Q3 2022 Atara Biotherapeutics Inc Earnings Call
Good afternoon, everyone. Thank you for standing by and welcome to the <unk> Biotherapeutics third quarter 2022 financial results Conference call. At this time, all participants are in a listen only mode.
Brief question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please be advised that today's call is being recorded I would now like to hand, the call over to Eric Highland Grant Vice President of Investor Relations and finance at a Toro Biotherapeutics. Please go ahead Sir.
Thank you operator, good afternoon, everyone and welcome to <unk> third quarter 2022 results conference call earlier today, we issued a press release announcing our third quarter financial results and corporate update.
This press release and an updated slide deck are available in the investors and media section at a tower of bio Dot com.
On today's call members from the entire executive team will provide an update on our financial results operational progress and strategy and also review our upcoming key milestones and objectives. Joining me on today's call are Dr. Pascal to Shaun <unk>, President and Chief Executive Officer, Dr. Jacob Dupont Executive Vice.
President and global head of research and development.
Paul Coffee Kerr, Chief Financial Officer, and Dr. AJ Joshi, Chief Medical Officer.
We will begin with prepared comments from Pascal and Jacob then open the call up for your questions.
We would like to remind listeners that during the call. The 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. These.
These statements are made as of today's date and the company undertakes no obligation to update these statements now I'd like to turn the call over to Pascal Pascal.
Thank you Eric and thank you all for joining goes this afternoon.
Extremely excited that tough sales under the trade name of add value.
Received a skewed shouldn't be positive opinion for its first indication.
He's on truck will.
Obtained European Commission approval by the <unk>.
And it'll be here.
This will be the first ever approval for an allogeneic off the shelf T cell therapy.
Upsell first indication.
Louis is a very significant unmet medical need.
These you'd be deep with ETE PTSD patients.
No approved therapy.
And just a few weeks to a few months median survival.
And May was accordingly, very pleased to highlight that value positive opinion in the public release as one of the landmark of the October see it shouldn't be Inc.
Meanwhile, our commercial partner Fibroid is actively preparing for the launch in Europe in Q1 2020 free.
We do anticipate this launch as we believe add value can deliver a compelling value proposition for patients they use in Europe , and that's K assistance.
With significant pricing potential in such an ultra rare disease and I double digit royalties will go agreement with Pierre Fabre, We believe add value commercialization will progressively contribute to other hubs with a news and cash runway.
We'd like now to give an update on the progress with stop sale in the U S.
What are we in constructive discussions with the FDA, including senior leadership.
We recently held a type a CMC meeting with the review team that could be needed in clear guidance and agreement.
On specifics UMC will do free requirements for a BLA submission.
In addition.
Type B clinical meeting request has been granted.
<unk> is being scheduled discussed and potentially align on the clinical data package requirements to prepare for a pre BLA meeting.
We're doing this meeting and possible further interactions with the FDA, we expect to give further guidance in Q1 2020 free on progress toward BLA submission.
At the Ash conference in December .
We will present updated interim analyses of efficacy and safety results of the phase III study in.
And without Trinity EBV positive <unk>.
We'd have to talk about EBV boosted PTSD with additional patients and longer photo with confirming the transformative potential of upsell.
We will also present exciting new data in patient with EBV positive <unk> sarcoma.
The type of EBV associated 32 months.
Jacob will provide more details on this in a moment.
Bye now.
Full stop sale, we have started to seek a commercial partner in the U S and.
Entering into such a partnership will avoid further investment and could provide additional cash inflows.
External cash run away.
We are confident in the significant business opportunity that upset a whole prisons in the U S with potential peak sales over $500 million per year across multiple indications.
Now onto a tier one HCA put.
I'm truly transformative therapy pollutes fulfilling from progressive forms of multiple sclerosis.
At the extremes 2022 conference, we presented new high biomarker imaging and open label extension clinical data.
The phase one study of 81 ath in populous heap M S.
New biomarker imaging desktop.
Exist patients, which ive confirmed disability improvement or C. D. I demonstrated significantly less buying a coffee over time, an increase in MTR in and then seen connected two lesions.
These data support that Blaine it took the whole changes, including potential Bohemia the nation may.
May underlie Dukhobor CDI confirmed disability improvement associated with 88 188.
Also the.
The data the results from the ongoing open label extension with up to 46 months totaled photo inpatient achieving CDI demonstrate durability of improvement once achieved.
Remarkably.
Patient with stable disease, meaning no decline in DSS.
Maintaining such stability for two full use.
Which would also present, a thoughtful national profile relative to the expected natural course of the disease.
As a reminder, based on the old a month at the end of July for Phase III and bolster the evaluating 80 188 versus placebo.
Non Ah Keith Pms patient.
Approximately 90 patients.
Our plan to be included in the readout of the study the primary endpoint of confirmed disability improvement by E. D assessed at 12 months.
We expect to communicate the final data readout in October of 2023.
All in all these new extremes data from a phase one study and OLED open label extension.
Whether we the two landmark studies published this year in science and nature.
And our two fast track designation with the FDA.
Further support our confidence in the possibility for 80 188.
Transformational clinical improvement to progressive Ms patients.
We are truly excited.
A T. When they see a potential as a unique game changer in Ms and we are eager to reach the Unbolt primary endpoint readout in October 2023.
We will continue to be opportunistic and exploring potential partnering opportunities with biopharma companies that could maximize the value creation potential of achy when a kit.
Now I would like to hand over to Jacob to provide more details on our pipeline portfolio and strategy before I give you an update on our financials Jacob.
Thank you Pascal.
As Pascal mentioned, we're extremely excited about the recent positive C. H M. P opinion for <unk> in Europe , we are advancing ever closer to receiving European Commission approval for this first of its kind off the shelf T cell therapy. We also believe that there is positive.
Decision provides clinical validation for our overall EBV T cell platform and portfolio, which now has treated more than 500 patients with clear evidence of efficacy and safety. The most of any allogeneic cell therapy company to date.
We're also encouraged by the steady progress, we're making on the U S regulatory front and expect to have more to say in Q1 of next year.
Looking ahead to the upcoming 2022 ash meeting in December we will present updated efficacy and safety results of the phase III <unk> study in relapsed refractory EBV positive P. T L T.
Now with additional patients and longer follow up.
The data to be presented that was published in the Ash abstracts last week are consistent with the transformative potential of tab cel in EBV positive <unk>, specifically, the overall response rate by independent Oncologic and Radiographic assessment was 51 point.
<unk>, 2% and the sample size of 43 patients. The response rate after H C. T was 50% and after S. O T was 51, 7%. The median time to response was very rapid one months and this response is needed for these patients with such.
The oncologic emergency as EBV positive <unk>.
The duration of response was an impressive 23 months and the median overall survival was 18.4 months with patients who.
With patients who responded having longer survival than non responders.
These new allele clinical trial data were impactful for the positive C. H M. P opinion that we just received.
Additionally, at Ash, we will present updated efficacy and safety data from two single Center Open label Studies and multi center expanded access program in patients with EBV positive Leiomyosarcoma coma, who have received at least one therapy now the clinical benefit rate.
From tab cel with 77, 8% with an objective response rate of 22, 2% in this rare and difficult to treat solid tumor and the estimated median overall survival was 77.4 months.
And all of these studies the safety profile of tab cel remains consistent with previously reported data with no new reports.
Tour flow reaction cytokine release syndrome.
<unk> mission of infectious diseases graft versus host disease or infusion reaction related to treatment. We believe these data continued to support the benefit of tab cel in its potential to transform the lives of thousands of patients each year across multiple indications and geographies.
Now onto a T. A 188 are potentially transformative therapy for those patients with progressive multiple sclerosis.
We believe the targeting EBV infected b cells is a validated approach towards finding a transformative treatment for these.
For this debilitating disease. The recent publications in nature showed that EBV infected b cells mature into antibody secreting plasma cells that generate brain reactive antibodies. In addition, EBV infected b cells can stipulate auto reactive T cells and thus.
<unk> chronic inflammation taken together these recent scientific advances support our excitement around the potential of this therapy now as Pascal noted the new MRI data and updated OLED data presented at <unk> on top of previous phase one data further reinforce.
Our belief in the transformative potential of <unk> 188, we look forward to the final data readout from the approximately 90 patients who will be included in the primary analysis of the randomized double blinded placebo controlled phase II and bold study in October of next year.
Now I want to provide an update on our car T therapies as well with respect to HCA $22 71, which has a reminder is our autologous MISO sealant product candidate being currently developed by our partner Memorial Sloan Kettering Cancer Center, and we are pleased to report that the face.
Is one dose escalation clinical study conducted by M. S. K has resumed enrollment after the voluntary pause earlier this year due to a fatal series event and one patient. Additionally for this program, we expect M. S. K to provide a phase one data update for HCA $22 71.
One in December of this year at ESMO I O conference.
In addition, we are advancing a $32 19, which is our potentially best in class Allogeneic car T for B cell malignancies, expressing CD 19, now the manufacturing process optimization is progressing to ensure appropriate scale up while maintaining a unique.
Memory T cell phenotype, following completion of process optimization and manufacturing runs and the GMP manufacturing suites of our strategic manufacturing partner Fuji film diode biotechs.
Biotechnologies, we now anticipate an IND filing in Q2 of next year.
As a reminder, we're using an optimized manufacturing process to ensure enrichment for a memory T cell phenotype, which has shown robust activity in preclinical studies as shown on slide 55 of our updated investor deck.
We're a T $32 19, outperforms and autologous car T benchmark on overall survival in a preclinical model. This manufacturing approach as part of the overall optimization of HCA, certainly 2019 to differentiate it from the existing product set to address the <unk>.
High unmet medical need.
Our focus on memory T cell phenotype for HCA 32, 19 product candidate is supported by recent preclinical and clinical presentations of autologous car T therapy upcoming clinical data at this year's Ash meeting of an autologous CD 19 car T therapy showed that car T.
Phenotype with more stephanus is associated with improved response rate and durability of response additional additionally, clinical data from another ash 2022 abstracts with the autologous CD 19 car T containing the new one Xx co stimulatory.
Domain invented by Dr. Michelle Sadly is this.
<unk> was favorable response rates durability and safety as a reminder, the <unk> co stimulatory domain that we have licensed from S. K is incorporated into the HCA 32, 19 construct we are particularly excited to bring <unk> to 19.
The clinic since this outlet generic CD 19 car T. As several key points of differentiation. These include the safety of the EBV car T cells potential best in class efficacy persistence and off the shelf accessibility as the 80 $832 19.
Program does not require TCR or HLA gene editing before I turn the call back to Pascal I would like to extend my gratitude to the entire staff our collaborators in the patients involved in our studies together, we hope to bring to patients in need of allogeneic T cell therapy.
So some with curative potential Pascal.
Thanks, Jacob not onto our financials in September 2022, we announced an additional near term milestone payment under an updated upsell commercialization agreement with <unk>.
Under this agreement <unk> will receive an additional $30 million upon EC.
E C approval and subsequent filing of the MAA transfer to PFS.
For the third quarter of 2022.
With regard to our cash position and underway.
We ended the third quarter with approximately $265 million in cash we believe that these cash balance.
Whether we have potential cash inflows from satellite and the expected reduction in future operating cash burn will be sufficient to fund the company planned operations into Q1 of 2024.
Following our recent restructuring that is now fully implemented we are on tuck, but we'd use our operating cash burn in 2023 and beyond according to plan.
I would like to conclude by extending my sincere gratitude to all our staff.
The unwavering commitment to patient lives, we seek to transform and his significant contributions in advancing truly innovative medicines for patients in need.
Thank you all for what you have done.
I will now turn the call over to the operator for the Q&A part of the call operator.
Thank you we will now be conducting a question and answer session.
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 if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the SRU.
One moment, please while we poll for questions.
Thank you. Our first question is from <unk> <unk>.
Salim Sayed with Mizuho group. Please proceed with your question.
Great. Good afternoon, guys. Thanks for the color on the question I.
I guess a couple from me on tab cel so.
Pascal just curious if you plan on providing any sort of guidance on the EU tab cel revenues at any point in 2003, and maybe the first part of 'twenty three for what format would that take place in and also maybe some of the logistical hurdles that.
That you plan on having four for having the first allo T cell product in Europe .
And then also just on the U S side, just curious what the gating factors are around finalizing discussions for a potential partnership for.
U S commercialization. Thank you.
Thank you so regarding Europe , we are not planning at this stage to give any guidance on the revenues coming from Europe .
Of course at the time of the launch which as I said is planned for Q1 'twenty free after we received the approval and we transfer that to peer Fob.
We'll have more to say about pricing, which is a very important starting point in any type of launch at this stage, we have aligned with their fab and we understand what is their pricing strategy, which we think is very relevant.
And fully aligned with the idea to price according to the value both to patients physicians, so psyche and the healthcare system.
It's too early to make any comment on pricing, we will be able to do so after the political at the time the product is being launched in Q1 2000 feet.
No we will at the time give more details if needed on that.
That launch, but regarding what's your call logistical hurdles, we don't see that many on all sides in the sense that this is really like biotech launch. It is of course cell therapy, but it is allogeneic cell therapy off the shelf cell therapy, which is basically I think the ability to deliver product to the institutions.
All the physicians, where the patient is being treated within just a few days.
Inventory.
Product that has already been made.
There is of course, some aspect of logistics that we have already tested time and time again since we started in a couple of years ago to do clinical trials in Europe as well as expanded access program. So we've treated across Europe and most of the key countries. A number of patients. So we are used to that type of logistic and the ability to deliver.
Within a few days to the patient in need of treatment and we have a trust we have transferred that knowledge that knowhow to February . So we're very confident that it will be able to handle that very efficiently.
On the U S bottling Holt.
As I said, we are starting to seek for partner I think to be able to sorry to finalize and execute on the partnership is not only a question about finding the right type of partner and negotiating the right type of value speed and financials. It's also to be clear about the timing of the BLA.
Submission and the approval for that product to prepare for the launch. So there is some ability to run in parallel the process of finding the right commercial partner that could maximize the value of the upset in the U S, which we believe is very significant while we are also progressing with the FDA in terms of.
Fine tuning the exact timing of the BLA submission and in some ways de risking that BLA submission with all this.
Activities of interactions in meeting that we have with the FDA does it answer your question.
Yes, very very helpful. Thanks, so much.
Thank you Sydney.
Thank you. Our next question is from John Newman with Canaccord. Please proceed with your question.
Other team thanks for taking my question.
Just curious if you could comment a little bit more regarding.
The number of patients that you currently have treated with the commercial formulation for.
Tab cel and also.
How much follow up time, you might have there just kind of curious as to how the.
Patient distribution looks across.
Commercial product versus the clinical study materials.
Thank you Jakob do you want to take that one.
Sure Pascal and John Thanks for the question.
So as you know we filed this IMD amendment.
Last year to put the intended commercial material into the clinic and then we had good discussions with the FDA and there are certainly interested.
To see the clinical data for these patients treated with the intended commercial materials. So.
That's going well, we are not going to comment at the present time on the number of patients that we've treated and the amount of follow up but I will say and.
We we mentioned this previously, but we've had constructive dialogues with the FDA about a possible path forward.
Two BLA submission without the need for new clinical trial and that we could use these commercially.
Commercial process.
Treated tab cel patients and again the FTA was.
Ported of not conducting a new clinical trial as we previously announced that and.
And again, we are proceeding ahead, and we're treating patients in the clinic, but at this point, we're not going to give specifics as to how many patients have been treated with the commercial material or the duration of follow up at this point Pascal.
Yeah, no nothing to add on my side I mean.
Terms of duration of photo at the typical one that has been done with the FDA in the past was to have response and to all of the patients followed for six months for the restaurants, but at this stage, we are not going to comment about what the exact requirements regarding this population of patients with either conventional product suffice to say that things are posting well and we are treating.
Patients in different settings with the commercial product.
With time.
And also do you use.
Just curious if you've discussed with the agency or perhaps you've you've thought about.
Utilizing patients in the future or currently in the multi cohort study if those patients were to receive commercial product.
Might that.
Satisfy fda's requests as well as perhaps give me the opportunity to potentially broaden the label.
Yes, maybe I'll start and Jacob you might want to chime in I mean, there are two aspects. One is from a safety database point of view for the intended commercial product any type of use of that pullback in terms of indication in terms of setting beat in the pivotal study. The Leda study you'll beat in expanded access.
Program or even single patient use all of that is of course, not only useful but required for safety assessment and that would be useful data from an efficacy point of view as you can imagine the FDA is looking more at the specific indications we are pursuing with the future potential BLA filing so that's where we will need to focus.
The efficacy data in that specific indication Jacob anything to add.
Yes, I think that's that's whilst summary, summarized pascal, but but I do think the spirit is right. We are treating patients in a variety of settings with the intended commercial material and all of this is certainly going to be informative for the FDA is that they.
What ultimately make a risk benefit assessment.
For these patients treated with tab cel.
Okay, great. Thank you.
Thank you. Our next question is from Tessa Romero with Jpmorgan. Please proceed with your question.
Hey, guys. This is Peter on for Paul.
Thanks for taking the question, but we're just curious what is size and the scope of the data that will be presented on ath <unk> fallen one.
Our next month and in particular, where we get more details on the P&L I'll say either it was reported earlier this year and what factors led to E N S K Eddie resuming.
Take up they want to take that one.
Yeah, absolutely so.
The.
The intended target and the presentation will be made to the ESMO Io conference here.
Coming up before the end of the year and certainly clinical data will be presented there now because of the hold on enrollment.
There will be patients presented here up too.
That first patient in.
In the third dose escalation cohorts are there.
We anticipate and again the presenting author is still putting together.
The slide presentation, but we fully expect there's going to be.
Safety data presented there is going to be some degree of PK data potentially also.
Some information on this particular patient there was an extensive work up as we have previously detailed including an autopsy.
For that patient and that type of translational work will also be part of the presentation.
We suspect and in terms of the factors that were assessed by the FDA that debt, where the FDA was an agreement that enrollment should start once again.
Included the information on that that patient who was treated on the clinical trial, who have very refractory mesothelioma in a lot of other comorbid illnesses.
And that.
Where the protocol amendment was created by the investigators at Memorial Sloan Kettering, They submitted to the FDA and again the FTA was.
Accepting of the workup of that patient the data provided and the proposed amendment as well that really led to the FDA agreement that enrollment could start once again for that particular trial.
Okay and are you able to provide any more details on the protocol amendment that was accepted.
They took.
Yeah. So in terms of the protocol amendment.
Some of the details what were that the study would be started once again now.
What was agreed.
Was that the study.
Treatment of the patients would resume at that dose at the cohort two dose so.
There would be a return to the second cohort that had already been cleared and treat a couple of more patient set that at.
At that dose of three times 10 to the sixth car T cells per kilogram. So we'll see information for a couple of more patients treated there and there is also a little bit of.
The amendment of the eligibility criteria here, where as I mentioned this was quite a confounded patient who had received a lot of different treatment, including checkpoint inhibitors COVID-19 vaccines and so forth. So there was a requirement that there was a bit longer of a washout of checkpoint inhibitor therapy.
Before the patient was treated on the clinical trial with the car T therapy I would say those were the predominant changes that were made.
Okay, great. Thank you so much.
Absolutely.
Thank you. Our next question is from Phil Nadeau with Cowen and company. Please proceed with your question.
Good afternoon, thanks for taking our questions a few clarifying questions first on your guidance for meeting with the FDA.
Are we correct that for the next meeting is a type b meeting and Thats simply to prepare for the pre BLA meeting the pre BLA meeting will happen at some time.
After the type B meeting.
Yes, that's the case I mean, it could be at a meeting will be after the type b and the <unk> is really to discuss in the line of them the number of patients and the duration of follow up that he wants to see in the clinical data package.
That will allow them to move to.
To the pre BLA meeting.
Got it and then updated in Q1 of next year Thats. After the type B meeting, presumably not after the pre BLA meeting.
Yes at this stage, what we are talking about the meeting that is being should do as we speak these a type b meeting.
Got it Okay and do you have a sense of how long it's going to take for you to complete the CMC module three based on the requirements that have been agreed upon with the FDA or is that dependent upon the outcomes.
It comes with a type b meeting with how many patients preclinical data youre going to need.
No. It is independent from the clinical meeting I mean, we have no very clear view about what's needed for the BLA filing what type of information needs to be gather then so nothing surprising here.
So it's in line with our expectations. So we are not giving any guidance for the time, but thats a reasonable timeframe.
In line with our expectations regarding the CMC part. So we think that the now that the main next item to clarify before we can give a guidance on the timing of the BLA filing is really the clinical path TNT is very clear.
Do you think you'll have a cool parts, keeping or is that likely to be gating for the friendly.
We cannot comment on whether it's going to be gating to if we have that meeting with the FDA.
Because thats really the key aspect to discuss with them about how many patients for how long and how do we relate to the other type of patients at home.
Got it okay.
And then last question from US just on the.
Partnership in the U S can you talk about a little bit more about the strategic rationale for setting a partner at this point in development. It sounds like you're getting close to the U S filing we wouldn't imagine the commercial spend is too large for.
A disease like <unk>. So so can you talk a little bit more about why why do you think a partnership would be one.
Yes, I think we believe that there is a clear business case for tab cel in the U S. In its first indication followed by additional indication as part of the EBIT expansion that we are already planning as you know.
Mexico study in particular, so the business cases, very key as you know we've had.
A significant level of work to prepare for that future launch in terms of pricing reimbursement with this because we still use we know the price level that would be an acceptable one in that particular health care system. We have already achieved the unique situation of having a.
The product.
And in fact into the DRG, a keen that will be implemented next year. So they use reimbursement all that has been well prepared we are also well prepared the mapping of all the centers, where we believe the focus of key account management and medical affairs, where it should be.
Really at the launch time, so all that is ready and it's true that the launch of a product like that in an ultra rare disease with significant unmet medical need no competition and clearly identified patients.
Post transplant patients now are all being tested for EBV and when there is a beautiful mind. These patient it's it's.
Really clearly linked with an EBV positive <unk> in most of the cases physicians are way about that so the awareness with physicians is going to be the key at the time of the launch and disease.
Progressing as we speak and for example, the new debt that will present at ash.
In a couple of weeks.
More than a couple of weeks or a few weeks.
Going to be very important again to stimulate that awareness with physicians about the ability of a treatment like <unk> cel to transform the lives of these patients with significant.
In terms of its <unk> <unk>. So all of that preparation of the launch has been done by us and we continue to to make sure that there is the public communication of scientific data that are very convincing.
Now this being said implementing a launch with T O requires.
The investment to create the full commercial and medical team and to be able then to.
Handle the launch before you start to us.
Breakeven and then profitability.
Constitution day, even though we believe that the penetration of that population could be relatively happy due to the unmet medical need and the lack of competition. So we think that from a corporate strategy point of view it is better to rely on the partner that is already.
Structure, they are commercial structure in the U S that they could leverage with that launch and the advantage for us at the corporation level will be to voice to us to.
For the <unk>.
First from a commercialization point of view and therefore to allocate some resources to that commercialization and then we can also get some cash inflows.
Based on that partnership as we've proven when we signed that deal for Europe , with a $45 million up front and as you know the U S. It's a much larger market than you hoped for.
For civil aspect in that particular disease area. So we are confident that we possibility here the opportunity to avoid allocating resources to commercialization to get some cash inflows that will help us to extend our cash runway and also to continue or creation of value for us.
Specially the allogeneic car T programs that we are developing does it answer your question, yes, that's very helpful. Thanks for taking our questions.
Youre welcome.
Thank you. Our next question is from Ben Burnett with Stifel. Please proceed with your question.
Hi, This is Kelly on for Ben Burnett, Thanks for taking our questions I just had a quick question about the phase III Lille updated slated for ash.
Just curious if you guys could give us.
Thank you have how many.
They're going to be.
At this update as opposed to the previous update that we had received I think actually maybe a couple of years to go on this program and then.
Maybe how many of these new patients that are in this update.
How many of these pieces are also new to the FDA. Thank you.
Okay, maybe I start and Jacob you can see I mean, just to clarify.
Clarify one point the last update we gave them. The lead was in fact, just a year ago. It was US 2021. So it was not a couple of years ago. It was just a year ago and now video update is based on the abstract that was released last week.
Oh, maybe Jacob you can comment on the number of patients and what I would say regarding the regulatory aspect.
That these are extremely important in getting the European positive opinion that the <unk> level because that to a path of the submitted data Jacob.
Yeah, absolutely so just to give a little granularity and this is also captured in our press release from today, but when you look at it in the phase III <unk> study, obviously in relapsed refractory EBV positive <unk> patients.
We're now presenting data from.
A total of 43 patients that are evaluable here and as I mentioned in my <unk>.
Initiating.
<unk>, we do have that overall response rate of.
51, 2% response rate in up those.
14 of those patients had.
Had been post HCP. So again, we have and the response rate here was 50%. So seven out of those 14 patients were responders and then if you look particularly at the DSO T patients.
We had 29 patients in 15 of those patients were responders for an overall response rate of 51, 7%.
Percent response rate, which again is a remarkably high response rate.
In this particular population of patients that have a very high unmet need and as Pascal mentioned.
These data.
From the <unk> study were really the crown jewel and the MAA filing that led to the positive <unk> opinion, just a few weeks ago and then obviously we had.
And overall survival data of 18, four months, which again is quite remarkable when you consider that for these patients post <unk>, you're looking at a median overall survival of somewhere between.
Seven months and four months median survival. So again. These are these are really pretty remarkable data.
Thank you.
Sure.
Our next question is from Jon Miller with Evercore. Please proceed with your question.
Hi, This is Jessica <unk> on for John a couple of questions from me first on <unk> could you just give a little bit more color on this new meetings planned with the FDA to discuss clinical data. So you just said now that in your phase III may not necessarily be required for BLA submission, but what are the range of possibilities.
Or clinical data package requirements for Capstone and then also.
How much could you expect.
To extend cash runway with a potential U S commercialization partner and then lastly, just a question on <unk>.
And are there any updates on potential large from our partnership interest. Thank you very much.
Thank you Jacob they won't take the first one I'll take the next door.
Yeah sure absolutely so.
And just to sort of summarize the status with the FDA. So.
We have had these constructive conversations with the FDA between Atari senior management as well within FDA and Pascal mentioned this but again the feedback that we got here over the summer was which was really a reversal I would say of some of the feedback that we got back in February is that.
There could be a possible path to BLA submission without the need for new clinical trial if.
If we were to use the <unk>.
The commercial intended commercial process version of tab cel and obviously, we did as I mentioned put this particular.
Product version into the clinic.
At the latter part of last year. So we're gaining real clinical experience. So what we proposed to the agency, which again they are.
Embracing is this concept that we can leverage the clinical data from patients treated with the intended commercial product as well in the pivotal study, but as we also discussed from other sources as well so.
The other really impactful meeting that we had with the FTA quite recently was a type a CMC meeting and Pascal mentioned this as well.
This culminated in this is very important and clear guidance from the FDA that we have agreement on the specific CMC module three requirements for the potential BLA submission. So again, we feel as if we have really cleared through the CMC hurdle, which has been a major source of discuss.
Over the last couple of years now we also mentioned that we have an upcoming clinical type B meeting and this was actually suggested by FDA.
The leadership that we actually have this clinical meeting to discuss and potentially align on the clinical data package requirements.
Leading up to the pre BLA meeting. So we are actively preparing those arguments again, we're going to leverage patients treated with the clinical material but.
We certainly have a very large clinical experience and we've discussed the fact that we've treated over 400 patients with tab cel in the clinic.
And again this is going to be improved approved in Europe , very shortly and we have.
Close to 200 patients with <unk> treated as well. So we think that that clinical experience is quite impactful. So again, we're preparing this argument between the intended commercial treated patients as well as our very robust other clinical experience. We're again this is going to be quite an interesting type b.
Clinical meeting coming up where we hope to gain agreement with the FDA on that the contents of that clinical package Pascal anything to further add.
No I think that's clear on that so to your other two questions I think up on the cash runway extension that we're not going to comment on that we are starting this discussion with potential partners, maybe what I could say that we had a very successful wholesale new hope we've I think we've seen six term sheet at the time on the pullback in which was PFS.
Some of the best partner with a $45 million a poem for Europe , plus a few emerging markets.
That's all the milestone both regulatory and sales plus very significant double digit royalties. So we.
Managed was a very good partner, but also a very good deal for the company. So when you think about the U S.
We'll supply to replicate these type of situations there and we think there is as you can imagine a much larger business opportunity in the U S entity in Europe , and I'll, let you decide how large it is compared with you all but it is very significant that we mentioned that particular, none bill over $500 million of big sales in our views regarding the.
Business built into it so that's going to be we hope.
Difficult in line with the value of the product.
It still communication and put other indications.
Now this being said, we've also I'll say lifetime.
In terms in terms of cash runway is progressively different type of activities to be able to fund the company into the.
<unk>.
The Q4 of 'twenty four.
End of 'twenty four.
Isn't it is to us.
One year, Oh gosh at some stage beyond the readout of <unk>, which is a very significant potential value inflection point for the company in October of 2000, and well. That's one tons. We are into Q1 'twenty for now, but we see a number of activities that we can.
Managed to support the funding of the company we are already.
Beyond the onboard with us which is important to notice in Q1, 'twenty four but we believe we have opportunities to go much further than that.
All <unk> partnering we are not giving any particular update we just reiterate what we say that we are of course discussing with various companies, but the most important is that.
If we were to consider partnering before the onboard without it would have to be also.
A very significant value with you.
Recognize value as well as potential value speeds in the future because we want to make sure that all shareholders benefit from the potential value inflection point, depending on the readout of our board in October 2020.
Thank you very much thank you.
Thank you. Our next question is from Sylvan Richter with Goldman Sachs. Please proceed with your question.
Hi, Thanks for taking the question. This is mason on for solving on 188.
What might give you confidence that one year could be sufficient for the phase II data there.
Thank you.
Hey, Jay do you want to take that one.
Sure. Thanks for the question.
The conference for one year being sufficient really drives from the phase one data that we saw where when you look for the disability Improvers confirmed disability improves by Etfs.
Almost all of them improved within that first 12 month time frame.
As you know we are the study at the two year study. So we are following patients beyond that one year time point, but because really the large majority of improvements occurred in that first 12 month timeframe, we have confidence that that's a that would be a good endpoint for AMOLED readout.
Okay. Thank you.
This concludes our question and answer session for today. Thank you for joining the <unk> Biotherapeutics third quarter 2022 financial results Conference call you may now disconnect.