Q2 2023 Allogene Therapeutics Inc Earnings Call
Hello, Thank you for standing by and welcome to allergy Therapeutics second quarter 2023 conference calls.
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I would now like to turn the call over to Christine <unk>, Chief Communications Officer discussing Donald Please go ahead.
Thank you operator, and welcome to our call today aftermarket close allergy and issued a press release. It provides a business update and financial results for the second quarter of 2023.
Press release and today's webcast are both available on our website.
And are prepared remarks suitable hosta Q&A session. We ask you to limit your questions to one per person is we will keep this call to an hour and do our best to get to as many questions as possible.
Signing me today or Doctor, David Chang, President and Chief Executive Officer, Doctor Zachary Roberts Executive Vice President of research and development and Chief Medical Officer, and Dr. Eric Schmidt Chief Financial Officer.
During today's call, we will be making certain forward looking statements gave me include statements regarding the success and timing of our ongoing and planned clinical trials data presentation regulatory filings future research and development efforts manufacturing capabilities in 2023 financial guidance among other things.
These forward looking statements are based on current information assumptions and expectations that are subject to change it.
Scripture and a potential risks can be found in our earnings press release and latest Jesse disclosure documents, you're a caution not to play send your reliance on these forward looking statements and allergy and disclaims any obligation to update these statements I'll now turn the call over to David.
Thank you Christine.
Thank you for joining the call today.
During the second quarter, we presented updated please when data on our lead elephant a car to your program targeting C. D 19 for relapse.
Refractivity info ma'am.
We are immensely proud that I'll off the shelf product candidates.
The ability to generate durable complete responses that by all accounts appear to be similar to approve what colors cocky therapies.
This is a significant milestone for the appeal and represents a great opportunity to reflect on the current state up card P, including the advanced ma'am.
Allogeneic officers.
To that end I would like to focus my comments today on the elephant a car P. P O at large.
It will then at Zac to talk specifically about our city 19 program.
Putting reviewing the data presented in June at the.
American Society of clinical oncology.
European Hematology Association and we've got our meetings.
During the Q&A, we will welcome questions on other programs within a pipeline.
First let's talk about the <unk> about therapy.
Add a car to your franchise report, increasing sales and detailed initiatives to address manufacturing constraints.
Some ask if there is a place for an allogeneic product.
Indeed, as one of the early developers about Thomas khaki therapy.
I am proud that this modality has become a commercial success.
Capable of changing the lives of many patients.
On the other hand allergen a car to your product represent.
Mentally different modality with properties that are inherently more attractive than or cocky therapy, and therefore capable a bath be changing and expanding the landscape of car P. Access.
Perhaps the most fundamental difference between the towers therapy, and then our genetic product is at the Walmart represents an individualized procedure.
Can never be manufactured at scale.
A palace car to your therapist move into earlier lies the potential patient population. There is eligible for therapy will undergo dramatic expansion and.
Company is producing therapist at linear scale will be hard pressed to keep up with accelerating demand.
Today in the market for refractory lymphoma in my Lola <unk> that only a fraction of eligible patients can gain access to these revolutionary therapies.
Potentially left out of the mix patients who cannot rarely secure manufacturing slash.
Patience with rapidly progressing disease or patients who cannot undergo successful collection of cells.
Also as car to your therapist move to a earlier lines.
No need to be referred from the community based on call designers to Specialise khaki centers.
Least to yet another potential delay.
Five 2030, it is estimated that the number of patients with lymphoma myeloma, who will be eligible for a car T will go up to 300000.
To put this figure in perspective. It is estimated that approximately 10000 patients will receive cocky therapies in 2023.
Several apologist providers are making large investments in manufacturing infrastructure and deliberate there are designed to increase capacity.
These companies are not forecasting the ability to perform as many as 10000 individuals manufacturing once in a few years' time.
But even if successful the four cats. They supply is dwarfed by the number of patients who could benefit from treatment.
The unfortunate upcoming is that even on the more optimistic forecast capacity expansion.
I will be far more patients without access to this morality than those who can be treated.
Adding more and more linear scale manufacturing is simply not a viable model perturbing, an increasingly large address market, which will most likely lead to authenticate market.
And patients without access to a potentially life saving treatment.
My next point of reflection focuses on the innovative nature of allergy in a car to your product.
Trillion dollar biopharmaceutical industry is based on very few of therapeutic modalities.
Often new classes of drugs are met with skepticism or even disbelief.
In 2012, kite and National Cancer Institute entered into cooperative research and development agreement or creator.
<unk> that would ultimately lead to the approval of your Scott.
But what many forget or may not know is how many biopharmaceutical companies spell first offered the same opportunity at kite, but decline.
The development of a palace cocky therapies now a multibillion dollar industry, what a lonely endeavor.
Cacophony of Naysayers, and the development challenges that needed to be overcome required an undoubted believe in the science.
As the year progressed and well the data on this new modality accumulated there was a shift in attitude towards a palace cocky therapies.
History doesn't repeat itself, but it often rhymes.
We are very excited to see progress not just from allergies, but others, who are developing allogeneic khaki products.
We view this as a sign.
That the viability of the modality is becoming increasingly evident.
The more companies that entered the arena with promising approaches the more investment we see from large farm accompanies.
The better it is for that field.
So at work, we have done to progress a clinical trial has allowed us to accumulate and master Tech knowledge that is second to none.
The learning that must come from the phase one trial, often hard one but the outcomes website in a recent dataset makes it clearly worthwhile and keep us excited for what is to come.
A future where patients do not have to wait and fight for access to card P.
They can start treatment within days and without the need to undergo look up races or creating therapy.
And I was in a car to your product provides one if not the only way to broaden the use of cocky therapy, making.
Making the deliberate yep therapy, much easier and convenient for patients and they are treating physician.
Molly I believe the convenience of an off the shelf allogeneic hockey product is the only way to introduce the potentially life saving modality of car key to a wider community setting where the majority of earlier line patients that currently careful while preserving the potential for a <unk>.
<unk> treatment.
An off the shelf option that is free of the hassle and inconvenience of having to return to the clinic for treatment again, and again and without the cumulative Texas cities that also come with lengthy chronic therapy.
With that now I would like to turn the call over to Zac.
Thank you David as we have noted in previous calls some of the biggest questions facing <unk> currency development was whether the safety and efficacy of intelligent a product to be comparable to approved autologous carty therapies, and perhaps even more importantly, whether an off the shelf product can induce durable complete remissions.
The American Society of clinical oncology annual meeting the European Hematology Association Congress and the International Conference a malignant lymphoma in Lugano, we shared longterm durability data from our phase one trials and answered these very important questions and substantially reinforced that are off the shelf C. D 19, Aloe car T product can.
<unk> demonstrates a promise and large please tell him home.
And <unk> with an encore presentation at <unk>, we presented an updated analysis of the Alpha and Alpha two trials focused on patients who received the regimen that is being deployed and are potentially pivotal phase two trial.
12 car T naive patients with relapse refractory L. D C L.
A single dose of Aloe 50145018 manufactured using the alloy process. Following a Lymphodepletion Regiment FCA 90, which is comprised of standard low doses of Fludarabine Cyclophosphamide, plus 90 milligrams of Aloe 647.
The median time from enrollment to just started therapy was three days and as of the April 20th 2023 data cut off all 12 patients were followed through a minimum of six months.
Seven of 12 patients are 58% achieved a complete response and five patients or 42% maintain to see our three months six.
The five patients who are N C. R. At six months for 480 per cent had an ongoing remission.
The fifth patient had disease progression at 24 months.
The median duration of response was 23.1 months with three patients remaining in remission for over 24 months and the longest remaining in remission for over 31 months.
To put these data in context, RCRA, a 58% can be viewed in light of approved autologous Carty therapy see our rates that range from 32 per cent to 54% per label.
Of course, the appeal of Karachi therapy does that complete responses can be durable RCRA at months six of 42 per cent compares favorably with autologous carty at their rates range from 29% to approximately 40 per cent.
At the meeting in Lugano, we presented data from all 33 patients with relapse refractory L. D. C. L who received 5015 or one eight made using the alloy manufacturing process.
In addition to the 12 patient data reported it <unk>. Just eight is that included additional patients who received either lower doses of aloe 647, or two infusions and download 50145018 spaced approximately one month apart and our consolidation regiment.
Across the 33 patients 100 per cent of patients received product per specifications no patients received bitching therapy.
And these 33 patients D. C. R was achieved by 14 patients or 42 per cent of whom 10 maintained a complete response at months six.
The median duration of response and these thirty-three patience was also 23.1 months demonstrating that we could still the cheapest fault within the parameters established by approved autologous car T therapies, even using less less optimize Justin.
We also observed robust car to sell expansion of persistence and patience, particularly in responders arguably at first for an off the shelf <unk> product.
And all presentations are safety analysis, including all thirty-three car T naive L. D C L patients who received halloy product.
It was generally well tolerated with no incidences upgrade three or greater Crs and no cases of I can or GBH D.
P as in infections were manageable and comparable to the experience with autologous car T therapies in patients with relapse refractory L V C L.
We showed patients neutrophil lymphocyte count is beginning to recover within the first month of confusion and achieving baseline levels with kinetics similar to autologous cell therapies, providing additional insight into our comparable infection right.
Our data are the first to demonstrate the potential of an <unk> 19 car T to induce terrible complete remissions and set the stage for potentially competitive profile to approved a tolerance city 19 car Ts.
Our focus now turns two important objectives for this program.
First being enrollment and the ongoing phase two alpha two trial, where we help to definitively established the potential of this new modality.
We are very pleased to have extended enrollment in this trial into Canada and expect to begin enrolling patients in Europe in Q3 in Australia before your end.
We also continue to focus on enrollment in our face to expand child, which is designed to demonstrate the superiority of aloe 647 containing lymphodepletion regiments over a regimen of flu sigh alone.
In parallel we're working through the trial design strategy could support regulatory approval and earlier line L. P. C L.
We believe heart proposed approach may be particularly advantageous and look forward to sharing more detail on this strategy by the end of the year.
We believe our success today, where others may have fallen short is attributable to our ability to support the expansion and persistence of our allogeneic heart T cells necessary to achieve durable timber elimination.
Pondering some data we've already presented from our C. D 19 program.
To an improved clinical performance. One may include Aloe 647, or anti C. D 52, monoclonal antibody was standard low doses of Blue Sky.
Platform enabled by Alice 647.
It's an extended window of car T cell expansion and persistence.
But 0647 does it cannot be reproduced even with high doses of chemotherapy that might be associated with severe toxicity.
Now focused on applying it rigorous approach to explore the boundaries of what works as a best practice to enrich our understanding of Karachi sell expansion of persistence as we investigate next generation technologies, including data, which is currently being utilized in our <unk> 316 anti C. D 70 solid tumor trial.
I will now I'll turn the call over to Eric.
Thank you <unk> and good afternoon, everyone I'd.
I'd like to begin by acknowledging that today is my last day analogy, a very bittersweet occasion.
The past five years have been rewarding exciting and fun.
They provide a new challenges allowed me to build life changing relationships, perhaps most intriguingly open my eyes to a side of the industry that I could not have previously fathom.
My respect for what management teams must do and complexity of decision, making in drug development throne.
Grown exponentially.
It has truly been a privilege to serve as the CFO of allergy.
Look forward to spending more time in New York with my family Allergy and will be it will forever be a part of me I am thankful to David and the team for the trust and the opportunity afforded me I look forward to following the company's progress as it turns the promise of Ala Carte T into a reality for patients.
Now onto our financials.
I'm pleased to share their balance sheet remains very healthy. We ended June 30th 2023 with $544.5 million in cash cash equivalents and investments.
In addition to our efforts to ensure operational efficiency. We raised net proceeds of approximately $88 million in the second quarter from our at the market or a T M equity financing facility.
Based on our current expectations. We believe we have extended our cash runaway into the second half of 2025.
And the second quarter of 2023, a research and development expenses were $62.0 million, which includes $6.9 million of non-cash stock based compensation expense.
General and administrative expenses were $18.5 million for the second quarter of 2023, which includes $9.7 million of non-cash stock based compensation expense.
Net loss for the second quarter of 2023 with $78.0 million or 53 cents per share, including non-cash stock based compensation expense of $16.6 million.
We continue to expect a decrease in cash cash equivalents in investments.
Approximately $230 million in 2023, we.
We expect our full year 2000, twenty-three gap operating expenses to be approximately $340 million, which includes estimated non-cash stock based compensation expense.
Proximately $80 million this guidance excludes any impact from potential business development activities.
That we will now open the call for your questions.
Thank you.
As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced.
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We ask that you please limit your questions to one per person.
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Our first question comes from the lineup Tyler Van Barron with T. D. Cowan. Your line is now open.
Great. Good afternoon, guys. Thanks, very much for taking the question and congratulations Eric and all that you help the company achieved during your tenure at allergies.
With with that said my question is I'd like to ask you to elaborate on the pace of enrollment in alpha too and whether you've seen an increase in the pace of enrollment, especially with all the recent conference presentations.
Yeah, Hi, Tyler attack. Thanks for the question. So the guidance that we have provided is that you know we expect to complete enrollment and the first half of next year, we're maintaining that guidance today I think the pace of enrollment is you know going to.
Change over time.
Can see the enrollment pick up towards the end of the enrollment period that is very standard for for clinical trials.
Additionally, we have gotten approval by the EMEA to open sites in Europe , and we expect to do that in the coming weeks.
And Furthermore plan to add Australia to the to the roster of enrolling sites by the end of the year. So all all signs are pointing in the direction of of momentum building in terms of geography is coming online and we expect to have the <unk>.
He enrolls by the end of the first half.
Thank you.
Our next question comes from the line of solving rector with Goldman Sachs. Your line itself.
Good afternoon. This economy down first housing just a two part question from US as you clearly described in the prepared remarks that seems like a supply situation I <unk>, especially with respect to B C. M. I K T. I guess at this contacts how long are you thinking about the competitive landscape, giving the.
Ongoing optimization, that's required for Alice had been one five.
Then and the lymphoma space I guess in the context of the recent data that was presented <unk> 19 program, which is also starting to evaluate the.
Acid in earlier line patients. Thank you.
Yeah. This is David Chang, let me take the first question on the <unk> and and I'll ask Zac to comment on the competitive data.
In terms of the autonomous Karakia supply I mean, we are definitely here what you're hearing is that <unk> into space is putting a lot of effort to increase the manufacturing capacity and along with that I think there has been some improvement and reducing the out of spec.
She also at least two not being able to provide commercial materials to patients.
Certainly that is happening and we were expecting that to happen, but the pace that is how it's happening as you know we are following is as expected.
There will be a lot of ramp up time that's needed.
No you know deadliest too I think what you are really asking about.
Same a program we are continuing to look for the arbitrary to improve the the the manufacturing process. I mean, certainly we always knew that manufacturing is one of the key components, so making the south product viable and also maintaining the level of <unk>.
Cause see that we are looking to do so we're making a good progress and we are continuously reviewing you know what we will be doing would that be same a program as we complete the manufacturing review.
On the second 19.
Yeah. So great question about the caribou update overall, we were very pleased to see another sponsor present data.
Supporting the use of Alpha beta T cells in an off the shelf al generics platform and driving benefit for patients.
We see that this is a very validating uhm milestone for the field and uhm, having been at this now for five years and and arguably some of the most experienced in this feels we we are very proud to C. N N on additional person enjoying this field, but you know we also stay on very.
Much by the data that we presented this this summer as as as part of the overall and growing experienced an off the shelf Ala Carte yourself.
Thank you.
Next question comes from the line of Michael E with Jeffries. Your line is now open.
Hey, guys. Thanks for the question one of the.
Things that comes up is the.
Use of car T. After yes, Carta and since there's uncertainties about that one could envision that your product would be an obvious fit earlier lines, particularly given off the shelf to do that you would need to run a second line study you suggested you would give us some tidbits and some.
Insight into how you would think about are designed for that later this year, but can you just remind us could you actually start a second line study next year are there things relevant to sort of having to make progress on third line.
You would you have the money to do that for a farmer company help you out a lot easier maybe just talk through the different challenges a second line. How you should think about that because I would think that's even more important that third line. Thank you.
Mike Let me take the first part of the question and are you asking you know all important and excellent questions and you know I'll ask the Zack to comment on the.
Study design, which is very much and you know in.
In the in on track.
In terms of the earlier line you know.
I I think that's really the opportunity you know.
South therapy to maximize the benefit you know one time treatment they can potentially lead to.
Something that's similar to care where.
Successfully treated patients no longer requires a second third or subsequent lines of therapy, I mean that is really the holy.
Holy Grail, but we are trying to do in the oncologist space and and when we think about how the patients are cared for you know in the earlier line setting as well as I mean, you know what I mean by that is most of these patients care for.
Not in the territory centers, but in the in the local oncology infusion clinic, San local you know colleges and so this is where we also see the benefit off the shelf allogeneic Carty really shining and you know that's.
Where we are trying to March as we think about our C. D 19 program beyond the current refractory in real upsetting in the third line setting.
Previously we've been guiding that we will work with the investigator to finalize the study design get regulatory input from the agencies and then look for launching the study sometime in 2024 <unk> plans still holds.
And comes up study design, let me yeah that to comment on that it's very early but.
Uhm Yeah. Thanks, Mike for the question. So I think the premise of it is spot on I think you know you look across C. D 19, and also be CMA and what we're learning is that for us as powerful as these therapies are and relapse refractory disease their utility in earlier lines is as compelling.
If not more so and obviously the numbers of patients are great are there. So we have been keenly focused on coming up with a study design and earlier lines that I think will play to our strengths and also serve an unmet need that exists in that second line and we're not quite ready yet to share a lot of.
<unk> on this study we hope to be able to do that by the end of this year, but suffice to say you know we think that this is a great opportunity for the field in for allergy in particular.
Thank you.
Our next question comes from the line of Brian Chang with J P. Morgan. Your line is now open.
Hey, guys. Thanks for taking my call. You mentioned that you are thinking of exploring combining car Swift, a dagger technology and human solid tumors.
Does that you would need to be efficient on resources. Since most of your focus today is now on C. D 19, how how does the potential explanation strategy fit into your current portfolio and timing for the next set of callous, it's more of a P. D a plant.
Brian they've changed her.
Today I mean, you know you guys are really asking excellent questions.
When we think about the allergy and eggs and I think this is something that we can say you know further south therapy as a whole.
This is still very early stages of cell therapy, you know, where I am right now and the potential upsell therapies ability to engineer the car T cells. In this case through the available technology, whether it's you know <unk>.
<unk> that'll change transaction and that's essentially what the autologous cell therapy players are doing to how the field has evolved to include you in editing.
Possibly multistep chain engineering, you know, including sites specific integration et cetera, et cetera, and that's really the Holy Grail of cell therapy that you know the not just us everybody in the allergy next field is trying to accomplish so in that context.
You know, we don't necessarily see the program instead, we are advancing as the answer to all the solution that we are trying to provide.
And advanced as field I mean, some of the things that we currently discuss is Alexis how to make the sauce works better but also can we potentially reduce the lymphodepletion make the therapy more easier to administer Arizona pace and all these questions and that's weird you know.
Concept of next generation, such as the dagger technology that concerned.
The question about how much can we do in the current environment, where the spending is highly scrutinized is a very good one I mean, Mike was asking the same question and this is something that we are trying to address through the privatization as well as trying to do things as efficiently and also in this this is.
Thank you.
Our next question comes from the lineup Michael Smith Guggenheim.
And.
Oh, Hey, guys. This is Kelsey M for Michael Congrats Eric on your last day, but sad to see you go and I just had a couple of quick questions. I guess first building on your prepared remarks David.
You know, there's a small percentage of eligible patients actually getting party and we hear a lot about capacity.
Typically in my Love of course, the ketchup early in the largest but I guess for D. L. D. C. L. In capacity still the biggest limiting factor or is it something else and then maybe building on that last question. How does kind of March partnerships set into uhm have stricter capital allocation. Thanks, so much.
Yeah, and the question about what's happening in autologous I think truthfully, we follow what the large companies in this space you know released the information on the in the quarterly basis. So you know as much information as we do.
The bottom line is by the estimate that sound in the farm up there in the car keys space I'm, making you said in the third line setting.
Only about 30 per cent of Dallas real patients are receiving cocky therapy that remark was made in 2022 19 2023, there may have been some uptake.
I've taken the percentage of patients eligible patients who are getting the carty and we are also looking in terms of the quarterly earnings release and how much. The revenue has gone up and trying to triangulate how much of that is due to earlier line usage versus further penetration and the third line.
On top of that we <unk> only with the card key experts, but also their hematologist oncologist, especially at the centers that do not have access.
Access to the the the commercial car T. Let's.
<unk> <unk>.
Be reminded in a car key is only using the certified centers and the number of certify center step can administer commercial supply is still limited so.
My comment in as well as the answer to your question is stomach guesswork as well, but our current estimate is that there is still a sufficient number in a large number of patients who are eligible to not getting access to the car T. In the <unk> lymphoma space.
The second part of the question with a notch and what we are doing I mean, Natchez is doing something incredible trying to differentiate the I P. S. C cells into functioning <unk> that really has been the Holy Grail up you know what the field may be able to do leveraging the power of I.
P S C.
We are sensitive in terms of time horizon, but that technology can really be scaled up and be realistic in terms that'd be introducing the clinics and this is an area that I'm always humbled by.
How difficult it is I mean back in 2015, 2006, 10, I thought <unk>.
Seven to 10 years I P. S C will be more or less in the mainstay of the Carty. You know we are about 10 years from that time and still I think it's several years before the Ips drive the car keys therapy can be in the clinics.
The future is definitely there, but I think it's just taking a time and we are definitely putting that in the context of how we are partnering and working with a notch.
Thank you.
Our next question comes from the lineup John Newman was can't according to your line itself.
Hi, Thanks for taking my question. So you mentioned that you're gonna be enrolling patients in a pivotal study in Europe and Australia here.
I think Europe shortly in Australia by the end of the year I'm curious if you could talk about whether or not there's any difference and the availability of the autologous Kochi therapies. There. There's an I'm asking the question is I'm just wondering if perhaps enrolling patients in those two regions.
Could really increase the chances that you're getting patients that would otherwise be giving autologous therapies. Thanks.
Yeah. So so we know that the utilization of car T. Generally in those regions is significantly less common than it is in the United States and and obviously we expect.
That over time that will change and.
Is is is additional pivotal datasets or it come to the table and and regulators begin to approve these therapies and payers get on board as well you know what the whole field is moving towards utilization of Karachi in third line and then second line, but you know <unk>.
These regions are significantly behind the United States. So there is plenty of patients in both of those regions.
Where are the unmet need in third line is is substantially higher than it is the United States. So we feel that <unk>.
And have felt for a long time that it's made a lot of sense to broaden the footprint in and be able to bring on those patients that are whose needs are not being met by current standards in those in those X U S regions.
Thank you. Our next question comes from the line of Jack Allen with your.
Your line is now open.
Oh, great congratulations with the amount of progress and Eric Congratulations to you and all of your complements our accomplishments over the last five years I'm Gonna try to do my best to put you to work on your last day here and I wanted to talk for a second about the February relationship.
Could you remind us maybe how things stand as it rises have yet and I'm seeing in the 10-K that or is it 10-Q that you received very the minimum payments from sitting in the last couple of quarters. Here do you expect that those payments can be higher as you move into the European region with the offer to study and what's baked in as it relates to the cash all my guidance.
<unk> February and the relationship there. Thanks, so much Jack Thank you very much for the kind of personal comments and the question. That's good to hear your voice and I think you must've studied more French than I did in high school because your pronunciation of Serbia is spot on we.
We continue to have a little bit of a challenging relationship with with Serbia. As we've discussed previously and then R. C. C filings there are disputes over certain aspects of our collaboration as you noted their disputes over cost recoveries, which we believe we're entitled to.
As well as our ability to opt into X U S develop into the future date. So at this point in time, you know rather than to to delve into legal matters. So I'll just leave it to what's what's going to be published in our 10-Q in terms of the update and.
Hopefully, we'll be able to find it in a couple solution going forward.
Thank you.
Our next question comes from the line in S. T <unk>, Let's trust your line itself and.
Hi, This is <unk> I had a question on Alice 75, I know you guys are looking I just wanted to know if you guys are looking to change the side of kinds of used culture days to get them more Nathan Sharpe phenotype.
And are you trying to get that to get more of a private you like efficacy if he can share some color on.
<unk> <unk> guidance on the tiny as well that would be great.
Yeah, It's a crazy out there about four things that we are doing with the manufacturing process review and.
So the question is will.
<unk> pointed out a side of kindness and important aspect of what we are reviewing without going into further detail <unk>.
Timeline up what we'll say about I hope you seem a program, let's preferred that until we complete the review and decide you know what we will when we will think about introducing back into the clinic.
Thank you.
Our next question comes from the lineup.
<unk>, what's the rally your line is now.
Yeah, Hey, good afternoon. Thanks for taking the question one more on the enrollment could you. Please comment on how many additional clinical sites you expect to include it for the expand.
Trial and is the guidance still unchanged to report data roughly around the same time from from this study is the alpha can study.
Uhm, yes. Thank you for the question. So we haven't gone into exacting detail on the number of sites for either Alpha two and expand we are continuing to bring on sites in North America <unk> expand it as you know this is a relatively new or trial, then alpha too.
So we didn't have the benefit of long standing relationships with phase one sites. There. So everything is starting from scratch, but so I started coming online as we speak and similar to the plan for Alpha two we also intend to bring expand into both you and Australia and the last point <unk>.
You asked about is still correct, yes, we do expect to have <unk>.
Data for expand coming at roughly the same time as alpha too.
Thank you Okay. Our next question comes from the line of Sammy Corwin William Blair and your line is Nelson.
Hi, there thanks for taking my question.
Yeah that the current commercial khaki therapy, there commercialized by large farm at players are through partnerships with large apartment I guess how are you are you thinking about commercializing off the 501 alone or do you think you'll need a commercial partner.
Yeah same here, let me take that a great question I mean, that's something that we are in totally disgusting and I think once we you know further at the physician and how are we going to commercialize we will share that information, but I think it's lipitor early for us to say one way or the other.
Thank you.
Our next question comes from the lineup Luka Itchy with Army C capital your lifestyle.
Oh, great. Thanks, so much for your question.
<unk>, if I may circle back on prior question can you just talk a little bit about your enrollment projections for alpha two verses expand what gives you confidence that you can complete enrollment of both trials in the first half question for you feel some need in enrolling expanding much harder in enrolling out the too I think I would love to hear your thoughts on that.
And then Eric.
She got it for all your help and all the best in your next chapter.
Hi, Thanks for looking for the questions is Zach so we.
The enrollment of each study is ongoing at.
Currently as we've said we've got into completion of enrollment of Alpha to you by the first half of next year, we actually haven't specified exactly what to expect to expand a complete enrollment but based on that the study designs of these two trials. We are our current projections are that maybe between the fewer patients that are required to enroll in <unk>.
<unk> as well as you know our our belief that the end point will actually take less time to to come about with that study that we do think that those datasets will be available at roughly the same time.
Thank you.
Our next question comes from the lineup Tony Butler with E F Hutton your lifestyle.
Thanks, very much David or Zack I I wanted to go back to the dagger, if I may I understand that.
There is a diagnostic be imported this time.
The question is and Dr.
Hours presentation.
But if your I don't believe any patience had damaged or there wasn't any data available for patients who were given 240 million cells and the question is or can you address whether there has been that does seem that has occurred in a number of patients and number two is.
The data for efficacy.
Not asking about but what I am asking if it's possible for you to make any statements because the data was so in my opinion. So we're so good and the side effect profiles.
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Consistent with other studies, but importantly, <unk> was.
They're minimal fatigue syncope indoor minimal C. R. S. As was demonstrated at the lower doses.
And finally.
Alright, Thank you very much and again.
Publicly all the best thanks.
Thanks.
Thank you for the questions. So as we are as we <unk> still true today, we are continuing with the dose finding does exploration part of this trial.
I I don't Wanna get into details about you know how many patients have been treated at each dose beyond what has been shared publicly at a C. R. We do expect to be able to share. It additional information from this trial later on and we're continuing continuing the enrollment now and other than that though I very much agree with what's your assessment that.
The data that was shared it ACR, certainly is compelling and and and superior to what these patients could expect from from standard of care.
Thank you.
Next question comes from the line of Heart sang with Oppenheimer. Your line is now okay.
Oh, great. Thank you thanks for the the question.
And also a good luck, Eric pneumonia, but best of luck.
The the question I have is just you know when you read out Alpha two later in 2024.
I was just wondering you know what what sort of what's out there in terms of a comparison or you know what what are you looking for that would give you comfort getting your discussion with the F. D. A.
Enable b L. A looking activities.
Activities.
It's you know response rates and duration of response, I mean, what sort of ballpark.
<unk> you were thinking about or that would make you comfortable and then just a minor follow up to a previous question, which is that Ah you dosing patience alpha too far away.
From your commercial facility. Thank you thanks for the questions.
So I'll, maybe I'll take the first one the so I I think primarily what's giving us comfort about about the the phase two program is all of the experience that we have some phase one which was.
Really again brought to the surface in June at the various conferences, where we shared data feedback there. An instance has been overwhelmingly positive from investigators both.
Those that are involved in the trial and and those that are not and and so you know those are in patients that meet the eligibility criteria for our phase two program.
And so that's sort of our view going forward and and you know I I don't Wanna get into specifics about conversations with F D a but.
We think that this is filling a a much needed niche in the landscape currently given all of the the access limitations that David alluded to previously done the prepared remarks, maybe David I'll hand, it to you for the commercial facility question.
Yeah. So the second question is about patient dosing and as we have previously communicated the patience currently being doors from the materials that our.
Contract manufacturer has produce it the way that we have treated.
You know the patience in the in the face while studying.
Thank you.
Our next question comes from the lineup.
<unk> with JMP Securities. Your line is now open.
Okay. Sorry. Your line is open please checking me patterns.
Hey, This is run Benjamin can you hear me.
Iran.
Uh huh. Thanks for taking my question I don't know, where they got can sure from but.
Eric all the best in your future endeavors.
The question that I have to do with al at 316, I view that as kind of like the next main value driver and and driver of shareholder value I'm kind of curious you know as you're looking at the in vitro companion diagnostic can you talk to you know provide a little bit more color regarding this how invasive is the process.
Are you you know identifying patients in the in the real World. That's you know kind of kind of different than what you might've predicted from epidemiological studies and I guess finally, you expect dose escalation to.
Complete by the end of 2023, but how many patients do you think.
You'll have it by the end of the year.
Thanks.
So the first question on on the companion diagnostic I can tell you that it is not I mean, it's a biopsy, but we're allowing uhm biopsies that were taken prior to study enrollment for evaluation. So some patients are requiring fresh biopsies. If there's no prior material that is accessible.
But but many others are just giving us blocks from their original diagnosis or a recent recent operation a biopsy. So in that regard. It's it's it's no more invasive than any other sort of tissue assessment that occurs everyday in oncology.
And then this.
The second question.
The second part of that question was are we seeing differences in the results of these tests in what way to expect it from the literature to answer that question is now what we're finding is very consistent with the literature. So there's been no surprises there.
As far as the second question the number of patience again, I don't want to get two <unk> two weeks here on on what uhm setting expectations for the future updates, but we have the interest in this program is is very high and that was again spiked after the ACR.
Nation has remained high ever since and so there's been a an abundance of patients who are interested in abundance of investigators who are interested in putting patients onto the trial.
Thank you.
Our next question comes from the line of Jason Carberry with Bank of America Securities. Your line is now open.
Hey, guys. Thanks for squeeze me in so just a quick question for David wanted to come back to earlier comment just about the challenges that autologous car keys space and sort of linear linearly scaling manufacturing and really wanted to get your perspective on what you see is like the biggest impediment, yeah, Paul I guess approaches you're moving.
Forward with like decentralized quite a sight model like is being explore explore by companies like Galapagos. So what do you see as sort of the biggest hurdle to operationalizing that and scaling. Thanks.
Yeah. Great question, you know I do have the same question <unk> questions that you're asking I mean, obviously you know I have to respect you know the how different companies are thinking about too advanced.
South Darkens, you know the sort of <unk>.
Quick manufacturing or <unk>.
Pulling up care manufacturing, sometimes comes up you know I have a C. D's you know early days and you know I don't have a clear picture about how that's gonna play out.
But when you think about <unk> therapy.
There are multiple dimensions. One is you know it has to be manufactured one at a time patience have to undergo leukapheresis.
And so as you know the waiting for you know like any other products that Houston human all the release test that has to be a part of the the manufacturing process before the product can be used in humans and I think all these things you know pro buys in my view some out of a P.
Area or to really realize the full potential.
Khaki therapy, and that's where the the the value proposition Dallas It aches all therapy is coming.
Thank you.
Our next question comes from the line of William Pickering with Bernstein's. Your line is now open.
Good afternoon. Thanks, so much for squeezing me N.
And your outfit to study how much outpatient dosing have you seen so far in the trial and what are your expectations for how common that might potentially be in a commercial setting and if I can maybe just ask one more what are your expectations for the time horizon for analogy neck therapy to be rolled out at hospitals that donate <unk>.
<unk> autologous carty today, such as a community hospital basically trying to understand you know when you might be able to access some of these market segments, where you're not competing head to head with autologous. Thank you.
Hi, Yeah, Great question in terms of a patient dosing you know the ongoing studies to allow that I mean at this point and as we treat palpation you know, we'll be able to provide more information, but I think it is relatively thoroughly and in terms of the second question about allogeneic and patient.
Setting and all that I mean, I think that's the direction that we want to take our programs too. So at this point, it's too early so stay tuned.
Thank you.
Our next question comes from the line of 10 Burnett Stifel. Your line is now open.
Hi, this is carolyn.
<unk>. Thank you for taking our questions I flew up one day and vitriol companion diagnostic you have designed for <unk> 316, you mentioned that this tissue based is this <unk> type I say mm mm.
Wondering if you are planning to come back a centralized diagnostic assessment.
Uhm Tayeb with appreciate though so if you can talk to do you know how you plan to count for heterogeneity in series 70 expression. Thank you.
Thank you that concludes our question and answer session I would like to turn the conference back on my management for any additional comments.
Thank you very much for joining a call today, we have three all that off the shelf saving 19, Albuquerque data continues to demonstrate both great promising hematologic cancers, and we remain focus on advancing the industries first potentially pivotal allergy and a car could try out in order to enable more pay.
<unk> to access Carty upgrade or you may not disconnect.
Thank you ladies and gentlemen, thank you for your participation in today's conference does that conclude the program, Amy now and log off and disconnect.
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