Q3 2022 Allogene Therapeutics Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Hello, Thank you.
Hello, and thank you for standing by and welcome to the <unk> Therapeutics third quarter of 2022 conference call.
After the speaker's presentation, there will be a question and answer session.
That's a good question.
Session, you will need to press star one one on your phone. Please limit yourself to one question and please be aware that today's conference call is being recorded.
I would now like to turn the call over to Christine Casiano, Chief Communications Officer.
Yes.
Please go ahead.
Thank you operator, and welcome to our Q3 call. After market closed we issued a business update and financial results press release for the third quarter of 2022 press.
Press release, and today's webcast are available on our website.
You don't limit your questions to one per person as people keep this call to an hour and do our best to get to as many as possible.
Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado Executive Vice President of research and development and Dr. Eric Schmidt Chief Financial Officer.
During today's call we booked.
Certain forward looking statements.
These may include statements regarding the success and timing of our ongoing and planned clinical trials data presentations.
Literary filings future research and development efforts manufacturing capability and 2022 financial guidance among other things.
Forward looking statements are based on current information assumptions and expectations that are subject to change at.
A description of potential risks can be found in our earnings press release and latest SEC disclosure documents.
Cautioned not to place undue reliance on these forward looking statements and Allergan disclaims any obligation to update these statements.
Now I'll turn the call over to David.
Thank you Christine and good afternoon.
I will start today's call focused on our most important milestone that you need.
He says about phase III trial with Allo 501 for the treatment of relapsed or refractory large b cell lymphoma.
Advancing our off the shelf allogeneic CD 19 car T product candidates.
<unk> II trial brings us one step closer to making this potentially lifesaving therapy more readily available to the patients.
It is a combination of a singular focus over the last three years and signifies our leadership in the development of Allo car T product.
And in my view.
<unk> for the entire field ourselves.
As you might imagine we were very pleased last month to share that we have initiated the industry's first potentially pivotal phase III trial for an allogeneic car T product.
Being the first comes with a special set of challenges, but it also comes with an enormous sense of accomplishment and responsibility.
When we started our journey, we knew there would be a unique set of challenges.
Would have to address.
Ensuring the safety of Allo car T products, especially with respect to the graft versus host disease.
Protecting allo car T cells from being prematurely rejected by the patients immune system.
Demonstrating meaningful responses.
And managing reliable manufacturing of Allo car T product.
Our depth of understanding around each of these elements combined with the breadth of our clinical programs.
The translation of knowledge, we have generated puts us at the forefront of science.
The journey of drug development is often a winding road.
As we proceed through this journey and work towards addressing the challenges we have tasked with keeping our focus.
We have been unwavering in our commitment to ourselves patients and investors could create and lead the next revolution in cancer treatment by delivering to patients. The first allogeneic car T products for blood cancers and solid tumors.
And initiating this phase III trial places that one meaningful step close to that goal.
To that end, we are very much looking forward to providing a clinical update on our CD 19 offer studies.
Our CMA Universal trial at all R&D showcase in New York on November 29.
While our usual practice for such update is to target medical conferences, we believe our R&D showcase who will provide more cai.
<unk> ability to fully review the clinical findings of our lead programs and discuss that in the context of a rapidly evolving landscape.
Before I turn the call over to Rafael I would like to make few more comments related specifically to the importance of collaboration with like minded individuals and institutions.
Our success to date and our best in cell therapy can only be accomplished with a partnership and support of engaged patient focus the investigators and clinical trial sites.
<unk> dedication to patient care is to be commended and their desire to bring about options for their patients is underscored by the launch of a first of its kind effort, we called car T. Together.
Reward access challenges have emerged since the commercial introduction of <unk> car T. Five years ago, chief among them. The pie bottleneck created by the complex individualized manufacturing process inherent in the delivery of autologous car T therapy.
This pioneering initiative conducted in collaboration with key opinion leaders from top oncology centers is aimed at supporting the advancement of Allogeneic car T products to address bottlenecks group collaboration education and clinical trial enrollment.
In that World members of this initiative include lead investigators from Moffitt Cancer Center.
Sarah Cannon, Colorado Blood Cancer Institute, the Mayo clinic and CFO .
We've dedicated physicians.
And the many more who will participate in clinical trials sponsored by <unk> and others.
Leading the Vanguard upsides.
So on a personal note I had the pleasure of working with many of the same kols as we traveled to look towards bringing our <unk> car T therapies to patients and I'm honored that they have chosen to join US again on this next chapter.
As we noted last quarter, we started allergan with a goal of baked in car T readily available to all eligible patients.
As we near the conclusion of our fourth year together, we believe we are well along the path with transforming car therapy from a complex individualized procedure to off the shelf on demand pharmaceutical product.
Thanks to all our employees investors collaborators and patients who have joined us on this journey.
I will now turn the call over to Rafael.
Thank you David as David noted our teams are very pleased to have initiated our potentially registrational outside the trial activities are also underway to launch our companion expanded phase II trial.
Also two trial utilize allo 501 in patients with relapsed or refractory large b cell lymphoma will deploy a single dose of allo 501, eight $120 million card posted itself with a LIFO depletion regimen comprised of Fludarabine and cyclophosphamide lifestyle of six or seven.
Single arm trial will enroll approximately 100 patients who have received at least two prior lines of therapy will have not received prior anti CD 19 therapies.
The primary endpoint of this trial is overall response rate with a key secondary endpoint of duration of response.
As we onboard clinical sites for <unk> in the U S. We're also continuing our discussions with the European Medicines agency to initiate the <unk> study at European clinical sites.
The expand trial a separate potentially registrational trial is intended to demonstrate the contribution of our $6 seven to the standup fludarabine cyclophosphamide lean for depletion regimen.
Patients will be randomized to receive the same single 120 million cell dose of Allo 500, <unk> I think the alpha good trial and either lucrative Felicia with Fludarabine and cyclophosphamide alone control arm or the thing for depletion regimen of the Alpha trial active arm.
The trial is expected to enroll approximately 70 patients with a primary endpoint of progression free survival and the key secondary endpoint of overall response rate and duration of response.
We are looking forward to sharing clinical data from our 2019 program at our R&D showcase at the end of the month.
We are planning to share longer term follow up data from the alpha and I'll touch the phase one trials, including our rationale for selecting the dose and schedule of Allo 501, <unk> being deployed in phase two.
We also expect to see our outcomes for patients treated with our alloy manufacturing process.
Our R&D showcase will also feature updated data from our <unk> program. The only such allogeneic cell therapy program to have established proof of concept.
The events, we plan to share longer term data from our single dose I looked at the one five in the treatment of patients with relapsed or refractory multiple myeloma.
Yellow 71, five program, that's increasingly exciting as we recognize the growing unmet need from the CMA direct to cell therapy, and the transformational opportunity that allo car T may play in addressing the need for treatment in these patients.
We recognize that the myeloma market is dynamic underneath our multiple innovative approaches will be required to further advance patient care.
Is exactly we'll have to transpire for the past 20 years in myeloma.
Unless the profile, we are targeting with our 71 five appears differentiated among the competition and having the potential to provide patients and immediate off the shelf option with one time goes forward.
Based upon physician interest in this profile and the clinical outcomes that we have previously shared we believe that Alison alongside could play a very important role in the myeloma treatment paradigm.
Over the next few days and weeks, we expect a lot of discussion around the potential for innovation in blood cancers.
At <unk>, we believe we now have line of sight, let's just potential innovation, but two potential products.
We look forward to continuing to execute on this mission and sharing an update with you on November 29.
I will now turn the call over to Greg.
Thank you Rafael and good afternoon.
In my formal remarks, I'd like to focus on a brief update on activities outside of the United States starting first in China.
But also with CEO , Dr <unk> and his team in Shanghai.
Does this partnership that will allow us the opportunity to extend the reach of our car Ts and to China, and we look forward to supporting allergy and overland as they begin to manufacture our car T cells.
Rightfully so our focus today has been on CD 19, and Allo 500, <unk> a program that we advanced with the support of Servier under our license and collaboration agreement.
We've obtained rights to Allo 501, and other CD 19 candidates in the U S from Serbia, while Servier had retained ex U S rights.
In September Serbia informed us that they would no longer seek to commercialize our 500 <unk> or other CD 19 products outside of the United States.
We are pleased to have obtained the right to opt in to ex us rights, which we are carefully evaluating.
U S commercial rights are unchanged.
Moving to our third quarter financials, we ended the quarter with $637 million in cash cash equivalents and investments.
Our Q3, 2022 research and development expenses was $63 6 million, which includes $11 million of noncash stock based compensation expense.
General and administrative expenses were $18 $9 million for the third quarter of 2022, which includes $10 1 million of noncash stock based compensation expense.
Our net loss for the third quarter of 2022 was $83 1 million or <unk> 58 per share, including noncash stock based compensation expense of $21 $1 million.
We are revising our 2022 guidance for spending down modestly we now expect GAAP operating expenses to be slightly below the low end of our prior range of $360 million and $390 million. This includes estimated noncash stock based compensation expense of 90 million to one.
$100 million and excludes any impact from potential business development activities cash burn for 2022 is now expected to be less than $250 million.
With that we will now open the call to your questions.
Thank you.
As a reminder to ask a question I need to press Star one one on your telephone.
Also ask that you please limit yourself to one question standby as we compile the Q&A roster.
One moment please file first question.
Our first question will come from <unk> Richter of Goldman Sachs. Your line is open.
Hi, Andrew.
Andrew first of all thanks for taking my question.
David maybe could you speak a little bit more on the process that will be necessary as we transition between our current manufacturing and alloy manufacturing.
In particular, what your plans are to tariff.
Thanks, so much.
Okay Andrea.
David Chang So let me take on that question.
I think what Youre asking is in reference to what we have said that will be used in a pivotal study the alloy process.
This is something that we took a lot of time to come to that.
This decision and Thats based on a lot of data review and alloy process has been used in number of patients that we have treated.
Our clinical programs. So the next step which is all in part to the question about is what are we doing with alloy process.
Doing exactly what you're saying.
Trying to bring that manufacturing process to our own manufacturing facility at <unk> and that involves the steps that we are very familiar with.
Validating few equipments and deploying our manufacturing personnel from different process that we were using to alloy process. So we expect that to occur in a relatively short period of time.
Thank you.
One moment please for our next question.
Our next question will come from Michael <unk>.
Of Jefferies. Your line is open.
Hey, David and team. Thanks for your question.
With regards to multiple myeloma update can you help us.
Set some expectations from the standpoint of the bar out there both from a CR rate standpoint, and PFS and overall response rates, which we can all look at just the tables in the labels.
And the concept that they were perhaps treating different types of patients first what you will show and what is the bar to say that this is a good drug and and we should be going forward versus what we had out there. Thank you.
Mike.
So yes, 71, five will be a part of R&D showcase and we will provide update on the 71 five.
And as we've been talking about the big component of the 71 five update is the longer term follow up.
On the patients that we essentially have reported the initial findings back end.
As 2021, so following those patients both from the durability as well as other sort of response parameters that will be key.
So the important question that you're asking about what is the bar.
As we've been saying the.
Multiple myeloma field is evolving pretty quickly.
This is also where the treatment paradigm has really changed significantly over the last.
A couple of decades from.
Limited treatment to something that is a combination as well as sequential so what we are looking here is really differentiation from other treatment.
Car T. Currently to Apollo this product is approved but we are coming as an allogeneic car T product and there are many benefits that we can talk about why the allogeneic therapy as needed. This is also a space where bi specifics that being approved but there are different attributes that we can emphasize.
<unk> about why allogeneic car T off the shelf therapy is needed. So this is really something that we are in constant discussion with the investigators and others, but let me also emphasize no matter how great the results there.
Treatment has to be available to the patients in need and that is one of the key differentiation and with that let me ask <unk> to comment about.
Some of the detailed questions response rate and all of that now, which always evolves with a small number of patients that that based on which we will be making decisions.
It's Michael.
Clearly.
The data we presented at Ash.
Last year was pretty encouraging and he was.
Approaching the numbers of one of the approved products already.
With the ability to treat virtually every patient.
Came into the study and that was very much valued by physicians, particularly.
The lack of need of given bridging therapy.
<unk> plus rating.
It's a 45% range at the time the durability of response with over eight months and now we will have at R&D day.
The year of follow up with additional few basins.
You did.
Given leave for depletion with which we are honing into.
So.
Yeah.
Data is becoming.
Pretty attractive for us in terms of.
Being very close to autologous therapy, clearly correctly has the numbers that are.
Our superior, but we have patients that really can't wait that come into this study with our <unk> therapy within days of entry and we get repeatedly.
Investigators are telling us that this is something that they would definitely use on wood.
We would like for us to move forward with clinical are going to have to.
Nickel trials so.
I think there is a space are seeing any disease for multiple products and definitely for another genetic til therapy. There is definitely.
Room for a product like this and we will see the profile evolve with time from the time that we presented last in 2021.
Thank you.
One moment please for our next question.
Our next question will come from Tyler Van Buren.
Colin Your line is open.
Hey, guys. Thanks, very much for the update.
I understand it's a trade secret, but is there anything more you can tell us with respect to what is unique about the actual alloy manufacturing process at a high level.
To be clear when you provide the update on November 29th will you stratify. The CD 19, <unk> be CMA data for patients who received alloy versus those who have not.
Yes. So Tyler you are absolutely right in on things that are related to manufacturing. There are a lot of trade secrets that we will not be able to talk about but in the R&D showcase we will give some insights into why we landed wood.
Outlook process as we.
Launching the pivotal <unk> study so stay tuned for the R&D showcase.
Thank you.
Please go to our next question.
The next question will come from Husky.
Okay.
Glen rewarding twist your line is open.
Hi, guys. Thanks for taking my question.
Wrap up.
You just mentioned that in the Universal update coming up you indicated that that will be a few more patients I was wondering if you could help us out and maybe indicate exactly what.
And more patients any sense would be helpful and I guess related.
Since the October 2021 data cut from the.
Two phase one data presented at Ash.
Would you enroll and dose more patients.
Is one portion of that study as well thanks guys.
Let me take that one it's Eric we're not going to get into exactly how many additional patients we've treated but of course at the at the conference to showcase on the 29th we'll give you a full and comprehensive update of where we are with the program and certainly we look forward to your participation in that event as we've talked.
Our focus for both of these programs has been on following up patients longer term that were treated.
Some months ago, and getting a better sense of how they're performing over time. So I think that will be the focus with the phase one program in particular, we've really been eye towards starting to phase two for 2019 as opposed to treating a lot more patients.
Thank you one moment please for us.
The next question.
Yeah.
Our next question will come from Raju Prasad of William Blair. Your line is open.
Thanks for taking the question.
Just wanted to get a sense of the expand trial. So it sounds like it's.
A dose of Allo 501, with flu side versus <unk> 47, with PFS as the end point. So is it really just to show.
Non inferiority here between the two arms or do you want to see increased expansion I'm, just kind of curious to know.
The measures that we're going to be considered.
From that trial.
Yes. Thanks for the question. This is Rafael yes, Youre right on the design it's really.
To isolate the contribution of $6 seven both to safety and efficacy.
And as such everybody gets <unk> at the same cell dose to offer too with their tooling for depletion regimens.
In terms of the design.
Have abundant data with regards to the dose response and ability to leave the fleet.
Real data. This is not a month model data showing a dose response and also correlations between concentrations of allo 607, and outcomes clinical outcomes, which obviously leads us to believe there's a six or seven eighth require and it's one of the critical components something for depletion.
And without.
Adequate links of depletion there support expansion and clinical outcomes are suboptimal.
Therefore, we have a lot of conviction that this is going to be a positive trial.
The endpoint is actually.
<unk> clinical endpoint will be a progression free survival in the sample size will be 70 patients. So that gives you a sense of.
The fact that we are looking for a difference that is meaningful because we really believe that the addition of six or seven is going to be critical to achieve.
Really meaningful outcomes.
Okay. Thanks.
Please go to the next question.
Our next question will come from Reni Benjamin of JMP Securities. Your line is open.
Okay.
Hey, good afternoon, guys. Thanks for taking the questions and look forward to November 29.
Can you talk a little bit it seems like in the.
It's very small study you're going to be treating patients with greater than two lines of therapy can you just remind us what was the average lines of therapy in the earlier studies and did you guys see any sort of worsening bettering, our kind of equivalent or our cross different exposures to therapy, and just kind of related to that or any of the patients.
<unk>.
Secondarily.
Any of the study.
Okay.
This is Raphael yeah. These patients were heavily pre treated.
Where.
Most of them had received.
About three to four lines of therapy.
We looked at a number of predictor lines of therapy with one of them chromosomal abnormalities, such as double had triple heads.
And other parameters, such as LDH et cetera.
We actually saw efficacy there was relatively comparable across multiple parameters certainly lines of therapy being found out that's one of the parameters that would discriminate good responders versus poor responders.
So.
In that regard.
No.
Critical criteria is that they are refractory to two lines or more.
Thank you one moment. Please next question.
Our next question will come from Mark Breidenbach Oppenheimer. Your line is open.
Hey, good afternoon guys.
So on the last earnings call.
Seem to remember you were talking about exploring pivotal trial options in multiple myeloma by year end I guess I'm wondering if that's still the case.
And also can you remind us if the universal is excluding patients with.
Any prior.
<unk> directed therapies, including <unk>.
And some of the Bcm ACD three five specifics or just that the <unk> car Ts. Thanks for taking my question.
Mark Let me this is Eric let me take the first part of that question and then I'm going to turn it over to Raphael to answer your Universal question in terms of our communications around the CMA program I think we've been fairly consistent in saying that we will be providing next steps for the program at year end not guaranteeing what those next steps could be.
And of course, that's something we intend to follow through on our showcase on the 29th So again, please join us at that event and Youll get our latest thinking on what's next for <unk> program.
Yes with regards to the CMA directed therapy those were allowed in universal not patients that had received a cell therapy with patients that have received.
Antibody therapy.
And.
No.
In general we saw no difference between those that have received the haddon.
The numbers are small.
Thank you.
One moment please for the next question.
The next question will come from John Newman of Canaccord Genuity. Your line is open.
Hi, guys. Thank you for taking my question.
I'm just curious.
Regarding the alloy process.
Could talk a little bit about how you plan on.
Incorporating that product manufactured at <unk> one.
After the process is approved for software is one.
Into the pivotal phase two and just curious as to how youre thinking about.
Comparability there with the.
The <unk> product.
Being manufactured using the alloy process at the moment. Thanks.
Yes, John This is David let me take that question alloy process. Obviously that is the process that we have announced as the product.
That will support the pivotal study.
In terms of some of the questions, which are growing a lot into the technical details. Let me just say that in concert demonstrating the comparability.
We have done that already as we were testing different processes.
Across different programs. So we do have confidence in our technical operations team about the key things that one has to do to demonstrate the analytic comparability. So those things we have.
Experienced system and we will apply the knowledge that we have as we have to show the analytic comparability and will provide some additional.
Details in.
R&D showcase about why we chose the our loan process.
And also I realize that we are talking about RMB showcase in a lot of our answers and let me just talk a little bit about our decision to have the R&D showcase which is something that we have thought very carefully.
Ultimate drive there for us to go with a showcase is when we think about the topics that we have to cover.
Based on all the inputs from.
Yeah.
Our analysts as well as some of the investors, it's really trying to really recap the history of <unk>.
<unk> 501, a development and why we landed with our final study design as well as the dose and the LIFO depletion regimen. This is really a complex issue and we felt that the best way to provide the clarity and not confused.
The presentation was.
More.
Setting that has a little more time and also provide context. So I think this was really the key driver for us to act as the R&D showcase to provide important updates on both CD 19 and be CMA programs. So.
It's coming up I mean November 29th is only about less than about four weeks to array and stay tuned daily.
Thank you.
One moment please for the next question.
The next question will come from Michael Schmidt Guggenheim Partners. Your line is open.
Hey, guys. Thanks for taking my question.
I thought it was interesting to see that you decided to move forward with a one time dosing.
Regimen for offer two after.
Looking at consolidation and re dosing a lot of the other allele.
I think companies are still looking at Reed.
And I thought it was interesting I was just wondering.
If that is that a onetime dosing.
Concept is something you think.
Applies to other programs as well for example, 71 five or if that is something that's unique to 2019.
Okay.
Yes, Michael very important question.
SDN and that the key driver for choosing the single dose is looking.
Really data driven decision.
We have investigated both consolidation as well as single dose.
And when we compare the data.
Felt the single dose is as good as consolidation and certainly it comes with the clarity.
What's the treatment as well as convenience completing the treatment with a single dose and when we sort of put all those things together I mean that the conclusions that we draw it came very clear and ISR August way that we will move forward. The second question about is this something that we will do.
Across all different program.
We will continue to make data driven decisions and we will investigate and make the right decision on the future programs.
Thank you.
And one moment for the next question.
Our next question will come from.
Is this.
RBC capital markets. Your line is open.
Oh, great. Thanks, so much for taking my question, maybe one on the randomized trial for <unk> can you just talk about why the FDA asked you to use PFS primary endpoint and response rate secondary endpoint and not the opposite.
We estimate at asking for statistical superiority in PFS at some risk of the trial and also will make the trial much longer but again, we would love to hear your thoughts. Thanks, so much.
Hello. This is Dave Chang Great question and I think this is a more of a technical things.
Response there.
Bear with me.
Single arm study FDA always has to use the response rate.
And duration of response.
When it goes to a randomized study.
There certainly has been many randomized study the best way to power the study as well as look at the both components of overall response rate as well as duration of response is time dependent endpoint of progression free survival. So sorry that my response to some of our technical.
But this is the most efficient way to really look at the contribution of $6 seven to the standard suicide regimen, which is the primary objective of that randomized expand study.
Thank you.
And one moment for the next question.
Our next question will come from Jason <unk> of Bank of America. Your line is open.
Alright, guys. Thanks for taking my question I just wanted to clarify on that last question just to be clear David is there.
Unexpected regulatory bar for.
This expanded study.
Port Registrational moving forward. If you can just maybe going to get more specific on that point that would be really helpful.
So Rafael.
How do you want to take that.
Sure.
It is the study powered for superiority in PFS.
Which are in cell therapy, because it is really.
<unk> that drive.
Long term.
Responses.
There's not a whole lot of difference between durability of response.
PFS.
So the study is powered for superiority.
The bar is set based on the sample size.
There's also a question of safety as well which is important.
But there really isn't.
As I've said bar, although that one that.
That is.
Detectable by the sample size.
Relatively small and you can imagine that.
Based on that it is a reasonable difference that we're looking for.
Thank you.
One moment please for our next question.
The next question will come from Caltech Patel of B Riley Your line is open.
Yeah, Hey, good afternoon, thanks for taking the question.
Maybe one for Allo 605.
Can you comment on how the enrollment is going for that trial.
As the interest.
As the interest in maybe ticking up given the manufacturing constraints of approved <unk>.
Great therapies.
And then do you intend on providing any updates from this study at the R&D event.
So all said hey, it's Eric Thanks for that question.
605, yes, as you know we're in a dose ranging study a phase one dose escalation study and that continues.
We've talked about having the R&D showcase focus on the 705 products. So.
You won't be seeing any data from 605 towards the end of this year.
And we will update you on that program as it goes forward as you can imagine that there's a fair bit of investor interest and investigator interest as well.
All of our CMA programs.
Thank you.
Please for the next question.
Our next question will come from David dye.
<unk> Your line is open.
Okay, great. Thanks for taking my questions.
Quick question on <unk>.
Because their trial.
On the question on the single dose regimen may be.
More about actually trevino for patients in.
In the trial and would that be operating two essentially later in the trial that you actually could be a VITAS patients and if so what would be the criteria for re dosing.
Yeah.
Yes, David This is Dave Chang.
Same question, we frequently get and when I think about the development of autologous car T that is something that we investigate it.
From the phase II clinical trial perspective.
Keep in mind the objective of the phase two study is demonstrate.
In effect that the single dose.
And when somebody.
Requires a re dosing, which usually will be the case when there is no benefit or somebody after.
Yes.
Having responded progresses.
Yes.
In those patients when that happens any peso forget we those will be censored from the efficacy analysis. So.
Going forward with a pivotal study dosing is not part of the study plan.
<unk>.
Regards to the primary objective of the study, but when there is an opportunity we will definitely investigate the re dosing as an exploratory analysis.
Thank you.
One moment for the next question.
Our next question will come from Jack Helen of Baird. Your line is open.
Thank you so much and congratulations to the team on the progress this quarter I.
I wanted to touch on the <unk> relationship and I was hoping you could provide an update as to where things sit there when we might hear more news and then as it relates to the Alpha to study how quickly do you think you'd get sites initiated in Europe or would you do that prior to settling the February relationship as well.
Thank you so much hey, Jack would you mind repeating initial part of the question there was a little bit of a glitch we didn't clearly here at the beginning part of your question.
Yes, sorry about that I was asking about the <unk> relationship I was hoping to understand when we make it an update as it relates to the European rights for 2019, and how quickly you could start to initiate studies in Europe .
As well.
Okay. Thank you Jack for that question, Yes on Serbia, as you know and as we disclosed back in September .
Made the decision to no longer participate in the development of the C 19, essentially allowing us.
It's outside the U S should we choose we have the option.
To take over the <unk>.
Global rights to <unk> 19, right now as you know under our collaboration with Servier, We just at the United States right. So that's an option that we're going to consider quite carefully.
Outcome, if we choose to with some some extra costs, we would be paying for 100% of the program as opposed to our current rate 60%.
But certainly the potential to market. The product globally is also an attractive opportunity in terms of what we're doing right now with the CD 19 Phase III study were already planned through the collaboration with Servier to enroll patients in Europe . So our plan was always to conduct a global study that would report.
We will provide for global registration should it prove positive.
Yeah.
Thank you.
Okay. Thank.
Thank you.
One moment for the next question.
Our next question will come from Brian Cheng.
P. Morgan your line is open.
And David and Tim Thanks for taking my question.
Just on the alloy process.
The outlet process only deploy for 2019.
And CD 19, if alloy or is there an alloy quick one also deploy in USB CMA program as well.
Would you be able to give us some color on how long alloy has been in place. Thank you.
Brian This is David So I'll take the question about the alloy, which I think we're getting into a third or fourth time in this call. So alloy process is one of the processes that we've been testing across our programs and it has definitely been used in more than one.
More than 501 program so.
It definitely I mean being able to generate data from across the program is helping our decision making and.
In the R&D showcase.
We'll.
Provide sort of thought process as well as supporting data about how we came to the plan of using the alloy for the pivotal study.
Thank you.
One moment please for the next question.
The next question will come from Robert Burns of H C. Wainwright Your line is open.
Hi, guys. Thanks for taking my question just one for me if I May you know I know you terminated.
The collaboration once frameworks to evaluate <unk> five in combination of Amerigas I was just curious if during the R&D day.
Gaining greater clarity as to the reasoning and some of the Pharmacodynamic and pharmacokinetic measures from that evaluation. Thank you.
Rob This is Derek thanks for the question.
Important consideration that we were trying to answer whether or not a gamma <unk> inhibitor added to the benefit of our 71 five in our hands.
And yes, as you know we discontinued that arm of the study.
Because we didn't see meaningful benefit from the addition of account separately whenever it was 715 and we will certainly try and make that data available to you in the future I'm not sure that the R&D showcases the right form to do so honestly, we already have a lot of things that we want to talk about and this trial arm is again not something we're going to be moving.
With the development going forward.
Thank you.
One moment for our next question.
The next question will come from Dane Leone, Raymond James Your line is open.
Hi, Thank you for taking the questions.
Look forward to the R&D showcase.
Can you, maybe just clarify what steps.
They'll need to happen internally too.
Get the pivotal Allo 501 study is up and going both the study itself and then the expand study as well.
Just kind of blocking and tackling type stuff, what still needs to be done there. Thank you.
Okay.
This is Dave Chang so in terms of alloy process what's needed.
<unk> has already done we have products that I've made in the alloy process. They will be used as suites in more patients into the pivotal study. So there is nothing that is on the credit cost stack in problems.
Enrolling patients to the pivotal study.
<unk>.
Underlying your question is what would it take for us to bring to our process to our manufacturing facility and this is a process in terms of.
Qualified machines as well as utilizing the cell manufacturing.
Operators. These are the people who actually manufactured the south at <unk>.
Making the products using the alloy. So this is something that we are very familiar about how to go about doing this and work is already ongoing.
Okay.
Thank you.
One moment please for our next question.
Our next question will come from Ben Burnett of Stifel. Your line is open Sir.
Alright, Thank you very much I.
I had a question on your multiple myeloma strategy I guess do you do you think there's any value or is there any interest in trying to elucidate the efficacy profile of 701, five or even the turbo car.
<unk> experienced patients.
In the event it.
<unk> be some mccarty ends up moving upstream.
I mean this is rafael.
<unk> is an interesting question.
We know that a lot of patients.
Progress soon after the CMA directed therapy still RMB SMA positive unlike.
Many patients in the 2019 space.
Another <unk> <unk>.
<unk> directed therapy may be effective or not.
It's definitely a question of clinical interest.
I think it's premature for us to really tackle that question with.
Our 605, where Eric said in dose escalation.
<unk> nave patients, but it's a question that we may consider in the future.
Okay.
Thank you.
That concludes our question and answer session I would like to turn the conference back over to management for any additional comments.
Okay. Thank you.
First of all thanks for joining us today and thank you we are in Mexico, very insightful questions and we look forward to seeing many of you in person I hope at our R&D showcase later this month.
You may now disconnect.
Thank you.
Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program and you may now log off and disconnect.
Have a pleasant day.
The conference will begin shortly to raise your hand during Q&A you can dial one one.
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