Q2 2020 Atara Biotherapeutics Inc Earnings Call

I O Therapeutics second quarter 2020 financial results conference call at this time all participant lines are in a listen only mode. After the speakers presentation. There will be a question answer session to ask a question. During the question you want me to press Star one on your telephone. Please be advised that today's call is being recorded I'd now like to handle.

Operator: Biotherapeutics Second Quarter 2020 Financial Results Conference Call. At this time, all participant lines are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press Star 1 on your telephone. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Heilengren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Thank you.

Hello were to Eric Hi, lingering Vice President of Investor Relations and finance at a car biotherapeutics. Thank you. Please go ahead Sir.

Thank you operator.

Eric Heilengren: Thank you, Operator. Good afternoon, everyone, and welcome to Atara's second quarter 2020 conference call. 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 for 2020. Earlier today, we issued a press release announcing our second quarter 2020 financial results and operational progress. This press release and an updated investor presentation are now available in the Investor and Media section at atarabio.com.

Good afternoon, everyone and welcome to a tars second quarter 2020 conference call.

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

Earlier today, we issued a press release announcing our second quarter 2020 financial results and operational progress. This press release and an updated investor presentation are now available in the Investor and media section Avatar bio Dot com.

Joining me on today's call are Dr. Pascal to show President and Chief Executive Officer.

Eric Heilengren: Joining me on today's call are Dr. Pascal Touchon, President and Chief Executive Officer; Dr. Jacob DuPont, Executive Vice President and Global Head of Research and Development Upal Kopikar, Chief Financial Officer Joe Newell, Chief Operations Officer Dr. A.J. Joshi, Chief Medical Officer, and Kristen Urima, Chief Commercial Officer. We will begin with prepared comments from Pascal and Jacob, then open the call up 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.

Dr. Jacob Dupont Executive Vice President and global head of research and development.

Paul coping car Chief Financial Officer.

Joe Newell Chief operations Officer.

Dr., Ajay Joshi, Chief Medical Officer, and Kristen Jarema, Chief commercial officer.

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

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

Eric Heilengren: 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?

These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings.

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

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

Thank you Eric Hagen. Thank you all for joining goes the substitute.

Pascal Touchon: Thank you, Eric, and thank you all for joining us this afternoon. As we know, we are all living and operating day-to-day amid a global pandemic never seen before in our lifetimes. And yet, at the same time, we at Atara remain committed to serving the patient in need and delivering on experience. Our mission, indeed, is to improve patient lives, and we are focused on bringing transformative therapies to those in need with even stronger commitment and resilience. To date, we have seen a relatively limited impact of the COVID-19 pandemic on our business.

As we know, we all leaving and operating day today and meet the global funded Meek never seen before no lifetimes and yet for the same time, we have to Petrohawk remain committed to serving the patient need and did you go and expectations.

Mission Indeed is to improve patient lives, we are focused on bringing transformative therapies to losing need we've even stronger commitment and those agencies.

To date.

We have seen relatively limited impact of covered 19 pump they make all know business.

Pascal Touchon: We have worked with our clinical trial sites to implement remote study visits, leverage telemedicine, home health care, and other methods to ensure continuity of care for patients and to preserve key endpoint data. From a supply chain perspective, we continue to deliver product to patients from our inventory on time, which is a clear advantage of such off-the-shelf allogeneic EBV t-cells. Most importantly, we remain on track to initiate a BLS submission for TAP cell therapy for patients with EBV-positive PTLD by the end of 2020, with more details to follow in this call. The COVID-19 pandemic is continuously evolving.

We have worked we have a clinical trial sites to implement a remote study visit leveraged 30 medicine home health care and other methods to ensure continued you have care for patients and to preserve key endpoint data.

From a supply chain perspective, we continue to deliver product to patients for more inventory on time, which has a clear advantage of search off the shelf allergenic you'd be VP sales.

Most importantly, we remain on track to initiate the beauty submission for Topcell for patients with NPV positive PTSD by the end of 2020 with more details to fully wouldn't be scope.

The company line can Thunder, Nick is continuously evolving.

Pascal Touchon: And going forward, we will closely monitor the situation and continue to assess its potential impact on our business and operations, including the timing and execution of clinical and preclinical studies. During the second quarter of 2020, we continued to make tremendous progress in delivering on our strategic priorities, TAP cell, AT188 in multiple sclerosis, and our emerging CAR T portfolio. Starting with TAP-Cell, as I mentioned, we remain on track to initiate the BLA submission by the end of the year. As a next step, we will conduct an interim analysis of the phase 3 study in the third quarter of 2020 and then discuss the totality of TAP cell data with the FDA in a pre-BLA meeting, after which we expect to initiate the BDA submission if the FDA is supportive. We believe that TAP cell therapy has the potential to transform the treatment of EBV-positive PTLD and offers a compelling value proposition for patients and, very importantly, healthcare systems. As a reminder, relapsed refractory BV-positive PTLD is an aggressive, often deadly condition, with no approved therapy, and median survival in the HCT and SOT populations is only 1.7 and 3.3 months, respectively.

And going forward, we will close the money till the situation can you continue to assess its potential impact on their business and operations, including the timing and execution of clinical and preclinical studies.

During the second quarter of 2020, we continued to make tremendous progress in delivering on the strategic priorities Topcell achy, when 88, it multiple sclerosis and or emerging coffee portfolio.

Starting with Upsells as I mentioned, we remain on track to initiate the beauty submission by the end of the year.

The next that we will conduct an interim analysis of the phase three study.

Third quarter of 2020, and then discuss the totality of Topcell data with the FDA P. OLED meeting after which we expect to initiate the beauty submission you supportive.

We believe that topcell as a potential to transform the treatment of NPV positive PTSD and offers a compelling value proposition for patients and very importantly, heska assistance.

As a reminder.

That's the fluctuate between positive. He has he is an aggressive of the deadly cancer.

With no approved therapy, and median survival in the city and as Suky populations is only 1.7 and frequency months respectively.

We stop sale to date, we've seen an enjoyable treatment effect with few treatment related serious adverse events. In addition, we expect to be able to deliver topcell two patients need within three days from inventory and we have a low burden of administration on the patients and treatment centers.

Pascal Touchon: With TAP-Cell, to date, we have seen a high and durable treatment effect with few treatment-related serious adversaries. In addition, we expect to be able to deliver TAP cells to patients in need within three days from inventory, and with a low burden of administration on the patients and treatment center, which will be confirmed through a pivotal study. Such a compelling value proposition could lead to significant business potential for TAP sales plan's first indication

If confirmed frugal profit pivotal study.

Such a compelling value proposition could lead to significant business potential for Topcell plan first indication.

In terms of potential number its penchant for Topcell, we remain on target to initiate enrollment in a single out of two for some 20 in phase two Multicore study with the goal of expanding TBSA label in PD L.D. and closely related diseases.

We will focus on extending further into you know deficiency associated deferred policy relative disease or Ltd.

Even the commonality of that you'd be viewed driven mechanism of disease immunocompromised patients.

Pascal Touchon: In terms of potential labor expansion for TAPSEL, we remain on track to initiate enrollment in the second half of 2020 in a Phase II multi-cohort study with the goal of expanding the TAP cell label in PTLD and closely related diseases. We will focus on extending further into immunodeficiency-associated lymphoproliferative disease, or IALPD, given the commonality of their EBV-driven mechanism of disease in immunocompromised patients, high and unmet medical need, and positive clinical data to date with TAP cell. We are very excited about this potential opportunity for TAP-Cell, and this population represents altogether an additional few thousand patients. Serious and Addressable EDV-Driven Disease in the U.S. alone

Hi, unmet medical need and positive clinical data to date, we stop sale.

We're very excited about this potential opportunity for Topcell as these populations could present altogether and additional few thousand patients Syracuse and addressable TV driven disease in the U.S. alone.

Therefore to maximize stuff so business potential on near term focus will be the successful inefficient and first an argument of this multicore phase two study on top of the plan via the indecision needy repurpose TPG L.D. by the end of this year.

Now moving onto 80, when they cig or DVT said immunotherapy for multiples capabilities.

Totally believes in the potential for 80 188 to become a transformative therapy improving lives of mess patients.

They remain significant unmet need in particular for progressive Ms patients with approximately 1 million patients living with such a progressive form of the disease.

Pascal Touchon: Therefore, to maximize top-sell business potential, our near-term focus will be the successful initiation and fast enrollment of this multi-cohort phase II study on top of the planned VLA initiation in EBV-positive PTLD by the end of this year. Now, moving on to 8188, or EBVT cell immunotherapy for multiple sclerosis. We strongly believe in the potential for 8188 to become a transformative therapy, improving the lives of MS patients. There remains a significant unmet need, in particular for progressive MS patients, with approximately 1 million patients living with such a progressive form of the disease.

Patients and caregivers are you need of new approaches with novel mechanism of action in order to truly improved clinical outcomes and reduced visibility.

We believe 18, when they create could have the potential to be such a therapy, creating tremendous value for patients healthcare systems and all shareholders.

Young Topcell energy related.

We also creating potential value, we're going exciting portfolio of innovative and differentiated approach any coffee programs.

These are based on all BV T cell platform and our ability to leverage new innovative technologies like one X X and PD one D. No license for memorial Sloan Kettering to improve efficacy persistence and durability for sports and to tackle both in Metallurgic and sold.

Pascal Touchon: Patients and caregivers are in need of new approaches with novel mechanisms of action in order to truly improve clinical outcomes and reduce disability. We believe ATO and AT8 could have the potential to be such a therapy, creating tremendous value for patients, health care systems, and our shareholders. We are also creating potential value for an exciting portfolio of innovative and differentiated allogeneic RT programs. These are based on our eBV T-cell platform and our ability to leverage new innovative technologies like 1xx and PD-1DNR, licensed from Memorial Sloan-Ketcham, to improve efficacy, persistence, and durability of response and to treat both hematologic and solid tumors.

The tumors.

We believe we are terribly position to provide patients with meaningful clinical benefit and create significant value.

With that and I'm excited to report that our collaborators at an escape I've recently submitted an eye in the application to the FDA.

Our next generation resulted in targeted or sort of go Scotty immunotherapy H.T., a 22 cents one.

We also continue to advance on or off the shelf allergenic, He said immune therapy manufacturing platform.

We are completing the manufacturing process validation activities for Topcell, while building inventory according to our commercial product supply strategy.

Oh, it BV T cell manufacturing platform continues to evolve and scallop auto wholly owned facility in Southern Docs, California.

We have generated data confirming that use of steel tongue perfusion by your reactors to improve yield.

Pascal Touchon: We believe we are strongly positioned to provide patients with meaningful clinical benefits and create significant value. With that in mind, I am excited to report that our collaborators at MSK have recently submitted an IND application to the FDA for next-generation mesothelin-targeted autologous CAR-T immunotherapy, ATA2271. We also continue to advance on off-the-shelf allogenic T-cell immunotherapy manufacturing plants. We are completing the manufacturing process validation activities for PAPCELL while building inventory according to a commercial product supply strategy. Our eBVT cell manufacturing platform continues to evolve and scale up at our wholly owned facility in Southern Docks, California. We have generated data confirming the use of steel tank perfusion bioreactors to improve yield.

Importantly, these data confirm that 80, when it yet can be manufactured in such Stiftung perfusion bioreactors with the potential to produce up to 40000 doors is the one the Nordic activities.

As kind of manufacturing technology, the key enabler to deliver biologic like cost of goods manufactured and we'd be leverage across the portfolio, including four allusion ekati programs.

Now onto a financial results.

We ended the second quarter 2020, with 347.7 million in cash cash equivalents and short term investment. This is an increase from the prior quarter and reflects aggregate net proceeds of 189.3 million from our recent public offering into.

During the full exercise of the option to purchase additional shares body under widens.

Cash used from operating activity was 56.6 million for the second quarter of two for some 20 as compared to 54.6 million for some period in 2019.

We believe that or cash cash equivalents and short term investment as of June 32020 are sufficient to fund plant operation into 2022.

Pascal Touchon: Importantly, these data confirm that AT188 can be manufactured in such steel-tank perfusion bioreactors with the potential to produce up to 40,000 doses per 1 donor leukocyte. Scale-up Manufacturing Technology is a key enabler to deliver biologic-like cost-of-goods manufactured and will be leveraged across a portfolio, including for halogenic RT programs. Now, on to our financial results. We ended the second quarter of 2020 with $347.7 million in cash, cash equivalents, and short-term investments. This is an increase from the prior quarter and reflects aggregate net proceeds of $189.3 million from a recent public offering, including the full exercise of the option to purchase additional shares by the underwriter. Cash used from operating activity was $56.6 million for the second quarter of 2020 as compared to $54.6 million for the same period in 2019.

The second quarter, we also successfully on boarded two well non scientific leaders in the field of Cellengine therapy.

Look the Jakob Dupont was named global head of R&D and Dr. Myokardia on coal was appointed to the board of directors, both as deep and diverse expertise incidents in therapies and im delighted to welcome them to our team.

In summary, I'm extremely proud of how a task in members are continuing to make excellent progress against our key objectives as a company we remain committed to a mission and I want to personally. Thank all of our employees contractors collaborators and of course the patients we seek to serve.

For all they do.

I hope that everyone on this call today is staying safe and healthy and I look forward to sharing of progress with you in a weeks and months ahead.

I would know turned the quarter over to you head of research and development. The Jakob Dupont to review further detail of October checkup.

Thanks, Pascal and good afternoon, everyone I'm excited to be part of the attire team and to provide an update on our innovative portfolio of programs as Pascal mentioned, we continue to advance tabs cell and phase three for P.T. LT for which we've obtained breakthrough.

Pascal Touchon: We believe that our cash equivalents and short-term investments as of June 30, 2020, are sufficient to fund planned operations into 2022. In the second quarter, we also successfully onboarded two well-known scientific leaders in the field of cell and gene therapy. Dr. Jacob Dupont, who was named Global Head of R&D, and Dr. Maria Grazia Roncarolo, who was appointed to the Board of Directors, both have deep and diverse expertise in cell engine therapies, and I am delighted to welcome them to our team. In summary, I am extremely proud of how Atara's team members are continuing to make excellent progress against our key objectives. As a company, we remain committed to our mission.

Nation in the United States and Prime designation in Europe. This quarter, we have made significant progress in working with our existing clinical trial sites to enroll and treat new patients in our pivotal study Weve opened several new sites in Europe, notably in Spain, Austria and Belgium.

As a result of the hard work of a tourist staff with the cooperation of our partners at our clinical sites. We are on track to conduct the interim analysis of our phase three trial in P.T.L.D. in the third quarter of this year. Following the interim analysis, we intend to meet with the FDA at ups.

Pre BLA meeting in the fourth quarter of this year to discuss the totality of the data and if the FDA supporters, we plan to initiate the B.L.A. by the end of this year.

Dr. Jacob Dupont: And I want to personally thank all of our employees, contractors, collaborators, and, of course, the patients we seek to serve for all they do. I hope that everyone on this call today is staying safe and healthy. And I look forward to sharing your progress with you in the weeks and months ahead. I will now turn the call over to our new Head of Research and Development, Dr. Jacob Dupont, to review further details of our program. Jacob?

As a reminder, in Europe, we are active discussions with the pediatric committee of the European Medicines agency regarding a pediatric investing investigational plan or pet following discussions with the prime team and after he may approval of the Pip, we plan to submit an E U mark.

Okay authorization application for patients with NPV positive PTCL D in 2021.

Looking ahead, we are on track to initiate enrollment in the phase three multi cohort study in the second half of this year and are eager to study tabs sell in these patient populations with such high unmet need we're exploring six populations in the multi cohort study with a focus.

Dr. Jacob Dupont: Thanks, Pascal, and good afternoon, everyone. I'm excited to be part of the Atara team and to provide an update on our innovative portfolio of programs. As Pascal mentioned, we continue to advance Tab-Cell in Phase 3 for PTLD, for which we have obtained Breakthrough Therapy designation in the United States and Prime designation in Europe. This quarter, we have made significant progress in working with our existing clinical trial sites to enroll and treat new patients in our pivotal study. We have opened several new sites in Europe, notably in Spain, Austria, and Belgium.

On extending further into immuno deficiency associated lymphoma, proliferative diseases, otherwise known as I LPD.

In particular this study will evaluate both treatment naive and previously treated patients in for patient populations with I, a lpds, including two cohorts addressing frontline NPV positive P.T. elderly patients with significant unmet need and additional two core.

Hertz addressing NPV positive lpds arising out of primary or acquired Immunodeficiencies will also be studied and represent an additional few thousand patients with it addressable NPV driven diseases in the United States alone.

Dr. Jacob Dupont: As a result of the hard work of Atara's staff and with the cooperation of our partners at our clinical sites, we are on track to conduct the interim analysis of our Phase 3 trial in PTLD in the third quarter of this year. Following the interim analysis, we intend to meet with the FDA at a pre-BLA meeting in the fourth quarter of this year to discuss the totality of the data, and if the FDA is, we plan to initiate the BLA by the end of this year. As a reminder, in Europe, we are in active discussions with the Pediatric Committee of the European Medicines Agency regarding a Pediatric Investigational Plan, or PIP. Following discussions with the Prime Team, and after EMA approval of the PIP, we plan to submit an EU market authorization application for patients with EBV-positive PTLD in 2021.

We expect the first cohorts to enrollment at approximately two years with data expected in 2023. In addition, we believe there is the potential to file either by cohort or for tumor agnostic designation.

As a reminder, previously reported clinical data from other E BV driven diseases at Ash in 2018, and frontline and second line CNS P.T.L.D. and at ESMO 2018, and Liar miles sarcoma suggests the PTAB sell may provide clinical benefit.

These patients.

We've also seen relevant clinical data for our tab sell expanded access program in Asia, I D. P LPD and P.I.D. LPD and we will present. These says he poster which has already been accepted to the European Society of medical oncology meeting in a few.

This time in Spain.

Our phase one be program into cabs sell in combination with Pembrolizumab and nasal fair NGL cancer or NPC successfully achieved at safety endpoints and stable disease in a subset of patients. We will look to present these data at an upcoming appropriate forms following.

Dr. Jacob Dupont: Looking ahead, we are on track to initiate enrollment in the Phase 3 multi-cohort study in the second half of this year and are eager to study TAB cell therapy in these patient populations with such high unmet need. We're exploring six populations in the multi-cohort study with a focus on extending further into immunodeficiency-associated lymphoproliferative diseases, otherwise known as IA-LPD. In particular, this study will evaluate both treatment-naive and previously-treated patients in four patient populations with IA-LPDs, including two cohorts addressing frontline EBV-positive PTLD patients with significant unmet need. An additional two cohorts addressing EBV-positive LPDs arising out of primary or acquired immunodeficiencies will also be studied and represent an additional few thousand patients with addressable EBV-driven diseases in the United

A strategic review and prioritization of our tabs how programs, we decided not to progress with the phase two portion of this study at this time, but instead to generate additional translational data from this NPC study to further inform our strategies for this patient population within an Eva.

Having medical need.

Turning now to our existing program 88, 188 for multiple sclerosis, as most of US know multiple sclerosis patients remain under served with the current treatment options, especially as their disease progresses. Sadly continued decline in their disease, it's expected and progressive.

M.S. the current treatment options offer a modest to efficacy benefit as best they only delay progression by a few months and clearly do not altered the course of disease. We believe there is tremendous opportunity to develop a transformative therapy to help patients in need we've seen early but encouraged.

During data with 80, a 188 recall, we presented important phase one eight data for 88 188 as they yeah and conference in May were seven patients showed sustained disability improvement and three out of six patients showed sci at six months that was confirmed the 12 months.

Dr. Jacob Dupont: We expect the first cohorts to enroll in approximately two years, with data expected in 2023. In addition, we believe there is the potential to file either by cohort or for a tumor agnostic designation. As a reminder, previously reported clinical data from other EBV-driven diseases at ASH in 2018 and Frontline and Secondline, CNS, PTLD, and at ESMO 2018 and leiomyosarcoma suggest the TAB cell may provide clinical benefit for these patients. We've also seen relevant clinical data through our Tab-Cell Expanded Access Program in AID-LPD and PID-LPD, and we will present these Our Phase 1b program of TAB cell therapy in combination with pembrolizumab and nasopharyngeal cancer or NPC successfully achieved its safety endpoints in stable disease in a subset of patients.

With our cohort three dose we are now reach treating patients in the phase one eight using the cohort three dose in the open label extension of the study and we expect to present preliminary Oh, well eat data entered appropriate pharma in the second half of this year.

In addition, we've all we also expect to present 12 month clinical results for cohort for in our Phase one study in an appropriate form in the second half of this year.

In June we enrolled our first patient in our double blind randomized placebo controlled study using the cohort three dose. This study is designed to evaluate the efficacy and safety of 88 188 in patients with progressive forms of multiple sclerosis. This is certainly an exciting time for this very innovate.

The program and we look forward to continuing to share our clinical results in the future. We're also planning to discuss with the FDA. The full dataset from our phase one study to explore possible accelerated regulatory pathways.

Dr. Jacob Dupont: We will look to present these data at an upcoming appropriate forum. Following a strategic review and prioritization of our TAB cell programs, we decided not to progress with the Phase 2 portion of the study at this time but instead to generate additional translational data from this NPC study to further inform our strategies for this patient population with an evolving medical need. Turning now to our existing program, ATA 188 for multiple sclerosis. As most of us know, MS patients remain underserved with the current treatment options, especially as their disease progresses.

Moving onto our car T portfolio as Pascal mentioned, we continue to make significant progress on all fronts, even in the midst of cobot 19, we're pleased to announce or collaborators at memorial Sloan Kettering have recently submitted and the iron de application to the U.S. half da.

For our next generation missile sealant targeted autologous Carty immunotherapy that we call 80, a 22 71. This marks a significant milestone in the evolution of the program and we look forward to initiating a phase one study in solid tumors with our collaborators in the very near.

Future.

Dr. Jacob Dupont: Sadly, a continued decline in their disease is expected in progressive MS. The current treatment options offer a modest efficacy benefit at best. They only delay progression by a few months and clearly do not alter the course of the disease.

As a reminder, 80, a 22 71 is designed to improve efficacy persistence and durability of response using a novel one X X car Costimulatory domain and the cell intrinsic checkpoint inhibition technology with a PD, one dominant negative or scepter the onex.

Dr. Jacob Dupont: We believe there is tremendous opportunity to develop a transformative therapy to help patients in need. We have seen early but encouraging data with ATA 188. Recall we presented important phase 1A data for ATA 188 at the EAN conference in May, where seven patients showed sustained disability improvement, and three out of six patients showed SDI at six months that was confirmed at 12 months with our cohort three dose. We are now retreating patients in phase 1A using the cohort three dose in the open-label extension of the study. And we expect to present preliminary OLE data in an appropriate form in the second half of this year.

Sex technology was innovated by Dr. Michel sat land and the 80 822 71 program and PD. One DNR technologies are led by Dr., Chris I'd add is seemingly at M.S.K. data from Identi, enabling studies of 80 822 71 were presented at HCR in June.

This year. This is the first application of the combination of one Xx car costimulatory demand and sell intrinsic checkpoint inhibition technology with PD. One DNR. This construct is associated with less sell exhaustion improvements and functional persistence cereal cell killing.

Okay and in vivo ex efficacy, which has maintained through multiple tumor re challenges when compared to first generation CD 28, Cdthree say the base knees wholesaling car.

Dr. Jacob Dupont: In addition, we also expect to present 12-month clinical results for cohort four in our phase 1A study in an appropriate form in the second half of this year. In June, we enrolled our first patient in our double-blind randomized placebo control study using the cohort three dose. This study is designed to evaluate the efficacy and safety of ATA 188 in patients with progressive forms of multiple sclerosis.

Avatar, we're also making progress through I empty, enabling studies with our allogeneic Nissan selling car T program, which we call 18 30 to 71. There's also you license the same one Xx and PD, one DNR technologies leveraged by our different leveraged by our differentiated.

Dr. Jacob Dupont: This is certainly an exciting time for this very innovative program, and we look forward to continuing to share our clinical results in the future. We are also planning to discuss with the FDA the full data set from our phase 1A study to explore possible accelerated regulatory pathways. Moving on to our CAR-T portfolio, as Pascal mentioned, we continue to make significant progress on all fronts, even in the midst of COVID-19. We are pleased to announce our collaborators at Memorials from Kettering have recently submitted an IND application to the U.S. FDA for our next generation mesothelium-targeted autologous CAR-T immunotherapy that we call ATA-2271. This marks a significant milestone in the evolution of the program, and we look forward to initiating a Phase I study in solid tumors with our collaborators in the very near future.

He BB T cell platform.

We are also executing on preclinical I NT, enabling studies of our off the shelves allergenic Cdnineteen targeted car T, which we call 80 832 19.

This program utilizes our next generation Carty technology is an NPV T cell platform. The 80 832 19 supported by the initial proof of principle from an academic off the shelf allogeneic SBB Cdnineteen car T. Clinical study that was presented at the 20.

20 TCT meeting.

These data showed the longest median duration of response in advance B cell malignancies for an hour generic Cdnineteen car T 26.9 months. This state that gives us further caught a conviction that are NPV T cell platform has the potential to generate off the shelf.

Allogeneic car Ts with high response rates durability, and low risk of toxicity, we've seen the NPV T cells offer numerous advantages as the basis of our allogeneic platform as they are potent sell killers that specifically target diseased cells are safe traffic.

Dr. Jacob Dupont: As a reminder, ATA2271 is designed to improve efficacy, persistence, and durability of response using a novel 1xx CAR co-stimulatory domain and a cell-intrinsic checkpoint inhibition technology with a PD-1 dominant negative receptor. The 1xx technology was developed by Dr. Michelle Sadelein, and the ATA2271 program and PD-1 DNR technologies are led by Dr. Prasad Adesi Data from IND-enabling studies of ATA2271 were presented at AACR in June of this year. This is the first application of the combination of the 1xx CAR co-stimulatory domain and cell-intrinsic checkpoint inhibition technology with PD-1 DNR.

To the sites of disease expand and persist in the patient most notably we believe that 18 32 19 has the potential to be a best in class off the shelf allogeneic Cdnineteen car T therapy utilizing the next generation one Xx Carty costimulatory demand.

And our NPV T cell platform as I noted preclinical studies are underway and we now expect to file a nine D and 2021 finally I would also like to extend our sincere thanks to our staff collaborators patients and caregivers we've accomplished much in this quarter. Thanks to you.

And I look forward to providing updates on our continued progress in the near future I will now turn the call back to the operator to begin the Q a portion of the call operator.

Dr. Jacob Dupont: This construct is associated with less cell exhaustion, improvements in functional persistence, serial cell killing, and in vivo efficacy, which is maintained through multiple tumor re-challenges when compared to first-generation CD28, CD3 zeta-based mesothelic CAR. At Atara, we are also making progress through IND-enabling studies with our allogeneic mesothelon CAR-T program This also utilizes the same 1xx and PD-1DNR technologies leveraged by our differentiated eBV T-cell platform. We are also executing on preclinical IND-enabling studies of our off-the-shelf allogeneic CD19 targeted CAR-T, which we call ATA3219.

As a reminder to ask a question you wanting to prep star one on your telephone to withdraw your question press the powerful please standby well, we compile the Q and a roster.

Our first question comes on the line of John Newman from Canaccord. Your line is now open.

Pardon me John Please check your line is now open.

John Newman from Canaccord, Please check your mute button.

Did you, let's take the next Calamos CFO, John can get back in the queue. Please.

Our next question comes on the line of telling the it from Mizuho. Your line is now open.

Great. Thanks, so much for the color guys I'm a few from me on multiple sclerosis like hand on anything you wanted to one I believe the deadline to submit the late breaking abstract for actresses August 13.

Pascal or.

Engineer Jacob can you just confirm if you've submitted the abstract already or if not you plan on doing it by that deadline number two on the cohort for data that we're going to get.

Later this year I'm curious what you're thinking is around.

Moving to a cohort for dose for the randomized portion, but what's your criteria versus cohort three if it's equivalent but marginally better are you think youre going to move to that cohort for dose or stay a cohort three are you thinking about that and then slightly under Yoli I'm, just give us a little bit more color about how many patients where you can expect to see in from with.

Dr. Jacob Dupont: This program utilizes our next-generation CAR-T technologies and EBV T cell platform. The ATA3219 is supported by the initial proof of principle from an academic off-the-shelf allogeneic EBV CD19 CAR-T clinical study that was presented at the 2020 TCT meeting. These data show the longest median duration of response in advanced B-cell malignancies for an allogeneic CD19 CAR-T of 26.9 months. This data gives us further conviction that our EBV T-cell platform has the potential to generate off-the-shelf allogeneic CAR-Ts with high response rates, durability, and low risk of toxicity.

Of the of the.

Cohorts are those patients coming from.

Thank you. Thank you sorry, I tell you want to entity.

Sure So system I think.

At this point, we're still we're going to.

Lastly, specific about where we're planning on presenting these data we are going to reaffirm that we will present the data in second half of this year.

In terms of the covert for dose and what does that look like what good would look like there for us where that's a question I apologize. If you can repeat yeah that was that was basically the question like what is good and then yes. What's the criteria you have in mind to protect you use that as the dose going forward versus stick sticking with coordthree.

Dr. Jacob Dupont: We've seen the EBV T-cells offer numerous advantages as the basis of our allogeneic platform. As they are potent cell killers that specifically target disease cells, our safe traffic to the sites of disease expands and persists in the patient. Most notably, we believe that ATA3219 has the potential to be a best-in-class, off-the-shelf allogeneic CD19 CAR-T therapy utilizing the next-generation 1XX CAR-T co-stimulatory domain and our EBV T-cell platform.

Sure. It's a good question then obviously, we want to see safety and certainly what we've seen in the previous cohorts is the main as the when we have sustained stability. We continue to see that we certainly want to see that but then beyond that you know we have to see that the whole dataset, we've talked before a little bit about you know.

Stable disease is really transformational here in addition to sustain disability improvement so we'd be looking at all those factors and kind of put that altogether to decide whether we want to.

The cohort for dose and took study and the energy recall, our adaptive design, that's sort of do that right away. So it doesn't really slow the study down in any way shape or form.

Operator: As I noted, preclinical studies are underway, and we now expect to file an IND in 2021. Finally, I would also like to extend our sincere thanks to our staff, collaborators, patients, and caregivers. We've accomplished much in this quarter thanks to you, and I look forward to providing updates on our continued progress in the near future. I will now turn the call back to the operator to begin the QA portion of the call. Operator?

I mean, when you think about and when you think about the open label extension data.

The right now we're not in a position to comment on exact numbers that we're going to have available when we talk about it.

But I think a way to look at it is that we remember when we picked the cohort three dose has the right dose to move forward.

Then we really opened it up to all the patients in the prior cohorts, who were able to coolant open label extension.

As you might imagine a lot of the covered three patients because there were so active right. There in the study worthy Merck rapid patients to kind of rolled over into but we are going to we are seeing patients across all four cohorts.

Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of John Newman from Canaccord. Your line is now open. Pardon me, John, please check that your line is now open. John Newman from Canaccord, please check your mute button.

Move on into the open label extension, just not able to comment now on the with cohorts, we'd be able to present at the.

At the right form in second half year, okay, but the cohort three patients for the ones that rolled over first so we can so it's possible we can get 15 month data for cohort three.

You'll you'll definitely have the on some patients recovery.

Okay got it and that and maybe one other point to make here is that just so you know for the owe a Lee we did grow patients into that cohort three dose. So even if there are patients at the earlier cohorts.

Operator: Gigi, let's take the next call, and we'll see if John can get back in the queue, please. Our next question comes from the line of Colleen Sears from Mizzouho. Your line is now open. Great. Thanks so much for the color, guys.

Lower doses they have been there now being treated indio early at the cohort three toes.

As I mentioned in my presentation I understand and appreciate also selling throughout that at the time, we present the call for 12 months data, we should be able to clarify whether we believe that the that that justify the need to add these goes to the RCP or not so be ready for that at the time.

Salveen Jaswal Richter: A few from me on multiple sclerosis, if I can, on APA 188. One, I believe the deadline to submit the late-breaking abstract for ACT-TERMS is August 13th. So, Pascal or, I don't know, Ajay or Jacob, can you just confirm if you've submitted the abstract already, or if not, if you plan on doing it by that deadline? Two, on the Cohort 4 data that we're going to get later this year, I'm curious what your thinking is around... moving to a Cohort 4 dose for the randomized portion? Like, what's your criteria versus Cohort 3? If it's equivalent but marginally better, are you thinking you're going to move to that Cohort 4 dose or stay at Cohort 3? How are you thinking about that?

Got it. Thanks Pascoe appreciate the color guys. Thank you.

Thank you. Our next question comes on the line of Ben Bernanke from Stifel. Your line is now open.

Hey, Thank you so much I appreciate you taking the questions.

I guess just a question on on on top selling PCL Diego since your last updated ash last year have you enroll the new patients into that EPA and when will you next see an update.

From that study.

Thank you Ben Jacob you want to take that question.

Yes, certainly so [noise].

We do.

We're obviously focused on the pivotal study the Threeo to study and to get continues you get that enrollment and as you heard we've achieved the sample size of now allows us to initiate the interim analysis, which is great.

Salveen Jaswal Richter: And then, lastly, on the OLE, can you just give us a little bit more color about how many patients we can expect to see and from which cohorts those patients are coming from? Thank you. Thank you, Salim.

And we do continue to see interest in the ERP and the SP you programs as well, obviously, we would prefer to divert patients to the pivotal studies that we can achieve as much enrollment as possible, but as Pascal mentioned these are quite sick patients where.

Dr. Jacob Dupont: Sure. So, Salveen, I think at this point we're still not going to be specific about where we're planning on presenting these data. We are going to reaffirm that we will present the data in the second half of this year. In terms of the Cohort 4 dose and what it looks like, what good would it look like for us, was that your question? I apologize if you can repeat that.

There can be times win.

When the EAP or the ASP you is a better solution for those patients in urgent need.

And clearly, but the next time, you can expect that down to up sell it.

But as you know where us take about said, we up and equals to accepted that is going to present data with topcell formed a peak in these new patient population the exciting new patient population of a P.I.E. any idea.

Salveen Jaswal Richter: Yeah, that was basically the question. What is good, and then what's the criteria you have in mind to actually use that as the dose going forward versus sticking with Cohort 3? Sure, it's a good question, and certainly what we've seen in the previous cohorts is when we have sustained disability, we continue to see that. So we'd certainly want to see that.

Got it Okay. That's very helpful and maybe just a follow up question, maybe also for Dr. Dupont.

You know one thing we'd heard about is just discussions around the logistics are running.

Its second line PLD study some of the challenges associated with a rolling such a rapidly progressing disease.

Dr. Jacob Dupont: But then, beyond that, you know, we have to see the whole data set. We've talked before a little bit about how stable disease is really transformational here in addition to sustained disability. So we'd be looking at all those factors, you know, and kind of putting that all together to decide whether we want to add the cohort 4 dose to the study. And as you recall, our adaptive design lets us do that right away, so it doesn't really slow the study down in any way, shape, or form. And when you think about the open label extension data, right now, we're not in a position to comment on the exact number that we're going to have available when we talk about it.

I guess, turning and thinking about the multi cohort I LPD study how does this compare to how to second line PLD in terms of disease severity and time sensitivity for treatment compared to the frontline detailed in somebody's other BBB positive disorders.

Yeah, maybe I'll start and then we can have AJ add some additional color on the Multiphy cohort study.

[music].

We do have six distinct patient populations that are included in the multi cohort.

Trial, and I think there is definitely different tempos of disease here. So you think about it the VA A.I.D., so AIDS associated outlook for proliferative disorder or the the pediatric.

Immuno deficiency patients.

Or the primary once I should say.

These are our populations, where where zeroing in on sites that have these specialty clinics for sure so and I think.

Dr. Jacob Dupont: But I think a way to look at it is that when we picked the cohort 3 dose as the right dose to move forward, then we really opened it up to all the patients in the prior cohorts who were able to move into open-label extension. As you might imagine, a lot of the Cohort 3 patients, because they were so active right then and there in the study, were the most rapid patients to kind of roll over into it. But we are going to, you know, and we are seeing patients from across all four cohorts move on into the Open Label Extension. Just not able to comment now on which cohorts we'd be able to present at the right forum.

It is a more prevalent.

A couple of disease states as we articulated so just focusing on these patients we think we can add.

Some some thousands of additional patients that we think or are you know does represent a good addition to the the opportunity for for tabs sell.

Then they're going to be other indications of the six populations and include lionized sarcoma, which may be less rapidly growing.

Again, each patient's tumor is a bit different in this regard, but you can think of some lionized. Her comments that are a bit more in the land where the urgency is not quite as great in terms of treatment. So I think there's going to be particulars for each of these six populations, but there are certainly all very high unmet need and.

Salveen Jaswal Richter: Okay, but the Cohort 3 patients were the ones that rolled over first, so it's possible we can get, you know, 15-month data for Cohort 3. You'll definitely have some patients from cohort 2. Okay, got it.

Some of them do obviously progressed rapidly the CNS Gtld. For example is that's quite a medical emergency, but AJ anything further that you want to add.

Pascal Touchon: And maybe one other point to make here is that, just so you know, for the OLE, we did roll patients into that cohort three dose. So even if they're patients in earlier cohorts at lower doses, they're now being treated in the OLE at the cohort three dose. As I mentioned in my presentation, understood. I appreciate it. And also, Salim, to add that at the time we present the court with 12-month data, we should be able to clarify whether we believe that these data justify the need to add this dose to the RCT or not. So be ready for that at the time. Got it. Thanks, Pascal. I appreciate the call, you guys.

And maybe just the two additional current as of.

To take us when there's a high unmet medical need, particularly for example to add di di setting when you're in the refractory population you have a pretty similar aggressive progression.

But you do with P. TLD, so that isn't that the space you want to get in as rapidly as possible.

And then when you think about the CNS detail the whether its first line or.

In the refractory setting those patients all the time to progressed rapidly because if you think about the first line therapy that they don't really penetrate the CNS as well as you'd like so that's actually area that maybe a sweet spot for us for taps out. So again those even in that first line setting looking NSP clearly progressed rapidly certainly not.

Operator: Thank you. Thank you. Our next question comes from the line of Ben Burnett from CFO. Your line is now open.

Rapidly Atlanta.

Relapse refractory, but you still have good right now.

Operator: Fei, thank you so much. I appreciate you taking the questions. I guess, just a question on CABCEL and PTLD. Since your last update at ASH last year, have you enrolled any new patients into that EAP, and when will we next see an update from that study? Thank you, Ben. Jacob, do you want to take that question?

Okay. Okay. That's all very helpful. Thanks very much.

Thank you as a reminder to ask a question you wanting to protect our one on your telephone to withdraw your question about pool.

Our next question comes on the line of Marc Frahm from Cowen and company. Your line is now open.

Thanks for taking my questions.

Just maybe to start off with just with the planned interim analysis and then the Billy meaning can you review what your plans are for the disclosure for every.

One for the underlying data, but also just around will you plan on informing investors when the interim analysis has occurred and likewise when the BLE meeting.

Dr. Jacob Dupont: Yeah, certainly. So, we're obviously focused on the pivotal study, the 302 study, and to get, and continue to get, that enrollment. And as you heard, we've achieved the sample size that now allows us to initiate the interim analysis, which is great. And we do continue to see interest in the EAP and the SPU programs as well. Obviously, we would prefer to divert patients to the pivotal study so that we can achieve as much enrollment as possible. But, as Pascal mentioned, these are quite sick patients, and there can be times when the EAP or the SPU is a better solution for those patients in urgent need. And clearly, Beth, the next time you can expect data on TAP cell is in September at ASML, where, as Jacob has said, we have an e-poster accepted that is going to present data with TAP cell from the EAP in this new patient population, the exciting new patient population of PID and AID LPD.

It is happening.

Yes tick up there like to start and I'm not allowed anything but maybe there.

Yeah, absolutely so [noise].

Thanks for the question and as we've described we have achieved the enrollment to activate the interim analysis, which is great news and as we also have disclosed it is and analysis, which is upcoming quite soon so in Q3 of this year apps.

We've had the appropriate follow up of these patients. So it's sort of near term, saying and we do you plan to requests a pre BLA meeting to discuss the totality of the data as I mentioned that this is gonna be not only the data from the.

Three or two pivotal study, but we've also been working very hard.

Some of the legacy tab sell programs from Memorial Sloan Kettering Phase two studies there we've already mentioned the EAP and the ESP you programs. So we really do intend to consolidate the totality of this clinical data, which we think it's quite an.

Dr. Jacob Dupont: Okay, that's very helpful. And maybe just a follow-up question, maybe also for Dr. DuPont. You know, one thing we've heard about is just discussions around the logistics of running a second-line PTLD study, some of the challenges associated with enrolling such a rapidly-progressing disease. I guess, thinking about the multi-cohort IA-LPD study, how does second-line PTLD in terms of disease severity and time sensitivity for treatment compare to front-line PTLD and some of these other EBD-positive disorders Yeah, maybe I'll start and then we can have AJ add some additional color on the multi-cohort study. We do have six distinct patient populations that are included in the multi-cohort trial, and I think there are definitely different tempos of disease here.

Substantial and to prove present that to the FDA.

After again, the interim analysis, which is here in Q3, and then of course. This all would lead to a BLE submission before the end of the year and again, that's pending a good outcome of that meeting with the FDA.

So I.

I think I'll I'll leave it to Pascal to comment on the disclosure aspect, we we don't want to disclose too early from the perspective that.

We want to we don't want to undermine the integrity of the of the ongoing study. Obviously this is an interim analysis, but Pascal if you want to lend color to the disclosures along the way.

Yeah, nothing that to us back in terms of disclosure in terms of the doctor themselves, we would see guidance from the year during that period and being on the appropriate onto shale such information to ensure the integrity of the ongoing title. So thats once we along with them. We can then classified where are we going to come UK in terms of.

Dr. Jacob Dupont: So you think about the AIDs, so AIDS-associated lymphoproliferative disorder, or the pediatric immunodeficiency patients, or the primary ones, I should say. These are populations where we're zeroing in on sites that have these specialty clinics, for sure. And I think it is a more prevalent couple of disease states, as we articulated. So just focusing on these patients, we think we can add some thousands of additional patients that we think do represent a good addition to the opportunity for TAB cell therapy. Then there are going to be other indications for the six populations that include Lyme sarcoma, which may be less rapidly growing. Again, each patient's tumor is a bit different in this regard, but you can think of some Lyme sarcomas that are a bit more indolent, where the urgency is not quite as great in terms of treatment.

Probably at Congress for example, now disclosure will be also led by the importance of material events, there and we believe that the patients the DNA Calumet event at which we plan to communicate.

And hopefully we these alignment with the FDA, we could not only communicate that we've been hitting the DNA, but hopefully some top line data, but again that would be based on I think in alignment with the because we want to make sure that we present the integrity of the ongoing trial.

Okay.

Maybe to follow up on a on earlier discussion of the multi cohort trial you.

Give the guidance that you think kind of across these cohorts. It's maybe a few thousand patients that you could potentially ultimately add to the label can you give us at least qualitatively.

Quality level kind of the rough breakdown between the cohorts are you guys. What is one or two of those really the primary driver of that couple thousand patients and the ones that we should be your most focused on in terms of though the market opportunity.

Yeah that nothing Thats, a great question I mean clearly the.

To call with key I'd any idea how to cope with the most patients.

Dr. Jacob Dupont: So I think there's going to be particulars for each of these six populations, but they certainly all have very high unmet needs, and some of them do obviously progress rapidly. The CNS-PTLD, for example, is quite a medical emergency. AJ, anything further that you want to add? Yeah, maybe just two additional points, I guess, to Jacob's point, there is a high amount of medical need, particularly, for example, in an AIG PID setting when you're in the refractory population, you have a pretty similar aggressive progression that you do with PTLD. So that is an area, that's a space you want to get into as rapidly as possible.

And we have the slide slide 27 on the new there that you just posted that give you an ideal the sudden adult patients that they are about 170000 patients. We go to even even a child. The sub 5000, we've kind of immune deficiency in the U.S.. That's about 205 southern patient population that within the U.S., but.

Incidence is low single digit for HBP Ltd, and high single digits, Wi Fi IDN, PD and NPV positive rate is about 30% to 50% in the idea PD in 30% to 75% NP again.

Altogether it leads to a few thousand first line in second line patients only in these two called.

Then the other cool off of interested of course, the first line cold in the TLD.

First line equally PLD that all patients where the current teledyne appropriate and then CNS Bill first line in second line.

And then it will be much railroad. He's like did you put some coal mine could dms and he has been so that's the kind of order of importance of the potential amenable patients and the first two really to one that up most patients and that's why these it also priority in terms of putting all month and people from all month once we start to Inc.

Dr. A.J. Joshi: And then when you think about CNS PTLD, whether it's first line or in the refractory setting, those patients also tend to progress rapidly because when you think about first line therapy, they don't really penetrate the CNS as well as you'd like. So that's actually an area that may be a sweet spot for TAP cell therapy. So again, those, even in that first line setting, you'll see CNS PTLD progress rapidly, certainly not as rapidly as when it's relapsed refractory, but you still have good, rapid progression. Okay, okay. That's all very helpful. Thanks very much.

Say that study.

Okay, great. Thank you very much.

And by the way not only are we going to quicken data on these two public a cohort in September as low but the reason that we are focusing on the is really that the disease itself is very similar to what we see good.

So it's a very nice placebo label expansion from our point of view to address a real important medical need in the population of a few presentation. The disease that is very you know to the one for which we have large set of data already it yet but that's also.

Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.

Very positive for us to really focus on location of resources into these public it off into material study.

Typically in this call through a number of patients in both on medical need.

Thank you. Our next question comes on the line or John Newman from Canaccord. Your line is now open.

Operator: Our next question comes from Mark Fram from Cowan & Company. Your line is now open. Thanks for taking my questions. Maybe to start off with, just with the planned interim analysis and then the BLA meeting, can you review what your plans are for the disclosure strategy, one for the underlying data, but also just, around, you know, will you plan on informing investors when the interim analysis has occurred and, likewise, when the BLA meeting is happening? Jacob, would you like to start, and I'll add anything that is needed there?

John Newman from Canaccord. Please check your mute button. Your line is now open.

Pardon me John Newman from Canaccord. Your line is now open.

Operator seems like John's, having some technical difficulties so on the hey, guys up within after Oh, There's a great. This is John I'm, sorry, guys, sorry about that thanks for taking the question. So the question I had is just if you could talk a little bit about.

The longer term view for TEP. So I know that we're all very focused on the interim analysis and that makes sense at some material that for the company.

You are starting to run a study where you're looking at other.

He BV positive malignancies, and I just wondered if you could talk about the longer term opportunity here because.

It's one thing to talk about it may be positive PT LTE, but.

Dr. Jacob Dupont: Yeah, absolutely. As we've described, we have achieved enrollment to activate the interim analysis, which is great news. And, as we also have disclosed, it is an analysis that is coming up quite soon. So, in Q3 of this year, after we've had the appropriate follow-up of these patients. So, it's a near-term thing.

It's interesting to start to think about all these other areas. So I just wondered if you could talk a little bit about that opportunity. Thanks.

Yeah, maybe I'll start and then age as you can add anything specific on the way we see that he called study, but from an opportunity point of view, we think it's a great opportunity due to the commonality of the maybe if you do even mechanism of the immunocompromised patients.

Due to high unmet medical need and the body of positive clinical data today that we have already for the P. and the and excuse we know from these early data that the the therapy. It seems to be working these patients any 70, a safe there. So we have thought.

Dr. Jacob Dupont: And we do plan to request a pre-BLA meeting to discuss the totality of the data, as I mentioned. This is going to be not only the data from the 302 pivotal study, but we've also been working very hard on some of the legacy Tab-Cell programs from Memorial Sloan Kettering Phase II studies there. We've already mentioned the EAP and the SPU programs.

The opportunity to develop the potential of Topcell. These should not take too long because as we say we believe that by 2023, we should that data available.

The first school the one that's how the most important one that now from a regulatory point of view, maybe a tier one to command of the possibility that we are either to a specific cohort.

SB latex indication automobile cyclical as they do incremental.

Dr. Jacob Dupont: So, we really intend to consolidate the totality of this clinical data, which we think is quite substantial, and to present that to the FDA after, again, the interim analysis, which is here in Q3. And then, of course, this all would lead to a BLA submission before the end of the year. And again, that's pending a good outcome from that meeting with the FDA. So, I think I'll leave it to Pascal to comment on the disclosure aspect. We don't want to disclose too early from the perspective that we don't want to undermine the integrity of the ongoing study. Obviously, this is an interim analysis, but Pascal, if you want to lend color to the disclosures along the way. I think there are two aspects in terms of disclosure.

Yes sure.

Ill ask Alan mentioned, we would expect the the larger courts, the Indian credit to enroll more rapidly than than some of the others, but as we start looking at that common mechanism.

And you look at the six different cohorts that we have they all have you know.

Several and have immunodeficiency associated and they're driven by NPV. So when you look at it from that perspective, it's certainly possible that the data that we generate off of ATP I'd as well as whatever data we have off of additional cohorts would enable a tumor agnostic label. When you think about adding that information from the multi cohort will increase.

She will already have on Gtld, so that certainly good profitability for that as well and we'll of course assessed that when we get close to that 2023 timeframe. The Pascal.

Okay, great and.

One additional question not sure if Youve mentioned this earlier on the call, but can you talk about plans going forward in terms of when you might put the.

TV.

Car T against Cdnineteen into the clinic that uses your when et cetera, One X X cost and domain I'm not sure if you've given timing on that as of yet. Thanks.

Pascal Touchon: In terms of the data themselves, we will seek guidance from the FDA during that pre-BLM meeting on the appropriate time to share such information to ensure the integrity of the ongoing trial. So once we align with them, we can then clarify where we're going to communicate in terms of the appropriate Congress, for example. Now, disclosure will also be led by the importance of material events there, and we believe that the initiation of the BLA is clearly a material event about which we plan to communicate. And hopefully, with this alignment with the FDA, we could not only communicate that we've initiated the BLA but, hopefully, some top-line data. But again, that will be based on having an alignment with the FDA, because we want to make sure that we preserve the integrity of the ongoing trial. Okay.

Yes. So this is Jacob I can.

Mentioned that.

As we've noted we.

We are in the midst of the idea enabling studies currently.

[noise] attitude era, and we have disclosed to we are heading towards an I'd filing in 2021.

So work is progressing well in that regard.

Okay, great. Thank you.

Thank you. Our next question comes from the line have you gone Nochomovitz from Citi. Your line is now open.

Hi, This is Matt I think I'll explain that share taking your question.

For me I wanted to start right you are more on your decision to focus on the additional maybe I could ask cancers are now person plant back in 2018, you touched on anything you'd add for ash.

That's not presentation.

Pascal Touchon: And then maybe to follow up on an earlier discussion of the multi-cohort trial, you gave the guidance that you think, kind of across these cohorts, it's maybe a few thousand patients that you could potentially ultimately add to the label. Can you give us at least a qualitative level, kind of the rough breakdown between the cohorts or, you know, is one or two of those really the primary driver of that couple thousand patients and the ones that we should be, you know, most focused on in terms of the market? Yeah, I think that's a great question. I mean, clearly, the two cohorts with PID and AID are the cohorts with the most patients. And we have a slide, slide 27 on the new deck that we just posted, that gives you an idea of the number of patients there. There are about 170,000 patients with autoimmune disease and HIV and 35,000 with primary immune deficiency in the U.S. So it's about 205,000 patient populations at risk in the U.S. The disease incidence is low single digit for AIDP-LPD and high single digits for PID-LPD.

Now there so.

But more attractive so.

Yeah, maybe a consultant and Ajay you might want to comment on that I think clearly at the time, we are on the presented.

Data once somebody gets you got that Arash 18 on the on the CNS PT again, they're not as 2019, we presented it secrecy data on PTSD that safety that them through one patient as you remember that included not only PTSD that although they do so.

So we have now these secrecy that on the 18 and this he makes it took us extremely encouraging and that's one of the reason we have accelerated or plan we are.

Moved ahead, and we are going to see that steady basis is really based on that because they were to be able to go directly into a phase two in the way we have funded so and again there is up slightly exceeding the protocol on all on all of you in that today based on already existing clinical data that clearly showing that every.

So with because in a few patients and an acceptable safety as presented at Ash typical 19. So it's based on data that we want to accelerate the sentiment. We know that there is a significant population out there need of an innovative therapy that topcell, but there is a medical need we up early that are encouraging data that's why we accelerate.

I think there to make sure that we can portfolio solution will be spatial if anything to what.

Yeah, and maybe just one additional point if you take a look at the data that we presented earlier that was pretty much on the LMS population and CNS P. kill the population notice that we haven't presented data on any idea and thats coming through September so as we developed more and more data on any idea.

Pascal Touchon: And the EBV positive rate is about 30 to 50% in AIDP-LPD and 30 to 75% in PID-LPD. So, all together, it leads to a few thousand first-line and second-line patients only in these two cores. Then the other cohort of interest is, of course, the first-line cohort in PTLD, the first-line EBV-positive PTLD that are patients where the current therapies are inappropriate, and then the CNS, both first-line and second-line. And then there will be much rarer diseases like EBD-positive sarcoma, including LMS, and CAE-EBD. So that's the kind of order of importance of the potential number of patients. And the first two are really the ones that have the most patients, and that's why this is also a priority in terms of enrollment and speed of enrollment once we start to initiate that study. Okay, great. Thank you very much.

As you are already heard that is the largest opportunity for us. So that's also part of the factor in accelerating this program because that was a data have supported moving the program forward much more rapidly.

Got it Okay. That's helpful. And then just a follow up I guess, maybe sort of answer that that's what it more attractive about me HBV.

Hi, LPD versus what you thought.

Cancer trial, and I guess, what factors are need all the placement, where you might consider pursuing NGL cancer again.

It took up the rocks like that one.

Yes, certainly so thank you for the question.

So with the.

80, NPD lpds.

I think AJ explained well the.

The value proposition, there and the opportunity with the new data that we've generated now with the MPC study, we did achieve our goals of.

Understanding the safety and the and seeing some stable disease at that point.

Pascal Touchon: And by the way, not only are we going to present data on these two particular cohorts in September at ESMO, but the reason we are focusing on this is really that the disease itself is very similar to what we see in PTLD. So, it's a very nice possible label expansion from our point of view to address a really important medical need in a population of a few thousand patients with a disease that is very similar to the one for which we have a large set of data already in the PTRD. So, that's also very positive for us to really focus our allocation of resources on this particular phase 2 medical study, specifically in this co-op with a high number of patients and important medical needs. Thank you. Our next question comes from the line of John Newman from Canaccord. Your line is now open. John Newman from Canaccord, please check your mute button; your line is now open.

And our are we really want to generate more translational data here and from that particular trial. Because this is a co administration.

Have a cell therapy with a checkpoint inhibitor. It it is actually a very active.

Area scientific research in the field right now to understand is a better to give a checkpoint inhibitor concomitantly with the cell therapy or do you give the checkpoint inhibitor before the cell therapy or after so theres actually a lot of these interesting scientific questions that need to be answered so from that perspective, we think.

The prudent thing to do here is actually to work with our partners at Merck, who are very engaged as well to answer some of these translational questions that we can build the proper study going forward the as mentioned here the.

Operator: Pardon me, John Newman from Canaccord, your line is now open. Operator, it seems like John's having some technical difficulties, so we'll catch up with him later. Oh, there's John.

The multi cohort study is quite a straight forward the experiment for the from the perspective. These are all NPV driven.

Operator: Great. This is John. Sorry, guys. Sorry about that. Thanks for taking the question. So, the question I had is just if you could talk a little bit about The Longer Term View for TABSOL. I know that we're all very focused on the interim analysis and that, but you are starting to run a study where you're looking at other things. EBV-positive malignancies, and I just wondered if you could talk about the longer-term opportunity here because it's one thing to talk about EBV-positive PTLD, but it's interesting to start to think about all these other areas. So I just wondered if you could talk a little bit about that.

Tumors were treating with tab, so we have.

Excellent.

Clinical data to this point, so we think thats the right opportunity in the priority opportunity to focus on while we are working with our partners that Merck to really understand some of the these aspects of co administration as the best way to go about that we think it's important also as we were to answer these types of quite.

As for the field in general because we are just at the beginning of these.

Clinical experiments, combining a checkpoint inhibitor with the cell therapy as well.

Well clearly we think that we can go faster to address an important clinical need we've relatively large corporation for Q presentation. Then you with within multi go up particularly the they are deeply I'd call there and we want to go fast that's why we focusing on that.

Pascal Touchon: Yeah, maybe I start and then, Ajay, you can add anything specific on the way we see that medical study. But from an opportunity point of view, we think it's a great opportunity due to the commonality of this EBV-driven mechanism of disease in immunocompromised patients due to high unmet medical need. And this body of positive clinical data today that we already have from EAP and SPUs, we know from this early data that the therapy seems to be working in these patients, and it's certainly safe there. So we have that as a very clear opportunity to develop the potential of TAP cells.

Okay understood. Thanks for taking my question.

Thank you. Thank you.

Thank you. Our next question comes on the line of Matt fit from William Blair. Your line is now open.

Hi, Rob onto onto them up et cetera. Thanks, very much the taking the question policies of on repeat in part question years I switch between calls here. This evening.

Just maybe on the multi cohort study.

I look forward to some are.

Another major ESMO ups, given a rarity of some of these diseases can you talk about the ease all the strategy for kind of identifying the patients are they being treated by the same docs that a tree in the detail the population under that Doesnt mean that the enrollment centers for the upcoming study are likely to be the saying.

Pascal Touchon: And this should not take too long, because, as we say, we believe that by 2023, we should have data available for at least the first cohort, the ones that are the most important ones there. Now, from a regulatory point of view, maybe Ajay wants to comment on the possibility that we have either to have a specific cohort SBLA type of indication or tumor agnostic label. Ajay, do you want to comment on that?

Kind of how how common is.

Testing for E. BD positivity in these the population is is that standard or is that something that.

There's not standardize that.

Yes. Thank you all for your question agent you want to answer this one.

Sure so.

Maybe just a couple of points you talked about the testing the testings. After you fairly routine it's not done as aggressively as it isn't the transplant population because you literally track that from the moment that transplant is done you want to make sure that they're easy viral load it isn't going up but in these populations when they developed tumors. It's it's fairly standard to check for ABVD.

Dr. A.J. Joshi: Yes, sure. As Pascal mentioned, we would expect the larger cohorts, the AID and PID, to enroll more rapidly than some of the others. But as we start looking at that common mechanism and you look at the six different cohorts that we have, they all have – several of them have immunodeficiency associated with them, and they're driven by EBV. So when you look at it from that perspective, it's certainly possible that the data that we generate off of AID-PID as well as whatever data we have off of additional cohorts would enable a tumor agnostic label When you think about adding that information from the multi-cohort, the information will already be on it. So there's certainly a good possibility for that as well.

So there's really not much of a concern in terms of a diagnostic.

There the second piece, you're asking about as where do these patients show up and certainly when you're taking look at the kind of larger transplant centers. They almost all will have a you know a dedicated group that looking at these lpds for ADP study, so not that theres, 100% overlap, but there are significant overlap at a large centers.

With that detail the has one of the ITC I'd there will be some you know some separate centers, but the majority there's a large group at that do overlap and you also get the other populations. The LMS population and we have the the CBB population a few others that show up at those centers. So I would say there's significant overlap we'll have some kind of unique centers that will all.

Dr. Jacob Dupont: And we'll, of course, assess that when we get close to that 2023 timeframe at Pascal. Okay, great. And one additional question. Not sure if you've mentioned this earlier on the call, but can you talk about plans going forward in terms of when you might put Car T against CD19 into the clinic that uses your 1XX co-STEM domain? I'm not sure if you've given time. This is Jacob.

Also at in but from an operational perspective, there are advantages to that commonality of occurrence.

Okay. Great. That's helpful. Thank you and then maybe if I can just squeeze in quick or.

On the previously meeting prior to the BLE finally, just assume you're not really imaging any difficulties in getting this kind of thing organized with the FDA just given the focus on on Coke Kobe than kind of likelihood of a slew of vaccine data kind of in all that.

Dr. Jacob Dupont: I can mention that, as we've noted, we are in the midst of the ID-enabling studies currently at Atara, and we have disclosed that we are heading towards an ID filing in 2021. So work is progressing well in that regard. Great, thank you. Thank you. Our next question comes from the line of Yigal Nochomovitz from Citi. Your line is now open.

Pickup.

So thank you William for the <unk>.

Question.

Obviously cobot 19 is a major concern at this point in the world as Pascal has alluded to as well I safety the very fortunate position that were in edits.

Our era.

Tap so is that we have feed designation so that.

We really have.

Frequent and excellent engagements with the FDA and similarly in Europe, we have prime designation, which really allows us to have an excellent dialogue and I do think that the agencies have really prioritized.

Operator: Hi, this is Samantha Andreev-Gahl. Thanks very much for taking our questions. It's a treat for me.

Operator: I wanted to start with, can you expand more on your decision to focus on the additional EBV-positive cancers now versus back in 2018, when you first generated the data for ASH? What's different now versus then that makes it more attractive to pursue? Yeah, maybe I can start, and NJ, you might want to comment on that. I think, clearly, at the time, we had only presented a few data, one from the Legacy data at ASH-18 on the CNS PTLD. Then at ASH-2019, we presented efficacy data on PTLD, but safety data on 61 patients, as you remember, that included not only PTLD but other diseases. So now we have this efficacy data on EAP. And this efficacy data is extremely encouraging, and that's one of the reasons we have accelerated our plan. We have moved ahead, and we are going to initiate that study very soon. It's really based on data because it's very rare to be able to go directly into phase 2 in the way we are planning to do so.

Discussions for programs.

That have breakthrough therapy and prime designation, so we've actually had.

Very good engagement from the agency even during this period of co but.

Great. Thanks very much.

Thank you. Our next question comes on the line of Michael deal Free from Evercore ISI. Your line is now open.

Hi, guys. Thanks, so much for taking my question Speaker May one question on 80 188 regarding the durability and non responders to therapy I was wondering if there's any developments are updated thinking about using.

And H. Adelaide restriction switch to rescue non responders and also perhaps patients who who may lose response and along those lines is there a mechanism.

In the current Randomize Phase one party trial for this rescue and what's the FDA views on allowing that to be employed.

In the context of other pivotal trial or any trial for that matter.

Jay.

Sure so.

Part of the question there is what is a non responder.

So for us.

As we talked about the this notion of transformational therapy. If you can have progression or reverse progression thats transformational. So the vast majority of the patients. So far really have maintained their disability status. So it's really hard to identify who wouldn't nonresponders at this point. So it really I wouldn't expect immediately.

Pascal Touchon: And again, there is a slide that explains the protocol on our new investor deck. Based on already existing clinical data, that clearly shows that there is some efficacy in a few patients and acceptable safety, as presented at ASH 2019. So it's based on data that we want to accelerate. At the same time, we know that there is a significant population out there in need of an innovative therapy like TAP cell.

Be able to provide information on that just because we don't we don't have someone how it officially say as a pure non responder based on that definition.

That said, there's already built in mechanisms that are part of the trial, though in a in the open label extension that allow switch for any of those for anyone who is felt to be a non responder.

And in terms or a question around how ft. If you look about that that concept of restrictions, which has already built into our phase three tap cell program. So they're very familiar with it in a very comfortable with the concept. So we can you were just simply applying it similarly to the one AG program. So it's really more we need more longer observation before we can get some of that.

Appearance on switch because we still havent in my mind seemed really much to be able to say, we definitely is what somebody.

Pascal Touchon: There is a medical need. We have early data, encouraging data. That's why we are accelerating there to make sure that we can propose, hopefully, a solution for these patients. AJ, anything to add?

Great that's helpful and just a quick follow up.

For just wondering how we should think about the placebo response rate in the current.

Phase one part two and that's trial, what we've seen from from the mid to experience how this could blow up.

Dr. Jacob Dupont: Yeah, maybe just one additional point. If you take a look at the data that we presented earlier, that was pretty much on the LMS population and CNS-PTLD population. Notice that we haven't presented data on AID-PID yet, and that's coming in September. So as we develop more and more data on AID-PID, as you have already heard, that is the largest opportunity for us. So that's also part of the factor in accelerating this program because those data have supported moving the program forward much more rapidly. Scott, that's helpful. And then just to follow up, I guess you maybe sort of answered this, but what is more attractive about these EBVs, the IA-LPG, versus what you saw in the nasal pharyngeal cancer trial? And I guess what factors would need to fall into place where you would consider pursuing nasal pharyngeal cancer again? Jacob, do you want to take this one?

In phase three and.

Just give us a refresher on on what the typical seasonal response rates are in the private progressive population that'd be helpful.

Sure. So so if you were to base it up the best ideas of course, the meant they study because they are using a similar where are using similar endpoint or what they did slightly different time points the quite similar.

And for them. They one of their studies had a zero percent.

A sustained disability improvement rate for placebo and the other steady had about a 9.2% so I think thats a.

We all think Thats, a pretty good benchmark for what we would expect in our study so somewhere between zero 9%.

Placebo rate and with a little bit different from their study versus ours, which might argue for even out you know obviously word on the lower end arson is that in their study they did allow.

Whatever medications that the patients are on there were lot to stay on and the mandate treatment as an add on on top of that versus our steady we're looking at pure placebo. So the likelihood is that we'd be on the lower end of that placebo range that they saw opportunities or 9%.

Great very helpful. Thank you quit that compares flavor favourably to what we've seen so far and that's in our phase one is experience.

Dr. Jacob Dupont: Yes, certainly. So thank you for the question. AID and PID LPDs, I think A.J.

Got it thanks, so much.

Thank you. Our next question comes on line no Palm Rama from JP Morgan. Your line is now open.

Dr. Jacob Dupont: Explained well the value proposition there and the opportunity with the new data that we've generated. Now, with the NPC study, you know, we did achieve our goals of understanding the safety and seeing some stable disease at that point, and we really want to generate more translational data here from that particular trial because this is a co-administration of cell therapy with a checkpoint inhibitor. It is actually a very active area of scientific research in the field right now to understand whether it is better to give a checkpoint inhibitor concomitantly with a cell therapy or do you give the checkpoint inhibitor before the cell therapy or after. So there are actually a lot of these interesting scientific questions that need to be answered.

Hey, guys. This is Pat on the call our mix evening frowned upon thanks for taking my question.

And just two quick ones from me.

We talked about it up as no update on in the prepared remarks and in some of the earlier question can you just can't Miss a bit more granular on how you would define away in at the conference.

And then my second question I. Prior question alluded to this bank and around the decision to just discontinued it out and then in MPC and what were the levers that went into making that decision was this efficacy driven at all and can you discuss it. They are there that translational work that you plan today. Thanks.

How much.

Thank you. Thank you for your question I'll start with but first let's sit on one for you and then ask at Taco before we talk about as more I guess, it's your question. So all the anti he just want to collect we're not discontinuing the development. We're just not moving into the phase two asset resolution plan, because we want to do.

Dr. Jacob Dupont: So from that perspective, we think the prudent thing to do here is actually to work with our partners at Merck, who are very engaged as well, to answer some of these translational questions so that we can build the proper study going forward. As mentioned here, the multi-cohort study is quite a straightforward experiment from the perspective that these are all EBV-driven tumors we're treating with TABSO. We have excellent clinical data to this point, so we think that's the right opportunity and the priority opportunity to focus on while we are working with our partners at Merck to really understand some of these aspects of co-administration and the best way to go about that. We think it's important also as we work to answer these types of questions for the field in general because we are just at the beginning of these clinical experiments combining a checkpoint inhibitor with a cell therapy as So, clearly, we think that we can go faster to address an important medical need with a relatively large population of a few thousand patients in the U.S. with a multi-cohort, particularly the AID, PID cohort there, and we want to go fast. That's why we're focusing on that. Got it, understood.

Additional work to clarify what is the best off to develop and quite some value there for the patient and for Topcell. There. So we're still working on but we've got caught up organs.

Tick up you want to come in for the on what led to that decision.

Yes, absolutely so as Pascal noted, we did actually achieved the goals of that the phase one portion of the study with we saw very good safety results. We also saw stable disease, and we are able to.

Combined the drugs successfully.

But as mentioned we really wanted at this point in terms of prioritization to focus on.

The the.

The resources of a Tara on the indications, where we could really will where we felt that we could create a lot of rapid Val value. There was another aspect here with the evolving treatment landscape and landscape in laser Ferrand shale cancer as well so with the.

The uncertainties of the shift in the the landscape. It also wanted to understand this key scientific question of.

Checkpoint inhibitor with cell therapy combination, we really wanted to do more translational work. So that is an effort that we've undertaken at.

Operator: Thanks very much for taking the question. Thank you. Thank you. Thank you. Our next question comes from the line of Matt Fitts from William Blair. Your line is now open. Hi there, Rob Andrew. I'm from Outfits here.

Atara, obviously working with colleagues at Merck as well.

So we have a number of.

Patient samples.

Operator: Thanks very much for taking the question. Apologies if I'm repeating quite a few questions here as I switch between calls this evening. Perhaps on the multi-cohort study, I look forward to some additional data from Esmo. Perhaps given the rarity of some of these diseases, can you talk about the ease or the strategy for identifying patients?

From the clinical trial, where we're looking at the.

The phenotypes of the cells before and after treatment.

Well just cellular therapy with the combination of the checkpoint inhibitor as well so we'll be able to do a very nice series of experiments.

Both editor Tara and then also with our collaborators at Merck as well, but it really was not as Pascal noted a decision to discontinue the program. It was just to do more work can figure out how did you the right type of experiment in the future if we choose to do so.

Operator: Are they being treated by the same doctors that are treating the PTLD population? And does that mean that the enrollment centers for the upcoming study are likely to be the same? And how common is testing for EBD positivity in these populations? Is that standard, or is that something that's not standardized there? Thank you, Rob, for your question. AJ, do you want to answer this one?

And in terms of resource allocation, we really need to invest where we can create value as rapidly as possible.

Hopefully we explain a in the cool answering questions. We believe that that opportunity in the mystical study weve values, a cohort, particularly those in immunocompromised patients we have difficulty cutting builders. They see you know to input, which we are they kicked off two potential.

Dr. A.J. Joshi: Sure. So maybe just a couple of points. You talked about the testing. The testing is actually fairly routine. It's not done as aggressively as it is in the transplant population because you literally track that from the moment that the transplant is done. You want to make sure that their EBV viral load isn't going up.

I get it only submission in that the rapid away the Heath, where we believe we should invest right now while continuing to work with Merck on clarifying above all in PC.

Now your question, it's more I guess is around what type of that are we going to put on that.

Ah ha do want to answer that one.

Dr. A.J. Joshi: But in these populations, when they develop tumors, it's fairly standard to check for EBV. So there's really not much of a concern in terms of a diagnosis. The second piece you were asking about is where these patients show up. And certainly, when you're taking a look at the larger transplant centers, they almost all will have a dedicated group that's looking at these LPDs for AID and PID. So not that there's 100% overlap, but there's significant overlap at the large centers with PTLD as well as AID and PID. There will be some separate centers, but there's a larger group that does overlap.

Yeah.

You are asking but we would consider good for that population I think maybe a way to look at this is when you think about the Nonpeak TLD data that we publicly presented to date, we've generally look at and routine and in one population or 17% response rate and another publishers, 20% response rate and these are all setting.

That were relapsed refractory. So these are fairly sick populations with really no other take alternative.

We like the P. I'd population will be presenting on it's similar to that group, where it's you're going to have that same relapsed refractory setting.

Dr. A.J. Joshi: And you also get the other populations, the LMS population, we have the CAEBB population, a few others that show up at those centers. So I would say there's significant overlap. We'll have some kind of unique centers that we'll also add in.

So data like that or better would be a real win here because of the aggressiveness of the disease. In these patients once you fail existing therapy and note that is a little bit different than what we're going to studying the multi cohort because we will study, both who relapsed refractory setting as well as the first line setting.

Operator: But from an operational perspective, there are advantages to that commonality. OK, great. That's helpful. Thank you. And then maybe I can just squeeze in a quick follow-up on the pre-BLA meeting prior to the BLA filing. You know, just assume you're not really envisaging any difficulties in getting this kind of thing organized with the FDA, just given the focus on COVID and the likelihood of a slew of vaccine data kind of in the fall there. Jacob.

Great. Thank you for the clarification and the color I appreciate it.

Thank you.

Thank you. Thank you. Our next question comes from the line on Lori Ray Crock from Jefferies. Your line is now open.

Hi, This is Kevin for Maury Tonight, I just wanted to.

Circle back briefly to the PTAB style.

I'd be positive Gtld read out.

So a quick question just about.

Given the sample sizes smaller than what you had initially planned do you think that.

Operator: So, thank you, William, for the question. Obviously, COVID-19 is a major concern at this point in the world, as Pascal has alluded to as well. I think the very fortunate position that we're in at Atara Biotherapeutics Inc. with TabCell is that we have a fee designation. We really have, you know, frequent and excellent engagements with the FDA. And similarly, in Europe, we have prime designation, which really allows us to have an excellent dialogue.

Effects your ability at all to hit the.

Desired response rate and then a quick follow it up a follow up excuse me on the meeting the Prebuy meeting with the FDA.

I know you talked about what's going into that data package can you talk about briefly what the FDA is expect expectations might be in terms about data.

Yes pickup.

Yes, absolutely so.

Thanks, Kevin for the question.

In terms of sample size I think we're actually operating here. According to plan because the study does actually have a pre specified interim analysis, which is actually what we're doing.

Dr. Jacob Dupont: And I do think that the agencies have really prioritized discussions for programs that have, you know, breakthrough therapy and prime designation. And so we've actually had very good engagement from the agency, even during this period of COVID. Great, thanks very much. Thank you. Our next question comes from the line of Michael Diokre from Evercore ISI. Your line is now open.

Now so that is that's part of the study design actually.

And so we're generating that data as I mentioned here in Q3 and we're also.

Providing data from other historical sources. So we've spoken about the memorial Sloan Kettering Phase two studies in the past and P. TLD also the ERP and the single patient use or the FPU as well. So I think there's a lot of informative data there that certainly the FDA.

Operator: Hi guys, thanks so much for taking my question. One question on ATA 188 regarding durability and non-responders to therapy. I was wondering if there's any developments or updated thinking about using an HLA restriction switch to rescue non-responders and also perhaps patients who may lose response.

Wants to see because it does provide insights into the overall safety and efficacy the clinical benefit equation for tab. So in this high unmet need. So again I think we have a lot of rich information to provide than we are bringing that together actively now at.

Operator: And along those lines, is there a mechanism in the current randomized phase one part two trial for this rescue, and what is the FDA's view on allowing that to be employed in the context of a pivotal trial or any trial for that? Yeah, AJ.

At a Tara I don't think will comment on the specifics of the data package here.

Dr. A.J. Joshi: Sure. Part of the question there is, what is a non-responder? So for us, as we talked about this notion of transformational therapy, if you can halt progression or reverse progression, that's transformational. So the vast majority of the patients so far really have maintained their disability status. So it's really hard to identify who a non-responder is at this point.

That we will supply and in terms of likelihood of success I just wanted to to speak to that directly so again I think that the.

The likelihood of success here is really very much. According to plan because again the interim analysis was built into the study design.

Dr. A.J. Joshi: So I wouldn't expect to be able to provide information on that just because we don't have someone who I would officially say is a pure non-responder based on that definition. That said, there's already built-in mechanisms that are part of the trial, both in the open label extension, that allow switch for anyone who is felt to be a non-responder. And in terms of your question around how FDA feels about that concept of restrictions, which is already built into our phase three TAP cell program, so they're very familiar with it and very comfortable with the concept.

As planned.

And in terms of the FDA expectations, obviously, we have breakthrough therapy designation.

For the program, which was established.

A little while ago.

Which was based on data that we had generated in the past, which includes those response rates and BNP TLD in the range of.

50% to 80%, depending on which patients you're looking at it across the diversity of our clinical experiment. Thus far we have also publicly disclose you know the 37% response rate as a target.

Dr. A.J. Joshi: So we can, we're just simply applying it similarly to the 188. So it's really more, we need longer observations before we can get some of that experience on Switch because we still haven't, in my mind, seen really much to be able to say we definitely need to switch. Great. That's helpful.

Here, obviously with some durability information as well so I think.

That.

That response rate is certainly one that we.

We've discussed with the agency as well, but I think things are tracking very well from our perspective as I mentioned the interim analysis is coming up quite shortly and we're also making good progress.

Operator: And just a quick follow-up, just wondering how we should think about the placebo response rate in the current Phase 1, Part 2 MS trial. We've seen from the med-day experience how this could blow up in Phase 3. And if you could just give us a refresher on what the typical placebo response rates are in the primary progressive population. So, if you were to base it on the best study, it's, of course, the BED-DAY study because they are using a similar, we're using a similar end point to what they did, slightly different time points, but quite similar. And for them, one of their studies had a 0% sustained disability improvement rate for placebo, and the other study had about 9.2%.

Bringing in the historical data and making sure that soon a good.

Format for discussion with the agency as well.

Great. That's a that's helpful. Thank you.

Sure.

Thank you. This concludes our question and answer session for today. Thank you for joining the tile Biotherapeutic second quarter 2020 financial results Conference call you may now disconnect.

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Dr. A.J. Joshi: So I think that's a pretty good benchmark for what we would expect in our study. So somewhere between a zero and 9% placebo rate. And what's a little bit different from their study versus ours, which might argue for even, you know, a placebo rate on the lower end for our study, is that in their study, they did allow, you know, whatever medications that the patients were on, they were allowed to stay on, and the med-day treatment was an add-on on top of that. In contrast, in our study, we're looking at pure placebo. So the likelihood is that we'd be on the lower end of that placebo range that they saw. And, of course, that compares favorably to what we've seen so far in our phase one. I got it.

Operator: Thanks so much. Thank you. Our next question comes from the line of Anupam Rama from JP Morgan. Your line is now open.

Operator: Hey, guys. This is Tessa on the call this evening for Anupam. Thanks for taking our questions. Just two quick ones from me.

Operator: We talked a bit about the ESMO update in your prepared remarks and in some of the earlier questions. Can you just give us a bit more detail on how you would define a win at the conference? And then my second question, a prior question alluded to this, but around the decision to discontinue development of MPC, what were the levers that went into making that decision? Was this efficacy-driven at all? And can you discuss a bit further the translation work that you plan to do? Thanks so much.

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Pascal Touchon: Thank you. Thank you for your question. I'll start with the first one, the second one, sorry, and then ask Jacob before we talk about S more. I guess that's your question.

Pascal Touchon: So, on the MPC, I just want to correct: we're not discontinuing the development. We're just not moving into phase two as it was initially planned because we want to do this additional work to clarify what is the best path to develop and create some value there for the patient and for TAP Cell. So, we're still working on that with our collaborators at Merck. Jacob, do you want to comment further on what led to that decision?

Dr. Jacob Dupont: Yeah, absolutely. So as Pascal noted, you know, we did actually achieve the goals of that phase one portion of the study with, we saw very good safety results. We also saw stable disease, and we were able to combine the drugs successfully. But as mentioned, we really wanted, at this point, in terms of prioritization, to focus on the resources of Atara on indications where we could really, where we felt that we could create a lot of rapid value. There's another aspect here with the evolving treatment landscape in nasopharyngeal cancer as well. So with the uncertainties of the shift in the landscape and also wanting to understand this key scientific question of checkpoint inhibitors with cell therapy combination, we really wanted to do more translational work.

Dr. Jacob Dupont: So that is an effort that we've undertaken, you know, at Atara, obviously working with colleagues at Merck as well. So we have a number of patient samples from the clinical trial where we're looking at, you know, the phenotypes of the cells before and after treatment, you know, with just cellular therapy alone or with the combination of the checkpoint inhibitor as well. So we'll be able to do a very nice series of experiments, both at Atara and then also with our collaborators at Merck as well. But it really was not, as Pascal noted, a decision to discontinue the program.

Dr. Jacob Dupont: It was just to do more work and figure out how to do the right type of experiment in the future if we choose to do so. And in terms of resource allocation, we really need to invest where we can create value as rapidly as possible. And as hopefully we explained in the call and in answering questions, we believe that opportunity in the multi-cohort study with various cohorts, particularly those in immunocompromised patients with lymphoproliferative disorders that are very similar to PTLD, for which we have a very clear path to potential regulatory submission in a very rapid way, this is where we believe we should invest right now while we continue to work with Merck on clarifying a path for N AJ, do you want to answer that one?

Dr. A.J. Joshi: Yeah, you were asking what we would consider good for that population. I think maybe a way to look at this is, when you think about the non-PTLD data that we've publicly presented to date, we've generally looked at any routine, and in one population, it was 17% response rate, and another population was 20% response rate, and these were all settings that were relapsed reflectory. So these are, you know, fairly sick populations with really no other treatment alternatives.

Dr. A.J. Joshi: The AID-PID population we'll be presenting on is similar to that group, where you're going to have that same relapsed, refractory setting. So data like that or better would be a real win here because of the aggressiveness of the disease in these patients once you fail existing therapy. And note that this is a little bit different than what we're going to study in the multi-cohort because we will study both relapsed refractory settings as well as the first line. Great. Thank you for the clarification and the color, guys.

Operator: I appreciate it. Thank you. Hi, this is Kevin for Morrie tonight.

Operator: I just wanted to circle back briefly to the TAB cell EBV positive PTLD readout. So a quick question just about, given the sample size is smaller than what you had initially planned, do you think that affects your ability at all to hit the desired response rate? And then a quick follow-up on the meeting the pre-BLA meeting with the FDA. I know you talked about what's going into that data package. Can you talk about briefly what the FDA's expectations might be in terms of that data? Jacob.

Dr. Jacob Dupont: Yeah, absolutely. So, thanks, Kevin, for the question. In terms of sample size, I think we're actually operating here according to plan because the study does actually have a pre-specified interim analysis, which is actually what we're doing now. So, that's part of the study design. And so, we are generating that data, as I mentioned, here in Q3. And we're also providing data from other historical sources.

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Dr. Jacob Dupont: So, we've spoken about, you know, the Memorial Sloan-Kettering Phase II studies in the past and PTLD, also the EAP, and single patient use or the SPU as well. So, I think there's a lot of informative data there that certainly the FDA wants to see because it does provide insights into the overall safety and efficacy of the clinical benefit equation for CABSOL in this high unmet need. So, again, I think we have a lot of rich information to provide, and we are bringing that together actively now at. I don't think we'll comment on the specifics of the data package here that we will supply. And in terms of the likelihood of success, I just wanted to speak to that directly. So again, I think that the likelihood of success here is really very much according to plan because, again, the interim analysis was built into the study design as planned.

Dr. Jacob Dupont: And in terms of FDA expectations, obviously, we have breakthrough therapy designation for the program, which was established a little while ago, based on the data that we had generated in the past, which includes those response rates in PTLD in the range of 50 to 80% depending on which patients you're looking at across the diversity of our clinical experiments thus far. We have also publicly disclosed the 37% response rate as a target here, obviously with some durability information as well. So I think that response rate is certainly one that we've discussed with the agency as well. I think things are tracking very well from our perspective. As I mentioned, the interim analysis is coming up quite shortly, and we're also making good progress bringing in the historical data and making sure that's in a good format for discussion with the agency as well. Great, that's very helpful.

Operator: Thank you. Thank you. This concludes our question and answer session for today. Thank you for joining the Atara Biotherapeutics Second Quarter 2020 Financial Results Conference Call. You may now disconnect. Thank you for watching!

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