Q2 2022 Atara Biotherapeutics Inc Earnings Call

Operator: Greetings and welcome to Atara Biotherapeutics Q2 2022 Financial Results Conference Call.

Greetings and welcome to Attar of Biotherapeutics Q2, 2022 financial results conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder, this conference is being.

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

Recorded I would now like to turn this conference over to your host Mr. Eric Helen Grant Vice President of Investor Relations and finance. Thank you Sir you may begin.

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

Thank you operator.

Good afternoon, everyone and welcome to <unk> second quarter 2022 results conference call.

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

This press.

The release and an updated slide deck are available in the investors and media section at <unk> Dot com.

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

Today's call members from the entire executive team, who will provide an update on our financial results operational progress and strategy.

I'll also review our upcoming key milestones and objectives joining.

Joining me on today's call are Dr. Pascal <unk>, President and Chief Executive Officer, Dr. Jakob Dupont Executive Vice President and global head of research and development to Paul Coffee Cart, Chief Financial Officer, and Dr. AJ Joshi, Chief Medical Officer.

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

We would like to remind listeners that during the call. The Companys management will be making forward looking statements.

Actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the company's business.

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

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

Operator: As a reminder, this conference is being recorded.

Thank you Eric and thank you all for joining US. This afternoon today, we announced plans to further focus our company's activities as the Lena research and development centered organization.

Operator: I would now like to turn this conference over to your host, Mr. Eric Hellingran, Vice President, Investor Relations and Finance.

Operator: Thank you, sir.

Designed to advance our innovative pipeline while at the same time.

Operator: You may begin.

Single future cash Bill.

Eric Hellingran: Thank you, operator.

This includes a reduction of staff by approximately 20% across the organization.

Eric Hellingran: Good afternoon, everyone, and welcome to Atara's second quarter, 2022 results conference call. Earlier today, we issued a press release announcing our second quarter financial results and corporate update.

Addiction in plan annual cash burn of over 20% versus last year.

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

These actions.

<unk> to extend our cash runway into Q1 of 2024.

While still delivering on key milestones for our most advanced strategic assets in terms of potential value creation that sale 80, 188, and <unk> 32019.

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

Eric Hellingran: Joining me on today's call are Dr. Pascal Tuchon, President and Chief Executive Officer, Dr. Jacob DuPont, Executive Vice President and Global Head of Research and Development, Gopal Kopikar, Chief Financial Officer, and Dr. A.J.

David imaging or defaulted delusion T cell therapy platform.

Eric Hellingran: Joshi, Chief Medical Officer.

Our unique clinical experience in more than 500 patients treated.

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

We will prioritize R&D activities over the next 18 months on three core priorities.

Eric Hellingran: We would like to remind listeners that during the call, the company's management will be making, forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filing.

The clinical development of 80 188 potentially.

Potentially transformative phase two asset for Pago achievements at <unk>.

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

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

Eric Hellingran: Pascal?

Second.

The EU and potential U S regulatory filings and approval for tab cel.

While seeking a commercial partner for <unk> in the U S, including all related activities and cost which is expected to further extend the company cash runway.

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

Finally.

Dissipated Q4, 2022, IND filing for <unk> 30 to <unk> 19, a potential best in class Allogeneic, CD 19 car T, which could address significant opportunity in this field for improving durable clinical response in armed to treat b cell malignancies.

We believe these fee product candidates could have meaningful impact on patients in great need and could deliver significant value for our shareholders.

Shareholders.

Pascal Touchon: Today, we announced plans to further focus our company's activities as a leaner research and development-centered organization designed to advance our innovative pipeline while at the same time reducing our future cash burn. This includes a reduction of staff by approximately 20 percent across the organization, and a reduction in planned annual cash burn of over 20 percent versus last year. These actions are expected to extend our cash runway into Q1 of 2024 while still delivering, on key milestones for most advanced strategic assets in terms of potential value creation, TAP cell, AT188, and ATA3219.

These actions are part of our strategy to focus the organization on research and development and build on the previously announced strategic partnership on manufacturing with Fujifilm, <unk> Biotechnologies and now commercialization collaboration with Pierre Fabre.

Pascal Touchon: Leveraging our differentiated allogenic T-cell therapy platform, and our unique clinical experience in more than 500 patients treated, we will prioritize R&D activities over the next 18 months on three core priorities.

The prioritization and actions announced today.

Generation of this strategy.

We believe this strategy is well suited for the current position of the company today.

<unk> new opportunities for future strategic partnerships and non dilutive funding.

And it Optimizes resources to advance development for lead clinical and pipeline assets.

Let me know detailed progress and plans for key strategic priorities.

Pascal Touchon: First, the clinical development of AT188, a potentially transformative phase two asset, for progressive multiple sclerosis.

As we announced in July we have completed the interim analyses of the <unk> phase III <unk> study.

And following the idea of SMC recommendation and importantly.

On internal assessment.

We determined that no sample size adjustment on modification will be made to the study.

Based on the whole month at the end of July .

Oximetry 99 zero patients are planned to be included in the readout of the study primary endpoint of confirmed disability improvement by E. DSS at 12 months.

Which the FDA recommended as a primary endpoint.

We expect to communicate the final data readout in October of 2023.

We are pleased with the progress made on the <unk> study and are confident in the possibility for <unk> to deliver a significant clinical improvement to non active policy of MF patients.

<unk>.

Targeting EBV infected b cell, he's now well supported therapeutic hypothesis towards funding a transformative treatment.

This debilitating disease.

A recent publication in Naturals showed how EBV infected <unk> sales drive pathology in EMS by stimulating auto reactive T cells and by differentiating into Autoreactive plus myself.

These EBV infected b cells.

Isn't in our CNS can drive chronic inflammation in the brain and the generation of active antibodies against some Brian parties.

We are therefore excited about the potential of <unk> to address the disease at east cool in targeting these EBV infected b sales and plus myself.

In addition to be sober scientific rationale.

Confidence in leadership industrial Ingo EBV targeted approach is reinforced by the encouraging clinical data as shown in our phase one and open label extension study so Phil.

As a reminder, in a phase one study 33% of the 12 patients in the Idose 80, 188 cohorts achieved confirm DSS improvement at the 12 month time point and FDA registration appropriate and primary endpoint assembled.

Furthermore, the phase one study and its open label extension showed that 20 out of 24 patients about either confirm eds's improvement all DSS stability.

Got the observation in the study open label extension for up to 42 months.

In Q4 of this year, we plan to present at the conference updated data from the OLED and new phase one MRI data.

Adding further evidence of the potential clinical impact of <unk> in progressive Ms patients.

Also we continue to plan for phase III readiness, including interacting with the FDA based on the two fast track designations importantly, we also continuing to further develop and scale. It appropriately bioreactor manufacturing process, which we expect to enable biologic like cost of goods manufactured.

Finally, we will continue to be opportunistic in exploring potential partnering opportunities with biopharma companies that could maximize the value creation potential of <unk>.

Following the unbound I E. The number of companies have confirmed interest in a potential partnership and we plan to have further discussion in the future with a keen focus on generating significant value.

Another key strategic priority to create value is tab cel.

Pascal Touchon: Second, The EU and potential U.S. regulatory filings and approval for TAPSEL, while seeking a commercial, partner for TAPSEL in the U.S., including all related activities and costs, which is expected to further extend the company cash runway.

I would like now to give an update on tab cel starting with recent progress on the U S regulatory reform.

Pascal Touchon: Finally, the anticipated Q4 2022 IND filing for ATA3219, a potential best-in-class allogenic, CD19 CAR-T, which could address significant opportunity in this field for improving durable clinical response in how to treat B-cell malignancies.

Indeed, following constructive discussion with the FDA, including senior leadership.

The agency recommended a potential path to BLA submission without the need for new clinical trial.

We are very pleased with this outcome and following additional upcoming scheduled intervention interactions with the FDA, we would give further guidance on progress toward BLA submission at our next quarterly earnings call.

Pascal Touchon: We believe these three product candidates could have meaningful impact on patients in, great need and could deliver significant value for Atara and our shareholders.

We believe the tab cel can become potentially lifesaving options for those EBV positive <unk> patients in need with <unk>.

Pascal Touchon: These actions are part of a strategy to focus the organization on research and development, and build on the previously announced strategic partnership on manufacturing with Fujifilm, Dioxin Biotechnologies and our commercialization collaboration with Pierre Fabre. The prioritization and actions announced today are a continuation of this strategy.

Pascal Touchon: We believe this strategy is well-suited for the current position of the company today. It includes new opportunities for future strategic partnerships and non-dilutive funding, and it optimizes resources to advance development for lead clinical and pipeline assets.

Prognosis and no approved treatment options.

Pascal Touchon: Let me know detail of progress and plans for key strategic priorities.

We also believe subset can deliver compelling value proposition for payers and the health care system.

Pascal Touchon: As we announced in July, we have completed the interim analysis of the ATA188 Phase 2, EMBOLD study, and following the IDSMC recommendation and, importantly, our own internal assessment, we determined that no sample size adjustment or modification will be made to the study. Based on enrollment at the end of July, approximately 9090 patients are planned to be included in, the readout of the study primary endpoint of confirmed disability improvement by EDSS at 12 months, which the FDA recommended as a primary endpoint.

Pascal Touchon: We expect to communicate this final data readout in October of 2023. We are pleased with the progress made on the EMBOLD study and are confident in the possibility for, ATA188 to deliver significant clinical improvement to non-active progressive MS patients. Indeed, targeting EBV-infected B-cells is now a well-supported therapeutic hypothesis, towards finding a transformative treatment for this debilitating disease. The recent publication in Natures showed how EBV-infected B-cells drive pathology in MS, by stimulating autoreactive T-cells and by differentiating into autoreactive plasma cells.

Pascal Touchon: These EBV-infected B-cells present in the CNS can drive chronic inflammation in the brain, and the generation of reactive antibodies against some brain proteins. We are therefore excited about the potential of ATA188 to address the disease at its core, in targeting these EBV-infected B-cells and plasma.

Pascal Touchon: In addition to this robust scientific rationale, our confidence and leadership in pursuing, our EBV-targeted approach is reinforced by the encouraging clinical data shown in our, Phase I and Open Label Extension studies so far.

Pascal Touchon: Another key strategic priority to create value is TAP-Cell. I would like now to give an update on TAP-Cell, starting with our recent progress on the U.S, regulatory front. Indeed, following constructive discussion with the FDA, including senior leadership, the agency recommended a potential path to BLA submission without the need for a new clinical trial.

Pascal Touchon: As a reminder, in the Phase I study, 33% of the 12 patients in the IDALS 8188 cohorts, achieved confirmed EDSS improvement at the 12-month time point, an FDA registration-appropriate and primary endpoint of inbought.

Pascal Touchon: We are very pleased with this outcome, and following additional upcoming scheduled interactions, with the FDA, we will give further guidance on progress to a BLA submission at our next quarterly earnings call.

Pascal Touchon: Furthermore, the Phase I study in its Open Label Extension showed that 20 out of 24 patients, have had either confirmed EDSS improvement or EDSS stability, forgot their observation in the study or Open Label Extension for up to 42 months.

Pascal Touchon: We believe that TAP-Cell can become a potentially life-saving option for those EBV-positive, PTLD patients in need with poor prognosis and no approved treatment options.

Pascal Touchon: In Q4 of this year, we plan to present at a conference updated data from the OLE and, new Phase I MRI data, providing further evidence of the potential clinical impact of 8188 in progressive MS patients.

We already knew that physician of strong interest in type sale based upon the clinical data presented last year at ash.

Pascal Touchon: Also, we continue to plan for Phase III readiness, including interacting with the FDA based on, our two fast-track designations.

Pascal Touchon: Most importantly, we are also continuing to further develop and scale up our proprietary, bioreactor manufacturing process, which we expect to enable biologic-like cost-of-goods manufactured.

Pascal Touchon: Finally, we will continue to be opportunistic in exploring potential partnering opportunities, with biopharma companies that could maximize the value creation potential of 8188.

Pascal Touchon: During the inbought IA, a number of companies have confirmed interest in a potential partnership, and we plan to have further discussion in the future with a keen focus on generating significant value.

Pascal Touchon: We also believe TAP-Cell can deliver compelling value propositions for payers and the healthcare, system.

More recently, our U S payer market research and payer advisory boards have shown us that they use and treating institutions clearly see tab cel as an important therapeutic improvement for the I need previously treated EBV positive <unk> patient population.

Pascal Touchon: We already knew that physicians have strong interest in TAP-Cell based upon the clinical, data presented last year at ASH.

Pascal Touchon: More recently, our U.S. payer market research and payer advisory boards have shown us that, payers and treating institutions clearly see TAP-Cell as an important therapeutic improvement for the high-need previously treated EBV-positive PTLD patient population.

Pascal Touchon: Our belief in TAP-Cell's value proposition has been recently supported by the CMS decision, in its newly released 2023 IPPS rule to formally assign TAP-Cell to DRG18, which is a diagnosis-related [inaudible] © BF-WATCH TV 2021 to formally assign TAP cell to DRG18, which is a diagnosis-related group that includes CAR T. Obtaining such assignment in advance, of BLA finding is extremely rare and is based on compelling value arguments developed by our team for such a potentially life-saving therapy for patients with EBV-positive PTLD.

A thorough belief in touch sales value proposition has been recently supported by the CMS decision.

Its newly released 2020 free Ips Hulu to formerly assigned tab cel to DRG 18.

Which is the diagnosis related.

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Ladies and gentlemen, we do apologize for technical difficulties event will resume momentarily again, please standby the event will resume momentarily.

So even though all these technical difficulty we'd like to resume the call and Joe just stocking type sale.

As I say, another key strategic priority to create value we step sale.

I would like now to give an update on top sell starting with our recent progress on the U S figured out the way fault.

So in constructive discussions with the FDA, including senior leadership.

Agency recommended a potential path to BLA submission without the need for new clinical trial.

We are very pleased with this outcome and following additional upcoming schedule interactions with the FDA, we will give further guidance on progress to a bit of submission at the next quarterly earnings call.

We believe that that sale can become potentially lifesaving options for EBV positive <unk> patients in need with poor prognosis and no approved treatment options. We also believe that <unk> can deliver a compelling value propositions for payers and the health care system.

We already knew that physicians a strong interest in top sales.

<unk> upon the clinical data presented at.

At Ash.

More recently <unk>.

Payer market research and advisory Board I've shown us that they use and treating institutions clearly see tab cel as an important therapeutic improvement for the I need the previously treated EBV positive <unk> patient population.

I tell us believe in <unk> value proposition.

Recently supported by the CMS decision in each new Dvds 2020 free IPP S. Food to formerly assigned tab cel to DRG 18, which is the diagnosis related group Inc. Scotty.

Obtaining such assignment in advance of B, a fighting is extremely rare.

And is based on compelling value arguments developed by our team for such a potentially lifesaving therapy for patients with EBV positive <unk>.

Pascal Touchon: Once TAP cell is approved, this will improve access, to reimbursement for patients in need.

Once that sale is approved this will improve access to reimbursement for patients in need.

Pascal Touchon: As we have said before, we believe that the TAP cell EBV-positive PTLD market is an attractive, ultra-rare opportunity with several hundred addressable patients in the U.S, who could benefit from this therapy.

As we have said before we believe that the tough sale EBV positive pickier D market.

He is an attractive.

Opportunity with several hundred addressable patients in the U S who could benefit from this therapy.

Pascal Touchon: When considering pricing in line with TAP cell value for patients, and the healthcare system, we believe that TAP cell has the potential to deliver peak sales in the U.S. of over $500 million coming from sales in EBV-positive PTLD following previous therapy or first indication that we are intent and potential labor expansion from the multi-cohort study.

When considering pricing in line with tab cel value for patients and the healthcare system.

We believe that upsell us the potential to deliver peak sales.

Over $500 million.

Coming from sales in EBV positive PTSD following previous therapy first indication that we are <unk>.

And potential label expansion from the multi cohort study.

Pascal Touchon: To realize such significant value opportunities, we have decided to seek a partner for commercializing TAP cell in the U.S, that could invest appropriately into commercialization activities, while Atara will focus on getting TAP cell filled and approved in the near term and on expanding the label in the future.

To realize the significant value opportunities, we have decided to seek a partner for <unk> in the U S that could invest appropriately into commercialization activities.

<unk> will focus on getting <unk> sales field and approved in the near term.

And on expanding the label in the future.

Pascal Touchon: At this stage, I want to thank our team at Atara, who have devoted tremendous effort in order to establish a solid foundation for the launch of TAP cell once approved.

At this stage I want to thank our team at Aha, we have devoted tremendous effort in order to establish a solid foundation for the launch of tab cel once approved.

Pascal Touchon: Moving on to Europe, we passed all pre-approval inspections, for GMP compliance required to support the marketing authorization application for TAP cell in Europe. This is excellent progress, and the European Medicine Agency, or EMA review of TAP cell is on track following our submission of answers to all day 120 questions.

Moving on to Europe , we passed all pre approval inspection for GMP compliance required to support the marketing authorization application for tab cel in Europe .

This is excellent progress and the European Medicines agency or EMA review of tab cel is on tuck photo Ingalls submission of answers to all day 120 questions.

Pascal Touchon: We anticipate European Commission approval, in Q4 2022. Our commercial partner, Piafab, is actively preparing, for the TAP cell launch in Europe, and we have already manufactured more than one year of commercial product inventory. I am excited that we, along with our partners, at Piafab, are very close to bringing TAP cell to the market, thereby generating value for patients and shareholders.

We anticipate European Commission approval in Q4 2022.

Our commercial partner <unk> is actively preparing for the <unk> launch in Europe , and we have already manufactured more than one year of commercial product inventory.

I am excited that we along with our partners at <unk> are very close to bringing top sell to the market, thereby generating value for patients and shareholders.

Pascal Touchon: Now, I would like to hand over to Jacob to provide more details, on our CAR-T portfolio and strategy before I give you an update on our financials.

Now I would like to hand over to Jacob to provide more details on our coffee portfolio and strategy before I give you an update on our financials Jacob.

Jacob Dupont: Jacob?

Jacob Dupont: Thank you, Pascal.

Thank you Pascal first I want to provide an update on our MISO sealant directed car T cell therapies, we have terminated with buyer the exclusive worldwide licensing agreement for our next generation Mesothelium directed car T cell therapies 80, $822 71, an autologous.

Jacob Dupont: First, I want to provide an update, on our mesothelium-directed CAR-T cell therapies.

Jacob Dupont: We have terminated, with Bayer, the exclusive worldwide licensing agreement for our next-generation mesothelium-directed CAR-T cell therapies, ATA-2271, an autologous version, and ATA-3271, an armored allogeneic T cell immunotherapy.

This version and 80 $832 71, an armored allogeneic T cell immunotherapy.

Jacob Dupont: The product rights for these differentiated, and innovative mesothelium CAR-T programs have now been returned, and thus are wholly owned by Atara.

The product rights for these differentiated and innovative meso car T programs and now been returned and Thats, our wholly owned by <unk>.

Jacob Dupont: With respect to ATA-2271, which is being currently developed, by a partner, Memorial Sloan Kettering Cancer Center, we continue to be supportive of the phase one dose escalation clinical study conducted by MSK. And I'd like to provide an update regarding the recent, fatal serious adverse event in a patient treated in this study, study. Over the last several months, MSK has generated significant autopsy-based and correlative data analyses, which they have shared with us. The autopsy established a specific end-organ adverse event as the cause of death. This AE is a rare but recognized complication associated independently with two of the non-CAR T therapies that this patient received.

With respect to HCA $22 71, which is being currently developed by our partner Memorial Sloan Kettering Cancer Center, we continue to be supportive of the phase one dose escalation clinical study conducted by <unk> K and <unk>.

Jacob Dupont: Based on the data that MSK has shared with us, we see no evidence in the tissues in question of on- or off-target toxicities from the CAR T. As such, our assessment is that the CAR T is not directly associated with the unfortunate adverse event.

Jacob Dupont: We appreciate the detailed correlative analyses performed by MSK to help shed light on this complex case of an unfortunate and very ill patient.

Jacob Dupont: We appreciate MSK will be communicating these assessments to the FDA along with their plan, for resuming patient enrollment via a protocol amendment per their policies.

Jacob Dupont: We intend to continue to support the development of 2271 through our collaboration with MSK once the study resumed.

I'd like to provide an update regarding the recent fatal or serious adverse event in a patient treated in this study.

Over the last several months MSA has generated significant our touch seed based and correlative data analyses, which they have shared with us.

<unk> established a specific and Oregon adverse event is the cause of death. This AE is a rare but recognized complication associated independently with two of the non car T therapies that this patient received.

Based on the data that <unk> shared with US we see no evidence in the tissues and question of on or off target toxicities from the car T.

As such our assessment is that the car T is not directly associated with the unfortunate adverse event.

We appreciate the detailed correlative analysis performed by MSA to help shed light on this complex case of an unfortunate and very ill patients we.

We appreciate it M S K, we'll be communicating.

These assessments to the FDA along with their plan for resuming patient enrollment via a protocol amendment per their policies. We intend to continue to support the development of $22 71 through a collaboration with MSA. Once the study resumed. Additionally for this program, we expect to provide a <unk>.

Jacob Dupont: Additionally, for this program, we expect to provide a Phase I data update for ATA 2271 in the fourth quarter of this year.

<unk> data update for HCA $22 71 in the fourth quarter of this year.

Jacob Dupont: Meanwhile, we have decided to temporarily pause our activities towards the IMD of the allogeneic mesothelium-targeted CAR T program ATA 3271. This pause will occur until additional funding is available, as Bayer was planned, to fund the IMD filing and the clinical development starting in Phase I.

Meanwhile, we have decided to temporarily pause our activities towards the IMD of the allogenic Mesothelin.

Targeted car T program 80, $832 71.

This pause will occur until additional funding is available as buyer was planned to fund the IND filing and the clinical development starting in phase one.

Jacob Dupont: However, our conviction remains strong beyond the potential of our mesothelium programs.

However, our conviction remains strong behind the potential of our meso feeling programs, we believe they target a high unmet medical need in several key solid tumors in the car T has been unique and differentiated design using next generation PD, one dominant negative receptor and one X X.

Jacob Dupont: We believe they target a high unmet medical need in several key solid tumors, and the CAR T has a unique and differentiated design using next-generation PD-1 dominant negative receptor and 1XX co-stimulatory domain CAR technologies.

Co stimulatory domain card technologies importantly, tires approach to car T does not require any TCR or HLA gene editing and retains the endogenous T cell receptor or non GSE gene edited format co stimulatory domain in our marine approaches.

Jacob Dupont: Importantly, ATAR's approach to CAR T does not require any TCR or HLA gene, editing and retains the endogenous T cell receptor.

Jacob Dupont: Our non-gene edited format co-stimulatory domain and armoring approaches have been shown in academic studies to increase persistence, durability, and trafficking.

<unk> have been shown in academic studies to increase persistence durability and trafficking. We also believe having an allogeneic approach to this target as a unique differentiator in this space, particularly since this allogeneic format utilizes our EBV T cells, where we have as Pascal.

Jacob Dupont: We also believe having an allogeneic approach to this target is a unique differentiator in this space, particularly since this allogeneic format utilizes our EBV T cells where we have, as Pascal mentioned, over 500 patients' worth of clinical experience.

Mentioned over 500 patients worth of clinical experience.

Jacob Dupont: In addition, we are advancing ATA 3219 as a potential best-in-class allogeneic CAR T for B cell malignancies expressing CD19 and are on track to submit an IND in Q4 of this year. We're using an optimized manufacturing process, which is enriched for, memory T cell phenotype as well as 1XX co-stimulatory domain invented by Dr. Michelle Sadlein, and this program continues to show robust activity in preclinical studies. This manufacturing approach is part of the overall optimization of ATA3219 to differentiate, it from the existing products and to address a significant unmet medical need in advanced, B-cell malignancies, especially lymphoma. Some of the key points of differentiation are the safety of the EBB CAR-T cells, potential, best-in-class efficacy, persistence to potentially increase response durability, and off-the-shelf accessibility.

In addition, we are advancing 80 832019 as a potential best in class Allogeneic car T for B cell malignancies, expressing CD 19 and are on track to submit an IND in Q4 of this year, we're using an optimized manufacturing process, which is.

Enrich for memory T cell phenotype, as well as <unk> co stimulatory domain invented by Dr. Michelle Sandlin and this program continues to show robust activity in preclinical studies. This manufacturing approach as part of the overall optimization of $88 $32.

<unk> to differentiate it from the existing products and to address a significant unmet medical need is advanced b cell malignancies, especially lymphoma.

Some of the key points of differentiation are the safety of the EBV car T cells potential potential best in class efficacy persistence to potentially increase response durability and off the shelf accessibility before I turn the call back to Pascal I'd like to extend my gratitude.

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

Due to the entire staff our collaborators in the patients involved in our studies.

Jacob Dupont: I am thankful for the progress our R&D team has delivered thus far.

I am thankful for the progress of our R&D team has delivered thus far going forward. We continue to have a very talented team in R&D and technical operations, who will focus on advancing our three key assets work constructively with our collaborators and academic teams bring forward our early research programs in <unk>.

Jacob Dupont: Going forward, we continue to have a very talented team in R&D and technical operations, who will focus on advancing our three key assets, work constructively with our collaborators and academic teams, bring forward our early research programs, and have an unwavering commitment to bring to patients in need allogeneic T-cell therapies, some with curative potential.

Of an unwavering commitment to bring to patients in need allogeneic T cell therapies, some with curative potential Pascal thanks Jacob.

Pascal Touchon: Pascal?

Pascal Touchon: Thanks, Jacob.

Pascal Touchon: Now on to our financials.

Now on to our financials for the second quarter of 2022.

Pascal Touchon: For the second quarter of 2022, we reported license and collaboration revenue of $51.6, million, primarily consisting of deferred revenue recognized due to the termination of the buyer collaboration agreements. We anticipate that license and collaboration revenues will decrease substantially in the, future quarters due to the termination of the buyer agreements.

<unk> reported license and collaboration revenue of $51 6 million.

Primarily consisting of deferred revenue recognized due to the termination of the collaboration agreements.

We anticipate <unk> license that license and collaboration revenues will decrease substantially in the future quarters due to the termination of the <unk> agreements.

Pascal Touchon: We also reported a net gain of $18.9 million for the second quarter. This amount included a gain on the sale of the ATOM facility of $50.2 million. With regard to our cash position and runway, we ended the second quarter of 2022 with approximately, $331 million in cash. This includes the impact of net proceeds of approximately $95 million from the sale of, the ATOM facility during the second quarter.

We also reported a net gain of $18 9 million for the second quarter.

This amount included a gain on the sale of the atone facility of $50 2 million.

With regard to our cash position and runway. We ended the second quarter of 2022 with approximately $331 million in cash. This includes the impact of net proceeds of approximately $95 million from the sale of the atone facility during the second quarter.

Pascal Touchon: We believe our second quarter cash balance, together with the expected benefit from reductions, in operating cash burn, will be sufficient to fund our planned operation into the first quarter of 2024.

We believe our second quarter cash balance together with the expected benefit from our predictions in operating cash burn will be sufficient to fund our planned operations into the first quarter of 2024.

Pascal Touchon: Finally, while I believe the actions we announced today will best position Atara to be successful, in advancing our pipeline of potentially innovative therapies, I also want to acknowledge that it is also a challenging day for Atarians. I would like to extend my sincere gratitude to all Atara staff, including those departing, as well as those staying with Atara, for their unwavering commitment to the patient lives we seek to transform, and their significant contribution in advancing truly innovative medicines for patients in need.

Finally, while I believe the actions, we announced today will best position <unk> to be successful in advancing our pipeline of potential innovative therapies.

Also want to acknowledge that this is also a challenging day for Italians.

I would like to extend my sincere gratitude to all the tough stuff, including goose, the bumping as well as staying with alcohol.

And wavering commitment to the patient lives, we seek to transform their significant contribution and advancing truly innovative medicines for patients in need.

Pascal Touchon: Thank you for all that you have done.

Thank you for all that you have done.

Pascal Touchon: I will now turn the call over to the operator for the Q&A part of the call.

I'll now turn the call over to the operator for the Q&A part of the call operator.

Operator: Operator?

Operator: At this time, we will be conducting a question and answer session.

At this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two to remove your question from the queue for participants using speaker equipment may be necessary for you to pick up your handset before pressing the star keys one moment.

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

Operator: In confirmation, someone will indicate your line is in the question queue.

Operator: You may press star 2 to remove your question from the queue.

Operator: For participants using speaker equipment, it may be necessary for you to pick up your, hands up before pressing the star keys one moment while we poll for questions.

We pull for questions first.

Operator: Our first question comes from the line of Salim Saeed with Mizuho, you may proceed with, your question.

First question comes from the line of Salim Syed with Mizuho. You May proceed with your question.

Salim Saeed: Great.

Salim Saeed: Good afternoon, guys.

Great. Good afternoon, guys. Thanks for the questions three for me if I can on HII wanted it.

Salim Saeed: Thanks for the questions.

Salim Saeed: Three for me, if I can, on ATA 188.

Salim Saeed: One, just for, just because I think there's some confusion on this, Pascal and Jacob, can you guys just confirm for us if you guys actually saw the IAEA data and if that factored into your decision to continue the study, just a yes, no, there would be great.

One just for just because I think there is some confusion on this Pascal and Jacob can you guys just confirm for us if you.

Actually saw the EIA data and if that factored into your decision to continue the study.

Yes Noah.

There would be great.

Salim Saeed: Two, on the bare thesis that's sort of arisen post the data that perhaps it was actually, the phase one, perhaps there was some EDSS baseline creep in the phase one data and that's why we saw a drop in the phase one.

Two.

On the bare thesis, that's sort of a risen come post the post the data that perhaps it was actually the phase one.

Hi.

Perhaps if there was some etfs in baseline creep in the phase one data and that's why we saw a drop in the phase one.

Salim Saeed: Could you give us any sense of comfort that, or how do we get comfortable that there wasn't, actually an EDSS baseline creep for the phase one?

Could you give us any sense of comfort that or how do we get comfortable that there wasn't actually in <unk> Etfs baseline creep for the phase one.

Salim Saeed: And then the last question just is on the predictability threshold, I don't know if, you guys ever disclosed what predictability threshold you used for the IAEA.

And then the last question just is on the predictability threshold I don't know if you guys ever disclose what predictability threshold you used in the for the IAA I know we were looking at 85% because that's what we saw in the phase <unk>.

Salim Saeed: I know we were looking at 85% because that's what we saw in the phase one, but did you, actually use 85% for the IAEA or did you use a lower number and if you could tell us what that number was.

One, but did you actually use 85%.

The IAA or did you use a lower number and if you could tell us what that number was thank you.

Salim Saeed: Thank you.

Pascal Touchon: Thank you, Salim.

Thank you Simon so I'll start answering the first question together with Jacob and then Jay will answer the other two so following the idea of SMC recommendation and detailed comment on that recommendation.

Pascal Touchon: So, I'll start answering the first question together with Jacob and then AJ will answer, the other two.

Pascal Touchon: So, following the IDSMC recommendation and their detailed comment on that recommendation, a few people within ATARA, including myself, Jacob, and AJ, have seen the top line data and our decision has been based on that as much as on the IDSMC recommendation, so we've seen the top line data.

A few people within that including myself, Jacob and AG I've seen the top line data.

And our decision has been based on that as much as on the <unk> at TSMC recommendation. So we've seen the top line data.

A.J. Joshi: AJ, do you want to address the second question, please?

Hey, Jay do you want to address the second question. Please.

A.J. Joshi: Sure.

Sure.

A.J. Joshi: Thanks, Salim.

A.J. Joshi: And, you know, in terms of the EDSS for the phase one, this concept of baseline creep, I think it's one of, there's two things I'd probably comment on there.

And in terms of the Etfs for the phase one.

The discounts that the baseline I think one there's two things that probably comment on there one is that.

A.J. Joshi: One is that we know EDSS has some variability to it, so once you have an improvement, you've, seen it maintained at every consecutive time point for all the way up to 39 months.

We know <unk> has some variability to it. So once you have an improvement you've seen it maintained at every consecutive time points, where all the way up to 39 months that in general would argue a little bit against some kind of baseline creep, giving you a random drop and then you're taking advantage of it later on I think probably the second thing, though that is Jeff.

A.J. Joshi: That in general would argue a little bit against some kind of baseline creep giving you a random, you know, drop and then you taking advantage of it later on.

A.J. Joshi: I think probably the second thing, though, that is just as important is the MTR data, that correlates with that EDSS improvement we saw, so whatever measurement creep you think may or may not happen, which we don't believe happened, but let's say if you think something might have happened, there's no measurement, you know, creep that's going to happen on the MTR piece, and then you've also heard from Pascal that, you know, there's some other MRI data that we're going to be talking about that continue to support that whole notion that there's something happening in those patients that's different when they have the EDSS improvement.

It is important.

Is the MTR data that correlates with that Etfs imprudently thought so whatever measurement you think may or may not happen, which we don't believe happened. So let's say you think something might have happened. There is no measurement creep that's going to happen on the MPR piece and then you've also heard from Pascal.

Some other EMR.

Morai data that we're going to be talking about that continue to support that whole notion that theres something happening in those patients that's different when they have the etfs improvement. So those are all the reasons.

A.J. Joshi: So those are all the reasons to really think that that's not really an issue here.

Really think that that's not really an issue here and in terms of we haven't really commented on any specific thresholds.

A.J. Joshi: And in terms of, you know, we haven't really commented on any specific thresholds related, to the IA, apart from that rationale that you articulated about the 85% predictivity, but we haven't commented on any specific thresholds that were used for the IA.

Related to the IAA apart from that rationale that you articulated about the 85% productivity, but we haven't commented on any specific threshold that we're used to the IAA.

Salim Saeed: Got it.

Got it Super helpful. Thank you so much.

Operator: Super helpful.

Sure.

Tessa Romero: Our next question comes from the line of Tessa Romero with JP Morgan.

Our next question comes from the line of Tessa Romero with Jpmorgan. You May proceed with your question.

Tessa Romero: You may proceed with your question.

Hey, guys. Thanks, so much for taking our question.

First one is.

On the cash side. So you ended <unk> with about $331 million in cash.

And you are guiding to a runway to 124. So can you provide some further detail on what assumptions are in that runway.

Including in terms of any milestones that you are expected to receive from your partnerships and what are the levers that <unk> could pull to further extend that runway if necessary and then I have one more on tax al if I could.

Yes.

The first question.

Bob do you want to address it is sure Paul Thanks for the question I think one of the key things that I'll mention is burn reduction.

You mentioned, 20% reduction versus what we had.

Last year now, it's something that's going to take some time to occur.

Some burn reduction has happened with the FTB deal and as we reduce that the burn will continue to go down and you can look forward as we get into 2023, when we wrap up all the filing and approval activities with peer Bob the Europe .

We will continue to decrease so that's the first key.

Thank you you have to keep in mind. The second thing that you asked about in terms of how could we further extend the cash runway, we're continuing to look at other.

Opportunities to do some non dilutive financing that we can talk a little bit more about but particularly related to European and U S. Tab cel is an opportunity for us.

Okay and any milestones there.

We should be reflecting.

Yes, there are milestones associated with Pierre Fabre in Europe , but we have not comment on them.

Okay, Okay and then.

One more from me on tab cel.

Just can you can you provide any more detail on the scenarios that we should be considering for a possible path to BLA submission here in the U S that has been recommended by the FDA or that Youre you are discussing with the FDA. Thanks, so much.

Yes, Jacob you also addressed that burn absolutely. So tessa thanks for the question so.

As Pascal mentioned in our comment prepared comments.

Had constructive discussions with the FDA and they do as you allude to recommend the possible path to BLA submission without the need for new clinical trials. So that is an adjustment from their previous recommendation. This path is consistent with.

The proposal that we made as you may recall from our previous quarterly call leveraging patients currently treated with commercial product in the pivotal study.

In terms of next steps meetings. Our plan there is one that schedule and there is one more to follow to align on the content of the potential BLA.

So we do plan on giving additional color to this path towards a potential BLA at our next quarterly call.

Okay. Thanks, so much for taking our question.

Thank you.

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

Tessa Romero: Hey, guys.

Hi, guys. Thanks for taking my questions Congrats on the progress.

Tessa Romero: Thanks so much for taking our question.

Tessa Romero: The first one is on the cash side.

Tessa Romero: So you ended 2Q with about $331 million in cash, and you are guiding to a runway 2-1-2-24.

So.

Just had a follow up question on <unk>. So.

Tessa Romero: So can you provide some further detail on what assumptions are in that runway, including in terms of any milestones that you're expected to receive from your partnerships?

Tessa Romero: And what are the levers that Atara could pull to further extend that runway if necessary?

Assuming that the <unk> okay.

Are you requesting.

Tessa Romero: And then I have one more on Tad Sal if I could.

Some type of additional data.

We believe that.

Ongoing clinical activities.

Be able to satisfy those types of requests without getting into.

What they are.

In a reasonable amount of time just curious for example.

If the agency is looking for more clinical data.

Patients.

So like the existing.

Client structure.

Okay.

All of that together.

Thank you.

Tessa Romero: The first question, Ismael, do you want to address this?

Pickup do you want to address that one.

Tessa Romero: Sure.

Yes so.

I think as.

We're reporting today I think the significant outcome is that the FDA recommends a possible path to BLA without the need for new clinical trial. So and then in terms of negotiations Thats. What we are involved in now and I mentioned, one scheduled meeting in another to follow after that.

But that's where we're going to be speaking about the content of that potential BLA filing but again it's.

The expectation here is that that data will not be.

Coming from a new clinical trial.

John as well that we are treating patients with a commercial product not only in the pivotal study <unk> study, but also in other studies and in particular in the EAP program. So we are basically accumulating a number of clinical data.

Casey and safety using the commercial product and all of that is really going to be important for the BLA submission.

Tessa Romero: Tessa, it's you, Paul.

Yes.

Okay, Great and then just one additional question.

832 19.

Actually really exciting to hear that.

Planning on filing an IND there near term.

And a question on <unk>.

Clinical design here curious.

Going forward.

Think about the patient population or the potential patient population.

Do you think that you'll be focusing patients.

That were naive to other CV 19 focus therapies or.

Would there be some types of CD 19 therapies that you might.

Think about allowing.

Yeah.

Thank you our focus will be even though we are not giving details today about the first in human study, but we can say our focus will be around the medical need and.

And we see different type of medical need today that are not being fulfilled by the existing and even most of the therapy in development.

One in the former is two of durability of clinical response, we see most of the other therapies, even car T. Youll Telugu so allogeneic car T, giving usually up to 40% complete remission at six months and really in lymphoma. In particular is important to look.

At the CR rate at six months and beyond so there is a need here towards a higher percentage of patients.

Good safety and improved safety compared with autologous car T. In these type of duration. So that's one type of clinical need the other type of clinical need is as you say patients that have been relapsing.

Not being control after could you CD 19 therapies and we know that this is not only due to a particular issue with a target, but they often do with a lack of persistence of the TRP. The car T. All the type of therapy that doesn't need to.

Durable remission, hence they are relapsing, so there'll be two type of medical need that we plan to address somehow in our clinical development, but more detail about that at a later stage.

Okay, great. Thank you.

Tessa Romero: Thanks for the question.

Our next question comes from the line of Phil Nadeau with Cowen and co. You May proceed with your question.

Tessa Romero: I think one of the key things that Pascal mentioned is burn reduction.

Tessa Romero: We mentioned 20% reduction versus what we had incurred last year. Now, it's something that's going to take some time to occur. Some burn reduction has happened with the FDB deal, and as we reduce that, the burn will continue to go down.

Tessa Romero: And you can look forward, as we get into 2023, when we wrap up all the filing and approval activities with TRFOB in Europe, the burn will continue to decrease.

Tessa Romero: So that's the first key thing you have to keep in mind.

Hi, Thanks for taking our questions. This is ernie.

Tessa Romero: The second thing that you asked about in terms of how could we further extend the cash runway, we're continuing to look at other opportunities to do some non-dilutive financing that we can talk a little bit more about, but particularly related to European and U.S. TAPSEL is an opportunity for us.

Phil.

Two questions. If I may the first one just a clarification on the HCA 188.

Tessa Romero: Okay.

If I understand now.

Your team if I could.

The team did see the data for the interim analysis. After the decision was made but it sounds from your prepared remarks.

Your internal assessment I agree with that decision and I was wondering if that.

That interpretation is correct.

So.

That agreement.

On your.

Assumptions.

Mutual assumptions going into that.

The interim analysis.

Tessa Romero: And any milestones there that we should be reflecting?

Tessa Romero: Yeah, there are milestones associated with TRFOB in Europe, but we have not commented on them.

Thank you for your question. So what we have clarified today is that as planned by the charter all these interim analyses.

Tessa Romero: Okay.

Tessa Romero: And then one more from me on TAPSEL.

A few individuals initially not myself Jacob where in form of the data to be able to put the data to the idea of SMC that then we view the data fully independently full unblinded data.

Tessa Romero: Can you provide any more detail on the scenarios that we should be considering for a possible path to a BLA submission here in the U.S. that has been recommended by the FDA or that you're discussing with the FDA?

And then after they put their recommendation a few of us, including Jacob and myself.

Jay I had access to the top line that are not the full and binding that not just the top line data to be able to see.

Where the recommendations is aligned with the best way to create value for this asset and we do indeed confirm that in our assessment.

These topline data for.

For led us to confirm that.

We can follow the recommendations from the idea of FMC and <unk>.

No changes in the sample size of that study based on the data we've seen.

Alright, Thank you and then.

Sorry.

I'll go ahead please.

Okay.

And then on tab cel.

Could you do you have an estimate on how long will the proposed pathway delayed their BLA filing.

The decision to partner, perhaps silhouettes.

We'll see what the FDA feedback factor in that decision they have something to do with it.

Thanks.

You want to take the first part of the question Jacob.

Yes so.

As I mentioned.

The next steps are clear from the perspective that we have an upcoming meeting that is sketch.

Scheduled and then there'll be another meeting after that.

So these will occur in the not too distant future and I think we'll be able to provide more detail on the timeline for the BLA submission and the content of the BLA submission at our next quarterly call.

And on your second question I think the decision to look for a commercial partner for <unk> in the U S is really to make sure that we have greater financial flexibility that will position us well to fully realize the value and key catalysts and milestones for our most advanced and promising asset upsell.

<unk> <unk> 42 to 19.

It's really around finding the possibility of partnering to of all the related activity and cost to prepare and launch the product is taken care by these partnering strategy and enabling us to potentially.

And further our cash runway and we think that we've demonstrated that with the European deal that we can create very significant value in partnering and that allows us to focus on where we believe our resource allocation could create most value for shareholders and creating reaching key milestones and catalyst for.

A priority asset.

Great very helpful. Thank you again for taking my question.

Our next question comes from the line of Michael <unk> with Evercore ISI. You May proceed with your question.

Tessa Romero: Thanks so much.

Hi, guys. Thanks, so much for taking my question a few from me.

Tab cel you keep on referring to this.

Registration as a potential path.

That was recommended by the FDA.

That implies that it may not even happen and what needs to be discussed with the agency at this point and what could possibly result in that not being.

Not not a not there being a potential path forward here.

Are they expecting post marketing studies on this as well.

It does sound like from your comments does sound that they are willing to accept.

Expanded access patients.

For this and the second part of my question is just on the U S. Commercial partnership like it sounds like this has been fueled by a desire to extend cash runway.

Led to this decision now.

How much additional runway could be achieved if a new partner ops into share costs. Thank you.

Jacob Dupont: Yeah, Jacob, do you want to throw to us that one?

Yes, let me address both question here I mean.

Jacob Dupont: Absolutely.

On the as usual you always talk about potential we haven't either pre BLA meeting, we have not filed the BLA yet.

Jacob Dupont: So, Tessa, thanks for the question.

So that's why we always talk about potential.

Jacob Dupont: So, as Pascal mentioned in our prepared comments, we've had constructive discussions with the FDA, and they do, as you allude to, recommend a possible path to BLA submission without the need for new clinical trials. So, that is an adjustment from their previous recommendation. This path is consistent with the proposal that we made, as you may recall from our previous quarterly call, leveraging patients currently treated with commercial product in the pivotal study.

We have now clearly.

Recommendation that allows us to work constructively as we've done over the last few months with the FDA to get a response of moving forward to a BLA submission, but we have some steps to achieve and that's what our plan interactions full before we can confirm the exact timing and again as Jacob ill say this particular above is fundamentally base.

Jacob Dupont: In terms of next steps, meetings are planned. There's one that's scheduled, and there's one more to follow to align on the content of the potential BLA.

Jacob Dupont: So, we do plan on giving additional color to this path towards a potential BLA at our next quarterly call.

On what we've.

Discussed and with them and also what we propose to them as we say that our previous quarterly calls.

There is no major differences there.

On the second aspect. It is always a decision to be made about resource allocation between investing in commercialization or partnering for commercialization at this stage. We believe that we have all the key value creating assets that we have and we are developing other clinical stage it makes sense for us.

To look for partnering there because again partnering when it is done in the right way.

<unk> was a significant share of the NPV that remains in the company and Thats, where we can really create further value for our shareholders. So we think it makes sense to consider that right now and to be able to focus our activities, but also again to a partnership that will create significant value for Ottawa annual shareholder.

Yeah.

Yes.

Got it thanks, so much.

Tessa Romero: Okay, thanks so much for taking our questions.

Our next question comes from the line of solving Richter with Goldman Sachs. You May proceed with your question.

Operator: Thank you, Lisa.

Hi, Thanks for taking a question this is tommy on for <unk>.

John Newman: Our next question comes from the line of John Newman with Canaccord.

Now about how is the cadence of R&D updates is going to work for the Mesothelin programs. So after we have the phase one update for TT seven one how would you plan out your timing for discussions and planning further studies in the context that you are now focusing more on $32 19 and.

Can you just explain the rationale behind prioritizing 32019, given that 2007, one is more events. Thank you.

So maybe just to clarify about that but we still plan to continue development of $22 71.

Jacob has explained we are now expecting.

Our collaborators at <unk> to make a proposal to the FDA about some amendment to the protocol for the study can resume that's what we do we can we are going to support that.

What we have decided to pause is 32 71 and just because the funding for that clinical study is first in human study and further clinical development.

Was supposed to be done by buyer and now that we have terminated the program.

Bush and with them, we are really in a situation where we are is fully owned assets 32, 71 that we certainly plan to bring to IMD. Once we have the appropriate funding.

And that could come from different sources, but certainly we are we have a strong belief in the potential of this program to create value and again. We are considering 2071 is just the allogeneic visions, we need to have further funding to be able to bring these to the clinic and to start the clinical development.

And maybe just one other point.

You asked about an update with me as wholesale and so as we discussed today as well we continue to see Q4. This year as an opportunity to provide updated data on that $22 71, autologous program with our partner Sloan Kettering.

Yes, and maybe also to add to your question about why.

Giving some priority to 30% to 19 instead of 50 to 71 in <unk> and first in human study. This is mainly because we believe that 30% to 19 us fully the potential of heartbeat lead to get a level of clinical data that could clarify what is the potential for best in class situation.

In terms of response rate and efficacy aspect and safety and then at the same time to create further confirmation that our differentiated allogeneic T cell platform is indeed, leading to benefit in patients.

In terms of speed to get clinical data, it's certain that developing.

Allogeneic CD 19 car T is gating to faster ability to evaluate the responses.

Going into mesothelioma lung cancer and other type of concept again this being said, we still plan to do that at the proper time. So we already to go into this.

Final steps and clinical development 30 to 71 is just a matter of.

Resource allocation right now, but that will be really our strategy to be able to find funding to move forward without assets, which we believe as potential value for patients and the company.

John Newman: You may proceed with your question.

Our next question comes from the line of Yigal <unk> with Citi. You May proceed with your question.

John Newman: Hi, guys.

Hi, This is Carly on for Yigal. Thanks for taking my question, maybe just to follow up on the prior question. I guess are you actively looking to re partner the mesothelin programs in order to advance the allogeneic version and then maybe more generally what's your level of interest in partnering additional car.

John Newman: Thanks for taking my question.

Our key targets beyond beyond Mesothelin.

John Newman: Congrats on the progress with the FDA on Tab-Cell.

Yes. So we have a platform that is extremely versatile and allows us to rapidly develop allogeneic car T on different targets now we have to make pulp.

John Newman: I just had a follow-up question on Tab-Cell.

Papa resource allocation and at this stage, even though we could develop further additional car T. We have decided not to go to IND, enabling studies and clinical development for additional coffee. We are in the early pipeline that we are pursuing by the way.

John Newman: Assuming that the FDA will be requesting some type of additional data, do you believe that ongoing clinical activities will be able to satisfy those types of requests without getting into details of what they are in a reasonable amount of time?

John Newman: I'm just curious, for example, if the agency is looking for more clinical data on specific patients, do you feel like the existing clinical structure is going to be able to pull that together in a reasonable amount of time?

John Newman: Thank you.

With Memorial Sloan got Fang with Moffitt cancer centers and also with <unk>.

Jacob Dupont: Jacob, do you want to address that one?

Our collaborators at <unk> in Australia, and Dr laws to up some work on new design, new construct new targets for allogeneic car Ts and other type of modalities. So that's really an exciting part that we are continuing at the early stage now investing into the IND, enabling studies and first in human.

Jacob Dupont: Yeah.

Jacob Dupont: So I think, you know, as we're reporting today, I think the significant outcome is that the FDA recommends a possible path to BLA without the need for a new clinical trial.

Jacob Dupont: So and then in terms of negotiations, that's what we are involved in now.

Jacob Dupont: And I mentioned, you know, one scheduled meeting and another to follow after that.

Jacob Dupont: But that's where we're going to be speaking about the content of that potential BLA filing.

<unk> is another level of investment and at this stage, we decided to focus our resources on the most advanced clinical asset.

Jacob Dupont: But again, it's the expectation here is that that data will not be coming from a new clinical trial.

Jacob Dupont: Yeah.

E Top said, Ecu and 88 and $32 19.

Pascal Touchon: And I may add, John, as well, that we are treating patients with a commercial product, not only in the pivotal study, the allele study, but also in other studies and in particular in the EAP program. So we are basically accumulating a number of clinical data, efficacy and safety using the commercial product.

Pascal Touchon: And all that is really going to be important for the BLA submission.

This being said our $4 30 to 71, we will be open to different possibilities, one being certainly a new partnering because this potential.

John Newman: Okay, great.

John Newman: And then just one additional question on ACA3219.

John Newman: Actually really exciting to hear that planning on filing an IND there near term.

John Newman: I had a question on clinical design here.

Therapy could address a number of very significant indications in solid tumors. So while we are.

John Newman: I'm curious, going forward, think about the patient population or the potential patient population.

John Newman: Do you think that you'd be focusing on patients that were naive to other CD19 focused therapies?

John Newman: Or would there be some types of CD19 therapies that you might think about allowing in the study?

John Newman: No, thank you.

Pascal Touchon: Our focus will be, even though we are not giving details today about the first in human study, but we can say our focus will be around the medical need.

Pascal Touchon: And we see different types of medical need today that are not being fulfilled by the existing and even most of the therapy in development.

Phil Nadu: Two questions, if I may.

Pascal Touchon: One in NIFOMA is to have durability of clinical response.

Phil Nadu: The first one is a clarification on ATA-188.

You mean soon hopefully this study on 22 71, and we think Thats a matter of a few months. We then can.

Pascal Touchon: We see most of the other therapies, even CAR-T, autologous or allogeneic CAR-T, giving usually, up to 40% complete remission at six months. And really, in lymphoma in particular, it's important to look at the CR rate at six months, and beyond.

Phil Nadu: So as I understand now, your team, your executive team, did see the data for the interim analysis, after the decision was made.

Pascal Touchon: So there is a need here to have a higher percentage of patients with good safety and ideally improved, safety compared with autologous CAR-T in this type of relation.

Phil Nadu: But it sounds from your prepared remarks that your internal assessment agreed with that, decision.

Pascal Touchon: So that's one type of clinical need. The other type of clinical need is, as you say, patients that have been relapsing, not, being controlled after a previous CD19 therapy.

Phil Nadu: And I was wondering if that interpretation is correct and if so, was that agreement based, on your assumptions, initial assumptions, going into the interim analysis?

Pascal Touchon: And we know that this is not only due to a particular issue with the target, but very, often due to a lack of persistence of the therapy, the CAR-T, or other type of therapy that doesn't lead to this durable remission, hence they are relapsing.

Phil Nadu: Thanks.

Pascal Touchon: So there are these two types of medical needs that we plan to address somehow in our clinical, development.

Jacob Dupont: Do you want to take the first part of the question, Jacob?

Phil Nadu: Thank you for your question.

Pascal Touchon: But more detail about that at a later stage.

Jacob Dupont: Yeah, so as I mentioned, the next steps are clear from the perspective that we have an, upcoming meeting that is scheduled, and then there'll be another meeting after that.

Pascal Touchon: So what we have clarified today is that as planned by the charter of this interim analysis, a few individuals initially, not myself, Jacob, were informed of the data to be able to put the data to the IDSMC that then reviewed the data fully independently, full unblinded data.

John Newman: Okay.

Jacob Dupont: So these will occur in the not-too-distant future, and I think we'll be able to provide, more detail on the timeline for the BLA submission and the content of the BLA submission at our next quarterly call.

Pascal Touchon: Then after they put their recommendation, a few of us, including Jacob and myself and, AJ, had access to the top-line data, not the full unblinded data, just the top-line data to be able to see whether the recommendations is aligned with the best way to create value for this asset.

I have more data coming from these clinical experience with the hotel group, but the main focus will be the allogeneic, which we'll be able to go to the clinique as soon as we have the funding available for that either partnering or some other ways to fund this development.

John Newman: Great.

Pascal Touchon: And on your second question, I think the decision to look for a commercial partner for TAPSEL, in the U.S. is really to make sure that we have greater financial flexibility that will position us well to fully realize the value and key catalyst and milestone for most advanced and promising assets, TAPSEL 81.88 and 88.32.19.

Pascal Touchon: And we do indeed confirm that in our assessment, this top-line data has led us to confirm that, we can follow the recommendations from the IDSMC and have no changes in the sample size of that study based on the data we've seen.

John Newman: Thank you.

Pascal Touchon: So it's really around finding the possibility for partnering to have all the related activity, and cost to prepare and launch the product, taken care by this partnering strategy, and enabling us to potentially extend further our cash runaway.

Pascal Touchon: I see.

Phil Nadu: Our next question comes from the line of Phil Nadu with Cowan & Co.

Pascal Touchon: And we think that we've demonstrated that with the European deal, that we can create, very significant value in partnering, and that allows us to focus on where we believe our resource allocation could create most value for our shareholders around reaching key milestone and catalyst for our priority asset.

Phil Nadu: And then on...

Pascal Touchon: So while we are resuming soon, hopefully, this study on 32-71, and we think that's a matter of a few months, we then can have more data coming from this clinical experience with the autologous, but the main focus will be the allogeneic, which we'll be able to go to the clinic as soon as we have the funding available for that, either for partnering or some other ways to fund this development.

Phil Nadu: You may proceed with your question.

Phil Nadu: Great.

Phil Nadu: Sorry.

Yigal Nochomovitz: Okay, great.

Phil Nadu: Hi, Steven.

Phil Nadu: Very helpful.

Phil Nadu: No, go ahead, please.

Yigal Nochomovitz: Thank you.

Phil Nadu: Thanks for taking our question.

Phil Nadu: Thank you again for taking my question.

Phil Nadu: Okay.

Phil Nadu: This is Ernie for Phil.

Michael De Fiore: Our next question comes from the line of Michael De Fiore with Evercore ISI.

Phil Nadu: And then on TAPSEL, do you have an estimate on how long would the proposed pathway delay, the BLA filing?

Michael De Fiore: You may proceed with your question.

Phil Nadu: And also, did the decision to partner TAPSEL, was the FDA feedback factor in that decision?

Michael De Fiore: Hi, guys.

Phil Nadu: Did it have something to do with it?

Michael De Fiore: Thanks so much for taking my question.

Phil Nadu: Thanks.

Michael De Fiore: A few from me, both about TAPSEL.

Michael De Fiore: You keep on referring to this registration as a potential path that was recommended by, the FDA.

Michael De Fiore: That implies that it may not even happen.

Michael De Fiore: What needs to be discussed with the agency at this point, and what could possibly result, in it not being, not there being a potential path forward here?

Michael De Fiore: Are they expecting post-marketing studies on this as well?

Operator: Ladies and gentlemen, we have reached the end of today's question and answer session.

Michael De Fiore: It does sound like, from your comments, it does sound like they are willing to accept, extended access patients for this.

Michael De Fiore: And the second part of my question is just on the U.S. Commercial Partnership.

Michael De Fiore: It sounds like this has been fueled by a desire to extend cash runaway.

Okay, great. Thank you.

Michael De Fiore: What led to this decision now?

Michael De Fiore: And how much additional runway could be achieved if a new partner opts in to share costs?

Michael De Fiore: Thank you.

Ladies and gentlemen, we have reached yet today's question and answer session. This does concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and enjoy the rest of your day.

Pascal Touchon: Yeah, let me address both questions here.

Pascal Touchon: I mean, on the, as usual, you always talk about potential.

Operator: This does conclude today's conference.

Pascal Touchon: We haven't had a pre-BLA meeting.

Operator: You may disconnect your lines at this time.

Pascal Touchon: We have not filed a BLA yet.

Pascal Touchon: So that's why we always talk about potential.

Pascal Touchon: We have now clearly a recommendation that allows us to work constructively, as we've, done over the last few months with the FDA, to get a response of moving forward to a BLA submission.

Operator: Thank you for your participation, and enjoy the rest of your day.

Pascal Touchon: But we have some steps to achieve, and that's what are the planned interactions for, before, we can confirm the exact timing.

Pascal Touchon: And again, as Jacob has said, this particular path is fundamentally based on what we've, discussed with them, and also what we propose to them, as we said at our previous quarterly call. So there is no major differences.

Pascal Touchon: On the second aspect, it's always a decision to be made about resource allocation between, investing in commercialization or partnering for commercialization.

Pascal Touchon: At this stage, we believe that with all the key value-creating assets that we have and we are developing at the clinical stage, it makes sense for us to look for partnering there because, again, partnering, when it is done in the right way, allows to have a significant share of the NPV that remains in the company, and that's where we can really create further value for our shareholders. So we think it makes sense to consider that right now and to be able to focus our activities, but also, again, to have a partnership that will create significant value for Atara and our shareholders.

Michael De Fiore: Got it.

Michael De Fiore: Thanks so much.

Operator: Our next question comes from the line of Salveen Richter with Goldman Sachs.

Salveen Richter: You may proceed, with your question.

Salveen Richter: Hi.

Okay.

Salveen Richter: Thanks for taking our question.

Salveen Richter: This is Tommy on for Salveen.

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Salveen Richter: We want to know about, how the cadence of R&D updates is going to work for the mezzothelan programs.

Salveen Richter: So after we have the Phase 1 update for 2271, how would you plan out your timing for discussions and planning further studies in the context that you're now focusing more on 3219?

Salveen Richter: And can you just explain the rationale behind prioritizing 3219, given that 2271 is more advanced?

Salveen Richter: Thank you.

Pascal Touchon: So maybe just to clarify about that part, we still plan to continue development of 2271, and as Jacob has explained, we are now expecting our collaborators at MSK to make a proposal to the FDA about some amendment to the protocol so the study can resume.

Pascal Touchon: That's what we're doing and we are going to support that.

Pascal Touchon: What we have decided to pose is 3271 IND and just because the funding for that clinical study, the 13-Human Study and for the clinical development, was supposed to be done by buyer and now that we have terminated the program, the collaboration with them, we are really in a situation where we have this fully-owned asset, 3271, that we certainly plan to bring to IND once we have the appropriate funding.

Pascal Touchon: And that could come from different sources, but certainly we have a strong belief in the potential of this program to create value.

Pascal Touchon: And again, we are continuing 2271.

Pascal Touchon: It's just the allogeneic versions.

Pascal Touchon: We need to have further funding to be able to bring these to the clinic and to start the clinical development.

Pascal Touchon: And maybe just one other point.

Jacob Dupont: You asked about an update with mesothelin.

Jacob Dupont: So as we, discussed today as well, we continue to see Q4 this year as an opportunity to provide updated data on that 2271 autologous program with our partners on Kettering.

Jacob Dupont: Yeah, and maybe also to add to your question about why giving some priority to 3219 instead, of 3271 in IND and 13-Human Study.

Pascal Touchon: This is mainly because we believe that 3219 has truly the potential rapidly to get a level of clinical data that could clarify what is the potential for best-in-class situation in terms of response rate, efficacy aspect, and safety, and then at the same time to create further confirmation that our differentiated allogeneic T cell platform is indeed leading to benefit in patients.

Pascal Touchon: So in terms of speed to get clinical data, it's certain that developing an allogeneic CD19 CAR-T is getting to faster ability to evaluate responses than going into mesothelioma, lung cancer, and other type of cancer.

Pascal Touchon: Again, this being said, we still plan to do that at the proper time.

Pascal Touchon: So we are all ready to go into these final IND steps and clinical development 3271. It's just a matter of resource allocation right now, but that will be really our strategy to be able to find funding to move forward with that asset, which we believe has potential value for patient and the company.

Operator: Thank you.

Yigal Nochomovitz: Our next question comes from the line of Yigal Nochomovitz with Citi.

Yigal Nochomovitz: You may proceed with, your question.

Yigal Nochomovitz: Hi, this is Carly on for Yigal.

Yigal Nochomovitz: Thanks for taking our questions.

Yigal Nochomovitz: Maybe just to follow up on the prior question, I guess, are you actively looking to repartner the mesothelium programs in order to advance the allogeneic version?

Yigal Nochomovitz: And then maybe more generally, what's your level of interest in partnering additional CAR-T targets beyond mesothelium?

Yigal Nochomovitz: Yeah, so we have a platform that is extremely versatile and allows us to rapidly develop, allogeneic CAR-T on different targets.

Okay.

Pascal Touchon: Now, we have to make proper resource allocation.

Thanks.

Pascal Touchon: And at this stage, even though we could develop further additional CAR-T, we have decided not to, go to IND-enabling studies and clinical development for additional CAR-T. We have an early pipeline that we are pursuing, by the way, with Memorial Sloan Kettering, with MoFitt Cancer Centers, and also with our collaborators at QIMR in Australia.

Pascal Touchon: And that allows to have some work done on new design, new construct, new targets for allogeneic CAR-Ts and other type of modalities.

Okay.

Pascal Touchon: So that's really an exciting part that we're continuing at the early stage.

Pascal Touchon: Now, investing, into the IND-enabling studies and First in Human is another level of investment.

Pascal Touchon: And at this stage, we have decided to focus our resources on the most advanced clinical assets, i.e., TAP cell 81-88 and 32-19.

Pascal Touchon: Now, this being said, for 32-71, we will be open to different, possibilities, one being certainly a new partnering, because this potential therapy could address a number of very significant indications in solid tumors.

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Hey, Matt.

Okay.

Yes.

Thanks.

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Please go ahead.

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