Q3 2019 Earnings Call

Biotherapeutics Q3, 2019 financial results call.

Operator: Q3 2019 Financial Results Call. At this time, all participants' lines are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star and then zero. I'd now like to hand the conference over to your speaker today, Dr. John Craighead, Vice President of Investor Relations and Corporate Communications of Atara Biotherapeutics. Please go ahead, sir.

This time, all participants' lines Arnold listen only mode.

After the speakers presentation, there will be a question and answer session.

Ask a question during the session you want me to press Star one on your telephone. Please be advised of today's conference is being recorded.

If you require any further assistance please press star and then zero.

I'd now like to and the conference over to your Speaker today, Dr., John Craighead, Vice President of Investor Relations and corporate Communications on the chart Biotherapeutics. Please go ahead Sir.

Thank you operator, good morning, everyone and welcome to a tars third quarter 2019 conference call on todays call. We plan to discuss our third quarter financial results as well as racing clinical operational and strategic progress.

Dr. John Craighead: Thank you, operator. Good morning, everyone, and welcome to Atara's third quarter 2019 conference call. On today's call, we plan to discuss our third quarter financial results, as well as recent clinical, operational, and strategic progress. Earlier this morning, we issued a press release providing an overview of the company's third quarter 2019. This press release, as well as an updated investor presentation, are available in the Investor and Media section of atarabio.com.

Earlier. This morning, we issued a press release, providing an overview of the company's third quarter 2019.

This press release as well as an updated investor presentation are available in the Investor and media section of the Tar bio Dot com.

I'm joined on today's call by Dr., Pascal to shown President and Chief Executive Officer.

Dr. John Craighead: I'm joined on today's call by Dr.

Dr. John Craighead: President and Chief Executive Officer, Upal Kopikar, Chief Financial Officer, and Dr. A.J. Joshi, Chief Medical Officer.

Copy cart, Chief Financial Officer, and Dr., AJ Joshi, Chief Medical Officer.

Dr. John Craighead: We will begin with prepared comments from Pascal and then open the call for your questions. We'd like to remind listeners that the company's management will be making forward-looking statements. However, actual results could differ materially from those stated or implied by our forward-looking statements due to...

We will begin with prepared comments from Pascal and then open the call for your questions.

We'd like to remind listeners that the company's management will be making forward looking statements.

Actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the company's business.

Dr. John Craighead: Risks and uncertainties associated with the company's business

Dr. John Craighead: These forward-looking statements are qualified in their

These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company SEC filings.

Dr. John Craighead: Transcripts provided by Transcription Outsourcing, LLC. These statements are made as of today's date, and the company undertakes no obligation to update these statements.

These statements are made as of today's date and the company undertakes no obligation to update these statements.

Pascal Touchon: Now, I'd like to turn the call over to Atara's President and Chief Executive Officer, Pascal Touchon. Pascal?

Now I'd like to turn the call over too as far as President and Chief Executive Officer, Pascal to Sean That's cool. Thank you gentlemen, thank you everyone for joining us this morning.

Pascal Touchon: Thank you, John, and thank you, everyone, for joining us this morning. Before we begin our discussion of our recent progress, I want to reiterate how proud I am of the advances we've made toward a vision of delivering an off-the-shelf allogeneic T-cell immunotherapy to every patient in need at any time. We know that lives depend on us achieving this vision, and our team is strongly motivated every day to deliver meaningful results for patients and the company. During today's call, we'll provide context surrounding our new strategic priorities, recent clinical and operational progress, and upcoming milestones. I would like to update you on Atara's strategic objectives and priorities, following the extensive review of technologies, assets, resources, and organization that I conducted during my first month as CEO.

Before we begin discussions on our recent hardwood.

On to reinforce how proud I am a b advances we estimate to all the vision of video sharing an oversell allusion makes you said immunotherapy.

Every patients in need of anytime.

We know about darts depend on us such having been vision and the team is pending what do they did everyday to deliver meaningful results for patients and the company.

During today's call will provide context, so lumping all news public priorities recent clinical and operational progress and upcoming milestones.

So.

I would love to it that you on outdoor strategic objective and priority for doing extensive review of technology assets resources and organization, but they have conducted during my first loan.

CEO .

Pascal Touchon: Moving forward, our objective is to become the leading Shell Phylogenic T-Cell Immunotherapy Company, transforming the lives of patients with cancer, autoimmune, and viral diseases. We are planning to accomplish this objective over the next three years by executing resolutely on four strategic priorities. First and foremost, file and launch tabletle cells, or TAP cells, for patients with relapsed refractory EBV-positive PTLD in the US and Europe, as well as develop TAP cells for other needs. Second, achieve clinical proof of concept with ATA188 or allogeneic MS-specific EBVT cell immunotherapy. Third, advanced mesothelin programs with autologous ATA-2271 and allogenic ATA-3271.

Our objective moving forward used to become the leading of the shale conversion. He says immuno therapy company.

Transforming delightful patient weve come so what's going in and viral diseases.

We are planning to accomplish this objective over the next three years like exhibiting reasonably on full strategic priorities.

First and foremost.

I'm a known subsequent sale topcell for patients weak results could fluctuate before the cctld in the U.S. annual.

That's where the different old stops and for all the indications.

So again achieved clinical proof of concept weve achy, when they create or lose unique I missed specific you'd be VCSEL immunotherapy.

So to advance on middle couldn't hold once we've looked at a good I just wanted to 71, another one need educate 50 to 71.

Pascal Touchon: And fourth, develop ATA3219, or allogeneic CD19 CAR-T, to clinical proof of concept in B-cell malignant; in parallel, will continue to leverage the capabilities and expertise of external partners for autologous CAR T immunotherapy development. Starting with TAPSEL, we are very pleased to share exciting long-term outcome data for a more multi-center expanded access program following acceptance of an abstract for presentation at ASH 2019. I would like particularly to highlight the long-term outcomes in a subgroup of 22 stem cell and solid organ transplant patients with relapsed refractory EBV-positive PTLD treated with TAP cells who would likely have been eligible for going phase 3 study. These results demonstrate that CABCEL was generally well-tolerated, with an overall response rate of 55% in HCT and 82% in SOT patients. Estimated 2-year-old survival was 79% for HCT and 81% for SO2, although with such a larger number of patients and longer-duration follow-up.

And pool digital AG filter through 19 or lose any cdnineteen car T. Two clinical proof of concept can be said letting them.

Don't know will continue to look about the capabilities and expertise of external partners for sort of go Sculpey immunotherapy development.

Okay. We stop sale, we're very pleased to share exciting gunk than outcome data.

Well, maybe some to expanded access program for wind acceptance open up to talk for presentation.

Our 2019.

I would like basketball is Twilight. The long term outcomes you Miss said group of 22 stem cell and solid organ transplant patients.

We've read outs constructively PBT for the DPP HIV.

Treated we stop sale.

What would likely have been eligible for all green phase three study.

These results demonstrate stop sale was generally well tolerated.

Weve overall response rate of 55% in education, and 82 persons in its oki patients.

Let's see make it to you have on survival was 79% forged sticky and 81 person voices.

With such a large number of patients and longer duration for do it.

Pascal Touchon: These data are consistent with previous studies showing a well-tolerated safety profile, high response rates, and durable overall survival at two years. They do reinforce our clinical development and regulatory strategy for patients with relapsed refractory EBV-positive PTSD. These new data also confirm that TAP cell is potentially the transformative shelf halogenic T-cell immunotherapy, with compelling value for patient, physician, and payers in this often deadly ultra-rare cancer. Turning to a Pimotor Clinical Development Program for TAP cells.

These data are consistent we pick a study showing the when sort of aged 60 portfolio I response rates and Drillable overall survival at two years.

This is reinforced our clinical development and regulatory strategy for patients with relapsed refractory b pretty picky.

These new data also confirmed that up sell.

He is potentially the close so much piece of the shelf I wish I mean, he said immunotherapy.

We have compelling value for patient physician failures. This often deadly you're trying to have concept.

Turning to our people talking to go to help them pulled one full stop sale.

Pascal Touchon: We remain on track to initiate a tap cell BLS submission for patients with EBD-positive PTLD in the second half of 2020. We now have 35 sites available for enrollment in the US and Australia, and plan to continue to open additional sites at transplant centers in the US and Canada over the coming months. We also plan to file a clinical trial application, or CTA, in several European countries by the end of this year and to open study sites there next. Meanwhile, we are engaged in discussions with the EMA.

We remain on talk to negotiate Topcell beauty submission for patients with NPV positive speakeasy.

Second half of the present one.

We know our 55 sites available for enrollment in the U.S. and Trulia and.

And plan to continue to open additional sites a transplant centers in the U.S. in Canada over the coming months.

We also plan to fight the clinical trial conditional 58 in several you opened country by the end of this year.

Central been study sites there next year.

Meanwhile, we are engaged in discussions with the year me and the outcome of these discussions with this I mean, the timing of the Topcell you conditional marketing authorization application for patients with NPV positive.

Pascal Touchon: The outcome of these discussions will determine the timing of the TAP cell EU conditional marketing authorization application for patients with EBV-positive PTSD. Our BLA submission guidance takes into account the recruitment constraints inherent in our pivotal study, due to the nature of PTLD as an ultra-rare and rapidly-progressing disease; phase 3 studies are also only open at about 10% of transplant sites in the US. And there are a number of competing, although less advanced, clinical trials. Since July, we have improved the way we are addressing these constraints, and importantly, we believe these development constraints should have a limited impact on the tap sale business case for PTLDs.

What will be a distribution guidance takes into account what cooking on cost trends you never want you know people study you to the not you're picking up.

And then try rare and the up in the progressing busy.

Well phase three study also only open at about 10% of trust on site in the U.S.

And there's a number of competing although less advanced clinical trials.

Since July we are a great is the way we are addressing these constraints and importantly, we believe these development cost trends should have limited impact on the Topcell business case wapiti.

Indeed.

Pascal Touchon: Indeed, the value to individual patients will be high with such a potentially transformative T-cell immunotherapy. Also, TAP cells could be delivered within three days of order to any center according to an appropriate patient's needs. And if Tap Cell becomes the first approved treatment for PTSD, it will likely be supported by patients and physicians based on proven efficacy and safety. The potential U.S. market size for this first capsule indication is several hundred patients. We believe there is a strong and profitable business case for Atara to commercialize TAP cells in the relapsed refractory BV-positive PTLD indication in this geography. We are also advancing studies in potential additional indications for TAFSA. We continue to enroll patients in a Phase I-II clinical study of TAP cells in combination with anti-PD-1 therapy in patients with platinum-resistant or recurrent EBV-associated NPC. We also expect to start enrollment in a Phase 2 multicore study targeting other EBV-positive cancers. We don't have optimism 20... to continue expanding the value proposition of that. Overall, these value studies show the potential opportunity for TAP cells as an ultra-rare disease pipeline in a product.

Got you to individual patients will be high we set your potentially talked so much he said and you know Philip.

Also tough said could be very bad we didnt free days of all the every center to an appropriate patients need.

And you stop sale becomes the first approved treatment for PMT, it would likely be supported by patients and physicians based on proven efficacy and safety.

The potential U.S. Mckim, sorry for his first up that indication he said 100 patients.

Taken together with a potential that's an opportunity can you help we believe there is a strong unprofitable business case for I've talked to commercialize stop sale.

That's effectively be deeply cctld in these geographies.

We also advancing studies in potential additional indication put themselves.

We continue to enroll patients no phase one two clinical study of Topcell in combination with anti PD one therapy.

Patients with plucky numbers isn't all that coolant you bbsis heated and DC.

We also expect to stop enrollment in the phase two vertical study targeting older NPV positive cancer.

We don't our optimism 20.

The continue expanding the value proposition of stuff.

Overall volume studies show that potential opportunity for subset of Ivan <unk> disease pipeline in the public.

Now turning to us so don't quite priority HIV, one HIV AIDS.

Pascal Touchon: Now, turning to our second corporate priority, HEA 180A. We reported encouraging data at extremes in September in patients living with progressive anxiety. Recently, we reviewed the six-month follow-up data of our co-op feeders. Based on this data, we are pleased to share that we have selected this core three-dose to initiate the Phase 1b portion of the study. The decision to initiate the Phase I-B was based on achieving in-court-free, or predetermined criteria, of the Continued Well-Tolerated Safety Profile and at least 50% of patients experiencing Clinical Improvement, based on the multi-scale assessment defined at X-TRAIN, with improving patients coming from more than one clinical study site. Recognizing these are early data and incorporating input from outside experts, We believe these results merit the acceleration of ATA In addition, enrollment in a fourth and final client, phase one of the escalation core, is complete.

We reported on collecting data I think pink in September in patients living with policy Dennis.

Recently, we reviewed the six months for North Dakota or for call freedoms.

Based on these data we are pleased to share that we have selected visco fritos initiate the phase one be portion of the study.

The decision to initiate the phase one be was based on achieving equaled free.

Oh predetermined criteria of the continued well tolerated safety profile.

And at least 50% of patients experiencing clinically important on.

Based on the movie scale assessments defined extreme.

We are improving patient coming for more than one clinical study site.

We took it I think these are early data and incorporating input from external experts. We believe these results vary the acceleration of 81 that Youve Laufman proposed received and MS. Patients was limited treatment options and he will continue decline is expected.

In addition, enrollment in the fourth and final Blaine phase one dose escalation cruelties compete.

It's not just thoughts on board.

Pascal Touchon: We'll be meeting here in April 2020. We plan to present them, all core data in detail, at an appropriate congress in 2020, following such encouraging ATA 188 results and in line with our strategic focus on allogenic T cell therapy. However, we have decided not to move forward.

We'd be met your when they put us on 20.

We plan squeeze them, then all called that I detailed at an appropriate congrats insisted on 20.

Putting such encouraging they can you when they get results and in line, we both strategic focus on Allergan He said sales.

We have decided not to move forward, we the phase two study for 80 190, autologous pullback I Miss.

Pascal Touchon: We will face to study for ATA190, or autologous product, in a minute. This decision will allow us to focus our resources on 80188 to ensure efficient study execution as well as reduce autologous operating complexity and associated manufacturing costs. We will continue to evaluate strategic options for ATA190. The first project priority is the mesothelin CAR-T programs, ATA-2271 and ATA-3282. 882271 is an autologous CAR-T for mesothelene-associated solid tumors for which an IND is planned in 2020. ATA 2271 will enter the clinic first, while we work to advance the development of ATA 3271, or Allogenic Mesothelin-Targeted Carcinogen, leveraging our EPVT cell platform. Both of these programs have great potential due to the incorporation of a novel 1XX co-stimulatory domain and a PD-1 dominant negative receptor. Finally, Atara's fourth strategic priority is ATA3290, or internal allogeneic CD19 cast. This asset is currently in preclinical stage and will later be brought to IND with the goal to demonstrate clinical proof of concept for our EDV CAR T-Cell platform. Here we intend to show that allogenic EBV CAR T's are safe.

This decision will allow us to focus our resources on 81 that GA.

Sure efficiency for the execution as well as reduce what sort of goose operating complexity and associated manufacturing cost.

We continue to evaluate strategic options for Q1 non deal.

Well first project priority is around the middle fit in coffee programs 88.2 incidents you won and 88 50 to 71.

Yes, 20, 271 is an auto Douglas coffee for missile sitting associated solid tumors, but which are now any slowdown in 2020.

He is going to 71 will enter the clinic says what we work to advance development of you 50 to 71 on different Beacon is looked at Intel targeted coffee leveraging will you be VCSEL platform.

Both of these programs are great potential due to the incorporation of novel, One X X Costimulatory domain and PD, one domain undercut the bus sector.

Finally, I talk about four strategic priority is 18, 30 to 90 or even though I don't need Cdnineteen car.

These asset is currently in preclinical study.

And we'll later you both to R&D with the goal to demonstrate clinical proof of concept.

For all NPV copy says GSL.

Yeah, we intend to show that I lose any TBD casualties assays.

Pascal Touchon: Expand in vivo. Traffic to Tumult Sites and Persist Efficiently to obtain a high response rate and durability of response. Turning to a few personal updates, facility commissioning and qualification activities to support clinical development at our operations and manufacturing facility, ATOM, are complete. Commercial production qualification activities are progressing well and align with our commercial strategy. Additionally, and as would be expected by a new CEO focused on maximizing Atara's operational efficiency. I am now in the process of adapting my leadership team to our new strategic priority. This effort includes active searches for a new global head of research and development, the head of commercial, and the general company.

Expand in vivo.

Trusted touching more sites and foresee sufficiently.

They are response rate and durability of responses.

Turning to a few operational update.

Facility commissioning and qualification activities to support clinical development at operations and manufacturing facility item of complete.

Commercial production qualification activities are progressing well and align with of conventional strategy.

Additionally, and.

Would be expected by you know piece on maximizing that's our other operational efficiency.

I am not in a process of adapting my leadership team to all new strategic priority.

These default includes active searches for new global head of research and development.

The head of commercial and the general concept.

Pascal Touchon: Before opening the call to questions, I would like to comment on our third quarter 2019 financial results. We ended the quarter with a cash balance of $282.9 million, reflecting proceeds from a recent secondary follow-on financing. We continue to expect to have cash to fund ongoing operations in 2021. I would like now to turn the call back over to the operator so we can go ahead and take your questions.

Before opening the call two quick questions I'm not to comment on a first quarter two person 19 financial results.

We ended the quarter with cash balance of 282.9 million, reflecting proceeds from our recent secondary for on financing.

We continue to expect to us cash to fund ongoing operation into 2021.

I would like now turn the call back over to the operator. So we can go ahead and take your questions operator.

Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. And our first question comes from Anupam Rama from J.P. Morgan. Your line is now open. Hey guys, thanks for taking the question and congratulations on all the progress.

Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound Keith please standby, while we compiled the Q any roster.

And our first question comes from on upon Ramos from Jpmorgan. Your line is now open.

Hi, Thanks for taking my question and congrats on all the progress in the past we've talked about in ppm at the need to follow patients long term to truly kind of understand the emerging clinical profile up 81, eight what are you seeing its a six month time point in cohort three dose that's really giving you the confidence and move forward here.

Anupam Rama: In the past, we've talked about, in PPMS, the need to follow patients long-term to truly understand the emerging clinical profile of AT188.

Anupam Rama: We're seeing it's a six-month time point in Cohort 3 that's really giving you the confidence to move forward here, given the 12-month and 18-month time points are not available. Thanks so much.

Given the 12 month 18 month time points are not available. Thanks, so much.

Pascal Touchon: Thank you, Anupam, for your question. I will start, and maybe Ajay will chime in there.

Thank you had it been play a question over to stop and maybe a Jay will chime in there. So clearly we are predetermined criteria for moving forward through the phase one.

Pascal Touchon: So, clearly, we had predetermined criteria for moving forward to Phase 1B. This Phase I study, as you know, is built as a one-year study with different time points for assessment of the clinical evaluation of the patient. So we have reached that particular situation.

These phase one day study as you know he's built as a one year study.

We did some time phone for assessment of the clinical evaluation of the patients there.

So we have reached that particular occupation, we'd call three doors are being talked about six months that shows up not only we have these were accepted 64 five that we have also the clinical improvement in at least 50% of the patient coming for more than one site.

Pascal Touchon: We've got free doses, and we have data at six. That shows that not only do we have this well-accepted safety profile, but we also have this clinical improvement in at least 50% of the patients coming for more than one site. And when we have this result in hand, we believe these results merit acceleration of our decision to move to the 1B, while we are, of course, pursuing the 1A. And we will have more mature data on these different cohorts, particularly cohort 4, for which we don't yet have six-month data.

And when we obviously have to enhance we believe these results married acceleration of our decision to move for the one be what we of course, because you're going to want a and we will talk more mature. That's all all these different cool Baltic laudico for for which we don't have yet the six month double A. J.

You want to comment on that.

Dr. A.J. Joshi: Sure. And, you know, Anav, I'm just recalling the... criteria that we use. We specifically set those criteria up to try to find early signals. Because, to your point, it does take a longer time frame to really have some of those, some of the, you know, EDSS and other style endpoints. So again, this approach specifically looked for early signals. Now based on this approach, when we talk about 50% having clinical improvement, the bar was relatively high because there were seven different scales we used, and we required an improvement on two separate scales at consecutive time points. So that means we measured at three months and six months. Those were our time points. You'd have to see improvement on two scales at each of those time points for the patient.

Sure and you know one of 'em just raise recalling the.

Hi, trade that we use we specifically set those criteria up.

To try to find early signals because to your point it does take a longer timeframe to really have some of those.

Some of the EDSS another style endpoint.

So again this this approach specifically looked for early signals now based on the approach when we talk about 50% having clinical improvement the bar was relatively high because there were seven different skills, we use and we required an improvement on two separate scales at consecutive time points. So that means we.

We measured at three months and six months, those where our time points you'd have to have improvement to skills at each of those time points for the patient and yet when we discussed that with a solid is if I wasn't they thought that was a relatively high bar for us to hit.

Dr. A.J. Joshi: And you know, when we discussed that with the father, they thought that was a relatively high bar for us to hit. But then we also said, you know what? It's an open-label study, so we want to make sure that these improvements are happening at more than one site. So the 50% target that we hit was 50% of improvers, plus it was at two different sites. The intent was to set a high bar using this kind of early signal detection. And that's what gives us confidence because it was a high bar, and we did have that early detection.

And then we also said you know what it's an open label study we want to make sure that these improvements are happening yet more than one site. So these that 50% target that we can't was 50% Improvers plus it was at two different sites. So the intent was to set a high bar, we using this kind of early signal detection and that's what gives us.

The content because it wasn't high bar and we did have that early early detection.

Dr. A.J. Joshi: Yeah, and as we say, there will be additional details to be shown at an appropriate scientific congress in 2020.

Yeah, and as we say they wouldn't be additional details to be shown as appropriate scented Congress in because I'm 20.

Great. Thanks, so much and congrats on all the progress.

Anupam Rama: Great, thanks so much, and congrats on all the progress.

Thank you.

Operator: Thank you. Thank you. And once again, ladies and gentlemen, if you would like to ask a question at this time, you may press star and then one on your touchtone telephone. And our next question comes from John Newman from Canaccord. Your line is now open. Hi, thanks for taking my question. This is Chris on the phone for John. So I just wanted to ask if we could get any additional color on enrollment. And you've also mentioned opening more clinical sites in Canada and the U.S. I was just wondering what that timeline would look like and how many sites you guys are thinking about.

Thank you and once again, ladies and gentlemen, if he would like to ask a question. At this time you May Press Star and then one on your Touchtone telephone.

And our next question comes from John Newman from Canaccord. Your line is now open.

Hi, Thanks for taking my question. This is Chris on the phone for John So I just wanted to ask if we could gets any additional color on enrollments and you also mentioned opening more clinical sites in Canada in the U.S. just wondering what that timeline would look like and how many sites you guys.

They're thinking about.

Thank you for your question please.

Chris: Thank you for your question, please. In terms of enrollment, enrollment is progressing as planned to be aligned with our guidance for initiating a BLA submission in the second half of 2020. As we mentioned earlier, part of the challenge in recruiting more patients in this study is the need to expand our number of sites because today we are only about 10% of transplant sites in the US. So this is done in two ways.

In terms of on the whole loans the enrollment is progressing as planned.

Be along we've all guidance for any seeking to be added submission in single involved both of us on 20.

As we mentioned early on bulk of the challenge in recruiting more patients. In this study is the needs to expand on on both sides. Because today, we are all need about 10% or pump on sites in the us for beef is going into way in the U.S. we are continuing.

Pascal Touchon: In the US, we are continuously increasing the number of sites. However, this takes the necessary time for these sites to be open and running. And then we obtained in July approval from the Canadian authorities to start opening sites in Canada. And that's why we're now moving into Canada. We've already opened sites in the past in Australia. And then the next stage will really be Europe, where we're going to file a CTA in several European countries by the end of the year to be able to open sites next year once the usual process of review of the CTA has gone through in these specific countries.

The increasing the number of sites. These take the necessarily time for decides to be open and running.

And then we for pain in July the approval from the can get majority to stop opening sites in Canada, and that's why we now moving into Canada. We had already opened sites in a box in Australia and then the next stage will really be you all where are we going to file a C.G.A.

Several European countries by the end of the year to be able to open side next year. Once the usual process of lead you will be C.G.A. outgunned pool, indeed specific countries.

Pascal Touchon: Got it. Thank you very much. Thank you. And our next question comes from Salim Saeed from Mizuho Securities. Your line is now open. Hey guys, thanks so much for taking my question and congratulations on the progress. Just a couple for me.

Got it thank you very much.

You're welcome.

Thank you and our next question comes from stream Syeed from Mizuho Securities. Your line is now open.

Hey, guys. Thanks for insurance, taking my question Congrats on the progress I'm just a couple from me.

Salveen Jaswal Richter: So when you were thinking about Cohort 3 and making the decision to either move Cohort 3 forward or wait for Cohort 4, was there a reason why you decided not to wait for Cohort 4 here specifically, theoretically or with actual data? And also, just on ATA 190, when you say you're not developing it at this time and you're evaluating strategic options, can you just give us a little more color? Does that mean you're planning to sell the product, or are you holding on to it? Do you no longer think that it's... can address a different part of the commercial market?

So when you were thinking about cohort three in making the decision to.

Their move cohort three forward or waiting waiting for cohort for.

Was there something there reason why you decided not to wait for cohort four here.

Typically.

Radically or would that actual data and then also just on the EPA oneninety.

When you think you're not developing and at this time and you're about in strategic options could just give us a little more color does that mean, you're planning to sell the product or are you holding onto the new long or things that its.

Part of it can address the different part of the commercial market. Thanks, so much.

Salveen Jaswal Richter: Thanks so much.

Dr. A.J. Joshi: Thanks, Aline, for your good questions. Maybe, Ajay, you could start with the first one, and we'll take the second one.

Thanks for your good questions, maybe A.J. you can start with the first one I would take the second one.

Dr. A.J. Joshi: Sure. So, it's a good question, Salveen. I think, you know, when we had our predetermined criteria for go, no-go, as I mentioned earlier, it was a relatively high bar. To some extent, actually, some of our thought leaders didn't think we'd hit that. They thought we'd be kind of in a middle zone.

Sure. So it's a good question system I think you know the.

The pre when we had our predetermine criteria for go no go.

As I mentioned earlier, there was a relatively high bar to some extent actually come are thought leaders Didnt think we'd hit that they thought we'd be kind of in the middle zone.

Dr. A.J. Joshi: And we hit it pretty nicely with cohort three, and the decision was that, you know what? The cohort three dose looks good. And because there's such a high unmet need here for these patients, because remember, this is a baseline decline population, and we should expect decline everywhere, right? And the measures that we use should pick those things up. And even despite that concept, we had those three patients experience clinical improvement, so it made sense to move forward with the cohort three dose. But we've also left ourselves some optionality because as we get the data, the six-month data will mature for the cohort four dose in the April timeframe. As we get those data in, if we're seeing a signal that suggests we need to actually take a look at cohort four, we've already set up a plan to adapt our protocol to allow for that dose to be evaluated as well. So for us, we feel like we have a good dose now. We may have a better dose, and we leave ourselves with options to go for both, but there is no sense in holding back given the high unmet medical need here.

And we had a pretty nicely with Coordthree and the decision was that you know what.

The core three dose looks good and because there's such a high unmet need here for these patients because remember this is a baseline declining population and we should expect decline everywhere right in and the measures that we use should pick those things up and even despite that concept. We have those three patients have clinical improvement. So it made sense to move.

Forward physical were three dose, but we've also left ourselves some optionality because as we get the date ended the six month data will mature for the core for dose in the April timeframe as we get those data and if we're seeing a signal that suggest we need to actually take a look at cohort for weve already set up a plan to adapt our protocol to allow for that dose.

To be evaluated as well so for us we feel like we have a good dose now we may have a better doesn't really have ourselves it options to go for both but no sense in holding back given the high hot given the high unmet medical need here.

And your second question study I mean, clearly we'd be to US said 81, 90 or 91 88. They were about at the same stage of development I would even say that you want to gauge was a bit more advance being in be pulled out of one they followed by one be we were ready to start phase two flights.

Pascal Touchon: And your second question, Salveen, I mean, clearly, with these two assets, AT190 and AT188, they were about at the same stage of development. I would even say that AT188 was a bit more advanced, being in this program of 1A followed by 1B.

190, or as we add.

Pascal Touchon: We were ready to start phase two for AT190, as we have explained in the past, but having these encouraging results, we say, let's focus on the allogeneic T-cell therapy there. Because clearly, for this type of disease, a chronic disease where we're going to bring for the first time ever, we believe, T-cell therapy, allogeneic offers significant advantages compared with autologous, and we don't see what autologous could bring right now in terms of advantages. But we also want to focus our resources on delivering some clear proof of concept from phase 1B in a double-blind, randomized, placebo-controlled way. So we will keep the 190 in our portfolio and review strategic options. There are other ideas that we are considering right now.

Explained in the past, but I think these encouraging results, we say, let's focus on the other was unique.

T cell therapy, there because clearly for besides of the he's a chronic disease, where are we going to bring for the first time as we believe a T cells to not be I've always an equal for significant that's on churches compared we've looked at Augusta.

And we don't see what sort of goes could bring right now in terms of advantages, but we also want to focus our resources on delivering grew up in the sub clear proof of concept from the phase one be double blind randomized placebo controlled way.

So we will keep 190, you know portfolio when we'd use project options. The other ideas that we have consuming right now, but we won't we need to focus and to execute recently on the development because let's face it won't be is truly the key elements of value creation for the company.

Pascal Touchon: But we want really to focus on and execute resolutely on these developments because Phase 1B is truly the key element of value creation for the company and for patients once we have these results. And the more we can accelerate based on proper achievement of predetermined criteria and with the support of external experts, the better for the patient and for the company.

For patients once we ought to piece reserves and the more we can accelerate based on top of achievements of Peter I mean criteria and we the support VIX not exposed the better for the patients and for the company.

Great. Thanks, so much time.

Yeah, that's perfect. Thanks, so much pascoe thanks, so much.

Thank you and our next question comes from Phil Naidoo from Cowen and company. Your line is now open.

Salveen Jaswal Richter: Great, thanks so much guys. You guys OK?

Good morning, Thanks for taking my questions a few on time, so I guess first of tableau to an earlier question you mentioned that you're in 10% of U.S. centers now I guess the question is why is it just 10% of your centers trial has been open for I think close to two years. So what has been a hold up in and getting more more sites.

Pascal Touchon: Yeah, that's perfect. Thanks so much, Pascal. Thanks so much. Thank you, and our next question comes from Phil Nadeau from Cowan & Company. Your line is now open. Good morning.

Phil Nadeau: Thanks for taking my questions. A few on Tab-Cell. I guess first, to follow up on an earlier question, you mentioned that you're in 10% of U.S. centers now. I guess the question is, why is it just 10% of U.S. centers? The trial's been open for, I think, close to two years. So what has been the holdup in getting more sites on board in the U.S.?

On boarded in the U.S.

Yes, Hi, Jay do you want to answer that.

Yes, I think when you.

I wouldn't necessarily call will hold up you know where we're at we're kind of focused in on the centers that we feel like are going to be the best geographically suited in the ones that are seat going to be seen the most patients.

Pascal Touchon: Thank you, AJ. Do you want to answer that?

Dr. A.J. Joshi: Yeah, you know, I think when you, I wouldn't necessarily call it a hold-up. We're kind of focused on the centers that we feel like are going to be the best geographically suited and the ones that are seen, are going to be seeing the most patients. Then we have a kind of a secondary structure that for the centers where we're not in, we've actually hired a fairly decently sized medical science liaison team to reach out to those additional centers where if there are patients being found at those centers, we're able to refer them in to those top, those 35 or so that we have now. So there's really never been an intent. There are over 300 transplant centers in the country. There's not an intent to be at 300 transplant centers. It's really to try to zone in and optimize the centers that we're at now, but that doesn't mean we're not going to continue. We are continuing to add centers, but we would really never try to get to, you know.

Then we have a kind of secondary structure that for the centers, where we're not in we actually hired a fairly decently sized medical science liaison team to reach out to those additional centers, where if there are patients being found that those centers, we're able to refer them into those top those that 35 or so that we have now.

So <unk>, there's really never intended there's over 300 transplant centers in the country. There is not an intent to be at 300 transplant centers, it's really to try to zoning and optimize the centers that we're at now doesn't mean, we're not going to continue we are continuing to add centers, but we'd really never try to get too you know.

Whatever 200 centers that the the goal would be to be at the top centers to refer patients in when they are found from the other centers and then of course, the geographic expansion through Canada, and Europe will be the next a key part of it.

And I will do you feel that the since July we have also i. Additionally, net sale to continue to increase awareness engine direction, we've hedged CBF trust from centers.

And we also starting to use artificial intelligence technology to evaluate claims data to identify potential patients suitable for an all non so we've upgraded always thoughts there so as not only the number of centers is all the false we've done and accelerated since July to be able to recruit in line with your guidance.

Pascal Touchon: Since July, we have also hired additional MSLs to continue to increase awareness and interaction with HCP at transplant centers, and we're also starting to use artificial intelligence technology to evaluate claims data to identify potential patients suitable for enrollment. So it's not only the number of centers; it's all the efforts we've done and accelerated since July to be able to recruit in line with the guidance.

Okay that makes sense and then second is on the the U.S. filing guidance you mentioned.

And we'll be initiating the second half 2020.

What modules will be filed for a student and do you ever.

A sensor or some guidance for when the filing will be completed.

So as we say last time and these filing will be based vindication of filing would be based on an interim analyses that has been pre specified in our political so that's why we mentioning these were the initiation of the beauty fighting there and at this stage there is some very specific.

Phil Nadeau: Okay, that makes sense. Second, on the U.S. filing guidance you mentioned, the filing will be initiated in the second half of 2020. What modules will be filed first, and do you have a sense or some guidance for when the filing will be completed?

The quick question from the international photo of the patients and I think we share that speed you left on the idea is asking for six months for the following response. So response, usually is being identified.

Pascal Touchon: So, as we said last time, this filing will be based, this initiation of filing, will be based on an interim analysis that has been pre-specified in our protocol. So that's why we're mentioning this wording of the initiation of the BLA filing there.

Two months after the first and vision. So two months, particularly about eight months offered oil from the last patient being an older. So that's.

Pascal Touchon: And at this stage, there are some very specific requests from the FDA in terms of follow-up of the patient. And I think we shared that with you last time, that the FDA is asking for a six-month follow-up response. So response usually is identified at two months after the first infusion. So two months per six months, about eight months of follow-up from the last patient being enrolled there.

An important aspect to take into account or guidance has been key about we will be able to initiate via the funding in a sick on behalf of 20 based on one hand on the interim analyses.

For the bulk of the total population on the other kind of calls on all the CMC and an older aspect that is needed for the fighting and Vince is on track on schedule base that sort of the new issue. There. It's really the a limiting factor for the timing is really the equipment an element of patient.

Pascal Touchon: So that's an important aspect to take into account. Our guidance has been clear that we will be able to initiate this BLA filing in the second half of 20 based, on the one hand, on the interim analysis for a part of the total population. On the other hand, of course, on all the CMC and other aspects that are needed for the filing. And this is on track, on schedule. There is absolutely no issue there. The really limiting factor for the timing is really the recruitment and enrollment of patients and achieving a predetermined, pre-specified number of patients for the interim analysis.

And achieving or predetermine in pre specified number of patients for the.

Into remobilizing.

So when will produce GDP decide be given to you by the if you will be upon initiation of filing or do you have to get that six my follow up and at first.

This is truly a review process because as expected we will go to a preview. The meeting we did you say and discussed we then how they see all data so far and what is the best placebo and way to four wall for these patients I would like to say that the FDA.

Pascal Touchon: So when will a PDUFA date be given to you by the FDA? Will it be upon the initiation of the filing, or do you have to get that six-month follow-up date in first?

As being very constructive discussion so far so we'll be very optimistic there that we find the best way to bring these transformative TRP to U.S. patients you can D. The results are de Novo, we'd beat it could be.

Pascal Touchon: This is truly a review process because, as expected, we will go to a pre-BLA meeting with the FDA and discuss with them how they see our data so far and what is the best possible way to move forward for these patients. I would like to say that the FDA has been very constructive in our discussions so far, so we're very optimistic there that we will find the best possible way to bring these transformative therapies to U.S. patients if, indeed, the results are at the level we believe they could be.

Great and one last question for me just on the you can you give us an update on the issues that you continue to.

Discussed with the regulators and any guidance for when you hear clarity from the M. and what will be necessary for European finally.

Yes, we're not going to give guidance on timing I would say we are.

Really discussing with them. We are as you know enough time system in the EU, which is a C send out a full transformer teas to appease lows also some into active dialogue, we've applied our Porter.

Pascal Touchon: And one last question for me. Just on the EU, can you give us an update on the issues that you continue to discuss with the regulators and any guidance on when you can get clarity from the EMA and what will be necessary for a European filing?

That is designated by the name and this dialogue is a constructive dialogue and the bolt on the east to agree specifically on yet so cheap because that's where we've challenge for doing alignment with the FDA. The pit use political in terms of joining the to growth in Taiwan, and and we want to make sure.

Pascal Touchon: We're not going to give guidance on timing, but I would say we are really discussing it with them. We are, as you know, in a prime system in the EU, which is a system that for transformative therapies allows for some interactive dialogue with a prime rapporteur that is designated by the EMA. And this dialogue is a constructive dialogue, and the importance there is to agree specifically on the SOT, because that's where we changed, following the line with the FDA, the previous protocol in terms of joining the two cohorts in one. And we want to make sure that this type of change is fully supported by the EMA through the prime system of interaction with the EMA. So we will inform you when we make progress there and when we have a clear view on when we believe we can file in Europe for conditional approval.

All that these type of change is fully supported by the amazed food the pipeline system of interaction with the anyway. So we will inform you when when we make progress there and when we are the clear view on when we believe we can.

Fine you all four condition on a pool.

Perfect. Thanks for taking my question.

Thank you and our next question comes from Tony Butler from Roth Capital. Your line is now open.

Thank you very much easier you made reference to in 188.

Tony Butler: Thank you. And our next question comes from Tony Butler from Roth Capital. Your line is now open.

True on an earlier question that.

Early signals give you confidence to move forward and and the British one be portion of the study what I'm about to ask use more theoretical and clearly not known.

Tony Butler: Thank you very much. A.J., you made reference in Question 188 to an earlier question that early signals gave you confidence to move forward in the Phase I-B portion of the study. What I'm about to ask you is more theoretical and clearly not known, but the question is, do those early signals tell you anything about the duration that a patient may see on therapy? And second... With that stated, do you think that EDSS actually, that as the patient progresses on the study, that their EDSS scores actually improve beyond that initial signal? So the question is more about what happens in the future, if you have a view. And then my second question, if I may, Pascal, could you maybe provide us with some of the criteria you think about when you're looking at a head of R&D and how you might think about those criteria when you wanna hire that person? Appreciate the time.

Question is do you have do those early signals told you something.

About the duration.

The patient may see on therapy and second.

With that stated do you think that EDSS actually that.

As the patient progressive on study, but yes scores actually improve beyond that initial signal. So so the question is more about what happens in the future. If you have a view and then my second question, if I may fiscal <unk>.

Could you maybe provide us with some other criteria you should think about when you're looking at a head of R&D.

And how you might think about those criteria when do you want to hire that person I appreciate the time.

[noise] or so so.

Dr. A.J. Joshi: As you might imagine, guessing into the future is always going to be a little bit difficult. Certainly when you, maybe just to give you an overall perspective, because when you think about clinical improvements, this is what we're really talking about. There are very few, people have not really thought about clinical improvement MF. There are very few companies, very few products, or programs that have ever looked at that. So the ones that have looked at it have anticipated that yes, over time, you would see some kinds of improvements in a variety of disability measures. So when they've looked, they haven't looked just at EDSS; they've looked at a variety of disability measures, sometimes separately, sometimes as a composite. So if you think about it, OK, we would look at our product in a similar fashion. If you're looking for improvement, you'd look for something like that. So maybe that's the best way I can answer it.

As you might imagine getting into the future is always going to be a little bit difficult certainly when you maybe just to give you an overall perspective because.

When you think about clinical improvement. This is what we're really talking about now.

There's very few people have not really thought about clinical improvement that mass. There's very few companies very few products and programs that ever looked at that.

So the one that have looked at it have anticipated that yes over time, you would see you know some kinds of improvements in a variety of disability measure. So when they look they haven't looked just it EDSS. They looked at a variety of disability measures, sometimes separately, sometimes as composites.

So as you if you think about okay. We would look at our product in a similar fashion, if you're looking for improvement you'd look for something like that so maybe that's the best way I can answer. It obviously, we're gonna have 12 months' data that's going to continue to mature over time, so we'll be presenting that style of 12 month data and 2020 . So.

Dr. A.J. Joshi: Obviously, we're going to have 12-month data that's going to continue to mature over time. So we'll be presenting that style of 12-month data in 2020. So we'll have a cleaner view of it. So we won't be just guessing into the future. But that's the best I can do in terms of expectations.

We will have a a cleaner if he wants we won't be just guessing into the future, but that's the best I can do in terms of expectation I hope that answers the question.

I appreciate that Oh, one other point to actually sorry, I would like to say sorry, Pascal is that we are for the phase one a portion of the study we are continuing I'm an open label extension. So we will be having annual dosing and that we will also get some additional long term information on this entire group of phase one eight.

Dr. A.J. Joshi: I hope that answers the question. What I would like to say, sorry Pascal, is that for the Phase 1a portion of the study, we are continuing an open-label extension. So we will be having annual dosing, and that way, we will also get some additional long-term information on this entire group of Phase 1a, 24 Phase 1a. That's exactly the point I wanted to add. On the 1A, it will continue and will continue to inform us.

24 patients.

That's exactly the portable did widen on the one day will continue and we'll continue to inform us and and position than expense about the durability of response.

Thank you Sir now Tony.

Your second question.

Yeah.

I think clearly we ask the I have in mind and we have in mind the ideal qualified and that's what we're looking for it to try to be as close as possible from that idea.

Pascal Touchon: and physician and experts about the durability of response. Thank you, sir. So now, Tony, your second question is here.

By that I mean, a clear scientist physician ideally and indeed BHD was his knowledgeable about sell TRP was being a clinician in oncology ideally or trust blunter as well. We also are developed product, particularly in oncology too.

Pascal Touchon: I think clearly, I have in mind, and we have in mind the ideal profile. And that's what we're looking for, to try to be as close as possible to that ideal profile. By that, I mean a clear scientist-physician, ideally an MD-PhD, who is knowledgeable about cell therapy, who has been a clinician in oncology, and ideally, a transplanter as well. We have also developed products, particularly in oncology, for the Finnish post in terms of getting FDA approval and EMA approval. And someone who has worked in both large companies and biotech companies and has been a true leader in bringing projects forward and delivering excellent execution and operational execution there in bringing projects forward to the Finnish lab. So that's really what we have in mind.

The finish forced in terms of getting the football and you gave me a pool and someone west work in Bull large company and biotech company and has been a tour leader in bringing project Ford and excellent execution and operational execution there in green.

Okay perfect falls to the finish line.

So that's that's really what we have in mind.

It's been stopping to meet with potential candidates and the result of excitements for these type of individuals in the sense that the scientific.

Pascal Touchon: I've been starting to meet potential candidates, and there is a lot of excitement for these types of individuals in the sense that the scientific basis of our platform, the technology that we have at our disposal now for the various collaborations, the way we've developed these technologies, but also the quality of the team is amazing at our job. And that's something that I would like to insist upon, that we are benefiting, and I'm benefiting myself, from what I would call a very strong bench of experienced leaders, with our CMO, Head of Clinical Development, A.J. Hiroshi, who is with us today, with our Head of Regulatory Affairs, Renu Vaish, and our Head of Preclinical and Transnational Research, Blake Haftar. So a very strong bench, very capable leaders, and very knowledgeable and experienced people there that are supporting OVIRU's development.

They these offshore platform the technology that we are at all is puzzled now for the values collaboration the way we have people of these technologies, but also the quality of the team is amazing et cetera, and that's something that they would like to insist to bond that we are benefiting a nine benefiting myself from whatever color.

Very potent bench of experienced leaders with all Cmos of clinical development educational she was with US today, we will head of regulatory affairs renovation of head of preclinical and 12% on reserves. They desktop so very strong, but very capable leaders very knowledgeable and experienced people. There that are supporting of I'll use the block.

We also benefits from direct support to our pipeline and technology not only from increased hock or foremost here. So we're continuing in an advisor we hold with a company.

But with key Academy experts in the field you shared sedan and pass out did you see media reach out already from an escape on all different programs. There Mako W. Dr. mifid not cheap cannot from two IMO. So we're really strongly supported by these expert well, taking active starting or discussion related to or science and tech.

Pascal Touchon: We also benefit from direct support to our pipeline and technologies, not only from Chris Hack, our former CSO, who is continuing in an advisory role with the company, but with key academic experts in the field, Michel Sadelin and Prasad Edusimili, Richard O'Reilly from MSK on all different programs there, Marco Davila from MoFitt, and Rajeev Khanna from QRMR. So we are really strongly supported by these experts who take an active part in our discussions related to all science and technology. And we add to that also some key advisors, especially in MS, where we are working with key experts in the field not only from Australia but from the US and more and more from Europe as well. I hope I have answered your question. Yes, sir, you did.

And we add to that also some key advisors, especially in a mess, where we are working with key experience of the field not only from Australia, but from us and more and more from Europe as well.

I hope I answered your question.

Certainly do thank you periscope.

Thank you and your next question comes from Salveen Richter from Goldman Sachs. Your line is now open.

Good morning, Thanks for taking my questions.

For me I guess Tesco one is a strategic question here as you look to creating Youre. Your card your allogeneic car T pipeline on you know just a question as to why you would go into the CD 19 space just given the crowded nature there versus maybe.

Salveen Jaswal Richter: Yes, sir, you have. Thank you, Pascal. Thank you, and our next question comes from Salveen Richter from Goldman Sachs. Your line is now open. Good morning.

Going after some other targets apart from as I feel and and then the second question just following up on what Phil said you know what gives you the confidence just given that you have only 10% of transload sites in the U.S. open for EBIT for the BB program that you can hit that second half 20 BLE submit.

Salveen Jaswal Richter: Thanks for taking my questions. Two for me, I guess, Pascal. One is, you know, a strategic question here. As you look to create your allogeneic CAR-T pipeline, you know, just a question as to why you would go into the CD19 space, just given the crowded nature there, versus maybe going after some other targets apart from mesothelin. And then a second question, just following up on what Phil said, you know, what gives you the confidence, just given that you have only 10% of transplant sites in the U.S. open for the EBV program, that you can hit this second half 20 BLA submission?

And then.

Thank you for your question so let's start with the first one there is one slide in all new investors take that I recommend you may be to what the look to slide 40, foreseeable and that's trying to explain how we see the different.

Assets for the difficulty that we have right now we have clearly.

Needs to accelerate the clinical stage development of 88, 22, 71 or middle TD Auto Douglas coffee.

And as you know we're also actively developing at the preclinical stage or allergenic version of the Middle City in car T 88, 50 to 71.

Pascal Touchon: Thank you for your questions. I'll start with the first one.

Pascal Touchon: There is one slide in our new investors deck that I recommend you maybe to have a look to slide 4040. And that's trying to explain how we see the different assets with the different CAR-T that we have right now. We have clearly a need to accelerate the clinical stage development of ATA-2271 or mesothelene autologous CAR-T. And as you know, we are also actively developing at a preclinical stage a halogenic version of the mesothelene CAR T, ATA3271. Now, the reason we are pursuing the development of a CD19 halogenic EBV-based CAR-T, ATF3219, is really because we can go there faster to get to the clinical stage, where we can compare what we will get there with currently approved products in that space, which are autologous, and also some clinical results that start to appear with some other halogenic type of platform We strongly believe that all EBV-based halogenic T-cells as CAR-T could lead to not only a very safe and well-tolerated way to treat these patients, but the level of expansion, trafficking, and persistence that is needed to have a significant level of response and durable response.

No. The reason we are pursuing the development also cdnineteen Allergan need GDV based car T. He is certainly to 19 is really because we can go there faster to get to the clinical stage, where we can't compare what we would get there weve currently approved product in that space.

We traveled sort of news and also some conoco reserves the stops to appeal, we have some older allusion need type of.

Platform that we strongly believe that or Ebays allergenic T cell.

It's called T could lead to not only a very safe and well tolerated the way to treat these patients, but the level of expansion trafficking and assistance that isn't it needs to have a significant level whats phones and durable response that persistence is one of the kiosk.

Great I believe there and I think that has been whether the change of many of the others any type of platform. We are data as you know for more top sell experience that shows that the sales are persisting and different type of patients and persisting long enough to us to our goal with mission that we.

We would like to show the same we'd be cdnineteen contract and that we believe will be the definitive proof of concept does not on the we have a visible platform for allusion ekati, but we have a better platform photos any coffee that any of that platform that exist right now so.

Pascal Touchon: Persistence is one of the key aspects, I believe, there. And I think that has been one of the challenges of many other allogenic types of platforms. We have data, as you know, for more cap cell experience that shows that the cells persist in different types of patients and are persisting long enough to have durable remission there. We would like to show the same with the CD19 construct.

Again, that's why we think in that program, it's really to US proof of concept that will support all of all the fall in terms of allusion in coffee and ABT to do so in a rapid away and to do so in the public it all type of disease B cell Magnum feed where the.

Pascal Touchon: And that, we believe, will be the definite proof of concept that not only do we have a feasible platform for halogenic RT, but we have a better platform for halogenic RT than any other platform that exists right now. So again, that's why we are investing in that program. It's really to have proof of concept that will support all of our other efforts in terms of allogenicity and the ability to do so in a rapid way, and to do so in a particular type of disease, B cell magnetism, where the existing data from autologous and some other early data from other allogenic platforms will help us to be able to compare the type of research we get, and hopefully, as we believe, to show how we could be I hope I have answered your question on that one.

Existing data from sort of move and some other early data from all the Allergan in platform will help us to be able to compare this type of research, we get and hopefully as we believe to show how we could be superior to other approaches there.

I Hope I answered your question look like.

Yes, okay on the number of site or as we say we are in about 10% of the size, but as you can imagine from what we say the increase number of side in the U.S. in Canada. Then they told me you all all of these we play a significant Paul in terms of.

The holding it up recruiting new patients in that people don't instead.

We are of call benefiting here from the work that has been dawn. So the guidance would you think about the second valuable Muslim 20 east based on the reasonable or on the whole much ways inline with what we seeing right now so thats something important it's a reasonable estimate in terms of.

Pascal Touchon: Then on the number of sites, as we say, we are in about 10% of the sites, but as you can imagine from what we say, the increased number of sites in the U.S., in Canada, then later on in Europe, all of these will play a significant role in terms of enrolling and recruiting new patients at that pivotal stage. We are, of course, benefiting from the work that has been done, so the guidance we're giving about the second half of 2020 is based on a reasonable enrollment rate in line with what we're seeing right now. So that's something important. It's a reasonable estimate in terms of what we're seeing right now. Any increase in the number of sites is going to help us to continue the work to be able to be in line with that guidance, which is our goal. We want to be able to execute as expected and really deliver as expected what we would like to do for patients and for our shareholders.

What we are seeing right now any increase in the middle size is going to help us to continue.

The work to be able to be in line with that guidance. We chito objectives, we want to be able to execute as expected and really to deliver our expected what we'd like to do for patients and for all shareholders.

Kim.

Thank you and our next question comes from Ben Bernanke from Stifel. Your line is now open.

Great. Thanks, so much congrats on the progress I've a question about the top sell expanded access program I guess, specifically the stem cell transplant group that you.

Reported on yesterday I think the the or are there was reported yesterday was 55%, which is a bit lower than than a a previous analysis of 80%.

Obviously, there are more patients, but you know I was wondering if there's any notable differences between the new the six new patients enrolled into the P.M. are included in this analysis versus the the original I think five just in terms of disease severity or baseline characteristics.

Pascal Touchon: Thank you. And our next question comes from Ben Burnett from CFO.

Ben Burnett: Your line is now open. Great, thanks so much. Congratulations on the progress. I have a question about the TAP cell expanded access program. I will specifically refer to the stem cell transplant group that you reported on yesterday. I think the ORR that was reported yesterday was 55%, which is a bit lower than a previous analysis of 80%. Obviously, there are more patients, but I was wondering if there were any notable differences between the six new patients that enrolled into the EAP and were included in this analysis versus the original, I think, five, just in terms of disease severity or baseline characteristics.

You bet for your question agent you want to take that one yeah, I wouldn't say that there's a significant difference as you as you've seen the abstract the HCT patients in general did have kind of an intermediate to high risk a higher proportion of them were intermediate or high risk relative to.

Yeah. So t. group. So they were generally a bit sicker patients, but honestly, it's a small number of patients. So I wouldn't it leads from our read I wouldn't over read that I think the key point for US has been that these data are pretty consistent with almost everything we presented we've generally had a 50, the eight little bit over 80% or our across all.

Dr. A.J. Joshi: Thank you Ben for your question. AJ, do you want to take that one?

Of the different study populations, we reported on so for me, it's it's still a fairly consistent view.

Dr. A.J. Joshi: Yeah, I wouldn't say that there's a significant difference, as you can see in the abstract, the 8CT patients in general did have kind of an intermediate to high-risk, a higher proportion of them were intermediate to high-risk relative to the SOT group. So they were generally a bit sicker patients, but honestly, it's a small number of patients, so I wouldn't, at least from our reading, I wouldn't I think the key point for us has been that these data are pretty consistent with almost everything we've presented. We generally had a 50 to 80, a little bit over 80% ORR across all of the different study populations we've reported on. So for me, it's still a fairly consistent view.

And I think the also because the ability of us from something that is very important there. The fact that we have the 79 to 81 person by the way on the full population there is extremely encouraging but in terms of.

Overall survival that two years.

Great that's helpful. Okay.

And then if I could just one more and maybe just a follow up on sabine's question.

Could you just maybe articulate a little bit more on the strategy with regards to the mesothelioma assets.

The two to seven to one is a tall again, so I guess is there.

There are plans shift away from this asset at some point to focus on three to seven one thanks so much.

Pascal Touchon: And I think also the durability of response is something that is very important there. The fact that we have 79 to 81 percent, by the way, of the full population there is extremely encouraging in terms of overall survival at two years.

Thank you for your question.

Here, we are as we say our priority is on both assets we want to go to the Clinique with 20 271, we believe it's going to offer superiority potentially to the first generation due to the integration. All these one xx costimulatory domain, which is going to have an impact we believe from preclinical.

Ben Burnett: Great, that's helpful. Okay. And then, maybe just to follow up on Salveen's question, could you maybe articulate a little bit more on the strategy with regard to the mesothelium assets? 2271 is autologous, so I guess there is a plan to shift away from this asset at some point to focus on 3271? Thanks so much.

For me shuts Atlanta on their systems and more physiologic way of a addressing the target there for the activation of the T. sale of the coffee and I think also the PD. One do you know we live in twin think ability to address the immunosuppressive of the argument that the coffee.

Pascal Touchon: Thank you for your question. Here we have, as we said, our priority is both assets. We want to go to the clinic with 2271. We believe it's going to offer superiority potentially to the first generation due to the integration of this 1xx co-stimulatory domain, which is going to have an impact, we believe, from preclinical data from Michel Sadlin on persistence and a more physiologic way of addressing the target there through the activation of the T-cell of the CAR-T and having also the PD-1 So we're very confident in this autologous CAR-T.

His encountering in this type of disease. There. So we're very confident on these sort of goose car T go into the clinic next year and the idea is to pursue that so we stopped weve first in human Clydebank, the doors and moving into hopefully proof of concept and then if we could accelerate too.

A pivotal study.

We will do so so that's really all aims to accelerate not only moving to the clinic, but ideally moving through a product that could be a pull day now the illusion exemption is beyond in terms of timing for good reasons and we are pursuing got an accelerating that because ultimately we believe that are being another.

As you need Carty that is able to offer I'm pleased to say me secrecy and safety and some significant advantages in terms of the delivery to patients within three days for more inventory as well as of course cost of goods will be significant in terms of what we can achieve in desktop.

Pascal Touchon: It's going to the clinic next year, and the idea is to pursue that. So we start with the first in humans, clarifying the dose, moving into, hopefully, proof of concept, and then if we can accelerate to a pivotal study, we will do so. So that's really our aim, is to accelerate not only moving to the clinic but, ideally, moving to a product that could be approved there. Now the allogenic version is behind in terms of timing for good reasons, and we are pursuing that and accelerating that because, ultimately, we believe that having an allogenic CAR-T that is able to offer at least the same efficacy and safety and some significant advantages in terms of delivery to patients within three But clearly, ADA-2271 is a priority for us to move as fast as possible to the clinic, to proof of concept, and, ideally, to some type of pivotal study.

He could all space, but clearly age. It went from 71 is a priority for us to move as fast as possible to the clinic.

Two proof of concept and ideally to some type of people study.

Got it that's helpful. Okay, Thanks, and congrats again on the progress.

Thank you.

Thank you and our next question comes from Moines, Raycroft from Jefferies. Your line is now open.

[laughter] everyone. Good morning, and thanks for taking my questions. So I just sort of question on the early access and single patient use program per cap. So just wondering if you could provide an update on how many patients you treated with tab, so and those programs and then are you acquiring specific data from these patients and do you plan on providing an update on those.

Patients at some point or could you provide a general update on the patients now.

Ben Burnett: Got it, that's helpful. Okay, thanks, and congrats again on the progress.

Sure so.

Pascal Touchon: Thank you.

In terms of kind of the total number of patients across all our groups, we're probably not going to be giving exact numbers. There what I will tell you. There was a couple of different things about this for example, this tool when expanded access program.

Operator: Thank you, and our next question comes from Morrie Raycroft from Jeffries. Your line is now open. Hi everyone, good morning, and thanks for taking my questions. So I just had a question on the early access and single patient use programs for CABCEL. Just wondering if you could provide an update on how many patients you've treated with CABCEL in those programs, and then are you acquiring specific data from these patients, and do you plan on providing an update on those patients at some point, or could you provide a general update on those patients now?

So you talked about or we can be providing data on some of the other patients yeah. So at a future Congress, we do plan I'm talking about some of the other populations that we're seeing I think the important thing to understand off of the two one data that's not p. TLD patients that we've got.

Is that those are data that we've utilized to plan for our multi cohort study that to a five study that we've talked about because it's the information that we got gained in that to a one study that's actually given us the necessary requirements to figure out how we want to do the 25.

Morrie Raycroft: Sure, so in terms of the kind of total number of patients across all groups, we're probably not going to be giving exact numbers there. What I will tell you, though, is a couple of different things about this, for example, this 201 Expanded Access Program. So, you know, you talked about whether we were going to be providing data on some of the other patients. Yeah, so at a future Congress, we do plan on talking about some of the other populations that we're seeing. I think the important thing to understand from the 201 data that's not PTLD patients that we've got is that those are data that we've utilized to plan for our multi-cohort study, the 205 study that we've talked about, because it's the information that we've gained in that 201 study that's actually given us the necessary requirements to figure out how we want to do the 205. So the data that we've gotten is useful, and we will be presenting that at some future conference.

So the data that we've gotten is useful and we will be presenting that assumption feature point.

Great. Thanks for taking my question.

Thank you and that concludes our question and answer session for today I'd like to turn the conference back to pass go to Sean for closing remarks.

Thank you everyone on the call today has been aggressive pleasure talking with you. We look forward to finishing the year very strong and hope to see many of you no longer what Josh.

I have a very nice day bye.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect.

Dr. A.J. Joshi: Great, thanks for answering my question. Thank you. And that concludes our question and answer session for today. I'd like to turn the conference back to Pascal Touchon for closing remarks.

Pascal Touchon: Thank you, everyone, on the call today. It's been a great pleasure talking with you. We look forward to finishing the year very strong and hope to see many of you in Orlando at ASH. Have a very nice day. Bye.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.

Operator: BF-WATCH TV 2021