Q1 2022 Atara Biotherapeutics Inc Earnings Call

Operator: Good afternoon, everyone.

Good afternoon, everyone. Thank you for standing by and welcome to the Apollo Biotherapeutics first quarter 2022 financial results Conference call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your tongue.

Operator: Thank you for standing by and welcome to the Atara Biotherapeutics First Quarter 2022 Financial, Results Conference Call.

Operator: At this time, all participants are in a listen-only mode.

Operator: A brief question and answer session will follow the formal presentation.

Operator: If anyone to require operator assistance during the conference, please press star zero on, your telephone keypad.

Our phone keypad.

Operator: Please be advised that today's call is being recorded.

Please be advised that today's call is being recorded I'd now like to hand, the call over to Erik Alexander Vice President of Investor Relations and finance at a terror Biotherapeutics. Please proceed sir.

Operator: I'd now like to hand the call over to Eric Hallegren, Vice President of Investor Relations, and Finance at Atara Biotherapeutics.

Operator: Please proceed, sir.

Thank you operator.

Eric Hallegren: Thank you, operator.

Eric Hallegren: Good afternoon, everyone, and welcome to Atara's First Quarter 2022 Results Conference Call.

Good afternoon, everyone and welcome to <unk> first quarter 2022 results conference call earlier today, we issued a press release announcing our first quarter financial results and operational progress. This press release and an updated slide deck are available in the investors and media section at a tower bio dot com on today's.

Eric Hallegren: Earlier today, we issued a press release announcing our first quarter financial results and operational, progress.

Eric Hallegren: This press release and an updated slide deck are available in the investors and media section, at atarabio.com.

Eric Hallegren: On today's call, members from the Atara executive team will provide an update on our financial, results and operational progress and also review our upcoming key milestones and objectives.

His call members from the entire executive team, who will provide an update on our financial results and operational progress and also review our upcoming key milestones and objectives.

Joining me on today's call are Dr. Pascal to Sean President and Chief Executive Officer, Dr. Jakob Dupont Executive Vice President and global head of research and development.

Eric Hallegren: Joining me on today's call are Dr. Pascal Touchon, President and Chief Executive Officer, Dr. Jacob DuPont, Executive Vice President and Global Head of Research and Development, Upal Kopekar, Chief Financial Officer, Dr. A.J.

Paul copy Kerr Chief Financial Officer.

Dr AJ Joshi, Chief Medical Officer.

Eric Hallegren: Joshi, Chief Medical Officer, and Dr. Kristen Urema, Chief Commercial Officer.

And Dr Christian <unk>, Chief commercial officer.

Eric Hallegren: We will begin with prepared comments from Pascal and Jacob, then open up the call for, your questions.

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

Eric Hallegren: We would like to remind listeners that during the call, the company's management will be, making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking, statements due to risks and uncertainties associated with the company's business. 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.

We would like to remind listeners that during the call. The Companys management will be making forward looking statements actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the company's business.

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.

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

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

Eric Hallegren: Now I'd like to turn the call over to Pascal.

Eric Hallegren: Pascal?

Pascal Touchon: Thank you, Eric.

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

Pascal Touchon: And thank you all for joining us this afternoon.

Pascal Touchon: I would like to start with ATA188, or Potentially Transformative Therapy for Multiple Sclerosis, where, in the first quarter, we have made good progress and momentum continues to build around this exciting program.

To start with a tier one.

A potentially transformative therapy for multiple sclerosis.

Were in the first quarter, we have made good progress and momentum continues to build around this exciting Pablo.

Pascal Touchon: This recent momentum was marked by two landmark publications in Nature and Science, which, continue to drive significant interest and awareness of EBV as the leading cause and trigger of MS in the medical, scientific, and investment community.

This recent momentum was marked by two long locked application.

Got you and science.

Which continue to drive significant interest and awareness of EBV as the leading co then trigger.

Yes.

Medical scientific and investment community.

Pascal Touchon: In addition, we conducted a successful EBV and MS Day in March, where we covered the, MS disease landscape, the history of ATA188, an overview of EBV as a cause of MS, and, very importantly, updated Phase I and open-level extension data, highlighting that a majority of patients have demonstrated either confirmed EDSS improvement or stability in up to 42 months follow-up.

In addition, we conducted a successful EBV analyst day in March where we covered unless disease landscape. The easterly of 80 188.

An overview of EBV is a cause of M S.

And very importantly, a day.

<unk> phase one and open label extension data.

Highlighting that majority of patients at.

Demonstrated either confirm E S S important all stability.

Up to 42 months photo.

Pascal Touchon: These events clearly establish ATA188 as a unique opportunity for value creation, with, its potential to transform patients' lives and the treatment paradigm in MS.

These events clearly establish <unk> as a.

Unique opportunity for value creation.

With its potential to transform patients' lives and the treatment paradigm in MFS.

Pascal Touchon: Jacob will have more to say in a moment.

Jakob will have more to say in a moment.

Pascal Touchon: Looking ahead, we are pleased to announce that we are on track to conduct the interim, analysis of the Phase II EMBL study in June. As a reminder, the goals of conducting the IA are, first, to decide whether we should, increase the sample size or not in order to achieve the target conditional power by the end of the study. Second, it will be used to inform Phase III timing, design, planning, and investment.

Looking ahead, we are pleased to announce that we are all truck to conduct the interim analyses of the phase III <unk> study in June .

As a reminder, the goal of connecting the IEA all first to decide whether we should increase the sample size or not in order to achieve the target conditional power by the end of the study.

Second it will be used to inform phase III timing design planning and investment.

Pascal Touchon: And lastly, it will inform broader development plans, including Phase II studies in potential, new indications.

And lastly, it will inform all the development plans, including phase II studies in potential new indications.

Pascal Touchon: Ultimately, the interim analysis data will allow us to accelerate and expand ATA188, development, starting Phase III preparation, discussing further development steps with, FDA, and finding the right partner for value creation.

Ultimately.

The interim analysis data will allow us to accelerate and expand <unk> development.

Well, starting phase III preparation.

<unk> for the development steps with FDA and finding the right partner for value creation.

Pascal Touchon: Once we analyze the data and decide on sample size and timing for study completion, we plan, to communicate both our decisions and the rationale behind our decision in July of this year.

Once we analyze the data and decide on sample size and timing of the completion, we plan to communicate both hold decision and the rationale behind our decision in July of this year.

Pascal Touchon: We then plan to discuss with the FDA the IA data and next steps for potential development, pathways under ATA188 fast-track designations for both non-active primary progressive MS and non-active secondary progressive MS.

We then plan to discuss with the FDA.

Data and next steps for potential development pathways.

<unk> fast track designation for both non active primary progressive Ms. A non active secondary progressive isn't it.

Pascal Touchon: In parallel, we intend to accelerate our partnering discussion with biopharma companies that are, progressing very well so far.

In parallel we intend to accelerate our partnering discussion with Biopharma companies that are progressing very well so far.

Turning now to stop sale I would like to provide an update on our end.

Pascal Touchon: Turning now to TAPFEL, I would like to provide an update on our MAA in the EU and our continuing, dialogue with FDA in the U.S. First, we are on track and continue to expect a decision regarding CAPSEL European Commission, approval in the fourth quarter of this year. As part of our ongoing dialogue with European Medicine Agency, EMA recently requested additional, time to review our answers to their Day 120 list of questions, which results in adding an additional 30 days to the review process.

In the EU and a continuing dialogue with FDA in the U S.

First we all talk and continue to expect the decisions regarding tab cel European Commission approval in the fourth quarter of this year.

As part of our ongoing dialogue with European Medicines agency.

EMEA recently requested additional time to review our answers to their de 120 list of questions.

Which results in adding an additional 30 days to the review process.

Pascal Touchon: We believe the answers we are preparing for the EMA will sufficiently address their questions.

We believe the answer is we are preparing for the EMA, we're sufficiently address their questions.

Pascal Touchon: As a result of their need for additional time, EMA transitioned CAPSEL to a standard assessment, review timeline.

As a result of their need for additional time, you may transition to upsell to a standard assessment review timeline.

Pascal Touchon: However, even after this transition to standard assessment, we continue to anticipate EC approval, in Q4 of this year.

However, even after this transition to standard assessment, we continue to anticipate EC approval in Q4 of this year.

Looking ahead the key step in the regulatory review is conducting pre approval inspections with EMA.

Pascal Touchon: Looking ahead, a key step in the regulatory review is conducting pre-approval inspections, with EMA, and we are pleased to say that the dates for the pre-approval inspection have recently been confirmed. We are making good progress and are looking forward to completing this inspection with EMA soon.

And we are pleased to say that the dates for the pre approval inspection has recently been confirmed.

We are making good progress and are looking forward to completing this inspection with EMEA soon.

In addition, as we previously noted.

Pascal Touchon: In addition, as we previously have noted, comparability data have been submitted to EMA, through our MAA filing. We have now received the EMA Day 120 critical assessment report, and EMA has considered, the comparability data between clinical and commercial manufacturing process versions as sufficient to demonstrate comparability.

Tolerability data have been submitted to EMA frugal MAA filing.

We have now received the Ema's day, 120 clinical assessments, we bolt and email us considered.

Comparability desktop between clinical and commercial manufacturing process visions are sufficient to demonstrate compatibility.

We are pleased with our progress and look forward to further dialogue with EMA.

Pascal Touchon: We are pleased with our progress and look forward to further dialogue with EMA.

On the U S regulatory hold we are actively discussing proposals.

Pascal Touchon: On the U.S. regulatory front, we are actively discussing proposals to enable a potential, filing of the BLA without conducting a new phase 3 study. Specifically, our proposal leveraged CAPSEL status as a BTD product, addressing an ultra-rare, and urgent medical need, as patients in second-line PTLD have no approved therapies and a very limited median life expectancy of just a few weeks to a few months. We have made several proposals to the FDA.

<unk> a potential filing of the BLA without conducting a new phase III study.

Specifically, our proposal leveraged upsell studies BTB product addressing an ultra rare and urgent medical need.

As patients in second line <unk>.

No approved therapies and the <unk>.

Very limited median life expectancy of just a few weeks to a few months.

We have made several proposals to the FDA.

Pascal Touchon: First, to use only commercial lots that meet a range of specifications coming from our, clinically used lots. Our extensive clinical data in more than 190 patients with EBV-positive PTLD clearly establish, we believe, a safe and effective range of values for key product attributes, enabling determination of acceptable commercial product specifications. Second, we propose to use the clinical data being generated with a commercial product, in current studies as a way to support the filing without an additional phase 3 study.

First to use only commercial lots that meet a range of specification coming from all clinically use logs.

Our extensive clinical data in more than 190 patients with EBV positive <unk> clear.

Clearly establish we believe.

Safe and effective range of values for key product attributes, enabling determination of acceptable commercial product specifications.

Second we proposed to use the clinical data being generated with a commercial product in current studies.

Way to support a filing without an additional phase III study.

Lastly.

Pascal Touchon: Finally, we propose an appropriate monitoring of patients in a post-marketing setting.

We propose an appropriate monitoring of patients.

Marketing studies.

Pascal Touchon: The FDA is reviewing our proposals, and we expect to provide further clarity on a potential, BLA pathway in the next few months.

EBITDA is reviewing our proposals and we expect to provide further clarity on the potential BLA pathway in the next few months.

Pascal Touchon: I continue to feel confident that we will find a constructive way to get TAP sales filed, and approved in the U.S.

I continue to feel confident that when we find a cost effective way to get that satisfies and approved in the U S.

Pascal Touchon: Moving to operational and financial updates.

Moving to operational and financial updates last month, we welcomed shall inbound to Ottawa as Chief Technical Officer.

Pascal Touchon: Last month, we welcomed Charlene Barnard to Atara as Chief Technical Officer, overseeing, process science, process development, quality, manufacturing, and supply.

We're seeing process science process development quality manufacturing and supply.

Pascal Touchon: We also successfully completed the sale of our manufacturing facility to Fujifilm Diocene, Biotechnology, or FDB, for $100 million upfront, and began a partnership with FDB for access to flexible capacity to manufacture clinical and commercial stage allogenic T-cell therapy. The partnership is going very well, and the transaction is expected to reduce Atara plant, operating expenses over the multi-year partnership period.

We also successfully completed the sale of our manufacturing facility to <unk>.

<unk> Biotechnologies SBB.

<unk> $100 million phones.

And began a partnership with SBB or access to flexible capacity to manufacture clinical and commercial stage allogeneic T cell therapy.

The partnership is going very well and the transaction is expected to reduce planned operating expenses over the multiyear partnership period.

With regard to our cash position and runway we ended the first quarter of 2022.

Pascal Touchon: With regard to our cash position and runway, we ended the first quarter of 2022 with approximately, $302 million in cash. We believe cash as of March 31, 2022, plus the $100 million received from the closing of the, strategic transaction with FDB in April, will be sufficient to fund the company plan operation into the fourth quarter of 2023.

Approximately $302 million in cash.

<unk> cash as of March 31st 2022, plus the 100 million received from the closing of the strategic transaction with <unk> in April .

Be sufficient to fund the company planned operations into the fourth quarter of 2020.

I will now turn the call over to Jacob to give you more details I'll make you an API development and a coffee program Jacob.

Pascal Touchon: I will now turn the call over to Jacob to give you more details on ATA 188 development, and OCAPI programs.

Jacob Dupont: Jacob?

Thank you Pascal.

Jacob Dupont: Thank you, Pascal.

Jacob Dupont: With regard to ATA 188, as Pascal mentioned, momentum and awareness continues to build, following the two landmark studies in nature and science, identifying EBV as the leading cause and trigger of multiple sclerosis. ATA 188 awareness has increased in physician surveys conducted by Atara and by external, parties as well. Of note, a longitudinal survey of a cohort of high-prescribing neurologists was conducted, six weeks following the publication and showed 56% were in agreement that targeting EBV is a viable therapeutic strategy in multiple sclerosis.

With regard to <unk> 188, as Pascal mentioned momentum and awareness continues to build following the two landmark studies in nature and science identifying EBV is the leading cause and trigger of multiple sclerosis, a ta 188 wariness has.

<unk> and physician surveys conducted by a Tara and by external parties as well.

Note a longitudinal survey of a cohort of high prescribing neurologists was conducted six weeks following the publication and showed 56% were in agreement that targeting EBV is a viable therapeutic strategy in multiple sclerosis. This was a three fold increase.

Jacob Dupont: This was a threefold increase versus survey results from Q4 of last year, which was prior, to the nature and science publications.

Versus survey result from Q4 of last year, which was prior to the nature and science publications.

During our recent EBV and MSA the momentum for this potentially transformative product continued to grow with the presentation of updated phase one and open label extension data that demonstrated that 33% of patients in the high dose cohorts achieved confirmed EDI.

Jacob Dupont: Following a recent EBV and MS day, the momentum for this potentially transformative product, continued to grow with a presentation of updated phase one and open label extension data that demonstrated that 33% of patients in the high-dose cohorts achieved confirmed EDSS improvement at the 12-month time point, and 20 out of 24 patients have had either confirmed EDSS improvement or EDSS stability throughout their observation in the study with up to 42 months of follow-up. Of note, one of our MS experts, Dr. Mark Friedman, commented that if ATA 188 were to show 20, to 30% confirmed EDSS improvement in phase two, we would have a game changer for patients.

S. S improvement at 12 months time points and 20 out of 24 patients have had either confirmed eds improvement or ESF stability throughout their observation in the study with up to 42 months of follow up.

Of note one of RMS experts Dr. Mark Friedman commented that if HCA 188 were to show, 20% to 30% confirmed Etfs improvement in phase two we would have a game changer for patients. We are very excited about the potential for this therapy to help patients.

Jacob Dupont: We are very excited about the potential for this therapy to help patients and are looking, forward to the results of the EMBOLD study.

And are looking forward to the results of the <unk> study.

Looking ahead as we prepare for the phase III <unk> interim analysis in June I would like to remind everyone that the primary endpoint of this phase II study is confirmed eds as improvement at 12 months, which has been agreed to by the FDA.

Jacob Dupont: Looking ahead as we prepare for the Phase 2 EMBOLD interim analysis in June, I would, like to remind everyone that the primary endpoint of this Phase 2 study is confirmed EDSS improvement at 12 months, which has been agreed to by the FDA. The IA will primarily focus on EDSS improvement at 6 months, which based on Phase 1 data, was found to be greater than 85% predictive of achieving confirmed EDSS improvement at, 12 months.

The IAA will primarily focus on Etfs improvement at six months.

Which based on phase one data was found to be greater than 85% predictive of achieving confirmed <unk> improvement at 12 months. This IAA will include Etfs improvement beyond six months for patients with longer treatment duration and will also include other clinical endpoints.

Jacob Dupont: This IA will include EDSS improvement beyond 6 months for patients with longer treatment, duration and will also include other clinical endpoints and various biomarker data, such as magnetization transfer ratio or MTR and other biological biomarkers.

And various biomarker data such as magnetization transfer ratio or MTR and other biological biomarkers.

Jacob Dupont: Results of the IA will determine whether any sample size adjustments would be needed to, achieve the target conditional power by the end of the study.

Also the I E. We will determine whether any sample size adjustments would be needed to achieve the target conditional power by the end of the study.

Jacob Dupont: The IA will also inform the best Phase 3 timing, design, and planning and will inform broader, development including additional indications.

I will also inform the best phase III timing design and planning and we will inform broader development, including additional indications as a reminder, our current target enrollment of 80 patients is expected soon after the conduct of the interim analysis as.

Jacob Dupont: As a reminder, our current target enrollment of 80 patients is expected soon after the, conduct of the interim analysis. As Pascal mentioned, after we make the decision on sample size and steps forward, we plan, to communicate both the decision and the rationale behind our decision to you in July.

As Pascal mentioned after we make the decision on sample size and steps forward, we plan to communicate both the decision and the rationale behind our decision to you in July .

Jacob Dupont: Turning now to our CAR T programs, I'd like to provide an update regarding our autologous, mesothelin product candidate called ATA-2271. This is being developed by our partner, Memorial Sloan Kettering Cancer Center, and the recent, serious fatal adverse event in a patient treated in the ongoing Phase 1 MSK conducted investigator sponsored trial. Final autopsy results are pending and additional studies are being conducted by MSK.

Turning now to our car T programs I'd like to provide an update regarding our autologous meso sealant product candidate called <unk> $22 71. This is being developed by our partner Memorial Sloan Kettering Cancer Center and the recent series.

Hello adverse event in a patient treated in the ongoing phase one MSA conducted investigator sponsored trial.

Final autopsy results are pending and additional studies are being conducted by M. S. K based on our assessment of the available information to date, we believe that the death has not caused by a $22 71, the final assessment and determination of causality will be made.

Jacob Dupont: Based on our assessment of the available information to date, we believe that the death is not, caused by ATA-2271.

Jacob Dupont: The final assessment and determination of causality will be made independently by MSK, and communicated to the FDA in addition to any intended informed consent and or protocol amendments. As a reminder, MSK voluntarily paused enrollment of new patients in the study.

<unk> lead by MS Kay and communicated to the FDA. In addition to any intended informed consent and or protocol amendments as a reminder, M. S. K voluntarily paused enrollment of new patients in this study. Additionally for this program Tara and M. S K <unk>.

Jacob Dupont: Additionally, for this program, ATARA and MSK expect to provide a Phase 1 data update, for ATA-2271 in the second half of this year.

Spec to provide a phase one data update update for HCA $22 71 in the second half of this year.

Jacob Dupont: IND-enabling work for ATA-3271, a separate off-the-shelf allogeneic CAR T therapy targeting, mesothelium using next-generation PD-1 dominant negative receptor and 1XX CAR T technologies for patients with advanced mesothelioma and other solid tumors is advancing well with the IND filing anticipated in Q4 of this year through our partner, Bio.

IND, enabling work for <unk> $32 71, a separate off the shelf allogeneic car T therapy targeting mesothelin using next generation PD, one dominant negative receptor and <unk> car T technologies for patients with advanced mesothelioma and us.

Other solid tumors is advancing well with the <unk> IND filing anticipated in Q4 of this year.

Our partner buyer.

Jacob Dupont: Importantly, Atara's approach to CAR-T does not require TCR or HLA gene editing and retains, the endogenous T-cell receptor. This has been shown in academic studies to increase persistence, durability, and tracking, of the CAR-T cells.

Importantly.

<unk> approach to car T does not require TCR or HLA gene editing and retains the endogenous T cell receptor. This has been shown in academic studies to increase persistence durability and tracking of the car T cells.

In addition, we are advancing the wholly a Tara owned 80, $832 19 program a potentially best in class Allogeneic car T for B cell malignancies, expressing CD 19, and we are on track to submit an IND in Q4 of this year as well.

Jacob Dupont: In addition, we are advancing the wholly Atara-owned ATA3219 program, a potentially best-in-class, allogeneic CAR-T for B-cell malignancies expressing CD19.

Jacob Dupont: And we are on track to submit an IND in Q4 of this year as well. For ATA3219, we have implemented a targeted design and manufacturing approach in order, to differentiate it from existing products through three essential factors.

For HCA $32 19, we have implemented a targeted design and manufacturing approach in order to differentiate it from existing products through three essential factors first our approach maintains the endogenous TCR second we are use utilizing the one.

Jacob Dupont: First, our approach maintains the endogenous TCR.

Jacob Dupont: Second, we are utilizing the 1xx co-stimulatory domain to prevent T-cell exhaustion.

<unk> co stimulatory domain to prevent T cell exhaustion and third our manufacturing approach delivers a cellular phenotype that enriches for central memory T cells to enhance in vivo expansion and persistence without the need for extensive litho depletion.

Jacob Dupont: And third, our manufacturing approach delivers a cellular phenotype that enriches for central, memory T-cells to enhance in vivo expansion and persistence without the need for extensive lymphodepletion.

Jacob Dupont: Given the data that has been presented thus far in the CD19 space, we believe that the, ATA3219 program has the potential to be a best-in-class differentiated therapy based on the expected safety of the EBV CAR-T cells, the potentially higher response rates and potentially longer duration of response, as well as the off-the-shelf accessibility. We believe this could address a high unmet medical need for the approximately 60% of, patients who do not achieve complete response at six months with existing CD19-directed, CAR-T cell therapy.

Given the data that has been presented thus far in the CD 19 space. We believe that the 832 19 program has the potential to be a best in class differentiated therapy based on the expected safety of the EBV car T cells, the potentially higher response.

And potentially longer duration of response as well as the off the shelf accessibility. We believe this could address this could address a high unmet medical need for the approximately 60% of patients who do not achieve complete response at six months with existing <unk>.

CD 19, directed car T cell therapy.

Jacob Dupont: Before I turn back to Pascal, I would like to extend my gratitude to ATARA staff, our, collaborators and the patients involved in our studies.

Before I turn back to Pascal I would like to extend my gratitude to HR staff our collaborators in the patients involved in our studies together, we hope to bring allogeneic T cell therapies to patients in need some of these with curative potential back to you Pascal. Thank you Jacob and thank you all again for <unk>.

Jacob Dupont: Together, we hope to bring allogeneic T-cell therapies to patients in need, some of these, with curative potential.

Pascal Touchon: Back to you, Pascal.

Pascal Touchon: Thank you, Jacob, and thank you all again for joining us this afternoon.

Joining us this afternoon.

Pascal Touchon: Before we begin Q&A, I'd like to end my prepared remarks by saying this is truly an exciting, time for ATARA. We have a forthcoming interim analysis for AT188, a unique, potentially transformative, therapy for MS.

Before we begin Q&A I'd like to end my prepared remarks by saying this is truly an exciting time for it to heart, we have a forthcoming interim analyses for 80 188 unique potentially transformative therapy for Ms.

Pascal Touchon: I am personally excited to achieve this key milestone in June, just in a few weeks, and, I look forward to communicating further with you in July, after which we will discuss further with the FDA and with potential biopharma partners.

I am personally excited to achieve this key milestone in June .

Just in a few weeks and look forward to communicating further with you in July after which we will discuss further with the FDA and with potential Biopharma partners.

Pascal Touchon: As I look forward to this upcoming event, I would like to thank all staff at ATARA for, their hard work in creating value for patients and the company.

Look forward to this upcoming events I would like to thank all staff for their hard work in creating value for patients and the company.

Pascal Touchon: I now turn the call back to the operator to begin the Q&A portion of the call.

I'll turn the call back to the operator to begin the Q&A portion of the call operator.

Operator: Operator?

Operator: Thank you.

Thank you at this time, we will conduct a question and answer session.

Operator: At this time, we will conduct a question-and-answer session.

Operator: If you would like to ask a question, please press star 1 on your telephone keypad.

We would like to ask a question. Please press star one on your telephone keypad.

Operator: A confirmation tone will indicate your line is in the question queue.

A confirmation tone will indicate your line is in the question queue.

Operator: One moment as we poll for questions.

One moment as we poll for questions.

Our first question comes from Salim Syed with Mizuho. Please proceed.

Operator: Our first question comes from Salim Syed with Mezuzah.

Operator: Please proceed.

Operator: Great.

Operator: Thanks for the question, guys.

Great. Thanks for the question guys just a couple from me on <unk>.

Operator: Just a couple for me on ATA 188, if I can.

Ken.

Operator: So Pascal, a lot of people around this IA seem to think that this is not going to be, an interpretable readout.

So Pascal.

Yeah.

A lot of people.

This IAA seem to think that this is not going to be in.

Interpretable readout, we're going to get a sample size adjustment.

Operator: We're going to get a sample size adjustment, and we're going to get rationale, but rationale, can mean a lot of different things here.

And we're going to get rationale, but rationale can mean a lot of different things here and so I'm just curious here.

Operator: So I'm just curious here, you know, if you were to put yourself in our shoes, right, or investors' shoes for a second, you know, is this the right way we should be looking at this, that, you know, it is going to be more or less uninterpretable to the external, but to the internal, you guys will have a lot more data, or are you guys thinking about this as, you know, there will be things that you can share that will make this an interpretable catalyst?

If you were to put yourself in our shoes, right or investor's shoes for a second.

Is this the right way we should be.

Looking at this that you know.

It is going to be more or less are integral to the external but internal you guys will have a lot more data or are you guys thinking about this is there will be things that you can share that will make this an interpretable.

Operator: And then I have a follow-up.

Catalysts, and then I have a follow up thank you.

Operator: Thank you.

Pascal Touchon: Thank you for your question, Salim. I would like to say that we believe that what will we communicate in July is going to be, something important for investors in giving them further understanding of the potential for this unique therapy to be successful at the end of its development.

Well. Thank you for your questions all in I would like to say that we believe that what will be communicated in July .

Going to be something important for investors in giving them further understanding of the potential for this unique therapy to be successful at the end of its development.

Pascal Touchon: And the reason we can say that is it allows to not only clarify sample size, as you said, but also the timing of the completion of the study, which then will have an impact on the timing of the different steps to further develop that product.

And the reason we can say that is it's a lowe's to not only clarify sample Sars as you say, but also the timing of the completion of the study, which then will have an impact on the timing of the different steps to further develop the product.

Pascal Touchon: The fact that this data will also be shared later on with the FDA and potential partners, is also a way to create further value.

The fact that these data will also be shared later on with the FDA and potential partners is also a way to create further value.

Pascal Touchon: But coming back to the rationale, the reason we have not been able so far to give a lot, of specifics to what this rationale could be is because it ultimately depends on the data.

But coming back to the rationale.

We have not been able so far to give a lot of specifics to what this rationale could be is because it ultimately depends on the data.

Pascal Touchon: But our intent is very clearly to give that rationale information of relevance for investors, so they can form their own view about the likelihood of success of that program.

But our intent is very clearly.

Good food, that's rational information of all of them for investors. So they can form their own view about the likelihood of success of that program.

Pascal Touchon: This program, as you know, is very unique.

This program as you know is very unique.

Pascal Touchon: I don't know many programs in the biotech today industry that have that potential for, value creation.

Don't know many programming the biotech to the industry that have that potential for value creation.

Pascal Touchon: If you think about the potential of disrupting a very important disease area with unmet medical, need.

If you think about the potential of disrupting that.

Importantly, we are with unmet medical need.

Pascal Touchon: We have, however, to focus our mind on creating value.

We have weather to focus on mind.

Creating value and to create value we need to make sure that we do not damage the integrity of that study.

Pascal Touchon: And to create value, we need to make sure that we do not damage the integrity of that, study, that phase two study.

That phase III study.

Pascal Touchon: But again, what we will be communicating, we believe, will be an important information, for investors to form their own view on the likelihood of success of that program.

But the gain what would be communicating we believe will be an important information for investors to form their own view on the likelihood of success of that program.

Pascal Touchon: Thanks, Pascal.

Pascal Touchon: Is it out of the cards here to assume that, or is there a possibility here that, you know, when you put out the qualitative.., readout that you would benchmark it somehow to the phase one data or the med-day placebo movement, or are you guys thinking that that would break the integrity of the study at this point?

Thanks, Pascal is it out of the cards here.

Two to assume that or is it or is there a possibility here that.

When you put out the qualitative.

Read out.

You would.

<unk> market somehow to the phase one data or the med D. Placebo movement or are you guys thinking about that would break the integrity of.

The study at this point.

Pascal Touchon: Our intent is to be able to be as clear as possible about why we're taking that, particular decisions about the size and the timing of the completion of the study.

Our intent is to be able to be as clear as possible about why we're taking that particular decisions about the size and the timing of the completion of the study.

Pascal Touchon: So the more details we can give the better, I understand, but at the same time we want to preserve the integrity of the study.

More details we can give the better I understand but at a center we want to preserve the integrity of the study. So we believe that the Colo will give all the qualitative aspect of why are we making that decision is going to be something important for investors because it is going to give an idea about how management.

Pascal Touchon: So we believe that the color we'll give or the qualitative aspect of why are we making that decisions is going to be something important for investors because it is going to give an idea about how management thinks about the likelihood of success of that particular program before there is further confirmation about this interpretation of the data by the discussion with potential partners at a later stage.

Thinks about the likelihood of success of that particular program before there is further confirmation about these.

Reputation of the desktop.

By the discussion with potential partners at the later stage.

Pascal Touchon: So again we cannot today give you details about how much we will say about confirmation of the phase one data or confirmation that the placebo arm is aligned with what has been seen with previous studies like the med-day studies you are referring to, but we'll certainly try to give as much detail as possible while preserving the integrity of the study.

So again, we cannot today give you details about how much we will say about.

Confirmation of the phase one data all confirmation that the placebo arm.

Is aligned with what has been seen with previous studies like the med. They studies, you're referring to but we'll certainly try to give as much detail as possible while preserving the integrity of the study.

Understood. Thanks, so much for the color.

Pascal Touchon: Understood.

Thank you Rob next question comes from Tessa Romero with Jpmorgan. Please proceed.

Pascal Touchon: Thanks so much for the clarification.

Hey, guys nice to talk to you hope everyone's doing well. Thank you for taking the question.

Operator: Thank you.

The first one.

Can you provide a bit more color on why you don't think there will be an impact to the approval of tab cel in Europe , given the shift to a standard SaaS men and then our second question is just on one on EPA 188, what activities are expected to occur at a tie between the interim and the disclosure.

Operator: Our next question comes from Tessa Romero with JP Morgan.

Operator: Please proceed.

In bold study thanks, so much.

Operator: Hey guys, nice to talk to you.

Thank you Jacob you won't take the first question and then Jay will take the second one.

Operator: I hope everyone's doing well.

Certainly so tessa thanks for the question so.

As Pascal described.

Operator: Thanks for taking the, question.

<unk> has transition.

<unk> MAA to standard review.

And this is.

Operator: So for our first one, can you provide a bit more color on why you don't think there will be an impact to the approval of Tab-Cell in Europe given the shift to a standard assessment?

This allows the agency to have additional time to review the company's answers to the email questions, but as Pascal also mentioned, we feel confident in our.

Operator: And then our second question is just one on ATA 188.

Operator: What activities are expected to occur at ATARA between the interim and the disclosure of the enrolled study?

Our responses that we're going to be able to address those.

Those questions.

So the result of the extension is just an additional 30 days.

For that review, but I think the most important thing here is that we're still on track for that EC approval in Q4 of this year, which is really the target that we're seeking so in essence, yes standard review very addressable and we're still on track for our ultimate goal.

So is it also had a question on Tesla.

Yes that answers that thanks, and then the one on <unk>.

Operator: Thanks so much.

Operator: Thank you, Tessa.

Hey, Jay.

Sure and thanks for the question, maybe I can ask for a clarification you were asking what activity between IAA and disclosure of <unk>. What are you thinking disclosure of the final one year results are involved is that with the.

No just the kind of the differentiation between kind of an interim in in June and I and.

Disclosure to us in July is it just.

Yeah.

Got it no. Thank you for clarifying the when we do the interim analysis I think we.

You mentioned it before that we're really going to look at everything. So this isn't going to just be let's take a look at the Etfs will be looking at Etfs will be looking at the full safety profile every piece of information we have on the secondary parameters Biomarkers mris et cetera. So.

We want to have a chance to take a look at those data analyze the data make good clean decisions based off of it and then communicate that to you. All in July . So it is really giving us that time to assess all of that information in totality.

And then actually provide Chris response here back in July .

Just a few weeks we're talking again.

That is just a few weeks okay, great. Thanks, guys.

Our next question comes from John Newman with Canaccord. Please proceed.

Jacob Dupont: Jacob, do you want to take the first question and then Jay will take, the second one?

Jacob Dupont: Certainly.

Okay.

Hi, guys. Thank you for taking my question. So my question is.

If you see clear separation between <unk> and placebo at the interim.

Jacob Dupont: So Tessa, thanks for the question.

Jacob Dupont: So as Pascal described, EMA has transitioned the Tab-Cell MAA to standard review and this allows the agency to have additional time to review the company's answers to the EMA questions.

Could you disclose these rates to us in the third quarter and wouldnt that be meaningful to investors second question I have is.

Do you also expect to report results at 12 months and the patients involved in the interim or would you wait until the study was potentially.

The final size of the study was established and then report.

Perhaps 12 months data on all of those patients. Thanks.

Jacob Dupont: But as Pascal also mentioned, we feel confident in our responses that we're going to be able to address those questions.

Well. Thank you John I'll start and then Joe you might want to chime in if needed so just to be clear.

Reporting the percentage of.

The response in terms of confirm at DSS improvement in active versus placebo is we believe a level of details on the data that kujawa dies.

The study value or the integrity of the study in a sense that this being made public with influence the behavior of patients and physicians in the study that will still be unloading is still be.

Evaluating patients over time.

So that's why we believe at this stage that it's not possible to disclose the percentage of confirming DSS improver in active versus placebo.

To your second questions and that's something by the way we will do at the time of the July communication will be to clarify when the study will end.

The last patient visit in some ways and then when do we plan to.

<unk> results available for disclosure.

And clearly that's going to be.

After the last patient in all that we can have the last visit and then as usual a couple of months before one kind of the data cleanup and QC. So you can communicate on the starts or whatever the form of that communication will be so.

We are not going to be able to present 12 month data on the patients in the middle of that.

Is that could you hear that the.

Patient of all nimble will be at the edge.

And of the study, which mean one year after.

One year plus a few months after the last patient has been enrolled.

Yes, that's clear thank you.

Our next thing that.

We're planning to so that we are planning to enroll patients 80 soon after the EIA.

So that's also something important to keep in mind for the end of the study in the current target enrollments.

Gold and the time of communication of the final results.

Our next question comes from Marc Frahm with Cowen <unk> Company. Please proceed.

Jacob Dupont: So the result of the extension is just an additional 30 days for that review.

Thanks for taking my questions and congrats on the progress on the EMA review in terms of getting to the confirmation of the conference comparability.

Jacob Dupont: But I think the most important thing here is that we're still on track for that EC approval in Q4 of this year, which is really the target that we're seeking.

Jacob Dupont: So in essence, yes, standard review, very addressable, and we're still on track for our ultimate goal.

Jacob Dupont: Does it answer the question, Tessa?

Operator: Yep, that answers it.

Operator: Thanks.

My question is on that.

Operator: And then the one on ATA 188.

Operator: Maybe I can ask for a clarification.

Operator: Sure, and thanks for the question.

The comparability established on the full everything he made commercially.

Operator: You're asking, you know what activity between IA and disclosure is in bold?

Operator: Are you thinking you know disclosure of the final one-year results is in bold?

Filed with initially and plan to file with the U S or maybe have you used the kind of day to day, one 'twenty process to go down one of those pads that youre proposing to the FDA and just done it within the review for the EMA.

Operator: Is that what the uh?

Operator: No, just the kind of the differentiation between kind of an interim in June and a disclosure, to us in July.

Operator: No, thank you for clarifying.

Operator: Is it just like the, yeah.

Operator: When we do the interim analysis, I think we've, mentioned it before that we're really going to look at everything.

Operator: Got it.

Operator: So this isn't going to just be let's take a look at the EDSS.

Operator: We'll be looking at EDSS.

Operator: We'll be looking at the full safety profile, every piece of information we have on the secondary parameters, biomarkers, MRIs, etc.

Operator: So really we want to have a chance to take a look at those data, analyze the data, make good, clean decisions based off of it, and then communicate that to you all in July.

Operator: So it's really giving us that time to assess all of that information in totality and then actually provide a CRIS response to you back in July.

Operator: Ultimately, it's just a few weeks we're talking about.

If I understand well your question I mean, we did de 120, maybe I come back to the E U.

Operator: Got it.

Operator: Just a few weeks.

Operator: Okay, great.

Operator: Thanks, guys.

EMEA process. Once you further M&A you cannot call additional desktop and.

So the day 120 list of questions and clinical assessments report is really based on the initial data you filed for approval. So based on this initial data which way of course.

<unk> all the comparability studies, we have done for the clinical process version versus the manufacturer or the commercial process version. That's on the basis of these data that the hopper coop auto and basically the <unk> TMA The committee.

I confirm that the data support compatibility.

So thats the same data set that we add also at that time. If you remember that we filed in November we had also some.

For the FDA type B meeting that we had in February so the same type of data set from that point of view.

What we've not given any additional data to the EMA at.

At this stage, but they have evaluated the data that we have put together and you remember we always say we believe.

These data confirmed compatibility that are very clear very good data very strong data and that's what has been confirmed by the review of the EMA. All these CMC powerful define.

I guess a follow up that's kind of I think one of the my understanding at least one of the proposals you plan to put in front of the FDA rated to.

Just simply restrict.

The range of commercial lots that you're actually going to use commercially.

Just want to meet.

Release criteria.

Product that will be used in a clinical trial have you.

Okay have you gone down that path with DMA or do you are you still intending to commercialize in Europe with the full range of commercial lots that were made.

Yes, with a full range of commercial lots because start from a basis that we since we've established compatibility that will be the basis of the specification.

Okay, great. Thanks for that and then maybe coming out of the interim.

We've done some general terms some of the next steps not just on the.

Phase two in terms of the resizing, but.

You know that this is going to impact how you think about phase III potentially going into some other indications as well.

Run through some of the options within there.

But you might be willing to pursue yourself as a tara versus potentially needing to bring in a partner and kind of have that in place before you could go down those paths.

Yes, maybe I'll start and Jay if you want to chime in.

One is <unk>.

Why are we considering that as a key milestone to then move into preparing the phase III and potentially starting phase III.

Because that this will allow us to add additional data compared with the face one, especially here versus placebo in additional number of patients and that will allow us to save.

Safety database that will allow us to grow into new indication and then of course two of <unk>.

Information, we hope of the.

The type of.

The difference between active and placebo that will allow us to optimize the design of the phase III studies as you May remember, we discussed already designed a phase III studies with the FDA as part of the fast track designation process.

And there were some alignment on potentially doing two phase three study one in non Actavis pms, one in non acute PD EMS. So I think the data from the <unk>.

To fine tune the design and to further discuss with the FDA and to start preparing the phase III.

So I'll stop there before talking about when exactly in link with partnering but does that answer your question on that talk about.

What type of steps, we will take him.

Yes, that's very helpful.

Hey, Jay anything to add to that.

So on the partnering aspect by definition moving into phase III moving into other phase III is something that requires financial and operational capability. So there is some step that we can start immediately after the IAA, which is certainly preparation and we have already as you can imagine we are already planning for that.

I mean, there is not such suddenly you will have to do all the work to prepare we are already planning whether it's on the manufacturing side on the inventory on these new manufacturing.

Process version that we want to use that is being made making the product in steel bioreactors in terms of looking at the different sites and so on so there is a lot of things that we can start to do before even the partnering is negotiated and executed.

And then the idea of the partnering will be able to accelerate and expand activities. So we can accelerate and expand value creation for the product.

Okay.

Very helpful. And then maybe the last piece is just on the potential go to additional pay Susan do you want that phase III.

Variability in them.

<unk> production up and running before you would do any morpheus shoes or will use the existing process for that.

Therefore, no I understand.

We haven't talked a whole im sorry.

Sorry, we have inventory of the existing process. So we can start studies with the existing process because they are phase III pivotal.

<unk> phase III study so it's really for the people told that our aim is to have a product that is then the same is I want to be commercialized, which will then allow us to avoid any particular debate on comparability.

Okay. Thank you very helpful.

Operator: Our next question comes from John Newman with Canaccord.

Our next question comes from Ben Burnett with Stifel. Please proceed.

Operator: Please proceed.

Okay.

Operator: Hi, guys.

Yes. This is Neil carnahan on for.

Operator: Thank you for taking my question.

Ben Thanks for taking our question on HCA to $2 71.

You conveyed that you guys believe that causes the patient deaths was not due to.

207, one could you just help us.

Understand your viewpoint here. Thank you.

Jacob Yes, I'd be happy to do that so Neil thanks for the question so.

Operator: So my question is, if you see clear separation, between ATA-188 and placebo at the interim, could you disclose these rates to us in the third quarter, and wouldn't that be meaningful to investors?

Operator: The second question I have is, do you also expect to report results at 12 months on the patients involved in the interim, or would you wait until the study was potentially, the final size of the study was established, and then report perhaps 12-month data on all those patients?

Operator: Thanks.

As we detailed here in February of this year Memorial Sloan Kettering notified the FDA of this serious adverse event in this very unfortunate patients.

Demise, and they put the study voluntarily on pause, which the FDA agreed with and then.

Memorial Sloan Kettering and the investigators there have been proceeding forward with the.

The autopsy in a number of additional studies that are in fact still ongoing so there is additional data coming in.

So these additional.

Analyses and so forth we believe in review.

Information regarding this case and additional information that it's very unlikely that this is an <unk>.

That's caused by.

$22 71 by the autologous car T against Mesothelin and then additional analyses are currently under review at Sloan Kettering, and we will be able to comment further on those once the data had been shared with the FDA.

Operator: So thank you, John.

Great. Thank you.

Operator: I'll start, and Ajay, you might want to chime in if needed.

Operator: So just to be, clear, reporting the percentage of response in terms of confirmed EDSS improvement in ARTI versus placebo is, we believe, a level of details on the data that could jeopardize the study value or the integrity of the study, in a sense that this being made public would influence the behavior of patients and physicians in a study that will still be enrolling and still be evaluating patients over time.

Operator: So that's why we believe at this stage that it's not possible to disclose the percentage of confirmed EDSS improvement in ARTI versus placebo.

Our next question comes from Jonathan Miller with Evercore ISI. Please proceed.

Operator: Now to your second question, and that's something, by the way, we will do at the time of the July communication, will be to clarify when the study will end, the last patient's visit in some ways, and then when do we plan to have results available for disclosure.

Operator: And clearly, that's going to be a year after the last patient enrolled that we can have the last visit, and then, as usual, a couple of months before one can have the data cleaned up and QC'd so you can communicate on this data, whatever the form of that communication will be.

Operator: So, we're not going to be able to present a 12-month data on the IA patients in the, middle of that.

Operator: Is that clear, that the communication on Enbol will be at the end of the study, which means, one year plus a few months after the last patient has been enrolled?

Hi, guys. Thanks for taking my question I guess, maybe I'll sneak in one on 188.

Operator: Yes, that's clear.

Operator: Thank you.

Operator: Our next question...

Operator: And don't forget that we're planning to...

Suppose the IAA hits that improvement bar that you were talking about from the from the MSA that you did.

Operator: Yes, sorry.

In that scenario would you need to increase the size to get to the power and you're looking for I'm, just trying to get a sense for what the that's bounds are for the potential upsize trials that youre looking at.

Maybe secondly, not on <unk> it feels like the tab cel regulatory process is still treading water a little bit in the U S and I feel like we haven't gotten a ton of clarity since we started talking about this last month.

A little while ago before that I guess.

At this point what needs to change to move forward, there and if the agency sort of put their foot down on requiring an additional study what would that look like.

What's your willingness to run an additional study under what circumstances would that makes sense for you guys.

Thank you John J do you want to take the first one and then sure.

Sure. Thanks for the question.

We haven't commented specifically on the statistical bounds was used for the study we have commented on the types of information that we've used to inform our approach and just as a reminder, on the types of information there as we've talked historically about the Med day study when you look at for what should we expect for placebo from non active.

Disease, and the Med <unk> study that specifically look at almost exactly the same population we're talking about once that had zero percent once that he had 6% Etfs improvement.

At the top line at that 12 month time point in.

In those non active patients now I think the second piece of information that informs that is recent publications that we put out at actress and EAN, where we showed that.

In a full pbms population. So we didn't have a breakdown of non active and active in that particular dataset from the multiple sclerosis outcomes assessment consortium.

But for <unk>. It was five 6% and four non active S. Pms. It was 4%. So again, you've got a pretty good sense on what we should expect from placebo in these populations and then certainly from what we should expect from <unk> 188, we've talked about the 33% improvement for <unk> improvement at 12 months, we saw in the.

Hi dose cohorts for the 80 188 phase one study so again thats the information that we've generally used to.

Inform that statistical design, but we have not have not and probably would not comment at the time of the IAA on the specific numbers there.

But what also I could add is that if we all based on this information. We've used if we are aligned with a statistical assumptions, we should not increase the number of patient, which would maintain and therefore will have the patient.

Operator: That we're planning to enroll patient 80 soon after the IA.

And all soon after the EIA.

Jacob the second question, yes, absolutely so Jonathan just to.

Operator: So, that's also something important to keep in mind for the end of the study in the current, target enrollment goal and the time of communication of the final results.

Speak a little bit more about the FTA and tab. So situation as you were asking about.

Operator: Our next question comes from Mark Fram with Cowen & Company.

Operator: Please proceed.

As you know we did have the type B CMC meeting with the FDA here in late February and at that point. The discussion was about the comparability between the manufacturing versions of tabs between the pivotal study and the intended commercial material we were not able at.

Operator: Thanks for taking my questions, and congrats on the progress on that EMA review in terms, of getting the confirmation on comparability.

Operator: My question is on that.

Operator: Is the comparability established on the full, everything you made commercially and kind, of filed with initially and planned to file with in the US?

That time based on the discussion to ally.

Line on comparability subsequently, we have received the final minutes from the FDA that confirm that the agency recommended that we conduct a new study with the commercial product.

Operator: Or maybe have you used the kind of day 80, day 120 process to go down one of those paths, that you're proposing to the FDA?

So we do not feel that that is required.

And following the type B CMC meeting we have remained in active dialogue with the FDA and as you've already heard on the call. Today. We have made several proposals to enable a potential filing of the BLA that does not require a new clinical study and some of the.

Operator: And just done it kind of within the review for the EMA?

Operator: I understand well your question.

Operator: I mean, the day 120, maybe I come back to the EMA process.

Operator: Once you file M&A, you cannot file additional data then.

Operator: So, the day 120 list of questions and critical assessments report is really based on the, initial data you filed for approval.

Operator: So, based on this initial data, which were, of course, presenting all the comparability, studies we had done for the clinical process version versus the commercial process versions, that's on the basis of this data that the reporter, co-reporter, and basically the CHMP at EMA, the committee, has confirmed that the data support comparability. So, that's the same data set that we had also at that time.

Pacific's of what we have proposed include that we would only use commercial lots that meet the range of specifications for clinically use process version lot. So thats the first aspect.

Secondly, we would use data generated by already having commercial product in the clinic. So we feel we can appease the agency by providing clinical data from patients treated with commercial material and we did describe at the last call that we have already filed that IND amendment and patients are actively.

Operator: You remember that we filed in November.

Being treated and the third component of our proposal is that we are willing to proceed with post marketing agreements as well with the FDA.

Operator: We had also sent for the FDA a type B meeting that we had in February. So, the same type of data set from that point of view.

Operator: What we have not given any additional data to the EMA at this stage.

Operator: But they've evaluated the data that we had put together.

Operator: And you remember, we always say we believe at ATARA that these data confirm comparability, that they're very clear, very good data, very strong data. And that's what has been confirmed by the review of the EMA of this CMC part of the, file.

Operator: I guess to follow up, Pascal, I think one of the, my understanding at least, one of, the proposals you plan to put in front of the FDA, right, is to just simply restrict the range of commercial lots that you're actually going to use commercially to just the ones that meet the release criteria of product that was used in the clinical trial.

Operator: Have you, you know, have you gone down that path with the EMA?

No.

Okay.

Oh, Okay fair enough I guess.

Maybe beyond this initial indication if this impasse doesn't get resolved or the F. D. A really put their foot down on wanting another trial and you wanted to do that.

Does that have impact on other indications for tab cel just the potential for an indication agnostic approval really depend on the product already being approved to be T. L. D.

The study that is on the multi cohort study in particular, you might want to chime in is designed as a label expansion study.

Whether of course, the data will be available to start to be available next year and then depending on the court.

And the speed of enrollment this calls for doing that but there will be that at some stage available now again, our aim today with a first indication in second line PTSD is to clarify the BLA pathway without doing another phase III study for that particular indication and then to be able to move forward.

Our proposal.

So in that type of scenario, we still having the multi cohort study data for potential label expansion coming after.

Our BLA filing and a pre approval.

And maybe I'll make one other comment the multi cohort study, which is currently enrolling.

Also using commercial material, obviously in the clinic for the for both studies and also for expanded access and compassionate use and so forth that studies ongoing.

Generating data and obviously with our progress in Europe , we intend for this to be label expanding in Europe as well.

Operator: Or are you still intending to commercialize in Europe with the full range of commercial, lots that were used?

Operator: Yeah, with a full range of commercial lots, because that's on the basis that since we've, established comparability, that will be the basis of the specification.

And so I do think that there is a lot of data being generated on tab cel and we believe that there are other mechanisms whereby we can solve this FTA.

Impasse.

Operator: Okay, great, thanks for that.

Operator: And then maybe for coming out of the interim, lay down some general terms, some of the next, steps, not just on the phase two in terms of the resizing, but that this is going to impact maybe how you think about phase three, potentially going into some other indications as well.

Great. Thank you so much.

Our next question comes from <unk> Richter with Goldman Sachs. Please proceed.

Operator: Can you just kind of run through some of the options within there and what you might be, willing to pursue yourself as Atara versus potentially needing to bring in that partner and kind of have that in place before you could go down those paths?

Hey, Thanks, This is Matt on for solving.

Operator: Yeah, maybe I start, and Eje, if you want to chime in.

I just wanted to know what are you hoping to see in the multi cohort data read in 2023.

What would give you confidence that tab cel would demonstrate benefit in these additional populations.

And then separately what will be included in the phase one update for Q2 seven one.

And does the enrollment pause effect would be presented thank you very much.

Operator: There are two aspects.

Thank you for your question Matt.

Just to be clear on the musical and Jacob we develop that we have already presented in different Congress is clinical data on the efficacy and safety in each and every of these cohorts over the last few years, so that Ts Timothy what makes us very confident that we should be able.

<unk> data from that particular study that replicates, what we've seen in the past take up you want to elaborate on that yes, I think thats right. So in essence, we feel that we have proof of concept.

In all six of these these cohorts that are included in the multi cohort meaning that these are really the same therapeutic hypothesis as the PTO setting where you've got an immuno suppressed state in an EBV positive individual which then drives our lymphoproliferative.

Disorder, where tab cel is quite effective.

So for example, we have presented data on the AI D L PD.

Indication and the PID L PD indications, which are two of the multi cohort.

Cohorts and we've seen response rates on the order of 33% to 38% there in historical Sloan Kettering and <unk> studies as well, but as Pascal mentioned, we really have data in all six of these indications and the product works and now we're obviously doing there.

This pivotal study there to generate.

<unk> registration intent data that will allow us to file on these other indications and as referenced.

These could each be filed individually or there may be an opportunity for a tumor agnostic filing as well.

And maybe the question specific yes, absolutely. So I think it's a good question about.

The $22 71, Mesothelin autologous program, so working with our partners at Memorial Sloan Kettering, who are conducting this.

This study.

We do have this intent to put.

The data into a medical meeting here in the second half of this year. So certainly not unlike the ESMO Io presentation last year, where we presented safety data some early efficacy data and biomarker data and PK data as well I think we would seek to present similar types of.

Data now Theres, obviously been this voluntary hold which is which has delayed the.

Enrollment of patients on study, but we certainly depending on the medical Congress that we're seeking and the re initiation of enrollment, which we believe should occur we'll be able to present data. We've previously described that this patient.

Who had the SAE event that was the first patient on cohort three to be dose. So certainly as you can tell we're in cohort three now.

With this study and then.

Pending re initiation of the study and then enrollment we will be able to provide updated data in that case and I will say.

To maybe reference while we think our our car T platform could be quite good is that the PK data that we presented at ESMO I O showed persistence of the cells with the <unk> co stimulatory domain out past.

10 weeks at that early look at the data, which we think is quite compelling.

Compared to other car T programs in solid tumors.

Great. That's very helpful. Thank you.

Thank you Lynn.

Our next question comes from Yigal <unk> with Citigroup. Please proceed.

Hi, Harry.

Yes, hi.

Okay.

My question is Theres still seems to be a little confused a little bit of confusion around what's going to happen at the IAA. So it would be very helpful. If you could just clearly delineate for everyone with a possible scenarios are for what can happen at the interim and perhaps rank order those scenarios for most.

Operator: One is, why are we considering that IA as a key milestone to then move into preparing, the phase three and potentially starting other phase two?

Likely thank you.

Operator: It's because that this will allow us to have additional data compared with the phase one, especially here versus placebo, in an additional number of patients.

Thank you for your question. So maybe I'll start and then Jay if you want to chime in.

Operator: And that will allow us to have a safety database, that will allow us to go into new indication, and then, of course, to have enough confirmation, we hope, of the type of difference between active and placebo that will allow us to optimize the design of the phase three studies.

The scenario that we are planning right now kind of base case scenario.

The data we see at the IAA align with statistical assumption in terms of the trend towards the target conditional power and therefore, we and all patients to 80, and then we stop enrolling patients or maybe a few patients that are in the process additional patients, but we basically.

Operator: As you may remember, we've discussed already design of phase three studies with the FDA, as part of the fast-track designation process, and there was some alignment on potentially doing two phase three studies, one in non-active SPMS, one in non-active PPMS.

Operator: So having the data from the IA will allow us to fine-tune that design and to further, discuss with the FDA and to start preparing the phase three.

Operator: So I'll stop there before talking about when exactly and the link with partnering, but, does that answer your question on that part about what type of steps we will take?

Then follow and evaluate these patients for additional time periods to go to the end of the study a year later.

So that's the base case scenario because thats our plan.

Now there is a scenario where we.

Can increase.

The likelihood of statistical significance for that study in increasing the sample size and in that case, we will need to decide by how many we need to increase in sample size and we'll communicate that particular increase when do we expect to.

And the on all months and therefore, when do we expect to have the final results of the study and the rationale for that increase.

So that's the oldest scenario we've been mentioning so far but again for us it's not our base case scenario base case and always tailed up just go and move forward with what we had planned because we hope that we will see results align what we've seen so far.

Now that's the most likely scenario is if you're thinking about the run called now there is also always the possibility that we have.

Utility.

Nonetheless, this that shows facility of that study that we don't believe that is very likely and AJ might want to detail that but it is part of any type of IAG. So thats kind of low likelihood type of scenario and then of course. There is also a scenario that we've been discussing in the past whether increasing significantly.

See the number of patients could lead to possibly to use that particular study.

Kind of pivotal study two.

File for accelerated approval, we believe that that is extremely on Nike as well as a bit like the futility one for various reasons, we can detail, but just wanted to set the scene and if you want a J you can come.

Operator: Yeah.

Comment further but at least that's the the scene as we seat base case scenario <unk>, we move forward, we and all the loss patient follow those patients for one year, then we have the data.

Operator: That's very helpful.

Well CBD to slightly increase the sample size to improve the likelihood of statistical significance at the end of the phase II study and we'll communicate in that case why that's the most likely scenario and then two very unlikely scenario futility or a situation where we are.

Yeah.

The ability to move towards a conditional approval doesn't make sunseeker.

No no that was very very helpful. Thank you. Okay and then just one more regarding the M&A question is required in a more clients throughout the year.

Answers with EMEA also asking about compatibility of clinical and commercial batches like FDA or they have different types of questions.

No I think they are.

Typical.

Type of submission question, which is a lot of detailed question and then a lot of aspects of the data out there and then.

And we believe that we have all the answers and we're putting together all of the answers to these questions on the particular aspect of comparability. They put in the words of the EMA in the D. 120 critical assessment report, which is still a preliminary assessments with bolt that they believe that the data support.

Probability between clinical and commercial.

So this is not <unk>.

Debate with the EMEA at that stage.

Okay Gotcha. Thank you very much.

Our next question is from Tony Butler with Roth Capital. Please proceed.

Okay.

Thanks, very much Posco simple question I think.

Based upon lets just assume a base case scenario.

Okay.

I guess you could argue.

Even one where you could increase the size.

According to <unk> Dot Gov.

There are 31 sites.

Our have been enrolling patients score.

So the question is do you communicate anything to those sites either at.

Hey.

At the time, a patient data such that they may in fact need to I'm, making this up enrolling additional patients.

If you were to make it even for all 31, because the size needs to go up by 31 patients or some other function.

What's communicated to the.

Clinical site if any can thank you now think they will of course with the AJ do you want to take that one sure. Thanks for the question, Yes, I think the main thing that you'd want to communicate to the sites at that point is theyre not going to get any detail on the outcomes of the.

But they would get.

Very specific detail on saying Okay. Here is now if we're going to increase sample size here is now the total target sample size and that's important of course, because they are doing a lot of work to try to bring these patients in and it takes time, because they've got a pre screen and screen and then go through all of these procedures. So there is always that lag time right. There's a lead time that you want to give them.

So we want to be as open and communication as possible about any any numbers increase but that would be the limit of additional communication to them.

Thank you AJ.

Sure.

That concludes our question and answer session for today. Thank you for joining the <unk> Biotherapeutics first quarter 2022 financial results Conference call. You May now disconnect your lines and have a great day.

Operator: Eje, anything to add to that?

Operator: So on the partnering aspect, by definition, moving into phase three, moving into other, phase two is something that requires financial and operational capability.

Operator: So there is some step that we can start immediately after the IA, which is certainly preparation, and we have already, as you can imagine, we're already planning for that. I mean, it's not that suddenly we'll have to do all the work to prepare.

Operator: We're already planning whether it's on the manufacturing side, on the inventory, on, this new manufacturing process version that we want to use that is being made, making the product in steel-towned bioreactors, in terms of looking at the different sites and so on.

Operator: So there is a lot of things that we can start to do before even the partnering is negotiated, and executed. And then the idea of the partnering will be able to accelerate and expand activities, so we can accelerate and expand value creation for the product.

Operator: Okay.

Operator: That's very helpful.

Operator: You may now disconnect your lines and have a great day.

Operator: And then maybe the last piece is just on the potential to go to additional phase twos.

Operator: Do you want that phase three comparability and production up and running before you would, do any more phase twos, or will you use the existing process for that and, you know, therefore continue to do that?

Operator: No, we have inventory of the existing process, so we can start studies with the existing, process, because they are phase twos, they are not pivotal phase three studies.

Operator: So it's really for the pivotal that our aim is to have a product that is then the same, as the one to be commercialized, which will then allow to avoid any particular debate on comparability.

Operator: Thank you.

Operator: Okay.

Operator: Thank you.

Operator: Very helpful.

Operator: Our next question comes from Ben Burnett with Stiefel.

Operator: Please proceed.

Operator: Yeah.

Operator: This is Neil Carnahan on for Ben.

Operator: Thanks for taking our question.

Operator: On ATA-2271, you conveyed that you guys believe the cause of the patient death was not due, to 2271.

Operator: Could you just help us understand your viewpoint here?

Operator: Thank you.

Jacob Dupont: Jacob?

Jacob Dupont: Yeah.

Jacob Dupont: I'd be happy to do that.

Jacob Dupont: So Neil, thanks for the question.

Jacob Dupont: So as we detailed here in February of this year, Memorial Sloan-Kettering notified the, FDA of this serious adverse event and this very unfortunate patient demise. And they put the study voluntarily on pause, which the FDA agreed with.

Jacob Dupont: And then Memorial Sloan-Kettering and the investigators there have been proceeding forward, with the autopsy and a number of additional studies that are, in fact, still ongoing.

Jacob Dupont: So there's additional data coming in.

Jacob Dupont: So these additional analyses and so forth, we believe in review of information regarding, this case and additional information that it's unlikely that this is an event that's caused by 2271 by the autologous CAR-T against mesothelium.

Jacob Dupont: And then additional analyses are currently under review at Sloan-Kettering.

Jacob Dupont: And we will be able to comment further on those once the data have been shared with, the FDA.

Operator: Great.

Operator: Thank you.

Operator: Our next question comes from Jonathan Miller with Evercore ISI.

Operator: Please proceed.

Operator: Hi, guys.

Operator: Thanks so much for taking my question.

Operator: I guess maybe I'll sneak in one on ATA 188.

Operator: Suppose the IA hits that improvement bar that you were talking about from the MS day that, you did.

Operator: You know, in that scenario, would you need to increase the size to get to the power of, you're looking for?

Operator: I'm just trying to get a sense for what the stats bounds are for the potential upsize, trials that you're looking at.

Operator: And then maybe secondly, not on ATA 188.

Operator: It feels like the tab cell regulatory process is still treading water a little bit in the, U.S. And I feel like we haven't gotten a ton of clarity since we started talking about this, last month or a little while ago before that, I guess.

Operator: At this point, what needs to change to make sure that we're able to get to the power, of that?

Operator: What needs to change to move forward there?

Operator: And if the agency sort of puts their foot down on requiring an additional study, what, would that look like?

Operator: You know, what's your willingness to run an additional study?

Operator: Under what circumstances would that make sense for you guys?

Operator: Thank you, John.

Operator: AJ, do you want to take the first one?

Operator: Sure.

Operator: Thanks for the question.

Operator: And, you know, we haven't commented specifically on the statistical bounds we've used for the, study. We have commented on the types of information that we've used to inform our approach.

Operator: And just as a reminder on the types of information, there's, you know, we've talked historically, about the med-day study when you look for what should we expect for placebo from non-active disease.

Operator: And the med-day study that specifically looked at almost exactly the same population we're, talking about.

Operator: One study had 0 percent. One study had 6 percent EDSS improvement at that 12-month time point, in those non-active patients.

Operator: Now, I think the second piece of information that informs that is, recent publications that we put out at ACTRIMS and AAN where we showed that in a full PPMS population, so we didn't have a breakdown of non-active and active in that particular data set from the Multiple Sclerosis Outcomes Assessment Consortium, but for PPMS it was 5.6% and for non-active SPMS it was 4%.

Operator: So, again, you've got a pretty good sense on what we should expect, from placebo in these populations.

Operator: And then certainly from what we should expect from ATA188, we've talked about the 33% improvement for EDSS improvement at 12 months we saw in the high-dose cohorts for the ATA188 Phase 1 study.

Operator: So, again, that's the information that we've generally used, to inform that statistical design, but we have not, have not and probably would not comment at the time of the IA on the specific numbers there.

Operator: But what also I could add is that if we are, based on this information we've used, if we are aligned with our statistical assumptions, we should not increase the number of patients.

Operator: We should maintain AT and, therefore, we'll have the patient AT and all soon after the IA.

Operator: Jacob, the second question?

Operator: Yeah, absolutely.

Operator: So, Jonathan, just to speak a little bit more about the FDA, and TAB cell situation, as you were asking about. As you know, we did have the Type B CMC meeting, with the FDA here in late February, and at that point the discussion was about the comparability between the manufacturing versions of TAB cell, between the pivotal study and the intended commercial material. We were not able at that time, based on the discussion, to align on comparability.

Operator: Subsequently, we have received the final minutes from the FDA, and that confirmed that the agency recommended that we conduct a new study with the commercial product.

Operator: So, we do not feel that that is required, and following the Type B CMC meeting, we have remained in active dialogue with the FDA. And as you've already heard on the call today, we have made several proposals to enable a potential filing of the BLA that does not require a new clinical study. And some of the specifics of what we have proposed include, that we would only use commercial lots that meet the range of specifications for clinically used process version lots, so that's the first aspect.

Operator: Secondly, we would use data generated, by already having commercial product in the clinic, so we feel we can appease the agency by providing clinical data from patients treated with commercial material, and we did describe at the last call that we have already filed that IND amendment and patients are actively being treated.

Operator: And the third component of our proposal, is that we are willing to proceed with post-marketing agreements as well. With the FDA for appropriate monitoring of these patients.

Operator: So long story short, we believe that these proposals really reflect Tab-Cell's clinical and commercial product data, that we've generated to date.

Operator: Also, the important BTD status of this product, to address an urgent medical need with these patients who have really a lethal disease with no therapeutic options, and this is an ultra-rare disease state where, again, the conduct of an additional clinical trial we do not believe would be appropriate.

Operator: So, importantly, the FDA is reviewing proposals currently, and we expect to be able to provide an update on the potential BLA pathways for it in the next few months.

Operator: And if you think about it, John, I mean, the Type B meeting was late February. We are early May, so, what, two months and a few weeks?

Operator: That's it, you know?

Operator: So we've been active, and we've had discussion, we have proposals, so it's not like there's been a very long time between that particular Type B and now.

Operator: Okay, fair enough.

Operator: I guess maybe beyond this initial indication, if this impasse doesn't, get resolved or the FDA really puts their foot down on wanting another trial and you don't want to do that, does that have impact on other indications for cab cell?

Operator: Does the potential for an indication agnostic approval really depend on the product already being approved in BTLD?

Operator: The study that is designed, the multi-cohort study, and Jigal, you might want to chime in, is designed as a labelled expansion study.

Operator: However, of course, the data will be available, start to be available next year and then depending, on the cohorts and the speed of enrolment of these cohorts following that, but there will be data at some stage available.

Operator: Now, again, our aim today with the first indication in second line BTLD is to clarify the BLA pathway without doing another phase 3 study for that particular indication and then to be able to move forward with our proposal.

Operator: So in that type of scenario, we're still having the multi-cohort study data for potential, labelled expansion coming after BLA sliding and hopefully approval.

Operator: And maybe I'll make one other comment.

Operator: The multi-cohort study, which is currently enrolling, and we're also using commercial material, obviously, in the clinic for both studies and also for expanded access and compassionate use and so forth, that study is ongoing, generating data and obviously with our progress in Europe, we intend for this to be labelled expanding in Europe as well.

Operator: And so I do think that there's a lot of data being generated on TAPSO and we believe that there are other mechanisms whereby we can solve this FDA impasse.

Operator: Great.

Operator: Thank you so much.

Operator: Our next question comes from Salveen Richter, with Goldman Sachs.

Operator: Please proceed.

Operator: Hey, thanks.

Operator: This is Matt on for Salveen.

Operator: I just wanted to know, what are you hoping to see in the multi-cohort data read in 2023 and what would give you confidence that TAPSO would demonstrate benefit in these additional populations?

Operator: And then separately, what will be included in the phase one update for 2.271 and does the enrollment pause affect what will be presented?

Operator: Thank you very much.

Operator: Thank you for your question, Matt.

Operator: Just to be clear on the multi-cohort and Jacob will, develop that, we have already presented in different congresses clinical data on efficacy and safety in each and every of these cohorts over the last few years.

Operator: So that is ultimately what makes us very confident that we should be able to have data from that particular study that replicates what we've seen in the past.

Operator: Jacob, do you want to elaborate on that?

Operator: Yeah, I think that's right.

Operator: So in essence, we feel that we have proof of concept in all six, of these cohorts that are included in the multi-cohort, meaning that these are really the same therapeutic hypothesis as the PTLD setting where you've got an immunosuppressed state in an EBV positive individual, which then drives a lymphoproliferative disorder where TAPSO is quite effective.

Operator: So for example, we have presented data on the AID-LPD indication and the PID-LPD indications, which are two of the multi-cohort cohorts.

Operator: And we've seen response rates on the order of 33% to 38% there in historical Sloan-Kettering and Attara studies as well.

Operator: But as Pascal mentioned, we really have data in all six of these indications, and the product works. And now we're obviously doing this pivotal study there to generate the registration intent data that will allow us to file on these other indications.

Operator: And as referenced, these could each be filed individually, or there may be an opportunity for a tumor agnostic filing as well.

Operator: And maybe the question in terms of... Oh yes, absolutely.

Operator: So I think it's a good question, about the 2271 mesothelial autologous program.

Operator: So working with our partners at Memorial Sloan Kettering who are conducting this study, we do have this intent to put the data into a medical, meeting here in the second half of this year.

Operator: So certainly not unlike the ESMO-IO presentation last year where we presented safety data, some early efficacy data, biomarker data, and PK data as well.

Operator: I think we would seek to present similar types of data now.

Operator: There's obviously been this voluntary hold which has delayed the enrollment of patients on study, but we certainly, depending on the medical congress that we're seeking and the re-initiation of enrollment, which we believe should occur, we'll be able to present data.

Operator: We previously described that this patient who had the SAE event, that was the first patient on Cohort 3 to be dosed.

Operator: So certainly, as you can tell, we're in Cohort 3 now with this study and then pending re-initiation of the study, and then enrollment will be able to provide updated data in that case.

Operator: And I will say, just to maybe reference why we think our CAR-T platform could be quite good, is that the PK data that we presented at ESMO-IO showed persistence of these cells with the 1XX co-stimulatory domain out past 10 weeks, at that early look at the data, which we think is quite compelling compared to other, CAR-T programs and solid tumors.

Operator: Great.

Operator: That's very helpful.

Operator: Thank you.

Operator: Thank you, Lent.

Operator: Our next question comes from Yigal Nochemovitz with Citigroup.

Operator: Please proceed.

Operator: Hi.

Operator: Can you hear me?

Operator: Yes.

Operator: Hi, Yigal.

Operator: Okay.

Operator: My question is, you know, there still seems to be a little bit of confusion around, what's going to happen at the IA.

Operator: So it would be very helpful if you could just clearly delineate for everyone what the possible scenarios are for what could happen at the interim and perhaps rank order those scenarios from most to least likely.

Operator: Thank you.

Operator: Thank you, Yigal, for your question.

Operator: So maybe I'll start, and AJ, if you want to chime in.

Operator: The scenario that we are planning right now, kind of base case scenario, is that the data we see at, the IA are aligned with our statistical assumption in terms of the trend towards the target conditional power, and therefore we enroll patient 80, and then we stop enrolling patients, or maybe a few patients that are in the process, additional patients, but we basically then follow and evaluate these patients for additional time and period to go to the end of the study a year later. So that's the base case scenario, because that's our plan.

Operator: Now, there is a scenario where we can increase the likelihood of statistical significance, for that study in increasing the sample size.

Operator: And in that case, we will need to decide by how many we need to increase in sample size, and we'll communicate that particular increase, when do we expect to end the enrollment, and therefore when do we expect to have the final result of the study and the rationale for that increase.

Operator: So that's the other scenario we've been mentioning so far, but again, for us, it's not a base, case scenario.

Operator: A base case scenario is still that we just go and move forward with what we had planned, because we hope that we will see results align what we've seen so far.

Operator: Now that's the most likely scenarios, if you're thinking about rank orders.

Operator: Now, there is also always the possibility that we have a futility analysis that shows, futility of that study there.

Operator: We don't believe that is very likely, and AJ might want to detail that, but it is part, of any type of IA.

Operator: So that's a kind of low likelihood type of scenario.

Operator: And then, of course, there's also a scenario that we've been discussing in the past, whether, increasing significantly the number of patients could lead to possibly to use that particular study as a kind of pivotal study to file for accelerated approval.

Operator: We believe that that scenario is extremely unlikely as well.

Operator: It's a bit like the futility one.

Operator: For various reasons, we can detail.

Operator: But just wanted to set the scene, and if you want, AJ, you can comment further, but at, least that's the scene as we see it.

Operator: The base case scenario, 80 is fine.

Operator: We move forward.

Operator: We enroll the last patient, follow that patient for one year, then we have the data.

Operator: Possibility to slightly increase the sample size to improve the likelihood of statistical, significance at the end of that phase two study, and we'll communicate in that case why.

Operator: That's the two most likely scenarios.

Operator: And then two very unlikely scenarios, futility or a situation where we'll have the ability, to move towards conditional approval.

Operator: Does it make sense, Igor?

Operator: Yeah, no, no.

Operator: That was very, very helpful.

Operator: Thank you.

Operator: Okay.

Operator: And then just one more.

Operator: Regarding the EMA questions that required EMA more time to review your answers, was, EMA also asking about comparability of clinical and commercial batches, like FDA, or did they have different types of questions?

Operator: No.

Operator: I think they have a typical type of submission question, which is a lot of detailed questions, and a lot of detailed questions.

Operator: And we believe that we have all the answers, and we're putting together all the answers, to these questions.

Operator: And on the particular aspect of comparability, they put, in the words of the EMA, in their, D120 critical assessment report, which is still a preliminary assessment report, that they believe that the data support comparability between clinical and commercial.

Operator: So this is not a debate with the EMA at that stage.

Operator: Okay.

Operator: Gotcha.

Operator: Thank you very much.

Operator: Our next question is from Tony Butler with Roth Capital.

Operator: Please proceed.

Operator: Thanks very much.

Operator: Pascal, simple question, I think.

Operator: Based upon, let's just assume a base case scenario, well, I guess you could argue even one where you could increase the size.

Operator: According to ClinTrials.gov, there are 31 sites that are or have been enrolling patients for ATA 188.

Operator: So the question is, do you communicate anything to those sites either at the IA or at the time of patient 80 such that they may in fact need to, I'm making this up, enroll an additional patient, just if you were to make it even for all 31 because the size needs to go up by 31 patients or some other function?

Operator: What's communicated to the clinical sites, if anything?

Operator: Thank you.

Operator: Now, thank you for your question.

Operator: AJ, do you want to take that one?

Operator: Sure.

Operator: Thanks for the question.

Operator: Yeah, I think the main thing that you'd want to communicate to the sites at that point is they're not going to get any detail on the outcomes of the IA, but they would get a very specific detail on saying, okay, here is now, if we're going to increase sample size, here is now the total target sample size.

Operator: And that's important, of course, because they're doing a lot of work to try to bring these patients in, and it takes time because they've got to pre-screen, then screen, and then go through all these procedures. So there's always that lag time, right? There's a lead time that you want to give them.

Operator: So we want to be as open in communication as possible about any numbers increased, but that would be the limit of additional communication to them.

Operator: Thank you, AJ.

Operator: Sure.

Operator: That concludes our question and answer session for today.

Operator: Thank you for joining the Attara Biotherapeutics first quarter 2022 financial results conference call.