Q1 2023 Autolus Therapeutics plc Earnings Call

Hello, ladies and gentlemen, and welcome to the Ultra loose Therapeutics first quarter 2023 financial results conference call an operational progress at.

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As a reminder, today's conference is being recorded I would now like to turn the conference over to your host Alexandra Deschner Investor Relations consultant Alexandra. Please go ahead.

Thank you so much alright, good morning, or good afternoon, everyone and thank you for joining us to take part in today's call for auto what's his first quarter 20, twenty-three financial results and operational highlights.

Hi, I'm Alexandra Deschner Investor relations consultant for Arliss.

With me today are Dr. Christian Eisen, our Chief Executive Officer, and Dr. Lucinda Crabtree, our Chief Financial Officer.

Before we begin I would like to remind you that during today's call. We will make statements related to our business that are forward looking under federal securities laws and the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995. These may include but are not limited to statements regarding the status of clinical.

Trials and development.

Or regulatory timeline for a product candidates.

And our expectations regarding our cash runway. These statements are subject to a variety of risks and uncertainties that could cause the actual results to differ materially from expectations and reflect our views only as of today we.

I assume no obligation to update any such forward looking statements.

For a discussion of the material risks and uncertainty that could affect our actual results. Please refer to the risks identified it today, It's press release and R. S. A C filings both available on the Investor section of our website.

On slide three you will see the agenda for today, it's called which is as follows Christian will provide an overview of our operational highlights for the first quarter of 2023.

You see well then discuss the company's first quarter 2023 financial results before Christian walking to conclude with upcoming milestones and any other concluding comments. Finally, we will of course welcome your questions over to Christian.

Thank you Alexandra and good morning to you well thank you for joining us.

My pleasure to review our progress for the first quarter in 2023.

Moving to slide number four.

We're really pleased with our program and operational progress during the first quarter of 2023, which is highlighted over the next four slides were.

We're making good progress with our pipeline off car T programs, particularly with our lead product <unk> in relapse refractory adult patients.

You will recall that we announced to December phase two pivotal clinical trial of every cell in this patient population have made his primary I'm point based on a pre planned interim analyses of 50 patients with morphological disease and Thats verified by an independent data monitoring committee.

This positive data triggered at 35 million dollar milestone from our partner Blackstone Lifesciences earlier than anticipated.

We're looking forward to presenting the top line data off the Phoenix study and an oral presentation at the American Society of clinical oncology annual meeting on June 2nd in Chicago.

And a second oral presentation at the European Hematology Association Congress being held from the eighth to the 11th of June in Frankfurt.

<unk> on longer follow up and additional stuff analyses off the data or a plan for the American Society of Hematology meeting at the end of 2023 as well as at medical conferences or the first half of 2024.

<unk>. The <unk> is the filing for biologics license application to the U S food and drug administration by the end of this year.

In February Dr. Claire Roadie from UCL presented longterm follow up data from out of adult patients and the old card 19 phase one study of <unk> at the tandem meetings off a S. T. C. T M C I B M T R.

Data demonstrated that 35% of adult patients remained in complete remission without additional anti leukemia therapy at immediate follow up of 36 months with ranges from 24 to 48 months.

We're now looking at the broader range of development options for Obi sell an auto 122 beyond adult patients with acute lymphoblastic leukemia.

The old car extension study, we have reported <unk> high level of clinical activity and well manageable safety profile across non hodgkins lymphoma indications and chronic lymphocytic leukemia.

We're completing enrollment in this study unexpected report final data in a peer reviewed publication.

Is it kind of self study reevaluate O b cell in peripheral C. N S lymphoma, we've completed enrollment and continued to see consistent and encourage you safety <unk> with adequate follow up but we are planning to publish the full data in a peer reviewed journal as well.

Referring with interest the early and very encouraging results from the team of gear upset and Andreas Makinson at the University of Erlangen in Germany, impatience with refractory, it's a systemic lupus and related b cell mediated autoimmune diseases treated with an academic C. D 19 car T product.

Considering O b cells excellent activity and safety profile.

Combined with our commercial manufacturing base. This set of indications may become an attractive additional opportunity for the program.

And an oral presentation at the 49th European Bow, Ma'am and transplant bathing in April Okay, investigators to restart Doctor, Sarah Russia, and and pursue some roadie awesome, Great Ormond Street Hospital Mountain presented updated data from auto 122 or C. D 19 M. C V 22 dual targeting card to your product candidates.

Can Brian ineligible pediatric patients showed a high level of clinical activity and good tolerability with over 80 per cent of patients are choosing a molecular complete information with no anti should negative relapses scene with a medium to follow up of 8.7 months and.

Included also where patients who had relapsed after Kim Brian therapy with C. D 19 negative disease.

Additionally data on the molecular design a order 122 am preclinical <unk> were published in molecular therapy in March and highlighted the state of the art design, a auto 122 with his high sensitivity C. D 22, <unk> receptor and the efficient quote targeting leveraging <unk>.

L C D 19 <unk> receptor.

Turning to slide five and other pipeline updates.

We're looking forward to updating the progress with the order for peripheral T cell lymphoma program and an oral presentation at the International conference for malignant lymphoma, Integon in Switzerland in June as well.

Finally, we conclude we continue to enroll patients into the Mccarthy phase one trial of auto eight in multiple myeloma and expect first data at the end of this year unexpected dose. The first patient interphase mom trial of auto six N G. In neuroblastoma this year as well.

Turning now to slide number six with continued progress against our strategic and operational goals throughout the quarter.

The company's new 70000 square foot commercial manufacturing facility in Stevenage in the U K has continued to progress on track.

Equipment installation and validation work completed by <unk> in the first quarter of 2023, enabling operational qualifications commencing now in the second floor of 2023.

This facility will have an initial capacity of up to 2000 <unk> per year sufficient to surf the global demand in adult L. L.

Just 18 months from Brian breaking we're not working on the qualifications validation of a nuclear facility and remain on track for good manufacturing practice operations commencing in the second half of this year.

What was the undertaking the development work and report generation for the CMC package plan to support a b L. A submission to the F D. A.

Our industry, leading south programming platform creates opportunities for collaboration and licensing.

Relationships with B M. S. At Moderna, we added in queue, a partnership with Cabaletta granting them access to our proprietary Archie alright, right texture mapping juice safety switch for incorporation into a set of select itself therapy programs.

In January we also announced to changes to the board of directors the company's non-executive chairman John Johnson grass helped at all since September 20th Mom will not stand for reelection at the arduous upcoming annual shareholder meeting. Additionally.

Additionally, at the end of February Doctor, Jay Backstrom that served in Artless Board of directors. Since August 20th 20 stepped down from the board after taken on in public C O double S skull Iraq.

We also announced a change to our management team with a doctor <unk> on the line today stepping down or planning to step down at August 2023 to pursue a new opportunity searches for successors for these posts are underway.

Finally, total cash and cash equivalents and restricted cash at the end of March for $343.4 million.

We've had a diversified treasury approach in place, which served as well through well during the Silicon Valley Bank Meltdown and we continue to diligently monitor developments in the financial sector.

Moving onto slight number seven there are also several posts period events I'd like to bring to your attention.

Last week, we announced that we had selected Cardinal health as a core distributor for <unk>, giving us the platform and distribution capabilities required to commercialize a car T cell therapy in the U S.

Cardinal Health innovative depot model is intended to reduce delivery time by allowing for transit about product releases being finalized.

Alongside this we continued to build I'd always one commercial infrastructure and are working towards Onboarding. The clinical centers over the course of this year.

Also at last week's last week, we held a virtual capital markets day.

That presented the positioning and commercial opportunity for <unk>.

<unk> started with professor Loury Muffley from Stanford University, reviewing the disease therapeutic options medical need for adult patients with acute lymphoblastic leukemia.

Professor Clare roadie from UCL, then introduced <unk> and the initial clinical experience in patients with a L. L.

Buy a video presentation of one of her patience and her experiences of living with a O L with an a O L diagnosis as well as her experience with the treatment regimen.

With the steep and understanding of the physicians and patients view of this challenging disease, Dr. Matthew Caitlin talked about at the market and the perspective payers are taking.

And particularly he looked at the cost of patient management and the impact on hospitals and payers highlighting the substantial impact on cost of managing high grade <unk>.

Finally, <unk> Chief operating officer walk through the commercial roadmap for <unk>.

We believe it was a very informative and well attended event and for anyone who missed it a replay is the events section of his website available to you.

Finally, we recently announced the publication of two papers the first of which included the publication of the preclinical data for auto 122, a molecular therapy, which I mentioned earlier and.

And the second published in molecular therapy nucleic acids focused on a new set of cell programming modules based on novel fast TNF receptor <unk>. This technology converts a threat to the car T cell into an activating or survival signal instead.

Wearing here from a martial arts principle of taking an incoming glow and rolling with it.

Slide eight <unk> moving to <unk> with that also moving forward to slide nine.

<unk> is a unique mechanism of action was fundamentally different about our product candidate that it has an ability to engage physiologically with the charge itself rapidly binding to the target, which delivers specificity and paired with a fast off right for rapid disengagement from the target wants to sell cable has been delivered this.

Nique engagement drives maximum activity, while minimizing toxicity and is at the heart of the differentiated clinical profile. We are observing for <unk> N E L L and non hodgkins lymphoma.

Moving to slide 10.

Our clinical experience would that'd be selling a allow shows a high overall response rate across all patient populations evaluated.

And our prior old COVID-19 study, we have 35 per cent of patients in longterm remission at 36 months of medium can follow up with a range of 24 to 48 months after receiving <unk> and without receiving any further anti leukemia therapy.

The safety profile, Israel manageable with low levels of high grade side of can release syndrome and I can't.

Mid section of the slide shows to patients with longterm Remissions have continued presence of car T cells over the entire observation period, pointing to Karachi self persistence as an indicator for long term outcome.

The program is developed on the arm at Prime and I laughed Phthisic nation.

Moving to slide 11.

If not completed the enrollment of dosing of of our pivotal study, which we called the Felix study in adult patients with relapse refractory a L L.

As I mentioned, we announced in December that we have met the primary endpoint based on the overall response rate as an interim analyses on the first 50 patients forward for at least three months clinic.

Clinical benefit <unk> will be assessed based on patients remaining in a sustained complete your mission.

We conducted this study and 34 centres 20, <unk> 24 centres in the U S. Seven changes in the U K and three centers in Spain enrolling patients from July 20th 21 to November 2022 during the peak infection period of the pandemic.

It's important to realize that relapse refractory. It all day allowed patients are highly immune suppressed and the <unk> approach to significant added risks to them.

Moreover, you to access restrictions and various other pandemic rules and regulations, we could actually not access our clinical should trial size for the most part of the Felix study.

This is about as difficult the population to work with US you can imagine, particularly in an environment, where there is a high risk of infection and indeed, we did lose a few patients to covet.

In many ways. This was more of a real world study conducted under difficult circumstances.

In addition to patient safety every aspect of product delivery and logistics for pressure tested during the trial with massively reduced air traffic and other impacts of the pandemic in our manufacturing teams remarkably manufacturing for all patients from our facility. The UK turned out to be an asset also for U S delivery. So long haul flights from the U S should the U K.

High priority over domestic flights.

We're pleased that we got it done under such challenging circumstances and credits to our patients and their caregivers clinical collaborators and a whole almost team for this achievement.

As mentioned earlier next key data is plan and oral presentations and <unk> and E O J in early June 2023.

Moving to slide number 12.

Summarizes the announcement, we made in December regarding the pre specified interim analyses of the first 50 out of 90 patients dosed and I've reached at least three months of follow up.

Primary endpoints is based on overall remission rates, which includes patients incomplete information and patients incomplete formation with incomplete bone marrow recovery or C. R. M. C. R I.

The aura or with 70% all recent programs and a O L have used R. R. As the primary I'm pointing their respective studies.

Safety analysis was conducted on a larger 92 patient data set and showed an excellent profile with high grade side can release experienced in less than three per cent of patients and hydrate icons in less than 8%.

Alright cats are fully reversible unless I'm 25 per cent of patients had any great of neurotoxicity.

In contrast to approve T cell or to some engaging therapies are very unusual profile in this patient population.

And as I mentioned earlier, the data triggered a 35 million dollar milestone from Blackstone move.

Moving to slide 13.

This slide summarizes our current experience with <unk> across a L. L.

As you can see the date are highly consistent across the various studies, both on safety and efficacy.

Worth, noting is that card Pal an old car were conducted prior to the pandemic well.

<unk> both parts of the Felix study were conducted during the pandemic.

Both the carpet and old car 19 studies were conducted in the UK, while the Felix study was largely conducted in the U S.

Well, we did pick up as to the patience of the Felix study, where more advanced in their disease based on Super birth, and an increased presence of so called extra Madonna liver disease. This is in essence again, a function of leukemia that allows it to leave the bone marrow and successfully settling grow in other organs patients with extra dollar disease respond poorly to anti leukemia therapies.

Moving to slide 14 to look at further into the data represented at Ash from the old car 19 study.

When we look into the outcome or a longterm observation from the old card 19th study, where we have up to four years of follow up you can see the unusually quite an unusual profile, we could see the clinical benefit in these patients has the ability to cover patients into complete remission sustained them over time without additional therapy and as you can see.

<unk>, obviously, a substantial proportion of the patients are indeed, insisting therapy.

So if you go from bottom up you can see at the bottom patients that all of a sudden did not respond we have that a group of patients that did respond with relapsed quickly, including patients that had lost the C D 99% of.

Then a group of patients that actually relaxed with C. D 19 positive disease those patients that have lost persistence of the car T product.

And then there is the top group with the long <unk> survival lines, where you can see patients that actually I continued remission and in fact those are also patients that have continued presence or persistence of car T cells.

Uhm overall, obviously it gives us a lot of confidence in terms of the consistency of data the data understanding the reasons when patients actually do relax in both the causes for that relapse are and obviously the proportion of patients that are an ongoing information without any additional therapeutic need.

Turning to slide 15.

I thought it might help here to give you an overview of the ALLL treatment landscape as it stands the figure out the right represents the S. N C. C N guidelines for the treatment of relapse refractory ALLL and you can see it as soon as two main arms the low arm actually looks at T cell lymphoma, which is a subset in relatively small group.

The patients and the upper two arms actually include B cell lymphoma, sorry, <unk> acute lymphoblastic leukemia and with that.

The disease setting that we're focusing on.

We can also see that we see three novel Therapeutics that are being incorporated into that scheme over the past 10 years. The first <unk>. This is a by specific T cell engaging anticity 19 therapeutic antibody, it's given as a continuous intervene intravenous infusion for 28.

<unk> at a cycle the cycles can be repeated with two weeks of vegetables in between the cycles.

Patient starts at the hospital and <unk> and eventually are discharged from.

The hospital with a container or back that actually contains the product that is continuously deliver it through central port over the entirety of a treatment cycle. These backs are being changed typically once weekly I'm Adam by a <unk>.

Nurse Uhm that actually usually visits patients at home to sort of support the therapy.

<unk> can be repeated but obviously, if the patient needs to be an information for a continuous cycle or a next cycle to be received.

The product is obviously, a very active and it's particularly active in patients that have low disease burden.

Unfortunately, like with all therapeutic options today available for adult patients with a O L. Well the the product has been reactive it does not actually lead to long term remissions and that is one of the fundamental challenges that we have in the field is that we have actually therapies, but we have a hard time converting dose.

Effects and responses into longterm relations.

The next therapeutic that we're looking at is in a <unk>. This is an antibody conjugate H drug therapy. It is directed to C. D 22, which is expressed on most b b.

<unk> <unk> confirm a L. LS and this drug is also associated with a very high response rates, but also like blue side, So as not curative and in fact is usually used as a bridge to transplant.

Finally, the newest product studies available is breakfast seller to Curtis, which was approved in 2021, which is the first car T cell therapy approved for it all day allow patients.

Uhm.

<unk>, <unk>, which are leveraging or utilizing T cells do show similar types of even illogical, toxicities, which rcra's and icons rasp as phones that can cause liver toxicity.

Overall, we do have obviously have you that if you have a product that has a high level of clinical activity with avail manageable safety profile well. This is very attractive for patients with B a L. L and is that a product actually can translate into at least a proportion of the patient's name.

Longterm remission I think that would represent a big step forward.

Moving to slide 16 to look at the data from these programs into space inside.

<unk> as I mentioned as a T cell engaging C 19, targeting Monica <unk> specific antibody or a <unk>.

<unk> has become the standard of care in relapse refractory a L. L S.

S.

Alright, please stay by widely compile the Q&A roster.

Alright. Thanks, so much for taking my question. So a couple of things 20th I'm, just curious about that date of disclosure <unk>, Okay and will there be anything else.

But it's gonna be probably slight differences in some of the stuff analyses that will be it will be discussing.

Local payment.

Two and a number of ways, but what is basically what show or shows is that once the compartment properly reset.

An example, or another indication so there's <unk>, there's probably going to be a bit of a difference, but I think there's a certain amount of just a period that you would like to see the visa of a pleasure to be in place to be sure that you really captured oldies potentially autoreactive details and.

In terms of design, we believe the designer the product actually is a really good design it fits very well and I will say with the safety profile without demonstrated in lots of different.

Remarkable.

<unk> an activity that we have seen two orange a patient pool.

The let me look in terms of the profiles and I think some of the errors to the <unk> to see is I think with the in this disease setting you'd like to see a production has a safety profile that consider be managed and handled in a in a broader range of centers not just at the.

A smaller number of academic transplant centers will be able to go more often than that so I think safety's important also with the H.

That's an average of the population as well.

And the.

Other aspect that in case that.

We also we haven't yet seen whether those initial remarkable activities to translate into true longterm headphones and I think that's an area that I think we will keep watching it certainly when we look at the ability to go after potentially driving cells, which is one of the reasons why we're including a CD ninth.

<unk> component into overweight.

But also having a more sustained presence.

Hopefully hopefully product and persistence.

May actually be helpful to actually create longer term outcomes, that's interesting and I understand that interested in understanding from a rotten product from all the way it is.

One of the key things from evaluating in this initial phase one study and I think depending on the outcome I think there are some of the different paths that we can take from there forward, but I think it's premature and the absence of the data to sort of guide on this particular plan.

Thank you Chrystal very helpful and just a quick one on auto for How's the company Sir.

On this program some interesting early data, but <unk>. This is more of a.

Company sponsored effort overall or maybe more partnership material or the jury still out on that one thank you.

Yeah. Good question. So I would say at this point you know, we're very focused on delivering <unk>. It's a full added effort.

To deliver the program and had really established she kind of initially infrastructure for commercialization both of manufacturing.

From an actual delivery perspective commercial delivered perspective.

And so that that certainly required us to sort of focus very substantially on early so and I think there's opportunity across the pipeline to considered entering into partnerships for some of the programs also as a way to be able to actually move in the former progressively more in parallel to the activities that we're conducting <unk>.

So there's opportunity there uhm I was super excited about the order for them to think it's a very interesting program that starts to have very interesting data.

It certainly is a program that we feel has has a real potential medical needs heading.

Thank you for taking our questions.

I appreciate it.

Standby for our next question.

Okay.

Next we have Kelly she with Jeffries Kelly Your line is open. Please go ahead.

Thank you for taking my questions for.

<unk> Auto alliance any temperature could you have to elaborate can assassination of July .

All criteria.

April 2nd 19, Carmine <unk> auto line for the temperature are also.

Alright.

How they can <unk>, having a headache.

1920, K running telephone telephone.

<unk> <unk> <unk> <unk> <unk>, <unk>, <unk>, which one is better on kitchen to tech comes to pay my T V.

Thank you.

Very good questions. Thanks for joining Kelly Uhm. So first one with regards to older 122, and the fact that we're we're describing this as a patient.

Eligible to to basic sort of settings that sort of exclude currently the patience certainly in the UK from to my therapy. One is if you already have been on camera and have failed.

You're not eligible for a second round of can Brian therapy. So that's one one group of patients and that includes also patients that actually have relapsed receiving 19 negative since Easter that did refer to before.

The the the second part of the population is this if you have isolated extra Madonna read disease, which also excludes view I'm currently for my therapy.

And then there's certainly certain patients that are just too.

In probably two poor condition to be considered to.

To be included on the on the commercial product since it's a truly refractory population.

That we have treated here that we also will just expect that if if we had treated these patients with <unk>, we might've been able to get it back.

40 per cent, maybe if we're lucky 50% into a C R. But certainly not anywhere close to the 83 per cent that we have seen.

India in this extension of the current phone study.

Now with regards to Kennedy is the dual targeting approach and the choice of antigen is there a number of of concentrations here and we've seen programs actually for quite some time on the one hand targeting C. D 19, together with a C D 22 targeting or city 19 with city 20 targets.

You know, we and others have been active in this space or focuses speed on C. D 22, and the reason for adding cities 22, <unk> two fold first similar to C. D 19, the expression of civic 22 is actually see a wide range of vsel differentiate.

<unk>, particularly also present in very early stages to their driving acute lymphoblastic leukemia and very in fact city 20th Samson. So you don't have seating 20 expression on a O L as in.

The second concentration, let me think about it.

Therapeutic pressure and selection.

Against a particular target.

Obviously, we do have the primary pressure when you think about it and I'll call scheduling for modifications to be on C. D 20, with all the hypocrisy.

And the full of them pulled up from the Ocean swell, which both actually put heavy pressure and what we're seeing is the patients that have an opening a prolonged C. D 20 therapy.

I'm, a relapse often have very low levels of C. D 20 expression recording <unk>.

If you look at it by <unk> <unk>.

So so you you haven't you sort of true these therapy sort of select for low levels of expression, which I'll say also then requires you to if you Wanna go utilize that anti trade as a second antigen and it.

Targeting a bird that you really have to drive a productive has the ability to go in to these very low levels of expression to ensure that you're not actually having or seeing escape uhm to to that to that extent.

Pressure on the targets.

Uhm when we looked at the data opposite the early work that was done at the University of Wisconsin T V. I T. C. D 20 combination showed a good level of activity, but also eventually.

Sure some relapses Uhm, there's limited data from some of the work that's being it was conducted in China. Then showed also could level of activity.

Uhm.

I have come at this point to add to our knowledge is certainly not have been published.

But I'm sure we're gonna see as one of the upcoming conference is.

What was it what's interesting when we think about C. D 19 loss at least in our hands, we haven't seen that in the normal Hodgkins lymphoma.

Treated with a V. So so we haven't seen patients actually last name was C. T 19 negative disease and we also actually have seen certainly an aggressive lymphoma, we haven't seen actually lapses location for the <unk> most of the patients as you might remember did actually <unk>, where there'll be so.

So whether or not there is a significant added contribution from city 20, I do not know at this point I think it's totally still you know something that will need to see over time and the well hopefully we're following the space, but if you want to use an address the area, where we know the most about C. D 19 negative disease lost the city ninth.

Which isn't a avail, Unfortunately city, 20th not suitable and the only other suitable antigen that it could go after that is actually useful in this headache is C. D 22, which is the reason why we chose it in the context of our life cycle for me Sir.

Alright, thanks, Sir thank you.

Okay.

Thank you very much on standby for our next caller.

And our next question comes from <unk> at Truest.

Let's take out your line is open. Please go ahead.

Hi.

Thanks for taking my question so <unk>.

Just wanted to take and do you get to guilt question for a minute Christian and maybe just <unk>.

How do you compare the type a number of centers, where you can get <unk> psycho versus the number at the the essentials, where you can get caught US and then as you plan to commercialize <unk>. What is your strategy for targeting need medical status, but it's likely to be used and besides that of salesforce that you'll need and then I have a couple of quick.

Follow ups.

Very good well thanks for joining us we got the.

This is a very interesting question and so when you look at where.

<unk> launched cause launch basically initially in the <unk>.

Transplant centers.

In the U S and also.

Which is in the U S give or take 60 censorship sort of really represent the the real core of sandwich treating patients with advanced disease. So you do have a pretty significant concentration all these very severe severely sick patients to be treated and there's a smaller number of sense.

So that's I think that's the first the first aspect obviously, we have in the current trial and a fee like study. We got 24 of those 60 sensors in the trial included and having gained experience with the product.

When you think about the dangers of broader opportunity.

Nowadays maybe they wanted a case of you sir thank the learnings sharply side to and I think there will be that will also be relevant for <unk>.

Is that the patients that have lowered disease burden.

Tend to be a better manageable tend to have less adverse events I'd also in the case of Precycle also then have elevated levels.

Responses are observed.

And it is that profile that I think allows you to consider actually trading these patients.

In non academic transplant centers in the U S and which actually allergic to expand the footprint quite a bit and frankly allows you to get closer on average get closer to where the patients actually to live in.

And that actually takes risk out it makes access easier and I think it's certainly an important part of what we do know with besides those that if you look at the second of course, a treat for the third course of treatments actually those courses 10 to actually induce very little adverse events typically.

I can actually be initiated without actually taking the patient into into the hospital. So basically have an ambulatory setting it'd be hooked up and then I wanted to work for a short while identification can actually move. So so there is made with the initial park, where you have the major tumor burden that needs to be taken care of we have most of the adverse events, which is true old <unk>.

So for the card free therapy of course, the difference being we're only giving a single dose we'd have to go have north Dakota back we don't have to change strawberry, so long as et cetera. So when we look at the actual mm adverse event profile than <unk> programs and <unk>.

Clearly O b cell if anything actually has an improved safety profile.

And that actually gives you a very good I think proxy for the ability to over the phone initially revolves who started off.

With a stem cell transplant centers.

60 centers are so that I quoted before which is sort of an initial core which address and allows you to actually reach.

Stanford proportionately.

Mmm, 70% to 80% of the patients uhm.

Uhm and overtime Masters more experience with the product and what was the case with website, though we'd expect to be able to actually increase the footprint.

To sensors that are known to academic transplant centers, obviously sophisticated a note academic transplants interested with that also could I have the footprint would that should be able to reach the same patient population have access and provide access to therapy for the same breath of the patient population after seeing today within sight, though so that is where are we looking at that.

Projecting that in terms of the sales for size actually that's pretty focused it's not a classical salesforce either cause what we're providing is is is more of a survey to stomach classical.

Marketing driven commercial activity and in fact, that's a very focus given the number of centres purpose team. What we did sushi is actually that the Irish the size, although the workload is a bit different than with French scientists actually very comfortable with a large.

Basically sides of your commercial organization for the U S. If that 120 250 people.

Great. Thank you for that and then you can follow up with a couple of quick one.

<unk>, what about what proportion of patients off the 50 patients in the efficacy analysis will have six months a follow up and then at E. I was just wondering if you could maybe give me a little color what kind of sub analyses will be presented I might need a little help convincing might get water as to why we need to go to Frankfurt.

[laughter].

Always the opportunity to have a beer that seems like a good a good reason for why you might want to go.

[laughter]. Okay. There you go there you go Okay Uhm look when we went so we're going to report on all of the the 90 plus patients that were dose in this study.

When we look overall.

In this study we will be close to.

Somewhere between eight and nine months a follow up on the medium. So that gives you I think a pretty good sense of.

Of what that May look like so that's what that's what in terms of the overall data the the nature of what we're gonna show ultimately on the on any additional potential at Alice is I think that is still actually being finalized it would be too early to guide them.

Alright, So I think it comes down to you you'd probably have to go for the beer.

To the other day, so I figure they are not going to Miss anything.

Perfect I appreciate the call I got it. Thank you so much.

<unk>.

Okay that concludes our Q&A for today I would like to now turn it back to your Doctor Christian item.

Chief Executive Officer for closing remarks.

Alright, well. Thank you very much first of all thanks, all for joining today Uhm fantastic to have you all alone and have you taken the time and we're obviously looking to forward to hopefully seeing you in person during one of the two main conferences this summer and if not hopefully up whenever I resent that.

Upcoming trips, it's either respect as you respect this areas.

And with that I'd like to conclude at this point, thanks, again and looking forward to keep it updated with the next update always say I'd ask though it a few weeks time. Thank you.

And thank you very much for your participation.

This does conclude our program you may now disconnect.

Mmm.

[music].