Q2 2021 Atara Biotherapeutics Inc Earnings Call

Good afternoon, everyone. Thank you for standing by and welcome to the <unk> Biotherapeutics second quarter 2021 financial results conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation, if anyone should require operator assistance.

Operator: Good afternoon, everyone. Thank you for standing by, and welcome to the Atara Biotherapeutics second quarter 2021 financial results conference call.

Operator: At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please be advised that today's call is being recorded. I now would like to hand the call over to Eric Heilengrand, Vice President of finance and investor relations at Atara Biotherapeutics.

During the conference. Please press Star zero on your telephone keypad.

Please be advised that today's call is being recorded I now like to hand, the call over to Eric Thailand Grant Vice President of Investor Relations and finance at a torrid Biotherapeutics. Please go ahead Sir.

Eric Heilengrand: Please go ahead, sir.

Thank you operator, good afternoon, everyone and welcome to <unk> second quarter 2021 results conference call.

Eric Heilengrand: Thank you, operator. Good afternoon, everyone, and welcome to Atara's second quarter 2021 results conference call. Earlier today, we issued a press release announcing our second quarter financial results and operational progress. This press release and an updated investor presentation are available in the Investors and Media section at atarabio.com. On today's call, members of the Atari executive team will provide an update on our financial results and operational progress and also review our upcoming key milestones and objectives.

Earlier today, we issued a press release announcing our second quarter financial results and operational progress.

This press release and an updated investor presentation are available in the investors and media section at a tower of bio Dot com.

On today's call members from the entire executive team 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.

Eric Heilengrand: Joining me on today's call are Dr. Pascal Tuchon, President and Chief Executive Officer; Dr. Jacob DuPont, Executive Vice President and Global Head of Research and Development; Upaul Kopecar, Chief Financial Officer; Joe Newell, Chief Operations Officer; Dr. Jose Vidal, head of GMP Quality and Process Sciences; Dr. A.J.

And Chief Executive Officer, Dr. Jakob Dupont Executive Vice President and global head of research and development, who Polycarpic Kerr Chief Financial Officer, Joe Newell, Chief Operations Officer, Dr. Jose V Dol head of GMP quality and process Sciences Dr.

Dr AJ Joshi, Chief Medical Officer.

Eric Heilengrand: Joshi, Chief Medical Officer, and Dr. Kristen Yurema, Chief Commercial Officer. We will begin with prepared comments from Pascal and Jacob, then open up the call for your questions. We would like to remind listeners that during the call, the company's management will be making forward-looking statements. However, actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business.

And Dr. Christian you Remap, Chief commercial officer.

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

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.

Eric Heilengrand: These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filing. 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?

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

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

Thank you Amy and thank you all for joining goes for this afternoon.

Pascal Touchon: Thank you, Eric, and thank you all for joining us this afternoon. We have completed a strong first half of 2021 and are making good progress on all three or four strategic priorities, TAP cell, 888 in multiple sclerosis, and our next generation halogenicarty program. Supported by our breakthrough therapy designation, we have been having regular dialogue since January with the FDA. We recently conducted productive meetings with the review team at the FDA and gained alignment, clarity, and actionable next steps in order to submit TAPSELBL.

We have completed a strong first half of 2021 and are making good progress on all for you for putting priorities.

L. A for you.

When a T H in multiple sclerosis, and on next generation Allogeneic car T programs.

Reported by our breakthrough therapy designation, we have been not been figured out dialogues since January with the FDA.

We recently conducted productive meetings with the hurt your team at EBITDA and gain alignment clarity and actionable next steps in order to submit the top sales period.

First we gained alignment with the FDA on the key methodology for.

Pascal Touchon: First, we gain alignment with the FDA on the key methodology for evaluating the comparability between TAPSEL clinical and commercial products. In addition, the FDA asked for, and we will provide to them data on substantially all tapcell lots made to date by Atara. We believe it should clear the way for the FDA to make a determination at an upcoming Type B CMC meeting regarding or expanded data package supporting comparability between the product used in a pivotal clinical study and the intended commercial product.

Evaluating compatibility between the clinical.

Clinical and commercial product.

In addition, the.

You asked for and we will hope to them data on substantially.

Substantially all upset a lot's made 2 day by adult.

We believe this should the other way for the EBITDA to make a determination at the upcoming type B CMC meeting regarding our expanded debt a package supporting compatibility between the product used in the pivotal clinical study and the intended commercial product.

Next the EBITDA decided it cannot make a determination of comparability between the non people total product and people towards clinical study product.

Pascal Touchon: Next, the FDA decided it cannot make a determination of comparability between the non-pivotal product and a pivotal clinical study product. Hence, clinical data from the historical non-pivotal studies will not be pulled together with the pivotal allele study data.

And clinical data from the historical non people don't study.

We'll not be Pud, we the people total Elliott studied other.

Rather we intend to present these data in Berlin as part of the BLA submission.

Pascal Touchon: Rather, we intend to present these data in parallel as part of the BLA submission. Importantly, at this time, the FDA has made no new request of Atara to conduct additional clinical studies, develop new assays, or conduct new manufacturing. We are confident that we will have a robust data package to demonstrate comparability to the FDA between pivotal and commercial process versions of TAPSEL, and we are encouraged by the ongoing interactions as we work towards finalizing CMC module 3 for the ELA submission.

Importantly at this time, the ABS made no new request for Qatar to conduct additional clinical studies develop new assays or conduct new manufacturing Gulf routes.

We are confident that we will have all those data package to demonstrate compatibility to the EBITDA.

Between people total and commercial process visions of tab cel and we are encouraged by the ongoing interactions as we work towards finalizing a CMC moving fleet.

For the submission.

Pascal Touchon: Turning to the pivotal Allil study, we have recently successfully completed the analysis of the Q2 data cut, previously requested by the FDFD. Stop-line data shows a strong objective response rate in line with prior results and a consistent safety profile with no new safety signals.

Turning for the people don't a little study.

We have recently successfully completed the analyses of the Q2 that I could have you see requested by the EBITDA.

Top line data shows tone objective response rate in line with Playa resorts and a consistent safety profile with no new safety signals.

Addition, we know other new all bus durability data as well.

Pascal Touchon: In addition, we know we have new robust durability data as well. These data from a pivotal study are impressive for such an ultraware and iron methanine condition like relapse refractory PTLD, where patients have no treatment. The latest data cuts will be discussed with the FDA for the type B clinical meetings and is what we plan to use as the basis of both the BLA and the MAA emissions. As a reminder, we continue to plan to present these Phase 3 allele data at an appropriate Congress in February 4, 2021.

These data from our pivotal study are impressive for.

As such on Air Tara and I haven't met need conditions like relapse can fluctuate PTSD, where patients have no treatment options.

The latest debt that goods will be discussed with the FDA with the diabetes community and is what we plan to use as the basis of book, the BLA and MAA submissions.

As a reminder, we continue to plan to present these phase III data at an appropriate Congress in Q4.2021.

Looking ahead, we know clarity there on the required next steps for resolution and submission of the BLA for subset.

Pascal Touchon: Looking ahead, we now have clarity around the required next steps for resolution and submission of the BLAFO tab set. Although this has taken some time, as Atara is a trailblazer for allogenic cell therapy in the world, and is paving the way for this first ever allogenic T-cell therapy to reach regulatory findings, we now expect to complete the BLS emission for TAPSEL in Q1, 2022.

Although these has taken some time as other hot is the trailblazer for allogeneic cell therapy is a world and is paving the way for his first day of a allogeneic off the shelf T cell therapy to which figure that somebody fighting we now expect to complete the BLA submission for tab cel in Q1.2022.

Our investment in U S commercial readiness activities have been shifted to be timing.

<unk> spending versus what was previously anticipated as we know planned for subset approval and U S launch in the second half hospitals on quantity.

Pascal Touchon: Our investment in US commercial readiness activities has been shifted to this new timing, gating, or spending versus what was previously anticipated, as we now plan for TAPS approval and US launch in the second half of 2020. As we continue to prepare for commercial launch, I am very pleased to announce that cell therapy and oncology commercialization veteran Amit Malik has been appointed to the board of directors. Amit brings to Atara's board a wealth of experience with US payers' access and reimbursement strategies and launches of innovative oncology therapy, including cartis. Now, turning to Europe, where we're also making excellent progress.

As we continue to prepare for commercial launch I'm very pleased to announce that says they would be in oncology commercialization veteran amidst Malik was appointed to the board of directors.

<unk> brings to our board a wealth of experience with U S per user access and reimbursement strategies and launches of innovative oncology therapy, including car Ts.

Now turning to Europe, where we are also making excellent progress.

We recently a successful pre submission as well as co op. After an uplift on meeting with EMA and clear or compliance checks. So we can now move forward to submit the EU marketing authorization application for patients with EBV positive <unk> in November of 2021.

In parallel there is a strong level of interest from ex U S partners.

Partnering discussions are progressing very well in line with our expectation to secure a partner for you hope by 2 for 2021.

Pascal Touchon: We recently had a successful pre-submission as well as co-rapporter and rapporteur meeting with EMA and cleared all compliance checks, so we can now move forward to submit the EU market authorization application for patients with EBV positive PTLD in November of 2021. In parallel, there is a strong level of interest from ex-US partners, and our partnering discussions are progressing very well in line with our expectations to secure a partner for Europe by Q4 2021.

And while we are also actively on boarding patient tap sales phase II multi cohort study in other EBV driven cancers.

The 6 study populations of which the largest 2 EBV positive a I D. L. P D and EBV positive PID LTE may support meaningful Labelle expansion beyond second line peaked.

Turning now 80 to 80.188 or pulse on my teeth product candidate for patients with multiple sclerosis.

I'm very excited to announce that important new data will be presented in October at that pace.

These would include new magnetization transfer ratio imaging data.

On imaging biomarker linked with nearly nation.

In addition to the 2 year clinical data update from the Phase 1 day open label extension study.

Pascal Touchon: In the meantime, we are also actively enrolling patients in our tap cell phase 2 multi-court study in other EBVGRIVN cancers; six study populations, of which the largest two are EBV-positive AID-LPD and EBV-positive PID-LPD may support meaningful label expansion beyond second-line PTLP. Turning now 8 to 80188, our transformative product candidate for patients with multiple sclerot. I'm very excited to announce that important new data will be presented in October at. This will include new magnetization transfer ratio imaging data, an imaging biomarker linked with milination.

We are excited to present this new debt and Jacob we'll have more to say in a moment.

Meanwhile, we continue to make progress in an all in the phase II on the MA is double blind placebo controlled study or <unk> study.

We are on track to conduct an interim analyses from this study in the first half of 2022, Inc.

Including efficacy and safety in patients with progressive forms of a net.

Following this interim analysis, we expect to have further discussion with the FDA regarding potential for the adjustment for people for into.

These are in book on discussion from both a regulatory and strategic perspective for the program and could provide optionality on how we advanced development.

Momentum. Meanwhile continues to built into community reinforcing the association between EBV Epstein Barr virus NMS.

On the transformative potential of 81 HCA trauma patients.

This was confirmed by a recent survey amongst top U S neurologist we.

We also continue to see significant interest from a number of large companies regarding a potential collaboration involving 80.188.

Pascal Touchon: In addition to the two-year clinical data update from the Phase 1A Open Label Extension Study, we are excited to present this new data, and Jacob will have more to say in a moment. Meanwhile, we continue to make progress in enrolling the Phase 2 randomized double-blind placebo control study, or Enbold study. We are on track to conduct an interim analysis of this study in the first half of 2022, including efficacy and safety in patients with progressive forms of MS.

As we 20 other unique asset.

The only investigational therapy.

On the managed controlled trial in policy for mess with disability improvement as the primary endpoint.

Moving to our coffee portfolio and first on military and franchise program, a 22.71 and <unk> 32.71.

This resulted in targeted coffee products are benefiting from a global strategic collaboration with value, which is off to a strong start for.

Ikea 22, 71, or total goose mediocre in coffee program, we expect to present, the first update on phase 1 data for patients with advanced mesothelioma in Q4.2021.

Pascal Touchon: Following this interim analysis, we expect to have further discussions with the FDA regarding potential study adjustment for pivotal intent. These are important discussions from both regulatory and strategic perspectives for the program and could provide optionality on how we advance development. Momentum, meanwhile, continues to build in the community, reinforcing the association between EBV-Pypresent-by-virus and MS and the transformative potential of 80188 for MS patients. This was confirmed by a recent survey amongst top US neurologists.

The other shelf allogeneic version of this Miss was it isn't coffee program 832, 71, using a PD 1 dominant negative of scepter and 1 X X car co stimulatory signaling domain built on our EBV T cell platform is currently in IND, enabling studies and he spoke.

Pacing well.

We expect bio to submit the 9 in the second half of 2022, and subsequently lead clinical development and commercialization activities.

Turning to 830 to 19 or allogeneic CD 19, directed car T for patients with B cell malignancies.

We've gone to submit the <unk> in Q1.2022 in line with all strategy goal to develop these assets are the best in class for B cell malignancies.

Pascal Touchon: We also continue to see significant interest from a number of large companies regarding a potential collaboration involving AT188, as we truly have a unique asset, the only investigational therapy in a randomized control trial in progressive MS with disability improvement as the primary endpoint. Moving to our CARTE portfolio and the first of our Mesothelene franchise program, AT2271 and ATA 3271, these mesoteline-targeted products are benefiting from a global strategic collaboration with buyers, which is off to a strong start.

Moving to our financials.

With regard to our cash positions and underway for <unk>.

Cash burn in Q2 was $61.8 million and we ended the second quarter was on 'twenty, 1 with $373.4 million in cash.

With these cash balance and a day.

I did and well control plan expense profile.

We believe we are sufficiently funded into 2023.

As we turn our head into the third quarter of 2021, I am delighted to see how for ATA has come from this time a year ago.

Each and every 1 of our stuff is delivered on our goal of saving and improving lives of patients we still use the Z on.

Pascal Touchon: For 882271, our Autologous Mesotelincarcy program, we expect to present the first update on Phase 1 data for patient with advanced mesotelioma in Q4, 2021, of the shelf, allogenic version of this Mesotheline Carty program, ATA 3271, using a BD1 dominant negative receptor and 1XX car co-stimulatory signaling domain built on our EBVT cell platform is currently in IND enabling studies and is progressing well.

On a daily basis, we partner closely with clinical study site, we for manufacturing and logistic partners and our collaborators in order to ensure patients continue to access all therapies.

For the hard work of the other other team we are on a clear path to final upset if I get it the way submissions and bring this life saving medicine to patients in need.

I will now turn the call over to Jacob Jacob.

Thank you Pascal I am pleased to provide further details on the progress we made during the second quarter in advancing our 3 strategic priorities.

Starting with tab cel, we are aligned with the FTA on several key aspects for acquired for BLA submission.

Regarding comparability of tab cel clinical and commercial product, we reached alignment on methodologies for evaluating these 2 sets of products as requested by FDA. We are providing data on nearly all pivotal in commercial taps out lots manufactured to date, we believe.

Pascal Touchon: We expect the buyer to submit an IND in the second half of 2022, and subsequently lead clinical development and commercialization activities. Turning to ATA 3219 or allogenic CD19 targeted CARTI for patients with B-cell malignancies, we plan to submit an IND in Q1, 2022, in line with our strategy goal to develop this asset as the best in class for B-cell malignant tumors. Moving to our financials, with regard to our cash positions and runway, our cash burn in Q2 was 61.8 million, and we ended the second quarter of 2021 with 373.4 million in cash.

Ta's should agree on our comparability data package when we discuss these new data at an upcoming type B CMC meeting.

This belief is directly related to the consistent and tightened process performance data that was generated from the pivotal in commercial production campaigns as well as the fact that process changes between pivotal and commercial were minimal and mainly related to the commercial GMP.

<unk> of the EBV viral reagents used in manufacturing.

With regard to comparability of historical non pivotal tab, so product versus pivotal clinical study product. The agency recently clarified that they would like to see comprehensive analytical data on most historical loss. Therefore, we have agreed with the FDA for comparable.

<unk> cannot be establish because we do not have product available for some of the lots manufactured by Ms. Kate in the past.

Pascal Touchon: With this cash balance and our updated and well-controlled plan-expanded profile, we believe we are sufficiently funded into 2025. As we turn ahead into the third quarter of 2021, I am delighted to see how far Ataras has come from this time last year. Each and every one of our staff has delivered on our goal of saving and improving the lives of patients with serious diseases. On a daily basis, we partner closely with clinical study sites, our manufacturing and logistic partners, and our collaborators in order to ensure patients who could continue to access. Because of the hard work of the Atara team, we are on a clear path to file tap cell regulatory submissions and bring this life-saving medicine to patients. I will not turn the call over to Jacob.

This important resolution of comparability means of clinical data generated using historical non pivotal product will not be pooled with pivotal clinical data.

Accordingly. This decision is consistent with our prior FDA decision to evaluate in parallel the data of a car T product from an academic centers non pivotal product versus the industry partners pivotal clinical study product for which ultimately the FDA granted market.

<unk> approval.

Turning to the pivotal <unk> study, we have recently successfully completed the analysis of the Q2 data card present.

Requested by the FDA for the Phase III allele pivotal study Todd.

Top line data evaluated through independent Oncologic and radiographic assessment shows strong Oh are are in line with prior results with half the patients responding and a safety profile consistent with previously published data with no new safety signals.

Accordingly, this new data cut demonstrates new robust durability of response.

Jacob Dupont: Thank you, Pascal. I am pleased to provide further details on the progress we made during the second quarter in advancing our three strategic priorities. Starting with Tab Cell, we have aligned with the FDA on several key aspects required for the BLA submission. Regarding comparability of Tabso, a clinical and commercial product, we reached alignment on methodologies for evaluating these two sets of products. As requested by FDA, we are providing data on nearly all pivotal and commercial Tab Cell lots manufactured to date.

This latest data cut is what we plan to use as the basis for both the BLA and MAA submissions, while also providing additional supportive data from our historical non pivotal studies expanded access and compassionate use study patients.

To summarize next steps, we anticipate speaking with the FDA in a type B CMC meeting to discuss our expanded data package on comparability between pivotal clinical study product and commercial product as well as the type B clinical meeting to discuss the latest data cut from the <unk>.

Now with a robust durability of response data requested by the agency that will form the basis of the BLA filing request to FDA for these meetings have already been made and pending alignment. We could then file the BLA in the first quarter of 2022.

Jacob Dupont: We believe FDA should agree on our comparatability data package when we discuss these new data at an upcoming type B CMC meeting. This belief is directly related to the consistent and tightened process performance data that was generated from the pivotal and commercial production campaigns, as well as the fact that process changes between pivotal and commercial were minimal and mainly related to the commercial GMP compliance of the EBV viral reagent used in manufacture.

As Pascal mentioned, we've also made excellent progress in Europe tab cel as prime and orphan drug designation with EMA has enabled regular engagements with the agency and our Pip compliance checks have been successfully cleared on.

Our recent successful pre submission as well as co rapid rapid term meetings means that we have cleared the path for the MAA submission in the EU.

Therefore, we can submit the market authorization application for patients with EBV positive P. T O D. In November of 'twenty 'twenty 1.

Jacob Dupont: With regard to comparability of historical non-pivotal tab cell product versus pivotal clinical study product, the agency recently clarified that they would like to see comprehensive analytical data on most historical law. Therefore, we have agreed with the FDA that comparability cannot be established because we do not have product available for some of the lots manufactured by MSK in the past.

Taking a step back and thinking about P. T. L D patients in dire need of treatment options. We recently joined the rare disease Company coalition alongside other rare disease leaders and constituents to engage in conversation with policymakers on the need for speed and access.

For life changing therapies, a tara is committed to leading the path forward for transformational therapies for rare disease patients.

Jacob Dupont: This important resolution of comparability means that clinical data generated using historical non-pivotal products will not be pooled with pivotal clinical data. Importantly, this decision is consistent with a prior FDA decision to evaluate in parallel the data of a CART product from an academic center's non-pivotal product versus the industry partner's pivotal study product. for which the FDA ultimately granted marketing approval. Turning to the Pivotal Allel Study, we have recently successfully completed the analysis of the Q2 data cut requested by the FDA for the Phase 3 Allel Pivotal Study.

Moving now to a T. A 188, our product candidate for progressive multiple sclerosis, we're excited and look forward to presenting at <unk> in October long term 2 year clinical data from the phase 1 open label extension and new translational data from the phase 1 study of <unk> 100.

88 in progress of MFS.

Included will be new imaging biomarker data consider to reflect the state of Maryland myelination.

Myelination in the CNS known as magnetization transfer ratio or M E R.

Jacob Dupont: Top-line data evaluated through independent oncologic and radiographic assessment shows strong OR in line with prior results, with half the patients responding, and a safety profile consistent with previously published data with no new safety signal. Importantly, this new data cut demonstrates new robust durability of response.

With respect to MTR decrease the MTR and M. S lesions may correlate with T Mo nation, and axonal loss in MF patients while increased MTR may correlate with Reem Island nation. These data may provide key information on the mechanism of Etfs improvement in.

Our <unk> 188 clinical data we are excited to present these new data on October. We also plan to use MTR as irrelevant imaging biomarker correlated with disability improvement in our ongoing phase 2 in bold study.

Jacob Dupont: This latest data cut is what we plan to use as the basis for both the BLA and the MAA submissions, while also providing additional supportive data from our historical non-pivotal studies, expanded access, and compassionate use study patients. To summarize next steps, we anticipate speaking with the FDA in a Type B CMC meeting to discuss our expanded data package on comparability between pivotal clinical study product and commercial product, as well as the type B clinical meeting to discuss the latest data cut from the Alleles study now with robust durability of response data requested by the agency that will form the basis of the BLA-5. Requests to FDA for these meetings have already been made, and pending alignment, we could then file the BLA in the first quarter of 2022. As Pascal mentioned, we've also made excellent progress in Europe.

Turning now to our car T programs. In addition to Pascal <unk> comments I would also add that we are making excellent progress on our EMEA socio and franchise programs with our partner buyer. This partnership is helping to demonstrate the progress of the technical and manufacturing elements.

Of our EBV T cell platform, we are delighted to leverage the capabilities of such an experienced company as buyer and look forward to providing further updates later this year.

832019, our allogeneic car T for patients with B cell malignancies is also advancing well and we.

We believe that this therapy could be a best in class treatment in B cell malignancies. As there is still significant unmet need despite increased therapeutic options.

Finally, I'd like to extend a warm welcome to our newest leadership team member Chief Scientific officer, Dr. Cookie and OEM Coke He comes to US most frequently or most recently from fate and brings his deep experience in car T paired together with a strong conviction around the unique benefits of our.

EBV platform to drive our exciting car T. So franchise forward into the future on.

Jacob Dupont: TAB cells prime and orphan drug designation with EMA has enabled regular engagements with the agency, and our PIP compliance checks have been successfully cleared. Our recent successful pre-submission as well as co-raperture, rapporteur meetings mean that we have cleared the path for the MAA submission in the. Therefore, we can submit the market authorization application for patients with EBV positive PtlD in November of 2021. Taking a step back and thinking about PTLD patients in dire need of treatment options, we recently joined the Rare Disease Company Coalition alongside other rare disease leaders and constituents to engage in conversation with policymakers on the need for speed and access to life-changing therapies. Atara is committed to leading the path forward for transformational therapies for rare disease patients.

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

At this time well be conducting a question and answer session. If you would like to ask a question. Please press star 1 on your telephone Keypad, Inc.

Information from our indicate your line is in the question queue. You May press star 2 share and move your questions on the queue for participants using speaker equipment and may be necessary for you to pick up your handset for for passing the Starkey 1 moment, while we poll for questions.

Our first question comes from the line of John Newman with Canaccord Genuity. You May proceed with your question.

Hi, there thanks for taking my question on.

On the good progress here.

Jacob you mentioned the submission has been made the request for a type b meeting with a comparability data for tab cel, but curious if you know.

Jacob Dupont: Moving now to ATA 188, our product candidate for progressive multiple sclerosis. We're excited and look forward to presenting at Ectrums in October long-term two-year clinical data from the Phase 1 Open Label Extension and new translational data from the phase one study of ATA 188 and progressive MS. Included will be new imaging biomarker data considered to reflect the state of myelination in the CNS known as magnetization transfer ratio or MTR. With respect to MTR, decreased MTR in MS lesions may correlate with demilination and axonal loss in MS patients, while increased MTR may correlate with remilination. These data may provide key information on the mechanism of EDSS improvement in our ATA 188 clinical data We are excited to present these new data in October. We also plan to use MTR as a relevant imaging biomarker correlated with disability improvement in our ongoing phase two embolded study.

But when that might take place and then on the clinical side.

Beyond the most recent.

Data look.

For allele that you've conducted just curious if you think the agency will require any additional data looks in the future.

Maybe on some additional patients for.

Longer follow up thanks.

Thank you John for your question Jacob do you want to take the first 1.

Thanks, Pascal on thank you John.

Yes, we have submitted meeting request for the type B meetings.

Both for CMC comparability and for the clinical discussion as well now per Purdue for timelines, we should hear back from the agency within 60 days of that request. So we believe that this meeting will occur within the next 2 months.

And the second question on clinical data beyond value yes.

Totally so.

We believe that this new analysis for allele is strong enough to support a BLA filing but of course, if the FDA wants updates specifically such as safety with a subsequent 90 day safety cut we can certainly do that.

But we do believe that the current Q2 data cut for our Lisle.

Is sufficient to support the BLA.

Emission as well as the MAA application and as you know, we're also going to be providing historical non pivotal data and EAP, an SBU clinical data in the BLA and MAA filings in parallel, but not in a pooled fashion due to the outcome.

Jacob Dupont: Turning now to our CART programs, in addition to Pascal's comments, I would also add that we are making excellent progress on our mesothel and franchise programs with our partner buyer. This partnership is helping to demonstrate the progress of the technical and manufacturing elements of our EBVT cell platform. We are delighted to leverage the capabilities of such an experienced company as our buyer and look forward to providing further support later this year.

Which we thought was quite favorable in terms of non comparability between historical and pivotal material.

Does it answer your question John.

Yes. It does thank you.

Thank you.

Our next question comes from the line of Jonathan Miller with Evercore ISI. You May proceed with your question.

Hey, guys. Thanks for.

Jacob Dupont: ATA 3219 is allergen-A-car-T for patients with B-cell malignancies is also advancing well, and we believe that this therapy could be a best-in-class treatment for B-cell malignancies, as there is still significant unmet need despite increased therapeutics. Finally, I'd like to extend a warm welcome to our newest leadership team member, Chief Scientific Officer, Dr. Koki Noyan. Koki comes to us most frequently or most recently from fate and brings his deep experience in KART-tee paired together with a strong conviction around the unique benefits of our EBV platform to drive our exciting KARTE cell franchise forward into the future. I'll now turn the call back to the operator to begin the QA portion of the call. Operator?

Thanks, taking my question and congrats on all the progress it does seem like the FDA is being pretty cautious on the tab cel BLA.

I guess given that you can't pool on that you think the Q2 update on allele is is as far as you're going to need to go.

What is the duration of response that you'll be able to claim on the pivotal data.

Relative to what you could have claimed on the on the pooled data.

Separately, it seems like I N D timelines for the allogeneic.

Car T programs are going to be a little bit back towards the back end of the prior guidance I just wondered what's the gating factor on those <unk> going forward from here.

Thank you for your question do you want to take the first question Jacob Please yes, absolutely so.

I would say that we've made great progress with the FDA in terms of understanding the comparability issues and then obviously also providing this Q2 data cut at the FTA request for it for months in on.

Operator: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press Star 1 on your telephone keypad. A confirmation film will indicate your line is in the question queue. You may press Star 2 to remove your question from the queue for participants using speaker equipment. It may be necessary for you to pick up your handset before pressing the Star One moment while we pull for questions. Our first question comes from the line of John Newman with Kana Corgenuity. You may proceed with your question.

Tober of last year's specifically to provide durability data on the patients that had already enrolled now the guidance that the FDA has provided to us which they provide you. Other sponsors is that they want to see durability of that response, which basically means that from the time that a response is detected.

You want an additional 6 months of follow up on those patients since the time of response. So if you think about we got that guidance in October of last year, we let the data mature further collected the data based on our Q2 data cut then provided to our independent review facility for independent oncology.

John Newman: Hi there, thanks for taking my question. Congratulations on the good progress here. Jacob, you mentioned a request for a type B meeting for the comparability data for tabs has been made. I'm just curious about when that might take place.

<unk> and radiographic response, it really fits those criteria of 6 months.

Our duration of response after that initial responses detected and that's pretty standard requests from the agency.

Jacob Dupont: And then on the clinical side, beyond the most recent data look for Allel that you've conducted, just curious if you think the agency will require any additional data looks in the future, maybe either with some additional patients or longer follow-up. Thank you, John, for your question. Jacob, do you want to take the first one? Yeah, thanks, Pascal. Thank you, John.

On the other thing the fact that we along with the agency on the durability of response he wants to see and we are is that on now makes us very confident in the strength of this data package that will present in a forthcoming diaby clinical meeting.

So on your second questions is just that we have refined our thinking on the different manufacturing timelines for this program and develop bonds that is needed to file the <unk>. Therefore, we are doing on this platform.

Jacob Dupont: So yes, we have submitted meeting requests for type B meetings, both for CMC comparability and for clinical discussion as well. Now, per PDUFA timelines, we should hear back from the agency within 60 days of that request, so we believe that this meeting will occur within the next two months. And the second question on clinical data beyond the allele? Absolutely. So, we believe that this new analysis for Allel is strong enough to support a BLA filing, but, of course, if the FDA wants updates specifically, such as safety with a subsequent 90-day safety cut, we can certainly do that.

Progress on these specific programs, we by the way it helps the rest of the early pipeline and we are leveraging our platform. There. So there is no particular aspect there that is a particular challenge apart from the fact that we have no fine tune the exact timing for the IND filing and for 832.19 will be of course other half on <unk>.

For 30 to 71 will be by your filing year in detail now we also trying in developing these indeed package make sure that we can optimize on chunk of other inc. The 2 best in class platform forward any coffee and this is we believe we're at 32.19 in particular, who the significant potential advantage and optimized.

Inc. Characteristic of the sales to make sure that we can leverage the unique properties of <unk> sales together with <unk> as a co stimulatory domain to really make something that could go to the clinic with the potential in the the goal to be a best in class in B cell malignancies.

Jacob Dupont: But we do believe that the current Q2 data cut for Alliel is sufficient to support the BLA submission as well as the MAA application. And as you know, we're also going to be providing historical non-pivotal data and EAP and SPU clinical data in the BLA and MAA filings in parallel, but not in a pooled fashion due to the outcome, which we thought was quite favorable in terms of non-comparability between historical and pivotal materials. Does that answer your question, John? Yes, it does. Thank you.

It answered your question from.

Oh, yes, absolutely. Thank you.

Okay.

Our next question comes from non line of selling day with me for Securities. You May proceed with your question.

Great. Good afternoon, guys and congrats on the progress a couple for me if I can on it day 188.

Pascal you sound pretty excited and I know the press release, even uses the word exciting new imaging data.

Jonathan Miller: Our next question comes from the line of Jonathan Miller with Eberchor ISI. You may proceed with your questions.

So as much as it.

Jonathan Miller: Hey guys, thanks for taking my question and congrats on the progress. It does seem like the FDA is being pretty cautious on the tab-celled LA. I guess given that you can't pool,

As much as you can see here about you know the MTR and whether that's actually you know.

For the first 2 myelination pattern or are you seeing or are you think youre seeing re myelination.

With me are with the with what they tell you 188.

Jacob Dupont: You think the Q2 update on allele is as far as you're going to need to go? What is the duration of response that you'll be able to claim on the pivotal data relative to what you could have claimed on the...

I'm curious to get your thoughts on the FDA being able to use this as a biomarker for accelerated approval I'm just given everything we've seen with accelerated approval around all timers. Thank you.

Thank you.

We are definitely excited but we're not going to give you. The data that you will have to wait for October but AJ do you want to comment on MTR in what we believe this particular set of data is very important and what's her plan with the EBITDA in terms of how this could be used as a biomarker.

Jacob Dupont: to what you could have claimed on the pool of data. Separately, it seems like IND timelines for the allergeniac CART programs are going to be a little bit towards the back end of the prior guidance. I just wondered, what's the gating factor on those INDs going forward from here? Thank you for your question. Do you want to take the first question, Jacob, please?

Yeah.

Thanks for asking all hate to Liam.

Yes, I think with the MTR data you you've heard that its pretty much. The when you look at MRI.

Jacob Dupont: Yes, absolutely. So I would say that we've made great progress with the FDA in terms of understanding the comparability issues and then, obviously, also providing this Q2 data cut that the FDA requested from us in October of last year, specifically to provide durability data on the patients that had already enrolled. Now, the guidance that the FDA has provided to us, which they've presented to other sponsors, is that they want to see durability of that response, which basically means that from the time that a response is detected, you want an additional six months of follow-up on those patients since the time of response.

Biomarkers looking at Myelination, that's really the most used 1 and all of the studies that Youre looking at and as you might imagine it's been correlated with declining.

Decline in Etfs, so decline in disability. So you know if you have lower MTR you actually have lower on chart means you have demyelination than when you have a decline in disability. So that correlation has been made whats interesting is no one's actually shown improvement because as you know no no product has shown improvement in disability and a progressive.

Situation, but what is interesting is if you take a look at MTR in relapsing disease. So this is where you've got an active lesions and you use a therapy that works in inflammatory disease, you'll actually see MTR increase because you get re myelination once the inflammation calms down so you do see.

Jacob Dupont: So if you think about, we got that guidance in October of last year, we let the data mature further, collected the data based on acute due data cut, then provided it to our independent review facility for independent oncologic and radiographic response, it really fits those criteria of six months duration of response after that initial response is detected. That's a pretty standard request from the agency.

MTR, increasing when you have your myelination is just never been shown on the progressive setting.

So from that came from what we're trying to as we're trying to say look MTR relatively established as a measure of myelination, both demyelination Andrey and we're now trying to apply that to the study data that we have now so.

Obviously, we're looking forward to presenting the data.

Coming in October and in terms of how you could leverage is going forward, it's really not been used as a anything like a surrogate marker or anything like that to date.

Jacob Dupont: Yeah, and I think the fact that we align with the agency on the durability of response to see, and we have these data now makes us very confident in the strengths of this data package that will be presented at a forthcoming type B clinical meeting. Now on your second question, it's just that we have refined our thinking on the different manufacturing timelines for this program and the developments that are needed to file the IND.

But again a lot of that we think is just because they're there hasnt been on lot of good reason to take a look at disability improvement in and MTR changes so certainly.

We're going to very closely monitor MTR throughout the course of the fate of the Ebola study and we're gonna be talking to FDA, and we will be including all of the MTR discussions in those conversations but today, it's a little bit too early to say, yes. There's this is going to be on.

Satish biomarker, but from a scientific perspective on the clinical as prospective it is established within the scientific community right now.

Yes.

J S said it will be 1 of the endpoints will be following in the curve on top of mind control trials from openly with data coming in October on the phase 1, but we are also data coming for wild later on on the Phase III study when we get access to this debt. So that's something.

Jacob Dupont: The work we are doing on this platform as we progress on these specific programs, we help the rest of the early pipeline, and we are leveraging our platform there. So there is no particular aspect there that is a particular challenge, apart from the fact that we have now fine-tuned the exact timing for the IND filing, and for 80 and 3219, it will be, of course, Astra filing the IND, whereas for 3271, it will be the buyer filing the IND.

Something of a plan in terms of leveraging these particular biomarker that hasn't been used in a number of studies, but not yet correlated with improvement in disability and that could be something very exciting.

Super helpful. Thanks, so much.

Our next question comes from the line of thought on that Joe with Cowen You May proceed with your question.

Good afternoon, congrats on the progress and thanks for taking my question a couple on the comparability issue you mentioned briefly in your prepared remarks, what the differences are between the pivotal on commercial material could you go into a bit more.

Jacob Dupont: Now, we're also trying to develop this IND package to make sure that we can optimize our chance of having a true best-in-class platform for Alogenic Carty. And this is, we believe, where ATEF3219 in particular could have a significant potential advantage in optimizing the characteristics of the cells to make sure that we can leverage the innate properties of EBVT cells together with 1XX as a cost-stimulatory domain to really make something that could go to the clinic with the potential and the goal to be best in class in B-cell magnanimity.

Detail on the significance of those differences and then secondarily.

That's the methodologies have been clearly defined you can talk a bit more about your confidence that you will find the pivotal on commercial material comparable.

Now certainly Joseph do you want to address the first question on the difference between people total in commercial material and then Jacob you cannot have a second question on the EBITDA.

We do see the confidence that we have that we adapt our debt will be being them to decide positivity on compatibility.

Yeah.

Certainly possible yes.

For instance are the actual source on grade of Epstein Barr virus that we use from the manufacturing process are we.

Jacob Dupont: Does that answer your question, John? Yes, absolutely. Thank you.

From Ah Ah Ah.

Clinical research grade for those sorts of like Joe for the survivors into a full GMP commercial grade producer cell line and we.

Salveen Jaswal Richter: Our next question comes from the line of Salim Said with MiSchool Securities. You may proceed with your question.

Salveen Jaswal Richter: Great. Good afternoon, guys, and congrats on the progress. A couple from me, if I can, on ATA188. So, Pascal, you sound pretty excited, and I know the press release even uses that word exciting, new imaging data. So as much as you can say here about the MTR and whether this actually refers to myelination patterns, are you seeing, or do you think you're seeing remilination with ATA 188? I'm curious to get your thoughts on the FDA being able to use this as a biomarker for accelerated approval, just given everything we've seen with accelerated approval around Alzheimer's. Thank you.

Switch also the manufacturing place up the virus to our own facility from the previous CMO of the CMO had no capacity to supply.

Volumes are we have done for characterization on debt and we're pretty confident that it's a minimal change, but that's the summary of the change between people on Pinnacle's Montreal.

Thank you Jacob on how do we see the data package for the FDA absolutely. So.

I think 1 of the really important things so that we have.

Learn from the FTA as Theyre thinking evolved around tab cel, which is as you know the first allogeneic T cell product, which is going across for FDA approval. We've learned that they had this requirement now to see the data from all of the lots that have been.

Pascal Touchon: Thank you, Salim. We are definitely excited, but we are not going to give you the data. You will have to wait for October. But, AJ, do you want to comment on MTR and why we believe this particular set of data is very important? And what's our plan with the FDA in terms of how this could be used as a biomarker? Yeah, thanks, Vescal. Hey, Aleem.

Created in order for a determination of comparability to be made between pivotal material and commercial material that was the reason why we could not deemed comparability between historical and pivotal because we simply didn't have some of the lots from memorial Sloan Kettering, but what we.

We do have on.

Virtually all of the lots from pivotal and commercial so that we can do for comparability analysis. So having the agency gave us the lay of the land and what the requirements were in terms of sharing the totality of that data that is something that is really accomplishable.

A.J. Joshi: Yes, I think, you know, with the MTR data. It's pretty much, when you look at MRI biomarkers looking at myelination, that's really the most used one in all the studies that you're looking at. And as you might imagine, it's been correlated with decline in EDSS, so decline in disability. So, you know, if you have lower MTR, you actually have, lower MTR means you have deemylination, that means you have a decline in disability. So that correlation has been made.

For from our perspective, and having that clarity from the agencies really valuable. So that's why we put the type B meeting request in which again will occur within the next 60 days or so and we will put to them exactly that question of have we now secured this comparability with the full data package with our help.

Jim Jose and his full team and CMC manufacturing and we believe that we're going to achieve this because we know what the rules of engagement are.

A.J. Joshi: What's interesting is no one's actually shown improvement because, as you know, no product has shown improvement in disability in a progressive situation. But what is interesting is if you take a look at MTR in relapse, so this is where you've got an active lesion and you use a therapy that works in inflammatory disease, you'll actually see MTR increase because you get remission once the inflammation comes down. So you do see MTR increasing when you have remilination, but it's just never shown in the progressive setting.

Yes, it will be a favorite where saw that.

That assets. We are is really very robust due to the whole business of on manufacturing process performance and the minimal changes that we've made between people out on in commercial pulses as rosy as just explained.

Great.

Yeah, maybe 1 just 1 on what what's the rate limiting factor for the Q1 filing because that comparing is that completing the comparability analyses or is there something else like beauty.

Jacob Yes so.

To provide these details so as mentioned we want to have the type B CMC meeting within 60 days.

Solidify the issue of comparability of pivotal for historical so that will get taken care of then we have the type B meeting for clinical where we share. The most recent data cut from a Leo and we get the agency agreement on that now that hopefully is going to solve most of the issues now there may be some more.

A.J. Joshi: So from that standpoint, what we're trying to do is we're trying to say, look, MTR is relatively established as a measure of myelination, both demyelination and ri, and we're now trying to apply that to the study data that we have now. So obviously, we're looking forward to presenting the data coming in October. And in terms of how you could leverage this going forward, it's really not been used as anything like a surrogate marker or anything like that to date. But again, a lot of that we think is just because, you know, there hasn't been a lot of good reason to take a look at disability improvement and MTR changes.

More administrative issues that could get taken care of in a pre BLA meeting. So our base case is had these 2 type b meeting with the FDA and then after that have a pre BLA meeting that leads to a Q1 completion of the BLA filing now there is an outside chance that if we saw.

The cure all of the issues in these 2 type of meetings that we may be able to have.

Faster submission of the BLA, but frankly, our base case is to say we need to have these 2 type b meetings than the pre BLA meeting and then we complete the submission of the BLA.

And what makes US confident there is again the strength of the data we know the data.

In terms of clinical data out there from the allele that occurred in Q2 and a very strong.

A.J. Joshi: So certainly, we're going to very closely monitor MTR throughout the course of the bold study. And we're going to be talking to FDA, and we will be including all of the MTR discussions in those conversations. But today it's a little bit too early to say, yes, this is going to be an established bymarker. But from a scientific perspective, From a clinical perspective, it is established within the scientific community.

No the whole business of a pulse says and we have all the debt are needed to provide year on year with substantially all of the lots or does that on older lots made by other hub. So in terms of delivering what the FDA is asking for we feel very clear.

That's very helpful. Thanks for taking my questions.

As a reminder, if you would like to ask a question. Please press star 1 on your telephone keypad, 1 moment, while we poll for questions.

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

A.J. Joshi: Yeah, and as AJ has said, it will be one of the endpoints we follow in the current randomized control trials. So not only will we have data coming in in October on phase one, but we'll also have data coming forward later on in the phase two study when we get access to this data. So that's something of a plan in terms of leveraging this particular biomarker that has been used in a number of studies but not yet correlated with improvement in disability. And that could be very exciting.

Good afternoon. Thanks for taking my question for a few.

First was it always the plan to have a type b clinical meeting after the Q2 day because it just seems like that would kind of made it impossible for previously have hindered your your guidance for Q3 submission completing the submission regardless of obviously the CMC issues. So just wondering if that is something new.

Because again it doesn't seem like that lines up with your previous guidance on timelines outside of obviously the CMC issues.

Pascal Touchon: Super helpful. Thanks so much.

Okay. So maybe answer the first question on the guidance and then you say that you have some other question now I think what when we put the guidance on Q3. It was really based on the type B CMC meeting that we had in Q2 and on the basis that following debt Tybee CMC meeting.

Phil Najee: Our next question comes on the line from Phil Najee with Cowan. You may proceed with your questions.

Phil Najee: Good morning, and congratulations on the progress and thanks for taking our question. A couple of questions on the comparability issue: you mentioned briefly in your prepared remarks what the differences are between the pivotal and commercial material. Could you go into a bit more detail about the significance of those differences? And then, secondarily, now that the methodologies have been clearly defined, you talk a bit more about your confidence that the FDA will find the pivotal and commercial material.

We could then move from a per.

EBITDA meeting and in the August timeframe based on the data cut and then then go with that with the submission of the BLA by the end of Q3 that was basically the guidance.

Basis debt now what's happening is we have the 2 aspect now we have the new data on the audience data set and then we are at the same time.

Data coming from this request of the EBITDA that will up.

Phil Najee: Now, certainly, Jose, do you want to address the first question on the difference between Pivotal and commercial material? And then Jacob, you can address the second question on the FDA, how we perceive the confidence that we are, that we have data that will be paying them to decide positively on comparability. Certainly, Pascal.

Need to see all the many factor on nearly all of the manufactured load by other other so we are aligned with the FDA. During our recent interactions and that was just a couple of weeks ago, where that's the best with for what will beat was in parallel Diaby meeting on the CMC aspects the ability on a clinical second look at the clinical data out there.

And then we can have a pre BLA that will just be the more check the box administrative part of the pre BLA meeting. So that's why it's put together, which is to type B meeting and then a PVA day and in the past it was supposed to be to move directly from the <unk> would put beauty Jacob anything to add to that.

Jose Vidal: Yes, the difference is the actual source and grade of the Epstein-Barr virus that we use in the manufacturing process. We switch from a clinical research-grade producer cell line to produce the virus into a full GMP commercial-grade producer cell line. And we switched also the manufacturing place of the virus to our own facility from the previous CMO, as the CMO had no capacity to supply commercial volumes. We have done full characterization on that, and we're pretty confident that it's a minimal change, but that's the summary of the change between PIVO and clinical materials. Thank you.

I think you've summed it up very well Pascal.

Does it answer your question Matt.

Yeah, I guess it just seems like maybe there's something that's come up that's required at other type B meeting since that obviously wasn't planned originally but okay.

Just wondering if you'd previously said that you had about 15 lots manufactured from durability I Wonder if that's still kind of the number you plan to go into this type B meeting with on the CMC side or if there are any additional lots that will be used in the comparability.

Jakob you want to stop and do what they can chime in if needed.

Absolutely so Matt I think this really speaks to how the thinking of the FTAA has evolved and where we now have this clarity of guidance because.

Jacob Dupont: And Jacob, how do we see the data package for the FDA? Absolutely not. So I think one of the really important things, Phil, that we learned from the FDA is how their thinking evolved around Tabsa, which is, as you know, the first allergen-A-t-cell product which is going to be submitted for FDA approval. We learn that they have this requirement now to see the data from all the lots that have been. created in order for a determination of comparability to be made between pivotal material and commercial material. That was the reason why we could not deem the comparability between historical and pivotal because we simply didn't have some of the lots from Memorial St. Catering

You are right what we presented to the agency was 15 lots from each process version, which really gives us robust statistical power for that comparison now.

For example, if you talk about a small molecule inhibitor or you talk about an antibody generally speaking they want about 3 lots to compares statistics on that we're providing 15 of each process version, but then the agency came out and said listen we really want to assess all year lots for pivotal and commercial which is really more.

Jacob Dupont: But what we do have are virtually all of the lots from pivotal and commercial so that we can do full comparability analysis. So, having the agency give us the lay of the land and what the requirements were in terms of sharing the totality of that data, that is something that is really achievable from our perspective. And having that clarity from the agency is really valuable. So that's why we put in the type B meeting request, which will occur within the next 60 days or so.

System with the requested they made for Allo car T. Because on the total gross I'm, sorry auto car T. Sorry auto is what I'm, referring to where each 1 of those products.

Each 1 of those sub products was an individual drug for that individual patients. So the agency wanted to see every single 1 of those now the whole idea with allo.

Jacob Dupont: And we will put to them exactly that question of whether we have now secured this. comparability with the full data package with the help of Jose and his full team in CMC manufacturing. And we believe that we're going to achieve this because we know what the rules of engagement are. Yeah, and we also say that the whole data set we have is really very robust due to the robustness of our manufacturing process performance and the minimal changes that we've made between the pivotal and commercial processes, as Jose just explained.

Allogeneic T cell therapy is that you are able to treat many patients from your inventory. So you don't need to make 1 product from each patient. So we have for proposed this robust statistical approach, where we gave them 15 lots from each of the process versions and but the agency.

Did fall back to this.

Approach with US and said, we want to see all lots and we said okay fine we can deliver that with our pivotal to commercial material and that's exactly what we're providing to them in this type B CMC meeting, which is where we have confidence that we're going to be able to resolve this comparability issue.

Phil Najee: Great. And maybe just one last question. Yeah, maybe just one last question. What's the late rate limiting factor for the Q1 filing? Is that comparing, is that completing the comparability analyses, or is there something else next?

So if anything for us.

Bob.

Yes.

Question on beyond the 15 lots up for.

For us it's very strong in total representing now 70 for lots to the agency.

Oh, okay.

Jacob Dupont: Jacob? Yeah, so to provide these details. As mentioned, we want to have the type B CMC meeting within 60 days to solidify the issue of comparability of pivotal to historical data, so that will get taken care of. Then we have the type B meeting for clinical where we share the most recent data cut from Aleo, and we get the agency agreement on that. Now, hopefully, that is going to solve most of the issues. Now there may be some more.

Yeah, that's right for them more than 95% of the total lots for you. So that that's exactly what the agency wants to see and we believe that day. The main rationale is that they want to confirm the whole business of manufacturing process for cell therapy and other used to with auto gross you know they they have habits zone.

Okay..1 last question on the.

Magnetic transmission.

On the MTR data that we're gonna see it's just something you've you've collected on every patient or how many patients should we expect because I can't recall this being something that was listed as a data being collected and just.

Jacob Dupont: more administrative issues that could get taken care of in a pre-BLA meeting. So our base case is to have these two Type B meetings with the FDA, and then after that, have a pre-BLA meeting that leads to a Q1 completion of the BLA filing. Now, there is an outside chance that if we secure all the issues in these two Type B meetings, we may be able to have a faster submission of the BLA, but frankly, our base case is to say we need to have these two Type B meetings, then the pre-BLA meeting, and then we complete the submission of the BLA.

Will it be how many type 1 does it a pretreatment and then now.

The 12 or 18 month follow up what kind of can you give us anything else on what to expect here.

Sure. So the way the MTR works is it's really an analysis you can do when you've got a good quality MRI done so.

So when you have a good quality MRO results you can actually go ahead and do them turn analysis. It at whatever time points. So for as you know for our phase..1 study we did 6 month and 12 month time points for E. S. S. So that's the kind of thing we'll be looking to talk about in India.

Jacob Dupont: And what makes us confident there is, again, the strength of the data. We know the data in terms of clinical data from the allele data cutting Q2, and it is very strong. We know the robustness of our process, and we have all the data needed to provide the FBA with substantially all the lots, all the lots made by Yatara. So in terms of delivering what the FD is asking for, we feel very clear.

In the.

With MTR and then going forward in the RCT literally every single time point than an MRI is done we will be able to assess the MTR as well.

And on the number of patients older patients in a phase 1 all the patients that have a good MRI will have a result there.

Okay. Good.

Yeah.

Yes.

Phil Najee: That's very helpful. Thanks for taking our questions.

Our last question comes from the line of Ben.

Burnett with Stifel. You May proceed with your question.

Operator: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. One moment while we pull for questions. Our next question comes from the line of Matt Fitz with William Blair. You may proceed with your question.

Hi, This is Kelly on for Ben Burnett, Thanks for taking our questions. We just have 2 kind of quick ones. I was wondering if you guys could give any additional color on what we might see on <unk>.

Matt Fitz: Good afternoon. Thanks for picking my questions. I have a few.

The 88 to 271.

Read out the first 1 on in terms of maybe duration of response or the number of patients we might see them and then Additionally, I'm wondering I had a question for 83 to 1.9.

Matt Fitz: First, was it always a plan to have a type B clinical meeting after the Q2 data cut? It just seems like that would kind of make it impossible to previously have hit your targets.

Matt Fitz: your guidance for the Q3 submission, completing that submission, regardless of

If you guys are planning on.

Releasing any preclinical data for that.

Matt Fitz: that submission regardless of obviously the CMC issues. So just wondering if that is something new, because again, doesn't seem like that lines up with your previous guidance on timelines outside of obviously the CM. Okay, so maybe answer the first question on the guidance, and then you say that you have some other questions.

Thank you.

Thank you for your question Jacob for you want to take this questions yeah, absolutely. So thank you for the question.

In terms of 80, $822.71, which is our autologous meso ceiling car T program.

Which we're doing with memorial Sloan Kettering, obviously, it's in the buyer partnership as well as we've announced we do plan on presenting the first clinical data at a relevant meeting medical meeting before the end of this year. So we're certainly intending on.

Pascal Touchon: Now, I think when we put the guidance on QFRI, it was really based on the type B CMC meeting that we added onto two, and on the basis that following that TIP CMC meeting, we could then move from a pre-ABLA meeting and, in the August timeframe based on the data cut, and then go with that with the submission of the... BLA by the end of the QFRI period. That was basically the basis for the guidance.

Presenting that clinical data now we do plan on presenting safety efficacy biomarker data from this study.

Pascal Touchon: Now what's happening is we have two aspects now. We have the new data on Allil's data set, and then we have at the same time the data coming from this request of the FDA that will need to see all the manufacturers, nearly all the manufactured load by Atara there.

And we have enrolled the first cohort of patients on this study with our partners at MSA and we are currently enrolling the second cohort as well so again, depending on data maturity and so forth you'll see.

These various elements and I do want to highlight this program. We think is really quite innovative and interesting because yes, it's autologous.

Pascal Touchon: So we aligned with the FDA during our recent interactions, and that was just a couple of weeks ago, where the best way forward would be to have, in parallel, a type B meeting on the CMC aspect, and a type B meeting on the clinical aspects, so you can look at the clinical data there. And then we can have a pre-BLA that will just be the more check-the-box administrative part of the pre-BL meeting.

And it has this 1 X X co stimulatory domain that we've in licensed from Michelle Sandlin.

And his team, which we think is a.

Potentially best in class co stimulatory domain for car T and it also has the PD 1 dominant negative receptor, which provides intrinsic overcoming a day immuno suppression of tumor PDL..1 so the auto program has both of these components now obviously, we're working on.

Pascal Touchon: So that's why it's put together with these two type B meetings and then a pre-BLA. And in the past, it was supposed to be the move directly from the type B-CMC to a pre-BLA. Jacob, anything to add to that?

Also on the Allogeneic program $32.71, and Thats moving towards an IND filing where at this point, we're leveraging our EBV T cell platform. Additionally, there now in terms of $18.32.19, and we're very excited about that program.

Pascal Touchon: No, I think that you've summed it up very well, Pascal. Does that answer your question, Matt? Yeah, I guess so. It just seems like maybe there's something that's come up that's required another type B meeting since that obviously wasn't planned originally. But okay. Just wondering, you previously said that you had about 15 lots manufactured for comparability.

Our first allogeneic.

Car T cell program out of the gate, it's directed against CD 19, We do believe this is a best in class potentially program and we did present at.

As last year in 2020 preclinical data from that $32.19 program. So we can certainly.

Matt Fitz: I wonder if that's still kind of the number you plan to go into this type B meeting with on the CMC side, or if there's any additional lots that will be used in the comparability.

That data is certainly available from ash.

And that also Leverages. This 1 X X co stimulatory domain for Doctor Saddling and his team at M. S. K.

Jacob Dupont: Maybe Jacob you want to start, and Jose can chime in if you need it. Yeah, absolutely. So, Matt, I think this really speaks to how the thinking of the FDA has evolved and where we now have this clarity of guidance because, you know, you're right. What we presented to the agency was 15 lots from each process version, which really gives us robust statistical power for that comparison. For example, if you talk about a small molecule inhibitor or you talk about an antibody, generally speaking, they want about three lots to compare statistics on that.

And we're excited about that forthcoming IND submission.

Pascal anything for low singles too.

Remind everyone that this program is also we believe supported by these clinical proof of principle that was established by the team at Memorial that's true at the Congress in 2020 that similar type of construct based on EBV T cells from healthy donors to which they are adding.

<unk>, a CD 19 car T in that case, we would traditional co stimulatory domain.

On the treated patients with advanced B cell malignancies, and they achieve an 83% CR rate and that study was quite amazing and unique in a sense that they followed patients for very long time and that CR rate was maintained over media on the photo of nearly 2 years. So I think that's really a very impressive data set.

Jacob Dupont: We're providing 15 of each process version, but then the agency came out and said, listen, we really want to assess all your lots for pivotal and commercial, which is really more consistent with the request that they made for alokartee. I'm sorry, auto car tea. I'm sorry, auto is what I'm referring to.

On the small nimble patients, but with long durability of response on excellent safety. So that's a nice proof of principle for what we want to achieve sales of potential best in class in particular, all other in a onex sectors across the military domain.

Jacob Dupont: To, where each one of those products, each one of those cell products was an individual drug for that individual patient, so the agency wanted to see every single one of those. Now, the whole idea with allogenic T-cell therapy is that you're able to treat many patients from your inventory, so you don't need to make one product from each patient.

Yeah.

Any further questions.

That's it for me thank you.

You're most welcome.

That concludes our question and answer session for today. Thank you for joining the <unk> Biotherapeutics second quarter 2021financial results Conference call. You may disconnect your lines at this time.

Jacob Dupont: So we proposed this robust statistical approach where we gave them 15 lots from each of the process versions. But the agency did fall back on this approach with us and said, "We want to see all the lots." And we said, okay, fine; we can deliver that with our pivotal to commercial material, and that's exactly what we're providing to them in this type B CMC meeting, which is where we have confidence that we're going to be able to resolve this comparability. Was there anything to watch out for? Yes, to the question of beyond the 15 lots per process version. In total, we're now presenting 74 lots to the age. Okay.

Thank you.

Okay.

[music].

Jose Vidal: That represents more than 95% of the total lots produced. So that's exactly what the agency wants to see. And we believe that the main rationale is that they want to confirm the robustness of the manufacturing process for cell therapy and whether they are used to with autologos.

Okay.

[music].

Jose Vidal: You know, they have habits. Okay, one last question, magnetic transmission, MTR data that we're going to see. It's just like you've collected on every

Matt Fitz: or how many patients should we expect? Because I can't recall this being something that was listed as data being collected. And just how many time points will it be? Is it a pre-treatment? And then now...

Matt Fitz: you know, 12 or 18 month follow-up; what kind of advice can you give us?

Matt Fitz: Can you give us anything else on what to expect here? Okay.

A.J. Joshi: Okay, Jay? Sure. So the way the MTR works is it's really an analysis you can do when you've got a good quality MRI done. So when you have good quality MRI results, you can actually go ahead and do the EMTAR analysis at whatever time points you want. So, you know, as you know, for our phase one study, we did six months and 12 month time points for EDSS, so that's the kind of thing we'll be looking to talk about with MTR.

Okay.

[music].

Sure.

Yes.

Yes.

Yeah.

[music].

A.J. Joshi: And then going forward in the RTSS, CT, literally every single time point that an MRI is done, we'll be able to assess the MTR as well. And on the number of patients, that's all the patients in phase one? All the patients that have a good MRI will have results. Okay, good. Because it's a different thing.

Ben Burnett: Our last question comes from the line of Ben Burnett. But Ceple, you may proceed with your question.

Kaylee Breeze: Hi, this is Kaylee Breeze on behalf of Ben Burnett. Thanks for taking our questions. We just have two quick ones. I was wondering if you guys could give any additional color on what we might see at the ATA 2271. Ah, read out the first one in terms of maybe duration or response or the number of patients we might see. And then additionally, I'm wondering, I had a question for ATA 3219. If you guys are planning on releasing any preclinical data for that, thank you.

Jacob Dupont: Thank you. Thank you for your question. Jacob, do you want to take these questions?

Jacob Dupont: Yeah, absolutely. So thank you for the question. In terms of AT82271, which is our autologous mesothelan CART program, which we're doing with Memorial Sloan Kettering, obviously, it's in the buyer partnership as well. As we've announced, we do plan on presenting the first clinical data at a relevant meeting, a medical meeting, before the end of this year. So we're certainly intending on presenting that clinical data. Now, we do plan on presenting safety, efficacy, and biomarker data from the study.

Okay.

Jacob Dupont: And we have enrolled the first cohort of patients in this study with our partners at MSK, and we're currently enrolling the second cohort as well. So again, depending on data maturity and so forth, you'll see these various elements.

Yeah.

Yeah.

[music].

Okay.

Yes.

[music].

Jacob Dupont: And I do want to highlight this program, we think, is really quite innovative and interesting because, yes, it's autologous, and it has this one XX co-stimulatory domain that we've been licensed from Michelle Sattelaine and his team, which we think is a potentially best in class co-stimulatory domain for CART. And it also has the PD1 dominant negative receptor, which provides intrinsic overcoming of the immunosup So the auto program has both of these components. Now, obviously, we're also working on the allogenaic program, 3271, and that's moving towards an ID filing, where at this point, we're leveraging our EBVET cell platform additionally there. Now, in terms of the ALOGEN.

Yes.

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Yeah.

Yeah.

Yeah.

Yeah.

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Yeah.

Yeah.

Uh huh.

Yes.

Jacob Dupont: terms of ATA 3219, and we're very excited about that program; it's our first allergenaic CART cell program out of the gate. It's directed against CD19. We do believe this is a best in class potential program, and we did present at Ash last year in 2020 preclinical data from that 3219 program, so we can certainly That data is certainly available from Ash, and that also leverages this 1XX co-stimulatory domain from Dr. Saddline and his team at MSK, and we're excited about that forthcoming I&D submission. Pascal, anything further?

Oh.

[music].

Yeah.

[music].

Pascal Touchon: The only thing is to remind everyone that this program is also, we believe, supported by this clinical proof of principle that was established by the team at Memorial that showed at the Congress in 2020 that a similar type of construct based on EBVT cells from healthy donors to which they have added CD19 CART, in that case, with a traditional stimulatory domain. Then they treated patients with advanced B-Sel malignancies, and they achieved an 83% CR8.

Pascal Touchon: And that study was quite amazing and unique in the sense that they followed patients for a very long time, and CR8 was maintained over a median follow-up of nearly two years. So I think that's a really very impressive data set, albeit on a small number of patients, but with long durability of response and excellent safety. So that's a nice proof of principle for what we want to achieve there as a potential best interest class, in particular having now 1XX as a costimilatory domain.

Pascal Touchon: That's it for me. Thank you. You are most welcome. That concludes our question and answer session for today. Thank you for joining the Atara Biotherapeutics second quarter 2021 Financial Results Conference Call. You may disconnect your lines at this time.

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