Q1 2020 Earnings Call
[music].
Operator: BF-WATCH TV 2021
Ladies and gentlemen, thank you for standing by and welcome to the I Takara bio therapeutics.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Atara Biotherapeutics First Quarter 2020 Financial Results Conference. Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Hallengren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please go ahead, sir.
First quarter 2020 financial results conference call.
Please be advised that today's call is being recorded.
I'd now like to hand, the call or to Eric How Lindgren, Vice President of <unk>, Investor Relations and finance and I Tara I O Therapeutics. Please go ahead Sir.
Thank you and.
Eric Hallengren: Thank you, Elaine. Good afternoon, everyone, and welcome to Atara's first quarter 2020 conference call. On today's call, we will provide an update on our operational and strategic progress, review our upcoming key milestones and objectives for 2020, and discuss the potential impacts of the COVID-19 pandemic on our current and planned activities. Earlier today, we issued a press release providing an overview of the company's first quarter 2020 financial results and operational progress. This
Good afternoon, everyone and welcome to a tars first quarter 2020 conference call.
On today's call, we will provide an update or operational and strategic progress review, our upcoming key milestones and objectives for 2020 and discuss the potential impacts of the cold in 19 pandemic on our current and planned activities.
Earlier today, we issued a press release, providing an overview of the company's first quarter 2020 financial results and operational progress.
This press release and an updated investor presentation are available in the Investor and media section at a tower bio dot com.
Eric Hallengren: are available in the Investor and Media section at atarabio.com. Joining me on today's call are Dr. Pascal Touchon, President and Chief Executive Officer, Rupal Kopikar, Chief Financial Officer, Joe Newell, Chief Operations Officer, and Dr. A.J. Joshi, Chief Medical Officer. We will begin with prepared comments from Pascal and then open the call for your questions.
Joining me on today's call are Dr. Pascal to show President and Chief Executive Officer.
To pull coffee car Chief financial Officer.
The only Newell Chief operations Officer, and Dr., Ajay Joshi, Chief Medical Officer.
We will begin with prepared comments from Pascal and then open the call for your questions.
Eric Hallengren: We would like to remind listeners that during the call, the company's management will be making
We would like to remind listeners that during the call the company's management will be making forward looking statements.
Eric Hallengren: 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. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's
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 FCC filings.
Eric Hallengren: and the company's SEC filings.
Pascal Touchon: 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 statements are made as of today's date and the company undertakes no obligation to update these statements.
Now I'd like to turn the call over to Pascal Pascal.
Pascal Touchon: Thank you, Eric, and thanks to all of you for joining us this afternoon. Let me open today's call by acknowledging the environment we are currently in. This global pandemic has impacted many lives across the globe, and all our thoughts go out to everyone who has been directly affected, sharing the same vision as our frontline healthcare workers to serve patients. We at Atara would like to honor and thank the health care professionals who are here, especially during this talk. This moment in time only reinforces our deep commitment to making a difference in patients' lives. It is with tremendous pride that I acknowledge the commitment and resiliency of our entire Atara team, who have remained focused on a mission to serve patients and implemented industry-leading practices to ensure safety while mitigating the impact of COVID-19 on our business.
Thank you Eric and thanks to all of you for joining goes up to do.
Let me open today's gold by an alleging the I'm feeling and we are currently.
The global probably make the bucketed many lives across the globe.
And all held school out everyone, we've been directly affected.
Shifting to send vision as a full time healthcare workers to serve patients.
We oh, we like to Ono and thank the healthcare professionals well here.
Especially during this time.
He smoked in time, only reinforces all deep commitment to making a difference in patients lives.
It is with tremendous part.
I I knowledge, the commitment and the resiliency of all and tie to our team was remain focused on a mission to serve patients and implemented industry, leading practices to ensure safety, while mitigating the impact of covered 19, although business.
We've made significant progress in the first quarter of two for some 20 towards accomplishing all key objective.
Pascal Touchon: We've made significant progress in the first quarter of 2020 toward accomplishing a key objective. Importantly, we remain on track to initiate the BLE submission for TAP-Cell in the second half of 2020 and to present key data from the Phase 1A study of ATA188 in patients with progressive multiple sclerosis in the second quarter. I want to take a moment to provide a brief update on the operational adjustments that we have made in response to the pandemic. First, prior to the COVID-19 outbreak, as part of our routine supply planning and Operational Risk Management Strategies. We had already manufactured significant inventories across TAPSEL, 8188, and other programs, including process intermediates and the required starting materials needed to maintain long-term product supply.
Importantly.
We remain on track to initiate the beauty submission for Topcell into single health of 2020.
And to present key data from the phase one they study of Achy when 88 impatience, we've probably seen multiples killed it in the second quarter.
I want to take a moment to provide a brief update on the your personal adjustments that we have made in response to the public first prior to covert 19, I'd like a thought of voting supply planning.
And operational risk management strategies, we had over the many affected significant inventory of course, Topcell, 80, 188, and or other programs, including process intermediates and the required starting materials needed to maintain long term public supply.
Pascal Touchon: Consequently, we continue to deliver product to patients for more inventory, which is a clear advantage of such off-the-shelf allogeneic EBVT systems. In addition, our teams have been working closely with our clinical side to ensure the safety of site staff and patients and to preserve data integrity and access to treatment as appropriate, when needed. They have established remote study visits, leveraged telemedicine for health care, and other methods to ensure continuity of care for patients and to preserve key endpoint data.
Consequently, we continue to deliver product to patients for more inventory.
Which is a clear advantage of such off the shelf allusion need <unk>.
In addition, our teams have been working closely we've all clinical site.
To ensure the safety of site stuff in patients and to preserve that the integrity and access to treatment as appropriate.
We are needed they have established who bought study visit their knowledge that in medicine on health care and other methods to ensure continue to you have care for patients and to preserve key endpoint data.
We're closely monitoring the evolving could be 19 pandemic and continue to assess its potential impact on their business and operations, including the timing and execution of clinical and preclinical studies.
Pascal Touchon: We are closely monitoring the evolving COVID-19 pandemic and continue to assess its potential impact on our business and operations, including the timing and execution of clinical and preclinical studies. Regardless of the current pandemic... Atara Biotherapeutics remains a pioneer in allogenic T-cell immunotherapy, with our lead program in phase 3 clinical development. We are the most advanced allogeneic T-cell immunotherapeutic company.
Regardless of the current Bundick I thought I'd biotherapeutics remains Apulia in allergenic T cell immunotherapy.
We've all lead program in phase three clinical development.
We are the most advance allusion League T cell immunotherapy company.
Pascal Touchon: And we intend to rapidly deliver off-the-shelf treatments to patients with eye and met medical needs, Platform, Leverage the Unique Biology of EBVT, and has the capability to treat a wide range of EBV-associated diseases or other severe diseases, including solid tumors and hematological cancer, for incorporation into engineer cars or TCRs. The key step toward achieving this mission is initiating the BLS emission for TAP cells in EBV-positive PTLD, which remains on track for the second half of 2020. We are very pleased to have enrolled a sufficient number of patients in a phase 3 study to perform an interim analysis in Q3 2020 after the appropriate follow-up. We plan to request a pre-BLA meeting with FDA to discuss the totality of data from the TAF cell program, including the MSKCC Phase II studies and Atara's expanded access program and Siegel patient care.
And we intend to rapidly delever off the shelf treatments to patients with high unmet medical need.
Our platform leverage the unique biology, NPV T cells and.
And as a capability to treat a wide range of you'd be associated disease or other ti vo disease.
Including solid tumors and in other words, he called cancers fog incorporation of engineer calls all pcls.
A key step toward achieving this mission.
He is initiating the beauty submission for that sale you put it is because the.
Which remains on track for the second as of 2020.
We are very pleased to have an all sufficient number of patients.
Phase three study to perform an interim analysis into FY 2020, after the appropriate for do it.
We then plan to request a PV at a meeting with FDA to discuss the totality of that tough on the test cell program.
Including the MSK T. phase two study and other has expanded access program and Siegel patient use.
If the totality of clinical data considered compelling enough study at the age we will initiate a BLE submission for Topcell.
Pascal Touchon: If the totality of clinical data is considered compelling enough by the FDA, we will initiate a BLA submission for TAP-Cell. With respect to site activity and patient enrollment for the ongoing phase 3 TAP cell study, most of the 40 active clinical sites in the US and Australia are available for enrollment. We are continuing to prepare to open additional sites in the U.S., Canada, and Europe. As discussed previously, we submitted clinical trial applications, or CTAs, to several European countries in November and December 2019 to enable the opening of European clinical sites in 2020. In addition to the previously reported approvals in the UK, Austria, and Spain, I'm very pleased to report that the CTA in France was recently approved and that we have just activated our first European site in Spain.
With respect to site activity and patient enrollment for the ongoing phase fit that sort of study most of the 40 active clinical sites in the U.S. in Australia.
Available for enrollment.
And we are continuing to prepare to open additional sites in the U.S., Canada and Europe.
As previously discussed we submitted clinical trial allegations of city to several European countries in November and December 2019 to enable the opening.
Of clinical European clinical sites into was on 20.
In addition to the previously reported approvals in the UK Austrian Spain.
I'm very pleased to report that the city enhance was recently approved.
And that we have just activated or first you open site in Spain.
As I've noted before these additional sites are being added to support food on the old man or the phase three study and not an interim analysis for which we have already and all sufficient number of patients.
Pascal Touchon: As I've noted before, these additional sites are being added to support full enrollment of the Phase III study, and not an interim analysis for which we have already enrolled a sufficient number of patients. With respect to tap cell regulatory filings in Europe in Q1 2020, we submitted a Pediatric Investigator Plan, or PIP, to the EMA as per the usual requirements.
With respect to Topcell regulatory fitting in Europe in Q1 thousand 20.
We submitted a bid you're taking this digital plan or P. IP to the he may have spare the usual requirements.
For the we usually approval of the peak IP, we intend to some meat Topcell you marketing authorization application for patients with very positive PTSD in 2021.
Pascal Touchon: Following EMA approval of the PIP, we intend to submit a tap cell EU marketing authorization application for patients with EBV-positive PTLD in 2021. We continue to see strong tap cell investigator, physician, and patient interest, even during this COVID-19 pandemic, and for cases in which patients are not able to enroll in the EBV-positive PTLD phase-free clinical study. We are providing TAP-Cell to patients in need under EAP and also ESP-2. Additionally, a growing body of data suggests that TAP cells may provide clinical benefit in additional EBV-positive diseases.
We continue to see strong topcell investigator physician and patient interest even during this could be 19 pandemic and four cases in which patients are not able to enroll in the NPV positive PTSD phase three clinical study, we're providing that said two patients who need and Oh yeah.
And also with you.
Additionally, a growing body of data suggest that Topcell may provide clinical benefit. In addition to all NPV positive disease, and we are advancing clinical study to further evaluated potential.
Pascal Touchon: And we are advancing clinical studies to further evaluate its potential. Toward this end, we continue to expect to initiate enrollment in the second half of 2020 in a TAP cell phase two multi-cohort study that will include up to six additional ultra-rare EBV-positive patient populations. I will now turn to ATA188, or Allogeneic T-cell Immunotherapy, for the treatment of patients with Multiple Sclerosis. We previously reported encouraging early data at Extremes 2019 from a phase one multicenter open-label dose escalation study, evaluating the safety and efficacy of ATA188 in patients with the progressive form of MS. We are looking forward to reporting results in the second quarter of 2020. In an appropriate forum, the six-month results for the dose-escalating cohort 1 to 4. And, very importantly, the 12-month results for the cohort who want to. We plan to present data on clinical measures, and in particular, the assessment of disability.
Well be 10, we continue to expect to initiate enrollment in a single Alt off because on 20 in the top sell phase two Realty Corp. study that would include up to six additional neutropenia NPV positive patient populations.
I'll now turn to AK, when 88 or allusion. It he said immuno therapy for the treatment of patient with multiple cyclicality.
We previously reported an encouraging early data at explains to present 19 from a phase one multicenter open label dose escalation study.
Evaluating the safety and efficacy of 88, when 88 inpatient with progressive form openness.
We're looking forward to presenting in the second quarter of 2020.
In an appropriate for the six months' results for the dose escalating growth one to four.
And very importantly, the 12 months' results for the quarter onto fleet.
We plan to present data on the clinical measures.
And in particular assessment of disability.
Pascal Touchon: We also expect to present 12-month-old full data in the second half of 2020 when such data are available. We are still treating patients in the open-label extension of the Phase 1a study in an appropriate setting, given the constraints of the COVID-19 pandemic, and as determined by the treating physician and patient. As previously announced, we have temporarily paused the screening and enrollment of patients in the Phase 1b Randomized Placebo Control Study to ensure that the participating clinical sites can focus on meeting the needs of patients with COVID-19 and to protect the safety of study participants, investigators, and staff. These polls will also help preserve the study and data integrity.
We also expect to prison 12 month called for data in a second Alf of 2020, when such that are available.
We are still retreating patients in the open label extension of the phase one a study in an appropriate setting given the constraints of the coffee 19 pandemic.
And as determined by the treating physician and patient.
As previously announced we have pump orderly posed the screening and enrollment of patients. This phase one be randomized placebo controlled study.
To ensure that the bucketing participating clinical sites can focus on meeting the needs of patients we could be 19 and to protect the safety of study participants investigators and stuff.
Dispose will also help preserve the study and data integrity.
Pascal Touchon: There are numerous assessments that require a specific clinical setting, and we want to have confidence that the clinical setting will allow these assessments to be conducted within the time period specified in the protocol. Based on our current assessment and information from the clinical sites, we expect this pause to be limited and therefore initiate enrollment in this study in the second or third quarter of 2020. Throughout the first quarter of 2020, we also continued to make progress in advancing our CAR T pipeline. We expect that our collaborators at Memorial Sloan Kettering will submit an IND application to the FDA in the second or third quarter of 2020 for our next-generation mesothelian-targeted autologous CAR T immunotherapy, ATA 2271. ATA2271 is designed to improve efficacy, persistence, and durability of response using novel 1xx car co-stimulatory domain and cell-intrinsic checkpoint inhibition technology with a PD-1-dominant negative reset.
Are they are new mills assessment that require a specific clinical setting and we want to us confidence that the clinical environment will allow these assessments to be conducted at the time period specified in the protocol.
Based on our current assessment and information from the clinical sites, we expect disposed to be limited.
And therefore to initiate enrollment in this study in the second or third quarter of 2020.
Well go the first quarter 2020.
We also continue to make progress in advancing a copy pipeline.
We expect that or collaborators at memorial Sloan Kettering, we submit a 90 application to the FDA.
The second or third quarter of 2020.
For all next generation middle that integrated autologous Carty immunotherapy 80, 22 71.
80, 22, 71 is designed to improve efficacy persistence and durability of response using novel, One X X car Costimulatory domain.
And the sale intrinsic checkpoint inhibition technology with PD, one domain and negative et cetera.
Pascal Touchon: Preclinical data from 882271 IMD-Enabling Studies have been accepted as a late-breaking e-poster at the AACR virtual annual meeting in June, and the abstract will be released on May 15. We also expect that MSK will present additional clinical data for the academic first-generation program in the second half of this year. We've also initiated preclinical IND-enabling studies for off-the-shelf allogenic mesothelene-targeted CAR-T, ATA3271, as well as for ATA3219, or CD19-targeted CAR-T. Both of these programs utilize our next generation CAR-T technologies and eBVT cell platform, ACS 3219 in particular.
Preclinical data from 88 wanted to 71 I ended up being studied I've been accepted as a late breaking E poster.
The HCR visual annual meeting in June.
And the abstract will be released on May 15.
We also expect that MSK will present additional clinical data for the Academy first generation program in the second as of this year.
We've also initiated preclinical I, Indiana being study for off the shelf Allergenic missile did in targeted car T. H E 30 to 71.
As well as for 80, 832, 19 or Cdnineteen targeted copy.
All of his programs utilize a next generation coffee technologies and easy T cell platform.
80 authority to 19 in particular is supported by the initial proof of principle from an academic off the shelf allusion need NPV Cdnineteen car you clinical study.
Operator: Oh...
Presented at the 2020 TCT meeting.
Pascal Touchon: is supported by the initial proof of principle from an academic off-the-shelf halogenic EBVCD19 cardiac clinical study presented at the 2020 DCT meeting, which, to date, shows the longest duration of response for an allogenic CD19 carcinoma, with 26.9 months median follow-up. As we advance multiple innovative programs and generate a growing body of promising clinical data, we are increasingly confident that our BVT cell platform and technologies are strongly positioned to provide patients with meaningful clinical benefits and create tremendous value for shareholders. EBVT cells offer numerous advantages as the basis of our allogenic platform, as they are potent cell killers that specifically target disease cells, are safe, travel to the site of disease, expand, and persist in patients.
Which to date show the longest duration of response for an allusion each cdnineteen car T with 26.9 months median follow it.
As we advance multiple innovative programs.
And generate a growing body of promising clinical data.
We are increasingly confident that always DVT cell platform and technologies, apparently position to provide patient with meaningful clinical benefit and create tremendous value for shareholders.
You DVD sales of a numerous advantages as the basis of all those unique platform.
They are potency killers that specifically target is itself a safe traffic to the size of disease expand and persistent patient.
Beyond that therapeutic potential for platform.
We have also as a robust and scalable manufacturing capability.
That is nearing commercial readiness.
We are on track to complete commercial validation this year and have the ability to rapidly delivered product from inventory to patients in the U.S. you hope in Australia in free days or less.
Pascal Touchon: Beyond the Therapeutic Potential of a Platform, we also have a robust and scalable manufacturing capability that is nearing commercial readiness. We are on track to complete commercial validation this year and have the ability to rapidly deliver product from inventory to patients in the US, Europe, and Australia in three days or less. We continue to innovate at our manufacturing facility in Southern California. Over time, we expect to further increase manufacturing yields to bring Atara's off-the-shelf allogenic T-cell therapy cost-of-goods manufacturing in range with those of traditional biology. In addition to the significant progress we achieved in the first quarter in our clinical, preclinical, and manufacturing activities, we also continue to attract highly talented individuals to the Atara team. I am confident in the leadership team we are building out, including Ron Renaud, who has been appointed as our new non-executive board chairperson, and Amar Murugan, who has been named senior vice president and general counsel.
We continue to innovate auto manufacturing facility in southern California.
Overtime, we expect to further increase manufacturing yields to bring at the heart of the shelf Allergan T cell therapy cost of goods manufactured in ranch with use of traditional biologics.
In addition to the significant progress we achieved the first quarter no clinical preclinical and manufacturing activities. We also continue to attract highly talented individuals to the at the heart team.
I am confident in the leadership team, we are building out including on the who know what's been appointed as our new non executive Board Chair and I'm not really gun was named senior Vice President and General concept.
We are making tremendous progress.
On hiring a new head of R&D and currently expect to make this announcement in a very near future.
We don't talk to achieve a key to present went your objectives and I strongly believe that we are the team the technology and the passion to succeed in omission of innovating with transformative you know therapies that have the potential to improve outcomes for patients with serious disease.
Now turning to a financial results. We ended the first quarter 2020, with 214.6 million in cash cash equivalents in short term investment.
Pascal Touchon: We are making tremendous progress on hiring a new head of R&D and currently expect to make this announcement in the very near future. We are on track to achieve our key 2020 objectives, and I strongly believe that we have the team, the technology, and the passion to succeed in our mission of innovating with transformative immunotherapies that have the potential to improve outcomes for patients with serious disease. Now turning to a financial return, we ended the first quarter of 2020 with $214.6 million in cash, cash equivalents, and short-term investments. This is a decrease of 44.5 million from the pre-acquired amount and reflects cash used from operating activities of $67 million offset by net proceeds from or at the market facility or ATM of $23.1 million.
This is a decrease of 44 from 5 million from the peer quarter and reflects cash used from operating activities of 67 million offset by net proceeds from or at the market's facility or ATM of 23.1 million.
We believe a cash cash equivalent and short term investment as of March 31st for them 20.
Our sufficient to fund plan operation into the second quarter of 2021.
In summary, despite operating in this unique in challenging times, we remain committed to a mission and believe that we'll be able to continue advancing a programs in the months ahead.
I believe that this experience will only strengthen or resolve and commitment to a company and the patients we seek to serve.
I know that many of you are experiencing disruption in your own professional and personal lives and I truly appreciate your time to that.
I also want to take this opportunity to Franco stuff.
And our clinical collaborations for continuing to support our trials are they say they're on changes in caring for patients in an unprecedented only on month.
Pascal Touchon: We believe that cash, cash equivalents, and short-term investments as of March 31st, 2020, are sufficient to fund planned operations into the second quarter of 2021. In summary, despite operating in these unique and changing times, we remain committed to our mission and believe that we'll be able to continue advancing our programs in the months ahead. I believe that this experience will only strengthen our resolve and commitment to our company and the patients we seek to serve. I know that many of you are experiencing disruption in your own professional and personal lives, and I truly appreciate your time today. I also want to take this opportunity to thank our staff and our clinical collaborators for continuing to support our trials as they face their own challenges in caring for patients in an unprecedented environment.
I also want to ensure that patients currently participating or interested in participating in austerity study.
But we remain committed to the safety and our position to continue dosing in ongoing studies as they and their physicians deem appropriate.
We understand that the public is another significant obstacle in what is already a tremendously changing patient journey and we're doing everything in a power to minimize its impact on how we move forward.
I hope that everyone on the call today, staying safe and healthy and I look forward to sharing of progress review in two weeks and months ahead.
I'll now turn the call back to the operator to begin the Q any portion of the code operator.
At this time, if he would like to ask a question have star and the number one on your telephone keypad Oh.
That's star and the number one.
And your first question comes from the line of Marc Frahm, and Cowen and company.
Yeah, Thanks for taking my questions and.
Okay. Thanks for the extra clarity and around.
Pascal Touchon: I also want to ensure the patients currently participating in or interested in participating in our studies that we remain committed to their safety and are positioned to continue dosing in our ongoing studies as they and their physicians deem appropriate. We understand that the pandemic is another significant obstacle in what is already a tremendously challenging patient journey, and we are doing everything in our power to minimize its impact on how we move forward.
The BLE submission the interim analysis, but I guess, what's the current plan on when we will see the data that's being generated in Q3.
Should we can do team that the timing will be amenable to something like an ash presentation should we expect to see that this year or is it likely not until 2012.
Thank you enough for you for your question as we say producing produce call we will discuss with the eight year during the PBM limiting the totality of data, including PC German rises and then we'll also discuss with them regarding what will be needed for the completion of the a submission as well as the possibly.
Operator: I hope that everyone on the call today is staying safe and healthy, and I look forward to sharing our progress with you in the weeks and months ahead. And I'll turn the call back to the operator to begin the Q&A portion of the call. Operator?
City for us to communicate and how to communicate on these interim analysis data.
So it all depends on the timing of these PB at a meeting and then of course, we will communicate with the agreement of de at an appropriate Congress after that period meeting.
Operator: At this time, if you would like to ask a question, press star and the number one on your telephone keypad.
And your next question comes from the line as John Newman and Canaccord.
Operator: The best star and the number...
Hi, guys. Thanks, very much for taking my question and thank you for the updates so Pascal I just wondered.
Mark Fram: Best star and number one. And your first question comes from the line of Mark Fram from Cohen & Company.
Pascal Touchon: Yes, thanks for taking my questions, and Pascal, thanks for the extra clarity kind of around the BLA submission and the NIRM analysis. But what's the current plan on when we will see the data that's being generated in Q3? Should we – it would seem that the timing would be amenable to something like an ASH presentation. Should we expect to see that this year, or is it likely not until 2021?
If you could comment a bit about.
What you expect to see in terms of enrollment for me a European sites.
I mentioned in your prepared remarks that has the first state opened for enrollment just curious if you.
You can talk to us about perhaps the number of additional sites should be looking to open in Europe.
And sort of what you would expect from enrollment there. Thank you.
Thank you for your question, where do you want to answer.
John Newman: Thank you, Mark, for your question. As we said previously in the previous call, we will discuss with the FDA during the pre-BLM meeting the totality of data, including this interim analysis. And then we'll also discuss with them regarding what will be needed for the completion of the submission, as well as the possibility for us to communicate and how to communicate about this interim analysis data. So it all depends on the timing of this pre-BLA meeting. And then, of course, we will communicate with the agreement of the FDA at an appropriate Congress after that pre-BLA meeting.
Sure.
Thanks, and I think a couple of important points right just to reinforce Pascal point earlier that our focus central now has been the 40, U.S. and Australia bites and that's driven us to the enrollment appointed Pascal mentioned earlier.
In terms of the European sites, we're not really going after and specifically talk about the numbers of state. The main point here is that the European pets are being open now so that we can complete the study enrollment and that gives us a much more expeditious path to complete it as rapidly as possible.
Pascal Touchon: And your next question comes from the line of John Newman from Canaccord. Hi guys. Thanks very much for taking my question and thank you for the updates. So, Pascal, I just wondered if you could comment a bit about what you expect to see in terms of enrollment from your European sites. You mentioned in your prepared remarks that you have the first site open for enrollment. I'd be curious if you could talk to us about perhaps the number of additional sites you'll be looking to open in Europe and sort of what you would expect from enrollment there.
And your next question comes from the line of selling Hi from Mizuho.
Thanks, So much guys. Thanks Pascal for all the clarity I guess, if you from me on on multiple sclerosis on 18 wanted it if I can one can you just I presume you you submitted on late breaker for yen and they're going to find out.
At some point or whether that's been accepted or not if we are going to get the data and he and can you tell us how your since it so close to how you're thinking about.
Displaying that data and other than that right, where the data is but how are we going to get that data, it's going to still be lump like the ACTRIMS data or it's going to be more granular.
A.J. Joshi: Thank you, Gilles, for your question. AJ, do you want to answer?
The first question.
A.J. Joshi: Sure. Thanks, John.
And then the second question I had was just on the clinical trials Dot Gov update.
Salveen Jaswal Richter: I think a couple of important points. Just to reinforce Pascal's point earlier that our focus until now has been the 40 U.S. and Australia sites, and that's driven us to the enrollment points that Pascal mentioned earlier. In terms of the European sites, we're not really going to specifically talk about the numbers of sites. The main point here is that the European sites are being opened now so that we can complete the enrollment, and that gives us a much more expeditious path to complete it as rapidly as possible.
Which looks like in March of this year, you guys up the trial for the Phase 118 wanted it from 72 patients to 97 patients and I'm wondering why you did that.
The implications coming out of that and then lastly, how much data do you need based in your discussions with the regulators perhaps file early on eating wannabe.
If you show if you're trying to differentiate from if you showed reversal from on disability from baseline okay.
Okay. Thank you said in the very detailed question Linda. Thank you I appreciate that and Jay do you want to take this question or will chime in if needed.
Sure.
So if anything I think yes, we have submitted team even for a late breaker and we're awaiting their decision as everyone else is quite frankly for the late breakers.
Pascal Touchon: And your next question comes from the line of Salim Saeed from Mizuho.
A.J. Joshi: Thanks so much, guys. Thanks, Pascal, for all the clarity. I guess a few from me on multiple sclerosis and on ATA188, if I can. One, can you just – I presume you've submitted a late breaker for EAN, and you're going to find out at some point whether that's been accepted or not. If we are going to get the data at EAN, can you tell us how you're – since it's so close to how you're thinking about – displaying that data? I don't know what the data is, but how are we going to get that data? Is it going to still be lumped like the ECTRIMS data, or is it going to be more granular? That's the first question. And then the second question I had was just on the clinicaltrials.gov update, which looks like in March of this year, you guys upped the trial for the phase 1 ATA-188 from 72 patients to 97 patients, and I'm wondering why you did that. The implications coming out of that. And then lastly, how much data do you need based on your discussions with the regulators? file early on APA 188 if you show a reversal of disability from baseline.
And in terms of the question on how we're going to be presenting they were certainly going to be giving more detailed information because as the latest matured, we're able to now actually provide that level of detail and to kind of reinforce the national in one of the biggest question screen continue to be asset what worthy doesn't.
But to the disability assessments look like and we'll be providing detail on those both by a composite kills as well and by individual disability scale.
And in terms of the the patient enrollment numbers.
Part of what we're looking to what we're doing here as we said the design of that study to allow us to have a very very elements of adaptive design. So that if we see any elements of clinical signal or biological signals in the course of that study, we're able to adapt the design and essentially.
Targeted towards potentially more meaningful statistical outcomes. So it's really an element of flexibility that you're seeing there as opposed to a specific need or driver that says we need to add more patients. It's meant to allow us the flexibility. So that we can power. The study along on variety of different matters, depending on how.
The cohort for data look as well as how some of the blinded information looks like in our city.
And I guess, a third question that you had was in terms. If we were seeing the reversal disability, then does that give us some kind of accelerate the pathway.
Pascal Touchon: Thank you, Salim. A very detailed question.
You know I'm not going to comment on a specific you know whether young reversal or specific and plans to swing what I would say is back.
A.J. Joshi: Thank you. I appreciate that. Ajay, do you want to take this question? I will chime in if needed.
If there is if we're able to show an efficacy see efficacy signal that would be a transformational product profile. When you prove it out in later study.
A.J. Joshi: Sure. We have submitted to EAN for a late-breaker, and we're waiting for the decision, as everyone else is, quite frankly, for the late-breakers. In terms of the question about how we're going to be presenting this, we're certainly going to be giving more detailed information, because as the data has matured, we're able to now actually provide that level of detail. To reinforce this notion, one of the biggest questions we continue to be asked is, what do the disability assessments look like? And we'll be providing detail on those, both by composite scales, as well as by individual disabilities.
When I do think that creates significant opportunity for various you know.
Conversations about FDA and some form of accelerated the pathway, but you know all of that obviously has already proven out a bit more in a randomized study to be able to say that there might be any kind of.
Hi, there, but certainly a transformational potentially transformational profile will give us.
Thank you Andrea and it's really what's important for studying this is really to aim at a transformative treatment of M.S.
That's what we would like to break through further development of that product or in line with the the need the medical need that is in months in that population because as you know no treatment today is really a boat reverse decline or they just delaying the decline in talking about treatment approved in progress Ethernet so.
A.J. Joshi: In terms of the patient enrollment numbers, part of what we're doing here is we've set up the design of that study to allow us to have various elements of an adaptive design, so that if we see any elements of clinical signals or biological signals in the course of that study, we're able to adapt the design and essentially target it towards potentially more meaningful statistical outcomes. So it's really an element of flexibility that you're seeing there, as opposed to a specific need or driver that says, we need to add more patients. It's meant to allow us the flexibility so that we can power the study along a variety of different measures, depending on how the cohort 4 data look, as well as how some of the blinded information looks in the heart. And I guess the third question that you had was in terms of if we were to see reversal of disability, then does that give us some kind of accelerated pathway? I'm not going to comment on a specific, you know, whether, you know, reversal or a specific endpoint at this point.
There is really an unmet medical need and we really aimed at addressing that unmet medical need.
Thank you.
And your next question comes from the line you Gal.
Not come on that.
From Citigroup.
Yeah.
For taking the question.
Can you just explain a little bit more.
He is going to happen at the.
Third quarter what.
That you set for what would be.
The success from analysis.
So I.
Understanding of what what do you need.
Yeah.
Oh, you got it we have some challenge to hear you, but I guess you have questioned about the interim analyses in Q3, 2020, and what will be considered the success isn't it.
Yeah, what what yeah.
That is there an interim.
Outline that need.
Or beat to a.
Trouble with the.
Okay, I think I understand your question. Thank you.
Pascal Touchon: What I would say is that if there is, if we're able to show an efficacy signal that would be a transformational product profile when you prove it out in later studies, then I do think that creates a significant opportunity for various conversations with FDA on some form of an accelerated pathway. But all of that obviously has to be proven out a bit more in a randomized setting to be able to say that there might be any kind of accelerated pathway there. But certainly, a potentially transformational profile would give us that opportunity.
Hey, Jay do you want to answer and then you go you will tell us whether its answering your question because we still have some difficulty to hear your clearly.
Yeah, How's that been just take a crack at it you got on Teesside [laughter] point, Yeah, I think the [laughter] as ever teeth, and most ultra rare condition. The totality of data is what's most relevant here, we're not gonna be specifically talking about exact numbers that are necessary or.
Beginning in the interim out I think in a key point here is that when you have the safety data and the totality of information that we described here.
It's that package and that will drive the ft. A view on things and if you think about an ultra rare condition. The package of information we have here fairly significant when you look at totality information. So I think yeah. So that's the main factor is how does that entire you look of course in.
Yigal Dov Nochomovitz: Thank you, Angel. It's really what's important for us, Salim, to aim for a transformative treatment for MS. And that's what we would like to bring about for further development of that product in line with the need, the medical need that is immense in that population. Because, as you know, no treatment today is really able to reverse decline, or they're just delaying the decline. I mean, talking about treatment approved for progressive MS. So there is really an unmet medical need, and we really aim at addressing that unmet medical need. Thank you.
Operating these major elements or 33.
Moment and studies.
Does that answer the question yeah.
Okay all right.
And I guess I was looking for numbers.
Probably don't want to give numbers.
I just wanted I was hoping to get a sense that a more detailed.
But I understand your vision to talk about that.
I also to understand the E <unk>.
Additional patients in.
So those pay.
I mean, there obviously not an interim.
Operator: And your next question comes from the line of Yigal Nochomovitz, from Citigroup. Yeah, hi.
They're gonna be that data will be submitted.
Later.
Presumably for approval.
Operator: Thank you for taking the questions. Can you just explain a little bit more exactly what's going to happen at CESA in the third quarter?
Well that when you get that data from these additional patients for the sake.
You started in.
Yeah, I guess, it's still very difficult to hear your email I guess your question is what is the objective of the patients the additional patient to complete the enrollment of the study and how do we plan to.
Operator: [inaudible]
Pascal Touchon: Yigal, we have some challenges to hear from you, but I guess you have questions about the interim analysis in Q3 2020 and what will be considered a success, isn't it?
Just because of this week regulatory authorities.
That's right.
Yes, you hear me better now that better yes, that's much better not yes.
Operator: Yeah, what, what, yeah, success. Is there an internal... outlined. This meeting is adjourned, for BEAT to...
Okay.
And you want to answer that question.
Yeah, So we'll see.
Typically when or if we went into when you're doing analysis like this year I think I got your question correctly, where those additional data that gets generated athletes and out there are our information that youre definitely going to provide to the regulators and oftentimes you know in a situation like that and I'm not going up.
A.J. Joshi: OK, I think I understand the question. Thank you. Ajay, do you want to answer? And then, Yigal, you will tell us whether it's answering your question, because we still have some difficulty hearing you clearly.
Predict which way things go but there was wouldn't necessarily be a prerequisite for example for moving forward. Most of time those are things that say you're the data that you provided at the time of the pre ballet discussion are the basis for the decision that they make that they yeah lessons you can move forward with your deal. They finally any data.
A.J. Joshi: Yeah, Paul, I'm going to just take a crack at it, Yigal, and see if it hits the point. I think, as is the case in most ultra-rare conditions, the totality of data is what's most relevant here. We're not going to be specifically talking about exact numbers that are necessary for getting an interim analysis. I think the key point here is that when you have the phase 3 data and the totality of information that we've described here... It's that package that will drive the FDA's view on things. And if you think about an ultra-rare condition, the package of information we have here is fairly significant when you look at the totality of information. So I think that's the main factor is, how does that entire view look? Of course, incorporating these major elements of phase three enrollment and study. Did that answer the question?
If you generate related to the pacing program. There always is going to want to see when you finish everything else, but they will not be necessary or that decision that happened that it made at the timing of the people it.
Okay, but that's the that's oh, yeah, but the fact that first the first submission for the deal a that'll be I.
I mean, it is it understood that that's going to be a conditional to err on on further data or is this going to be a full approval or you don't know yet.
I think that's a review issue that's that's that that's going to be part of the discussion with FDA and typically.
But I learned a prior I say that this is going to be conditions.
It would not okay got it and then I cannot imagine a priority Uh huh.
Not a priority additional okay.
Yigal Dov Nochomovitz: Bye. And I guess I was looking for numbers, so I don't want to give you any numbers. I just wanted I was hoping to get a sense of more detail. But I understand, you know, the mission to talk about that. I also want to understand that the additional patients in the. [inaudible] I mean, they're obviously not in the interim. They're going to be, that data will be submitted later, presumably for approval, when you get that data from the additional patients for the site.
And then I just have a question on on a on N.S.. So you know weve talked to some of the experts in the United States than we thought the one cielo Cleveland Clinic reserve, none of that Khalezin, and easy biology, and well in Ns and he was saying that that he his view is that the E.
The V. hypothesis is quite quite strong in relapsed refractory disease, but not as not as clear in.
Okay. We lost you again, but I guess you want to be Cinedigm s.
So already your question is that Aponte Vsix built you mentioned things a D.V. I put it is in M.S. is conga and relapse remitting the netease in progressive It did you want to take that under will chime in.
Pascal Touchon: You've started in...
Yigal Dov Nochomovitz: Yeah, I guess it's still very difficult to hear you, Yigal. I guess your question is, what is the objective of the patient, the additional patient, to complete enrollment in the study? And how do we plan to discuss this with regulatory authorities?
Sure.
The hypothesis, so and I'd love to maybe have some conversations because it needs are always the dialogue, but for that particular individual the the easy hypothesis actually they're not differentiate between whether its relapsing remitting are progressing on that and give you a little perspective, we had a recent advisory board with all our top advisors.
Pascal Touchon: Is that right? Yes.
Yigal Dov Nochomovitz: Yes, can you hear me better now? Is that better?
Yigal Dov Nochomovitz: Much better now.
Yigal Dov Nochomovitz: Much better, no? Yeah.
Yigal Dov Nochomovitz: Okay.
A.J. Joshi: AJ, do you want to answer that question?
And it's the ethic and you know these are these are very well established individuals with any M.S. space and very consistently there's no reason why it should impact to one space versus the other their comment is.
A.J. Joshi: Yeah, so typically, when you do an analysis like this, I think I got your question correctly, where those additional data that get generated after this analysis are information that you are definitely going to provide to the regulators. And oftentimes, in a situation like this, and I'm not going to predict which way things go, but those wouldn't necessarily be a prerequisite, for example, for moving forward. Most of the time, those are things that say, the data that you provide at the time of the pre-BLA discussion are the basis for the decision that they make to say, yes, you can move forward with your BLA filings. Any data that you generate related to the FACES program are always going to want to see when you finish generating those, but they will not be necessary for that decision that is made at the time of the pre-BLA meeting.
Hey, if we start seeing something in Tms, usually be looking at all of them and that has always been the plan. So there's not really been a differentiation. The hypothesis is and that's it's not just panna.
There should be really no difference between those two spaces in terms of any me being a major elements in the pathogenic separately I must process.
[noise] and clearly what would the reason we went into progressive M.S. as I said earlier on this because of the months unmet medical need that exists there and if we can show safety in these early studies safety and the potential clinical efficacy signal does represent Woodward present a transformed.
National product profile in Tms. We will then go of course, not only to pursue that npls, but also in other type of a mess.
Yes.
And your next question comes from your line of Ben Panicked from Stifel.
Yigal Dov Nochomovitz: Okay, but that's, yeah, but the first submission for the DOA, that'll be, I mean, is it understood that that's...
Hi, This is calibrate the on for Ben Bernanke. My first question just pertaining to can sell I know that you guys are liking USA till now say cohort study and clean it up to six additional ultra rare MTV last patient I was wondering if you could provide any additional color.
Pascal Touchon: Google. I think that's a review issue. That's going to be part of the discussion with FDA at the pre-billing stage. But I wouldn't a priori say that this is going to be conditional.
Switching to like you said there already.
Yigal Dov Nochomovitz: Thank you very much.
Patient population size relative to Gtld.
Pascal Touchon: Not a priori conditional, okay. And then I just have a question on MS. So we've talked to some of the experts in the United States, and we talked to one fellow at Cleveland Clinic who's one of the KOLs in EBV biology, well, in MS, and he was saying that his view is that the EBV hypothesis is quite strong in relapsed refractory disease.
Yeah, I think clearly this study that we are doing is intending to expand the topcell like labels beyond so going back into TLD.
And to address the serious unmet need in patient with NPV positive disease.
Mr. These plan with up to six additional called creating the possibility for additional indication or even potentially to discuss the boulder mechanistic label.
And this is based on experience that we have both of self at Idaho, We've all E P and a single patient use as well as all collaborators at memorial in earlier study that we have some clinical data in this type of patients. The we building upon these clinical data.
Pascal Touchon: Okay, we lost you again, but I guess you wanted to say PMS. So probably your question is that, on the visexpert you mentioned, things that the EBV hypothesis is in MS are stronger in relapsed remitting than they are in progressive.
To move forward in visibility girls study.
A.J. Joshi: AJ, do you want to take that? And I will chime in.
We eat each of the school TWIC prisons, your trial, where conditions, but collectively they represent a potentially addressable TV population to be positive population several times greater than the size of the second line Illiquidity DMD.
A.J. Joshi: Sure, the hypothesis, and I'd love to maybe have some conversations because these are always good dialogues, but for that particular individual, the EBD hypothesis actually does not differentiate between whether it's relapsing, remitting, or progressive MS. And to give you a little perspective, we had a recent advisory board with all our top advisors. And these are very well-established individuals within the MS space. And very consistently, there's no reason why it should impact one space versus the other. Their comment is...
And they are different type of disease that we are exploring there of patient population. So all related to immunodeficiency difficulty CRT disorders like primary immunodeficiency L.P.D. and also quite Immunodeficiency Ltd. We're also going to explore LMS legal.
Your sarcoma and for which we are presented data in the past as well as a first line beekeepers P.L.D. for patients where current first line treatment and appropriate and first of stick online C.N.S.P. TLD. So as you can see ranch of different type of patient population at.
Pascal Touchon: Okay, if we start seeing something in PMS, you should be looking at all of MS, and that has always been the plan. So there's not really been a differentiation. The hypothesis is MS. It's not just PMS. There should really be no difference between those two spaces in terms of EBV being a major element of the pathogenesis of the MS process.
And all together these are representing a significant commercial potential if we're successful and the population that is several times greater than the size of the Silicon Valley Beep Whiskey PTSD, which is the first litigation that we appeal shrink.
Ben Bennett: And clearly, the reason we went into progressive MS, as I said earlier, is because of the immense unmet medical need that exists there. And if we can show safety in this early study, safety and a potential clinical efficacy signal that would represent a transformational product profile in PMS, we will then go, of course, not only to pursue that in PMS but also in other types of MS.
Great. Thank you and I guess, one more question I had question regarding 88 to 271, what gating right. The latter Fiona I, Andy and are there any plans to develop there's an additional 17 right outside and I don't see liana.
Thank you for your question. So as we said there will be the presentation of some preclinical data from the only in a big studies.
Pascal Touchon: And your next question comes from the line of Ben Bennett from Stiefel. Hi, this is Kaylee Bresa on behalf of Ben Burnett.
Pascal Touchon: My first question is just pertaining to Tab-Cell. And I know that you guys are looking to do a phase two multi-cohort study that includes up to six additional ultra-rare EBV plus patients. I was wondering if you could provide any additional color pertaining to disease severity, patient population size relative to PTLD.
That will be a I've been accepted as a late breaking poster at S. yard you have talked will be released on May 15.
And these that are part of the package that we need or color voyages were going to attend SK, we're going to submit that I and he needs to Cemig D. N D. Older data in order studies have been done now so it's just more of a moving into the preparation of the submission and that's why we're confident that these.
Pascal Touchon: Yeah, I think clearly this study that we're doing is intended to expand the TAP cell label beyond second-line PTLD and to address a serious unmet need in patients with EBV-positive disease. This study is planned with up to six additional cohorts, creating the possibility for additional indications or even potentially to discuss a broader mechanistic label. And this is based on experience that we have, both at Atara with our EAP and single patient use, as well as our collaborators at Memorial in earlier studies, that we have some clinical data in this type of patient. So we're building upon this clinical data to move forward in this multi-goal study.
Hi, Andy submission or should be able to be done in Q2 or Q3 2020.
Now in terms of these first study it will be addressing advance mesothelioma, but we have the plan to grow in other type of solid tumors, where you have I expression of little city in particular ovarian cancer and pancreatic cancer.
Okay, great. Thank you.
Your next question comes from line as Tony Butler from Roth capital.
Right.
[noise] carrasquel. Thank you very much really three very brief questions number one is.
Pascal Touchon: Each of these cohorts represents ultra-rare conditions, but collectively, they represent a potentially addressable EBV population, an EBV-positive population several times greater than the size of the second line EBV-positive PTLD. And there are different types of disease that we're exploring in the patient population. Some are related to immunodeficiency, lymphoproliferative disorders, like primary immunodeficiency LPD, and also acquired immunodeficiency LPD. We're also going to explore LMS, leiomyosarcoma, for which we have presented data in the past, as well as first-line EBD-PTLD for patients where current first-line treatments are inappropriate, and first- or second-line CNS-PTLD. So, as you can see, a range of different types of patient population. And altogether, these represent significant commercial potential if we are successful and a population that is several times greater than the size of the second-line EBD-PTLD, which is the first indication that we are pursuing.
When you when you think about the 188 or when they study there.
In the open label portion nurse Retreatment and I'm curious if potentially there will be some retreat with data that will also be presented to you and that's question one and I hope not finished the other two very quickly.
If I may from the second.
Is.
With respect to the one be study.
188, I say currently you have.
Nine sites open because you pause the one be study will do then decide to create a greater number of sites in order to speed up that enrollment opportunity and then finally on the core programs on 70 119.
Youre a programs do you think or is it a goal to file I in these for those two this calendar year or is that more a 21 of them. Thank you.
Thank you Tony at age I'd want to take the first two question I'll take the last one.
Sure.
So so with respect to the themes or the one a long term extension.
And the just a quick reminder, we chose the dose for that long term extension based on the cohort three data. So if your car once we achieve the pre specified.
Pascal Touchon: Great, thank you. And if I could have one more question, I have a question regarding ATA-2271. What's the status of the mesothelioma IND, and are there any plans to develop this in additional solid tumors outside of mesothelioma?
Endpoints in the phase one eight to move into the RCT. We did we did that based on the phase three cohorts. So that became the dose that we use for the open label extension.
Pascal Touchon: Thank you for your question. As we said, there will be a presentation of some preclinical data from the INA Ineptic Studies that will be accepted as a late-breaking poster at ASER. The abstract will be released on May 15. And these data are part of the package that we need. Our collaborators at MSK, we're going to submit that IND to the FDA. All the data and all the studies have been done now. So it's just more of moving into the preparation of the submission, and that's why we are confident that this IND submission should be able to be done in Q2 or Q3 2020. Now, in terms of this first study, it will be addressing advanced mesothelioma, but we have the plan to go into other types of solid tumors where you have a high expression of mesothelin, in particular ovarian cancer and pancreatic cancer.
So it makes you know so because of that we treated several patients actually we've begun to treat them in that open label extension, but they're not far enough along to present at the end. So we will ultimately presented data, but they're not going to be available for the end discussion.
And in terms of your question on adding additional sites to trying to catch up on the RCT. The good news for active although we pause the actual enrollment we were able to continuing the pre screening activity. So we do have several patients lined up for the lower Jay we cannot hear them for that study once were able to Brazil.
Full enrollment activities.
So I don't really just has to pay needing to Oh sorry.
Yeah. We lost you. So as you can start eraco, explaining that what's happening in the in a in the current time, where we expose but we still active in preparing the side I guess, that's what you want me to say.
Operator: Okay, great. Thank you. And your next question comes from the line of Kelly Butler from Roth Capital.
Yes, sorry, sorry about the connection issue yeah. So weve remained active in essentially prescreening patients.
Pascal Touchon: Pascal, thank you very much. Really, three very brief questions. Number one is, when you think about the 188-1A study, in the open-label portion, there's retreatment. And I'm curious if, potentially, there will be some retreatment data that will also be presented at EAN. That's question one, and I'll finish the other two very quickly, if I may. The second is... With respect to the 1B study of 188, I think you currently have nine sites open. Because you've paused the 1B study, will you then decide to create a greater number of sites in order to speed up that enrollment opportunity? And then, finally, on the CAR programs on 7119, your programs. Do you think, or is it a goal, to file INDs for those in this calendar year, or is that more of a 21st century event? Thank you.
For the study so that we've actually got several patients lined up so that the at the moment, we resume enrollment activities, we can put them through the full screening process.
Because of that I don't really anticipate needing to add additional sites and where we are now is we do expect to resume enrollment activities. Soon in that study specifically the approach is going to be that as you might imagine Coca 19, There's center by center variability, we've have really close relationships with the sites. So what we're gonna.
It is on a state isight basis, the expeditiously get them started up again, we've just got a checklist that ensures that the sites have the capability to do all the assessments that are necessary that they have the staff facilities and equipment all available and as long as we're able to meet that checklist, we're going to be able to resume enrollment at those sites.
So again I anticipate that happening very soon because of that and it patients with.
We can.
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[noise] team as you know we have started or the eye in the anybody you lately, there and we're making steady progress toward bringing these are exciting asset into the clinic. We will we are not communicating right now the timing of such.
A.J. Joshi: Thank you, Tony. AJ, do you want to take the first two questions? I'll take the last one.
A.J. Joshi: Sure.
A.J. Joshi: So, with respect to the phase, the one, a long-term extension. Just a quick reminder, we chose the dose for that long-term extension based on the Cohort 3 data. So, if you recall, once we achieved the pre-specified endpoints in Phase 1a to move into the RCT, we did that based on the Phase 3 cohort dose. So that became the dose that we used for the open-label extension. So it may, you know, so because of that, we've actually treated several patients. We've begun to treat them in that open-label extension, but they're not far enough along to present at EAN. So we will ultimately present those data, but they're not going to be available for the EAN discussion. And in terms of your question on adding additional sites to try to catch up on the RCT, the good news for us is that although we paused the actual enrollment, we were able to continue the pre-screening activity. So we do have several patients lined up for those for that study once we're able to resume full enrollment activity. And so I don't really anticipate needing to add... Oh, sorry, go ahead.
Andy finding and we'll communicate the timing.
And your next question comes from the line of Maury Raycroft from Jefferies.
Hi, This is fighting on for Mike.
I guess color question Hardy and the underlying studies of the tier two to seven one do you expect include like non human primates tell you can go by some more perspective and to what extent.
Sure.
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[laughter].
Thank you Simon disconnect at any time backend now one moment.
Okay.
[laughter].
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No matter conference I'd number please.
[laughter].
Let me.
Do you want me to just trying to get back into the conference.
Oh.
Yeah, it's funny somebody like us.
Yes, yeah that'll be great. Okay, I'm, just kind of return you back into the conference.
A.J. Joshi: Yeah, we lost you, so if you can start explaining what's happening in the current time where we pause, but we're still active in preparing the site, I guess that's what you wanted to say.
Thanks, Matt you happen to lines one moment please.
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[laughter].
Yeah.
Yes.
Yeah.
Sure.
A.J. Joshi: Yes, sorry about the connection issue. Yes, so we've remained active in essentially pre-screening patients for the studies so that we've actually got several patients lined up so that the moment we resume enrollment activities, we can put them through the full screening process. Because of that, I don't really anticipate needing to add additional sites, and where we are now is that we do expect to resume enrollment activities soon in that study. Specifically, the approach is going to be that, as you might imagine with COVID-19, there's center-by-center variability.
Yeah.
Yes.
Hi, everyone to his AJ Joshi, sorry for the technical issues I think I've, just been able to get back in <unk>. Okay.
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Okay.
Eric are you on.
[laughter].
No.
It doesn't even really came have him they don't like they have him and about study and then.
Okay.
It doesn't see maybe where we can do is monitoring <unk> do you know, where we got lost or was it in the middle of my response on the M.S. So I could.
A.J. Joshi: We have really close relationships with the sites. So, on a site-by-site basis, to expeditiously get them started up again, we've just got a checklist that ensures that the sites have the capability to do all the assessments that are necessary, that they have the staff, facilities, and equipment all available. And as long as we're able to meet that checklist, we're going to be able to resume enrollment at those sites. So again, I anticipate that happening very soon because of that and the patience we have.
Continue that while we wait for other starting back in.
I think it might be AJ I think it was when I want to thank you everyone. So when they get lighting.
So maybe can start that connect alpha burrito.
Operator, we can have thought.
Are we on line.
Yes. She may go ahead.
<unk>.
So hello, everyone and very very sorry, I really apologize for these technical issue. So I'm going to go back to the questions from Tony on 50 to 90 as I say at this stage. We are working actively on the R&D any of these studies, but we not only to say when is that three to.
Pascal Touchon: team. As you know, we have started the IND Enabling Study.
Filed we will do that at the appropriate time, whether I would like to say that lease program. We believe is very exciting because these field of Cdnineteen car T is well known in terms of the level of safety and efficacy achieved by auto Who's got the at this stage.
Operator: Thank you.
Operator: And your next question comes from the line of Mari Raycroft from Jeffries.
Operator: Hi, this is Faisal Inam from MAUI. I have a couple of quick questions. For the IND endobrine studies of the ATA 2271, do you expect to include non-human primates later? Or if you can provide some more perspective into what to expect.
And we believe that we in going as fast as we can elect clinique, we can't really deliver a proof of concept of our platform in terms of its ability to deliver safe and effective aloe carty, but at the same time, if you to the specificity of follow platform basketball.
Operator: I think his line is disconnected, and he's dialing back in now. One moment.
Operator: Thank you.
Operator: Oh, man. Hello, may I have your conference line number, please?
Operator: Me? What?
Operator: Do you want me to just join you back in the conference? Hello.
Operator: Yeah, is it for me? For my record, right?
Operator: Yes. Yes.
Operator: That'll be great. Okay. I'm just going to rejoin you back at the conference.
Operator: Okay, I'm just going to rejoin you in the conference. I think something has happened to the lines. One moment, please.
So the DVT sale, and one X X as a unique costimulatory domain that impact on the at the system. Phil if he can give the T cells I think less exertional. The T cells. These might lead to superior activity in patients and in that case of course that could create a base.
A.J. Joshi: Hi, everyone. This is AJ Joshi. Sorry for the technical issues. I think I've just been able to get back.
Operator: [inaudible]
Operator: It looks like they have him; it looks like they have him and are about to put him in. OK.
A.J. Joshi: I was going to say, maybe what we can do is, moderator, do you know where we got lost? Was it in the middle of my response on the MS? So I could continue that while we wait for others to join back in.
This becomes value for that product.
Does it answer your question Tony.
Okay, maybe next question operator.
Mary Ray half was.
Operator: I think it might be A.J., I think it was when I was 32 and so on, A.J., 32 and I... So maybe you can start there. Can I start, Operator?
Jaffray's Wes.
And the question I am.
Okay.
Yes, we can yeah okay.
This is focusing on for Mike. So the first question is by the FDA. Peter 71, Okay, I'm going to have non killer ballast data, good again, as well and even a good.
Operator: Operator, can I start? Are we online?
Operator: Yes, you may go ahead.
Pascal Touchon: So, hello, everyone, and very, very sorry. I really apologize for this technical issue.
For eight here 22, 71, the meditating autologous coffee, that's a one year you asking about.
Pascal Touchon: So I'm going to go back to the questions from Tony on 3219. As I said, at this stage, we are working actively on the IND enabling studies. But we're not going to say when that is going to be filed. We will do that at the appropriate time.
Yes.
Okay. So the a I IND, enabling studies are mostly in between in vivo studies that are needed as well of course CMC.
Pascal Touchon: However, I would like to say that this program, we believe, is very exciting because this field of CD19 CAR-T is well known in terms of the level of safety and efficacy achieved by autologous CAR-T at this stage. And we believe that by going as fast as we can in a clinic, we can really deliver a proof of concept of our platform in terms of its ability to deliver safe and effective allocRT. But at the same time, due to the specificity of our platform, particularly through the EBVT cell, and 1xx as a unique co-stimulatory domain that impacts the persistence and efficacy of the T-cells, having less exhaustion of the T-cells, this might lead to superior activity in patients. And in that case, of course, that will create very significant value for that product. Does that answer your question, Tony? OK, maybe next question, operator.
Package that is a needed for the year to review a truly R&D process.
So the data that will be presented are related to in vivo preclinical studies and I'm not going to give anymore detail at this stage at the F. Park is going to be really very soon.
Okay.
Right.
The escalator previously the off the shelf Hello immediately Cdnineteen beta Lactamase specifically.
On the cat expansion by system.
Yes, So did you get a chance to evaluate the peripheral and analysis goes on the tankers.
So this is a you know an academic study and the data they presented at the TCT meeting with by the way on the six patients that were treated with this a third party dental sales modified Weve Cdnineteen car have been quite clear in terms not on.
Operator: Maury Raycroft was from Jeffrey's World and the question queue.
Operator: Can you hear me? Yes, we can.
The of the level of response, we five out of six NCR, but the durability of response for a million fluid of 26.9 months. So the longest ever for another Carty now we don't have and Needham MSK as data at this stage on the kinetic so the sales these other type of.
Operator: OK. Thanks. This is Farsinan from MAUI. So the first question is for the AATA-2271 program. Are you going to have non-human primate data included there as well that you're going to present?
Pascal Touchon: For LTA2271, the mesothelin otologous CAR T, that's the one you're asking about? Yes. Okay, so the IND-enabling studies are mostly in vitro and in vivo studies that are needed, as well as the MC package that is needed for the FDA to review for the IND process. So the data that will be presented are related to in vivo preclinical studies, and I'm not going to give any more detail at this stage, as the abstract is going to be released very soon.
Data analyses that hopefully there will be able to do in the future based on the simple they are but we don't have is that are available at this stage.
Okay, that's fine.
The other question is why the 80 188.
Okay, we kept and reducing glance strategy and insight about how did it doesn't go.
Yes. Thank you for your question, where do you want to answer this one.
Sure. So just reducing plan is when I when patients come due for the dosing that essentially we've left a relatively open window, but after the 12 month time point. So it's usually it anywhere between 12 and I think we leave a window of about 12 months to too.
Pascal Touchon: Okay, that's fine. For the MSK data previously, the off-the-shelves LO, EPP, and CD19 data, it lacked many specifics on the CAR T expansion persistence area. So did you get a chance to evaluate the peripheral and the nanosamples from the 10 patients?
Pascal Touchon: So this is, as you know, an academic study. And the data they presented at the DCT meetings with, by the way, on the six patients that we treated with these third-party donor cells modified with a CD19 CAR have been quite clear in terms not only of the level of response, with five out of six in CR, but the durability of response for a median follow-up of 26.9 months. So, the longest ever for a nalocalc.
Any four months because that allows some of the earlier cohort patients to be retreated, but the goal is to retreat as close to that 12 month timeframe as we head.
And it will be it's basically one cycle treatment that points. So we'll be day, one day eight a. 15.
You get doses.
Pascal Touchon: Now, we don't have and need MSK data at this stage on the kinetics of the cells. This is the type of data analysis that, hopefully, they will be able to do in the future based on the samples they have. But we don't have this data available at this stage.
Of 18 when needed.
And the goal is going to be that we're going to continue annual treatment on these patients all the way through to five years, a follow up from the initial studies entry.
Okay, great. Thank you.
And your next question and your last question.
Operator: The other question is for the ATI-188; can you recap the re-dosing plan strategy and give insight about how the re-dosing is going?
It's funny solving richer.
Goldman Sachs.
Thanks for taking my questions, Andrew I understand the now and maybe just one question on capsule and as you've seen an increasing number of clinical sites come online, particularly in Europe has provided any additional insights into the potential market size opportunity.
A.J. Joshi: Yes, thank you for your question. AJ, do you want to answer this one? Sure.
A.J. Joshi: Sure. So the re-dosing plan is when patients come due for the dose, and that's essentially, we've left a relatively open window, but it's after the 12-month time point. So it's usually anywhere between 12 and 24 months. I think we leave a window of about 12 months to 24 months because that allows some of the earlier cohort patients to be retreated. But the goal is to retreat as close to that 12-month time frame as we can. And it will be, it's basically one cycle of treatment at that point. So it would be day one, day eight, day 15. You get doses of APA 182, and the goal is going to be that we continue annual treatments on these patients all the way through to five years of follow-up from the initial study. Great, thank you.
No. Thank you for your question.
As you know we are working on opening new side can you help in various countries and we do so once we obtain of course the city approval and this has been obtain in four countries right now the UK, Austria, Spain and home. So we working in this four countries.
Keep opening and activating sides and as we said earlier on we've just activity to first you opened site in Spain.
Other very recently, so things are progressing there, but I guess your question is about the medical need and the patient population and when we discussed with you open expert they clearly pulled us at the reason medical need to the outpatient stuck bolt on options for treatment today.
Operator: Okay, great. Thank you.
Salveen Jaswal Richter: And your next question and your last question is from Salveen Richter from Goldman Sachs. Thanks for taking the questions. This is Andrea on behalf of Salveen. Maybe just one question on Tab-Cell. As you've seen an increasing number of clinical sites come online, particularly in Europe, has this provided any additional insights into the potential market size opportunity?
And they are very eager to get access to data. So we see that in terms of the clinical trials, but also we plan to open as with all in Australia in the U.S. in parallel to all clinical trials compassionate use program, which is a different system or the 80 detailing our indifferent jochen countries, which has to be able to address the need of pay.
Pascal Touchon: Now, thank you for your question. As you know, we are working on opening new sites in Europe in various countries, and we do so once we've obtained, of course, CTE approval, and this has been obtained in four countries right now: the UK, Austria, Spain, and France. So we're working in these four countries on opening and activating sites, and as we said earlier, we've just activated a third European site in Spain very recently. So things are progressing there, but I guess your question is about the medical need and the patient population. And when we discussed it with European experts, they clearly told us that there is a medical need. They have patients that don't have options for treatment today, and they are very eager to get access to TadCell.
And that for whatever reason cannot be an all in this study. So we clearly see strong demand there from these sites in terms of having access to topcell and we're getting ready to be able to deliver to up sell to them either through the clinical pivotal study of full compassionate use because they have many patients waiting for.
For transformative treatment for the very savvy and RPD progress in disease.
Pascal Touchon: So we see that in terms of clinical trials, but also, as we've done in Australia and the U.S., in parallel to our clinical trials, the Compassionate Use Program, which is a different system of the EAP but similar in different European countries, which is to be able to address the needs of patients that, for whatever reason, cannot be enrolled in a study. So we clearly see a strong demand from these sites in terms of having access to TadCell, and we're getting ready to be able to deliver TadCell to them, either through the clinical pivotal study or through Compassionate Use, because there are many patients waiting for transformative treatment for their very severe and rapidly progressing disease. Now for the questions.
It's.
No further question.
That concludes our question and answer session for today. Thank you for joining me I Tara I, our therapeutics first quarter 2020 financial results Conference call.
You may now disconnect your line.
[music].
Operator: That concludes our question and answer session for today. Thank you for joining the Atara Biotherapeutics First Quarter 2020 Financial Results Conference Call. You may now disconnect your line.
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