Q4 2020 Atara Biotherapeutics Inc Earnings Call

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Good afternoon, everyone. Thank you for standing by and welcome to the Ettarre Biotherapeutics fourth quarter and full year 'twenty 'twenty financial results Conference call. At this time, all participants are in a listen only mode.

Operator: Good afternoon, everyone. Thank you for standing by, and welcome to the Atara Biotherapeutics fourth quarter and full year 2020 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would now like to hand the conference over to your speaker today, Eric Heiligrand, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please go ahead.

We will conduct a question and answer session and instructions will follow at that time, Inc.

Any one should require assistance during the conference. Please press Star then zero on your Touchtone telephone.

As a reminder, gift conference call is being recorded.

I would now like to hand, the conference over to your speaker today.

Thailand growth.

Vice President of Investor Relations and finance that SRP five therapeutics. Please go ahead Sir.

Eric Heiligrand: Thank you, operator. Good afternoon, everyone, and welcome to Atara's fourth quarter and full year 2020 results conference call. On today's call, members of the Atara executive team will provide an update on our 2020 financial results and operational progress, and also review our upcoming key milestones and objectives. Earlier today, we issued a press release announcing our fourth quarter and full year 2020 financial results and operational progress.

Thank you operator.

Back to you and everyone and welcome to <unk> fourth quarter and full year 2020 results conference call.

On today's call members from the executive team will provide an update on our 2020 financial results and operational progress and also review our upcoming key milestones and objectives earlier.

Earlier today, we issued a press release announcing our fourth quarter and full year 2020 financial results and operational progress. This press release and an updated investor presentation are available in the investors and media section at a tire bio dot com.

Eric Heiligrand: This press release and an updated investor presentation are available in the investors and media section at atarabio.com. 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 Kopikar, Chief Financial Officer, Joe Newell, Chief Operations Officer, Dr. A.J. Joshi, Chief Medical Officer, and Kristen Urema, Chief Commercial Officer.

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

Paul Golby Kerr Chief Financial Officer, Joe Newell, Chief Operations Officer, Dr. AJ Joshi, Chief Medical Officer, and Christine <unk>, Chief Commercial officer.

Eric Heiligrand: We will begin with prepared comments from Pascal and Jacob, then open up the call to 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.

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 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.

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

These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings. These statements are made as of today's date and the company undertakes no obligation to update these statements now I'd like to turn the call over to Pascal Pascal.

Pascal Touchon: Thank you, Eric, and thank you all for joining us this afternoon. In the fourth quarter of 2020, we advanced very significantly our three strategic priorities, TAP cell, AT188 in multiple sclerosis, and our next generation allogeneic CAR T program. For TAPSEL, Atara is on track to complete a rolling BLA submission for EBV-positive PTLD in Q3 2021. As a reminder, we have already completed preclinical module 4 in alignment with FDA requirements. We are ready to initiate a rolling BLA with this module once the FDA decides whether or not the drug product manufactured by your academic partner for the historical non-pivotal studies is comparable to the one manufactured by Atara for the pivotal studies.

Thank you Eric and thank you all for joining US. This afternoon in the fourth quarter of two was on 'twenty, we advanced very significantly all free.

Strategic priorities tab cel achy, when a T 18, multiple sclerosis, and next generation Allogeneic car T programs.

For tab cel at all.

Is on track to complete all in BLA submission for EBV positive <unk> in Q3 2021.

A reminder, we have already completed the preclinical model full in alignment with FDA requirements.

We are ready for initiating a rolling BLA, we'd be smoothed ERO once the EBITDA decide upon compatibility on not off the drug product manufactured by your Academy partner for the Easter He called non people thought the studies and the one manufactured by Idaho for the people don't study.

Pascal Touchon: Recall that FDA has already agreed that the non-pivotal studies will be supportive clinical data in the BLA submission in any case, and that this procedural decision will just determine whether we provide the data as pooled or parallel analysis with the phase-free allele data in a clinical model file. Meanwhile, we are in frequent and productive discussions with the FDA on the content of CMC Module 3. In fact, we just had an informal teleconference with the FDA CMC reviewer late last week, and we are making progress with the agency on the final content of this module.

Heiko that's M. D is already agreed that the non people total studies will be supportive clinical data and the BLA submission in any case.

These positive on a decision, we'll just determine whether it'd be pulled by the doctor as pooled.

On a like this with a phase III data in the clinical model five.

Meanwhile, we are in frequent and productive discussion with the EBITDA on the content of P. M seem within fleet. In fact, we just had an informal teleconference with the FDA CMC or have you were late last week.

And we are making progress with the agency on the final content Avi Smith.

Pascal Touchon: Our plans remain unchanged, that we expect to initiate a rolling BLA and then complete the BLA submission with a clinical module in Q3 of this year, once we have the final clinical data required by the FDA. And finally, in Q4, we expect to present data from the Phase III allele study at an appropriate congress. With regard to Octav-Cell's Phase II multi-corps study in patients with other EBV-driven cancer...

Our plans remain unchanged that we expect to initiate a rolling BLA and then complete the BLA submission with the clinical mildew into free Avitia. Once we have the final clinical data required by the FDA.

And finally in Q4, we expect to present data from the phase III study at an appropriate Congress.

With regard to our top sales phase II multi golf study in patients with all the EBV driven concept the.

Pascal Touchon: The opening of the clinical study sites is accelerated, and these sites are actively evaluating potential study participants. As a reminder, there are six study populations which may support meaningful label expansion. The largest two are EBV-positive AID-LPD and EBV-positive PID-LPD, for which there is high unmet need and a similar mechanism of disease to PT-LPD.

The opening of the clinical study sites is accelerating and these sites are actively evaluating potential study participants.

As a reminder, they are six study populations, which may support meaningful label expansion.

Just to EBV positive a I D. L. P D and E. D. Deep was a T. B I D. L. P D for which there is high unmet need and see me, though mechanism of disease to PTSD.

Pascal Touchon: Most recently, new TAP cell data in patients with life-threatening complications of EBV viremia were presented at ASH 2020, showing a 50% to 80% objective response rate and overall survival at one year of 100%, for a median follow-up of 14.6 months. Over the last 12 months, we have made significant progress on the manufacturing front in building capsule inventory. Successfully HLA-matching 89%! of Patients Eligible for Screening in a Phase III Allele Study We are on track to reach our goal of over 95% of PTLD patients being covered at the time of commercial launch.

Most recently, new top sales data in patients with life threatening complication of EBV by radio were presented at Ash 2020, showing 50% to 80% objective response rate and overall survival at one year of 100 per cent.

Median flow at a 14 six months.

Over the last 12 months, we have made significant progress on the manufacturing front in building top sell inventory.

Successful really it's really much Inc, 18, 9% of patients eligible for screening in our phase III study.

We are on talk to reach our goal of over 95 per cent of Pickier day patients Covid at the time of commercial launch.

Pascal Touchon: We have started to invest further in our U.S. commercial readiness activities in anticipation of capsule approval and planned launch in the first half of 2022. We intend to undertake a very focused commercial approach consistent with rare disease models. By the way, yesterday was Rare Disease Day in the U.S., which we were proud to support as patients with rare cancers like PTSD need to know that they are not alone in their fight.

We have started to invest further you know U S commercial readiness activities in anticipation of perhaps an approval and plan to launch in the first half of 2022.

We intend to undertake the very focused commercial approach consistent with rare disease models.

By the way yesterday was rare disease day in the U S, which we were proud to support patients with cancers like PTSD need to know that there are multiple only net fight.

Pascal Touchon: Atara's activities are already underway for disease area education, identifying key providers' accounts, and performing specific analysis to support top cell value storage. We believe that the unique attributes of PTLD are a serious and deadly disease with no approved therapeutic treatment, and together with TAP cell potential unique benefits as a transformative therapy, support a targeted and highly efficient commercialization model. Regarding TAP cell in the EU, which has prime designations.

I think all those activities are already underway for disease education, I don't define key providers accounts and performing specific analyses to support upsell value story.

We believe that the unique attributes of PTSD as a serious and deadly disease with no approved therapies together with upsell potential unique benefits as a transformative therapy.

Support a targeted and highly efficient commercialization model.

Regarding tab cel in the EU, which has prime designation on pediatric investigation plan B IP was approved in December because on 'twenty.

Pascal Touchon: A Pediatric Investigation Plan, or PIP, was approved in December 2020. In the fourth quarter of this year, we plan to submit an EU marketing authorization application for TabCell in EBV-positive PTLD. Recently, we announced we are seeking a partner for the commercialization of tap cells outside the U.S., and discussions with interested parties have started. Moving on to AT188, a potentially transformational multiple sclerosis program for patients with the progressive form of MS, enrollment is progressing well in the Phase II Randomized Double Blind Placebo Control Study, or RCT, following first-patient enrollment in June of 2020.

In fourth quarter of this year, we plan to submit an EU marketing authorization application for tab cel in EBV positive <unk>.

Recently, we announced we are seeking a partner for the commercialization of top sales outside the U S and discussions with interested parties or stop it.

Moving on to eight year, when 88 potentially possible national multiple sclerosis program for patients with policy form of M. S.

And the whole month is progressing well in the face to optimize double blind placebo controlled study on C. T photo Inc. First patient enrollment in June of 2020.

Pascal Touchon: Atara will conduct an interim analysis for this study in the first half of 2022, including efficacy and safety in patients with progressive forms of MS. Following the IA, we expect to complete enrollment in this phase two study in the first half 2022, the head of the IA next year. We plan to present, in the second half of 2021, long-term two-year clinical data from the Phase 1a Open-Level Extension, or OLE, study, as well as translational data from the Phase 1a. Recently, we've seen increasing momentum in independent publications and review articles reinforcing the association between EBV and MS, as well as a possible rationale for EBV latent infection to be a triggering factor for disease progression.

Although I will conduct an interim analysis for this study in first half 2022, including efficacy and safety in patients with policy forms so if I Miss.

Following the I E. We expect to control complete enrollment of its phase III study in.

In first half 2022.

The head of the eye and next year, we plan to present in second half of 2021 long term two year clinical data from the Phase One day open label extension or elite study as.

As well as translational data from the phase one eight.

Recently, we've seen increasing momentum in independent fabrications and review articles, we enforcing the association between EBV and M. S. As well as supposed to go to Washington, now for EBV latent infection to be a triggering factor for disease population.

Pascal Touchon: In parallel, we are seeing significant interest from patients, patient advocates, and physicians in our RCT, and separately, significant interest from a number of large companies regarding the potential collaboration involving ATA-188. Now, to our differentiated next generation CARTI portfolio.

Parallel we are seeing significant interest from patients patient advocates and physicians in all of your T and symbolically significant interest from a low number of large companies regarding the potential collaboration involving a T. A one a kit.

Turning now to a differentiated next generation car T portfolio.

Pascal Touchon: Atara CAR-T programs are based on our eBV T-cell platform and our ability to leverage new technologies, such as novel co-stimulatory domains, like 1xx, and novel armoring technology, like PD-1-DNR, to improve efficacy, persistence, and durability of response, hence addressing limitations of autologous and other allogeneic approaches. In December of last year, we announced a strategic collaboration with Bayer While only a few months have passed since the collaboration began, the rollout has been very smooth due to the commitment of both parties to bring life-saving cell therapy to patients and also both parties' prior expertise in mesothelin as an oncology target.

Our coffee programs all based on the EBV T cell platform and our ability to leverage new technologies, such as mobile co stimulatory domains like one ex X and no bad are moving.

Technology like PD, one DNR to improve efficacy persistence and durability of response, hence addressing limitations of autologous and allogeneic car Ts.

In December of last year, we announced a strategic collaboration with via for the development of all mitigated in coffee pulled one.

While only a few months have passed since the Cotai Bosch and began the rollout has been very smooth due to the commitment of both parties to bring life saving cell therapy to patients and also both southeast PA your expertise in negotiating as a non core as you target.

Pascal Touchon: Our partnership with Bayer allows us to accelerate and expand the development of ATA3271, our allogenic mesothelin-targeted CAR-T, to parallel studies in multiple thermal types, potentially speeding its delivery to patients and creating shareholder value. Atara will perform IND-enabling studies and process development for ATA3271.

Partnership with via allows us to accelerate and expand the development of a T. A 32 71, all allogeneic Mesothelin targeted car T. Two pilot studies in multiple tumor types potentially speaking its delivery to patients and creating shareholder value.

Adult will perform I N D, enabling studies and process development for 830 to 71.

Pascal Touchon: Bayer will submit the IND expected in Q2 or Q3 of 2022 and lead its subsequent clinical development and commercialization for ATA3219, or halogenic CAR-T for patients with B-cell malignancy. Atara recently presented exciting preclinical data. So Jacob will detail this shortly. We plan to submit an IND for ATA3219 in Q4 2021 or Q1 2022 in line with our strategic goal to develop this asset as best-in-class in B-cell malignant cells. Now, moving on to our financial... With regard to our cash position and runway, we ended the fourth quarter of 2020 with $500.7 million in cash, cash equivalents, and short-term investments. This cash balance includes the net proceeds from the upfront cash payment from the buyer collaboration, proceeds from the December 2020 financing, and proceeds from Stock Sold Food or ATM Facility.

You will submit the I N D expected in Q2 or Q free of 2022 and need its subsequent clinical development and commercialization.

For 832, 19 O illusionary copy for patients with B cell malignancies, I thought recently presented exciting preclinical data the Jacob will detail shortly.

We plan to submit the 94 832 19 in Q4 2021 for Q1 was on 22 in line with both strategic goal to develop these assets as best in class in B cell malignancies.

Now moving onto our financials.

Figure out to our cash position on underway. We ended the fourth quarter of 2020, we five.

$500 7 million in cash cash equivalents and short term investments.

This cash balance includes the net proceeds from the upfront cash payment from the buyer collaboration.

Proceeds from the December 2020 financing.

And proceeds from stock sold who or ATM facility.

Pascal Touchon: With this cash balance and projected revenue from U.S. tap sales, we believe we are sufficiently funded into 2023, inclusive of expenses for the DADA filing and U.S. commercial launch of TAPSEL. Reflecting now upon Atara in 2020, a highly unusual and challenging year for all due to the COVID-19 pandemic. I would like to express gratitude to our extraordinary Atara staff, whose tireless efforts enabled our company to deliver on our milestones. In the past year, together, we conducted the TAP-Cell IA, made significant progress on the TAP-Cell regulatory front, initiated the ATA 188 RCT, initiated a CAR-T clinical study, and signed a CAR-T strategic collaboration with Bayer.

With these cash balance and projected revenue from U S. <unk> sales. We believe we are sufficiently funded into 2020 free.

Inclusive of expenses for the B, a day fighting and U S commercial launch of tab cel.

Reflecting now at the heart and towards on 'twenty.

IV unusual and challenging year for all due to the COVID-19 pandemic.

I would like to express Kolache Toot tool ex told you know even a thought on stuff.

Whose tireless efforts enabled the company to deliver on our milestones in the past year together, we conducted the tab cel I E made significant progress on the top set of figured out the reforms initiated the D. E G. When a T H R E T E.

Shaky the car T clinical study and sign a call Keith about the J code ablation, we buy it.

Pascal Touchon: Not only did we meet this external milestone, doing what we say we will, but the Atara team also stepped up to support one another during the global pandemic, an incredible internal achievement. Atara's progress in leveraging our unique allogeneic EVT cell platform to deliver transformative therapy to patients during a challenging year like 2020 is only possible because of the perseverance of Atara staff in collaboration with patients, caregivers, academic, and industry partners, as well as investors. I will now turn the call over to Jacob. Jacob?

Not only did we meet these external milestone doing what we say we will.

But the other hot team also step up to support one another during the global pandemic and in critical internal achievement.

The highest progress in leveraging our unique allogeneic EBV T cell platform to deliver transformative therapy to patients during a challenging year like two thirds on 'twenty.

It was only possible because of the perseverance of our stuff in collaboration with patients caregivers Academy and industry partners as well as investors.

I would now turn the call over to Jacob Jacob.

Jacob Dupont: Thank you, Pascal. Now, as Pascal mentioned earlier, we've made tremendous progress across all three of our strategic priorities in 2020, and our employees are geared for continued success in this. For TABSA, we continue our plans to initiate the rolling BLA and are on track to complete the rolling BLA submission for EBV positive, PTLD, and Q3 of this year. We remain on track with and continue to have frequent and productive conversations with the agency on the most appropriate and expeditious pathways for this life-saving therapy.

Thank you Pascal now as Pascal mentioned earlier, we've made tremendous progress across all three of our strategic priorities in 2020 and on.

Employees for continued success this year for.

For cancer, we continue our plans to initiate the rolling BLA and are on track to complete the rolling BLA submission for EBV positive P. G. L D in Q3.

This year, we remain on track with and continue to have frequent and productive conversations with the agency on the most appropriate and expeditious pathway to approval for this life saving therapy.

Jacob Dupont: In addition, through our advanced and leading process science and manufacturing efforts, we have created reliable and reproducible allogeneic cell therapy products like TabCell and ATA-188. Evidence of our advanced manufacturing was recently featured at last month's 2021 Transplantation and Cellular Therapy, or TCT, meeting. At that meeting, we presented, for the first time, transcriptional data for CABCEL, demonstrating consistency of the product's activation profile, irrespective of donor, and consistent enrichment of receptor-targeting EBV-driven diseases. The study evaluated the in vitro characteristics of CABCEL that helped elucidate its proposed mechanism of action.

In addition through our advanced and leading practices signs on manufacturing efforts, we have created reliable and reproducible allogeneic cell therapy products like tab cel and HCA 188.

Evidence or other advanced manufacturing was recently featured at last month's 2021, transplantation and cellular therapy or TCT meeting at that meeting we presented for the first time transcriptional data for tab cel demonstrating consistency of the.

Products activation profile irrespective of donor and consistent enrichment of receptor targeting EBV driven diseases. This study evaluated the in vitro characterization characteristics of tab cel that help elucidate its proposed mechanism of action vs resolve.

Jacob Dupont: These results demonstrated that, upon stimulation, CABCEL exhibits a consistent activation signature at the level of gene expression, indicating Cell Receptor Engagement and Secretion of Factors Associated with Effective T-Cell Response. We have made significant progress on manufacturing a consistent, off-the-shelf drug product, which is critical in order to get TAB cell therapy to PTLD patients who have very limited options and can't wait. Continuing with our program, ATA 188 for Multiple Sclerosis, recently, we provided an update on our discussions with the FDA regarding the ATA 188 clinical data, the design of the randomized control trial, and the potential registrational path for this potentially groundbreaking therapy in multiple sclerosis.

<unk> demonstrated that our pons stimulation tab cel exhibits a consistent activation signature at a level of gene expression.

To cell receptor engagement and secretion of factors associated with effective T cell responses, we have made significant progress on manufacturing a consistent off the shelf drug product, which is critical in order to get tab cel. The P. T L D patients who had very.

Limited options and can't wait.

Continuing with our program H, a 188 for multiple sclerosis recently, we provided an update to our discussions with the FDA regarding the a T. A 188 clinical data the design of the randomized controlled trial and potential Registrational path for this potentially groundbreaking therapy.

Multiple sclerosis regarding the Registrational path for H, a 188, the FTA articulated a preference for an E. D. S. S improvement endpoint and agreed the patient population criteria that Atari used to define patients with non active secondary progressive Ms and non <unk>.

Jacob Dupont: Regarding the registrational path for ATA 188, the FDA articulated a preference for an EDSS improvement endpoint and agreed that the patient population criteria that Atara used to define patients with non-active secondary progressive MS and non-active primary progressive MS are appropriate for registrational study. Furthermore, the agency agreed that our Phase II RCT study duration should be at least 12 months after the initiation of treatment.

Active primary progressive Ms are appropriate for Registrational studies.

Furthermore, the agency agreed that our phase two RCT study duration should be at least 12 months after the initiation of treatment day.

Based on this feedback from the agency with the amended the study protocol changing the primary endpoint of this study to E. D. S. S disability improvement SaaS at 12 months and increase the number of patients to 80 to accommodate for this change bylaw.

Jacob Dupont: Based on this feedback from the agency, we've amended the study protocol, changing the primary endpoint of the study to EDSS Disability Improvement over 12 months, and increased the number of patients to 80 to accommodate for this change. Biological and Functional Endpoints will still be maintained. In our discussions, the FDA also agreed to an interim analysis in the ongoing Phase II RCT and that statistical power should be allocated to this IA for the sake of rigor.

Biological on functional end points will still be maintained in our discussions. The FDA also agreed to an interim analysis in the ongoing phase two RCT and that statistical power should be allocated to this I E for the sake of rigor.

The timing of the I E. In the phase two RCT will be the first in the first half of 'twenty 'twenty two and this will include efficacy and safety and shortly thereafter enrollment will be completed also on the first half of 'twenty 'twenty two.

We will have a number of options for the eye data Firstly, we can discuss with the FDA the potential to amend the study for Registrational intent based on the Fda's feedback secondly, with the data we can discuss.

Jacob Dupont: The timing of the IA and the Phase II RCT will be in the first half of 2022, and this will include efficacy and safety, and shortly thereafter, enrollment will be completed also in the first half of 2022. We will have a number of options for the IA data. Firstly, we can discuss with the FDA the potential to amend the study for registrational intent based on FDA feedback. Secondly, with the data, we can discuss with potential partners opportunities for partnership.

With potential partners.

Opportunities for partnering and thirdly, we can make simple sides adjustments to the trial since the I E will occur before enrollment is completed.

Furthermore, the body of evidence supporting the potential borough of EBV in multiple sclerosis continues to grow as highlighted in the recent recently published New England Journal of Medicine, a review paper Zamzow in Hauser from UCSF. This review paper adds new information.

Regarding E B b and that it may be implicated in multiple sclerosis.

Jacob Dupont: Thirdly, we can make sample size adjustments to the trial since the IA will occur before enrollment is completed. Furthermore, the body of evidence supporting the potential role of EBV in multiple sclerosis continues to grow, as highlighted in the recently published New England Journal of Medicine review paper by Zanvill and Hauser from UCSF. This review paper adds new information regarding EBV and suggests it may be implicated in multiple sclerosis.

Now we know that EBV is implicated in the pathogenesis of M. S. Specifically.

From other evidence we know that 100 per cent of MS. Patients are EBV positive EBV infection appears to be necessary for the development of M. S N genetically.

Susceptible individuals', there's also a strong correlation between the presence.

Presence of E. B V antibodies in the blood and disease onset.

B b infected b cells and plasma cells can also be detected in the brain of patients with multiple sclerosis, and there have also been reports of the elevated antibodies against EBV antigens, such as that no one being associated with more MRI disease findings MFS like cortical atrophy.

Jacob Dupont: Now, we know that EBV is implicated in the pathogenesis of MS. Specifically... From other evidence, we know that 100% of MS patients are EBV positive. EBV infection appears to be necessary for the development of MS in genetically susceptible individuals. There is also a strong correlation between the presence of EBV antibodies in the blood and disease onset. EBV-infected B-cells and plasma cells can also be detected in the brain of patients with multiple sclerosis.

Now with the New England Journal of Medicine publication, we find that there is another argument added to the E V. M. S hypothesis, specifically the publication reviews, how EBV may be involved in molecular mimicry in which protein sequences and EBV can induce a CD four T cell.

Jacob Dupont: And there have also been reports of elevated antibodies against EBV antigens such as ABNA1 being associated with more MRI disease findings MS like cortical atrophy. Now, with the New England Journal of Medicine publication, we find that there is another argument added to the EBV-MS hypothesis. Specifically, the publication reviews how EBV may be involved in molecular mimicry, in which protein sequences in EBV can induce a CD4 T-cell immune response that can also target a protein in the brain.

Immune response that can also target a protein in the brain as such E. D. The may trigger the pathological cascade of en masse as noted the body of evidence for EBV is a causative agent for the development of multiple sclerosis is growing and we are enthusiastic about our HCA 188 program.

That specifically targets E b b infected cells.

Cells in multiple sclerosis, with the hope of providing significant clinical benefit to these patients.

Turning now to our car T programs as Pascal mentioned, we recently started on a strategic collaboration with buyer for our meso fail on car T therapy, specifically, a T. A $22 71, and a T. A $32 71 for the treatment of solid tumors.

Jacob Dupont: As such, EBV may trigger the pathological cascade of MS. As noted, the body of evidence for EBV as a causative agent for the development of multiple sclerosis is growing, and we are enthusiastic about our ATA 188 program that specifically targets EBV-infected cells in multiple sclerosis with the hope of providing significant clinical benefit to these patients. Turning now to our CAR-T programs, as Pascal mentioned, we recently started a strategic collaboration with Bayer for our mesophilic CAR-T therapy, specifically ATA-2271 and ATA-3271 for the treatment of solid tumors.

Starting with a T. A 'twenty 271 or autologous mesophyll on targeted car T.

We've already started enrolling patients as performed by our collaborators at Memorial Sloan Kettering to an open label Phase one clinical study a T. A 'twenty 271 incorporates both the novel one ex ex co stimulatory domain and a PD one dominant negative versus receptor for intrinsic checkpoint <unk>.

Inhibition initial phase one safety and efficacy data for HCA twenty-two 71 are targeted to be presented in Q4 of this year. We're excited about the potential for this innovative construct which is being used for the first time in this setting. We believe this approach could be a way to address the price.

Jacob Dupont: Starting with ATA 2271, or autologous mesothelon-targeted CAR T, we've already started enrolling patients, as performed by our collaborators at Memorial Zone Kettering, in an open-label Phase I clinical study. ATA-2271 incorporates both a novel 1XX co-stimulatory domain and a PD-1 dominant negative receptor for intrinsic checkpoint inhibition.

Our challenge is other car T have had in successfully treating solid tumors.

Now turning to $32 71, the first preclinical results of 80 830 to 71, our allogeneic EBV car T cell therapy targeting meso feeling designed for the treatment of solid tumors were presented at sits he recently findings from in vitro 80 830 to 71.

Studies shows potent anti tumor activity against meso feeling they expressing cell lines and potency is maintained in the presence of high tumor PDL one expression.

Jacob Dupont: Initial Phase 1 Safety and Efficacy Data for ATA 2271 are targeted to be presented in Q4 of this year. We're excited about the potential for this innovative construct, which is being used for the first time in this setting. We believe this approach could be a way to address the prior challenges other CAR-T have had in successfully treating solid tumors. Now turning to 3271, the first preclinical results of ATA-3271, an allogeneic EBV CAR-T cell therapy targeting mesothelium designed for the treatment of solid tumors, were presented at CITSI recently. Findings from an in vitro ATA3271 study show potent anti-tumor activity against mesothelin in expressing cell lines.

These data support the design of 80, $832 71 to maintain function in the presence of suppressive PDL, one expression, commonly associated with solid tumor microenvironment, including meso Sealy OMA non small cell lung cancer and other solid tumors. In addition results further.

To support the combined functional design of 80 $832 71 a.

One ex ex co stimulatory domain technology, and maintaining a memory phenotype, while limited while limited cell exhaustion and the content context of repeated tumor cell challenges, which could be part of it.

Jacob Dupont: And potency is maintained in the presence of high tumor PD-L1 expression. These data support the design of ATA3271 to maintain function in the presence of suppressive PD-L1 expression commonly associated with solid tumor microenvironments, including mesothelioma, non-small cell lung cancer, and other solid tumors. In addition, the results further support the combined functional design of ATA3271 1XX co-stimulatory domain technology in maintaining a memory phenotype while limiting cell exhaustion in the context of repeated tumor cell challenges, which could be particularly important for the success of CAR T therapy in solid tumors.

Particularly important for the success of car T therapy in solid tumors now in vivo a T. A $32 71 exhibits potent anti tumor activity and significant survival benefit in mice implanted with mesothelioma cells and highly that highly express both meso feeling as well.

S. P D. L. One this in vivo potency was demonstrated without evidence of toxicity, such as allo cytotoxicity, both in vitro and in vivo results for a T. A 32 71 suggested allogeneic Mesothelin car T engineered EBV T cells.

Our a promising approach for the treatment of meso field on positive cancers. Now finally with regard to 32 19, our next generation off the shelf allogeneic CD 19 car T. Utilizing again, one ex X technology without the need for TCR editing for the treatment of B summit.

Jacob Dupont: Now, in vivo, ATA3271 exhibits potent anti-tumor activity and significant survival benefit in mice implanted with mesothelioma cells that highly express both mesothelin as well as PD-L1. This in vivo potency was demonstrated without evidence of toxicity such as allocytotoxicity. Both in-vitro and in-vivo results for ATA3271 suggest that allogeneic mesothelon CAR-T-engineered EBVT cells are a promising approach for the treatment of mesothelon-positive cancer.

Six we are on track to submit an I N D. In Q4 of this year or Q1 of next year, we presented promising preclinical data showing potent anti tumor activity both in vitro and in vivo with long term functional persistence and no evidence of the allo cytotoxic.

The in vivo at the December 2020 American Society of Hematology annual meeting pre clinical results presented at Ash detailed findings from in vivo and in vitro evaluations of 80, 832, 19, specifically the studies demonstrate potent anti tumor.

Jacob Dupont: Now, finally, with regard to 3219, our next generation off-the-shelf allogeneic CD19 CAR-T utilizing, again, 1XX technology without the need for TCR editing for the treatment of B cell malignancies, we are on track to submit an IND in Q4 of this year or Q1 of next year. We presented promising preclinical data showing potent anti-tumor activity both in vitro and in vivo with long-term functional persistence and no evidence of allocytotoxicity in vivo at the December 2020 American Society of Hematology annual meeting.

Activity of 32, 19 against CD 19, expressing target cells and in vivo against the disseminated tumor model of a L. L.

We believe these results are associated with long term persistence and survival benefit. In addition, both in vivo and in vitro assessments of 32, 19, Allo cytotoxicity support a potentially favorable safety profile that would be required for <unk>.

Jacob Dupont: Preclinical results presented at ASH detailed findings from in vivo and in vitro evaluations of ATA3219. In particular, the studies demonstrate potent anti-tumor activity of 3219 against CD19-expressing target cells and in vivo against the disseminated tumor model of ALL. We believe these results are associated with long-term persistence and survival benefit. In addition, both in vivo and in vitro assessments of 3219 allocytotoxicity support a potentially favorable safety profile that would be required for an allogeneic off-the-shelf CAR T-cell therapy.

Allogeneic off the shelf car T car.

Car T cell therapy to gather these findings support advancing a T a $32 19 to clinical evaluation.

I would like to conclude by reiterating Pascal commit comments a thank you to our tire staff collaborators patients and caregivers, we could not have accomplished this much in 'twenty 'twenty without your dedication to bringing these life saving therapies to patients I will now turn the call back to the operator.

To begin Q&A portion of the call operator.

Yes.

Operator.

Yeah.

Okay.

Hello, operator ready to begin the Q&A portion please.

Yeah.

Hello, Operator can you hear us we're ready to begin the Q&A portion please.

Jacob Dupont: Together, these findings support advancing ATA3219 to clinical evaluation. I would like to conclude by reiterating Pascal's comments of thank you to our Atara staff, collaborators, patients, and caregivers. We could not have accomplished this much in 2020 without your dedication to bringing these life-saving therapies to patients. I will now turn the call back to the operator to begin the Q&A portion of the call. Operator?

Yes. Thank you at this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad again that is star than day number one on your telephone keypad, well pause for just a moment to compile the Q&A roster.

We have our first question comes from the line of John Newman with Canaccord. Your line is open.

Operator: Operator. Hello, operator. We're ready to begin the Q&A portion, please. Operator, can you hear us? We're ready to begin the Q&A portion, please. Thank you. At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. Again, that is star, then the number one on your telephone keypad.

Hi, guys. Thanks for taking my question and congrats on the progress in 2020, especially such a difficult year for everyone.

So two quick questions. The first one regarding the tab, so a rolling BLA submission.

I'm just curious if the agency.

Operator: We'll pause for just a moment to compile the Q&A roster. We have our first question coming from the line of John Newman with Canaccord. Your line is open.

Needs to come to a definitive conclusion as to whether they consider.

Prior taps on material comparable to the current material.

John Newman: Hi guys, thanks for taking my question. Congratulations on the progress in 2020, especially such a difficult year for everyone. I just have two quick questions.

Or if perhaps you might be able to just submit both analyses.

At some point and let them.

John Newman: The first one, regarding the Tab-Cell rolling BLA submission, I'm just curious if the agency needs to come to a definitive conclusion as to whether they consider prior material comparable to current material, or if perhaps you might be able to just submit both. And the second question on the mesothelium CAR-T program. I'm just curious if we might happen to get an update on the study that Sloan-Kettering had, and Mike, give us an update on your product. Thank you, John, for your questions. Jacob, do you want to take the first one?

Choose on.

And then the second question on the news with you on the car T program.

Just curious if we might happen to get an update from the study at Sloan Kettering had running.

Started a few years ago I'm, just not sure if yes, it might give us an update early this year or if we will wait for your product later this year. Thanks.

Thank you John for your questions.

Do you want to take the first one share.

Jacob Dupont: Sure. Thank you, Pascal. And John, thank you for your question. So I'll begin by saying we've had productive and frequent discussions with the FDA, and that's obviously because of our breakthrough therapy designation status. The focus of the current discussions is to secure all the guidance that we need to complete Module 3, or the CMC module of the BLA. In parallel with gaining the necessary guidance on completing Module 3, we also are expecting resolution to the procedural decision from the FDA as to whether we can submit the clinical data from the historical non-pivotal studies as pooled or parallel, as you're alluding to. And that's obviously with data from the 302 or allele study.

Pascal and John Thank you for your question.

So I'll begin by saying, we've had productive and frequent discussions with the FDA and that's obviously because of our breakthrough therapy designation status. The focus of the current discussions is to secure all the guidance that we need to complete our module free or the <unk>.

The jewel of the BLA.

In parallel with gaining the necessary guidance on completing module three where we also are expecting resolution to the procedural decision from the FDA assets.

Whether we can submit the clinical data.

From the historical non pivotal studies as pooled or power parallel as you're alluding to and that's obviously data with data from the three O two or a Lille study. So overall, we're very pleased with the progress that we've made with the FDA and we are on track and this is really important.

Jacob Dupont: So overall, we're very pleased with the progress that we've made with the FDA. And we are on track, and this is really important, to complete the rolling BLA submission for TAP cell in the third quarter of this year. And then the second question about the first-generation academic study that was done with different mesothelin carthines, Jacob? Absolutely.

To complete the rolling BLA submission for tab cel in the third quarter of this year.

Thank you and on the Silicon question about the sales generation with cutting edge study that was going on with different means that they didn't call team Jacob absolutely. So thanks for the question John on the academic Nissan feel on program. So.

Jacob Dupont: So, thanks for the question, John, on the academic mesothelin program. So, importantly for Atara, as you know, and now in our partnership with Bayer, we have these two programs, 2271, which is the autologous program, and then 3271, which is the allogeneic program. So, those are the ones that Atara oversees in collaboration with our partners now at Bayer. Now, as you alluded to, there is an academic program that preceded the Atara partnership, and this had the mesothelin binder in it, and it was a more conventional or first-generation co-stimulatory domain there. Now, we are separate from that program.

Importantly for Atari as you know now and our partnership with buyer. We had these two programs $22 71, which is the autologous program and then $32 71, we since the allogeneic program. So those are the ones that are Tara oversee in collaboration with with.

Our partners now at buyer now as you alluded to there is an academic program that preceded the tar partnership and this had the MISO feeling binder in it and it was a more conventional or first generation co stimulatory domain there now.

We are separate from that program, it's not part of the entire partnership so in essence, we don't have insights into when are they.

Jacob Dupont: It's not part of the Atara partnership, so, in essence, we don't have any insights into when the colleagues at Memorial Suncater are going to be producing that data, but certainly, we look forward to any updates from them. Yeah, and we know they are continuing to follow the patient. So one might expect some updates at some stage, but this is not being supported or funded by Atara. Does that answer your question, John? Yes, great.

On the colleagues at Memorial Sloan, Kettering and it'll be producing.

That data, but certainly we look forward to any updates from them.

And we know they are continuing to follow the patients. So one might expect some of the data at some stage, but this is not being supported all funded by at the hub.

Does it answer your question from.

Yes, great. Thank you very much.

Jacob Dupont: Thank you very much. We have our next question coming from the line of Salim Shihab with Mizuho. Your line is open. Great, thanks very much for the questions, guys. There's a couple for me on ATA 188.

We have our next question coming from the line of Salim Sayed with Mizuho. Your line is open.

Great. Thanks, very much for the questions guys. Just a couple from me on the MTA you wanted it.

Salveen Jaswal Richter: So, Pascal or Jacob, on the interim analysis that you'll be conducting in the first half of 2022, I'm trying to understand what you guys would perceive to be a best-case scenario here, a worst-case scenario, and a middle-case scenario, because, you know, I know, we've sort of touched on this before where you can increase the N, you know, a little bit, or you can go larger. And, you know, is there a futility analysis, maybe some color on how we should be perceiving the different scenarios coming out of the RCT? If you increase that a little bit or a lot, or nothing at all?

So.

Pascal or Jacob on the interim analysis that youll be conducting the first half of 'twenty two I'm trying to understand what you guys would perceive to be a best case scenario here.

The worst case scenario in our middle case scenario.

I know you know we've sort of touched on this before where you can inc.

Kris the yen a little bit or you can go larger.

And is there a futility analysis, just maybe some color on how should we be perceiving the different scenarios coming out.

Of the RCT.

Hum do you increase that a little bit or a lot or nothing at all.

Salveen Jaswal Richter: And then just a second question on OLE. I noticed in the slides that you're no longer presenting first half 21 OLE data, and I'm just curious why that's the case. Thanks. Thank you, Salim, for your question. AJ, do you want to answer the first question, please? Sure. Thanks for the question, Salim. From the perspective of the interim analysis, this is going to be kind of your classic interim analysis, where we spend some alpha to take a look at everything. So this is going to be efficacy, safety, all the general parameters you'd look for. So in any one of these kinds of analyses, you'd look at everything, right?

And then just.

Question on the.

On the Oh L I noticed in the slides.

On a longer presented in first half 'twenty, one OLED data and I'm just curious why that's the case. Thanks so much.

I think you were studying for your question Hey, Jay do you want to answer the first question. Please sure.

Thanks for the questions who am I.

From the perspective of the interim analysis. This is going to be kind of your classic interim analysis, where we you know we spend some alpha to take a look at everything. So this is going to be you know efficacy safety all of the general parameters you'd look for so in any one of these kinds of analyses you'd look at everything right.

I think the best way to look at this is.

From what we do coming out of that interim analysis, you'll have a pretty good idea of what you know what where we're going right. So and we will try to be as clear as possible. Once we make any adjustments to design. So once we see their interim analysis to your point earlier, we've got a robust phase III study design, a small increase in sample size may be something that we do just.

A.J. Joshi: I think the best way to look at this, from what we do coming out of that interim analysis, you'll have a pretty good idea of where we're going, right? So, and we'll try to be as clear as possible once we make any adjustments to the design. So once we see their interim analysis, to your point earlier, we've got a robust phase two study design. A small increase in sample size may be something that we do just to make it a bit more robust.

To make it a bit more robust a large increase in sample price match it would be an opportunity where we're having discussions with FDA, where they're thinking that this can be more supportive or even a larger registrational pathway. So I think what we'll try to do is you will see changes we made to the development plan now hopefully not too many but you know it will all depend on.

I'm going to look like but we'll try to provide some clarity on it however won't provide the specific data that.

A.J. Joshi: A large increase in sample size may actually be an opportunity where we're having discussions with FDA where they think that this can be more supportive of even a larger registrational pathway. So I think what we'll try to do is. You will see changes we make to the development plan. Hopefully, not too many, but it'll all depend on what the future looks like.

Coming out of that interim analysis that will be provided really at the end of the the primary observation period.

Or end of the study I should say.

And I could add that to the base case scenario for US about this study is powered to be at the right level for a potential significance between placebo and active treatment. There. So I think to increase the sample size too.

So to an extent, it's something that will just increase the whole business of leads as a phase two study, but as HSA. The best case scenario will be really that then we can further increase the sample size to make each one of the people don't study that you might want to see and that will be done in discussion with EBITDA, because we can't discuss the details of that.

A.J. Joshi: But we'll try to provide some clarity on that. However, we won't provide the specific data that's coming out of it. That will be provided really at the end of the primary observation period, or end of the observation period. I could add that the base case scenario for us is that this study is powered to be at the right level for potential significance between placebo and active treatment. So having to increase the sample size to a certain extent is something that will just increase the robustness of these as a phase 2 study.

With the FDA, which is something that will be important for the next step moving forward with that.

Now on the second question, a J I'd like to comment on the new Dot Dot Com, Inc. For the OLED.

Sure.

And to your question around the timing of the data as we've been going through this you know you've seen that we've provided data.

A.J. Joshi: But as AJ said, the best case scenario will be that then we can further increase the sample size to make it one of the pivotal studies that the FDA might want to see. And that will be done in discussion with the FDA because we can discuss the detailed data with the FDA, which is something that will be important for the next step moving forward. Now on the second question, AJ, I'd like to comment on the new data coming for the OLE.

Three months on cuts.

At this point it doesn't really make sense to keep dribbling that data out, but we really want to think about it now what are the meaningful on.

Data releases that we're going to have and what's nice about that second half is it allows us to have a full two year readout on the open label extension study. So that's why we're targeting the second half is to give you kind of add that meaningful two year readout for all the patients.

A.J. Joshi: Sure, and to your question around the timing of the data, as we've been going through this, you've seen that we've provided data for like three months. I cut. At this point, it doesn't really make sense to keep dribbling that data out, but we really want to think about it now. What are the meaningful data releases that we're going to have? And what's nice about that second half is that it allows it to have a full two-year readout on the Open Label Extension study.

And we also off to a some translational data available by the time.

Home values type of studies that were conducted on the phase one day.

Great Super helpful. Thanks, a J thanks Pascal.

Yeah.

We have our next question coming from the line of Michael before when.

With Evercore your line is open.

Hey, guys. Thanks, so much for taking my question and congrats on on the progress two questions on 80 188, if I may.

We got one regarding the change the primary endpoint.

A.J. Joshi: So that's why we're targeting the second half, to give kind of that meaningful two-year readout for all. And we also hope to have some transnational data available by that time from various types of studies that we are conducting on the phase I end. Great, super helpful. Thanks, AJ. Thanks, Patrick. We have our next question coming from the line of Michael Dufour. With Evercore, your line is open.

From a sustainability improvement too.

Yes.

Does this change that was mandated by the FDA or preferred I should say.

In any in any way diminish your confidence in the program given that any benefits in time 25 foot walk that would've.

That would've occurred.

Would have been attributed to STI now not possible and.

Michael Dufour: Hey guys, thanks so much for taking my question, and congrats on the progress. Two questions on ATA 188, if I may. One regarding the change of the primary endpoint from sustained disability improvement to ADSS. Does this change that was mandated by the FDA, or preferred, I should say, in any way diminish your confidence in the program, given that any benefits in time for the 25 foot walk that would have occurred and would have been attributed to SDI are now not possible? and as a follow-up, at www.salveenrichter.com.

And I have a follow up thanks.

Hey, Jay do you want to take that one sure. Thanks for the question.

It's a good question you really for US the good news for us really throughout the entire phase on a program is when you look at the basis of improvement that we saw in sustained disability improvement.

Vast majority of it was driven by Etfs, so from our perspective and activate it doesn't really hurt us at all in.

In terms of the likelihood of success at the end of the study and when we focus just on Etfs, because again all of that improvement. The majority of that improvement was driven by Etfs, bringing on.

We did make a small sample size adjustment as you know to the 80 patients. So you can see it's a very minimal adjustment to account for that change, but our confidence is high because whether it was in the main 12 months of the study or to the open label extension, we continued to see Etfs as a driver of improvement.

A.J. Joshi: So, from our perspective, it actually doesn't really hurt us at all in terms of the likelihood of success at the end of the study when we focus just on EDSS because, again, all of that improvement, the majority of that improvement, was driven by EDSS. We did make a small sample size adjustment, as you know, to 80 patients, so you can see it's a very minimal adjustment to account for that change, but our confidence is high because whether it was in the main 12 months of the study or through the open label extension. The second question is regarding the interim analysis for ADT188.

Great. Thank you I just have a couple.

Question.

Yes, I do.

Second question is regarding the interim analysis.

Houses for 80 188.

It sounds like after.

After the interim analysis occurs but before enrollment is complete you're going to have that discussion with the FDA.

What I mean, what do you think the FDA could be looking for in terms of a treatment <unk> treatment effect.

In order to.

Of support moving moving forward and expanding the enrollment of the trial to a registrational study.

A.J. Joshi: It sounds like after the interim analysis occurs, but before enrollment is complete, you're going to have that discussion with the FDA. What do you think the FDA could be looking for in terms of treatment, EDSS kind of support moving forward in expanding the enrollment of the trial to a registrational study? Yeah, I think there's a couple of things that we'd want.

Hey, Jeff.

Yeah, I think Theres a couple of things that we really want in terms of one of the big things that we need to kind of align on with FDA is the population target here because we are as you know we've got non active secondary progressive.

On the mass and non active primary progressive Ms.

We need to kind of align with FDA do they want to treat them as a separate populations are combined populations.

A.J. Joshi: In terms of one of the big things that we need to kind of align on with FDA is the population target here. Because, as you know, we've got non-active secondary progressive MS and non-active primary progressive MS. Then, we need to kind of align with FDA. Do they want to treat those as separate populations or combined? And that's an important piece because, you know, for us, we're conducting the study, so it really doesn't matter which way they go. We've got it robust enough so that we can either put them together or keep them.

And that's an important piece because you know for US we're conducting the study so it really doesn't matter, which way. They go we've got a robust enough. So that we can either put them together or keep them separate.

But in terms of the next steps this is where it really comes in because once we do the interim analysis. So step one we expect to align with them over the next couple of months on exactly where they want to go.

Then when we do the interim analysis it allows us after the interim analysis to actually.

Apply for an expedited pathway because the expedited pathway that we're talking about do require you to have a very specific target population. That's an important steps apply price pathway, but also from a registrational perspective, you have to have that specific population.

A.J. Joshi: But in terms of the next step, this is where it really comes in. Because once we do the intramenal... So step one, we expect to align with them over the next couple of months on exactly where they want. Then when we do the interim analysis, it allows us, after the interim analysis, to actually, at www.salveenrichter.com. So that's one key piece that we're going to be doing between now and the interim analysis. And to your point, you're asking about what would now make that interim analysis registerable. One, you need that alignment.

Well identified so that's one key piece that we're gonna be doing between now and the interim analysis and to your point you were asking about what would now make that interim analysis registration on why do you need that alignment and then two as you know that that's going to be really just a question of when the interim analysis comes out and we take a look at those.

Datasets.

How is the FDA on looking at it both in terms of population dynamic as well it would be early results. We're seeing on the interim and I will add that as usual they will also.

Of course, a significant difference between placebo and active treatment and then the question would also be about the safety database, how many patients who would like to see to transform the harvest phase two into the regulatory pivotal trial. So that's that's a different aspect will discuss we then that's why we planned on IAA before finalizing it.

A.J. Joshi: And then two, it's going to be really just a question of when the interim analysis comes out and we take a look at those data sets, how is FDA looking at it, both in terms of population dynamics, as well as early results. And I will add that, as usual, they will also have to see, of course, a significant difference between placebo and active treatment. And then the question will also be about the safety database.

On the old one because when we say that we will finalize the on the old months in total from day to thus far with Phase two study to then go to people don't program, but of course easily.

Loans with us and they say on one hand, you off significant difference versus placebo, you'll have good safety on your patients, but they would like to see more patients day and at the same time. There is vs clarification on the population then that allows us to expand that study before it's fully enrolled by definition and want to expand it before them and that's why but.

Pascal Touchon: How many patients would you like to see to transform this robust phase 2 into a regulatory pivotal trial? So that's a different aspect we'll discuss with them. And that's why we've planned that IA before finalizing the enrollment. Because when we say that we'll finalize the enrollment in first act 22, that's for a phase 2 robust study to then go to a pivotal program.

Timing is very important and we are very well organized to really address the particular timing aspect of first EIA then to fund inflation on the on the whole month, depending on that discussion with the FDA.

Got it very helpful. Thank you.

Yeah.

We have our next question coming from the lineup on new time Rama with J P. Morgan Your line is open.

Pascal Touchon: But of course, if the FDA aligns with us and they say, on the one hand, you have a significant difference versus per se, you have good safety for your patient, but they would like to see more patients there. And at the same time, there is this clarification about the population. Then that allows us to expand that study before it's fully enrolled. By definition, we want to expand it before there is. And that's why timing is very important.

Hi, guys. Thanks, so much for taking the question on.

On the eight T. A 188 phase one presentation in the second half you mentioned a couple of them times on this call. Some translational data that will be presented at the conference maybe you could give us a little.

Color on.

What specific translational analyses, we should be focused on thanks, so much.

Well. Thank you just one final question a J.

Pascal Touchon: And we are very well organized to really address that particular timing aspect of first the IA, then the finalization of the enrollment, depending on that discussion with the FDA. Very helpful, thank you. We have our next question coming from the line of Anupam Rama with J.P. Morgan. Your line is open.

Yeah. So on me.

Thanks for the question on all of them I think you know we've got a variety of different translation elements that we've looked at in the phase. One study. We have mentioned previously that we're working on that assay to detect 80 188 in the serum and CSA happened, we've conquered kind of be the main technological barriers now we're just looking to validate.

Anupam Rama: Hi guys, thanks so much for taking the question. In the APA 188 phase one presentation in the second half, you've mentioned a couple of times on this call some translational data that'll be presented at the conference. Maybe you can give us a little color on, you know, what specific translational analyses we should be focused on. Thanks so much.

That assay. So that's one component that we might see there's other things as you know on the study that we had different elements of MRI results and some other biomarkers that we assessed in the phase one study. So some of those may also be possible to present in the second half. So right now we're just putting some of those data together.

And it'll be some combination of those elements that we anticipate in the second half.

Thanks, so much.

A.J. Joshi: Thank you for your question, A.J. Yeah, so thanks for the question, Anupam. I think we've got a variety of different translation elements that we've looked at in the Phase Ia study. We've mentioned previously that we're working on that assay to detect HA188 in the serum and CSS, and we've conquered kind of the main technological barriers.

Thank you everyone.

Okay.

We have our next question coming from the line of <unk> Mitra.

With Goldman Sachs. Your line is open.

Good afternoon, and thank you for taking our question. This is Elizabeth on.

First of all been I'm wondering if you could talk a little bit more about your commercial readiness plans.

The tab cel launch on the first half of 2022 on what that looked like and then what our sales force might look like that.

A.J. Joshi: Now we're just looking to validate that assay, so that's one component that we might see. There are other things, as you know, in the study where we had different elements of MRI results and some other biomarkers that we assessed in the Phase Ia study. So some of those may also be possible to present in the second half.

Thank you for your question Kristen So you want to take that question.

Yes, thanks for the question.

P T L D. As we know is an ultra rare disease and so consistent with that we're really looking at a commercialization approach that's very much in the model of a rare disease model.

A.J. Joshi: So right now, we're just putting some of that data together, and there'll be some combination of those elements that we anticipate in the future. Thanks so much.

And that will include a very limited number of highly specialized commercial as well as medical fields chat.

Operator: Thank you, everyone. We have our next question coming from the line of Salveen Richter with Goldman Sachs. Your line is open. Good afternoon, and thank you for taking our question. This is Elizabeth on behalf of Salveen.

And and then we will have a it will.

We will be supplementing that with different sorts of communication multichannel peer to peer Congress and so forth.

Thank you and I think what it will add as well is that these patient population of PTSD.

First line therapy is very well identified I mean these patients have gone for good transplants, then yeah. Unfortunately being diagnosed with P. TLD, they've all day value testing, including EBITDA positivity of the PTSD then to get the first line treatment, which could be as you remember we took the mob on the came on price chemo and then really there were like.

Salveen Jaswal Richter: I was wondering if you could talk a little bit more about your commercial readiness plans ahead of the TabFel launch in the first half of 2022, what that could look like, and then what a sales force might look like there. Thank you for your question. Kristen, do you want to take that question? Yes, thanks for the question. So PTLD, as we know, is an ultra-rare disease.

<unk> so what's important from a commercialization point of view is that at that time, the physicians will be aware of stop sale and be able to plan in advance in case, the patient does not respond to first line therapy or at a cocktail of relapsing. After a response to first line therapy that they can immediately accessed upset.

Kristen Urema: And so consistent with that, we're really looking at a commercialization approach that's very much in the model of a rare disease model. So that will include a very limited number of highly specialized commercial as well as medical field staff. And then we will have, we'll be supplementing that with different sorts of communication, multi-channel, peer-to-peer, congress, and so forth. Thank you.

This ability to identify the patient early on in their pathway is extremely important in the way we go into commercialized stop sale to make it a product that is sufficiently available in a way for the physicians. So they know when to okta for their patients in the best interest of their patients day.

Yeah.

Pascal Touchon: And I think what I will add, as well, is that this patient population for PTLD first-line therapy is very well identified. I mean, these patients have gone for the transplant. Then they have, unfortunately, been diagnosed with PTLD. They've had various testing, including EBV positivity for their PTLD. Then they get a first-line treatment, which could be, as you know, rituximab or rituximab plus chemotherapy.

Does it answer your question yes.

Thank you.

Okay.

We have our next question coming from the line of earn your Rodriguez with Cowen and co. Your line is open.

Hi, Thank you for taking my call on my question Oh, So actually my question folks on the commercialization of tab cel you mentioned.

I'm thinking about partnerships for.

For the ex U S commercialization and I was wondering if you can add any color to that on what kind of what are you focusing on those partnerships.

Pascal Touchon: And then, really, they are well identified. So what's important, from a commercialization point of view, is that, at that time, the physicians will be aware of TAP cell and be able to plan in advance, in case the patient does not respond to first-line therapy or is resistant or is relapsing after responding to first-line therapy, that they can immediately access TAP cell. So this ability to identify the patient early on in their pathway is extremely important in the way we're going to commercialize tap cells to make it a product that is sufficiently available and intelligent for physicians so they know when to act for their patients in the best interest of their patients.

You know our focus on the indication on on a very particular geography or how are you approaching that.

Well. Thank you for your question. So in terms of partnering discussion ex U S. We have initiated a number of discussion with interested parties that are really focused on first.

First on Europe, because as you know we have a very clear line of regulatory pathway in new hope frugal Prime designation and regular interactions with the review of their new halt. So we knew exactly what is needed there and we know the timing for submission now that is planned for Q4 'twenty.

One.

That means these key regulatory path logos 'twas discussion with interested parties, so they'd get ready to be able to launch that sell in new hope.

Pascal Touchon: Does that answer your question, Miguel? Yes, thank you. We have our next question coming from the line of Ernie Rodriguez with Karen and Co., your line is open. Hi, and thank you for taking my questions also. Actually, my question is also about the commercialization of Capsule. You mentioned...

In the second part of 2022.

The type of partner, we're looking for is a partner that has already an infrastructure for.

Our commercialization in Europe.

On a metallurgy transplantation and rare diseases and oncology in general because that's where this partner could really mentally stuck infrastructure in creating further value with such a transformative TRP that as you know is a therapy that is much easier to deliver on supply down for example.

Ernie Rodriguez: Thinking about partnerships for the ex-U.S. commercialization, I was wondering if you could add any color to that, what kind of, what are you focusing on those partnerships? You know, focus on the indication in a very particular geography or how you approach Now, thank you for your question. So in terms of partnering discussions outside the US, we have initiated a number of discussions with interested parties that are really focused first on Europe. Because, as you know, we have a very clear regulatory pathway in Europe through prime designation and our regular interactions with the reviewer there in Europe.

Autologous car T. Because this is truly an off the shelf product. So the path of just out towards the commercialization and of course medical infrastructure there to handle such a pullback to get access, but the delivery and supply could easily be managed by other half full Doc partner in this type of geographies and in fact, we've already have ex.

Billions of that because we have open clinical sites for people don't study and for the 205 study in Europe. So we already delivering and you're all top sales as we speak to vs clinical sites when their ease of patients included into our study. We've also opened a compassionate use program in Europe, which will allow us to treat patients day. So that experience is really.

Ernie Rodriguez: So we know exactly what is needed there, and we know the timing for submissions now that that is planned for Q4 21. So that means this key regulatory path allows us to have discussions with interested parties so they get ready to be able to launch TAP cell in Europe in the second part of 2022. The type of partner we're looking for is a partner that already has an infrastructure for commercialization in Europe around hematology, transplantation, and rare diseases in oncology in general.

At Aha, and we will be looking for partner that can prolong that experience into the awareness and commercialization of top selling your home now beyond you hope it will be really depending on the type of partner, we're talking too because some of them might have interest we are already experiencing on 20 of course, we are also opening sites.

Pascal Touchon: Because that's where this partner could really leverage that infrastructure in creating further value with such transformative therapy that, as you know, is a therapy that is much easier to deliver and supply than, for example, otologoscar T because this is truly an off-the-shelf product. So the partner just has to have the commercialization and, of course, medical infrastructure there to handle such a product to get access. But delivery and supply could easily be managed by Atara for that partner in this type of geographies.

Canada. So there on number of geographies, where there is already the possibility to treat patients and it might be an interest for partner day, all the world does it answer your question.

Yeah very helpful. Thank you.

Yeah.

Again in order to ask a question simply press Star then day number one on your telephone keypad.

Again that is star then the number one on your telephone keypad.

We have our next question coming from the line of Matt <unk> with William Blair. Your line is open.

Hi, good afternoon, Thanks for taking my question.

Just wanted to clarify the discussion with the FDA around the final content for CMC module three is that related to the procedural question on the non pivotal data or is that a separate discussion.

Pascal Touchon: And in fact, we already have experience of that because we have open clinical sites for the pivotal study and for the two or five studies in Europe. So we're already delivering TAP-Cell to these clinical sites whenever there is a patient included in a study. We've also opened a compassionate use program in Europe, which allows us to treat patients there. So that experience is really at Atara.

Thank you my question Jacob.

Absolutely so Matt Thanks for the question so in essence as mentioned we've had.

A number of productive discussions with the FDA about module three and we want really want a secure responses.

Pascal Touchon: And we will be looking for a partner that can prolong that experience into the awareness and commercialization of TAP-Cell in Europe. Now, beyond Europe, it will really depend on the type of partner we're talking to because some of them might have interest. We have already experienced this in Australia, of course. We have also opened a site now in Canada.

Regarding the module three and the guidance for the CMC content of the BLA.

And so with that guidance, we're also going to be receiving the guidance when it comes to.

On the presentation of the historical non pivotal data. So it's really connected in point of fact, but our key point here is that we want to get that.

Pascal Touchon: So there are a number of geographies where there is already the possibility to treat patients, and it might be an interest for a partner there as well. Does that answer your question? Yes, very helpful. Thank you. Again, in order to ask a question, simply press star, then the number one on your telephone keypad.

Our secure all of that guidance needed to complete the module three for the BLA.

Yeah, No I will add to that also without having this alignment with the EBITDA on the content of more than free is something very important in advance of the submission to optimize the chance of success in the BLA submission.

And the FDA agrees with US that's why we are talking in advance and we have visibility studies that total so it's very frequent and productive interaction with the FDA. In fact, if you think about it we are the first company coming to the EBITDA with a BLA submission for an allogeneic T cell.

Matt Hicks: We have our next question coming from the line of Matt Hicks with William Blair. Your line is open. Good afternoon. Thanks for taking my question. Just wanted to clarify the discussion with the FDA around the final content for CMC Module 3, is that related to the procedural question on the non-pivotal data, or is that a separate discussion? Thank you, Matt, for your question. Jacob?

Did the FDA knows that in fact, we have got all the expert on the product.

And the goal of the ongoing discussion is make sure that we fully on line before the submission and it is not the gating factor because we know that the gating aspect is more related to the maturity of the clinical data that allows us to be able to finalize the submission to free 'twenty one but all of this work all the progress we are making now are really there to optimize the transfer.

Jacob Dupont: Yeah, absolutely. So, Matt, thanks for the question. So, in essence, as mentioned, we've had a number of productive discussions with the FDA about Module 3, and we really want to secure responses regarding Module 3 and the guidance for the CMC content of the BLA. And so, with that guidance, we're also going to be receiving guidance when it comes to the presentation of the historical non-pivotal data. So, it's really connected, point of fact.

Success in the BLA submission, especially on the CMC aspects of the file.

Does it answer your question.

Yeah, I think so and then have you submitted any additional data to the FDA just as maybe a comparability.

That's it or something like that since you started having these discussions on on the press.

The real question.

Yes, when we discussing Baltimore free in Fox, we are it's not on your discussion in principle you know it's a discussion based on data. So we are submitting to the dust off of a typical type D setting.

Jacob Dupont: But our key point here is that we want to secure all of that guidance needed to complete Module 3 for the BLA. I will add to that also that having this alignment with the FDA on the content of Module 3 is something very important in advance of the submission to optimize the chance of success in the BLA submission. And the FDA agrees with us. That's why we are talking in advance.

We are already at the last few months to type B meeting on different topics. We've done on the CMC fall away, we fought with semi to them that on and we disclose about these data and then how do they want to see vs that are being presented in the final submission. So he's not on the conceptual discussion, it's really data driven discussion, which I think is very important to make progress here.

And maybe one other comment there that for each of these interactions their formal briefing books that are submitted in advance of those type b meetings, but but.

Pascal Touchon: And we have this BTT status that allows us very frequent and productive interaction with the FDA. In fact, if you think about it, we are the first company coming to the FDA with a BLA submission for an allogeneic T-cell therapy. The FDA knows that, in fact, we at Atara are the experts on our product.

They'll even be requests have come from the agency for additional information that we service to.

Our reviewers over at the FDA. So this is a very rich very productive and very frequent engagement that we have with the FTA on this topic can you go on the when we have what we call informal Cola drove the one we had last week, we send to them in advance.

Pascal Touchon: And the goal of the ongoing discussion is to make sure that we fully align before the submission. And it's not a gating factor because we know that the gating aspect is more related to the maturity of the clinical data that allows us to be able to finalize the submission to 321. But all this work, all the progress we are making now, is really there to optimize the chance of success in a BLA submission, especially the CMC aspect of the file. Does that answer your question, Mike? Yeah, I think so.

Really a briefing book with all that on the largest and details that we think is bolt on to this because even in an informal coal, which then is different from the type B meeting with I B within responds day.

Great. Thanks.

We have our next question coming from the line of married Raycroft with Jefferies. Your line is open.

Yeah.

Maury Raycroft.

Your line is open you may ask your question.

Hi, This is Ken channel on for Mary craft.

Jacob Dupont: And then have you submitted any additional data to the FDA? Because maybe comparatability assays or something like that, since you started having these discussions on, Yes, when we're discussing Module 3, in fact, it's not only a discussion in principle. You know, it's a discussion based on data, so we are submitting data to them for the typical Type B setting. We have already had, in the last few months, two Type B meetings on different topics with them in the CMC file, where we submit data to them, and we discuss this data, and then how do they want to see this data presented in the final submission. So it's not only a conceptual discussion.

On 188 on whether the current phase two can be used as a registrational.

Is there.

What day to does the FDA need to accept and a pool of P. P. M S.

Plus S pms arm versus running separate trials for the two arms.

Thank you for your question, Hey, Jake you want to take that one.

Sure Yeah, it's essentially the same data that we're generating we're generating one set of data that's driven by E. D. SaaS as the disability improving endpoint. The only question that you know that we're aligning on with them is what population that we're looking at so when do we see it as a single non active progressive Ms population, which by the way.

You really talk to the thought leaders in the space. That's how they look at this they think that the progression in this space is identical in both settings. So that's what we're shooting for.

Jacob Dupont: It's really a data-driven discussion, which I think is very important to make progress. And maybe one other comment there: for each of these interactions, there are formal briefing books that are submitted in advance of those type B meetings, but there'll even be requests that come from the agency for additional information that we serve to our reviewers over at the FDA. So this is a very rich, very productive, and very frequent engagement that we have with the FDA on this topic.

Or again, if the FDA decides to let's say to look at the population separately theres still going to look at the endpoints and the same exact fashion. So we still need to have separation of <unk>.

Hey, 188 versus placebo within whichever population target that they agreed to so there's no different it's just the population piece and that's why if I may had what we say that these are phase. Two study we are running right now on the lives come from Trialed in fact adapted to either scenario.

Jacob Dupont: And even when we have what we call an informal call, the one we had last week, we send them in advance, really, a briefing book with all the data analysis and details that we think are important to discuss, even in an informal call, which is then different from a type B meeting or a type B written response. We have our next question coming from the line of Marie Raycroft, with Jeffrey. Your line is open. Where are we right now?

But from our point of view and that's great because that's what those two off the discussion with EBITDA and then the IEA and then to adapt to whatever alignment we have with the FDA to them.

Yeah.

Yeah.

Yeah.

Does it answer your question.

Yes. Thanks.

Yeah.

We have our last question coming from the line of Yigal <unk> with Citi. Your line is open.

Hi, This is carly on for Yigal, Thanks, very much for taking our questions.

And then can you just talk about how changing the primary endpoint to Etfs.

Impact the interim analysis, if it does at all and can you just remind us of what triggers the interim analysis and whether increasingly involved that means you'll need more patients.

Operator: Your line is open; you may ask your question. They're, um, what data does the F- plus SPMS collect? Thank you for your question, Ajay. Do you want to take that one? Sure, you know, it's essentially the same data that we're generating. We're generating one set of data that's driven by EDSS as the Disability Improvement Network. The only question that, you know, that we're aligning on with them is what population are we looking at?

On the interim or does that CAGR non change. Thank you.

Thank you for your question P J.

Yeah, So sylvie.

The Etfs.

Change does not really impact us at all on the interim analysis, but the goal for the interim analysis is that we've talked about is the enrollment target that we have of 80 patients. The way. The interim works is we're really going to do the interim analysis.

Operator: So do we say it's a single, non-active, progressive MS population, which, by the way, if you really talk to the thought leaders in the space, that's how they look at it. They think that the progression in this phase is identical in both sets.

Just before we hit that 80 patient target and so the driver is getting close to that enrollment target more so than anything else.

A.J. Joshi: So that's what we're shooting for. Or again, if the FDA decides to look at the population separately, they're still gonna look at the end points in the same exact fashion. So we still need to have separation of AT188 versus placebo within whichever population target that they... So there's no difference, it's just... And that's why, if I may add, what we say that this phase two study we are running right now, the randomized controlled trial, is in fact, adapted to either scenario from our point of view.

Because that allows us to have the most possible data when we do the interim analysis.

And then once we and then again once we do the analysis. When you were talking about expansion of the study again that will just depend on the the numbers that we get but Pascal kind of alluded to this before with the strong phase II a small expansion would be managed to just kind of beef up that statistical target.

A large expansion may signal for example, the possibility that the FDA says hey, this could be potentially registrational on one little bit more safety in a bit more total on numbers for your study.

Pascal Touchon: And that's great, because that allows us to have the discussion of the FDA, and then the IA, and then to adapt to whatever alignment we have with the FDA. Does that answer your question? Yes, thanks. We have our last question coming from the line of Yigal Nochomovitz with Citi. Your line is open.

Does that answer the question.

Yes.

Yeah. That's helpful. Thank you.

Thank you.

There are no further question at this time. This does conclude today's conference call. Thank you for your participation you may now disconnect.

Carly: Hi, this is Carly on behalf of Yigal. Thanks very much for taking. For MS, can you just talk about how changing the primary endpoint to EDSS impacts the interim analysis, if it does at all? And can you just remind us of what triggers the interim analysis and whether increasing enrollment means you'll need to enroll more patients to trigger the interim analysis, or does that trigger it? Thank you for your question, AJ. Yeah, so, um, so the EDSF.

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A.J. Joshi: But the goal for the interim analysis is that we've talked about the enrollment target that we have. The way the interim works is we're really going to do the interim analysis just before we hit that 80 patient target. And so the driver is getting close to that enrollment target more so than anything else because that allows us to have the most possible data when we do the... And then once we do the analysis. When you're talking about expanding the study, again, that'll just depend on the numbers that we get. But Pascal kind of alluded to this before, in strong phase 2.

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A.J. Joshi: A small expansion would be meant to just kind of beef up that statistical target. A large expansion may signal, for example, the possibility that FDA says, hey, this could be potentially registerable. We want a little bit more safety and a bit more total all numbers for your... Did that answer the question? Yes, that's helpful. Thank you. Thank you. There are no further questions at this time. This then concludes today's conference call. Thank you for your participation. You may now disconnect. Salveen Richter, Gwendolyn Binder, Atara Biotherapeutics Inc. Atara Biotherapeutics Inc.

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