Q1 2021 Atara Biotherapeutics Inc Earnings Call

It's and uncertainties associated with the company's business. These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the Companys SEC filings.

These statements are made as of today's date and the company undertakes no obligation to update these statements now I'd like to turn the call over to Pascal Pascal.

Operator: Uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings. These statements are made as of today's date, and the company undertakes no obligation to update these statements. Now, I'd like to turn the call over to Pascal. Pascal?

Pascal: Thank you, Eric, and thank you all for joining us this afternoon. We are off to a strong start in 2021, making progress on all three of our strategic priorities. TAP cell, ATA 188 in multiple sclerosis, and our Next Generation Allogeneic Copy Program. We are moving ahead to deliver on key milestones this year, including the expected top cell BLN NAA filings. Progress on the ATA-AIT program, especially presentation of new clinical and translational data from a phase one open-label expression study and first clinical data on the mesothelium CAR-T program in advanced mesothelioma.

Thank you Eric and thank you all for joining us this afternoon.

We are off to a strong start in 2021, making progress on all three of our strategic priorities.

Phil.

And 188 and multiples closes.

And our next generation Allogeneic car T programs.

We are moving ahead to deliver and key milestones. This year include.

Including the expected top sales be it in and.

<unk> filings.

<unk> on the <unk> program, especially presentation of new clinical and translational data from our phase one open label extension study.

And the first clinical data on the missile did in coffee program and advanced mesothelioma.

Pascal: For TAPSEL, we are in active discussions with the FDA on the content of CMC Module 3, including methodologies and data to assess comparability between the product used in the pivotal clinical study and the intended commercial product. Supported by our Breakthrough Therapy designation, we have been having regular dialogue since January with the FDA on CMC Module 3. And most recently, the teleconference last Friday, where we discussed key aspects of a comparability data package.

For tab cel, we are in active discussions with the EBITDA on the content of CMC module free.

Including methodologies and data to assess comparability between the product use in the pivotal clinical study and the intended commercial product.

Reported by our breakthrough therapy designation.

We have been at the in regular dialogue since January with the EBITDA on the CMC and we'll do the free.

And most recently the teleconference last Friday.

Where we discuss key aspect of our comparability data package.

Pascal: We believe that we have provided the FDA with a robust data package to demonstrate comparability between various process versions of TAP cell, and we are encouraged by the ongoing interactions as we work towards aligning with the FDA. Atara is a trailblazer for allogenic T-cell therapy as well. And as such, we are paving the way for the first ever allogenic off-the-shelf T-cell therapy for Atara and for our industry. We understand that doing so will take time, effort, and constructive discussion with regulators, and we are well on our way.

We believe that we have provided the FDA the robust data package to demonstrate comparability between values processed version of tap sales and we are encouraged by the ongoing interactions as we work towards aligning with the FDA.

Otherwise the trailblazer for Allogeneic T cell therapy is the world and as such we are paving the way for the first day of allogeneic off the shelf T cell therapy for auto and for our industry.

We understand that doing so will take time and fourth and constructive discussions with regulators and we are well on our way.

Pascal: Meanwhile, recent analysis shows that duration of response in our allele study is maturing as anticipated, with a large number of responders followed now for at least six months, and a safety profile consistent with previous published data with no new safety signals. As a reminder, we will present data from the Phase III allele study at an appropriate Congress in Q4 2021. In summary, we are making progress to align on comparability with the FDA and are confident we will do so. Pending this alignment, we plan to complete our BLA submission for PTSD in the third quarter of 2021.

Meanwhile, the recent analyze this shows that duration of response.

The <unk> study is materially Inc. As anticipated.

With the large number of responders followed now for at least six months.

And the safety profile consistent with previous published data with no new safety signals.

As a reminder, we will present data from the phase <unk> study at an appropriate Congress in Q4 2021.

In summary, we are making progress to align and comparability with the FDA and are confident we will do so.

Pending this alignment we plan to complete a BLA submission for <unk> and the third quarter of 2021.

Pascal: In the EU, where TAP cell has prime designation, we have submitted a letter of intent to the European Medicine Agency, or EMA, thereby starting the process of submitting an EU marketing authorization application, or MAA, for TAP cell in patients with EBV-positive PTM, which we expect to complete in Q4 2021. In parallel, there has been strong interest from potential partners for the commercialization of the tap cell in Europe and continuous support from physicians and medical experts.

In the EU with tab cel as time designation, we have submitted a letter of intent to the European Medicine agency of EMEA, thereby starting the process of submitting and EU marketing authorization application of <unk>.

And for tab cel in patients with EBV positive <unk>.

Which we expect to complete in Q4 2021.

In parallel they are.

There's been strong interest from potential partners for commercialization of subsidy and Europe and continued support from physicians and medical expense.

Pascal: We continue to invest in our U.S. commercial readiness activities, mainly disease test education and payer access preparation, in anticipation of TAP cell approval and planned launch in the first half of 2021. We are also building tap cell inventory and are on track to reach our goal of over 95% of PTLD patients covered at the time of commercial launch. With regard to our TAP cell Phase II multichord study in patients with other EBV-driven cancer

We continue to invest and our U S commercial readiness activities, mainly disease state education, and payer access preparation in anticipation of tab cel approval and planned launch and the first half of 2022.

We are also building top sales inventory and are on track to reach our goal of over 95% of PTSD patients covered at the time of commercial launch.

With regard to tab cel phase II multi cohort study in patients with other EBV driven cancers. We continued to actively open clinical study sites.

Pascal: We continue to actively open clinical study sites, and evaluation of potential study participants is well underway. Six study populations, of which the largest two are EBV-positive AID-LPD and EBV-positive PID-LPD, may support meaningful label expansion beyond PTLD. Turning to ATA188, our transformative product candidate for patients with the progressive form of multiple sclerosis. We continue to make progress in enrolling the Phase II randomized double-blind placebo-controlled study, or RCT. We are on track to conduct an interim analysis for this study in the first half of 2022, including efficacy and safety in patients with the progressive form of MS.

Evaluation of potential study participants is well underway.

The six study populations of which the targets the largest too.

And the positive AIG, LPG and EBV positive <unk>.

NPD may support meaningful label expansion beyond PTSD.

Turning to <unk> 188 of transformative product candidate for patients with progressive form of multiple utilities.

We continue to make progress and and holding the phase III randomized double blind placebo controlled study or RCT.

We are and talk to conduct an interim analyses for the study in first of 2022, including efficacy and safety in patients with progressive form of index.

Pascal: Following this interim analysis, we expect to have further discussions with the FDA regarding potential study adjustment for pivotal intakes. These are important discussions from both a regulatory and strategic perspective for the program and could provide optionality in how we advance development.

Following the interim analyses, we expect to add further discussion with the FDA regarding potential stood the adjustment for pivotal intent.

These are important discussions from both the regulatory and strategic perspective for the program and could provide optionality and how we advance development.

Pascal: Meanwhile, Momentum continues to build in the community, reinforcing the association between EBV and MS. This contributed to Atara's successful approval of a clinical trial application for the Phase II RCT in Canada in the first quarter of 2021. We also continue to see significant interest from a number of large companies regarding a potential collaboration involving ATA 188.

Meanwhile, the momentum continues to build and the community reinforcing the association between <unk> and MF.

These contributed to what the our successful approval of the clinical trial application for the phase II <unk>, Canada, and the first quarter of 2021.

We also continue to see significant interest from a number of large companies regarding a potential collaboration involving eight 188.

Pascal: As a reminder, in the second half of 2021, we plan to present long-term, two-year clinical data from the Phase I Open Label Extension, or OLE, as well as transnational data from the Phase I study. Moving to our CAR-T portfolio, and first, our mesothelin franchise program, ATA 2271 and ATA 3271. These mesothelin-targeted CAR T products are benefiting from a global strategic collaboration with Bayer, which is fully underway, with positive alignment with our partner and a successful launch of our joint governance and activities. For example, for APA 2271, our autologous mesothelin CAR-T program.

And as a reminder, and the second half of 2021, we plan to present long term two year clinical data from the phase one open label extension of OLED as well as translational data from the phase one study.

Pascal: The Phase I clinical study has completed enrollment of the first cohort, and first clinical data is expected to be presented in an appropriate forum in Q4 2021. The off-the-shelf allogenic version of this mesothelene CAR T program, ATA3271, using PD-1 dominant negative receptor and 1XXK co-stimulatory signaling domain through our EBV T-cell platform is currently in an IND-enabling study, work that Atara is doing. Subsequently, Bayer will submit the IND, expected in Q2 or Q3 of 2022, and lead

Moving to our coffee portfolio and first of military and franchise program.

22, 71, and <unk> 30 to 71.

These military and targeted coffee products are benefiting from a global strategic collaboration with buyer, which is fully underway with positive alignment with our partner and the successful launch of joined governments and activities.

For $82 71 for our autologous Mesothelin car T program. The phase one clinical study has completed enrollment of the first cohort.

First clinical data is expected to be presented and an appropriate form and Q4 2021.

The other shelf allogeneic version of this Merseyside and coffee program 832, 71, using a PD one dominant negative receptor and one ex ex car co stimulatory signaling domain.

Of EBV T cell platform is currently in IND, enabling studies, where the other is doing and subsequently buyer will submit the IND expected in Q2 of Q3 of 2022 and lead clinical development and commercialization.

Pascal: Turning now to ATA3219, or allogeneic CAR-T for patients with B-cell malignancy, we plan to submit an IND in Q4 2021 or Q1 2022 in line with our strategic goal to develop this asset as the best in class in B-cell malignancy. Moving to our financials, with regard to our cash position and runway, we ended the first quarter of 2021 with $435 million in cash.

Turning now to <unk> 32019 of allogeneic therapy for patients with B cell malignancies.

We plan to submit the <unk> in Q4, 2021, or Q1, 2022, and non with our strategic goal to develop this asset as best in class in B cell malignancies.

Moving to our financials with regard to our cash position and the runway. We ended the first quarter of 2021 with $435 million and cash with this cash balance and projected revenues from U S. Tab cel sales. We believe we are sufficiently funded into 2020 free <unk>.

Jacob: With this cash balance and projected revenues from U.S. TAPSEL sales, we believe we are sufficiently funded into 2023, inclusive of expenses for the BLA filing and U.S. commercial launch of TAPSEL. As we head into the second quarter of 2021, I've been reflecting how far Atara has come from this time a year ago. With the pandemic just beginning to gain a foothold in the US back then, we focused on our staff and collaborators' safety in order to continue our mission of bringing transformative therapies to patients.

<unk> of expenses for the refining and U S commercial launch of the upset.

As we head into the second quarter of 2021.

The reflecting how far at the highest comp from this time of year ago.

With abundant and just beginning to gain a foothold in the U S. Back then we focused on our staff and collaborator of safety in order to continue our mission of bringing transformative therapies to patients we.

Jacob: We work closely with clinical study sites and with our manufacturing and logistics partners to ensure patients will continue to access our therapies in our study. Thanks to the hard work of our Atara team, we are on the path to file a top-selling BLA in the third quarter of this year and bring this life-saving medicine to patients in need. I will now turn the call over to Jacob. Jacob?

We work closely with clinical study sites and we of all manufacturing and logistic partners to ensure patients will continue to access of therapies in our studies.

For the hard work of other team we are on path to file a subset of BLA and the third quarter of this year and bring the slide 13 medicine to patients in need.

I will now turn the call over to Jacob Jacob.

Jacob: Thank you, Pascal. As Pascal described, we've made steady progress across all three of our strategic priorities in the first quarter. For Tadso, we are in active discussions with the FDA and are aligned on key aspects of comparability with regulators. We are the first allogeneic T cell therapy company to be ready to submit a BLA for FDA approval. The discussions we are having with FDA are part of our BTD status prior to BLA submission and may set precedents for other allogeneic products that follow.

Thank you Pascal as Pascal described we've made steady progress across all three of our strategic priorities and the first quarter.

And for tab cel, we are in active discussions with the FDA and.

And our aligned on key aspects of comparability with regularly.

For the first allogeneic T cell therapy company to be ready to submit the BLA for FDA approval and the discussions we're having with FDA are part of our BTB status prior to BLA submission and May set precedents for other allogeneic products that follow.

Jacob: At this time, we are focused on CMC Module 3 with the FDA, and we believe that we have provided a robust data package to determine comparability between various process versions of Tab-Cell and are encouraged by the ongoing interaction. We expect to agree on comparability, and then we plan to complete our BLA submission for PTLD in the third quarter of this year.

At this time, we are focused on the CMC module free with the FDA and we believe that we have provided a robust data package to determine the comparability between various process versions of tab cel and and are encouraged by the ongoing interactions.

We expect to align non comparability and then we plan to complete our BLA submission for <unk> and the third quarter of this year.

Jacob: Our confidence is reinforced by the fact that Tab-Cell is truly remarkable for an investigational product being developed for an ultra-rare disease in that it already has many years of clinical experience with nearly 300 patients treated with life-threatening EBV-positive diseases in clinical trials, as well as expanded access and single-patient use settings, including. This clinical experience shows that TAB cell's efficacy and safety profile in PTLD patients is consistent from both an efficacy and Additionally, we are presenting combined long-term overall survival data from clinical studies of TAB cell at two medical conferences.

Our confidence is reinforced by the fact, the tab cel is truly remarkable for an investigational product being developed for an ultra rare disease and that it already has many years of clinical experience with nearly 300 patients treated with life threatening EBV positive diseases and clear.

For trials as well as the expanded access and single patient use settings, including 150 patients with EBV positive <unk>.

This clinical experience shows the tabs of efficacy and safety profile and <unk> patients is consistent from both and efficacy and safety perspective, irrespective of product version and across studies, including the pivotal <unk> study interim analysis data.

Additionally, we are presenting combined long term overall survival data from clinical studies of tab cel of two medical Congresses.

Jacob: Data from three clinical studies in TAP cell demonstrate that patients with EBV-positive PTLD following either HCT or SOT, who are relapsed to refractory to initial treatment, have over 80% two-year survival, whether they achieved a complete or a partial response. For perspective, these patients with EBV-positive PTLD after HCT or SOT have a median survival of only two to three months in the second line and beyond These data suggest the potential transformative impact for these patients in great need, and the TAB cell may provide an effective treatment option marked by long-term overall survival regardless of whether partial or complete.

Data from our three clinical studies of tab cel demonstrates that patients with EBV positive <unk>.

Following either HCP or <unk> that is relapsed to refractory to initial treatment have over 80% two year survival, whether the achieved a complete or partial response.

For perspective, these patients with EBV positive <unk> after HCP or so T has the median survival of only two to three months in the second line and beyond treatment setting without tab cel treatment.

These data suggest the potential transformative impact for these patients and great need and the tab cel may provide an effective treatment options marked by long term overall survival, regardless of partial or complete response of.

Jacob: Of note, the British Society of Hematology just released updated guidelines for the management of EBV-positive PTLG. These guidelines specifically recommend the use of EBV-positive or EBV-specific CTL immunotherapy for relapsed refractory PTLD, including CNS-PTLD, where available, and TAD cell data were particularly referenced among several data sets.

Of note the British Society of Hematology, just released updated guidelines for the management of the EBV positive <unk>. These guidelines specifically recommend the use of EBV positive or EBV specific CTO immuno therapy for relapsed refractory <unk>, including.

CNS PTSD.

We're available and tab cel data, we're particularly referenced among several datasets.

Jacob: These guideline recommendations are similar to the NCCN guidelines for non-Hodgkin's lymphoma that also recommend EBV-specific CTL therapy, like TABCEL, for relapsed refractory EBV-positive PTL. Now, with regard to ATA188 for multiple sclerosis, I'm pleased to report we're making progress in rolling out the phase 2 randomized double-blind placebo control trial, evaluating Importantly, we are on track to conduct an interim analysis of the Phase 2 RCT in the first half of 2022, including efficacy and safety.

These guideline recommendations are similar to the NCC and guidelines for non Hodgkin's lymphoma that also recommend EBV specific CTO therapy like tab cel for relapsed refractory EBV positive <unk>.

Now with regard to <unk> 188 for multiple sclerosis.

I am pleased to report, we are making progress enrolling the phase II randomized double blind placebo controlled trial of.

Evaluating the efficacy and safety of <unk> 188, and patients with progressive forms of multiple sclerosis.

Importantly, we are on track to conduct an interim analysis of the phase III RCT and the first half of 2022, including efficacy and safety and as Pascal mentioned, we expect to have further discussions with the FDA regarding potential study adjustments for pivotal intent following the instrument.

Jacob: And, as Pascal mentioned, we expect to have further discussions with the FDA regarding potential study adjustments for pivotal intent following the interim analysis. Based on the current sample size, we expect complete enrollment in this phase 2 study in the first half of next year.

Analysis.

Based on the current sample size, we expect to complete enrollment of this phase III study and the first half of next year.

Jacob: In addition, we plan to present long-term, two-year clinical data from the Phase I Open Label Extension, as well as translational data from the Phase I study, in the second half of 2021. We are making good progress on translational work looking at possible correlation with clinical response. Finally, we filed and received approval of a clinical trial application for the Phase II RCP in Canada, and we look forward to opening sites in Canada soon.

In addition, we plan to present long term two year of clinical data from the phase one open label extension as well as translational data from the phase one study and the second half of the 2021, we are making good progress and translational work looking at possible correlation with.

Clinical response.

Finally, we filed and received approval of a clinical trial application for the phase III, RCT and Canada, and we look forward to opening sites and Canada soon.

Jacob: Turning now to our CAR-T programs, our strategic collaboration with Bayer for our mesothelium CAR-T cell therapies, ATA-2271 and ATA-3271, for the treatment of solid tumors is progressing well. We continue to work collaboratively with Bayer to move both programs forward. What differentiates Atara from other approaches is that Atara's CARD-C programs are based on our allogeneic EDV T cell platform and our ability to leverage new technologies, such as novel co-simulatory domains like 1XX and novel armoring technologies like PD-1 dominant negative receptor to improve efficacy, persistence, and durability of response.

Turning now to our car T programs, our strategic collaboration with buyer for our Meso car T cell therapies, <unk> and 'twenty.

The $22 71, and <unk> $32 71 for treatment of solid tumors is progressing well, we continue to work collaboratively with buyer to move both programs forward.

And what differentiates the tire from other approaches is the Taurus.

The car T programs are based on our allogeneic EBV T cell platform and our ability to leverage new technologies, such as novel co stimulatory domains like one ex sex and novel Armoring technologies like PD, one dominant negative the receptor to improve efficacy purse.

Systems and durability of response.

Jacob: We believe this could address limitations of autologous and other allogeneic CAR-Ts. Specifically, our platform's use of starting materials that are long-term central memory T cells that have previously encountered EBD is intrinsically less prone to differentiation and exhaustion. As such, homeostatic proliferation and fitness are already embedded at the core of our technology. This, together with Atara's 1XX signaling domain, which prevents premature differentiation and exhaustion, represents an ideal combination. In fact, at this year's AACR meeting, our collaborator, Dr. Michelle Sabling from Memorial Sloan Kettering Cancer Center, presented a plenary talk on Advances in Cardiology.

And we believe this could address limitations of autologous and the other allogeneic car Ts specifically our platforms use of starting materials that are long term central memory T cells that have previously encountered DVD are intrinsically less prone to differentiation and exhaustion.

As such homeostatic proliferation, and fitness, it's already embedded at the core of our technology. This together with the tariffs of <unk> signaling domain, which prevents premature differentiation and the exhaust and represents an ideal combination.

In fact at this years ACR meeting our collaborator Dr. Michelle Saddling from Memorial Sloan Kettering Cancer Center presented a plenary talk on advances and car T doctors and length featured onex ex as a potent new co stimulatory domain for car T with remarkable ability.

Jacob: Dr. Satterling featured 1XX as a potent new co-stimulatory domain for CAR-T with a remarkable ability to support functional persistence. Specifically, he presented in vivo data from Dr. Yilmaz Maksim and colleagues of a mesothelium CAR-T with the 1-X-X domain that revealed impressive survival outcomes in a mesothelium-expressing ovarian cancer tumor model 1XX outperformed mesothelium and CAR T's designed with either 28 zeta or 4-1BB co-stimulatory domains.

And to support functional persistence, specifically he presented in vivo data from Dr. <unk> and colleagues of the meso seal and car T. With one ex ex domain that revealed impressive survival outcomes in the MISO thielen expressing ovarian cancer tumor model.

<unk> outperformed meso, it's the only car Ts designed with either 28 data or for one BB co stimulatory domains.

Jacob: With regard to ATA3219, we are progressing with various IND-enabling activities to submit an IND in the fourth quarter of this year or the first quarter of next year. As a reminder, ATA3219 is our next generation, off-the-shelf, allogeneic CD19 CAR-T, utilizing the 1xx technology without the need for TCR editing for the treatment of B-cell malignancy. We are excited about the technology, and our strategic goal is to develop this asset as a potential best-in-class product for B-cell malignancies.

With regard to <unk> 32019, we are progressing with various IND, enabling activities to submit and R&D in the fourth quarter of this year or the first quarter of next year.

As a reminder, 80 832019 and so our next generation off the shelf allogeneic CD 19 car T and utilizing the <unk> technology without the need for TCR and editing for the treatment of B cell malignancies. We are excited about the technology and our strategic goal.

<unk> is to develop this asset has the potential best in class product for B cell malignancies, I would like to extend my gratitude to our entire staff collaborators patients caregivers of tire success in bringing these life saving therapies. The patients is because of you.

Jacob: I would like to extend my gratitude to Atara staff, collaborators, patients, and caregivers. Atara's success in bringing these life-saving therapies to patients is because of you. I'll now turn the call back to the operator to begin the Q&A portion of the call. Operator? Thank you. Our first question today will be from the line of John Newman with Canaccord Genovese.

I'll now turn the call back to the operator to begin the QA portion of the call operator.

Thank you.

Our first question today will be coming from the line of John Newman with Canaccord Genuity. Please proceed with your question.

John Newman: with Canaccord Genuity. Please proceed with your questions.

John Newman: All right guys, thanks for taking the questions and congratulations on the continued progress.

Hi, guys. Thanks for taking the questions and congratulations on the continued <unk>.

Yes, the question I have.

John Newman: The question I have is regarding the tab cell filing.

As regarding the tab cel filing.

John Newman: Pascal, if I can remember correctly, last year when you...

Pascal if I can remember correctly.

Last year when you.

John Newman: and Atara disclosed the...

And the entire disclosed the data on tab. So I. Thank you and also mentioned debt.

Operator: https://www.kenhub.com

John Newman: I think you had also mentioned that you had come to an agreement.

You had come to an agreement.

John Newman: or an understanding with the FDA in terms of the number of patients that

And our understanding with the FDA in terms of the number of patients debt.

John Newman: they would like to see for the filing. I'm just curious if that was the case. The reason I'm asking is because... It's always seemed to me like the discussion you're having regarding the previous data generated at Sloan-Kettering and the data that you've generated.

They would like to see for the filing.

I'm just curious if that was the case reason I'm asking is because.

It's always seemed to me like the discussion youre, having regarding the previous data generated at Sloan Kettering.

And the data that you've generated.

It's more around the analysis.

Rather than.

The amount of data. So just wondering if you could discuss the thank you.

Jacob: is more around the analysis, rather than the amount of data. So this Thank you, John, for your question. Jacob, do you want to start answering that?

Thank you John for your question Jacob the one can start answering that.

And one other comment for the.

Jacob: And I'll make another comment after that. Yes, so we do believe that the guidance still holds, that the number of patients that we've enrolled in Allele is sufficient for the BLA filing. Now, what we've been working on, which Pascal reported on today, is that we now know more about the durability of response in these patients, and that data is looking good. Now, of course, we still are working on this issue of comparability, which will help us to get to the point of initiating the BLA, and it will also help us to position the historical data relative to the pivotal data from the allele study, where we either present the historical data Pascal?

Yes, so we do believe that the guidance still holds that.

That's the number of patients that we've enrolled and the real is sufficient.

For the BLA filing now what we've been working on which pet Scout reported and today is that we now know more about the durability of response of these patients and that data is looking good now of course, we still are working on this issue of comparability, which will help us to get to the point of.

Of the initiating the BLA and it will also help us to position of the historical data relative to the.

Pivotal data from the <unk> study, where we either present, the historical data and parallel and the BLA filing.

All of the analysis has gone and just to clarify as we said in the past John but we are planning that occurred in Q2 with new data available and in Q free to be able to complete the clinical mobile the five for the via the submission and what we're doing Meanwhile is really to work on the CMC.

Pascal: Yeah, and just to clarify, as we said in the past, John, that we are planning a data cut in Q2. Oh, yeah, new data available in Q3 to be able to complete the clinical module, module 5, for the BLS submission. And what we're doing meanwhile is we need to work on the CMC module.

The free.

Does it answer your question.

Yes. Thank you.

Thank you.

Salveen Jaswal Richter: Our next question comes from the line of Salim Syed with Mizuho. Please proceed with your question. Great. Good afternoon, guys. Thanks for all the color and congratulations on all the progress.

Our next question comes from the line of Salim Syed with Mizuho. Please proceed with your questions.

Salveen Jaswal Richter: A couple for me on ATA 188, if I can. The first is, and maybe this is for AJ or Jacob, perhaps, or Pascal. As we approach the interim data in the first half of 2022, just curious how you guys are thinking about the overall program here for ATA 188. What do you need to see on that interim that would make you confident that you can convert this to a registrational study and apply for approval just on this one trial?

Great. Good afternoon, guys. Thanks for all of the color and congrats on all of the progress couple from me on <unk>, one and if I can.

The first.

And then maybe that's for Hey, Jay for.

For Jacob perhaps for Pascal.

As we approach the interim data and the <unk>.

First half of <unk>.

<unk> thousand two just curious how you guys are thinking about the overall program here for <unk>, what do you need to see on the interim that would make you confident that.

You can convert this to a registrational study and apply.

For for approval just on this one trial and.

Salveen Jaswal Richter: And then the second question is more just on your discussions with the FDA. If I recall, on the last call, you mentioned in the coming months you'd have some discussions on whether SPMS and PPMS would be treated as one.

And then the second question is more of just on your discussions with the FDA and if I recall and the last call. You had mentioned in the coming months you'd have some discussions on whether S Pms and.

And PPA massive you treated as one population or two.

Salveen Jaswal Richter: All right. We've got a lot of questions and discussions. Or is there any update you can provide there?

Have you had those discussions or is there any update you can provide there. Thanks so much.

Salveen Jaswal Richter: Thank you, Salim, for your two questions. So first question, AJ.

Thank you for setting for your two questions. So first question agent.

AJ: Sure, and to some extent, they're a little bit interrelated. When you talk about the interim analysis...

Sure and then to some extent some of them, they're a little bit of interrelated. When you talk about the the interim analysis.

AJ: There are two elements to it. In our field, for what would make this a potential registrational trial, it starts with a line load.

There's two elements of it and.

Our feel for what would make this potential registrational trial starts with the with the alignment with FDA and that patient population, we talked about earlier, so whether they are going whether they want us to look at this as two separate progressive Ms populations or as we've articulated a single non active progressive Ms population.

AJ: as two separate progressive MS populations, or as we've articulated it.

AJ: to articulate a single non-active progressive MS population.

AJ: Depending on how that answer comes out, we will then take a look at the interim analysis data.

Depending on how that answer comes out then we will then take a look of the interim analysis data.

AJ: And when we see the data, and again, you know we have a specific SAP that's kind of going to govern how we approach this.

And there when we see the data and again, we have a specific S&P that take the debt kind of going to govern how we approach. This.

AJ: When we see the data, we're going to look to potentially adjust the sample size to make sure we have the best chance of hitting the right power for the study. And now, if the FDA, for example, has given us good alignment around that patient population, we might have a small adjustment in sample size to kind of make this a robust phase two study, or maybe a larger adjustment in sample size if we think that there's an opportunity to essentially turn this into one of two pivots. Whether this could be the only pivotal point, I think that's a...

And when we see the data we're going to look to potentially adjust the sample size to make sure. We have the best chance of hitting the right power for the study and now if the FDA for example has given us.

Good alignment around that patient population, we might have a small adjustment and sample size.

And to kind of make us a robust phase II study, where maybe the larger jets and the sample size of if we think that there's an opportunity to essentially turn this into one of two pivotal.

Whether this could be the only and pivotal I think thats a.

Operator: https://www.salveenrichter.com

That would be of great kind of Grand Slam, but I think that would really be dependent on lots of conversations of that day I think our base case is strong phase III good potential to turn this into a.

AJ: Strong Phase II, with good potential to turn this into one of two pivotal programs depending on those discussions with FDA and the interim analysis.

A one of two pivotal programs, depending on those discussions with FDA and the interim analysis and.

AJ: And then, you know, the last piece that you mentioned would really be, you know, would be amazing, but I think that's not really something we can anticipate as a single study.

And then the last piece that you mentioned would really be would be amazing, but I think thats not really something we anticipated the single study just yet.

Pascal: Yeah, and maybe to also answer your second question a bit more in detail, what we've done recently, we had a very nice interaction with four leaders, medical experts in MS. But in fact, I've worked with different kinds of consensus positions on patients with SPMS and PPMS there, and these experts are all clear that this is the same disease. And this is the same evolution of these patients from the pathophysiological aspect.

And maybe two and also answer the second question a bit more in detail. What we've done recently, we had very nice interaction we've for leaders medical expert of index, but in fact, I've worked with different kind of consensus position on the patients with Sps and Pms, there and this expense.

For clear about this is the same disease and this is the same evolution of these patients data from the pathophysiology of course.

Pascal: So we are reinforcing our belief with this expert position that has been communicated publicly. And now we are planning an interaction with the FDA, leveraging these expert opinions to discuss with them whether it could be one or two populations from a pivotal point of view. It doesn't change anything in phase two. It's just, as JJ just said, we want to leverage this phase two in potentially transforming this into a phase three pivotal study.

So we are reinforcing our belief with the expense position that's been communicated publicly and now we are planning and interaction of the EBITDA leveraging this ex fifth physicians to discuss with them whether it could be one of two population from the pivotal.

It doesn't change anything on the phase II is just as J J, just say if want to leverage for these phase II and puts training transforming <unk> into a phase III pivotal study we need to have this alignment above is up one population and we did two population in that study, but we were very encouraged by the expert view on this particular question does it answer your question.

Pascal: We need to have this alignment about that one population or the two populations in that study. But we are very encouraged by the expert view on this particular question. Does it answer your question? Yes, it does. Thanks so much.

Salveen Jaswal Richter: Yes, it does. Thanks so much, guys. I appreciate it. Thank you, Ben. Our next question is coming from the line of Jonathan Miller of Evercore ISI. I'm pleased to see you with your questions.

Yes. It does thanks, so much guys I appreciate it and.

And since then.

Our next question is coming from the line of Jonathan Miller of Evercore ISI. Please proceed with your questions.

Jonathan Miller: Hey guys, thanks so much for taking the questions. Just a couple quick ones, I guess. Just to clarify, it seems like the Tadfell BLA, Colexpected 3Q, obviously you're having all these interactions with the agency, but it feels like there's still some teeth to cross. When do you know for sure that you'll be able to file on time?

Hey, guys. Thanks, so much for taking the questions just a couple of quick ones I guess.

Jonathan Miller: [inaudible]

Just to clarify it seems like the <unk> BLA to the expected <unk>. Obviously, you are having all of these interactions with the agency, but it feels like there's still some t's to cross when do you know for sure that youll be able to file on time or is that the sort of thing and we're not actually going to know until the filing comes and three Q and secondly.

And secondly, the types of multi cohort study is opening sites, but are you enrolling and dosing it what's the timeline look like for actually getting patients into those cohorts and do you have a sense of and when we could hope to see the initial data from the most important.

The first couple of cohorts.

Jonathan Miller: And then just switching gears a little bit, on mesothelium CAR data coming in Q4, is it fair to expect enough patients there to get a sense of ORR, or is this...

And then just switching gears a little bit on Mesothelin car data coming in Q4 is it fair to expect enough patients there to get a sense for or or or is this going to be really of very small cohort and we shouldnt be expecting to get a robust of our off from it.

Jonathan Miller: This is going to be a really small cohort, and we shouldn't be expecting to get a robust ORR from it.

Jonathan Miller: Will we get persistence data at that point to complement the AACR presentation that you were talking about?

Will we get persistence data at that point to complement the ACR presentation that you were talking about what can we expect out of the initial mesothelin presentation. Thanks.

Jonathan Miller: about what we can expect out of the initial Mississippi 11 presentation. Thanks.

Jacob: OK, John, for your three questions. Let's start with the first one.

Okay. Thank you John for your free question, let's start with the first one Jacob the want to address the first one about the when we would know exactly whether we and.

Jacob: Jacob, do you want to address the first one about when we will know exactly whether we can sign and complete the BNA? Yes, absolutely. So John, thank you so much for your question. So because of our BTD status, we benefit from a number of active interactions with the FDA to speak about this comparability issue. So we've had a number of type B meetings and informal calls with the FDA over the last several months to discuss comparability and other topics related to CMC Module 3.

The complete the BLA, yes, absolutely so.

John Thank you so much for your question so.

Because of our <unk> status, we benefit from a number of active interactions with the FDA to speak about the comparability issues. So we've had a number of type b meetings and informal calls with the FDA over the last several months to discuss comparability and other topics related to that.

<unk> module three and as we've described these are progressing well.

Jacob: And as we've described, these are progressing well, and the active dialogue with the FDA has to be taken into context because we are bringing forward the first allogeneic T cell therapy for FDA approval. So we think with these discussions, we're making good progress on comparability, and we, as Pascal mentioned, are also working towards an additional data cut to complete Module 5. So, as we mentioned, we are still moving towards the completion of the BLA filing by Q3 of this year, obviously with these active engagements with the agency on comparability.

And the active dialogue with the FDA has to be taken into context because.

We are bringing for us the first allogeneic T cell therapy.

For the.

Our submission for an FDA approval.

So we think with these discussions we're making good progress on comparability and we as Pascal mentioned are also working towards and additional data cut to complete that module five so as we mentioned we are still moving towards that completion of the BLA filing by Q3 of this.

This year, obviously with these active engagements with the agency on a comparability.

Jacob: Yeah, so just to add to that, I think we are really, according to our plan, working on the different aspects, I would say in parallel, both the clinical and the CMC part. And so we are working ahead to move into that BLE filing in Q3. Moving ahead with different discussions with the FDA, we'll continue to transparently communicate with our investors and key analysts there about the progress there. But today, we are really moving ahead for that particular BLE into Q3 2021. Now, your second question was about the multi-goal study. AJ, do you want to address that one?

And so.

Adam that I think we are really according to plan and we're working on with different aspect and we say in parallel and both the clinical and the CMC part and so we are.

Working and go head to moving to that the BLA filing in Q3.

Moving ahead, we are different discussion with the EBITDA, we will continue to transparently communicate with our investors and the key underneath the above of progress there, but today. We are really moving ahead for that the coffee crude oil.

BLA into Q3 for us in 'twenty one.

Now the second question was around the Mexico for the AJ do you want to address that one sure. So this is a study of <unk>.

AJ: Sure. So this is a study. It's a good question.

AJ: This is a study that has had some COVID-19 impact in terms of the initiation of our sites, but we have not enrolled a patient yet. However, we have really started activating initiating sites at a very good pace. Now, the early pace was slow as compared to COVID-19 because this was a study that we were starting up in the middle of COVID-19. So that's where we made a bit of an impact. But the most recent development has been that we've opened up a bunch of sites. So we would expect enrollment now to get on the pace.

Good question and as the study that has had some COVID-19 impact in terms of the initiation of our sites.

So we have not enrolled the patient and however, we.

And have really started activating initiating sites at a very good pace now the early pace with slow related to COVID-19, because this was the study that we were starting up.

And the middle of the COVID-19.

So that's where we took the bit of and the impact but the the most recent.

Scenario and has been that we've opened up a bunch of sites. So we would expect now of the enrollment to get onto the pace that we were anticipating and that still leaves us with the same target timeline that we've given previously of data coming out which is 2023.

AJ: And And that still leaves us with the same target timeline that we've given previously of data coming out, which is 2020. Does that answer your second question, John? Yeah, absolutely. Thank you.

Does it answer your second question Jim.

Yeah, absolutely. Thank you and then on Mesothelin.

Jacob: Yeah, the first question on the meso CAR-T and what to expect at the end of the year, Jacob? So, as Pascal mentioned in his introductory remarks, we have enrolled the first cohort on the mesothelial and the autologous CAR-T, the 2271 program, and so we're certainly collecting safety data there. We will also have tumor assessments. Of course, these are relatively small cohorts of patients, but we will certainly get response data. Tumor assessments are built in at regular intervals in the protocol.

And the first question on the Meso car T and what to expect at the end of the year Jacob absolutely. So.

Jacob: And we will also get some sense of how long the patients stay on study. And then some of the translational elements around persistence of the cells in the bloodstream of patients will also be something that we'll be able to report out on as well. Yeah, and I will add that this is a very exciting type of clinical data because this is the first time ever that a CAR-T with PD-1-DNR and 1-X-X as a co-stimulatory domain is being used in patients in the US.

As Pascal mentioned and the introductory remarks, we have enrolled the first cohort of.

And the MISO sealing the autologous car T and the 22 71 program and so we're certainly collecting safety data. There. We will also have tumor assessments of course. These are relatively small cohorts of patients, but we will certainly get response the tumor assessments of.

Our built in at regular intervals and the protocol and we will also get some sense of.

How long the patients stay on study.

And then and some of the translational elements around persistence of the cells in the bloodstream of patients will also be some.

And that will be able to report out on as well.

And I will add that this is a very exciting type of clinical data because that's for the first time ever.

The car T.

<unk> of PD, one DNR and one <unk> is a co stimulatory domain is being used in patients in the U S. So we are all very eager to get.

Jacob: So we are all very eager to get a view of this data and to share that with you at the appropriate time, because we think that's very exciting, as we believe that we are really building these CAR-Ts with the mesothelin binder, the SCAV, the PD-1-DNR, and 1-X-X are the best way to address solid tumors. And of course, today's advanced mesothelioma, where we are testing the product, but beyond that, we intend to go into other types of tumors. So it is a very exciting time indeed.

The view of the time to share that we view of the appropriate time, because we think that's very exciting as we believe that we are really building. These car Ts with the missile did in binder of the TSV the PD, one DNR and <unk> the <unk>.

Best way to address solid tumors and of course, today's advanced mesothelioma, where we are testing the product and but beyond that we intend to grow and other type of tumors. So very exciting time and did.

Anupam Rama: Our next question is coming from the line of Anupam Rama with J.P. Morgan. Please proceed with your question.

Our next question is coming from the line of <unk> Rama with Jpmorgan. Please proceed with your question.

Tessa: Hey guys, how are you? This is Kessa on the call tonight for Anupam. So just one question for my... As we are thinking about, APA 188 NMS. As it stands today, is this a program that Atara is, XUS, say in Europe, similar to what you guys are doing for CAPSEL. Thanks.

Hey, guys. How are you. This is Dan <unk> on the call Tonight and training.

Thanks for taking our question so just one for Matt.

We're thinking about the commercial potential of <unk>.

And then.

As it stands today and just the program that is far and.

Thinking about partnering ex U.

And Europe similar to what you guys are planning to do for cash Sal. Thanks, So much.

Pascal: Thank you, Tessa, for your question. I'll address it. So we are now in phase two of this randomized control trial. We're also moving ahead on a lot of translational work that is pretty exciting. And we will come in first half 22 with the interim analysis data plus some other data that we believe will allow different things. One is, of course, this discussion with the FDA on the potential to transform this phase two into a phase three and discuss further steps in a pivotal study.

Thank you for several of your questions of other assets. So we are now in phase III and this compromised console trial. We also moving ahead on the lot of transmission of the work that is pretty exciting and.

And we will come in first half 'twenty two with the interim analyzes data plus some other data that we believe will allow different things. One is of course this discussion with the EBITDA on the potential to transform these phase II into a phase III and discuss about further steps and the pivotal study, but we think it would be the lifetime also to discuss.

Pascal: But we think it would also be the right time to discuss this data confidentially with potential partners, and we are really engaged with a number of companies. And as I say in my remarks, a number of them are extremely excited about this potential for 80 and 88 to be a big game changer in the field of microscopy. So this discussion is progressing. We'll have further data there. But the idea is that we believe we would benefit in terms of value creation from having a partner for us, with us, for this pivotal study type of program to address not only pivotal in PMS, in progressive MS, but also pivotal in relaxed-limiting MS, where we believe the product has great potential as well, and maybe some other diseases.

First is that our confidentially with potential partners and we are already engaged with a number of companies and as I said during my remarks and number of them are extremely excited about this potential for <unk> and 88 to be of big game changer in the field of MSA for.

These discussion of progressing without further debt out there, but the idea is that we believe we would benefit in terms of value creation from I think of partner for us with us for the pivotal study type of program to address not only people total in pms in progressive Ms.

But also people tall, and relapsed remitting and Thats, where we believe the product is of great potential as well and maybe some other disease day. So I think the partner would be important and we are not at this stage going to communicate on what type of partnership, but let's just say that this is of partnership we believe will allow us to accelerate and expand the development of <unk>.

Pascal: So I think a partner would be important, and we are not, at this stage, going to communicate about what type of partnership. But let's just say that this is a partnership we believe will allow us to accelerate and expand the development of 8188 across different types of indications, but at the same time, preserve value for Atara and our shareholders for this potential game changer in the field of MS and autoimmune disease. Does that answer your question, Tessa? Absolutely. Thank you so much for taking the time to read this.

The cost of some type of indications, but the same time preserve value for other high and our shareholders for the potential game changer in the field of MFS and autoimmune disease.

And does it answer your question for Tom.

Absolutely. Thank you so much for taking our question.

Thank you.

Phil Nadeau: Our next question is coming from the line of Phil Nadeau with Cowan & Company. Please proceed with your question.

Our next question is coming from the line of Phil Nadeau with Cowen and company. Please proceed with your questions.

Phil Nadeau: Good afternoon, congratulations on the progress and thanks for taking our questions. A few from us, so first on Tab-Cell. We're curious whether you'd be willing to provide any more detail on what remains to be aligned between Atara and the FDA on comparability and, If not, maybe just broadly, as we think about allogeneic cell therapy products, what are the key elements?

Good afternoon, Congrats on progress and thanks for taking our questions a few from us So first on tap so.

We're curious whether you'd be willing to provide any.

More detail on what remains to be aligned.

Between the tour and the FTA and comparability.

And.

If not maybe just broadly as we think about allogeneic cell therapy products, what are the key elements of characterizing.

Phil Nadeau: are the key elements of characterizing comparability between one and another.

Comparability between the.

The one production batch versus another.

Jacob: Cells that are manufactured by one. Thank you, Phil, for your question. Jacob, do you want to start, and then I'll follow on?

Sales of other manufactured by one group versus another.

Thank you for you for your question Jacob the answer is tough for them.

Jacob: Yeah, absolutely. So, in our discussions with the agency about comparability, we're focused on the discussions regarding the pivotal material that we used in the allele study and then the commercial material. In point of fact, there are some very small differences, actually, between the pivotal material and the commercial material. It's really just refinements that we're making.

Absolutely so.

When we in our discussions with the agency about comparability, we're focused on the.

And the discussions regarding the pivotal and materials that we used and the <unk> study and then the commercial material and.

And point of fact, there are some very small differences actually between the pivotal and material and the commercial material. Its really just refinements that we're making so we believe that we actually have a very strong data package supporting the comparability of the pivotal material.

Phil Nadeau: So we believe that we actually have a very strong data package supporting the comparability of the pivotal material to the commercial material. And yes, there are a few refinements that have been made to get this product up to the GMP level for commercialization as well. But again, we think this is manageable, and we have a strong case.

Two the commercial material and yes. There are a few refinements that have been made to get this product up to the GMP level for commercialization as well. So again, we think this is.

This is manageable and we have a strong case.

Phil Nadeau: And maybe I could add, Phil, that while at this stage we cannot share specifics of this ongoing dialogue with the FDA, maybe I can give an example of the type of topics that we are discussing with them. That example would be the number of manufactured lots to be included in an allogenic cell therapy comparability study. I think we shared in the past that we analyzed for each process version, 15 lots per product version of our comparability study, which, on the one hand, is much, much more than the typical free loads that one will have to use for comparability studies for small and large molecule types of products.

And maybe of what I could feel debt while at this stage, we cannot share specifics of this ongoing dialogue with the EBITDA. Maybe you can give an example of the type of topics that we are discussing with them.

The example would be the number of manufactured lots to be included and allogeneic cell therapy commodity.

I think we shared in the past that we have analyzed for each posted <unk> 15 loss per product version of the.

Comparability studies.

And on one hand is much much more than the typical free notes that one will have to use for comparability studies for small and large molecule type of product.

Phil Nadeau: And it's less than what otologoscopy will do because for otologoscopy, as you know, each patient requires his own unique manufacturing lot. And that's why they have more, as many patients as they have in the study. They have a lot more patients.

And it's less that's what the autologous car T will do because for a total of those coffee as you know each patient requires its own unique manufacturer and growth.

And Thats why they have more of as many patients of the odds and the study the lots of the patient we are different debt and Thats. The award purpose by the way of allogeneic cell therapy. It is to treat many patients with one manufactured lots and so you cannot pure lots of being manufactured and you have lower cost of goods and more accessibility and availability of therapies for patients. So we believe 50.

Phil Nadeau: We are different there, and that's the whole purpose, by the way, of allogenic cell therapy. It is to treat many patients with one manufactured cell. So you can have fewer lots being manufactured, and you have a lower cost of goods and more accessibility and availability of therapies for patients. So we believe 15 knots is significant for such allogenic cell therapy, particularly in the context of a rare disease. And that's why we feel strong about the robustness of our data package.

Of note is significant for such illusion et cetera, IP, particularly in the context of a rare disease and that's why we feel strong about this whole business of for data package there.

Phil Nadeau: That gives you an example of the type of discussion we have with the FDA to make sure that it applies to TAP cells. And also, it's in line with what are the fundamentals of allogenic cell therapy. Does that answer your question, Phil? Yeah, that's very helpful. That's perfect. Then, second question, on the Q2 data cut that you noted would complete module 5, the clinical module, what determines the timing of that data cut? Is there 51 of maximum time elapsed from the data cut to the completion of the filing?

And that gives you. An example of the type of discretion and we have with the EBITDA to make sure that it applies to tap sales and also it's in line with what is the fundamentals of allogeneic cell therapy.

Does it answer the question Phil Yes, that's very helpful.

Perfect and then.

Phil Nadeau: You make that data. Yeah, thanks for the question. I think the data cut timing is really based upon the prior discussions we've had.

Second question on the Q2 day to cut that you noted would come.

Complete module for the clinical module.

Determines the timing of of that did it does there is there.

So if they want the maximum time elapsed from the data cut for the completion of the filing or is it some other element that determines when and exactly.

And you make that day to come.

Hey, Jay.

Yes.

Thanks for the question I think the data kind of timing is really based upon the prior discussions we've had with FDA on the amount of data that they wanted to complete the filing. So remember they were looking for specific numbers of patients with a specific amount of duration of follow up so the data cut its time to ensure we have the right amount of data to complete the.

Phil Nadeau: with FDA on the amount of data that they wanted to complete the filing. So remember, they were looking for specific numbers of patients with a specific amount of duration of follow-up, so the data cut is timed to ensure we have the right amount of data to complete that. Perfect. The last clinical question is on the mesothelium, program. What do you imagine would be the path to market for 2271? Do you think that what we saw from the initial CAR T's in B-cell malignancies is reasonable, meaning like a single-arm study in a very severe patient population, or would you expect something more rigorous?

Phil Nadeau: Now, thank you. I think it's a good question. I'll start, and Jacob or AJ, you might want to chime in there.

Perfect.

The last critical question is on the Mesothelin.

Program, where do you imagine would be the path to market for two to slip and one do you think that.

What we saw from the initial car Ts and PS.

B cell malignancies is reasonable and anyway because of single arm study and a very severe patient population or.

Would you expect something more rigorous.

And I think Youre upping its a good question I'll start and and Jacob J, you might want to chime in there.

Pascal: I would say, in the CAR-T space, it depends very much on the indication and what's available for that indication. So in advanced mesothelioma, for example, there is a clear medical need with no treatment that is able to really allow for long-term control of the disease in these patients, or elimination of the disease. So having a treatment that is having a very impactful effect in terms of objective response rate, in terms of MR-assist in particular, and then having duration of response is what usually allows the FDA to accept that as a pivotal to go to approval. It has to be a really high level of objective response and duration of response.

And the coffee space it depends very much of the indication and what's available for that indication there so and advanced mesothelioma. For example, there is of key medical needs.

No treatment that is able really to low for long term control of the disease in these patients the.

Or elimination of the disease there.

So I think of treatment that is I think of very impactful FX in terms of objective response rate in terms of MRI assist and particularly oil and then nothing duration of response is what's usually the role as the FDA to accept that as the people told to go to approval.

It has to be relieved as the level of objective response and duration of response.

Pascal: Now, to move beyond that into situations where there are existing therapies, that's where there might be a need, at some stage, for the CAR T field to go into more comparative type studies. But the way we see right now, our first type of clinical work with ATA2271, this is addressing patients that have limited options. And then having a high level of objective response rate, as well as duration of response, means that these could be discussed with the FDA for potential submission there. I don't know whether, Jacob or AJ, you want to add anything to that?

Now to move beyond that into situations, where the existing therapies, that's where they might be of need at some stage for the coffee field to go into more commodity type of studies, but the way we see right now of first.

Type of clinical work with <unk> towards the 71. This is the dosing patients that have limited options and then of Ing I level of objective response rate as well as duration of response means that this could be discussed with the EBITDA for potential submission. There I don't know where the checkable age of you won't for had anything for that.

Yeah, I completely agree Pascal with the statement of.

Jacob: Yeah. I completely agree, Pascal, with that statement. I do think in mesothelioma, there is a treatment paradigm focused, obviously, on chemotherapy. But we know the checkpoint inhibitors, the PD-1 axis drugs, do have activity here. But again, focusing on that unmet need, those patients that really don't have any more treatment options, that is the best path now. As we've also described for 2271, it is a mesothelium antigen-directed CAR T. It also has 1xx, which we think is going to be a preferred costimulatory domain for the persistence and activity of that CAR.

Do you think of MISO Sealy OMA there as the treatment paradigm focused obviously on chemotherapy, but we know the checkpoint inhibitors the.

PD, one axis drugs do have activity here, but again, focusing on and that unmet need those patients that really don't have any more treatment options that is the best path now as we've also described for $22 71. It is the needs of Zealand antigen directed car T and it also has.

<unk>, which we think is going to be of preferred co stimulatory domain for persistence and activity of that car, but the other key point here is that we built and PD one dominant negative receptor into that car T. So you are intrinsically providing.

Jacob: But the other key point here is that we've built in a PD-1 dominant negative receptor into that CAR T. So you're intrinsically providing an overcome of the immune suppression that the mesothelioma is providing through PD-L1 tumor expression. So the fact that this is built into the cell, we think augments the chances of success here. But I think from a development standpoint, by far the clearest path to rapid approval is to go into a late line, unmet need population, single-arm study, response rate, and duration of response.

And the overcoming of the immune suppression that the music mesothelioma is providing through PDL one tumor expression. So the fact that this is built into the cell. We think augments the chances of success here, but I think from a development standpoint by far the clear.

The pass to rapid approval is to go into of late line unmet need population single arm study of response rate duration of response.

Phil Nadeau: Perfect. That's very helpful. Then last question is just a housekeeping question on financials. You had about $3.6 million in revenue this quarter from the buyer collaboration. Was there anything special about the amount of activity you did for the buyer in Q1? Or should we assume some similar amount of revenue?

Perfect. That's very helpful. And then last question is just a housekeeping question on financials, you had about $3 6 million and revenue this quarter from the buyer collaboration was there anything special about the amount of activity you did for buyer and Q1 or should we assume some similar amount of revenue.

Phil Nadeau: Some similar amount of revenue in all quarters going forward.

And all quarters going forward.

Paul: Phil, it's you, Paul. Thanks for that question. Um, you know, we have roughly $70 million of deferred revenue on our balance sheet, and it's going to be a bit choppy, um, in terms of how this revenue gets recognized on the P&L. So, um, as you start to model it out, um, it's a level of effort that we're putting into, um... Delivering on the commitments to the buyer. So this 70-odd million you should see come through the P&L over the next two to three years.

So Paul Thanks for the question.

Phil Nadeau: That's what we should be looking for. That's very helpful. Thank you.

We had roughly $70 million of deferred revenue on our balance sheet, and it's going to be a bit choppy.

In terms of how this revenue gets recognized from the P&L. So as you start to model it out.

The model of effort that we're putting into.

Delivering on commitments the buyer. So the 70 odd million you should see come through the P&L and over the next two to three years, that's what you should be looking for.

That's very helpful. Thank you.

Salveen Jaswal Richter: Our next question comes from the line of Salveen Richter with Goldman Sachs. Please proceed with your question.

Our next question comes from the line of solving Richter with Goldman Sachs. Please proceed with your questions.

Elisabeth: Good afternoon, this is Elizabeth on behalf of Salveen. I guess just a broad question here and how you're thinking of allocating resources in the context of expanding the TADSAL program, running the MS program, and then also the emerging mesothelium CAR T program, how all of these are developing in parallel. Thank you. Thank you, Elizabeth, for your question. I'll stop, and Nick Palm might want to chime in

Hey, good afternoon, and this is like the guys on first of all been I guess, just a broad question here and how you're thinking of allocating resources and the context of expanding the types of program.

Running the and that program and then also the damn I came away feeling.

The line car T program.

For all of these are developing and parallel thank you.

I'll think of it as a bad for your question and I'll stop and part of May want to chime in the it's an important question because we are moving into not on the commercial stage. We expect next year for tab cel with of course pivotal development of <unk> and NPA.

Pascal: It's an important question because we are moving into not only the commercial stage, which we expect next year for TAP cell, but also, pivotal development of 81-88 and then further clinical studies with our allogeneic RT portfolio and pipeline. So the way we see it is, for Tapsell, it's relatively clear that we have decided to partner for Europe. So we are now actively discussing with a number of companies. So it's moving very well indeed.

And then.

Further clinical studies with Allogeneic car T.

For your day and pipeline. So the way we see it is for tab cel is relatively clear about we have decided to partner for Europe. So we are now actively discussing with a number of companies. So it's moving very well indeed, and so the idea would be that we won't have any expenses linked with Europe for top sales because that will be covered by the.

Pascal: And so the idea will be that we won't have any expenses linked to Europe for Tapsell because that will be covered by the partnership. For the US, we have decided to launch ourselves. So we are starting to invest progressively in some activities, and that will gradually go up in time to be ready for the launch, possibly in 2022 there. So we believe that we have the approach that makes sense to make it a successful launch in terms of the balance between investment and return on investment there. And we have a very detailed plan put together by Christine Jaremel, our Chief Commercial Officer, for that. So that's for TAPSEL.

And the partnering there for the U S. We are we have decided to launch of itself. So we are starting to invest progressively into some activities and that will progressively.

And time to be ready for the launch.

Possibly in 2022, there. So we believe that we have the.

The porch that makes sense to make it the successful launch in terms of the balance between the investment and the return on investment there and we are of very detailed plan put together by Cristina Alaimo, Chief commercial officer for that so that's what GAAP sales. So we are controlling well the situation there for you and the gate as we say moving into pivotal studies, especially if we.

Pascal: So we are controlling well the situation there. For 8188, as we say, moving into pivotal studies, especially if we want, as we aim to, to make that a big game changer in the field of MS and autoimmune disease, that's where we believe we'll need a partner to go into that. And that's why we believe a partner in 2022 will allow us to accelerate and expand pivotal studies across many indications for 8188

As we aim to make that a big game changer in the field of medicine between the disease, that's where we believe we would need a partner to go into that and that's why we believe of partner in 2022 were the lowest to accelerate and expand the people talks to the across many indications for <unk> and 88.

Pascal: At the same time, we are also investing in new manufacturing processes, which we believe will allow us, with Styrton bioreactor, to cover a large number of patients with a low cost of goods. So that's really a significant investment in 8188, which is really going to pick up next year. But that's going to be aligned with a partnership with a large company there. Now, on the yellow CAR-T, on the one hand, we have the mesothelin-CAR-T franchise for which we already have a partnership in place.

And the same time, we are also investing in new manufacturing process, which we believe we have Lois we have shift and bioreactor to cover large number of patients we've of low cost of goods. So that's really a significant investment in the queue and 88, which is really going to pick up next year, but that's going to be aligned with the partnering with the large.

And even now on the Allo car T. On one hand, we of the middle did and coffee of Sunshine for which we are already of partnering and place and Thats being funded with you buy of value of there and then for <unk> for 2019, and we can fund the next stage of development to be able to go to the Clinique next year and to prove that we have here.

Pascal: And that's being funded, really, by a buyer there. And then, for ATA3219, we can fund the next stage of development to be able to go to the clinic next year and prove that we have here a potential best-in-class in B-cell magnansis. And then we have a number of other programs that are early stage and might move to IND-enabling studies in the future. And in that case, we believe that we will be well-funded to be able to pursue these programs.

<unk> best in class and B cell malignancies, and then we have a number of other programs that are early stage and might move to IND, enabling studies over the future and and updates. We want we believe that we will be well funded to be able to pursue these programs. So clearly today.

Pascal: So clearly, today, the key in terms of resource allocation is to get to the finish line with that cell, have a partner in Europe, launch by yourself, and gradually create revenues, opportunities, and profitability in the US. And then on IT188, which is the second big type of investment we need over the next two years, this is really going to rely on partners. And we are very confident in finding a partner there, because if we are right, everybody will want this type of product. Because that's really what everybody's waiting for, something really new, really transformative in the mobile space. This is something in high demand.

The key in terms of resource allocation is to get to the finish line and we start sales of a partner and Europe launched bio sales and creates revenue opportunity and profitability progressively in the U S. And then of the Nike <unk> and 88, which is the cig and big type of investment needed over the next two years. This is really going to rely on partners and we are going to come.

And then finding a partner of there because if we are like everybody will want this type of product because thats really what everybody is waiting for something really new really transformative and a net.

It's something in the month.

Elisabeth: Does that answer your question? Yes, that's helpful. Thank you. Thank you.

Does it answer your question.

Yes. That's helpful. Thank you. Thank you.

Thank you.

Matt Phipps: Our next question comes from Matt Phipps of William Blair. Pleased to see you with your question. Hi guys, thanks for taking my question. I'm hoping you can kind of clarify some things with me because when I go back and look at your January regulatory update press release and your Q4.

Our next question comes from the line of Matt Phipps of William Blair. Please proceed with your questions.

Hi, guys. Thanks for taking my question I'm, hoping you can kind of clarify some things with me because when I go back and look at your January regulatory update press release, and your Q4 press release all of the talk of CMC and module III, it's related to the comparability.

Matt Phipps: Module 3 is related to the comparability between non-pivotal studies and pivotal studies. And there was a lot of discussion about whether this was going to be looked at parallel or pooled. And now you're saying that it's more an issue with the product used in the pivotal study.

<unk> between non pivotal study and pivotal study and it was a lot of the discussion on whether this was going to be looked at parallel or.

Pooled and now Youre, saying that its more an issue between the product using the pivotal and the intended commercial product for the seems like a much different issue and I'm wondering if the original issue has been resolved and if this one has just recently come up or if there are any other details you can give us on that.

Jacob: Yeah, no, thank you for the question, Matt. Jacob, do you want to stop, and I'll chime in?

And thank you for the question on particularly on desktop and I'll chime share absolutely. So thanks for the question Matt.

Jacob: Sure, absolutely. So thanks for the question, Matt. So what? They are really related questions here because the comparatability issue of pivotal to commercial is something that needs to be solved for the sake of the BLA filing. And we're focused on that particular part. So once we have discussions with the FDA and we've come to agreement around those comparatability aspects, they are going to be applied to the same topic when you think about the historical to the pivotal.

Jacob: So this is really all part of the same discussion. Now, we are focusing particularly on pivotal to commercial because that is where we are getting all of the information that's going to help inform this other topic of historical to pivotal. And I will add that it was really in two steps.

And so what.

They are really related questions here because of the comparability issue of pivotal to commercial.

That needs to be solved for the sake of the BLA filing now and.

And we're focused on that particular part so once we have the discussions with the FDA and we've come to agreement around those comparability.

<unk>, they're going to be applied to the same topic. When you think about the historical two the pivotal. So this is really all part of the same discussion.

Now we are focusing particularly on pivotal to commercial because that is.

And there we're getting all of the information that's going to help inform this other topic of historical two pivotal and I will note that it was willing to step and Thats why the communication has been sort of stepping up I mean, there was the first step back and look for where we are discussing with the FDA cleared and different aspects of what would be needed for submission, but we provided them.

Pascal: That's why the communication has been in two steps, Matt. I mean, there was a first step back in the fall, where we discussed with the FDA creating different aspects of what would be needed for submission. But we provided them with data showing, we believe, comparability between historical and pivotal. Now, since then, we've had, as we say, several type B meetings and informal calls to discuss something else, which is the Module 3 CMC. And in any Module 3 CMC, one needs to show comparability between the pivotal and intended commercial. That's a prerequisite for fighting a BLA.

With that are showing we believe comparability between historical and people total.

Now since then we've had as we say several diaby meeting and for more calls for this goes about something else, which is the module free CMC and the ending with the free CMC one needs to show comparability between people total and intended commercial that's a prerequisite to file the BLA. So it was really two steps in terms of the distribution of.

Matt Phipps: So it was really two steps in terms of the discussion with the FDA, and that's why the communication is evolving now. We are really focusing on that one and solving it, and we believe we are making great progress there. We'll also answer the other one, because it's about the methodology and the type of data that we have on comparability. So it really was two steps. And it's really since January that we have had all these specific interactions as part of a BCD status with the FDA, and progress made on this aspect that is essential for Module 3, because you need to have this comparability fully aligned with the FDA to be able to move forward with the BLA. Does this make sense, Matt?

The EBITDA and that's why the communication is evolving now we are really focusing on that one but so and.

Was hoping thats, one and we believe we are making great progress there and.

We're also answer the other one because it's about the methodology and the type of debt that we havent. The comparability. So it's really was to step and its really since January that we have at all of this debt.

Specific interaction as part of for BCD status with the EBITDA and progress made on this aspect that is essential for the mood of free because you need to have these compatibility and fully aligned with the EBITDA to be able to move for wall there with the BLA.

Does it make sense month.

Matt Phipps: I mean, that helps, and I understand that it's all related, but I guess back in the fall and early in January when there was talk of non-pivotal versus pivotal, had you yet at that point completed your, you know, I guess 15 lots of commercial product to show to the FDA, or is that something that you have recently shown them, and they are now questioning the comparability of that to the pivotal study?

That helps and I get that it's all related but I guess back in the fall and early in January when it was talk of non pivotal versus pivotal had you yet at that point completed your.

I guess 15 lots of commercial product to show to the FDA or is that something that you have now recently shown them and they are now question and the comparability of that to the pivotal study.

Exactly it was in two steps first step for US and you may remember when we say last year back in September and we had the type B meeting, where we provided compatibility that are between historical and pivotal second step of been since then that we have provided them and they started to discuss debt. We had the type B and January talks.

Pascal: Exactly. It was in two steps. The first step was, and you may remember when we said last year, back in September, we had a type B meeting where we provided comparability data between historical and pivotal. The second step had been since then that we provided them and started to discuss that. We had a type B in January talking about pivotal to commercial, so it was a second set of data. And then we had further discussions with them based on their guidance. We've done new analysis, and so on. So that's the second step of the discussion has been based on pivotal to commercial.

Matt Phipps: Okay, I mean, I guess the reason you've done 15 lots of comparability for, I guess, all commercial products is because you're seeing higher than expected variability as you, you know, go try to compare this to the pivotal or not. No, there was not higher variability.

Talking about <unk>.

Total to commercial so thats one of the second set of data and then we have at.

Further discussion with them based on the guidance, we've done new analyses and so on and so that's the second type of discussion has been based on people total commercial.

Okay, and I mean, I guess, the the reason you've done 15 lots of <unk>.

<unk> ability for the for I guess, that's all commercial product is because youre seeing higher than expected variability.

As you go and try to compare this to the pivotal or non pivotal.

Pascal: No, there was not higher viability. I mean, the 15 knots were based on statistical methods there to be able to show equivalence based on value statistical tests there between two types of process versions there. And the 15 knots have been done for historical, for pivotal, for an intended commercial there. So the 15 is not linked to a particular aspect, but statistical power to be able to show equivalence between these different process versions.

No there was not the audio viability of the <unk> notes have been based on statistical methods to be able to show equivalents based on volume Statistical test. The between two type of process version, there and the 50 notes have been done for historical for pivotal for <unk>.

And intended commercial there so the <unk> is not linked with.

The particular aspect, but statistical power to be able to show equivalents between these different process versions.

Okay.

Matt Phipps: Also, you know, the wording specifically states methodologies to assess comparability. I assume these are methodologies with data that you have already generated and not something that has to be done as a new analysis, or something.

Also the warning specifically announced the.

Methodologies to assess comparability I assume this is methodologies with.

Data that you have already generated and not something that has to be.

And as a new.

And our food or something like that.

Pascal: Yeah, I think we provided the FDA with methodology from the point of view of statistical analysis and other types of aspects of that methodology on the data on these manufactured lots with different process versions. And the alignment that we are having with the FDA is around these methodologies. And again, I'd like to remind you that we are the first in kind.

Yes, I think we provided the EBITDA with <unk>.

<unk> from the point of view of statistical analyses and other type of aspect of the methodology on the on the data on this manufactured lots with different pulses versions and the alignment that we are having with the.

EBITDA is around these methodologies and again I would like to remind you that we are the first and kind of and nobody else has been coming to the FDA with the type of allogeneic cell therapy. So as I say with the example of something of size.

Pascal: Nobody else has been coming to the FDA with that type of allogenic cell therapy, so as I said with the example of sample size, the FDA has to agree with us being the first about the number of samples, number of lots, that makes sense for an allogenic cell therapy because nobody else has been to that level with the FDA.

The FDA.

And along with us being the first about the number of samples and then the of lots that makes sense for a number of leading cell therapy, because nobody else has been put up leveled with the EBITDA and I gave that example that is for a small molecule large molecule compatibility study you need free manufactured lots for.

Pascal: And I gave that example, that is, for a small molecule or large molecule comparability study, you need three manufactured lots. For an autologous CAR T, you have to provide as many as you manufacture for treating patients. And it's one lot per patient. So if you have a study with 60 patients or 100 patients, that means you have 60 or 100 lots. In allogenic cell therapy, it's different. We believe 15 is very significant, much higher than the three that is being used with molecules. And at the same time, it's something that is powered from a statistical point of view to be able to address the variability in ARAM2 cell therapy.

And not sort of go Scotty you you have to provide as many as for manufacture of treating patients and he has one more per patient. So if you of a study the 60 patient of 100 patients and EUR 6100 growth in allogeneic cell therapy different we'd be the 15 is very significant much higher than the free that is being used with molecules and and the same time, it's something that the.

And is powered from a statistical point of view to be able to address the viability and net run to cell therapy.

Matt Phipps: Okay, and then I guess I think the last question, you know, the wording is also clearly changed from on track to complete a rolling submission by Q3 to now working towards completing a BLA in Q3. No mention of rolling. I assume this is just kind of getting things closer to Q3 in general, where you're not going to even do a rolling submission; you'll just submit it all in Q3. We can still have a rolling submission. It's not.

Okay, and then I guess I think the last question the war.

<unk> is also clearly changed from on track the complete a rolling submission by Q3 to now working towards completing the.

The Q3, no mention of Rolling I assume that's just kind of getting the it's closer to Q3 and general.

Youre not going to even do a rolling submission of those committed all of Q3 of them right.

Pascal: We can still have a rolling submission. It's not that we cannot have a rolling submission.

We can see of a rolling submission, it's not that we cannot devoting submissions just and there will be some time and where.

Pascal: It's just that there will be some time where we can hold the submission and then complete the submission with the clinical module. And altogether, we think that we are working towards this Module 5, which is based on the data cut and the analysis in Q3, while we are working on Module 3. So it depends when we'll have that alignment with the FDA on comparability, so then that means Module 3 can be finalized. But there is nothing in our description of the ADA that says that we cannot do a rolling DNA test, just to be clear.

We can hold the submission and then complete the submission.

With the the clinical material and.

And altogether, we think that we are working towards this moving five as you know thats based on the debt occurred and the analogies and Q3, while we are working on the mood of free so it depends when we'll have that alignment with the FDA on comparability. So then that means that we do free can be finalized.

But there is nothing there.

Discussion of the NDA that say that we cannot do of holding period just to be clear.

Okay. Thank you.

Okay.

Tony Butler: Our next question is coming from the line of Tony Butler with Roth Capital. Please proceed with your question.

Our next question is coming from the line of Tony Butler with Roth Capital. Please proceed with your questions.

Tony Butler: Yes, thanks a lot, Pascal. Apologies, I was just disconnected for a little bit, and you may have said this, so please forgive me.

Yes, Thanks, a lot per scope apologies I was just disconnected a little bit and you may have said the so please forgive me there are really three questions. One is.

Tony Butler: There are really three questions. One is, Jacob alluded to enrolling sites for ATA 188 very, very rapidly. On clinicaltrials.gov, it lists 17.

Jacob alluded to.

Enrolling sites for 80, 188, very very rapidly and <unk>.

Clinical trials Dot Gov.

17.

Tony Butler: Is that a fair number, or would there be more sites to be added? That's question one. Number two. Pascal, you sent up a little bit of a trial balloon on 188, suggesting that there was a great deal of, I think your phrase was large, and 1N8, and you know, that implies partnership, but I just wanted to know what you were thinking around 188 longer-term.

Is that a fair number or would there be more sites to be added that's question one number to cash.

Tony Butler: And the third question involves 2271, or importantly, the relationship with Bayer. Is that relationship, because they're responsible for filing the IED, as well as eventually commercialization, will you all be doing the manufacturing? I'm just trying to separate church and state there with respect to that program. Thanks very much. Thank you, Tony, for your free question. Maybe the first one, AJ, you want to address it on a number of sites? Sure. Absolutely. So you're asking whether we are continuing to enroll more sites or activate more sites in the event.

Pascal you set up a little bit of of trial balloon on 188, suggesting that there was a great deal of I think your phrase was large.

Company interest and one of the NDA and.

That implies partnership, but I just wanted to know what.

You were thinking around.

188 longer term and the third question involves.

$22 71.

More importantly, the relationship with Bayer is that relationship because they're responsible for filing the R&D as well as eventually commercialization.

You won't be doing the manufacturing I'm, just trying to separate church and state there with respect to the program. Thanks very much.

Thank you Tony for your quick question, maybe the first one a J you want to address it from the number of sites sure absolutely. So youre asking whether we are continuing to enroll more sites activating more sites and the answer is absolutely. Yes. We've got sites open now in the U S and in Australia, and we're continuing to add more USA and will also be open.

AJ: The answer is absolutely yes. We've got sites open now.

AJ: in the U.S. and in Australia, and we're continuing to add more U.S. sites, and we'll also be opening up Canadian sites over the course of this year as well.

AJ: have made the insights available over the course of this year as well.

And we have Canadian sites over the course of this year as well.

Thank you.

Pascal: Regarding the 81-88 partnering aspect, the discussion we are having with some companies is really around establishing the type of framework for partnering that will create significant value for the company and our shareholders and, at the same time, allow us to expand and accelerate the development of this potentially transformative treatment. So that's the type of thing that we think clearly, as I was trying to explain earlier on, moving into pivotal studies in PMS, in relapse-limiting MS, maybe in some other type of autoimmune disease where you have a link, an association, between EBV and the disease, such as lupus or RA, that requires some partnering, because that's a very significant effort, we believe. But partnering should be done in a way that preserves value for the company and its shareholders.

And regarding the <unk> and 88 partnering aspect I mean, the discussion and we are being we have some companies is really around establishing the type of framework from partnering that will create significant value for the company and our shareholders and the same time of Lois to expand and accelerate the development of these potentially transformative treatment.

Pascal: So that's the overall framework, and I cannot give you more details about that. But, of course, we're working actively on this type of framework. Now, your last question, 2271, maybe to clarify. 2271, at this stage, this is the autologous version.

So that's the type of thing that we're seeing the clearly as I tried to explain earlier on moving into pivotal studies in Pms in the <unk> maybe in some other type of autoimmune disease, where you have the link and association between EBIT and the disease, such as lip Bu's alright, that's.

And from partnering because thats, a very significant efforts, we believe the partnering should be done in the way that piece of value for the company and our shareholders. So that's the overall framework and I cannot give you more details about that but of course, we are working actively and these type of framework there.

Your last question put through 71, maybe to clarify.

$20 71 at this stage. This is the autologous version. So the <unk> is run by Memorial Sloan Kettering and we are funding that and of course, we have access to these.

Pascal: So the IND is run by Memorial Sloan Kettering, and we are funding that. And, of course, we have access to it.

Pascal: Now, moving forward in that development, there will be a need for someone else to move forward if it goes into further development. And that's the plan to have Bayer as a partner there to move forward in 2271. Meanwhile, as we know, we are working toward the IND for 3271, the halogenic version. And this one, we are doing the work right now. But Bayer, and that's part of the deal; Bayer will be the company filing the IND.

Now moving forward in the development there will be of need for someone else can move forward. If it goes into further development and Thats the plan.

Buyers of partner out there to move for what for 2071. Meanwhile, as we know we are working towards the IND for <unk> 271 of the Allogeneic version and this one we are doing the work right now, but buyer and Thats part of the deal buyer will be the company filing the IND.

Pascal: We believe it could be in Q2, Q3 next year, and then we will start developing the product, and then we will commercialize the product. So at this stage, the work done by Atara is really to support the first in-human study for memorial with 2271, and at the same time, work on the halogenic 3271 IND-enabling studies to be able then to provide a partner with the right set of data to move forward toward the IND

We believe it could be and Q2 Q3 next year and then developing the pullback and then commercializing the products. So at this stage the <unk>.

The AUM by alcohol is really to support the first in human study for memorial with $22 71 at the same time worked on the allogeneic 30 to 71 IND, enabling studies to be able then to provide a partner with the right set of data to move forward towards the IND.

Tony Butler: Does that answer your question? Thank you. Yes, sir, it does. Thank you very much for your time.

And as you can see your question.

Yes. It does thank you very much for your time.

Ben Burnett: Our next question comes from the line of Ben Burnett with Stiefel. Please proceed with your question.

Our next question comes from the line of Ben Burnett with Stifel. Please proceed with your question.

Ben Burnett: Hey, thanks very much. I just wanted to ask a few questions about the commercial.

Hi, Thanks, very much I just wanted to ask a few questions about commercial the commercialization plans for tab cel and.

Ben Burnett: questions about commercial commercialization plans for TAP cell and I guess specifically what what capacity do you expect to be at on approval just in terms of the size of the cell banks and then secondly I guess is there any unique thing that needs to happen here to certify or onboard hospitals I know that you guys use the Atara match me delivery process I'm just curious how easy it is to adapt that to do sites and if there's any any certification process like we've seen with some CAR T programs

I guess, specifically what capacity do you expect to be at an approval just in terms of the size of the cell banks.

And then secondly, I guess is there any unique.

Think of that needs to happen here of just certifier onboard hospitals out of that you guys use the of Tara matched me delivery process.

And I'm just curious how how easy it is to adapt that to do sites and if theres any any certification process like we've seen and with some car T programs.

Kristen: Now, thank you, Ben, for your question. Kristen, do you want to address that question? Sure, absolutely. Thank you for the question.

Thank you Ben for your question Kristen the you want to address that question.

Sure absolutely.

Thank you for the question.

Kristen: So, as...

So as.

Kristen: As we said before, we're on track to build inventory.

As we said before and we're on track the building inventory and so we expect at the time.

Kristen: And so we expected at the time of launch and soon thereafter to be able to address about 95% of patient needs with our capacity and our inventory. So that's very exciting for us. And again, we're well on track with that.

And of launch and soon thereafter to be able to address them.

95% of patient needs with our with our capacity our inventory. So that's very exciting for us and again, we're well on track with that.

In terms of.

I'm kind of certification requirements or the model, we're getting a lot of work with institutions right now.

Kristen: We're doing a lot of work with institutions right now, really going in and doing research with pharmacy directors and cell labs at an individual level, and we are not anticipating that we'll require extensive certification requirements.

And really going in and doing research for us pharmacy directors, and so labs and individuals novel and <unk>.

We are not anticipating that will require a sense of certification requirements and fact that from one of the things that we think is quite exciting about our model.

Kristen: extensive certification requirements. In fact, that's one of the things that we think is quite exciting about our model. Okay, thanks very much, Nicola. I appreciate it.

Okay. Thanks for the Ashwin the color I appreciate it.

Pascal: Yes, and one thing is also important to clarify there, and maybe Joe might want to comment on that, because the differences between the pivotal process version and the commercial process versions are minimal there. That's why we're confident in terms of comparability, and that's why we're also confident in terms of building inventory. Joe, do you want to comment on that?

Yes, and one thing is important also to clarify the and maybe Joe might want to comment on that because the.

The differences between the people total processed version and the commercial deposits versions of minimal debt. That's why we're confident in terms of comparability and Thats. Why we are also confident in terms of building inventory towards the one comment on that.

Joe: Absolutely, Pascal. And the other aspect of it is that we've seen great process control across all of the process versions supporting commercial and clinical product. We're seeing increased yield production. So to that point of building that inventory, very confident with what we have already made and released to support pre-commercial inventory. And we've seen the same level of process control and manufacturing robustness to continue to build up.

Absolutely Pasco.

And the other aspect of it is just we've seen great process control across all of the process version and supporting commercial.

And the clinical product, we're seeing that we're seeing.

Kris yield production so to that point of building the inventory very confident with what we have already made and released to support free commercial inventory and.

We've seen the same level of process control and manufacturing of robustness as we continue to build out that library.

Yeah.

Joe: Okay. Okay. Got it. Great. Thank you.

Okay. Okay got it great. Thank you and Joe on the on the differences between the.

Joe: And Joe, on the differences between the pivotal and the commercial.

The pivotal and the commercial.

Joe: Yes, absolutely. I think they're so minimal. You know, quite honestly, if a change was made, it would be

Yes, absolutely I think there is so minimal.

Quite honestly of the change was made it was generally made to support the commercial GMP compliance requirements to support the BLA and I'll give you an example.

Joe: This is generally made to support the commercial GMP compliance requirements to support a VLA.

Joe: We moved the manufacturing site for our EBV viral reagent from a CMO to our own facility in Thousand Oaks. We did that for two reasons. One, better control of our supply. And, most importantly, to ensure that we can meet the commercial GMP compliance requirements in support of the BLA from that facility. So again, minimal changes, and generally, if a change was made, it was made to support the BLA system.

We moved the manufacturing site for our E. B the viral reagent from our CMO to our own facility and we did that for two reasons, one better control of our supply and then most importantly to ensure that we can meet the commercial GMP compliance requirements and support of the BLA from that facility. So again minimal changes.

And generally of the change was made it was may.

To support the BLA success.

Jeff: Thank you, Jeff. Thank you. Our next question comes from the line of Yigal Nochomovitz with Citi. Please proceed with your question.

Thank you Joe.

Thank you. Our next question comes from the line of Mako and that's with Citi. Please proceed with your question.

Yigal Dov Nochomovitz: Hi, this is Carly on behalf of Yigal. Thanks very much for taking our questions. We have a couple in the CAR-T pipeline, specifically on ATA. 3219, the CD19 program. We're just curious if you had considered incorporating the PD-1 dominant negative receptor into the CD19 program as a potential strategy for boosting persistence. Obviously, it's incorporated into your mesothelin program, so we were just wondering, kind of expand on the rationale for including it in the Mississippi LN car keys, but not first. Thank you, guys, for your questions. Jacob, do you want to address that one? Yeah, thanks for that, Carly.

Hi, This is carly on for Yigal, Thanks, very much for taking our question that we have a couple on on the car T pipeline specifically.

30 Q&A.

And a key program.

Great.

You had considered incorporating that PD, one dominant negative interest I'm sorry into.

And to the CD 19 program as the as a potential strategy for.

And I think persistence.

And obviously, Inc.

Incorporated and tier Mesothelin programs that we were just wondering if you could kind of expand on the rationale for it.

And then at the C O N E and whatnot.

But not for Nike.

And thank you kind of follow up for your question Jacob the one for the rest of them.

Thanks for that currently and so.

Jacob: So in terms of a liquid tumor targeting product like 3219, it makes sense, obviously, for the binder to be against CD19 as we target these B cells. It also makes sense for 1XX to be in there, as we think this is a potentially best-in-class co-stimulatory molecule. But the PD-1 DNR is not as useful in the context of liquid tumors because if you think about the mechanism of immune suppression that occurs in solid tumors, there's the creation of the PD-1 protein by the tumor that prevents the T cells from really having their effect against solid tumors. But that's really not an effect that you find in liquid tumors.

In terms of the liquid tumor targeting product like 32019.

It makes sense, obviously for the binder to begin <unk>.

The 19 as we target TSB sales. It also makes sense for <unk> to be in there as we think this is a potentially best in class co stimulatory molecule, but.

The PD one DNR is now.

Useful and the context of liquid tumors because of you think about the mechanism of immune suppression that occurs and solid tumors. There is the creation of the PD lone protein by the tumor that prevents the T cells from really having the fast against solid tumors.

But thats really not an effect that you find and liquid tumors and so.

Jacob: And so there's really not a good need to put the PD-1 DNR into the 3219, specifically because it targets B cells that express CD19 in this regard. Now, we do think the other aspect about 3219 that's so compelling to us is the fact that we're using our allogeneic EBV-specific T cell. Because, in essence, you have a T cell, a CAR T cell, that will target CD19 on the B cell malignant cells.

There is.

Theres really not.

A good need to put the PD one DNR into the 32019, specifically because it is targeting.

B cells that express the <unk> 19 in this regard now we do think the other aspect of about 32019, that's so compelling to US is the fact that we are using our allogeneic EBV specific T cell because what in essence, you have is you've got a.

The T cell of car T cell that will target CD 19 on the B cell malignancy cells.

Jacob: But the EBV specificity, the native EBV TCR that is in these allo T cells, is one that's actually complementary in this setting. You don't need to delete that T cell receptor with something like CRISPR-Cas9 and so forth. So it actually leaves these allogeneic T cells more intact by leaving the native TCR in place, which is specific for EBV. So we think that the performance, and part of the reason why we think 3219 could be best in class, is not only because of the 1xx but also because of the allo EBV T cell specificity of those cells. Got it, that's really helpful. And then I guess I'll just stick with 3219.

But the edd specificity the.

Nathan the EBV TCR and that is in these our T cells is one net and Thats actually complementary in this setting and you don't need to lead that T cell receptor with something like CRISPR cash nine and so forth. So it actually leaves these allogeneic T cells more.

For intact by leaving the native TCR and place, which is specific for EBV. So we think that the performance of part of the reason why we think 32 19 could be best in class is not only because of the one ex sex, but also because of the allo EBV.

The T cell specificity of those cells.

Got it that's really helpful. And then I guess, just sticking with 32 19.

Jacob: , and Dr. Yigal Nochomovitz. Thank you so much, everyone.

These back and think about kind of debt and initial clinical development plan can you share of any any preliminary thoughts on the phase one trial design, particularly average.

Dr. Erikson-Eckert: I'm going to turn it over to Dr. Erikson-Eckert to talk about the initial clinical development plan. Can you share any preliminary thoughts on the Phase I trial design, particularly regarding the types of V-cell mulligans you plan to enroll, whether you would plan to study 3219 in patients who have previously had a V-cell mulligan in the past, treated with CD9 therapy, and any early thoughts you have? Yeah, I can start, for sure.

Got it and types of B cell malignancies, and plan to enroll whether you plan to study and each of your 19 and patients who had previously.

And with the STB 19 targeted therapy and any early thoughts you have on that side of the nation.

Helpful. Thank you.

Jacob: So we will do, obviously, a classic dose escalation and expansion study, that Phase I. We did, as we announced last year, have a good pre-IND meeting with the agency that was very successful last year. So we had some early discussions around the Phase I clinical trial design, but we have not per se spoken about the details, and it's still an area of refinement that we're working on now. But certainly, CD19-expressing B-cells, and B-cell malignancies will be the target there.

Do you want to sort of yes, I can start for sure. So.

We will do obviously of classic dose escalation and expansion study that phase one we did as we announced last year have a good pre IND meeting with the agency that was very successful last year. So we had some early discussions around the phase one clinical trial design, but we have not per.

<unk> spoken about the details and that's still an area of the refinement that we're working on now, but certainly CD 19 expressing.

Expressing <unk>.

T cells B cell malignancies will be the target there.

Jacob: And we think there are some very interesting opportunities, again, because of the 3219 molecule or product, where we think there's going to be better persistence here. But because it's allogeneic, there's some other things that you can consider, including potentially re-dosing of patients as well. So there is a lot of flexibility with that program, and we're going to refine the clinical trial design in the coming months. Yeah, I think the other aspect maybe to add on that is, so far, whether it's autologous CD19 CAR-T or first kind of initial data with lack of durability proven so far of other allogeneic technologies on CD19, the level of response, if you look at DL-BCL, really, not follicular, which is different, the level of response has been more on the 40% in terms of long-term response, long-term CR, because here you need CR in this type of patients there.

And we think there are some some very interesting opportunities again because of the $32 19 molecule.

Or or product, what we think theres going to be better persistence here, but because of its allogeneic theres. Some other things that you can consider inc.

<unk> potentially re dosing of patients.

And as well so there is a lot of flexibility with that program and we're going to refine the clinical trial design and the coming months.

The other aspect maybe to add and that is so far whether it's auto growth CD 19 car T or first of kind of the initial data with lack of durability equivalents of Allergan over the allogeneic technologies and CD 19, the level of West Palm. If you look at the <unk> really not not follicular.

Which is different the level of restaurants has been more of on the 40% and in terms of long term westfall and smoked and CR because here you need see R&D cycle of patients. There. So we believe there is still room to the best in class with iron level of response and the same time durability of response because of the intent is to really of long term the average of restaurants with the.

Jacob: So we believe there is still room to have a best-in-class with higher levels of response and, at the same time, durability of response because the intent is to really have long-term durability of response with a curative intent for this type of product. And then, of course, better safety than the autologous.

Curative intent for this type of product and then of course, the better safety than the three of US. So all of these aspect of aspect of why we think our approach might bring some interesting data we need of cost of goods of clinique, there, but from the way we've built the product we think that we could address this medical need in terms of response rates and safety and driver.

Pascal: So all of these aspects are aspects where we think our approach might bring some interesting data. We need, of course, to go to the clinic there. But from the way we've built the product, we think that we could address this medical need in terms of response rate, safety, and durability of response. Does it answer your question, Carly? Yes, it does. I appreciate all the detail.

City of response.

Does it answer the question.

Yeah. It does I appreciate all the detail. Thank you for taking the questions again.

Thank you.

Carly: Thank you for taking the questions again. Thank you. Thank you. Thank you for joining the Altera Biotherapeutics first quarter 2021 financial results conference call. You may now disconnect.

Thank you.

Thank you for joining the Alterra Biotherapeutics first quarter of 2021 and financial results Conference call. You may now disconnect.

Okay.