Q3 2023 Allogene Therapeutics Inc Earnings Call
Hello, and thank you for standing by welcome to the Allergan Therapeutics third quarter 2023 conference call.
Please be aware that today's conference is being recorded I would now like to turn the call over to Christine Casiano, Chief Corporate Affairs and brand strategy Officer Ms. Kathy Yano. Please go ahead.
Thank you operator, and welcome to our call today after market close <unk> issued a press release that provides a business update and financial results for the third quarter of 2023.
Press release and today's webcast are both available on our website.
Following our prepared remarks, we will host a Q&A session. We ask you to limit your questions to one per person and then we'll keep this call to an hour and do our best to get to as many questions as possible.
Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Zachary, Robert Executive Vice President of research and development and Chief Medical Officer, and Geoff Parker, Our Chief Financial Officer during.
During today's call, we will be making certain forward looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trial data presentation regulatory filings future research and development effort manufacturing capability.
<unk> efficacy of our product candidates and 2023 financial guidance among other things.
These forward looking statements are based on current information assumptions and expectations that are subject to change a description of potential risks can be found in our earnings press release, and our latest SEC disclosure documents you are cautioned not to place undue reliance on these forward looking statements analogy disclaims any obligation to update these statements I will now.
Turn the call over to David.
Thank you Christine and welcome to all listening to our call today.
The last few weeks have been exciting in the field of cell therapy.
And uptake of Apollo's car T cells and the release of abstract this morning for the upcoming American Society of Hematology meeting.
Those things are potential of car T therapy.
It is clear that we are just at the beginning of what's possible for patients with this modality.
While indications outside of oncology have been the focus of the field as of late something we are keeping a keen eye on our focus I'll call today when car T in oncology.
Throughout the decades cancer therapies have come in great waves.
Toxic chemotherapy with the first wave.
Most of the 20th century, that's fundamental discoveries in blood cancers gateways to increasingly sophisticated combination therapies that could be used against solid tumors.
The second wave.
Antibody.
Greg Route that EBIT to date continues to fuel innovation with follow on technology platforms.
Our view that this way also include antibody drug conjugates plaque specific antibody and bi specific T cell engagements.
The third way has been a more gradual the American targeted therapies today.
Cerro.
Pathways that governs the behavior of ourselves have been delineated paving a way to precisely answer Vic disease.
We are now at the beginning of our fourth great way.
For engineered cell therapy.
The enablement of synthetic biology to harness the power of EMEA itself is not feasible.
Joe of knowledge.
Pathways and technological breakthroughs in gene editing and cell.
Engineered.
But this fourth grade Wade can only be fully unlocked with industry mix car T accessible to all eligible patients.
This was an important positive during recent discussions at both the future SMA posted by that as well as at the American Society for transplantation and cellular therapy sponsored accelerate forum on apparel moderated by Dr. Peter marks director of center for Biologics evaluation and research.
<unk> and Doctor Marcello, that's gaining at the center for international Blood and marrow transplant research.
At <unk>, we believe that the key to unlocking that potential is allogeneic car T and if you will creating the nonrecourse futsal therapy.
For those who love video games. The Konami code was originally a simplest sequencer buttons that would give you a full set of power apps to make testing easier for developers.
Modern day concept that this quarter, it's no longer just about making a game easier.
It is now unlocking hidden expert months, enabling the expansion of the game.
And that is exactly how we're thinking about our platform.
It is creating the Konami code for allogeneic cell therapy.
That can be applied that just seems the industry's first potentially pivotal trial of an allogeneic car T product, but in other hotter modes, such as earlier lines file.
Tumors non oncology indications.
And next generation products.
And we look forward to the months ahead, where certain scientific aspects of this call will come to light unlocking new opportunities and broadening patient access to report great way.
Before I turn the call over to Zack to give a brief overview of what will be presented at the society for immunotherapy of cancer and what to expect that as our <unk>.
Also like to take the opportunity to officially welcome newest member of our leadership team.
First our quarterly call Geoff Parker.
And this especially challenging market Jeff's extensive experienced in biotechnology across all aspects of finance and business development strategy will be a tremendous value to allergy and as we advance our critical pipeline assets and explore new opportunities I am confident he will be in.
Now to our success as we navigate the next chapter.
I'd now like to turn the call over to Zack.
Thank you David while we focus on execution of our potentially pivotal altitude global trial with Allo 501 in relapsed refractory large b cell lymphoma, or 2023 data readouts have been designed to answer foundational questions that support the viability of an allogeneic car T product.
Over the summer at the American Society of clinical oncology annual meeting the European Hematology Association Congress and the International conference on malignant lymphoma in Lugano, we shared the long term durability data from our phase one trials that answered one of the most important questions in the field can an off the shelf CD 19 car T.
Product candidates demonstrate durability comparable to an autologous car T therapy, and large b cell lymphoma.
In car T. The best surrogate for duration of response is a six month CR rate.
Based on the data from patients who received our phase II regimen. During the phase one trial, we have now shown that our six month CR rate is comparable to what has been reported in the pivotal studies of Kim Ryan, Yes, <unk> and <unk>.
And all of these presentations are safety analysis included all 33 car T naive L Bcl patients who received alloy product.
Treatment was generally well tolerated with no cases of grade three or higher Crs can no cases of ICANN or gvhd.
Cytopenia as and infections were manageable and comparable to the experience with autologous car T therapies in patients with relapsed refractory <unk> with <unk>.
Show of patients' neutrophil lymphocyte counts beginning to recover within the first month of infusion and achieving baseline levels with kinetic similar to autologous cell therapies.
Comparability of immune reconstitution in patients receiving investigational allo 501 to those who receive autologous products yielded important insights into our comparable infection rate.
But we wanted to dig deeper and address outstanding questions posed as it relates to the safety profile of our 647, our investigational anti CD 52 monoclonal antibody when used in conjunction with standard low dose <unk> Si.
That will be the focus at this year's annual meeting of the American Society of Hematology.
At Ash, we will have a comprehensive safety review of all 85 patients treated in the phase one alpha and Alpha two studies in <unk> and Follicular lymphoma to characterize the overall safety profile. When Allo 647 is added to standard for depletion.
Because of the risk of rejection by a patient's immune system, creating the necessary window of persistence for an allogeneic car T likely requires an enhanced approach to input depletion.
Current approaches have been used in other allergen eight clinical trials, including high dose chemotherapy that might be associated with severe toxicity.
The results of our trials reinforce our belief that in the <unk> patient population are unique and proprietary lymphoid depletion regimen can set the right conditions for our cell products to induce deep and durable remissions, while keeping the safety in line with approved autologous car T therapies.
Our nuanced understanding of loan for depletion based on the breadth of our trials has fueled our early stage research.
This weekend, we look forward to poster presentations at the society for immunotherapy of cancer annual meeting highlighting our next generation cloak and dagger technologies designed to help enhance and grafman expansion and the persistence of Allo car T cells.
And <unk>, while we continue to be pleased with the overall profile demonstrated in our trials, we fully recognize the evolving practice patterns with autologous car T therapies moving into second line.
Our CD 19 program strategy contemplated this challenge and we are attacking us on two fronts.
The first strategy is in the phase III clinical trial execution, and we focused on increasing the global footprint of our trials.
<unk> is now open to enrollment in the U S, Canada, Europe, and Australia for Phase two expand trial designed to demonstrate the superiority of an allo $6 seven containing lymphoid depletion regimen over a regimen of <unk> alone.
Turning to enrollment in the United States and Europe.
The second strategy lives in the design of an earlier line trial and how we ultimately think this market will evolve.
We are all very excited about our intended approach when all aspects are locked we look forward to sharing with you more about this trial and believe it will address many questions you have about our overall approach to treating <unk>.
Lastly, I'd be remiss, if I didn't talk a bit about our phase <unk> trial with Allo 316.
We do not take lightly the responsibility we carry to demonstrate the potential of an allo car T. In solid tumors as such we have taken a very deliberate approach and are proud of the way in which we are conducting this trial we.
We've continued to gain incredible insights for car T. In solid tumors that we hope will advance this trial into potentially pivotal phase and even more importantly provide another option for patients with advanced or metastatic renal cell carcinoma.
The importance of such data to our investors and the medical community at large cannot be understated. So we will now target. Our next update for an academic forum in early 2024, I will now turn the call over to Jeff.
Thank you Zack and good afternoon, everyone. In my first few weeks as part of Allergan I've had the chance to speak now with a handful of our covering analysts and I look forward to getting to know all of our analysts and investors over the next few months and years to come.
It made early conversations the number one question I get is why did I join allergy.
For me there is a simple answer.
I've been in this industry for over 30 years and I firmly believe that this is one of the best management teams.
Ever encountered.
As a quick note regarding my background I worked at Goldman Sachs from 1986 to 2009 in investment banking ultimately running the West Coast Health care banking practice for the last 10 years of my tenure at the firm.
Following my time at Goldman Sachs in 2009, I decided to move to the company side to serve as the CFO as well as to serve as a board member with a number of health care companies, which I have now done for the last 14 years.
Fast forward to this past summer when I received a call from Dave I was immediately intrigued by the opportunity to be a part of this team and to play a role in fulfilling the promise of how allogeneic car T products could address the access gap to this important modality.
Let me now turn to another of allergy and strength our balance sheet in a careful way in which we manage our resources.
We ended the third quarter with $497 7 million in cash cash equivalents and investments.
As noted on our last quarterly call based on current assumptions, we expect our cash runway to fund operations into the second half of 2025.
In the third quarter of 2023, our research and development expenses were $46 million.
Which includes $6 7 million of noncash stock based compensation expense.
General and administrative expenses were $17 million for the third quarter of 2023, which includes $8 6 million of noncash stock based compensation expense.
Our net loss for the third quarter of 2023 was $61 3 million or.
Or <unk> 37 per share, including noncash stock based compensation expense of $15 4 million.
We continue to expect a decrease in cash cash equivalents and investments of approximately $230 million for the full year 2023, and full year 2023, GAAP operating expenses to be approximately $340 million.
Which includes estimated noncash stock based compensation expense.
Of approximately $80 million this guidance excludes any impact from potential business development activities.
With that we will now open the call for your questions.
Okay.
Thank you as a reminder to ask a question at this time. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, we ask that you. Please limit yourself to one question one moment.
Compiler Q&A roster.
And our first question is going to come from the line of Michael Yee with Jefferies. Your line is open. Please go ahead.
Great. Thanks, Good afternoon, guys. Thanks for the question.
I just wanted to ask on the ongoing progress of the potential pivotal trial. You said you have expanded into different countries can you just give us a sense of I appreciate it's still early.
Sort of a blocking and tackling.
The expectation for geographic mix.
And.
The progress you're making in terms of the types of patients. You think you are getting and whether there's any challenges with other competitors or other types of car T.
Which are things that are weighing on people's minds.
Then as a follow up you did mention that <unk> is important and I heard that can you just.
Clarify why the data would be 2020 for not 2023, maybe you could just shed some light on that thank you.
Okay.
Please remain on the line your conference will begin shortly.
Again, ladies and gentlemen, please stay on the line we will begin shortly.
Operator, you still there.
I am Mr. Yu, just give them a moment, they're having technical issues and they will be back with us.
Okay. Thank you Youre welcome.
Hello, Mr. Ian could you tell me a favor CERN go head and state. Your question again, they are reconnected now.
I remember the question, Jeff just behind Michael. Thank you, so much and apologies for the technical glitch. There. So I don't know how much you heard Michael So I'll just start over from the beginning.
So regarding the first question around altitude enrollment.
The potentially pivotal programs with the <unk> 19.
We're really excited about the progress we've made on the regulatory front.
And our we have approval in multiple geographies for both programs and we are in rolling out the Q and U S, Canada, Europe, and Australia and expand.
In our U S and in Europe as far as the patient mix that we anticipate having yet we're still bringing in patients.
From the U S and so we don't exactly know how this is all going to shake out in the end, but it will be a nice mix with a significant fraction coming from U S.
And then.
I think probably a large number coming from ex U S as well.
And then the types of patients that we are getting it done very much consistent with the patients that we have set out suited to enroll based on the ongoing criteria again, we're really.
Focused on.
Enrolling patients who would have been very similar to those that were written that were enrolled in the in the autologous pivotal studies from a few years back.
For the second question on 31, six so as far as the timing of the data update.
We were sort of always planning towards the end of this year beginning of next year and as we mentioned in the prepared remarks.
We are just really keen to make sure that we are.
In executing this study well and then also updating with the data.
And taking that all very very seriously and not rushing take so we don't expect that the delay will be.
Angela that data and we just want to make sure that it can.
It meets everybody's expectations.
Hopefully your assessment is correct.
Yeah, all good thank you.
Operator, we have the next question.
Our next question is going to come from the line of Celgene Richter with Goldman Sachs. Your line is open. Please go ahead.
Hey, this is an omega on for Xiaomi and thank you for taking our question could you provide an update on.
The progress of enrollment in the traverse study have there been any headwinds there and then just a second one on the coking and <unk> our technology I guess, what other programs are used in king to incorporate the technology in and with multiple myeloma via possible direction. There given the profile to date. Thank you.
Thanks, very much given back so as far as the traverse enrollment goes I will say that the enthusiasm.
That we've been communicating all year since the announcement of the data at ACR earlier in 2023 has very much persisted and in fact, we are continuing to get incoming interest from sites that are participating in the trial actively so I would say that as far as as the level of interest audits.
It's really quite impressive.
That's really coming down to that efficacy that we show a backend and ECR reminding everybody that.
That the options for these patients are very slim and the profile that we showed you in April which was pretty encouraging to pay the lease.
On the second question around Cloak-and-dagger.
So the specifics around.
How which which card target we choose to pair with that technology.
Youre absolutely right, we can do that with either 2019 or V CNA and Youre right that the.
The bcm a fee.
Field is evolving continually involve any just a preliminary look at the data from accurately does look encouraging for patients perspective.
The and internally we have data to show that we compare our data technology, either CD 19 or V. CMA. So we look forward to sort of sharing more specifics as far as next clinical candidate.
In the coming months, but the data that you show us at these paired with the CD 19. So that is a very nice proof of concept for what we can do with the data.
Sure.
Thank you and one moment for our next question.
Our next question is going to come from the line of Tyler Van Buren with TD Cowen. Your line is open. Please go ahead.
Hey, guys. Thanks, very much for the update can.
Can you talk about the ongoing enrollment of the expand trial and in particular would be our own fiber one a only arm and if.
Do you think it will complete enrollment given the lack of six or seven being used.
I guess my question is if enrollment ends up being increasingly challenge, which I believe it should would you aim to go to the FDA by the end of next year with data that you have available at around the same time as the alpha to readout and could that be sufficient.
Thanks, Tyler again back so.
So as far as the enrollment to be in the two arms code.
There is no choice, obviously that best investigators locations can make their lives a randomized trial and so that is how that will unfold in.
And so we don't expect necessarily there'll be a disparity union in the enrollment of the patient pull out of the out of the study because they get randomized one upon the other a patient will be replaced.
On the second part of your question around.
What data and when we go to the FDA.
Your question is very much centered on how we're thinking about it so as the data analysis to begins to mature and we have something.
No tangible to take to the FDA I think I do think that we would go at the same time with what we have from expanded and as a reminder, this study is supported with the data safety monitoring Board, who will also be able to weigh in on the emerging data from that but that is absolutely a part of our strategy.
Thank you and one moment for our next question.
And our next question is going to come from the line of Brian Cheng with J P. Morgan. Your line is open. Please go ahead.
Guys. Thanks for taking my question.
On <unk> 70 won't be needed for you to take the program in a into the pivotal stage can you give us a preview on Huawei team as the bar to gauge the SaaS early next year before dedicating resources to push this program to the next stage. Thank you.
Thanks, Brian.
So what we're looking for I think in this program as it is in the neighborhood of what we have shown already as it pertains to the C 70 positive patients.
Recall on the ECR presentation, we had.
Two groups of patients one when we can see 70 expression was lower unknown and then one that was measurable and that was a range of expression levels within that group and in that CD 70 positive group. We saw a response rate of about 30%. So we think that that is would be a meaningful improvement to our patients.
Currently have an offer in that that includes some of the data. That's been released more recently so we can come in around that Mark we do think there's a path towards a.
Our pivotal program.
Thank you and one moment as we move onto our next question.
And our next question is going to come from the line of Jack Allen with Baird. Your line is open. Please go ahead.
Great. Thanks, so much for taking the question.
Maybe first on expand I was wondering if you can comment on the geographic Buildout there or are you fully satisfied with the footprint in the U S. In a year do you expect to expand new additional territories there.
Then just briefly on the earlier line strategy you made some comments around finalizing that and then hopefully providing some updates do you have any additional comments around timing as it relates to locking in that strategy.
Thanks Jack.
So as far as expand goes we.
We are still making progress there.
We will intend to bring on Australia in the coming weeks. There. So we are still working to expand.
The the footprint, Eric and even within the countries in Europe, where we're still adding sites. So we're still in execution mode for both alpha to them and expand in bringing on new sites to two to grow that footprint to support enrollment.
And then.
The.
The Irvine studies so.
We'll say again, we're not quite ready to share the details there on what we're thinking but suffice it to say we are making good progress internally on on the <unk> study concept and we're pretty excited about.
About.
The the way that this is taking shape in and how it's mirroring the developing.
Practice patterns for diffuse large b cell lymphoma.
We're still on track I think Jed to share details around the time that we've guided to so stay tuned.
Thank you and one moment as we move to our next question.
And our next question is going to come from the line of Kelsey Goodwin with Guggenheim Securities. Your line is open. Please go ahead.
Oh, Hey, good afternoon. Thanks for taking my question I guess first regarding.
Regarding the Bcm a program I guess can you provide any kind of updates there and maybe any learnings from the assessment that you guys have been doing regarding the manufacturing process and then maybe secondly.
Specific to the notch partnership I guess is there any kind of qualitative update you could give or maybe some sort of timing.
As you kind of work with them on Ips C strategy. Thank you.
So thank God feed for the question.
I'll take the first one and then you can take and Daniel paper announced question so as far as the <unk> program goes.
We are still.
Those programs, we're not enrolling patients into these DNA.
Currently we are still.
Sort of examining the manufacturing process, what I, what I can say, obviously I won't go into specifics there but.
We are learning as I think every currency company is that.
There are elements of the manufacturing process that are ripe for optimization and you know I do think that what we are learning.
Across our portfolio in the manufacturing side is that many times, what we learned in loan program can be translated into another so we are sort of overall quite excited about the progress that we're making on understanding that manufacturing within the context of <unk> and our other clinical programs.
So downtown and the second question the anticipated spring last update is our partner in the ICSC area and we didn't working with them.
Now for about four years, they have made a tremendous progress in a differentiating ICSC into the CDK preposterous and subsequently after that.
The branch daily into the CDA T cells.
<unk> is being made and we're working to.
<unk> worked very closely with not in.
To incorporate that technology into what we're doing but given all of the things that we are handling now I think is going to abate as we set stage for a little bit longer.
Thank you and one moment as we move onto our next question.
And our next question is going to come from the line of John Newman with Canaccord Genuity. Your line is open. Please go ahead.
Hi, there and thank you for taking my question.
I just wanted for the alpha to trial.
You're allowing.
Excuse me outpatient treatment.
At the investigator's discretion I'm wondering if you expect a substantial number of patients to be treated this way.
I also have a question on.
The enrollment of the clinical sites for the trial I'm wondering if you've been able to open clinical sites in the EU, Canada, and Australia, where autologous C 19 car Ts are not as widely available.
Our used versus the U S to help with enrollment.
Okay.
Okay.
Thanks, John So.
I'll answer the second question first so you know.
That has long been part of our strategy for enrollment is to expand into.
Geographies countries and indeed clinical sites were autologous product is not as widely used and that can be for many reasons.
Reimbursement related or access related where we're sort of encountering all kinds of different reasons why those patients are not getting access to this life saving therapy. So.
In other cases, it's not.
Having access to a clinical trials, such as our T or expand our reach.
Really is welcomed quite heartily by the by the patient and by the physicians.
And sorry, Jonathan Blake on the first question.
Oh outpatient absolutely. Thank you. Thank you David.
So we are seeing actually.
<unk>.
A fair number of patients being managed fully allocations and that means both.
The lymphoma accretion as well as the car T infusion.
And.
And it's being.
I would say very encouraging so far and many of the centers that have that has met with some success.
In their first few patients continue to have that be their default position of course, if a patient needs to come in for <unk>.
One or more reasons, that's no problem at all patients can be admitted but there seems to be a high level of enthusiasm around managing these patients outpatient and in fact some of the vendors are actually we're having them talk to other centers to try to teach them. How they are managing that so there does seem to be quite a high level of interest to handle that.
Sure.
Thank you and one moment as we move on to our next question.
Our next question is going to come from the line of Cal Patel with B Riley. Your line is open. Please go ahead.
Good afternoon. This is Andy pleasure on for Talbot. Thank you for taking the question one of your Ash abstracts for <unk> the impact of recipient Alloreactive CDA positive T cells.
Allogeneic car T rejection can you. Please elaborate on ways that this could potentially be addressed.
Sure. Good question, so we've noticed.
I think the field is known as Germany. Other allogeneic car T developers have no net debt when you J J and HLA unmatched product from donor into a patient that the risk of Ala rejection is is is there and so I think everybody is crafting new strategies around how to mitigate this hall.
<unk> versus graft response what.
What I think allergy is has got this quite exciting actually is indeed, a robust and targeted selected logo depletion strategy.
The allo six or seven component.
And when used paired with our CD 52 negative car T cells.
That is how we are so far I think rather successfully manage this host versus graft reaction with the abstract is really showing us that this is something that we can further refine go from an L. E strategy, but also we're taking those learnings and folding them into our new product development and looking for what.
Phase two through genetic engineering or other strategies.
<unk> helped to prevent or mitigate that host versus graft and not relying entirely on L. D. However, I would say that just what we've done so far around completion.
And our clinical data will show is we bought we've managed to create a great window of persistence for ourselves, where we can see high levels of expansion and persistence and that corresponds to a durable complete remission. So I think allergies on the right track, but the point of that that abstract is really bad.
There's probably more that we can learn and we're taking that forward into into our R&D product development.
Thank you and one moment as we move on to our next question.
And our next question is going to come from the line of Sami Corwin with William Blair. Your line is open. Please go ahead.
Hi, Thanks for taking my question I noticed in the 10-Q that it was reported that there were some cases at the a.
<unk> and immune effector cell.
Madison Finfet codec info hit those cytosis like syndrome.
Wondering if you guys could elaborate on that a little bit and if you think it's related to the Gagger technology at all and if that changed the guidance for data on the trial.
Thanks, Andy for the question and nice job.
Got it.
With that mouthful of a base of a new entity. So.
But we can get we're thinking about IEC Hs is likely probably a.
April an umbrella term that as described an inflammatory process that is likely see across car T products. In fact, it's been described.
He deemed programs not running programs, but others as well as other solid tumor programs and so I think when we when we see sort of an inflammatory response.
We have begun to call that IAC Hs as opposed to HLA HR Crs Fry, Kansas, sometimes this different description is a little bit more.
More straightforward to us.
So when it comes to the frequent fixed program.
We.
We just want to reiterate just how careful we want to be as we are moving through this dose escalation and so this is really.
I believe probably some of the best solid tumor data that has ever been shown for car T.
Especially for an allo car T and so as we are moving forward, we want to be careful that we mitigate any emerging toxicity.
And so that when we get to the expansion cohorts, we have a good sense of what to expect.
Thank you and one moment as we move onto our next question.
And our next question is going to come from the line of Harte <unk> Singh with Oppenheimer. Your line is open. Please go ahead.
Great. Thank you I just had a couple of questions and thanks, Paul Thanks for all the updates.
My question, a little bit more broad.
One is.
You know just on on five zero, Bonnie you see 19 program.
We would be move off for example, gilead into second line L. B C L.
Over the last year are you seeing sort of changes in those patients that are in third line L. B C. L are there more patients I imagine the patient pool is probably increasing.
But whereas bone marrow transplant relative to that.
Nothing's changed.
As has taught us therapies have moved up.
Yeah early in lines of therapy, and then secondly, just on manufacturing follow up.
You know for your lead program.
Are you technically what would be a commercial material process, meaning that something that you'd be able to file your BLA with or are you sort of still in that clinical material process. Thank you.
Yeah, Hi, guys. This is James let me give that a little bit of a break because you've been answering question ask the question.
Your first question about fiber one eight program and.
The approval of autologous car T in the earlier lines and how that's affecting us.
Sort of thinking in from that client set.
Certainly this is something that we had expected as the car T.
Makes a way incident in early July and we are seeing this book in the CD 19 program as long as.
As announced in today's at Ash abstract a ladder.
Threats coming in multiple myeloma with at the same age targeting cars. So in 501, a obviously studied.
That still is that Theres, a large number of patients who are not getting access to the car T. So that segment is still open for us to tap into up and out the two study.
One of the reasons that we are really.
Trying to move to the earlier line as quickly as possible is too.
Addressed in a disciplined and mental changes in the patient flow that we are witnessing in not asking for a while now and so as to you know, we're certainly expecting that made the changes.
In a multiple myeloma area.
The second question about the menu batch frame. This is something that we have worked on for a while just added our CSI manufacturing study could potentially support a commercial launch the process that we are using is really will be the basis for the commercial launch so the answer to your <unk>.
<unk> is here.
Thank you and one moment as we move on to our next question.
Okay.
And our next question is going to come from the line of Luke ESI with RBC. Your line is open. Please go ahead.
Oh, great. Thanks for taking our questions left is Lisa on for Luka.
Can you remind us of the timeline for one alpha to and expand could read out and if you would have sufficient runway that would align with both of those data readouts.
Thanks.
Yes, so in the back.
We are expecting our first look at the <unk> two data by the end of next year and we expect to have.
Indeed, it's almost every somehow expand data around the same time, so as far as the runway goes I'll, let him speak to it at the highest level. Yes, we do have runway that would extend beyond those two data readouts.
Thank you and I would now like to turn the conference back over to David Chang for any closing remarks.
Yes, thank you for joining us today and your ongoing baked in housing as we create a kohl's or allogeneic car T.
We will continue to do everything possible to validate your belief in our ability to make this a reality completion.
And look forward to sharing you.
Sharing with Uni sparkman advances across our pipeline over the coming months.
Operator, you may now disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
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