Q3 2021 Atara Biotherapeutics Inc Earnings Call

Operator: All lines have been placed in a listen-only mode, and the floor will be open for questions and comments following the presentation. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Eric Halgren, VP, Investor Relations and Finance. Sir, the floor is yours.

2021 financial results conference call.

Things have been placed on a listen only mode and the floor will be opened for questions and comments. Following the presentation. If you should require assistance throughout the conference. Please press star zero on your telephone keypad to reach a live operator at this time. It is my pleasure to turn the floor over to your host Eric Hello, Gordon VP Investor Relations and finance.

Sir the floor is yours.

Eric Halgren: Good morning, everyone, and welcome to Atara's third quarter 2021 results conference call. Earlier today, we issued a press release announcing our third quarter financial results and operational progress. This press release and an updated corporate slide deck are available in the Investors and Media section.

Thank you operator.

Everyone and welcome to <unk> third quarter 2021 results conference call.

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

This press release and an updated corporate slide deck are available in the investors and media section at a terabyte of Dot com on.

Eric Halgren: and Media section at atarabio.com

Eric Halgren: On today's call, members of the Atara executive team will provide an update on our financial results and operational progress, and also review our upcoming key milestones and objectives. Joining me on today's call are Dr. Pascal Touchon, President and Chief Executive Officer, Dr. Jacob DuPont, Executive Vice President and Global Head of Research and Development, DuPal Kopekar, Chief Financial Officer, Dr. A.J. Joshi, Chief Medical Officer,

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

Joining me on today's call are Dr. Pascal to Sean President and Chief Executive Officer, Dr. Jacobs, Dupont Executive Vice President and global head of research and development, Paul Kobe Kerr Chief Financial Officer, Dr. AJ Joshi, Chief Medical Officer, and Dr. Christian Your EMA Chief commercial officer.

Eric Halgren: Chief Medical Officer, and Dr. Kristen Urema, Chief Commercial Officer. We will begin.

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

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. These forward looking statements are qualified in their entirety by the cautionary statements contained in today.

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

<unk> press release, and the company's SEC filings these.

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

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 morning. We continue to make the Ministry of Health and Human Services a course of three strategic priorities. Tab cell 8188 in multiple sclerosis, and our next generation halogenate CAR T program. Today, we announce for the first time positive top-line data for a more pivotal phase-free allele study for TAP cell in EBV-positive PTLD, which includes new analyses, additional patients, and extended follow-up. These data confirm a strong objective response rate of 50%, with clear durability of response and overall survival of 89% at one year in response, while still demonstrating a well-tolerated safety profile in line with priorities.

Thank you Ed and thank you all for joining goes to be smaller.

Morning.

We continue to make money.

Of course, all three priorities.

So achy when they create and multiple sclerosis.

And our next generation Allogeneic car T programs.

Today, we announced for the first time was at top line data from our people towards Phase III study.

For tab cel in EBV positive <unk>.

Which includes new analyze these additional patients and extended photo it.

These data confirmed objective.

Objective response rate of 50%.

We've clear do ability of response and overall survival of 18, 9% up one year responders.

While still demonstrating well tolerated safety profile in line with Playa resorts.

These data will be the basis for the ruminant and a submission in the EU.

Pascal Touchon: These data will be the basis for the imminent MAA submission in the EU and our planned DLA submission in the US next year for patients with EBV-positive PTLD. We are very excited to submit our application for approval in the next few days, and we've all recently been granted accelerated assessment. We anticipate a decision regarding EU TAP cell approval in the second half of 2022.

And our planned BLA submission in the U S next year for patient with EBV positive <unk>.

We are very excited to see.

In the next few days.

Fighting for approval in Europe.

And we've also recently granted accelerated assessment, we anticipate a decision regarding EU tab cel approval in a single all of 2022.

Pascal Touchon: Additionally, in October, we were extremely pleased to announce our exclusive commercialization agreement with Pierre Sabré for tap sale in Europe, the Middle East, Africa, and other select emerging markets for EBV-positive cancers. We believe this partnership reinforces the commercial opportunity for tap sales in these markets and maximizes the strategic and financial value of this potentially transformative therapy. On the U.S. regulatory front for TAP cell, we continue to make stepwise progress in type B meetings with the FDA.

Additionally in October we.

We're extremely pleased to announce or exclusive commercialization agreement with care subway.

For tab cel in Europe, Middle East Africa, and although select emerging buckets for EBV positive cancers.

We believe this partnership reinforces the commercial opportunity for tab cel in these markets.

And maximizes the strategic and financial value of it.

Potentially transformative therapy.

On the U S. That's always painful tab cel, we continued to make stepwise progress for type a meetings with the FDA.

Pascal Touchon: In particular, we have aligned with the FDA on the comparatability approach, including the statistical methodology. Based on new requests from the CMC review team, following our recent interactions, we will provide the agency additional analysis of CMC data we have already submitted.

In particular, we are aligned with the FDA on comp.

Compatibility approach, including the statistical methodology.

Based on the new request from the CMC review team. Following our recent interactions we will provide the agency additional analyses of CMT that though we have already submitted.

Pascal Touchon: We plan to have further interactions with the FDA in Q1 2022 to resolve the outstanding items and expect to complete the BAD submission for TAF cell in Q2 2022. Concurrently, we continue to work on pursuing the development of TAP cells in additional EBV patient populations, with a primary focus on immunodeficiency-associated lymphoproliferative disease, IALPD. Braumann is continuing a site in the label expansion multi-core study, which is evaluating six patient populations, including four within IA LPDs and two in other EBV-driven diseases in the US and EU. The multi-cohort study data is expected in 2023. And we believe this could be a meaningful labor expansion opportunity.

We plan to have further interactions with the FDA in Q1 2022.

All of the outstanding items and expect to complete the BLA submission for tab cel in Q2 2022.

Concurrently we continue to work on pursuing the development of tab cel additional you'd be the patient population.

We have a partner with focus on immuno deficiency associated leave for 40 favorite T V. I a L. P D.

Poland is continuing upside to the label expansion multi golf study, which is evaluating six patient populations.

Adding four we've within E L D.

And two in all the EBV driven disease in the U S.

The multi cohort study that is expected in 2023.

And we believe this could be a meaningful label expansion opportunity.

Pascal Touchon: Turning to ATA 188, or Potentially Transformative Therapy for Patients with Progressive Multiple Sclerosis. Last month, we presented at ECTRIMS updated Phase I Open Label Extension, or OLE, data and patients with progressive MS treated with 8188 for up to 39 months. As a reminder, the natural history of patients with progressive MS is continuous disability progression.

Turning to 81 eight gig.

I'm sure he talks formative therapy for.

Patients with progressive multiple sclerosis.

Last month, we presented at X dreams, they keep the phase one open label extension.

Early data in patients with progressive M S.

It's either with a Q&A for up to 59 months.

As a reminder, the natural history of patients with Progressive M. S is continuous disability progression.

Pascal Touchon: The OLE data we presented demonstrate that patients have achieved sustained disability improvement, or SDI, at a higher rate and longer duration than would be expected based on this natural history. The majority of SDI seen in the data presented is driven by sustained EDSS improvement, which is our primary endpoint in our phase 2 randomized control, or the so-called EMBL study. Additionally, we presented magnetization transfer ratio, MTR data, and an imaging biomarker considered to reflect the state of myelination in the central nervous system, a statistically significant increase in NTR.

The early data, we presented demonstrate that patients have achieved sustained disability improvement.

Hi.

Are your weight and longer duration.

That would be expected based on these <unk> that you're already story.

The majority of <unk> seen in the data presented is driven by sustained E. D. S says improvement, which is a primary endpoint in a phase II randomized control.

The so called <unk> study.

Additionally, we presented the magnetization transfer ratio MTR data.

And major biomarker considered to reflect the state of the nation.

In the central nervous system.

The statistically significant increase in MCR.

Pascal Touchon: Parallels to EDSS Improvement Observe, and provide evidence. While potential biological bases for Clinically Significant EDSS Improvement, observed with 8188, continue to build awareness and interest in the transformative potential of AT188 in the medical community and with potential partners. As a reminder, in the first half of 2020.

Parallels you DSS improvement observed.

And provide evidence that the elimination made.

It may be the driver for clinical improvement.

These potential biological basis.

For clinically significant Etfs improvement observed with ATM and a T H.

Continues to build awareness and interest in the <unk>.

Some of these potential of achy when they create in the medical community and with potential partners.

As a reminder in the.

First half of 2022.

Pascal Touchon: We will conduct an interim analysis, or IA, to assess efficacy and safety, and WIPLA to disclose our decision regarding the next steps for the program and our rationale for this decision, based on data from the IA, while still maintaining the integrity of the study. We believe this IAEA will be an important... for the company, investors, and potential strategic partners. With regard to our CAR-T portfolio, our mesothelin product candidates, ATA-2271 and ATA-3271, partnered with Bayer, are progressing well.

We will conduct an interim analyses or I E.

The assess efficacy and safety.

And we plan.

To disclose our decision regarding the next steps for the program and I should know this decision.

Based on data from D. R E y.

While still maintaining the integrity of the study.

We believe these are you it will be an important milestone.

While the company investors and potential strategic partners.

We've laid out to our car T portfolio.

They started in product candidates eight year, 'twenty 271, and <unk> 271.

In other words by you.

Progressing well.

Pascal Touchon: Our collaborators at Memorial Sloan-Kettering will present preclinical, clinical, and translational data from the lowest-dose cohorts of the open-label, single-arm Phase I clinical study of ATA2271, an autologous cardiac therapy targeting mesothelin, through a mini oral presentation at ESMO-IO on December 21. Meanwhile, we continue to make progress on IND-enabling studies for ATA3271 and North Shelf Allogenic RT Therapy targeting mesothelin using next-generation PD-1 dominant negative receptor and 1x X-carve co-stimulatory signaling domain technologies, for which we anticipate an IMD-5 link in the second half of 2020.

Collaborators at Memorial Sloan Kettering will present, preclinical clinical and translational data from the lowest dose cohorts of the open label single arm Phase one clinical study of 822 71, an autologous car T therapy targeting mesothelin.

Who are many oil presentation at ESMO.

In December 'twenty one.

Meanwhile, we continue to make progress on our IND, enabling studies for <unk> 271 and <unk>.

Also shelf allogeneic car T therapy targeting meso team using next generation PD, one dominant they've got people et cetera.

And one X X golf course, stimulatory signaling domain technologies.

I wish we anticipate 90 fighting in the second half of 2022.

Pascal Touchon: Additionally, we plan to present new preclinical data confirming potential benefits in solid tumors for ATA3271 at CT in November, turning to ATA3219 or halogenic CD19, a targeted CAR-T for patients with B-cell malignancy. We expect to submit an IND in Q1 2022.

Additionally, we plan to present, new preclinical data.

Many potential benefits in solid tumors for 832 71 sits here in November.

Turning to 832 19.

Our allogeneic <unk> 19.

Targeted car T for patients with B cell malignancies.

We expect to submit in Q1 because in 'twenty two.

Pascal Touchon: ATF3219 leverages our next generation 1xx car co-stimulatory signaling domain and halogenated PVT cell platform and is a potential best-in-class therapist that does not require TCR or HLA gene editing, which we believe is a key differentiator of our platform. To further support our differentiated allogeneic RT platform, we have invested in new capabilities to support our product pipeline and further drive innovation by opening our new Atara Research Center, or ARC, in Southern Oaks to house our translational and preclinical science, process science, and analytical development.

32, 19 leverage is our next generation, one X X golf co stimulatory signaling domain.

In allogeneic EBV T cell platform.

And is a potential best in class therapy.

That does not require TCR or actually gene editing, which.

Which we believe is a key differentiator of our platform.

But for the support of defaulted Allogeneic car T platform, we have invested in new capabilities to support our product pipeline and further drive innovation.

By opening our new research center or <unk>.

In fact, the Nox.

House of translational and clinical science process science and analytical development teams.

Pascal Touchon: Our talented team at this new facility will support our product pipeline and further drive innovation by leveraging our unique and differentiated eugenic cell therapy platform. Moving now to our financial... With regard to our cash position and runway, we ended the third quarter of 2021 with $357 million in cash. This includes $46 million for the sale of shares of common stock through our ATM facility.

Our talented team at this new facility will support our product pipeline and further drive innovation by leveraging our unique and differentiated cell therapy platform.

Moving now to our financials.

With regard to our cash position and are underway. We ended the first quarter of 2021 with 357 million in cash.

This includes $46 million for the sales of shares of common stock.

ATM facility.

Pascal Touchon: We believe we are sufficiently funded in the second quarter of 2023 with this cash and the $45 million upfront payment received in the TSA trade commercialization agreement. As we head into the final month of 2021, I'm proud of the Atara staff and partners for steady progress in improving the lives of patients with serious diseases. We are very close to filing the MAA in the EU for TAP cells. The first ever application for allogeneic T-cell therapy in the world, and her progress in 1981-1988 clinical studies could bring a truly transformational therapy to MS patients. We look forward to providing more updates to you in the coming weeks. I will now turn the call over to Jacob. Okay?

We believe we are sufficiently funded in the second quarter of 2020 free we've reached gosh and the $45 million payment received in the P. S outlay commercialization agreement.

As we head into the final months of 2021.

I'm, a part of the other stuff and partners.

Steady progress in improving the lives of patients with serious diseases.

We are very close.

Two filing MAA in the EU what upset.

First is the application for an allogeneic T cell therapy in the world.

And our progress Nicky when they kick clinical study could bring a truly transformational therapy to Mds patients.

We look forward to providing more data to you in the coming weeks.

Turn the call over to Jacob Jacob.

Jacob Dupont: Thank you, Pascal. I'd like to provide further color on the progress we made during the third quarter in advancing our three strategic priorities. As Pascal mentioned, today we announce the first presentation of new positive data from the Pivotal Tad Cell Phase III Allele Study in EBV-positive PTLD confirming a strong objective response rate or ORR, durability of response, and continued well-tolerated safety profile, which support the imminent European MAA submission and planned BLA submission.

Thank you Pascal.

To provide further color on the progress we made during the third quarter in advancing our three strategic priorities.

As Pascal mentioned.

We announced the first presentation of new positive data from the pivotal tab cel phase III <unk> study and EBV positive <unk> confirming a strong objective response rate or <unk> or durability of response and continued well tolerated safety profile, which support the.

Imminent European MAA submission and planned BLA submission. These data will be presented in an oral session at the American Society of Hematology annual meeting next month.

Jacob Dupont: These data will be presented at an oral session at the American Society of Hematology annual meeting next month. In these data, we observe a 50% ORR as measured by independent oncologic response adjudication with a response of 50% at PTLD following SOT and PTLD following HCT. This response includes both complete and partial response.

And these data, we observed a 50% or or as measured by independent Oncologic response adjudication.

With a response of 50% at both <unk> following Esso Chi.

And P J O D. Following hcg.

This response includes both complete and partial responses importantly, overall median time to response was one one months, which is critical in this setting where patients are in urgent need of treatment as they only have a few months to live of 19 responders at this point in time.

Jacob Dupont: Importantly, the overall median time to response was 1.1 months, which is critical in this setting where patients are in urgent need of treatment as they only have a few months to live. Of 19 responders, at this point in time, 11 had duration of response lasting more than six months, with a median duration of response not yet reached. The one-year survival rate was 61% overall, 57% for SOT, and 67% for HCT.

11 have duration of response lasting more than six months with a median duration of response not yet reached the one year survival rate was 61% overall, 57% for <unk>, 67% for hcg.

Jacob Dupont: Those who responded had longer survival compared to non-responders, with a median OS not breached and a one-year survival rate of 89 percent, compared to 32 percent in non-responders. Safety findings were consistent with previously published data with no reports of tumor flare reactions and no confirmed evidence of graft-versus-host disease related to SAD cell treatment. Next month at ASH, we will present additional data on TAD cell therapy through several abstracts, including a second oral presentation on long-term survival from phase II and multicenter EAP studies in relapsed refractory EBV-positive PLT, showing median overall survival of 54 months and OS at 2 years, reaching over 86% in responders where patients experience CR or PR. As a reminder, both pivotal data from the allele study and historical data will be included in the regulatory filings for TADSO.

Those who responded had a longer survival compared to non responders with a median OS not reach and one year survival rate of 89% compared to 32% and non responders safety findings were consistent with previously published data with no reports of tumor.

<unk> reaction and no confirmed evidence of graft versus host disease related to tab cel treatment next.

Next month at Ash, we will present additional data on tab cel through several abstracts, including our second oral presentation on long term survival from phase II and multi center EAP studies in relapsed refractory EBV positive PLT showing median overall survival.

54 months in OS at two years, reaching over 86% and responders or patients.

Experience CR or PR.

As a reminder, both pivotal data from <unk> study and historical data will be included in the regulatory filings of capstone.

Yeah.

Jacob Dupont: We believe that TAP cell therapy is a truly transformational therapy for these patients with EBV-positive PTLD, where the median survival is just a few months for patients who have progressed on one prior line of therapy. And the data we have shown today serves to deepen our conviction around the potential benefit that TAP cell therapy can bring to patients. Regarding the TAB cell regulatory discussions in the U.S., as Pascal mentioned, we continue to make good progress with the FDA.

We believe the tab cel is a truly transformational therapy for these patients with EBV positive <unk> with a median survival is just a few months for patients who have progressed on one prior line of therapy and the data. We've shown today serves to deepen our conviction around the potential benefits of tab cel.

It can bring to patients.

Regarding the tab cel regulatory discussions in the U S. As Pascal mentioned, we continue to make good progress with the FDA, we held a type b meeting with the FDA CMC review team in October and we achieved agreement on comparability approach, including the statistical design.

Jacob Dupont: We held a type B meeting with the FDA CMC review team in October, and we achieved agreement on the comparatability approach, including the statistical design to assess comparability between pivotal and commercial TAB cell products. Importantly, the FDA has not requested additional new studies or manufacturing lots.

To assess comparability between pivotal and commercial tab cel products importantly, the FDA has not requested additional new studies are manufacturing lines. We are planning to submit additional analyses and data already submitted to the FDA at their request we.

Jacob Dupont: We are planning to submit additional analyses on data already submitted to the FDA at their request. We plan to interact with the FDA in the first quarter of 2022 regarding these analyses to gain agreement on comparability for pivotal to commercial taps. We've also shared the clinical data from the pivotal allele phase 3 study, along with data from supportive and historical studies. We received productive feedback from the agency that will help to guide the structure of our BLA filing.

Land to interact with the FDA in the first quarter of 'twenty two regarding these analyses to gain agreement on comparability for pivotal to commercial tab cel. We've also shared the clinical data from the pivotal allele phase III study along with data from supportive and historical studies we receive.

Productive feedback from the agency that will help to guide the structure of our BLA filing.

Jacob Dupont: Following agreements on comparability, we plan to have a pre-BLA meeting prior to submitting the BLA for TAB cell and the EBV-positive PTLD in the second quarter of 2022. Moving on to ATA 188, our product candidate for multiple sclerosis. At ECTRIMS last month, we presented encouraging two-year clinical data from the Phase I Open Label Extension and new translational MTR data from the Phase I study of ATA188 in progressive MS. In context, patients who have progressive MS will unfortunately only continue to get worse over time as the disease progresses.

Following agreements on comparability, we plan to have a pre BLA meeting prior to submitting the BLA for tab cel in the EBV positive <unk> in the second quarter of 2022.

Moving to <unk> 188, our product candidate for multiple sclerosis at <unk> last month, we presented encouraging two year clinical data from the phase one open label extension and new translational MTR data from the Phase one study of <unk> 188 in Progressive Ms.

As context patients who had progressive Ms. Unfortunately, only continue to worsen over time as the disease progresses. If there was a treatment that offers the possibility of maintaining their current level of physical function. It would have a tremendous impact on these patients' lives.

Jacob Dupont: If there was a treatment that offered the possibility of maintaining their current level of physical function, it would have a tremendous impact on these patients' lives. As we saw in the clinical data presented at Ekrem, most patients in the OLE were progression-free.

As we saw in the clinical data presented at outcomes most patients in the oily where progression free.

Jacob Dupont: Taking it a step further, the prospect of a treatment improving a patient's disability would be even more transformational for them and has never been seen before. The data we presented at ECTRIM showed that 7 of 8 patients with sustained disability improvement, or SDI, in the Phase I or Open Label Extension phase, SDI was maintained at all subsequent time points up to 33 months, with multiple patients regaining enough function that they no longer needed a walking aid and were able to walk a few hundred meters unassisted.

Taking it a step further disrupt the prospect of a treatment improving ah patients disability would be even more transformational for them and has never been seen before the data. We presented at <unk> showed that seven of eight patients with sustained disability improvement or STI and the phase one.

Or open label extension SDI was maintained at all subsequent time points up to 33 months with multiple patients regaining enough function that they no longer needed to a walking aid and we're able to walk a few hundred meters an assistant.

Jacob Dupont: With regard to presentation of new MTR data, there is an increasing body of scientific evidence using MTR as a key measure of remyelination in MS. For example, in patients treated with ATA 188 who achieved sustained EDSS improvement versus those who did not, MTR for non-enhancing T2 chronic brain lesions increased with a trend at six months that achieved statistical significance at 12 months. This significant MTR increase may be indicative of remyelination. A similar trend of MTR increase has also been seen in normal appearing brain tissue.

With regard to presentation of new MTR data, they're seeing an increasing body of scientific evidence using MTR is a key measure of remodel nation and MFS in patients treated with <unk> 188, who achieved sustained etfs improvement versus those who did not.

MTR for non enhancing T to chronic brain lesions increased with the trend at six months that achieved statistical significance at 12 months. This significant MTR increase may be indicative of re myelination.

A similar trend of MTR increase has also been seen in normal appearing brain tissue.

Jacob Dupont: The ATA188 Phase I MTR data assessing normal appearing brain tissue in PPMS and SPMS patients compares favorably to Sopanoma data from their Phase III study in SPMS. This comparison is made on slide 37 of our updated corporate presentation, on which I'd like to highlight the following.

The <unk> 188 phase one MTR data assessing normal appearing brain tissue and P. Pms and S. Pms patients compares favorably to <unk> data from their phase III study and S. Pms.

This comparison is made on slide 37 of our updated corporate presentation.

For which I'd like to highlight the following do you expect this course of MTR in progressive and mass is decline or demyelination as seen in the placebo group from the phase III <unk> study data. So Panama showed slowing of demand patient based on the small decrease in MTR versus placebo.

Jacob Dupont: The expected course of MTR in progressive MS is decline or demyelination. As seen in the placebo group from the phase 3 Sopanomad study data, Sopanomad showed slowing of demyelination based on a small decrease in MTR versus placebo. On the other hand, ATA188 uniquely indicates remyelination based on a relatively large magnitude increase in MTR. On slide 38, starting at six months after ATA188 treatment, in normal appearing brain tissue and unenhancing T2 lesions, MTR is increased in patients with EDSS improvement and relatively stable in those without.

On the other hand, HCA 188, uniquely indicates re myelination base on a relatively large magnitude increase in MTR on slides 38, starting at six months. After <unk> 188 treatment in normal appearing brain tissue on enhancing T. Two lesion.

MTR is increased in patients with Etfs improvement.

Relatively stable and those without this parallels the time course of clinical Etfs improvement for.

Jacob Dupont: This parallels the time course of clinical EDSS improvement. For the first time in progressive MS, ATA 188-treated patients with EDSS improvement demonstrated a statistically significant increase in MTR in unenhancing T2 lesions in patients with EDSS improvement. This MTR analysis, where the time course for increased MTR parallels the EDSS improvement observed, provides evidence that remyelination may be the driver for clinical improvement and supports a potential biological basis for the clinical EDSS improvements observed with ATA 188.

For the first time in progressive Ms. <unk> 188 treated patients with Etfs improvement demonstrated a statistically significant increase in MTR and uninhabited T. Two lesions in patients with <unk> improvement. This MTR analysis, where the time course for increased MCR.

Parallels Etfs improvement after observes provides evidence that rebound nation may be the driver for clinical improvement and supports a potential biological basis for the clinical Etfs improvements observed with HCA 188. Moreover, these unique amateur findings suggest.

Jacob Dupont: Moreover, these unique MTR findings suggesting remyelination have generated new investigator inquiries and excitement as we continue to enroll the Phase II randomized placebo-controlled studies in bold studies. We believe this MTR data further support the probability of success of ATA 188 as we head towards the upcoming interim analysis in the first half of 2022, turning into our potentially best-in-class CAR-T portfolio. As a reminder, our approach does not require TCR or HLA gene editing and presents a differentiated approach that retains the endogenous T-cell receptor. This has been shown in academic studies to increase persistence, durability, and trafficking.

Yes.

<unk> has generated new investigator inquiries and excitement as we continue to enroll the phase II randomized placebo controlled and bold study.

We believe this MTR data further support the probability of success of <unk> 188, as we head towards the upcoming interim analysis in the first half of 2022.

Turning into our potentially best in class car T portfolio. As a reminder, our approach does not require TCR are HLA gene editing and.

And presents a differentiated approach.

That retains the endogenous T cell receptor. This has been shown in academic studies to increase persistence durability and trafficking.

Jacob Dupont: The safety and tolerability of our allogeneic EBV T-cell therapies and platform have now been supported by clinical studies and evidence in approximately 400 patients in various disease areas, and our EBV platform enables scaling of manufacturing in stirred tank bioreactors. In closing, I would like to send my gratitude to the Atara staff, our collaborators, and the patients involved in our studies. Working together, we're hopeful that we will bring our transformative therapies to patients in need. I will now turn the call back to the operator to begin the QA portion of the call. Operator?

Safety and Tolerability of our allogeneic EBV T cell therapies and platform has now been supported by clinical studies and evidence and approximately 400 patients in various disease areas and our <unk> platform that enables scaling of manufacturing and stirred tank bioreactors.

In closing I would like to extend my gratitude to the HR staff, our collaborators and the patients involved in our studies working together we are hopeful that we will bring our transformative therapies to patients in need I will now turn the call back to the operator to abate in the QA portion of the call.

Operator.

Operator: Thank you. The floor is now open for questions. If you do have a question, you may press star 1 on your telephone keypad at this time. If your question has been answered, you can remove yourself from the queue by pressing 1.

Thank you the floor is now open for questions. If you do have a question you May press star one on your telephone keypad at this time. If your question has been answered you could remove yourself from the queue by pressing one.

Operator: Again, ladies and gentlemen, it's Star 1 to ask a question. And our first question comes from Salim Saeed from Mahudo. Go ahead.

Ladies and gentlemen, its star one to ask a question and our first question comes from Atlanta.

<unk> from <unk>.

Go ahead.

Salveen Jaswal Richter: Hi, thanks guys for all the color and congrats on the progress.

Yeah, hi, thanks. Thanks.

Guys for all the color and congrats on.

Salveen Jaswal Richter: So, a couple for me on ATA 188.

Progress.

So a couple from me on <unk> NDA, So Pascal Jacob when we get the data in the first half of 'twenty two historically in multiple sclerosis trials I think folks generally understand companies mean, two trial to file for regulatory approval, but progressive multiple sclerosis. There was also an unmet need.

Salveen Jaswal Richter: Pascal, Jacob, when we get the data in the first half of 22...

Salveen Jaswal Richter: Historically, in multiple sclerosis trials, I think folks generally understand companies need two trials to file for regulatory approval. Because of the progressive nature of multiple sclerosis, there's also an unmet need.

Salveen Jaswal Richter: And I think it's pretty established that you guys will let us know if you're going to have a large increase in N here or a smaller increase. And I'm just wondering if it's a fair way to interpret this that if you say, hey, we're going to increase this by a large N, that the p-value you're seeing is less than 0.01, and you only need one trial, and if it's a smaller increase, the p-value is something like, you know, you think you can get to 0.05 or less. And I was just wondering if you could actually give us that p-value.

And I think it's pretty established that you guys will let us know if youre going to have a large increase in here or a smaller increase and I'm. Just wondering is it fair is it fair way to interpret this is that if you say hey, we're going to increase this by a large and that the P value.

<unk> you are seen as less than <unk>, one and you only need one trial and if its a smaller increase the P value.

Like do you think you can get to a 0.5 or less.

And just wondering if you can actually give us that P value when you disclose the data and then the second question just more around the limited disclosure that we're going to get in the first half of 'twenty two could.

Salveen Jaswal Richter: IUE Disclose the data and then the second

Salveen Jaswal Richter: And then the second question, just more around the limited disclosure that we're going to get in the first half of 2022, can you just remind us, is this being driven by the FDA where they've asked you to limit the disclosure, or is this more an Atara decision? And the reason why I ask is...

Could you just remind us is this being driven by the FDA, where they've asked you to limit the disclosure or is this more and its hard decision and the reason why I ask is.

Salveen Jaswal Richter: I think some investors would argue here that it's more capital efficient to disclose more data. So I'm just sort of curious how conceptually you're thinking about that. Thank you.

I think some investors would argue here that its more capitally efficient to disclose more data and so I'm just sort of curious how conceptually you're thinking about that thank you.

Pascal Touchon: Thank you, Salim, for your question. I will ask AJ to start answering there and start with the second question because that will give color to the first one there. AJ?

Thank you for standing by your question.

A J to start answering that and starting with the second question because it will give color to the first one but hey, Jay.

A.J. Joshi: Sure, thanks for the question, Salveen. You know, again, starting with that second question, maybe we can just give an overall kind of view on this. So, as you know, the IA for this, you know, randomized placebo-controlled phase two study, we're going to hit both efficacy and safety criteria, as well as some additional biomarkers. And as you know, when we do the IA, we'll have a

Sure. Thanks for the question Celine.

Starting with the second question, maybe we can just given overall kind of view on that surprise. So as you know.

For this.

Randomized placebo controlled phase II study, we're going to hit both Africa and thank the criteria as well as some additional biomarkers.

And as you know when you do that I will have a range of results everything from people who've been on study for well beyond the year, albeit people hard.

Data around the three month timeframe. So it is going to be a fairly large data set for us there.

And the objective is you've kind of alluded to is to adapt the sample size, which at this stage if any but.

A.J. Joshi: at www.ncbi.nlm.nih.gov and possibly discussions with the FDA. And what we're saying is that we are in an appropriate forum. We will communicate publicly after the IA is done, both what we plan to do in terms of the adjustments in sample size, as well as provide detail on the rationale that we're using based on those IA results. So we are going to provide some additional detailed rationale there. Now, today, we won't get into the specifics of, you know, the actual data that we're going to share because, to some extent, the actual data that we share would depend on the IA results.

We could certainly the plan is to potentially tap into a larger size, depending on the kind of thing and possibly discussions with the FDA.

And what we're seeing is weird and an important form we will communicate publicly after that is done both what we plan to do in terms of the adjustments and sample size as well as provide detail on the rationale that we're using based on those results. So we are going to provide some additional detailed rationale there now today, we won't get into the specifics.

So the actual data that we're gaining share because to some extent the actual data that which there will depend on the higher result, but we can emphasize that the IEA based rationale for any adjustments, we're going to make in both study will be made clear, but we still have to maintain the integrity of that double blind setting that kind of leads into my last question that youre asking.

A.J. Joshi: But we can emphasize that the IA-based rationale for any adjustments we're going to make in the in-bulb study will be made clear, but we still have to maintain the integrity of So, maybe I can just give an example to add a little color to this as to what we'll provide and what we won't be able to provide. So, at the time of the IA, let's say we see a trend of EDS improvement in the active HA188 arm that's similar to what we observed in the Phase Ia study.

So maybe I can just give an example to add a little color as to what.

We'll provide and what we won't be able to provide.

So at the time of the IAA, let's say, we see a trend of Etfs improvement that.

Active 80, 188 arm, that's similar to what we observed in the Phase One study and then we see a trend for placebo that's pretty much what we expected in our modeling.

A.J. Joshi: And then we see a trend for placebo that's pretty much what we expected in our modeling. So at that point, we'd likely either decide to make no or minimal change to the sample size, except if we believe that, you know, once we have a discussion with the FDA, we could transform the study into phase 3, which would be, of course, much larger. At that point, then we'd publicly disclose our decision, we'd give the specific rationale around it, without disclosing the detailed data so we can preserve the integrity of the study. So this is really, again, it's really about this is a strong, robust phase two; it's still fully

So at that point, we'd likely either decide to make no or minimal changes in the sample side, except if we believe that once they have a discussion with the FDA that we can transform the study into phase II, which will be of course, a much larger expansion.

At that point, then we would publicly disclose our decision we'd give the specific rationale around it without disclosing the detailed data. So we can preserve the integrity of the study. So this is really again, it's really about this as a strong robust phase two it's still holding placebo control so not like an oncology setting.

And I'm actually going to happen.

Much as we can to maintain.

In terms of that study so that's the main rationale behind.

A.J. Joshi: giving details on the rationale but not details on the data itself. So, you know, that kind of leads into your second question about whether or not we will be disclosing p-values. We're not going to be discussing specific p-values or the statistical methodology at this point in the study, and we wouldn't be disclosing that at the IAEA. And again, Salim, the aspect related to the specifics, we cannot give you the specifics at that time or the actual information we share because the specifics will depend on the results and not the schedule of the FDA. But we do plan to communicate enough to make sure that there is clear understanding from the investor community, in particular, about how meaningful this particular milestone of this interim analysis is there.

Giving details on the rationale, but not detailed on the data itself.

Salveen Jaswal Richter: Super helpful. Thanks so much, guys, and congrats on the progress.

Operator: And our next question comes from Matt Phillips.

Matt Phillips: Hi everyone, thanks for taking my question. Just wanted to try to clarify some of the regulatory discussions around C&C. Any color on what the CMC team is focused on this point, because you said on the Q2 call that you were aligned regarding the comparability approach?

In regulatory discussions around C N C. So.

Any color on what the C. M. C team is focused on this point because you said on the queue to call that you were lying regarding comparability approach.

Matt Phillips: And so, just kind of curious what additional information you're looking for. And then, again, just to make sure I understand the sequence of events correctly, you're going to submit this additional analysis that the FDA requested, and then...

And so it just kind of curious what additional information you're looking for and then again just to make sure I understand the sequence of events correctly, you're gonna submit this additional analysis that the F. D. A requested and then.

Matt Phillips: And then discuss that in Q1. Will that be another type B meeting or something informal, and then hold a pre-BLA meeting in Q2? Thank you, Matt. And maybe I'll start, and Jacob can chime in if needed there.

Discuss that in Q1 will that'd be a tight another type be meeting or something and formal and then hold a prebuilt VLA meeting in queue too.

Thank you Martha maybe I started and Jacob Punch on me and you can eat eat them.

Pascal Touchon: As you said, we have reached agreement on the methodology. We presented this new comparativability analysis during the recent IP in October. And you may remember, we said in Q2, this is a new analysis based on analyzing all the batches manufactured by Atara, you know, these 74 batches there. So that's a lot of data that we sent to the FDA there. And we believe, and we've shown in our analysis, that this set of data demonstrates comparability between the pivotal study process and the internet commercial process there. Keeping in mind, of course, as you may remember, that in reality, these process differences between these manufacturing process versions are minimal. They're really minimal out there.

As you said, we we have reached agreement on the major Oh Gee, we presented during the recent type in October this new compatibility in the nineties and you may remember, we send you to V. C's and you analyze he's based on analyzing all the botch manufactured by a dog and it'll be 74 by chance there. So that's a lot of thought that.

We we sent to the F D. A and we believe in and we were shown in on the lazy D set up that the most tried compatibility between the people don't study Paul says and the intended commercial pulses fashion.

Keeping in mind of course as you may remember that in reality. These pulses differences between these manufacturing process fashion now minimum.

Pascal Touchon: But we analyzed all the batches, presented all these data, an immense amount of data, to the FDA. So what the FDA has asked is additional data analysis related to a few attributes there. And we will provide them because they have the data already, but they ask us to do additional analysis. So we'll do that additional analysis. We'll provide the FDA with this analysis for the data already submitted, and then once they have the analysis, we plan for further discussion.

Many of them on there, but we analyze all the budget presented the oldies that the immense amount of that that will be it yet.

So what the F D. A I ask each additional that allergies related to have to attribute today and we will provide them because that's how they they have to that already but they ask us to do additional analogy. So we'll do visa national and he says he will provide the F. D. A we'd be psychology for at least that already submitted and then once they are.

Dear nausea sweep painful for the discussion we are not commenting yet I'm the type of discussion, but type it wouldn't make sense for sure. There and then once we've got to that level of discussion and alignment with the idea of an agreement on the compatibility.

Pascal Touchon: We are not commenting yet on the type of discussion, but a type B would make sense for sure there. And then once we've got to that level of discussion and alignment with the FDA and agreement on comparability, that's where we will go to a pre-BLA meeting to be able then to present all we plan to submit, including clinical and all the other stuff. And then we'll be able to file for a BLA. So that's the sequence of events that we are planning based on this discussion with the FDA.

That's way. It then we will go with with creepy and everything to be able then to presents or what we plan to submit including clinical and all the other stuff and then we'll be able to a site for <unk>. So that's the sequence of events day that we are planning based on this discussion with D at Ya.

Pascal Touchon: Yeah, no, thanks. Thanks, Pascal. It's helpful. Then maybe on the, on the...

Cause you don't see your question.

Yeah, I don't think thanks desk I was hopeful that maybe on the on the.

Matt Phillips: The kind of ash data we'll see in just the allele study.

The the kind of asked dated we'll see you in just the the legal study maybe.

Matt Phillips: I don't know if you can say this yet,

Maybe you can just.

I don't know if you can say this yet, but maybe how many patients received like a switch and so line and if that was included in the Kennedys response rates could you remind me on that.

Matt Phillips: https://www.kenhub.com

Jacob Dupont: Jacob, do you want to answer that one? Yeah.

Just kick up do you want to answer the phone.

Jacob Dupont: So, Matt, thanks for the question. So, we haven't included that particular detail in the abstract at this point in time, but what you can see here, and this is what we're reporting, obviously, is that we have a 50% response rate in all these PTLD patients and a 50% response rate in both HCT and SOT. And this is, of course, by independent oncologic and radiographic assessment, so this is really independently reviewed. And I will say that most of the responses were with the first therapy, but, of course, we can switch lots, but those details were not included in the current abstract presentation. But you can expect it's an oral presentation at ASH, so you can expect much more detail at ASH.

Yeah. So thanks for the questions. So we haven't included that particular detail in the abstract at this point in time, but.

What you can see here and this is what we're reporting obviously is that we have a 50% response rate and all these.

M P T O the patients and a 50% response rate in both.

A C T and S O T and this is of course by independent Oncologic and radiographic assessment. So this is this is really independently reviewed and I will say that most of the responses were with the first therapy, but of course, we can switch slots uhm, but.

Those details were not included in the current abstract presentation.

Yeah, but you can expect send all presentation of ash. So you can expect much more detail that's ash.

Operator: And our next question comes from John Newman from Canaccord. Please go ahead.

Great. Thank you.

And our next question comes from John Newman from Canaccord go ahead John.

John Newman: Hi guys, good morning. Thanks for taking my question and congratulations on all the progress, especially in Europe with TAPSEL. The question I have...

[noise] Hi, guys. Good morning, Thanks for taking my question and congrats on all the progress, especially in Europe was tab. So.

The question I have [noise].

John Newman: In the past, FDA has tended to look at durability of six months for CAR T products or T cell products. In your case, I think you provided some additional durability data to the FDA, but I just wanted to ask, my understanding is that the median follow-up for this study, at this point, is very, very low.

Excuse me in the past F. D. A has tended to look at.

Durability at six months for a car cheap products or T sell products.

In your case I think you've provided some additional durability data to the F. D. A but I just wanted to ask my understanding is that.

The median follow up for this study at this point is very very long and the reason I'm asking that.

John Newman: It is very, very long, and the reason I'm asking that is because I'm assuming that at this point the FDA may have all the data that they would want regarding durability, but I just wondered if you could perhaps just comment a bit about the follow-up for the study. Thanks.

Because I'm assuming that at this point the F. D. A may have all the data that they would want regarding the durability, but I just wondered if you could perhaps just come in a bit about.

About the follow up for the study thanks.

John Newman: Thank you, John, for your question. Jacob, do you want to take that one?

Well. Thank you John for your question that Jacob do you want to take that one.

Yeah sure absolutely. Thanks, John So as you recall last year, we disclose that the data cut that we provided the agency with the number of patients and this is in October of last year, whereas a reasonable number from the F D a perspective, but they want.

Jacob Dupont: Yeah, sure, absolutely. Thanks, John. So, as you recall, last year we disclosed that the data cut that we provided the agency with the number of patients, and this was in October of last year, was a reasonable number from the FDA perspective, but they wanted this six-month duration of response data, which, again, is required for regulatory approval, which is why we did this most recent data cut. And so we do, again, have this durability of response data, as I mentioned earlier in my comments, that we think are quite encouraging, and I think the 89% survival rate of responders at one year is quite encouraging.

The six months duration of response data, which again is is required for regulatory approval, which is why we did this most recent data cat and so we do I again have disturbed Dirty response data as I mentioned earlier in my comments that we think are quite encouraging and I.

I think the 89% survive.

Survival of responders at one year is quite encouraging so that's for the Aledo study now I also mention that we have a second world presentation.

Jacob Dupont: So, that's for the allele study. Now, I also mentioned that we have a second oral presentation at ASH, which is about our historical and supportive studies, and there, again, we have a median of 56 months of overall survival in that circumstance, which, again, is, of course, a very profound result for these patients. So I think the totality of the data between the allele study and then the additional supportive data that will also be presented at ASH shows a long-term benefit for these patients where you get high response rates, a rapid response, a durable response, and an impact on overall survival for these patients that have a really lethal disease. Okay, great. I have one additional question, sort of a general question on ATA-188. I just wondered if you could comment on... The understanding that you have regarding the way the agency thinks about

Ash, which is on our historical and supportive studies and there again.

We have a medium or 56 months of overall survival in that circumstance, which again is is of course, a very profound result for these patients. So I think the totality of the data between the allele study and then the additional support of data that will also be presented at ash again.

And shows a longterm banner for these patients where you get high response rates.

Rapid response Ah durable response, and an impact on overall survival for these patients that have a really lethal disease.

Okay, Great I have one additional question sort of a general question on H. A 188, just wondering if you could comment on.

The understanding that you have regarding the way the agency thinks about the potential for.

Jacob Dupont: for EDSS improvement versus simply slowing EDSS decline. I think the MS therapies that have been approved for progressive MS are simply slowing the decline.

R E D S S improvement versus simply.

Flowing E D. S. S decline I think the M. S therapies that have been approved for progressive M S or simply slowing the decline I'm. Just curious if you could perhaps provide some color on how the agency thinks about something like E. S. S. Two minutes.

Pascal Touchon: and Progressive MS are simply slowing the decline. I'm just curious if you could perhaps provide some color on how the agency thinks about something like EDSS. So thank you, John, for your question. I'll start, and AJ or Jacob, you might want to chime in.

Well. Thank you John for of course I was taught in in a jail Jacob you might want to chime in but I mean, that's why it was so important for us to the dialogue would be at the at the end of last year, where we are lying on these I'm I'll be quite tell Ya all E. D. S says sustained improvement of 12 months.

Pascal Touchon: But, I mean, that's why it was so important for us to have this dialogue with the FDA at the end of last year, where we agreed on these primary criteria of EDSS sustained improvement at 12 months, which is having two consecutive time points for improvement and the last one being at 12 months. That was very important because, as you say, it has not yet been approved. And to our knowledge, only one has tried to develop the DSS improvement for phase 3.

Which is the two consecutive time for improvement and the last one being a 12 months there.

Both of them because as you say it was not yet no public is gonna push it.

And two of them old age will be one apply to develop on the D. S. That's important for the face Sweet that's what I submitted a study there we've we've unfortunately, that's the the fading so.

Pascal Touchon: That was a May Day study there, and unfortunately, that study failed there. So it was very important for us to talk with the FDA, and we aligned ourselves with them. And they did say that sustainability improvement is an important primary endpoint for progressive MS, and they prefer to have EDSS improvement. That's why we changed our primary criteria in the EMBOL study to be sustained EDSS improvement. So that's a first. Nobody else has done that before.

So it was very important they're about to be talk with you again, we along with them and they did say that assistant deputy can pull month is unimportant primary endpoint for policy that mess and they prefer to F. E. D. S. That's important that's why we change our primary cause I tell ya in the on board study to be sustained E. D. S.

It's important cause that's a first nobody else has done that nobody is trying to do that cause even the few studies about trying to go now B M. S. Nobody's trying to look at the assistant India. That's important so but that's that's been lying with Yankee.

Pascal Touchon: Nobody else is trying to do that because even the few studies that are trying to go now in PMS, nobody is trying to look at this sustained EDSS improvement. But that's a first that has been aligned with the FDA. Does that answer your question, John? Yes.

Cause it don't say a question John.

Operator: And our next question comes from Tessa Romero from JP Morgan. Okay.

[noise], yes. Thank you.

And our next question comes from.

I sat around my around from J P. Morgan go ahead.

Hey, guys I come morning, a couple of questions for me. This morning, I'm Cranky currently I'm definitely card.

Tessa Romero: Hey guys, good morning.

Tessa Romero: A couple of questions from me this morning on the CAR T programs, if I could. So, just thinking a little bit about the mesothelium CAR-T program, ATA-2271, ahead of the updates coming up here at ESMO-IO in December, what are you looking to understand in this data update, given what we know about from the prior MSK data and also your allogenetic program? What would be a win scenario in your view here? And then my second question is about the ATA-3271 allogenetic program. What are the gating factors for IND submission at this time? Thanks so much.

<unk> just thinking about all that about then you've got the alien Karachi program a T. H T T. Seven wine I had at the at the it's coming up here. It has no I am in December what are you looking to understand and they'll be happy getting what we know about trying to prior N S. K U data and also your allergy now that program.

What would be a win scenario in your view here.

And then my second question is on that that a T. A <unk> seven one allergy NAMIC program. What are the gating factor is too I N D submission at this point.

Tessa Romero: Thank you very much for your question. Jacob, do you want to take the first one?

Thanks, so much.

Thank you very much for that question Jacob do you want to take the first one.

Jacob Dupont: Yeah, absolutely. So, Tessa, thanks for your question. So, as mentioned, we're excited to announce that we have a mini oral presentation with our collaborators at Memorial Sloan Kettering for the autologous mesothelium program. And again, we think that our Allocar T platform really is an exciting one and potentially best in class because we are leveraging technology like the 1XX next-generation co-stimulatory domain and PD-1 dominant negative receptor. And of course, this first study is for the Auto program, and then we have the following allogeneic one using our EBD T cell platform. And again, we don't do gene editing, and we think that that's really important for the performance of the cells and to limit risk as well.

Yeah, absolutely. So tessa. Thanks for your question. So as mentioned we're excited to announce that we have a mini oral presentation with our collaborators at memorial So catterick for the autologous measles ceiling program and again.

We think that our our car T platform really is an exciting one and potentially best in class because we are leveraging technology like one Xx next generation co stimulatory domain and P. D. One dominant negative receptor and of course this first study.

Is for the auto program and then we have the following our genetic one using R. E. B B T. So platform and again, we don't do G. Netting and we think that that's really important for the performance of the south until limited limit risk as well so asthma I O.

Jacob Dupont: So, at ESMO-IO, our collaborators at St. Kettering will present preclinical data for the program, but also clinical data from low-dose patients. So, you'll see safety there, translational data, as well as some potential early efficacy. I will say, of course, these are low-dose cohorts. But again, safety is really important here, of course, as we move into... into these CAR-T therapies for solid tumors. And then I also think, you know, these questions of the persistence of cells are really important.

Or a collaborator sits on Kettering will present preclinical data for the program, but also clinical data from low dose patients. So you'll see safety there translational date as well as some potential early efficacy I will say of course these are low dose cohorts, but again I would.

Say safety is really important here of course as we move into.

Into these.

These court T therapies for solid tumors and then I also think these questions are persistence of the south is really important.

Jacob Dupont: Turning on to the Allogeneic Program 3271, just one comment. We are having a presentation here at CITSE very shortly with preclinical data, updated data for that allo-mesothelon program. So that will be a poster presented at CITSE, and then we're very much on track with the IND filing in the second half of next year. And I will say, you know, as with any IND, you have to get all of your studies ready for the IND filing, including, of course, for this type of therapy, the manufacturing aspects of this type of program.

Uhm turning on two D.

The Allogeneic program 32, 71, just one comment we are having a presentation here at city.

Very shortly with preclinical data updated data for that Aloe me Sophie on program. So.

So that will be a poster presented it said C. And then we were very much on track with the R&D filing in the second half of next year and I will say you know as with any I D. You have to.

Get all of your studies your.

Ready for the I M E filing including of course for this type of therapy at the manufacturing aspects for this type of program, but I will say everything is moving had very well with our partner buyer here and and again preceding that will be the I D filing for 32 19.

Jacob Dupont: But I will say everything is moving ahead very well with our partner Bayer here. And again, preceding that will be the IND filing for 3219, which is our allogeneic CD19 CAR-T, which we think would be best in class. And again, we're targeting a Q1 IND next year. And Tessa, maybe two additional points.

Which is our allogeneic C. D 19, Cartier, which we think would be best in class and we're targeting a Q1 int of next year.

Okay. So maybe two additional point that we are very excited about this program until 50 to 71 in particular, one aspect that is very unique to us off and suck too aspect first one is the 32 71, he's going to be made is being made right now E. T. A thong bioreactor that's a.

Pascal Touchon: We are very excited about this program, and 3271 in particular, one aspect that is very unique to Atara, in fact, two aspects. First one is, this 3271 is going to be made, is being made right now, in the Steel Tongue Bioreactor. That's a big first for an allogenic CAR-T, or CAR-T in general, in there. And I think that's why it's taking the time to put that together, because that's a big first. But we have already evidence at some early stage that we can make this allogenic CAR-T into stirred-tongue bioreactors, which is going, we believe, to change radically the manufacturing efficiency of allogenic cell therapy manufacturing. So watch the pace there.

Big first for another with any coffee or call to ensure that all day and I think that's why it's taking the time to put that together because that's a big first but we have over the evidence at some early stage that we can make these allogeneic call T E. Two still talking about your actor, which he's going we believe to change radically.

The manufacturing deficiency of I'll go ahead, and eat <unk> manufacturing so what's the pace that the other aspect is the fact that we are maintaining T. T. O N 32, 71, we mentioning D E. B V. P. C. All day in manufacturing process, we really think that's very important not only from a safety point of view.

Pascal Touchon: The other aspect is the fact that we are maintaining TCR in 3271. We're maintaining the EBV TCR there in our manufacturing process. We believe that's very important, not only from a safety point of view, as recent examples have been shown, but also, we believe, from an efficacy point of view. In fact, recently, a clinical study was published in Nature using mesothelin CAR T cells that were edited to lose TCR and PD-1 expression.

As a recent example, that's been shown but also we'd be D. Four minutes. He can <unk> in fact recently a clinical study has been published and not you're using misleading coffee sales just the way it did it to lose D. C. O N D. One next question.

Pascal Touchon: And what was very interesting in this phase one study was that the machines could not detect CAR T cells in 12 of the 15 patients and only three patients after just a few weeks. And the only three patients for which they were, in fact, having a few TCRs that were not gene-edited, and they were the TCR-positive CAR T cells that were there.

Which was very interesting in the phase one study that you'll just could not dictate coffee sales in 12 of the 15 patient and.

And you only see patients until just a few weeks and you'll need pre patient in which they could detect where the patient for which they were in fact I think a few of T. C. All that well not junior digits and the way the T. C. A positive copy sales that's way of that that's the way I put some day. So forth is a clear evidence that issue.

Pascal Touchon: So for us, it's clear evidence that if you maintain the TCR, you are more persistent. If you delete the TCR or you modify the TCR, the endogenous one for allogenic CAR Ts through gene-editing, not only do you create a risk in terms of having additional gene editing in terms of safety, but you also limit the persistence of these cells, which will stay only for a few weeks. Does that answer your question?

Maintaining that you feel you have more persistent if you delete the T. C. All all your modify that you see all the ambition was one four I'll also need copies for Virginia D. T. Mobile you create a risk in terms of having additional gene addition in terms of safety, but you also.

The Pistons have you said that will stay only for a few weeks.

Cause it doesn't tell you of course.

Tessa Romero: Absolutely. Thanks so much for the color. Pascal and the team really appreciate it.

Absolutely. Thanks, so much for in that color Pascal and can really appreciate it.

Operator: And our next question comes from Phil Nadeau from Cohen and Cohen. Go ahead, Phil.

And our next question comes from film needing from Cohen and Cohen go ahead Hell.

Phil Nadeau: Hi, good morning. Let me add my congratulations on the allele data. A few questions from us on Tap Cell. I guess first, on the guidance for Q2 FDA filing, I'm curious how confident are you that you can complete the BLA in Q2. It does seem like the FDA and the CMC division, in particular, in dealing with cell therapies, are kind of... evolving their requirements on the fly. So, appreciating that you have alignment. How confident are you that you know exactly what the FDA wants and that there's not going to be a newer request when you talk to the agency in Q1? Thank you, Phil.

Hi, Good morning, let me add my congratulations on the wheel data a few questions frozen from us on tab. So his first on the guns for Q2 F. D. A filing I'm curious how confident are you that you can complete the billing and Q2. It does seem like the F. D. A an CMC division in particular.

Dealing with cell therapies is kind of.

[noise] evolving its requirements on the fly so appreciating that you have alignment.

How confident are you that you know exactly what you have to watch and that there's not going to be a newer request. When you when you talk to the agency in Q1.

Oh, Thank you for stopping Jacob which I mean, I mean first of all I'd say, we are very confident that we are ready to fight I mean as I said, we are fighting in the next few days in Europe.

Pascal Touchon: I'll start, and Jacob will chime in. First of all, I'd say we are very confident that we are ready to file. I mean, as I said, we are filing in the next few days in Europe. So we have a full dossier ready to go, and on all aspects of this product, we believe we have invested in and developed a product that is of high quality and with great data there, and we're going to file in Europe in the next few days.

[laughter], so we have a food fight ready.

To go and on all aspects of his product. We believe we have invested in the naval all but pulled up the teeth of I quality key and we've quite that's all day and we're going to follow you up in the next few days no in terms of the U S. N D. F. D. A discussion I mean, it's too that the it's a step Y type of.

Pascal Touchon: Now, in terms of the U.S. and the FDA discussion, I mean, it's true that it's a stepwise type of process so far, with a lot of questions coming there, and there is a lot of data also that we put to them. I mean, we are discussing things that are very often more at the BLA review level, and we're doing that in various Type B meetings that we are doing with the CMC review team, and we are making progress, stepwise progress there.

Perfect. So far with a lot of questions coming day I know, there's a lot of thought that was so that we could do that and I mean it.

Discussing think that they often I'm off the pier they review level and we're doing that in values T. D meetings that we have increased with the skin check your team and we are making progress step wise progress. There. So we certainly understanding that questions and we're going to put together this new one that I hate the asking for.

Pascal Touchon: So we certainly are understanding their questions, and we're going to put together these new analyses they're asking for and have other interactions with them. We cannot predict whether they will have other questions, but we think we have given them all the data that exists on the product. And it's really around new analysis more than trying to create new data at this stage. Jacob, anything to add? Yeah, and just to maybe amplify that as well, I do think, as you see, we're making this stepwise progress.

And all the interactions with them, we cannot predict whether they will ask all the questions that we think we have given them all does that thought that exist on.

On the product and it's really wrong, new on the like D. Mold on trying to create new dot that at this stage Jacob anything to add.

Yeah, and just to maybe amplify that as well I do think as you see we're making this step wise progress. So at the last quarterly call, we announced that we.

Pascal Touchon: So at the last quarterly call, we announced that we've got this clarity and agreement that the FDA wanted to see all of the lots that were manufactured in order to make this determination of comparability between pivotal and commercial material. And the great news is, we can do that. We have all those lots.

Got this clarity in agreement that D. FTA wanted to see all of the loss. The <unk> that were manufactured in order to make this determination of comparability between pivotal in commercial material in the Great News is we can do that we have all of those slots. So that was great clarity to get.

Jacob Dupont: So that was great clarity to get from the agency. And at this quarterly call, we can now announce that we've made further stepwise progress with that October type B meeting, where we've now come to agreement with the FDA on the comparability approach, including the statistical methodology. So again, this was an area of much discussion, and we came to agreement there.

From the agency and then this quarterly call. We can now announced that we've made further step wise.

Progress with that October type be meeting, where we've now come to agreement.

With the F D. A on comparability approach, including the statistical methodology. So again this was an area much discussion and we came to agreement there and then the agency have now.

Jacob Dupont: And then the agency has now further focused us and said that they want additional analyses on certain data points here, which we're now providing to them in advance of our next interaction with the agency in Q1 of next year. So again, I think there is clear evidence of progress here, and I think we are confident in that progress. And as Pascal says, it's really incredible, you know, as a pretty small company here that we're completing our first regulatory filing and submitting it in Europe here, as Pascal mentioned, within the next couple of days.

Further focus and said that they want additional analyses uncertain data points here, which we're now providing to them in advance of our next interaction with the agency in Q1 of next year. So again I think there is clear evidence of progress here and I think.

We are confident in that progress in this Pascal says it's really incredible.

You know as a pretty small company here that we're completing our first regulatory filing and submitting in Europe. Here is Pascal mentioned within the next couple of days, but the implications of that is that we have a full regulatory filing that's been completed and we can leverage all of those documents all of those in our.

Jacob Dupont: But the implications of that are that we have a full regulatory filing that's been completed, and we can leverage all of those documents, all of those analyses, and all of that data in the BLA filing. So we're really ready to go.

<unk> and all of that data in the BLA filing. So we're really ready to go and so we've also of course shared clinical data with the F. D. A from the study and the other supportive studies as well and gotten guidance from the F. D. A N in that clinical feedback their acts.

Jacob Dupont: And so we've also, of course, shared clinical data with the FDA from the allele study and the other supportive studies as well, and gotten guidance from the FDA on that clinical feedback that actually helps us to position the data in the BLA filing, the type of information that you would get in a pre-BLA meeting. So again, very nice progress here, and again, very proud of the team here at Atara that's worked so hard on getting this regulatory filing together.

<unk> helps us to position the data in the BLA filing the type of information that you would get in a preview a meeting so again I think very nice progress here and again very proud of the team here Detar. That's worked so hard on getting this regulatory filings together.

Jacob Dupont: Maybe a follow-up to your second point there. Management suggested that if you thought you had perfect clarity on what was necessary for the FDA filing, you might be able to progress to the filing without a pre-BLA meeting. Today, it sounds like you need that pre-BLA meeting. So I guess we're curious, what do you expect to learn at the pre-BLA meeting that you haven't already established from all the other type B meetings that you've had? Yeah, maybe I can answer that one.

Maybe a follow up to your your second point there in the past.

Management suggested that if he thought he had perfect clarity on what was necessary for the F. T. He following you might be able to Ah progress to the filing without a previous meeting.

Yeah. It sounds like you you think you need a P. P. O meeting so I guess I'm curious what do you expect to learn at the preview already meeting that you haven't already established from all the other type of meetings that you've had.

Yeah, maybe I can answer that one I think it's it's really a step wise aspect there that we need to find out in agreement on compatibility and that will lead also to the content of the Gonna do free and then the <unk> will be just to a line on the different aspect of the file in terms of content because as we said we.

Pascal Touchon: I think it's really a stepwise aspect there that we need to have that final agreement on comparability, and that will also lead to the content of module 3. And then the pre-BLA will be just to align on the different aspects of the file in terms of content.

Pascal Touchon: Because, as we said, we have a file ready to go to EMA, but FDA is asking for some different types of analysis, and so on. So we want to make sure that the way we put together the file, or we plan to put together the file for the BLA, is aligned with the FDA there. So that's why a pre-BLA meeting, we believe, and we discussed that with them, will be necessary more for what I would call maybe the administrative part, which is to make sure that the way we put the data together that we have is aligned with their expectations. Perfect.

The side ready to go to being made but if D. H F. King some different type of allergies and so on so I wanted to make sure that the way we put together the file we plan to put together the filed for the D. N. A E along with the F. D. A there. So that's why you P. B. It it became we believe and we discuss that with them will be will be necessary multiple what I would call maybe.

At least 20 fault, which is to make sure that the way we put that together that we up atheist, along with that we the expectations.

Phil Nadeau: The last question from us is on 3219. Sounds like the IND is on track for the first quarter of next year. How long do you think it'll take from the IND to actually dosing the first patient? I think for prior CAR T therapies, there was somewhat of a lag, maybe six months or so. Will that apply to 3219, or is it possible that you could dose a patient sooner than that? Yeah, we're not going to comment on that field at this stage, so we will make that comment at a later stage when we are reaching that point.

Perfect and last question from US as I'm 32, 19 sounds like they are indeed.

On track for first quarter of next year, how long do you think it will take from the I N D. Two actually dosing the first patient thinking for prior Carty therapies that there was somewhat of a lack maybe six months or so without apply to 32 19 or is it possible that he could dissipation sooner than that.

Yeah, we're we're not going to comment on that field that'd be stage. So we'll do that come onto the latest stage. When we we ought to reaching that point, but suffice to say that we all trying to get older. They'll next weekend and then you said a lot of expense and the company about total call T. N T. D 19 guilty about the best way to accelerate the <unk>.

Phil Nadeau: But suffice to say that we are trying to get all the learnings we can, and there is a lot of experience in the company about auto CAR T and CD19 CAR T, about the best way to accelerate the timing from IND to first patient and to make sure that we have the right type of patient that studies there. So, we're actively working on that as we speak, but sorry, but we cannot give you details. It's too early for that. Fair enough. Thanks again for taking our questions.

<unk> for my N D. Two first patient and and to make sure that we have the the the the right type of patient. That's the these days. So we're working on that that keeps me as we speak but sorry, but we cannot give details is too early for that.

Sure enough. Thanks, again for taking our questions.

Operator: And our next question comes from Jonathan Miller from Evacor. Go ahead.

I don't know next question comes from Jonathan Mellor from Evercore go ahead.

Jonathan Miller: Thanks guys for taking my question. One on 188, I thought the MTR data you showed at Ekstrom's was very interesting and, obviously, we went through it again a little bit on the call today, but

Okay. Thanks, guys have for taking my question one on 188.

<unk>, that's the M. T O D. D. You Should've Atkins is very interesting and nervous you went through it again, a little bit on the call today, but I understand that MTI declines are associated with clinical decline in N. S broadly, but has the <unk> ever been demonstrated I mean that is.

Jonathan Miller: I understand that MTR declines are associated with clinical decline in MS broadly, but...

Jonathan Miller: Has the inverse ever been demonstrated?

MCR stabilization been associated with the destabilization orange or increase associated with disease improvement how how much confidence do we have in this band worker.

Jonathan Miller: has MTR stabilization been associated with?

Jonathan Miller: How much confidence do we have in this biomarker being predictive in both directions? I guess that is my question there.

Being too they give me both directions I guess is my question there.

Jacob Dupont: Thank you very much for your questions.

Yeah no. Thank you very much for that question is.

Jacob Dupont: Sure, yeah, thanks for the question. I think the best way to look at it is that this biomarker has been most utilized in the relapsing-remitting space when you're looking at trying to make those correlations. And when you're thinking about the disability improvement or resolution of symptoms in MS, remember, this is all about myelination, right? So when you look at relapsing-remitting lesions that are active, you'll see MTR having a significant decline, substantial decline. And then when those lesions resolve, you'll see the MTR increase. That's, by definition, the disability that's associated with

Did you want to take that one.

Sure Yeah. Thanks for the question I think.

The best way to look at it is this biomarker has been most utilizing the relapsing remitting space when you're looking at trying to make those correlations and when you're thinking about the disability improvement or resolution of symptoms and M. S. Remember this is all about myelination right. So when you look at relapsing remitting lesions that are.

Active you'll see M T are having significant decline.

Substantial decline [laughter] and then when those lesions resolved you'll see the M. P. R increase that by definition that that the disability that's associated with that lesion, he's getting better right. So <unk>, there's been connections between M. T R increase and presumably a mile.

Jacob Dupont: that's associated with that lesion is getting better, right? So in RMS, there's been connections between MTR increase and presumably myelination there and improvement in the clinical status of those patients. In progressive MS, as you know, no one's ever seen disability. And that's why, to the questions you've asked, it's not been shown in progressive MS. You see evidence of MTR utilization for improvement in disability in RMS, just hasn't been seen in progressive MS.

A nation, they're an improvement in the clinical status of those patients.

In progressive methods, you know no one's ever seen disability equipment, and that's why the <unk> to the questions. You bet. It has not been shown and progressive M. C. C. Evidence a V. A N P R utilization for improving and disability in our math.

It hasn't been team and.

Jacob Dupont: And that's why the data that we have are so unique, because if you take a look at, for example, in the chronic T2 lesions, where they're generally considered really old, and many of those lesions will be considered almost dead lesions, those lesions are where we're seeing statistically significant remyelination, and really importantly, that's associated with when you see the remyelination, the So this is the first time that people are seeing that in progressive MS, and this is why the data are so important because there are hints of it in relapsing-remitting. But here, we're showing something really powerful in the progressive MS.

Progressive and that's why the day that we have are so unique because if you take a look at for example in the chronic T. Two reasons, where they're generally considered me old and and many of those losing so we can get around with that Legion those lesions are where we're seeing.

Statistically significantly myelination and really importantly, that's associated when you see the <unk> the patients who hadn't that remodel in Asia are the ones who had this is really an appointment. So this is the first time that people are seeing that and progressive M. S. And this is why the data or so.

Uhm important because hints of it and relapsing remitting, but here, we're showing something really powerful in the progressive M. S.

Jonathan Miller: Thanks so much. That makes a lot of sense. I guess one more on the MS franchise, just following up on the call you gave to Selim earlier in the call.

Okay. Thanks, so much it makes a lotta sense I get one more M. S franchise, just following up on the color you gave to sell them earlier in the in the call. When you talk about maintaining the integrity of the study you know obviously the the you know even a smaller part of the city here is randomized double blind are we.

Jonathan Miller: When you talk about maintaining the integrity of the study, obviously, even the smaller part of the study here is randomized and double blinded. Are we to assume that the blinding is going to be maintained throughout the interim analysis, and therefore, the amount of data that you actually have in-house is going to be limited by what the pre-specified DSMB run analysis provides you with? You're not going to have a bunch of data that you're hiding from us. It's more about maintaining the blind in the study and a limited amount of data being pulled out of the IA.

To assume that the blinding is gonna be maintained throughout the interim analysis and therefore the amount of data that you actually have in house is going to be limited by what the police specified D. S N B a.

Run analysis provides you with like <unk>, you're not you're not going to have a bunch of data that you're hiding from us as as it is more about the maintaining the blind in this study in a limited amount of data being pulled out at the I E <unk>.

Jonathan Miller: Is that fair? Yeah, I want to stop, and I'll chime in. Sure. I think the best way to look at it is that we're...

[noise], Yeah, My name's <unk>.

Sure I I think the best way to look at it as weird.

As you might imagine for any really robust randomized controlled trial work, putting in as many controls as possible to make sure we maintain a stronger blinds as possible. So of course the D. S. M is the the safety Badri can you will see all those at the data monitoring you will see all the data you know there'll be very <unk>.

Jacob Dupont: Imagine for any really robust randomized control trial, we're putting in as many controls as possible to make sure we maintain as strong a blind as possible. So, of course, the safety monitoring committee will see all those; the data monitoring committee will see all the data. You know, there'll be very limited exposure to the data internally, so it's not like we're looking to hide any specific information. But again, the best way to look at it is that this will be conducted robustly so we maintain the blind as much as possible.

Emitted exposure to the data internally. So it's not like we're looking to add any specific information, but again the best way to look at it. This will be conducted robustly. So we maintain the blind it as much as we can so that way the power of the results at the end will be as long as we can get.

Pascal Touchon: Yeah, and again, John, I think that, as we say, the specifics of what we can say are going to be clarified at the time of the IA, because that depends very much on the data. It depends very much on the status of that study, following the discussion with the FDA, could it be transformed into phase 3 or not. I mean, there are many variables there. But what we can confirm today is that this IA will not only be a very important milestone, but we'll be able to say, while preserving the integrity of the study, not only what we are deciding based on that but why we are disengaging it to a certain extent in terms of the study.

Yeah, and again Ah drove nothing we say the specifics of what we can say are going to be 25 at the time with the idea because that depends very much on the dot that it depends very much on the start to suggest to the sort of we can schedule a D. D. A could you be transferring to patient enough I mean, they they have many valuables Dale what.

We can come to some today is that <unk> nothing you will be a day and pop a milestone, but we'll be able to say while preserving the integrity of study to say nothing to me what we I'll be studying based on that that's why we disengage to us up to the next town in terms of detail.

Jonathan Miller: Thanks so much, Pascal, that makes sense. Maybe switching gears for just a second to 2271; looking forward to seeing some of that early data at ESMO-IO. Just to expand on what you said previously there, I understand this is from the lower dose cohorts, but can you tell us how many patients in total you're going to have there and whether we should expect meaningful dose responses to continue beyond these cohorts we see at ESMO-IO? Yeah, I think so.

Alright. Thanks, so much that's gonna makes sense, maybe switching gears for just a second to 22 71, so I'm looking forward to seeing some of that early data N as in Ohio. It just to to expand on what you said previously there I understand this is from the lower dose cohorts, but can you can you tell us how many patients until you're gonna have there and.

Whether we should expect meaningful dose response to continue beyond. These go once we see it has no I O.

Yeah, I think we not come on take at least H M. On the on the patient then so you'll have to wait for a few weeks there would give some details at the time, but we we say less time that it was really there's always those cool. Thank you still wanted to call to one and two on me so obese step wise to remember it.

Pascal Touchon: Yeah, I think we're not commenting at this stage on how many patients and so on. You'll have to wait for a few weeks there.

Pascal Touchon: We'll give full details at the time, but we said last time that it was really the lowest-dose cohort. It's around cohorts 1 and 2 only. So these are, I mean, step-wise. Remember it was 1 million per kick for cohort 1, 3 million per kick for cohort 2, and these are the low doses there.

When the enter key for <unk> for call too and N D solve the Lord Doris day. So that's why we already focusing on safety entrails National day, and I think that's it for US one of the key aspects, we'd be we need the P. K because I mean, it can be seen data from this type of coffee.

Pascal Touchon: So that's why we're really focusing on safety and transnational there. I think that for us, one of the key aspects would be the PK, because, I mean, we've seen data from this type of CAR-T that shows, you know, expansion, and then the CAR-T starts to exhaust, and there is no more CAR-T or at least a much lower level there. And if we could be able to see something different there, that would really be some proof of concept for having 1xx as a co-stimulatory domain and PD-1-DNR, both of them having a role to play on persistence and, I would say, a defense mechanism against the immunosuppressive tumor microenvironment there. So I think that would be great if we could show that. All right, thank you very much. And our next question comes from Salveen Richter.

They'll toss showing you know expansion and then the the coffees thoughts to to exhaust and and that there is no more coffee or at least I'm not sure what the other day and if we could be able to see something different day that would really be some proof of concept for having one xx and as a costume that the way domain.

<unk> both of them I think a hold to play on the assistance and I will sit defense mechanism against even though so of course he came on my Columbia on Monday, So I think that would be great. If we could show that.

Okay. Thank you very much.

And our next question comes from the South even right first time from Goldman Sachs go ahead saline.

Thank you for taking the question. This is Tommy on first housing can you just remind us of the key points of differentiation on a torres that's not feeling targeting parties compare it to other competitors. Thank you.

Operator: And our next question comes from Salveen Richter from Goldman Sachs. Go ahead, Salveen.

Salveen Jaswal Richter: Yes, Jacob, do you want to take that one? Yeah, sure, absolutely. For our mesothelium CAR-T, just a reminder that this is a program that we partnered with Bayer, and there are two programs in the franchise. There's the autologous program 2271, which is currently in the clinic, and that is the Esmo I.O. presentation that's going to occur here in December.

Yes take up they want to take that one.

Yeah sure absolutely so for our <unk> Carty just a reminder, that this is a program that we partnered with buyer and there are two programs and the franchise Thursday autologous.

Program 22, 71, which is currently in the clinic and that is the asthma I owe presentation, that's going to occur here in December and then there is the 32 71 program, which is the allergy in a program, where we're heading towards an I N D filing in the second half of.

Jacob Dupont: And then there's the 3271 program, which is the allogeneic program where we're heading towards an IND filing in the second half of next year. So, firstly, what both of these programs have in common is the binder against mesothelium. So, this is a binder that's already been de-risked by an academic first-generation program at Memorial Sloan Kettering. So, we know from the first-gen program that this is a safe binder, and again, we'll share data here at the end of this year at Esmo I.O.

Next year, so firstly, what both of these programs have in common is the binder against MISO ceiling. So this is a binder that's already been derisked by an academic first generation program at memorial. So <unk>. So we know from the first Jan program that this is the same.

[noise] Binder and again, we will share data.

I'm here coming at the end of this year add asthma I Oh. Additionally, what we have in our programs are the one X X co stimulatory domain. So this is next generation co stimulatory domain developed by a Doctor Shaw sat Lane at Memorial Sloan Kettering where D.

Jacob Dupont: Additionally, what we have in our programs is the 1XX costimulatory domain. So, this is a next-generation costimulatory domain developed by Dr. Michelle Sadelein at Memorial Sloan Kettering where the idea is to innovate costimulation in T cells so that you enhance in vivo expansion, persistence, and reduce exhaustion of those cells. So, again, this is an important costimulatory domain.

It is to innovate co stimulation in the T cells. So that you enhance N vivo expansion persistence and reduce exhaustion of those sounds. So again. This is an important co stimulatory domain. Additionally, both programs also have P D one dominant negative or sector.

Jacob Dupont: Additionally, both programs also have PD-1 dominant negative receptors constructed into the cells where you do not—where the cells are not at risk for tumor suppression from tumor PD-L1 expression. So, again, this is a unique feature that could also enhance in vivo persistence and prevent exhaustion as well. And so, the additional feature of the allogeneic program is that we're using our allogeneic EBV T cells as the cellular foundation for those allocar T cells. And I think what's really important here is that we have a lot of clinical experience.

Constructed into the cells, where you do not where the cells are not at.

At risk for the tumor suppression from tumor P. D O. One expression. So again. This is a unique feature that could also enhance in vivo persistence and prevent exhaustion as well and so the additional feature with the.

Genetic program is that we're using R. E B, our genetics E. B V T cells as the salaries are foundation for that those aloe current T and I think what's really important here is that we have a lot of clinical experiences. We mentioned today nearly 400 patients treated with R E.

Jacob Dupont: As we mentioned today, nearly 400 patients have been treated with our EBV allo T cell platform. These cells have great performance in patients, a great safety profile, and importantly, we retain the intrinsic T cell receptor in those allo EBV T cells. And that's really important because, as Pascal also mentioned a few minutes ago, those programs where you knock out the T cell receptor with CRISPR Cas9, you're actually really limiting the function of those T cells in vivo.

B V L O T cell platform. They had these sounds have a great performance in patients at great safety profile and importantly, we retain the intrinsic T cell receptor in those L. E. B V T cells, and that's really important because.

<unk> also mentioned a few minutes ago that those programs, where you where you knock out the T cell receptor with Crisper Castle nine you're actually really limit limiting the function of those T cells in vivo and yes. There's this.

Jacob Dupont: And, yes, there's this evidence from a German publication in Blood from a few months ago that shows that if you knock out the intrinsic T cell receptor, the persistence of those cells, the in vivo cytotoxicity of those cells, and the performance of those cells is not as good as if you retain the intrinsic T cell receptor.

<unk> from the German publication and blood from a few.

Months ago that shows that if you knock out the intrinsic T cell receptor the persistence of those cells. The in vivo center <unk> toxicity of those cells and the performance of those cells is not as good as if you retain the intrinsic T cell receptor and I will say another important feet.

Jacob Dupont: And I will say another important feature, and probably really critical here, is that we do not do gene editing in our approach. We know that gene editing can have safety liabilities and issues. We do not do gene editing in our CAR T programs. And so we think that that could also be a differentiating factor for us as well. Pascal, anything further?

Sure and probably really critical here is that we do not do gene editing in our approach. We know the gene editing can have safety liabilities and issues. We do not two gene editing in our car T programs and so we think that that.

It could also be a differentiating factor for us as well Pascal anything further.

Pascal Touchon: No, I think you cover all the aspects there, and it's a very unique and differentiated platform there, and also, I think not only an autologous but a halogenic following is very fast. It's very exciting indeed. Thank you.

No I think you could get all the aspect there and it's a very unique indeed constituted cuts on there and also I think not on the yellow total goes better not as unique photo being very fast. It's it's it's very exciting indeed.

Cause he don't feel for him.

Pascal Touchon: And our last question comes from Yigal. No, I'm sorry, I can't pronounce your last name, Nochomovitz?

Oh, sorry [laughter].

And our last question comes from Heck I'll.

No I'm, sorry, I can't pronounce your last name Nacho movie.

Yigal Dov Nochomovitz: No worries. Hi Pascal and team. Thanks for taking the questions.

Heck out of come out of it [laughter].

Hi.

Or high priced gallon team. Thanks for taking the questions. Just curious are there scenarios for at the interim analysis for a T. A 188 study could either be stopped for either either overwhelming efficacy or utility or is the interim analysis necessarily going to result in a sample size adjustment with the study.

Yigal Dov Nochomovitz: Just curious, are there scenarios where at the interim analysis for ATA-188 the study could either be stopped for either overwhelming efficacy or futility, or is the interim analysis necessarily going to result in a sample size adjustment with the study continuing? Thank you for your question, AJ.

Genuine.

Okay. Thank you for your question a J.

Yeah, Yeah there's.

A.J. Joshi: Yeah, there's, as with any other kind of robust interim Yigal, there's always a possibility that you would, you know, the highly unlikely event that you'd stop for futility. You know, and our intent would not be to, but there's always a possibility that you stop if you have amazing efficacy. So it's a standard interim analysis where you have those possibilities. But the primary intent really here is an adjustment in sample size; that would be our expectation.

As with any other kind of robust entrance you got we there's always a possibility that you it's.

Highly unlikely event they've stopped perfect yeah utility.

You know and and our intent would would not there's always a possibility that you stop I've got an amazing advocacy uhm. So it it the standard interim analysis, when we have those possibilities, but the the primary intent really here is adjusted and sample size that would be our expectation.

A.J. Joshi: Okay, and then just a separate question: when are we going to get an update on the MAPS trial and where will this be presented? I don't think we have the matched trial anymore. When we merged it into the trial, that became the allele. So, the allele is now the pivotal study. When we merged, remember, about two years ago, we merged that into one study only, one pivotal study only, having both SOT and HCT cores. Okay.

Okay, and then just a separate question when are we going to get an update on the match trial and where would this be presented.

I think we don't have the much finding nemo when we measure to try all that'd be can be a little so.

No that people don't study when we we met should remember about two years ago, we messed up into one study on the one people don't study on me, having both S O T N a shitty cold.

Ah Okay got it thank you.

Yigal Dov Nochomovitz: Okay, I got it. Thank you.

And the other question.

And there are no further questions at this time. Thank you. At this time, the conference is now concluded. We appreciate your attendance. You may now disconnect your lines and have a wonderful day.

No further questions at this time.

Thank you.

At this time since the conference has now concluded we appreciate your attendance. He may now disconnect your lines and have a wonderful day.