Q2 2022 Cellectis SA Earnings Call
Okay.
[music].
Good morning, everyone and welcome to the selective second quarter 2022 earnings call.
This time, all participants are in a listen only mode.
Later, we will conduct a question and answer session and instructions will follow at that time.
Please be aware that today's conference call is being recorded.
Now I'd like to introduce the first speaker Arthur.
True.
This officer you may begin.
Good morning, and welcome everyone to selected second quarter, 2022 corporate update and financial results Conference call.
Joining me on the call today with prepared remarks are a doctor homes actually Kal, our chief Executive Officer and Dr. There being Wang our Chief Financial Officer Dr.
Dr. Brownstein his absence for today's call. So I will be speaking about the car T program updates.
Yesterday evening selective filed its interim reports and issued a press release reporting its financial results for the second quarter and six months period ended June 30th 2022 there.
Reports and press release are available on our web site selectors that's called.
As a reminder, we will make statements regarding selective financial outlook. In addition to its manufacturing regulatory and product development plans.
These forward statements, which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our license partners are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
A description of these risks can be found in our most recent form 20-F filed with the SEC and the financial reports, including the management report for the year ending on December 31st 2021, and subsequent filings select this makes with the Securities Exchange Commission from time to time.
I would now like to turn the call over to Andre.
Thank you Arthur good morning, and thank you everyone for joining us today.
Like this continues to make progress enrolling patients in our three sponsored phase one dose escalation trial.
And take those little steps forward with our preclinical data on programs.
This week, we're proud to announce the FDA clearance of our investigational new drug application.
For your cart 20 by 'twenty, two our product candidate being developed for patients with relapsed or refractory non Hodgkin's lymphoma.
They do cart 20 by 22 program is very exciting and we will be selective first dual targeting allogeneic car T cell product candidate.
Third clinical trial.
Targeting CD 20 antibodies 22, both validated targets in B cell malignancies.
The potential to enhance.
Tumor cell, killing and increases the breadth of antigen targeting.
These advantages may increase the addressable patient population.
And provide the potential therapeutic alternative to CD 19 directed therapy.
Your car T 20 by 'twenty two.
He will also be our first product candidate it's fully integrated in house. This walkman showcasing our transformation into an end to end cell and gene therapy company from discovery and product they've left then.
And transfer into Jan P manufacturing and clinical development.
This quarter. We're also pleased to publish research data on our novel immune evasion, Universal Cart T cell nature communication.
Our oral presentation, Dr Mirkin society of cell and gene therapy.
These novel immune evasive Universal car T cells are very promising.
And they may address the main challenges F allogeneic car T cells.
The first of which is depletion by the host immune system via the host versus graft reaction.
By enabling the proliferation of cells without attacking cost issue do you have the grasberg since host reaction.
While the prevention of graft versus host reaction can be readily address dine in activation of T cell receptor.
T Alpha expression and car T cells or engineering approach could enabled in universal car T cell to become transit fleet invisible to natural killer cells.
And allogeneic T cells, allowing them to eradicate tumor cells before being rejected by patient immune system.
This can enable the broad you suffer a universal car T cells and allogeneic setting.
For the benefit of a wider population of patients.
This quarter. We also continued to expand our incredible leadership team like this announced during our annual shareholders meeting that I felt that Malcolm it.
Doctor Donald Berg strength.
Has been appointed as director for the company's Board of director. We are very pleased to continue our work with Dr. Berger trend.
And to welcome Mr. Malcolm is to select the sport.
There are both seasoned leaders with the health care industry, who brings decades of experience in both the healthcare and financial services sector to collect it.
We're confident that they will provide meaningful and valued perspective actually continues to progress toward becoming one of the few end to end cell and gene therapy company.
Now I would like to turn the call over to Arthur Trail, our Chief business Officer, who will give an overview of the three sponsored clinical trials.
And twin critical product pipeline our third please go ahead.
Thank you Andre.
Our clinical stage allogeneic car T cell product candidates continue to make progress in the clinic.
The Bally's Euro one study evaluating you called 22 in patients with relapsed or refractory b cell acute lymphoblastic leukemia is currently enrolling patients at dose level, three 5 million cells per kg, which the diabetes cyclophosphamide and alemtuzumab pre conditioning regimen.
We plan to initiate the administration of shook out to 'twenty two batches manufactured silly in house from our Raleigh facility in the second half of this year.
The Melanesia, one study evaluating your cups, yes, one in patients with relapsed or refractory multiple myeloma is currently enrolling patients at dose level, one 1 million cells per kg. It with food that are being done cyclophosphamide pre conditioning regimen.
We look forward to sharing clinical data from at least one of these three programs by the end of the year. When we will have a robust and meaningful data set to present.
Lastly, as Andre mentioned, we are pleased to announce the F. D. A I N D clearance for our product candidates you koppes 'twenty by 'twenty two.
First allogeneic <unk> car T cell product candidate being developed for patients with relapsed or refractory non hodgkin lymphoma.
You call. It 'twenty by 'twenty two features tailing mediated disruption as opposed to attract gene that has been shown to reduce the risk of graft versus host disease.
And the city 52 gene to permit the use of a CD 52, directed monoclonal antibody in preclinical to enhance cartoon grassman expansion and persistence.
We are extremely excited to start then that'll either one study evaluating you called 20 by 'twenty two in patients with relapsed or refractory non hodgkin lymphoma in the second half of this year.
This quarter our partnerships also proved to be an exciting highlights for selected.
In June allergy and announced that the FDA granted generative medicine advanced therapy designation to Allo 501, eight in relapsed refractory large b cell lymphoma.
They are mad designation was based on the potential of Allo 501, eight to address the unmet needs for patients who have failed other therapies.
And so all of those positive data from the phase one alpha trial in heavily pretreated patients with relapsed refractory large b cell lymphoma.
Other gene previously announced that enrollment in the phase one portion of the Allo 501 Alpha trial in relapsed refractory large b cell lymphoma reopened with the goal of offering allo 501, the age of patients while allergy and prepare to launch the pivotal phase III altitude trial.
They also previously said that the single arm pivotal our such a trial with allo five a one eight in relapsed refractory large b cell lymphoma is on track to begin mid year 2022, when FDA discussions director, that's finalizing clinical trial design and chemistry manufacturing and controls requirement.
Inmate allergy and also announced that the FDA granted orphan drug designation for Allo 605 for the treatment of relapsed refractory multiple myeloma.
Allergy and previously announced that enrollment has resumed in trials targeting DCM aid for the treatment of patients with relapsed refractory multiple myeloma and targeting CD 74 patients with its also metastatic clear cell renal cell carcinoma.
Enrollment also resumed in the Universal trial with Allo sat on the one side and the ignite trial with a tool called candidate Allo 605.
I will now move on to our research collaboration with Io Van and Phytobezoar.
This quarter I, often began site activation and patient recruitment for the iOS, Jim wanted to old ones, Firstly human study of iOS or what.
I have four one is a PD one and activate the til therapy that incorporates the tailing gene editing technology.
I owe for one may leverage the combination of til and interruption of PD, one signaling within a single therapy.
In the marine model of melanoma, the anti tumor activity of I O. Four one was superior to non edited til products, whether alone or in combination with a non type PD one antibody.
The I O G M. One two O. One study includes two patient cohorts.
Advanced melanoma patients who were previously treated with anti PD, one therapy and metastatic non small cell lung cancer patients, whose disease has progressed after up to three lines of prior therapy.
I also have announced it looks forward to dosing the first patient in this study in the second half of this year.
Finally, Ireland has a robust research pipeline advancing towards the clinic.
Following the success of IL four won several targets a genetic modifications are in preclinical studies using the gene editing talent technology, including double genetic knockout program.
Our research and development collaboration with Pfizer have yet to develop talent and they said induced pluripotent stem cell NK and car NK cell is progressing.
So like this has developed custom tailoring, which titles yeah. He's using two added Ics he's in a safe and effective manner.
Additionally, Titan has generated promising preclinical data peillon edited Ips derived NK cells that it expects to present at upcoming scientific conferences later this year.
These announcements reiterate once more that tailing is the technology of choice for gene editing, which continues to provide the company with expanded business opportunities.
With that I would like to hand, the call over to Dr. They're being Wang selective Chief financial officer for another view of our financials for the second quarter of 2022.
Thank you Arthur.
I will provide a brief overview of our financials for the second quarter of 2022.
I would like to highlight that our financials.
Cash cash equivalents current financial asset our restricted cash position of select us excluding calix as of June 30th.
2022 was $123 million compared to 177 million as of December 31st 2021.
This difference mainly reflects 56 million of net cash flow used in operating investing and lease financing activities and 4 million of negative foreign exchange impact.
Partially offset by $5 million of cash received related to research tax credit a pre financing.
Based on our current operating plan and financial projections. This cash position is expected to be sufficient to fund selective stand alone operations into early 2024.
The consolidated cash cash equivalents and current financial assets and restricted cash position was selected including Capex was $135 million as of June 30th 2022, compared to 119 1 million as of December 31st 2021.
The net cash flow used in operating capital expenditure and leases were 56 million of select us and 30 million a calix in the first six months of 2022, partially offset by a 10 million capital raise of colleagues and $5 million of cash.
Received related to research tax credit pre financing I felt like this.
The net loss attributable to shareholders of select us excluding calix was $47 million in the first six month of 2022 compared to a loss of 43 million in the first six months of 2020. One there's 4 million increase in net loss between 2020, two and 2021.
It was primarily driven by a decrease in revenue and other income of 18 million, partially offset by an increase in net financial gain of 8 million and a decrease of R&D expense of $4 million.
Consolidated net loss attributable to shareholders of select us, including Kelloggs was $51 million or $1.12 per share in the first six months of 2022 compared to a loss of 52 million or $1.17 per share in 2021.
The consolidated adjusted net loss attributable to shareholders of select us excluding calix, excluding noncash stock based compensation expenses was $43 million or 95 cents per share in the first six months of 2022 <unk>.
<unk> to a loss of 38 million or <unk> 86 cents per share in 2020 one.
Based on current plans, we anticipate our cash runway will take us into early 'twenty 'twenty. Four we are focused on spending our cash developing our deep pipeline of wholly owned product candidates in the clinic and operating our state of the art manufacturing facilities in Paris and in Raleigh, Our focus remains on me.
Entailing, an efficient corporate infrastructure that will enable us more limited growth in G&A spend.
Thank you very much and back to Andre.
Thank you Bing to close out this call I would like to reiterate how excited we are about the continued progress.
For a clinical trial.
Coming milestones for the remainder of 2022.
To date.
Close to 200 patients have been treated with allogeneic car T cell utilizing technology.
They've loved by selected.
Most inflict the sponsored clinical studies and those of our licensed partner allergy and in Turkey.
We continue to make progress with our pipeline.
Three ongoing clinical trials in Hematological malignancies, this quarter actually.
It makes that's closer to becoming a true end to end time gene therapy company.
These updates clearly show our potential and a ability to advance the field of allogeneic car T cell therapy.
Mhm selected which strongly believe that our product candidates, our technology and our in house manufacturing capability will lead us to a paradigm shift where patients with hard to treat cancer positioning us at the forefront of this promising medical and scientific field.
Now I would like to open the call for Q&A.
Thank you and at this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Our first question comes from the line of Juno Wang with Barclays.
Please proceed with your question.
Thank you for taking my question and.
Congrats on the IV clear now.
Now since you know you called 20 by 22 can start clinical trials second half. This year would you be able to share a little bit more color regarding the clinical trial design.
Including my initial thoughts on initial dose and also the patient population that specifically related to you know which line or whether they will have a prior CD 19 car T therapy and then my second question is regarding the U.
You are nature come publication.
Very impressive data. So wondering do you have or what kind of I T. You have for you do approach.
Lucky and laid out to them.
Rocco.
Thank you so much gena for these two great questions to start this call. This is Arthur and I think I will hand over to questions to Andre.
So I don't think we can hear Andre for now so I will take the first question.
So on the you called 20 by 'twenty two.
Excuse me excited.
Clear.
This is the first allogeneic car T develop design and manufactured end to end that select this so it's a fantastic milestone for the company and we definitely look for wood to administering this product to patients we haven't disclosed the full clinical trial design. Yes, we have said that this will be in relapsed refractory.
Three non hodgkin lymphoma patients.
And we will be disclosing the full clinical trial design later this year as the trial. It is getting started but we do believe that this will be a very strong differentiated.
<unk> car T in the NHS states in particular, because it's a dual targeting approach and the fact that it is strongly differentiated versus the CD 19 targets.
So on your other question around the I T. I mean definitely we strive to protect all the innovation that we're doing at select this we had a strong protection on the CD 52 knockouts approach for heme malignancies.
Car T and we definitely have protection as well around the <unk>.
It's really a growth that will be sent to you disclosed in the nature of gums.
And we think this is indeed exciting to have a very strong arsenal of persistence enhancing technologies that allow us to adjust and adapt depending on the indication that we targets be it in the heme space or in the solid tumor space.
Thank you.
Our next question comes from the line of Eagle locomotives.
<unk> with Citi. Please proceed with your question.
Hi team. This is Oscar Mubarak on for Yigal. Thanks for taking my questions for 2022 I'm, just as you're thinking about starting the study I'm just curious how you're thinking about.
Oh escalation generally I think we've seen kind of a wide range of starting doses from somebody other cell therapies. So I'm just kind of curious if you can comment at all where do you think you'll start maybe relative to those other other cell therapies out there and just more generally how dual antigen targeting might make your dose escalation different if at all.
Yeah. Thanks, a lot for this question. So Andreas has disconnected so I will take it this is Arthur.
So I think it's a it's a great question and we've put a lot of castle thoughts into the clinical trial design both in terms of our.
Starting dose as well as the limit for the eastern regimen are indeed due to the dual targeting nature of the of the of the shield of the car T.
So at this stage again, we are not disclosing the exact to deal with I think what we can say safety as this will be a standard dose escalation dose expansion design.
But since this is a very competitive field right now in particular for dual targeting.
We are not yet disclosing the trial design and we will do so in due course when the trial has started.
Okay makes sense and then maybe if I can ask one more about a 22 I think you've indicated that you're switching to your fully in house manufactured version and I think you've previously alluded to this version being more potent compared with.
Part of you used before so I was just wondering as you switch over if you'll need to make any adjustments to the dose escalation or maybe even dose escalate dose escalate a bit and Ah is this does this version the commercial ready version of the world they'll be well there will there be additional iterations down the road and will you have to do maybe do some.
Comparability work for those words, if there any further ones.
Thank you and these are excellent questions on your call. It 22, I think Andre reconnected. So Andre do you want to take that.
Apparently not.
I will again take the question on your 'twenty two so basically on your Cal 'twenty two you're absolutely right. The product from what we've seen is more potent than what we had manufactured at our CMO in the past. So this is definitely.
A big milestone that testimony to our Raleigh internal manufacturing capabilities.
We definitely are we have had our intense discussion with the FDA on comparability and what will happen with the with the dose escalation and there is a possibility that the FDA asked us to de escalate, but if that's the case this will be to acknowledge that the product is more potent and therefore smaller dose could lead to the same effect.
With obviously the added benefit of a reduced cost of goods. So if that happens this will not delay the trial and we will still be able to rely on the data from the previous version that you've got 22, that's what that's what is manufactured at our CFO .
Okay, great. Thanks for all the color.
Sure.
Our next question comes from the line of Kelly She with Jefferies. Please proceed with your question.
Hi, This is Dave on for Kelly. She thank you for taking my question. So just a quick question on overall plan for the next 12 months.
He said he will be a distant <unk>.
Losing at least one set of data so apart from that the what English to Investor should look forward and next 12 months. Additionally, can you add color on my son from allergies on physical trial itself, a little final one and allo seven month data update thank you.
Great. Thank you so much we will try our Andre at another time Andre are you on the line.
Yeah.
Yeah.
And thank.
Thank you.
And this actually could you hear me.
Yes, yes, okay.
Okay. So the.
Well, we know that although allergy and starting their clinical trial our pivotal.
Pivotal phase very soon and of course, there are milestone there on stage.
Our preclinical milestones clinical milestones up to the BLA and post.
Commercialization milestones and.
These total approximately.
Million in total.
But the details have not been disclosed on part of the.
The Oh.
Confidentiality between us and them.
The other thing is also we expect potentially next year to have also the BCA.
The trial from an allergy to start people who'd trial and also to receive milestones are like 185 million in total.
After the B B L, a and post commercial milestones and.
About the detail also are not disclose that in our part of the confidentiality.
Allergy.
Allergy Blue bar, so we're very excited by the data.
And with those both car T.
We think that the allo 501.
Yeah.
Not ultimately firsthand.
Allogeneic car T. But it's also part of the first in class.
Columnists and allogeneic all of the CD 19 car T.
And we think that that's a.
That's about it.
Okay.
Okay.
Alright.
To start I'm going to be blown trials seem to date on the BCA Mead Park. We are also very excited by the data.
Pain by allergy, we definitely believe that.
That's something that matches better basketball.
Of course, there are like five.
<unk> became a car T targets.
Given all of the difficulty in the logistics, we believe that also the performance the commercial performance and the potential for the.
For physicians of these too.
Through car T being off the shelf will definitely change.
Andrew in the states.
Yeah.
Thank you.
Yeah.
Our next question comes from the line a hard time seeing with Oppenheimer. Please proceed with your question.
Oh, great. Thank you. Thank you for the question and Andre I might suggest how you're helping get some of that product out on the door there down in parents, but you might want to move away from those steel tanks.
Reception why isn't it.
Just a quick question Andre team on.
The the data at the end of the year from walking into one of the projects and then maybe looking into next year.
The trials are for all 123 C S. One and our new car trying to have been designed with like a dose expansion.
If you had seen a really good signal in some tumor type to maybe go to a pivotal trial are you still thinking of those two projects are not not regards and then you know how can we see that play out you know assuming you have some good data readouts.
Essentially over the next 12 months. Thank you for the question.
Thank you so much hard to ask for the question Oh, It's great that you sold do you want to take this Andre.
Well as you always do you want to get started I can continue in a problem.
Okay I can get started so so hard times youre spot on and I think this will be not only very indication that very data specific.
But definitely we designed the phase one two trials in two blocks of dose escalation and dose expansion.
That could have depending on data and the indication the potential of being a registrational. We think for example that so you got 22, because there is a high unmet need and the scar city of options beyond CD 19 autologous.
There is definitely room for the dose expansion phase of the trial. Once we found the recommended phase two dose without rally internal manufactured product.
The those extension to be potentially Registrational and that's why we decided to switch the product to our Raleigh facility. So that when we get closer to BLA, we don't have to switch from a CMO and we completely control the production and.
And we can file our own facility in the BLA.
Andre if you want to add any additional color to that.
Yeah. It sounds like that's like one first of all it's a great question, Bob the thing is that Ah.
You know we've been developing serious off Carson's allogeneic Carson.
A number of years from now like you know your.
Your car T 19 that has been renamed Allo 501.
We started dosing the first patients six years ago like in 2015 like seven years ago by the way more than seven years ago and then since then there was like the became a khaki so 19 with licensee therapy.
Dessert and became allergy that allergen.
Very brilliantly lapping two car T that we went for 123, that's yes, one and 'twenty two.
Oh, we think it's a lot of.
Things on our plate now like were moving to 20 by 'twenty two.
Like certain targets that are.
Let's see do you risk targets like such as 19 and became a but theres plenty of them. Some are derisked target such as CD 22, or <unk> 20. This is why we think these two car T 20 by 'twenty, two and 'twenty two.
Two are playing like north of 22.
Fairly straight forward the ones that you should see a potential Dol curse and the game, which are one two or three for AML and she has done for multiple myeloma corridor too.
And that was a hard to treat the indication and the target is.
It's a complex targets are being challenged several times.
And we expect potentially to see some.
Some data in the future.
Yes.
Definitely.
Great great. Thanks, Andre Thanks, everyone for the App could be yeah.
For the answers and the color.
Thanks Arthur.
Our next question comes from the line of Jack Allen with Baird. Please proceed with your question.
Hi, Thank you so much for taking my questions congratulations on the progress.
So two quick questions on the <unk> one program I was hoping you provide some more color as to how enrollment is going it sounds like you're at dose level, one and I just want to hear about how many patients maybe I've been given dose level, one and what are you looking for to advance to our additional doses potentially in that study and then on 'twenty one 'twenty two.
The study design is gonna be disclosed as you enter the clinic.
Good to hear any thoughts you have as far as how quickly we could reach proof of concept with that asset as well. Thank you. So much for taking the question.
Thank you so much stack and I can start and and and Dragon can definitely chime in so for U S. Yes, one.
Again, we're not disclosing individual patient numbers I think the the thing that we can say is that yellow one as mentioned in the call is 1 million cells per kg. So it's already quite high compared to the other dose levels of the.
The other car T. So.
So we started that that.
That trial at a dose level that was that was higher so that's definitely one indication we can give towards the overall trial by itself.
And then for you got 2022, I think again without getting into specifics of clinical trial design with we can safely say is theres, a very large patient population and the need at this stage because once patients are refractory to the CD 19 options that have actually moved to second line and there is very.
Limited options and a very limited targets opportunities and so we taken the two most derisked targets that are non CD 19, CD 20, <unk> 22.
For a meaningful alternative not only to patients with relapsed from 19, but also the patient that could potentially not a receiver 19 in particular, India Indian autologous field. So we believe there is a large patient population a large opportunity and this could be conducive to a swift.
Swift enrollments.
Andre any thoughts to add.
Yes, like first yes, yes, where our gel one.
Mike.
Goldman is not very fast.
There is a lot of trials in this space in the U S.
So we have.
There is of course.
Those patients are.
And it's not the faster we're having currently for numerous reasons their enrollment in the United States I'm going to talk a lot of physicians.
Something that I think also like maybe the plan is to expand to other countries.
Yeah.
Great. Thanks, so much for the color.
Our next question comes from the line of David de with F. N. B C to proceed with your question.
Hey, great. Thanks for taking my questions and I also want to add my congratulations to the current progress. So two quick questions for me Andre. So the first question just around your card are you trying to could you just remind us how many patients have been rolled in dose level three with the FCA on pre conditioning regimen. So far and then a second question is just.
Round the data expectations in the second half this year I know you're going to be providing some you know some updates from all of the programs. I was just you know Kincaid just in a position is in terms of the wife data to expect.
Thank you.
Andre do you want to take that.
Is it is it turns unlike your cart through 'twenty two.
I missed a little piece of it.
Okay.
So yes, so for.
Okay. So on the FCA you there is a free patients or level.
Gel <unk> gel to jail free when completed deal free so.
Oh.
Like the plant.
Oh.
Try to bridge with few patients.
Our problem is being made.
In house.
Our rallies facility.
Globally, all the S. T. A S T Park in FCA Park has been completed.
Oh God.
Those funds.
So that's the whole thing that has been done but now we're expecting today.
Are you sure.
Rally.
And then move to expansion.
Yeah.
We hope of course.
Cool.
Also.
Yeah.
If that answers your question.
I think you can do the math.
And our next question comes from the line of Susan <unk>.
Sure Ken with JMP Securities. Please proceed with your question.
Hello, Congrats on a quota and thanks for taking my question.
Maybe.
One question you. Your cart 22 could you just remind us of the exact mechanics of what still needs to be done to get.
The array late material into the clinics are what are the mechanics of our interactions with the regulators here and I think last time, we were talking about the potency assay for the assay is required for comparability.
They are now all in place it would be great. If you could provide some more color there and then my my second question is around.
Recently, they must deal with Roche and obviously, you have to say that and as part of that.
Large deal and interesting that Roche is getting into one of the big Allo car T space now.
As a C D 19, CD 20 car T.
Could you just tell us a little bit about the differences. Obviously you know 19 retired you're fine team why would you do that and why is 2022, perhaps a better idea. Thank you.
Yeah.
Yeah. Thank you so much stuff and the great questions and I can talk on the Raleigh. One so definitely he has mentioned before we had interactions with regulators to understand exactly what they would be looking for in that seamlessly transitioning from our CMO manufactured products to the rally manufactured product.
Have a good understanding and basically the steps are filing a 90 amendments with the regulators with the FDA.
In order to.
Approved a rally manufactured product.
This then has to go through their clinical centers that their rfps. So that's we get then safely administer the products. So all of this is undergoing a we have all the assays in place to make that happen.
And we're confident that we'll be able to dose the first patient with the rally product in the second half of this year.
And and I think on the yeah.
Yeah Andre Please go ahead.
Well the size of the potency assay.
Quite straight forward I'm not going to get into the details of this for a number of reasons first of all I think that there is I'm not sure that's really interesting for.
For anyone that plus I don't want to disclose everything we're doing to do these type of compatibilities.
Globally, it's essentially killing potency.
So the number like that.
Potency of a relief.
Oh, perfect Grands arms, and the number of recycling that it could do at the time of the recycling between two releases the expansion potential of the cells the number of cell.
Cloud division, they can do that interferon gamma assays et cetera, and all of this gives you.
Quite the broader idea.
Performance of destock for our products and are well I think its good but the performance that we are paying is totally not a.
Uh huh.
Not that bad and we're very excited to see that they are very pro forma promo, but definitely the comparable E. Boston stand, it's not totally comparable so that's why there is a potential rule.
Necessity are potentially do quite like few doses below and rates time. After you do them do a full cohort, but that's what you'd get there was a technical question I like the beginning of your question was about what like Silvana excuse me.
Yeah.
Oh, Yeah. There was a question around the rush partnership and their cartoon targeting car T, which also targets targets basically CD 19, I'm just what are the rationale.
Why.
Well I don't see the rationale behind the fact that most of the patients who received a 19 cart that start.
And they will arrive they will probably deliver in our space who are.
Stand of CD, 19 car T allogeneic and autologous.
Of course, the allergy and car T will be approved by them of course.
You have yes, cart, a camry et cetera, et cetera, et cetera, and then you come with yet another CD 19 car T where you see the performance are already quite good so either you show a superiority compared to the other 19 khaki and added the CD 20.
I think it's way more interesting to have a CD 20 by 'twenty two we're doing all the relapses.
I was gonna give them another CD 19 car T. So it's better to give them a car T that we believe the performance really high but don't have CD 19, so I'm sort of surprised that the reaction of this type of approach.
Great. Thank you thanks for taking my questions.
Thank you for that.
Our next question comes from the line of Nicholas Abbott with Wells Fargo. Please proceed with your question.
Hi, good morning, Thanks for taking the question. So the first one just.
Oh and you got 22, so have you filed the int amendments and if not when do you intend to do that.
Andre.
Uh-huh it broke up a bit at the time.
Could you just repeat the question excuse me.
Andre.
Ask him whether you have what you call. It 22 final.
Yeah. Good morning, if you file the IND amendments and if not when do you think you'll do that.
Oh for 'twenty two.
Yes so.
Well.
It's a well you should expect to see a patient dosing I hope sooner than later.
Okay loves it.
We are not delayed.
Okay.
And then I.
I may have missed it I didn't I didn't the hearing.
He was off his prepared comments.
123, but.
I seem to recall that you had completed dose level to the next dose is going to be an intermediate.
At dose level 2.5, piccolo jumping to dose level. Three can you just provide us an update on personnel I think what are you all with 123.
Well, yeah actually you know.
We've been very cautious with this type of card because we had a series of Crs.
In the past and we think that those level two could be an interesting goes so so far and we are.
Concerned by dose level, three that being two high dose. So we are trying an intermediate dose and potentially I think that maybe are there is lack of in Germany did between the two like giving a repeat dose.
Onto or something like this because it's quite a reactive.
Reactive targets and it started easy disease, so I'm not going to go through all the details of this but I think we are in the water that are.
Interesting for that dose level deal to ore and that maybe it could be a you know a high waters I'm guilty.
So this is not simple.
Simple cartoon to the dose.
Right understood. So there maybe be filed.
Like an amendment to try do you need to file an amendment to try dose level 2.5, I'll repeat dosing.
Uh huh.
Dell to eye you just like how you can do this but to do a repeat you need to file an amendment and were not delayed.
So it's a it's still a.
It remains a challenging our approach and we've.
We've been very cautious with that.
Okay, great. Thanks, Alan something where we're not considering boats were just doing.
Okay. Thank you.
Our next question comes from the line of Brooks just two weeks.
William Blair. Please proceed with your question.
Hi, this is bret.
Raj Prasad.
Question regarding the manufacturing.
'twenty 'twenty tail.
If you could provide more color on how the manufacturing process.
First from a single target Eid products and details on the running yield between the two.
Thank you Brook I. This is a great question and I can definitely start.
So we'd you got 2022 uses the same allogeneic car T manufacturing platform that we developed that's selected.
So the same manufacturing process, that's one 'twenty three 'twenty twos, yes, one with all the improvements that come from manufacturing in house from a rally facility.
There is definitely some specificity in the viral vector construct due to the dual targeting so we use a bicyclist tronic construct to carry both cars and we found that this was the most optimal construct for allogeneic, but put the allogeneic approach.
We have found that.
Not modify at all the value proposition of allogeneic, which is getting significant yields in order to get the true off the shelf therapy that can be distributed either at an industrialized. The scale. So there was definitely a lot of process improvements to cater for this dual targeting approach.
We have found that we could get to a similar yields into the one hundreds of doses.
Manufacturing campaign that we're getting for the other car T.
Okay.
If if you.
If you take a technician that is making your car T 22, or a dual card 20 by 'twenty two.
He if you don't right exactly to Chew for example, Ken containing lentivirus vector.
For CD 20 by 'twenty two versus 22, he will not realized so it's exactly the same.
The only thing that the first is <unk>.
QC again to be sure that both cars that are expressed or like the killing on 2020 two notwithstanding the fact that the other targets that PRASM et cetera. So there is a QC processes slightly more complex for your car T 20 by 'twenty two to be sure that you have to Joel but during the man.
Factoring process itself. If you don't know what's contained in the lengthy then you don't know it's exactly the same.
Okay awesome. Thank you.
Yeah.
And our last question comes from the line of Saudi which do with Goldman Sachs. Please proceed with your question.
Hey, Good morning, this is Matt on for Celgene.
Could you elaborate on the rates of patient enrollment across the portfolio are there any headwinds we should be aware of and then a CD 20 by 'twenty two given the C. D 52 gene disruption are you able to use a lot of talks or pre conditioning regimen.
Thank you Matt Great question Andre.
Well the pace of enrollment so far has been slow for numerous reasons.
Across the three trials, so 22 and acute lymphoblastic leukemia for plastic leukemia is a rare disease.
Barrett to non Hodgkin's lymphoma, or like 120000 patients in the U S.
Ah patient every year in the U S versus like 6000.
120000 burst that 6000 sites quite huge so it's been the enrollment has been slow she has sworn as I said before also there are a lot of products in the space of the trials are.
Our recruiting patient that says the criteria and they're like tight criteria for numerous reasons also is quite slow where ideal one well completed deal free for a P. One for 'twenty two about.
Just one for Jeff one falling to home and one two or three is a difficult disease to treat so also like the patient selection and.
Is something that slows down their enrollment and we are like completed deal two in Belleville to deal too high.
Have difficulty to jump to gel three as I described before and that takes also a lot of time now one of the things we're doing we're expanding to other countries because like in the U S. There is a lot of trials going and we.
We are opening other countries and we believe that all the countries have less.
These are complex film gene therapy trials. So there is more.
Potential and recruiting patients that's what we believe so.
And are you a car T 20 by 'twenty, two which is not touching lymphoma is opening in multiple countries.
Altogether because of the U S was faster, but potentially you will see in our trial expanding to other countries that should extra rate all sorts of trials.
And I think our math on the C. D 52, no calls I think what Super interesting with this approach compared to others is that you can definitely tune the Lin for depletion because you can dial up or down the level of administration of this anti CD 52, which.
It's true for the single dose, which could also be true in the re dosing regimen. So we really have a dial as opposed to an on off like like beat that's when we really have a dial that will definitely allow us to fine tune the length of depletion.
Single and potentially a repeat dose study exactly to the right.
<unk> safety benefit ratio. So so you're spot on and I think this is what we love about the city 52 approach is it it's inherent to an ability.
Great. Thank you very much.
And we have reached the end of the question and answer session I'll now turn the call back over to Andre to Leeco for closing remarks.
Thank you very much for all of Q4.
Supporting the company and asking question.
And I think they're all like very great question of course, we're super excited by the start of your Cart T 20 by 'twenty two I think the company is heading at a very interesting moment.
In the near future.
Your cart T 22 is moving to P. Two hospital surcharge of cards 20 by 20 to in House manufactured product also we are also progressing long. She has sworn in one two or three and the thing is like we will definitely keep you updated on these trials in the near future.
Sure.
And with that I'd like to thank all of you and wish you a very great day.
This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.
Yeah.
Okay.
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Yes.
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