very busy season also a dash abstracts coming out I appreciate you joining.

I was looking forward to keeping updated I have to go through I think are very.

Important set of weeks or months ahead of us for at all is progressing the pivotal study and there were gearing up towards the actual data presentations in the middle of next year, Alright, Thanks, everybody and speak to you soon thank you.

Thank you for participating in today's conference. This does conclude the program and you may now disconnect.

[music].

[music].

[music].

[music].

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

Third quarter 2017, and also result conference call I'll remind you. This conference call is being recorded.

Now I'll turn the conference over to your host Olivia that's instructor Investor Relations. Please go ahead.

Thanks, Ryan and good morning.

Everyone.

Joining us taking part in today's call on the financial results and highlights.

And maybe a month that director of Investor Relations and with me on today's call as he is not there.

Christian I can our chief Executive Officer.

Lucinda Crabtree, our Chief Financial Officer.

Before we begin I'd just like to remind you as usual that during today's call. Our discussion will contain forward looking statements. Please.

Please make sure you are familiar with our disclaimer slide which you Don.

Let's see.

And then turning to slide three you'll see the agenda for today, which is as follows Christian will provide an update of our operational highlights since third quarter of 2022.

Sundar will then discuss the company's finance yourself, well Christian will complete milestones and any other statements.

And finally, even though of course welcome your questions.

Thank you Christian.

Thank you Olivia and good morning to you all and thank you for joining US. It's my pleasure to review our progress for the third quarter of 2022 moving to slide four.

Really pleased with our strategic and operational progress during the third quarter of 2022, which is highlighted over the next two slides firstly, we remain on track to provide an update on our pivotal field trial in Q4, 2022, and we plan to present Felix Phase II data at a medical conference in the first half of 2023, most likely at <unk>. We're also likely.

We're also looking forward to presenting longer follow up data from our ALLL patients can be old car 19 phase one trials at ash and are planning a more in depth look at the patients.

Alright.

Okay.

Looking forward to the patients that we've treated.

<unk> non Hodgkin's lymphoma.

We're presenting further data.

At the three phase one trials at Ash in December 1st as indicated on the old car 19 Phase II extension study for Ob sell NBA NHL car Pallet study, which is also a phase one trial with only about 22 pediatric allo and from a labor T. One phase one trial of order forward peripheral T cell lymphoma.

The abstract to these data updates will be online later this morning, so we won't be discussing them. During this morning's call. In addition, the phase one Mccarthy trial exploring auto eight in multiple myeloma.

Patient is progressing and the phase <unk> trial exploring <unk> is expected to start in the first half of 2023, turning to slide five we've made some great operational progress during the quarter and post period end.

We're very pleased to report on two technology deals in October 2022, which underscore the scientific capabilities and expertise at <unk>, We signed an agreement.

Raymond with Bristol Myers Squibb mounting them access to our proprietary RCRA rituximab induced safety switch for incorporation into a set of selected cell therapy programs in return for a loaded.

Low to mid single digit million dollars upfront payment with potential for near term option exercise fees and developed milestones.

Plus royalties earn exercised an option on one of the proprietary behind us being developed against an undisclosed immuno oncology targets for the delivery of their messenger RNA therapeutics in return for a low single digit million dollars upfront payment as well as development and commercial milestone payments for each product successfully commercialized plus royalties on net sales of <unk>.

<unk> commercialized under the agreement.

The license option stems from the deal we signed with <unk> in August 2021.

We also continued to make progress in our manufacturing in CMC operations face amount of the build of our Stevenage facility is on track for transfer to outlets before the end of the year to start the qualification and validation work with the facility and remains on track for good manufacturing practice operations commencing in the second half of 2023.

We're also on track with the CMC workflow and report generation for the CMC package plan to support a BLA submission to the FDA.

Cash and cash equivalents at the end of September were $163 1 million not including the R&D tax credits for HRC of $19 1 billion received in October .

Slide six with that let's talk about our primary focus our lead product <unk> cel on slide seven just to remind you <unk> has a unique mechanism of action and builds on a highly specific engagement of CD 19, coupled with a fast release from CD 19 wants to kill ability <unk> sale has been initiated.

This fastest engagement is based on the fast off rate of the binder and drives three key properties of Ob sale reduction of the amount of cytokine release per target selling cantor, which in turn will reduce the amount of immune toxicity in the patients reduced exhaustion of the car T cell and improved and grasp and overall persistence.

And those of you who are not familiar I refer you to a paper by Ceragon Roscian at nature of Medicine published in 2019.

Moving to slide eight we show. This slide is a reminder, that there remains a very high unmet medical need for treatment of adult AML patients with approximately 8400, new cases diagnosed yearly on a worldwide basis in the last slide setting.

Approximately 3000 of these cases reside in the U S and EU.

And whilst a combination chemo <unk> been able to about 90% of the adult <unk> patients to achieve complete remission only about 30% to 40% will achieve longer term innovation.

Once relapsed patients had a median overall survival of less than a year current approved therapies for adult patients our billing cycle and the Carter's both therapies are highly active but frequently followed by subsequent treatments. For example, allogeneic stem cell transplants blend site has a favorable safety profile with few patients experienced severe.

<unk>, but with limitations on durability of effect and convenience due to the need for continuous IV infusion of <unk> four week treatment cycles.

Carter's is more challenging to manage and reduce this elevated levels of Crs high levels of ICANN require spirits invasive prices for many patients to manage adverse events. Both therapies have been shown to be highly active. However, most patients progressed rapidly and requires subsequent allograft achieved their ability.

Moving to slide nine.

Many of you have seen this slide before but it's useful it's a useful reminder of why we think Obi cell is a potentially transformational therapy for adult AML building.

Building on its unique mechanism of action or we sell has shown a high overall response rate with a favorable tolerability profile and sustained event free survival attracts long term persistence in those patients.

<unk> has been granted orphan drug designation by the FDA and EMA for ALLL and obtained prime designation by EMA for the EU highlight designation by NHRA for the U K and most recently, our Mac designation by the FDA.

Moving to slide 10.

Based on what we believe is potentially transformational data from the old car study, we're conducting the pivotal Felix trial within approximately 90 patients in morphological with morphological disease trading at 34 sites in the U S. The UK and Spain.

We're on track with our previous guidance and expect to provide a qualitative update in Q4, 2022, which we would expect to reference whether the primary endpoint has been that.

We're planning on presenting data from the Felix study at a medical conference in mid 2023.

In order to maximize outcomes from the Felix trial in parallel we're also assessing ob sell in additional cohorts of up to 50 patients in second or later complete remission.

Who would have developed minimal residual disease. However, this additional cohort does not impact our planned filing timeline as the primary data will be based on the data from the morphological cohort.

Moving to slide 12.

<unk> unique profile means it could be applicable to a broad range of indications, where consequently evaluating the product candidates outside of AML and b cell non Hodgkin's lymphoma indications.

On ongoing in an ongoing phase one clinical trial.

As we said before we have positive clinical readouts at the recent EAA Congress from the Phase one studies in B cell non Hodgkin's lymphoma, and primary CNS lymphoma presented by way of the poster as well as an oral presentation of the first auto on 'twenty two phase one data in pediatric <unk> patients.

Cover these state of the upcoming slides as I said, we'll be presenting additional data at ash in December this year with abstracts due to go online later today.

On slide 13, as a reminder, the academic old car 19 study has been extended as a basket study, where we are testing or we sell it in a number of b cell malignancies to date, we've treated 17 patients with Follicular <unk> and mantle cell lymphoma, and no patients experienced high grade Crs at non had any grade of neurotoxicity.

Of the 17 patients dosed 16 achieved a metabolic complete remission 707.

<unk>.

Follicular lymphoma patients six to seven diffuse large b cell lymphoma patients in three of III b cell lymphoma patients.

We lost one patient to covered and while an mcl patient relapsed <unk>.

<unk> 14 of the 16 patients that have responded remain in metabolic CR with a median follow up of $9 two months, the longest being $19 one months as of the last reported data costs and the data continues to mature.

We've also started treating some CLI patients and from the three patients that have reached initial evaluation as of the last data cutoff to vent into molecular CR in the bone marrow that have some residual lymphadenopathy LCD scans.

We're looking forward to presenting additional patients and longer follow up data from the solar car extension study at Ash in December .

Turning to slide 14, we're also exploring <unk> in primary CNS lymphoma or academic Carousel study.

This is a type of aggressive b cell lymphoma, but because of its anatomical location. It has a particular poor prognosis initial treatment is often intensive and outcomes for these patients tends to be poor.

And the data we presented at DHA, we didn't see high grade Crs two patients experienced neurotoxicity grade three and four <unk> patients improved with steroids and Anakinra. The second patient had several neurological deficits consistent with progressive disease, and then respond to steroids in the kingdom.

Overall, you can see on the right hand side of this slide that despite these patients having no disease outside of the CNS and having had lots of rituxan that treatment, we still see really nice expansion of Ob sell a peripheral blood and we expect to provide more data from this study in 2023.

Moving to slide 15, our initial experience with Ob sell in children achieved high level of sustained Crs without experiencing high grade Crs.

Those children, who relapsed.

After treating with Ob sale.

Most of them had lost CD 19 expression on their leukemic cells at the time of relapse here, we're taking the next step in Ob sales lifecycle with over $1 22, a dual targeting products building on <unk> b cell and adding a highly potent CD 22 targeting <unk> receptor. The CD 22 car was designed to be active against leukemic cells.

With low levels of CD 22 expressed on their surface.

We evaluated over 122 and an extension of the <unk> study in children, who are ineligible for <unk>. The children either relapsed after receiving <unk> I could not be treated or they had extra medullary disease, a singular lesions in tissue without having disease in the bone marrow the normal location of the leukemia. This is a very.

Challenging group of patients to treat out of 14 children four had prior <unk> therapy and three of them had lost CD 19 expression seven kids had extra medullary disease.

Moving to slide 16 data were presented at EHR and showed that nine of the 11 patients achieved a molecular CR on day 28.

The 122 was well manageable with no patients experiencing high grade Crs no patient relapsed with antigen loss and two of the CD 19 negative patients achieved a molecular CR demonstrated the isolated activity of the CD 22 car.

We're continuing to follow the patients and we will be presenting this data at ash.

The upcoming weeks.

Slide 17.

Moving straight to slide 18 on the pipeline Here's a brief depiction of our broad cell programming toolkit, we have developed over the last few years and drove the deals with BMS and <unk>.

All in the technologies covered programming modules for targeting control shielding and enhancing car T cell activity.

At <unk>, we have more than 100 patent families covering these products.

On cell programming technologies.

Illustrations of three technology applications were shown at <unk> annual meeting in May this year.

Each of one of our product candidates supplies, one or several of the technologies to maximize its impact on the specific cancer. It is designed to tackle.

Moving to slide 19.

This slide shows more of our next generation programs beyond Ob cells I pipeline program. We are particularly excited about is <unk> four which is in phase phase one study in T cell lymphoma, I'll give you a refresh of the data we presented at <unk> in just a minute.

<unk> moved into the clinic earlier this year in a phase one clinical study in patients with multiple myeloma.

And we're now dosing patients and also want to mention that our first solid tumor program <unk> <unk> positive solid tumors will be moving into the clinic in the first half of next year.

Turning to slide 'twenty, we're actively exploring T cell lymphoma, which is an aggressive disease with very poor prognosis for patients.

Recall, our EAA analyst call, where Dr. Horowitz from Department of Medicine Lymphoma Service Memorial Sloan Kettering Cancer Center talked about the majority of patients being either refractory or relapsing after initial treatment side.

Standard of care is variable and often based on intensive chemotherapy treatment.

Median survival for patients with relapsed or refractory disease is less than six months.

<unk> lymphomas or are a clonal disease that either express TWC, Wang or TWC to the T cell receptor beta chain constant domain, one or two are expressed on more than 95% of all T cell lymphoma patients only gamma Delta T cell or NK cell derived lymphomas lack of T cell receptor beta chain.

Instant domain volume too.

<unk> targets <unk> and is the first product candidate to do so using next generation sequencing, we identify patients with <unk> expressing T cell lymphoma, and then these TWC bonds positive patients are treated of the currently open order for study and in the future. We plan to open a study targeting <unk> positive patients.

With auto five as well.

<unk> four is designed to selectively kill lymphoma cells in a manner that we believe will preserve a portion of the patients normal healthy T cells to maintain immunity in that patient.

Turning to slide 21, we presented data on the Libra <unk> study evaluating <unk> in patients with T cell lymphoma.

We are seeing encouraging activity and a favorable tolerability profile, indicating clinical proof of concept for the new approach for targeting T cell lymphoma, we're looking forward to presenting longer follow up at ash.

So with that we'd like to turn to slide 23.

Manufacturing of cell therapies is complex and we've developed a great deal of skill and experience manufacturing products throughout the pandemic and for a range of product candidates. We are building a new manufacturing facility in Stevenage in the UK dislocation is about a mile away from our current clinical manufacturing operations at the cell and gene therapy.

<unk> and will allow us to transition our entire operation, including our experienced staff to the new facility in an expeditious and efficient way, both maximize minimizing startup risks and costs for commercial supply.

As evidenced by our successful manufacturer of car T.

Products for the pivotal study with centers across the U S and Europe location is well suited for global supply with easy access to several international airports, including loans.

The new 70000 square foot facility.

We will provide <unk> with a capacity of approximately 2000 cell therapy batches, a year and with the ability to expand capacity.

Further when needed you can see on this slide a rendering of what the facility looks like once completed by the end of the year in the Middle you can see the actual facility a few weeks ago. When the large pre assembled HVAC units were lifted onto the roof.

Our progress earlier phase monitor the build build project is scheduled to complete.

In the fourth quarter and the equipment installations at qualifications that <unk> is on track for GMP operations for the second half of next year.

For our clinical supply operations. We currently operate with four shifts seven days a week a commercial manufacturing model will continue with that pattern of a seven day a week.

Throughout the year.

So with that I would like to turn to slide 25, and pass the call to Lucinda for our third quarter 2022 financial update Lucy.

Thanks, Christian and good morning, or good afternoon to everyone. It's.

It's my pleasure to review our financial results for the third quarter to September 2028.

We'll start with our cash position, which at September <unk> 2019 totaled $163 $1 million.

This doesn't include a $19 1 million R&D tax credit we received from hatred Mouthy post period end in October .

With regards to our cash I will note given the majority of our spend is in GDP, we actually hosted a large portion of our cash has reported.

Approximately 80% impairment.

The majority of the remainder in USD.

Net total operating expenses for the quarter with $43 5 million, which included license revenue income totaling $2 4 million, which primarily resulted as a result of agenda option exercise announced in October .

Research and development expenses increased by $5 3 million to $37 6 million during.

During Q3 this was primarily.

Following an increase of $3 $6 million in clinical and manufacturing costs, primarily related to ADSL.

An increase of $2 million and salaries and unemployment related costs, mainly driven by an increase in the number of employees engaged in research and development activity.

We also have marginally increase making 90 fees as we transition to the quarter offset by a decrease in facilities cost and depreciation of PPE.

General and administrative expenses remained stable year on year.

Although extended showed income.

Net income decreased to an expense of $3 7 million from.

From an income of $1 million in the first three months ended September <unk> 2021.

The decrease of $2 $7 million is primarily due to the weakening of the pound sterling relative to the U S. Dollar exchange rate during the three months period.

Interest expense increased to $1 $1 million in the quarter, which relates primarily to the liability related to sales and future royalties and sales milestones through our agreement with Blackstone.

Thank you maam.

Finally, net loss attributable to ordinary shareholders was $42 8 million for the quarter.

And diluted net loss per ordinary share for the quarter potentials.

Negative, which simpson compared to index inclusion.

Q3, 'twenty to 'twenty one.

We estimate that our current cash on hand, including.

The anticipated milestones in the relevant period from Blackstone extends the company's runway into 2024.

And now back to Christian to give you a brief outlet unexpected milestones Christian.

Thank you Lucy.

Slide 27 finally on next steps, we believe we have an exciting period ahead of us at <unk> with a summary shown on this slide the main focus of course is obi sell in relapsed refractory adult AML patients with our initial update on this pivotal field study coming before the end of the year.

And obviously the planned presentations at medical conference in the Middle of 2023 longer term follow up will be then shown plant or planned to be shown by the end of 2023 as well.

Beyond that the studies of <unk> in relapsed refractory NHL in CLA and primary CNS lymphoma are ongoing as well as our older 122 program and our <unk> program and we expect to have more data over the course of this year and next whilst we progressed the other phase one.

Programs.

And our pipeline finally, as a result of our collaboration with Blackstone in anticipation of the milestones we expect to receive during the relevant period, we project our cash runway unchanged into 2024, we're now happy to take questions.

Thank you.

We will conduct a question answer session. As a reminder, the question one on <unk>.

Okay.

Our first question is going to come from Mexico.

Your line is now open.

On CLA and the data disclosure.

Fourth quarter can you sort.

So to speak to you.

What we will see.

Whether or not.

I'm, assuming there will be some read on the primary endpoint of response rates, but I'm curious about the secondary endpoints and again.

That and might be negative cohort.

Uh huh.

That you start enrolling and then the.

The other question I had as it relates to the manufacturing and where that process will be with respect to the filing of the BLA.

And how.

How you'll be able to layer that does two things for filing of the BLA.

Okay. Thanks, Laura Thanks for the question. So first off what we're planning to do at the end of the year, obviously provide an update on the ceilings study will be high level update will.

We will be able to make a statement towards the primary endpoint of the study.

I do not believe that we'd be able to actually make comments, where the cost of the secondary endpoints of the study that will be premature at the MG cohort is obviously ongoing and will continue to enroll.

Next year, but of course that cohort.

The key data center will go into critical data set that would.

For the BLA.

The focus is all of the helix data data itself.

Will that be targeted to be showing middle of next year as we said we target <unk>.

Of course, you do remember that there are very strict disclosure rules.

If you want to prevent that.

Which also basically reduces the amount of information that we can share within the press release that we're planning for at the end of the year.

The second question I think was related to the manufacturing setup.

As we had indicated the commercial manufacturing site is on track.

<unk>, obviously go through all the qualification validation work that needs to go into.

The DRA.

Heidi.

He is going to be income for BLA is hot and targeted for the end of next year.

Alright. Thank you. Thank you.

Operator, do we have another question.

And I'll just jump in I think Brian in the accounts and the next question was asked Scott Chan estimating your line's open.

Hi, guys can you hear me okay, yes.

Yes, we can.

Oh, Hey, good afternoon guys. Thank.

Thanks for taking the question.

Maybe just want to build on <unk> question.

Specifically disclosed in the press release, a number maybe.

Patients in remission.

And the primary endpoint can you provide a number in the press release or is this something that.

We want to hold back.

How stroke.

<unk>.

Looking forward to the all kind 19 update beyond what <unk> ash and I'm just curious how many more patients in follow up would you need to give confidence initiate pivotal studies based on any specific indications.

And I'm Gonna pivotal trial initiation is something we can expect.

In 2023.

And then lastly, something for listening here.

Can you give us some direction on how R&D, possibly going to move next year.

Given that Felix is winding down and majority of the other studies.

Thanks.

Alright, well, thanks, a lot Aussie gap that we managed to connect.

So the first question you asked was related to the type of disclosure.

We can make the statements obviously as I indicated will be about the primary endpoint of hybrid endpoint of the study.

Overall remission rate.

Which is based on complete remissions and complete remissions with incomplete.

Logical recovery.

<unk>.

These statements with regards to the endpoint, obviously is physical cash that we have to pass to.

To actually be sure that indeed, the signal is truly above the threshold.

Set for.

For the study, which is obviously basically in very simple terms basically getting us substantially.

The level, where the current standard of care and bring value to basically.

It was coming out so I think that if you need to reference point that gives you a reference point in terms of them lower bond rates.

Tom that Youre looking forward that you have to be sure.

Substantially all of the.

Cost.

So when are we going to be able to give a specific number I don't think we're going to be able to give a specific number without actually kind of crossing the line in terms of disclosures from the contract. So it will be the statement arrived in the primary endpoint based on objective.

Sure.

That will be the key.

On there with regards to the old car study, we're exploring obviously the hodgkin's indications in that study we have.

Been adding additional patients.

The various cohort.

And for those patients that we already have treated by middle of the year with.

We start to have meaningful long term follow up I think we start to get a good feel for the program.

This gives us opportunity to move the program forward into into those applications.

As we said it progressed with the program will grow the primary focus for 2023 will clearly be on the execution of the adult day health program and getting the program to be able to pilot.

And also the additional activities around.

The ALLL indication, which is the primary focus.

Evaluating our options with regards to initiating a pivotal trial I think the data that we're going to starting to see across these indications I think is starting to shape up to a point where that decision in terms of picking that pivotal program that has the potential to go pivotal.

In terms of the comment.

The point, where I would assume there's some middle of next year, we should have a good feel for which data set we should actually be thinking out of the various indications.

And then it's going to be a decision depending on the market conditions et cetera.

The exact timing for the size of the pivotal study, but from a basic data perspective, we think we have a lot of confidence that the overall profile of the product.

This is the right timing for our next step here beyond they are now.

And then I think there'll be R&D cost Lucia.

Let me take that.

Yes, hi, thanks for the question.

I'm not going to go into specifics at this stage.

I think you can assume that development.

Heading into 2023.

<unk>.

Same level as 2022.

Hello.

As you can imagine quite specifically reviewing and these things as part of the company's normal budgetary process.

I will say Devin stellar numbers.

A number of activities in such trade Street related.

Thanks.

Bracket.

On the regulatory side and as we anticipate patient follow up et cetera.

<unk>.

Yes, I think you can safely team and the development cost will be at the same level of concentration.

Great. Thanks, so much guys.

Okay. Thanks, a lot appreciate it thank.

Thank you and our next question comes from Matthew Phillips and you are now on the line.

Okay, great. Thanks for taking my questions and open the call.

Leave it tier one study with <unk> four.

Do you think at Ash, we'll have any patients that were treated with the new manufacturing protocol.

Hey, Matt Thanks for joining we started treating patients with the new protocol.

Im not sure were going to have data from that from those patients quite yet I think we've been able to make some statements around the process change itself is the properties that we generate.

It's probably it's still premature to actually.

Data from patients.

<unk> treated with the new protocol tranche.

Transition as you May remember was made after the EAA presentation.

When you go through the normal regulatory cycle from it but didnt leaf an awful lot of time before data comp here for the Ash conference.

Got it it's interesting talking to you all the abstracts are coming out of the real time here.

But when will auto five get into clinics and what's the gating factors at this point.

I think what we're planning to do with all the five is good that program ready towards the towards the end of the year we do.

The gating factor here is to transition.

Finalized basically the the.

<unk> side of the process that we're going to be adopting some of the changes that we're making for the older forward process. We want to actually also include each of the <unk> process.

Before we get going on the program. So that's one of the key elements, let's build a flowing.

The.

Few early patients that think of the new processes modify policies I think will be indicative of hotel.

And an awful lot of that transition.

Patients into the <unk> program as well.

Okay, and then lastly, I guess just can you give us any updates on switching moving to IHT assay.

For the diagnosis of the patients or the.

Collections right.

So what we had indicated for the program is that we have basically three ways to detect tumor cells.

What we're using in the clinical trial is based on next Gen sequencing.

Good day.

Yes.

Well established methodology for.

Sure.

A diagnostic on diagnostic tool.

But it does take a bit of time in terms of turnaround time, and so as alternatives. We looked at IAC and we also have a look.

<unk>.

Detection by flow.

Both of those are obviously antibody based along against.

The exit average and are typically in the IHT, where you have fixed issue versus basically life sales in the case of the facts.

Apologies do work well and we are currently going through kind of the selection, which one we're going to take forward.

And that patient actually happened yet so technology.

Well just a couple.

The data right that the final decision, which one we're going to take full development actually has not yet.

Alright, great. Thanks, Chris for the question.

Thanks, a lot and I appreciate it.

Thank you and our next call. Our next question will come from Jamie Shen Your line should now be opened.

Good morning, guys can you hear me.

Hello.

Hi, James we can hear you.

Great great. Thanks for clarifying on <unk> 22 press release.

When the full data doesn't release next year, though could you share what your view would be for a positive ESG data and.

Mark are you going to be available at the conference or is that going to be updated.

I'll get you talked about towards the end of the year.

So on <unk> I would expect that Thats more focus for at the end of the year, because obviously what I understand.

Also some of the follow up in that cohort as explained before we continue to enroll patients.

E cohort.

So the expectation is that they get more data.

At Ash next year. So there is a target.

With regards to the.

The types of secondary endpoint data, obviously, we're going to be looking at various types of tech.

Data related to the secondary endpoint.

And we're probably going to look at.

As we're looking at the data.

Probably look at subset of the patients earlier in this study that may not longer falloff that gave us some of the longer follow up.

Information.

By Middle of next year.

That you're referring to and including in that is obviously the CLA overtime.

As well as obviously event free survival. So we will start to build that but I'll ask it clearly as we go through the course of the year, including at Ash.

We're obviously going to gain additional information in terms of longer term Paul.

You may remember when we looked at the PFS curve.

From the old car T study.

Remember that that S curve basically shows.

Still drops until about 12 months of follow up on me then we saw a stabilization from 12 months before.

And so I think what we're going to look at ESA state I think to get to the sufficient longer term view on the data, we're probably going to have to go to ash to really understand.

The longer term outlook.

For that curve actually looks like.

So that will be early data, but I think in terms of actually getting a better understanding and more stability in the data book what would have to go into that.

Understood.

Have you disclosed what MRV sensitivity here looking at for the quota is it turns negative by chance.

Well that is obviously one of the measures we're going to look at.

All of those levels.

You can always the measure down to about 10 to the minus six with the assay.

We're certainly going to look at.

The old OLED that he can get to typically what you'd love to see us at least a lock step reduction to actually call. It a response to the MRV response, that's typically the way that was shuttles in the past using.

Either flow or.

Our PCR so.

That's one of the ways. How you can look at if you want to look at the absolute reduction and see whether there is any.

Differences and potentially out of the company.

Depending on the cutoff that you're actually looking at.

Understood and if I may just one more on mccarty.

I know mccarty excludes acquire cell therapy, but our patients allowed to have scaled by specifics such as the recently approved type with the mab.

I don't think we have excluded in that study.

The targeting of <unk>.

Obviously, what's already available with regards to Pcm's targeting are.

Adcs to be CMA, what youre actually available in the market some of the Bispecific T cell receptor coming available.

They are allowed.

As you pointed out correctly, we happened to have it.

Car T <unk> targeted car T. We're conducting the study in the UK and in fact, there is no availability.

Related to these patients.

Few therapies targeting piece at this point.

It's more of a theoretical exclusion at this point, but it become Coca Cola practically collusion.

For the rest of the study progresses.

Okay. That's all from my end thank you.

Thank you.

Thank you and our next call. Our next question sorry comes from Gil Blum and your line is now open.

Joe Your line is open.

Good morning, and good afternoon, just a couple of quick ones from us.

Kind of as a follow up here.

Are you, hoping are going to be the differentiating features for Ottawa and the CMA given how crowded spaces.

Hi.

Great to have young so differentiating features I think that what we're looking for.

In sort of the second generation approach a multiple myeloma I think that what we do know from the current product, particularly if we're looking at <unk>, if we do get higher response rates.

And I would also have very meaningful durability of effect, what we've done what we see is still challenging.

At a very high percentage of.

Oh.

Got it.

Sure.

Disease.

As to the level of 10 to the minus six or below.

In terms of the detection. So is there any sort of element there in terms of the molecular responses are being achieved by you could actually see differentiation can pick that now allows the standard response rate, but when you look at <unk>.

Second aspect is what we're seeing with all the products.

Clearly as much more of a challenge in multiple myeloma to actually generated products would have longer persisting products.

As the centers in.

The disease is relatively slowly progressing.

Challenging microenvironment with your findings across tomorrow.

That he could have pockets that actually were volatile withheld basically survive and ultimately rebound was clearly essential we buy a significant amount of his time with current therapies.

Difficult its difficult to actually switch it to a state where there is the highest degree of confidence that you have true long term remissions.

Thank you wanted to see very deep responses at the other aspect is you want to see indeed.

Indications for good levels of sustained persistence product positioning products and I think those are two features.

I think we'd be we'd be looking for.

And I think will give us I think a very clear indication that we're starting to.

The feature.

Obviously, the fundamental piece in terms of the design that we put in on the <unk> side is okay. It vary.

<unk>.

Approach that allows us to target cells with very low expression.

Okay.

Expression levels with the CMA, which is one of the fundamental challenges with the target.

Alright, Thank you for those details and maybe one last one.

Auto for study are you still are you enrolling additional patients at the high dose right now.

Yes, so we are enrolling patients.

We had enrolled continued leftover core against the 450 level and with the amendment.

Through for the modified manufacturing process.

We took a step down in 2000.

25% through the first patients will initially be dosed at $2 25.

Once you have initial data from that feedback off escalated to 450.

But we haven't gone beyond $4 50 in terms of cell dose.

Excellent. Thank you for taking our questions.

Okay I appreciate it.

Thank you and our next question comes from Nick Howard Your line is now open.

I think in euros.

So I think I'm just wondering there was that for Nicolas.

So this year online perfect alright.

Yes, it's Nick on for Cai. Thank you for taking my question.

Just a couple if I May festival for the Ash update later this year could you just help us frame expectations for what we might expect in terms of patient numbers on what the key data points, we should be looking out for and then if possible would you be able to give us an idea of some of the key design elements of the <unk>.

<unk> and J trial. Thank you.

Yes, Thanks, a lot for joining Nick with regards to the update that ask are the key focus is really on longer term follow up.

Obviously patients with <unk>.

Yes.

Actually the AML patients with <unk> as well as I remember there is an additional six months or actually more than six months follow up.

Since the last update was given all of that cohort. So we will have long term follow up on these patients.

So that's kind of the key focus with regards to obesity.

There are a few more patients on the non Hodgkin's cohort that the primary really I think the primary reason for your long term longer term.

With regards to Ottawa 22 out at very early data on the pediatric patients. So we have longer term pull off with really before particularly.

We're obviously looking to minimize or eliminate the risk of CD 19 negative relapses.

In these cases.

The data that we have the EHR.

I think indicative.

But of course, we didn't quite have that much falloff until the patients so at least.

Theoretically that might've been a risk that we might still be pick it up.

Negative.

And so the additional follow up I think is meaningful and will give us a good.

Additional.

Automation and also design premises.

The program.

With regards to our report as well longer follow up is kind of the key piece there and then obviously some views with regards to the modified process and what it might do for the product going forward.

But.

Critical piece, though is the areas that we have limited follow up on the patient.

Cheap metabolic Crs.

Obviously with the additional data comp.

We should get closer to one year.

These happy as long as a year of these patients I think that starts to be meaningful.

Remember these patients typically passed away within about six months at this stage of the disease.

We both in terms of the patients enrolled into the study.

So those I think some of the key expectation I think with regards to.

Through the trial.

That's great. Thanks, very much Christian and did you have any detail you can provide on the fix charges, yes sure. Thank you.

On the <unk> six trial obviously.

Turning to have.

We're introducing a number.

Our new modules.

Q2 modules each Athena module.

Basically our case IL seven type module.

So that's a significant addition and where.

We're still working through kind of the exact.

Initial approach also with the.

With the regulators here in the UK.

So obviously.

We have an approach that allows us at lower dose levels.

The modules.

And be able to sort of actually start generating.

Safety data first obviously in that trial, and then obviously pushed doses.

<unk> demonstrated safe too you saw its actually look and that impact on <unk>.

Activity, the antitumor activity as well.

But the details are still in part.

Negotiated with the regulators.

Pipeline.

I appreciate that thank you very much thank you.

Thank you.

And we now have Kelly she now on the line.

Hi can you hear me okay, yes.

Yes.

You're fine.

Hi, this is clearer for Kelly.

Sure.

Pivotal trial can you comment on patient baseline characteristics for the anvil patients.

Consistent with this one.

Just wanted to ask just one stage.

And also according to clinical trial Dot com one of the inclusion criteria for Philips trial is to screen patients with.

5% flashing bone marrow with 75% CR rate for if part of Bonefish will be actually included a 25% of the patients with less than 5% lapping from narrow so shall we expect lower response rates were solid topline data.

Lastly, tire ethylene Cytogen Manhattan pack on Mexico and Africa.

Vishal. Thank you.

So with regards to inclusion exclusion criteria those are actually consistent decrease.

The phase <unk>.

The phase II portion.

They're obviously also largely consistent with the.

Prior development business space, including pivotal study in relapsed refractory <unk> equivalent type of ore for cognizant.

<unk>.

The inclusion exclusion criteria are.

Very similar across the board in these trials.

Decision between the studies and the phase III.

The terms of patients.

Enrolled obviously the patients that are part of the analysis.

That will go into.

Are patients that have more than 5% in tumor burden at the time of enrollment.

And that is helpful.

The key.

The inclusion criteria patients that have less than 5% tumor burden.

That would be enrolled into the second cohort that we're running.

Ah patients had minimal residual disease.

But theyre clearly differently.

Two different cohorts and analyzed separately.

Also in terms of the endpoint that would be the eight months.

Response endpoint that you looked at it.

Primary endpoint, if you look at the of the morphological cohort.

Is complete remission or complete remission.

Patients with <unk> in patients with CR with incomplete recovery.

Logical recovery both of those measures obviously are looking at going from a level of.

Last was off 5% to a level of over 5% which is there.

Nation to meet.

Yes.

Just sort of.

Before we get into the SCR is.

In the cohort dose it would be minimal residual disease that are starting to below 5% of those patients are technically Oxford in complete remission.

And what we're measuring but those patients. This is goes back to I think the question.

I'll ask before.

Do that actually can look at the conversion.

These patients into a molecular complete remission.

Which actually fits in Nebraska as additional reduction of the typically those tunnels.

If you looked at there to the.

The minus four.

So those are kind of the differences between the two populations Theres no difference that we expect to have in terms of the actual patient characteristics.

Compared to the phase lumpy.

Also when it comes to.

General composition of the patients with regards to prior lines of prior therapies.

<unk> prior exposure to coincide that we don't expect to see that.

Got it.

Can you also share some details regarding your preferential preparation of Ob sell lunch on manufacturing from do you expect the same patient baseline.

Bill we're asked you're asking in clinical trials for adults.

And how what's the difference in path.

Obi cells manufacturing success rate on the efficacy.

So I assume that you actually have a group of patients that are above 5% tumor burden. Obviously the range can be quite kind of vary quite a bit. So it can have patients with Ida just slightly above 5% of patients who are in the 95% range of tumor burden in Nevada.

<unk> can also vary in terms of the amount of the TV sell through not just as a narrow window in circulation. So theres a big variability you have been here. We believe that we have a very good representation across the entire board of those levels of tumor burden as well as levels of circulating leukemic cells in the trial.

With that we expect the trial to actually be.

Nicely predicted for this truly advanced stage of disease.

It will be interesting to see what the outcome is for patients that have lower disease burden.

Less than 5% disease burden and minimal residual disease and Thats. Obviously the reason why we're running the second cohort.

It is obviously not the prime rate.

Primary group of patients to dose it will drive for label.

Okay. Thank you.

Thank you I appreciate it.

Thank you and our next question comes from Noah Eisenberg.

Hey, guys. This is now on for Eric Thanks for taking our question.

Just a couple of quick ones for us.

So could you could you remind us does the Felix trial use the same exact conditioning regimen as the.

Previous phase one trial for <unk> and then also.

How is enrollment progressing.

Paris, all trial and what can we expect.

The data next year. Thanks.

Could you repeat which trial, where the enrollment question James.

The carousel trial, the Carousel trial, Okay, sorry, I couldnt negotiate can understand okay.

Alright.

So the first question is to pre conditioning regimen and in fact, the pre conditioning regimen that we're using is consistent which was which was used in the phase one b and consistent way streets not typically used across.

Across the industry and the various car T trials in terms of.

Use with.

Fludarabine and cyclophosphamide, so that is very consistent.

<unk>.

Slightly different from what we had in the old car study, which was obviously study that started a few years before and we're still closer to some of the original work that was done.

Okay.

Okay.

And then on.

Carousel trial.

And then with regards to the Carousel trial wells that we expect to have about that.

Between 10, and 12 patients enrolled in total we expect to be able to provide an update that during the course of next year, probably more towards the middle of the year.

Okay, great. Thank you.

Okay. Thank you.

And that was our final question I would like to now turn it back to Christian for closing remarks, alright, well. Thank you very much well. Thanks, everybody for joining today is obviously a very busy season also at the Ash abstracts coming out appreciate your joining and obviously looking forward to keeping updated as we go through I think a very important.

Set of weeks or months ahead of us for at <unk> assets that are progressing the pivotal study and that we are gearing up towards the actual data presentations in the middle of next year, alright, Thanks, everybody and speak to you soon thank you.

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