Q2 2021 Cellectis SA Earnings Call
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Thank you for joining us for today's conference your conference will begin shortly thank.
Thank you again for joining us and your conference will begin shortly thank you.
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Greetings and welcome to the select US second quarter 2021 earnings call.
At this time, all participants will be in listen only mode.
A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please note this conference is being recorded.
At this time I'll now turn the conference over to Eric <unk>, Chief Financial Officer, Eric You May now begin.
Thank you very well for me, we want to sell at.
Second quarter, 'twenty, 'twenty, 1 corporate update and financial results Conference call.
Joining me on the call today with prepared remarks is doctor Andre should equal our chief Executive Chair.
Ductile Cary bounds, our chief Medical Officer, and he's got Alright, all senior Vice President of U S manufacturing will be joining for the training.
Yesterday evening.
Keys for the interim report and issue a press release.
Are you talking our financial results for the second quarter and 6 months per yard Andy.
And in June 'twenty 'twenty 1.
The only for credit Suisse I have anybody on our website at selected Dot com.
As a reminder, we.
We'll make forward looking statements regarding <unk> financial outlook.
2 its manufacturing regulatory and product development plan.
These statements are subject to east and uncertainties that may cause actual results to differ from those forecasts.
A description of these can be found on our must be sent form 20-F filed with ACC and the financial report for the year ending on December 31st 2020, and subsequent fighting till it keeps makes with ETT from time to time.
Now I would like to turn the corner over up to 1 day.
Thank you Eric Good morning, and thank you everyone for joining us today. Despite challenges the world is facing so like this has achieved series of key milestones and we are incredibly grateful and proud of all the hard work achieved by our team our partners.
And our stakeholders.
During the first half 2021, we have made significant progress although from debt, we're thrilled to share with you over the next half an hour.
Today, we believe that select is reaching a turning point and is entering into a new phase of fits the walkman demonstrating excellence in clinical execution and acceleration of our internal wood product manufacturing of both new products and <unk>.
So new stock of existing products for expansion phases of our clinical program.
So like this has enrolled patients in parallel and the 3 sponsored phase 1 dose escalation trial for our 3 clinical stage wholly owned product candidate <unk>.
<unk> 22.
<unk> zero, 1 for relapsed or refractory b cell lymphoblastic leukemia.
You've called 123 in Emily zero, 1 for relapse or refractory acute myeloid leukemia.
And your car T X, 1 and Melanie zero, 1 for relapsed or refractory multiple myeloma.
During the second quarter, we presented preliminary translational data for the first group of patient enrolled for the melon easier 1 of few car tier 1 at the virtual American society of debt, the gene and cell therapy.
For to 'twenty for 24th annual meeting.
Early preliminary data validates, yes, 1 as a target for allogeneic car T cells in multiple myeloma.
You cards, yes, 1 expansion and persistence was observed and correlated with the change in relevant serum <unk> and anti myeloma activity.
Melanie Zero 1 trial is currently enrolling patients at the dose level -1 day.
The first of the 3 planned doses level.
We organized the virtual event pull select this innovation day that took place in May 2021.
Good day event provides an inside look at select this and was a huge success with greater attendance through the week where.
We presented a clear view into our pipeline of new product candidates, our gene editing platform, our electroporation technologies as well as our end to end state of the art internal manufacturing capabilities.
These new immuno oncology product candidates include <unk> 20 by 22, the first allogeneic <unk> car T cell candidate product.
For B cell malignancies.
Power a few car 20 by 'twenty 2 is that it is not yet another CD 19 product CD 19 is known for crowd of target space and new card 20 by 'twenty 2 with the power of dual card can address all patients with b cell malignancies, including the 1.
Not responding to numerous TD 19 targeting treatment.
In addition.
We also presented <unk> meso targeted mazatlan expressing solid tumors and new card Mark 1 targeted mucin, 1 expressing italia cancer.
Finally, we presented you park FAP, a fairly innovative mechanism to pursue solid tumor for targeting.
Targeting cancer associated fibroblast cash.
In the tumor microenvironment, which has the potential to turn cold tumors Hot.
We plan for <unk> of <unk> 20 by 'twenty, 2 a new manslaughter land in 2022.
During these innovation days, we also introduced the market to heal.
Our genome surgery platform for genetic diseases, the platform leverage the power and precision of cash.
Palin gene editing to perform therapeutic genome surgery of hematopoietic stem cells.
We announced programs in sickle cell disease leads it's almost storage disorders in primary immune deficiencies.
He'll lead product candidate is titled Logan Zero, 1 for the treatment of sickle cell disease.
Logan Zero 1 is using.
Using both talent and technology to induce a double strand DNA break.
The mutation at the sickle cell disease, causing haemoglobin subunit beta HBV gene.
And in AAV debt will be providing a DNA repair matrix designed to correct. The faulty HBV gene via homologous recombination.
<unk> planned to file a 90 for Tau globe in zero, 1 and 2022.
If you are interested.
And watching select this innovation days on demand episodes, you can get more information on our website selected dot com.
In May 2021 selected and Sanofi entered into a partnership agreement and a supply agreement regarding alemtuzumab and anti <unk> monoclonal antibody to be used as part of the lymphoid depleting regimen in certain inflicted sponsored neocart clinical trials.
Sanofi will supply Alemtuzumab to support select this clinical trials and we agreed to enter into discussions to execute the commercial supply of <unk>.
Alemtuzumab.
They are pre agreed financial condition.
In our Paris, JMP manufacturing facility manufacturing of plastic blackmun's, starting material. It's Danny Matrix's is now fully operational.
1 very critical element was the production of messenger RNA coding tailings.
That's where our debt are at the center of our gene editing approach.
We are proud to announce that messenger RNA are now in production at select us.
We finally remain on track for the manufacturing of viral vectors in the second half of 2021.
In a rally GMP manufacturing facility, we successfully completed 2 U car training runs from starting cells, 2 vile drug product and we have started mid year production of first batches.
Manufacturing independence.
And execution in the cell and gene therapy space.
Is a key success factor for all companies operating in this pit.
If arena.
We believe that selected is a state of the art Biotechnology company with the product development post debt.
<unk> master from a to Z, including the construction of our appropriate or at low proportion devices to the production of buffers up to the vial final product ready to be injected with that I would like to hand, the call over to Eric to talk select this chief financial Officer.
For an overview of our financials for the quarter.
Eric. Please go ahead. Thank you all day day.
Before I provide a week for broadview off our financial for the second quarter and the first 6 months of 'twenty 'twenty 1.
I'd like to highlight some of our business development activities in 2020 day.
In fact at the beginning of 'twenty 'twenty..1 we are now I guess with types of Yep, which includes up to say that all of that and $16 million up development. They get up to a certain milestone and we are eligible to receive single digit payment the net share of all partners.
Well, that's very much liked by types of him.
In addition, we expect to receive an equity stake for 15.
They're low insightful, yes.
All of it gets paid for.
15 million debt up you Stephane condition, all net net.
By December 31st 2021, as well as an option to invest in future I don't see low.
With respect to well.
With other gene in 2020, 1 we received a 5 million milestone payment on the non trophy.
Oh, I know <unk> in renal cell carcinoma.
As a reminder, we are too risky for began to build out in each day.
Development and sales milestones.
The way I can share.
Jim Sabia and types of zone.
Okay ill Nino financial.
The cash cash he keven share on financial debt and cash position activity, excluding Kenny I love to talk just 2021 was $38 million compared to 2 other items.
For me and it all adjusted some buffer detail 2020.
E Mini wheats ex 15, 9 million debt out of net cash flow.
Investing and financing activities, which were partially offset by 46 million debt I'll.
And I think we keep with heat right under the company's ATM program in April 'twenty 'twenty 1.
$11 million per seats on the stomach churning.
This cash position is expected to be to teach them to pump for the key.
Although low enough, where I sense into early 2022 day.
<unk> current away this caused any future milestone payments.
The consolidated cash cash he keep adding non financed for that asset.
And I guess your cash position of Synoekete, including Kelly.
It was 257 million, but all I'd love to talk just for me 21.
Panel, 2.274 million as of December for the.
Well 2020.
The net cash flow used in operating capital expenditure for immediate well 15.9 million below a set of keys and 20 million debt up a study in the first I missed out 'twenty 'twenty 1.
The net loss attributable to shareholders.
Excluding <unk> was 43 million debt off in the past in itself when you 'twenty, 1 compared to a net income of $3 million in 'twenty Duane.
The 46 million.
No no decrease in the next piece that between 2020, 1 and 'twenty 'twenty was primarily driven by unique with no revenue.
Can you and other income of $25 million or an increase in R&D expense is up $19 million.
The consolidated net just had to compete day boats and shell does authentic tea, including Calix was 52 million thereof, or 1 day out 17 cents per share in the first time itself 2021 compared to $12 million or 29 cents per share in 'twenty 1.
The consolidated adjusted net loss attributable to shell does a finicky ex.
Excluding non cash stock based compensation expenses.
Hockey 8 million debt off $1.08 per share in the first San Michele 2021 compared to 4 million debt alcohol 9 cents per share in 'twenty 'twenty.
We are laser focused to spend our cash on their growth.
Our deep pipeline of 41.
In the T and hope for eating all set up manufacturing facilities in Paris and London.
Neil on yours are all focused on making a decision for fine inputs suggestion I know about volume growth in G&A.
With that I will explain to the polo, Ralph long day for concluding remarks.
Although it is quiet.
Thank you Eric.
At selective we continued to leverage our groundbreaking gene editing platform to develop novel per person or a medicine to transform the lives of patients with serious diseases.
Our current perpetual or a clinical stage programs are focused on patients with advanced hematologic malignancies, and we continue to advance our robust pipeline into the clinic.
Tackle additional oncology settings, including solid tumors and to address unmet medical needs of patients with severe genetic diseases.
We look forward to entering the clinic with the novel I O and heal product candidates in 2022.
With that I would like to open the call for Q&A.
Thank you.
At this time, we'll now be conducting a question and answer session.
If you'd like to ask a question at this time. Please press star 1 from your telephone keypad and a confirmation tone will indicate your line is in the question queue.
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Thank you.
Our first question comes from the line of Gena Wang with Barclays. Please proceed with your question.
Thank you. Thank you for the comprehensive update I.
I have 2 questions. The first 1 is regarding do you call 22, you will have data later this year just wondering should we expect that data at Ash and then what kind of data package will you be presumption and then second question regarding your heel on new technology at Berry.
Preston.
But so far most of the indication and are focusing on debt ex vivo system. Just wondering if you have any thoughts to meet this technology to the in vivo.
Hi, Gena. Thank you very much for these questions to our excellent questions by the way. So my suggestion is maybe to have carry answering the first question and I'll take the second 1.
Gary Please.
Or are you starting on day, Yeah, Hi, Gena, so we're aiming to present the data at Ash. So you know we don't know obviously, how that how that will work out for submissions as we pointed out last year, we started enrolling patients into the twos.
Mab arm's length of depletion that includes alemtuzumab since we.
I thought that would be more appropriate for them going forward and we would hope to be presenting that data with some cohorts by the end of the year.
Uh huh.
Thank you Carrie for answering the first question I'll take the second 1 so concerning heal.
Juno, we are of course, focusing on gene editing to fixed genes. So what is a real genuine gene repair.
As we've shown it for the sickle cell disease program called Tao Globe in zero 1.
Uh huh.
The idea that we have today is trying to move.
<unk>.
We have our first platform for.
For the gene therapy product that we'll be focusing on hematopoietic stem cells at first and that's the first focus we have because it would give us a lot of insights underway functioning and also on the way we can conduct all the quality control.
The safety of the probe and channel and how the tail and can behave in a colleague itself for a long time. So most of the product are developing today are based on the ex vivo platform in the metabolic stem cells at first and then.
We are currently working on the second phase debt.
We have not disclosed during this innovation days that I hope will be the new next generation product that will be in vivo in vivo is part of collective strategy of course, but once we will have some very good IV and clearance on the safety and.
The efficacy of our technology ex.
Vivo with Hfcs was older control and.
The quality that can be applied on these type of platform because it sells them for working Jack.
Jackson, then we'll move step wise into in vivo, you've seen recently series of articles in nature magazine et cetera that shows that there are some.
To be checked 1 such as likes ex off.
Off target cleavage, COVID-19 practice et cetera that can happen with a lot of alternative gene editing technology, and we believe talent is an extremely safe and efficient.
Knowledge at the conduct in vivo gene therapy, and Palin our vector is.
Messenger RNA.
And messenger RNA is not.
<unk> nuclear particle.
Most of the competing technology. It's open some gates debt are very powerful for the company and we're very excited moving forward and this ex vivo platform that would definitely paved the way for the in vivo gene therapy bad debt, we have but step wise is definitely the way we would like to move forward.
I hope that answers your question, yes. Thank you.
Thank you Gina.
The next question is from the line of Michael Schmidt with Guggenheim. Please proceed with your questions.
Hey, guys. Good morning, Thanks for taking my questions I had a big picture question first so obviously you have a lot going on.
Pre clinically with.
Programs now spanning car T is a lot of that genetic disease et cetera.
Wondering how you're thinking about longer term your partnering strategy. Historically, obviously you had the the collaboration with Pfizer and sort of EBITDA on the car T side.
Just curious how you think about partnering with a larger company going forward to perhaps accelerate or you know extend especially on the clinical execution side.
Yeah.
Thank you very much Michael for this question is not a simple question because.
When I take the history of the company in the past. So 2014 has been a very fruitful partnering for year as we signed 2 partner partnership in February 2014 service partnership with license your car T 19 to serve you for O B cell malignancies in general so ever.
I think that with CD 19 targeting.
And survey in 'twenty like end up 2015 licensed out the U S rights to Pfizer at this time and 1.
In June 2015, 2014, we signed this agreement with Pfizer licensing out 14th targets.
15 targets for Pfizer, including the CMA or like Sydney, 70 et cetera.
Pfizer decided later to spin out into a company called allergy.
And that had also.
CD 19 rights in the U S.
And a 2.
To date I have the feeling that there was more criticism towards led this on the fact that we license our targets for third parties.
And the potential debt I believe it represents in terms of.
Power execution more resources and more of.
Potential in developing these products. So I've always seen the survey partnership and the Pfizer Slash allergen fire partnership.
As a huge potential for select this even is CD 19, and D. CMA debt was considered as the most of their waste targets that had been licensed to them I don't think that it's.
Only by BCE, I mean, 19, I think day Truecar 'twenty twos, just 112 or 3 'twenty..1 'twenty..2 an example in sob Mach 1 et cetera represent a huge potential for selected.
The wholly controlled targets for us, but also heel. Nevertheless for like this have signed since then 2 partnerships for.
First 1 was in tumor infiltrating lymphocytes, I events or predict and we believe that this partnership brings a lot of potential for selective and also for our Io events in term of the weapon for our gene editing technology in tumor infiltrating lymphocyte, we're not experts in this field and routines.
With the best company in the World to the Latino and fifth trading lymphocytes and I believe that.
I hope that is about to solve a problem they have into like this.
Quality stuff and I leave it to the island seem to answer this question, but also recently in.
Uh huh.
For the NK cells that are derived from Ips cells car T. So and pay card.
Cars that are going to be the block buy a site sized rvs. So we're also very excited about our own portfolio. We've been very much focusing on trying to push that forward in the clinic as much as we can with the resources we have nevertheless.
We believe that select this have the potential and parking because.
There is some options to develop some of these products.
The potential of select us and producing them with the manufacturing.
For clinical supplies, but also for muscle supply opens the gate to bigger.
<unk> pharma partnering in the future and this is something we definitely consider for remain very opportunistic and field.
And it depends of what can be considered.
Future and select is definitely poised to.
For the consider any type of partnership in the field I'm not going to emphasize on this because we have a series of discussion the question.
Understood in the field and.
Well, we're definitely remain very open they're opportunistic, but we will definitely continue also to self develop our own portfolio. Because we think that this will provide probably the best value and consideration for the company in the future.
Okay, great. Thanks, Andrea and then just 1 follow up on Tom Ben This is obviously a very elegant.
Perhaps differentiated mechanism to address sickle cell disease.
Based on that I guess, how would you expect the products clinical profile, perhaps 2 to differentiate from some of the other programs out there be it a gene editing or gene.
Gene therapy program.
Okay.
Oh. Thank you microphone. This question well you know you have.
A series of different type of for approaches for first approaches.
Classical gene therapy approach that dispersed by 1 of our competitors in the space.
Leave the sickle hemoglobin inside the cells.
And just to bring another gene.
That is going to start producing normal hemoglobin bar the sickle haemoglobin will remain at yourself.
This is random insertion of the June inside the cell that can in thirds.
Sometimes and low side.
<unk> produces the hemoglobin gene like EBITDA.
<unk> gene correctly, sometimes it will be inserted in some places where there are sizable silencing of wobbling, so they're expecting would not be consistent or sometimes in person could induce some side effect into the metabolism of the cell that could be potentially harmful.
So we consider this option, even though a close to commercialization.
Work present, a window in the spectrum.
<unk>.
Approaching power.
Haemoglobinopathy and Joe.
So I don't think that this type of classical transgenesis approaches without fixing our modeling will prevail.
It would be and then terminated he had the second approach, which represents more of the used oil.
Danny Scissors I'm not speaking here you would notice.
<unk> gene editing because gene editing means everything to text you go so people consider that gene editing is getting into the cell and edit the mistake.
Most of these approaches are fixed on destroying a gene which is D. C. L 11, 8 which is the repressor, therefore presses the expression of fetal hemoglobin.
So St case as before you keep the sickle hemoglobin inside the cell for the problem remains the same but you left the expression of fetal hemoglobin that could compensate.
For the <unk> model of an inside itself. So I destroy Jean I don't fix the problem I just destroy gene to trying to imbalance the way like the cell behave and that obviously works also but I also consider that this is going to be a parenthesis index.
Field or therapies in the field and then you have selected co he'll approach, which is a bonafide gene editing approach you have a mutation in the bundle or indeed, Jim you get inside the cell.
Please do.
For the mutation itself.
And repair the vacation.
Is a patch that will fix the journey, so really do true editing. It means you removed the mutation and the mutation will be removed from the cell and the normal physiological haemoglobin will be expressing at this time and are very high and very iffy.
Fishing way. This is what we believe would represent in the 21st century. The future of these type of gene editing approaches, which are true editing of the mutation inside the cell not trying to for example, if you had a flat tire at the site for spire.
The car, but a real fixing this gene. It means you removed the flat tire and put a real tire for the fourth sorry for tires for the car to move forward. That's a kind of a comparison that we have year end debt, where we believe that these cells will behave totally normal with normal adult and modeling a day.
In for select US pursuing this approach would find probably in 2021day first R&D in this field.
'twenty 2 sorry, 2021in the field.
Of course, there is competition, that's field, but not that much it requires a lot of power it means and the ability to target very precisely the mutation in this model being D. G fixing with a very high efficiency the mug Libyan gene the gene.
At the very high level without inducing some.
Tyler stomach mutation, which is beta zero, Mark Levin for destroying the model in itself.
And at the end like this I think has the best by far technology in this field and that's why we believe that the steel platform with definitely change the game. It's a game changer in the field of gene therapy and gene editing.
Great. Thanks, Andrew.
Okay.
Our next question's from the line of Kelly <unk> with Jefferies. Please proceed with your question.
Thank you for taking my questions. My first questions is about let's say on your program targeting <unk> 2020.2 simultaneous I'm curious what is the rationale to pursue things that you were targeting strategy what are the expression levels relative.
The city of 19 for these 2 antigens and also how rapidly they are ex crashed or they are complementary to each other.
And also another question is about your car cash bond program, a prolonged lymphopenia well I think I have got a in that program and I Wonder. If this is caused by size wise ubiquitous expression not only to be south, Florida on Pizza Sandra day.
South and NK cells like I don't even yourself and how do you address may see share when he saw that thank you.
Yeah.
Thank you so much Kelly I think these 2 questions definitely fits Kerry.
And space, all carry clean or a few European absolutely 20 by both C. D 2020.2 are validated targets and do something malignancies in there just as the frequently if not more commonly expressed at 10 CD 19. So as you all well know we're talking about.
Did you pick for this treatment for all B cell malignancies, particularly for NHL is target CD 20.
CD 22 is similarly expressed that they are in NHL is expressed at more than 90 per cent of patients and the idea obviously of having 2 targets is number 1 you can prevent antigen escape. If you lose 1 or the other you also had increased sitting opposite between that the car T and the tumor cell which showed the.
Ended up with a better expansion and end and.
Because of the.
The synapse. So we think 'twenty 'twenty 2 is an excellent target for NHL and it can also be used in our in abroad.
M B cell malignancy space, because 2020.2 are expressed from early they're early b cells through more mature so.
That's the rationale for that and then in terms of C. S..1 so yes, we did see some prolonged lymphopenia and in 1 of the patients and theoretically it could be due to the C. S..1 expression because as you pointed out correctly. So that's 1 that's expressed on hum multitude of items.
At the immune cells, but at this point, we don't know yet what we.
We don't know exactly why the Lymphopenia was as long as it is we also know from autologous car Ts that are not N D. C. M. H, so non C. S..1 expressing.
Car T is that people and Pete patients, who receive them can have prolonged lymphopenia out for 6 months, so and 6 months or more so it's unclear 100%. If that's the reason, but that said we've updated our protocol, we have lower doses of the Olympics, the Olympia depletion chemotherapy.
Arab B and monitoring for infectious causes and I'm, well keep moving with the program and see how things Pan out.
Thank you very much very helpful.
Yeah.
The next question is from the line up for you going backwards with Citi. Please proceed with your question.
Hi, great. Thank you very much for taking the questions I'm curious about the U cart muck, 1 product candidate with multiple edits, which is a fascinating product.
And I'm curious about your credit Mark 1 specifically from an IP perspective, and the reason I'm asking is that there's another company caribou that recently went public debt.
Also has a product with a PD 1 knockout and their season 19 car T a product as well as a beta to micro Goblin knock out with an HLA knock in to provide immune cooking, which appears also very similar to what you were doing with you caught them up 1 so based on that I'm, just wondering where do you stand from an IP protection perspective with.
<unk> just some of these edits and new card book 1 thank you.
Thank you so much the Gal for this question is very much appreciated.
I tend not too much to to commence to the IP situation for obvious reasons for this.
Factors that select this has been.
Long term.
In the field of gene editing and the company has been founded in 1999 gene editing lumping series of different type of approaches.
With gene editing.
Using as the basis snag any places.
We've been also lapping series of different type of approaches with Palin.
Since 2013, even March 2013, so before carey or any type of company.
Company, even had the idea of being inserted at this time.
We're already filing IP in the CRISPR slide so I strongly believe.
This has a very strong position in this field.
And.
We had a very strong merit lumping. These type of approaches we can see the history of the company since at least 10 years in the field.
Or 20 years, even if you want to take hold the history of the company 21 years.
In all these ideas of Bunking of all these deals kind of lumping oldest strategies.
In the product the Watson, including Mark 1 an older attributes that are included in that makes these.
Development of our part per port for patent portfolio strategy extremely strong.
Nevertheless, you know, we're still all companies in the clinical or preclinical development phase.
[music] the thing will be solved at the time, the FERC Paula will start to be commercialized. So I guess are the oldest space around alternatives competing technology that seems very easy to approach intellectually I don't think that it's easier to approach.
Technically, but it seems to be more approachable intellectually will start to resolve at the time. The first product will come to commercialization and I think it's going to be more disciplined and more complex approach at this time, but for the time being is it still in the safe Harbor situation.
The thing seems to be quite simple for a competitor. So I would keep it here, but I think that's like this have a very.
1 of the.
You know free.
Like first company in the field of like Big Lumping gene editing tools in this space and very strong strong position in this space and we're not going to compromise on the scale.
Great. Thanks, and just 1 follow up on an.
Unrelated topic regarding your solid tumor strategy, how much can you say at this point regarding which which solid tumors you would you would tackle first.
Given your your product candidates are there certain solid tumors that would make more sense to start with.
The first target debt will probably go into the clinic is something that seems to be quite a.
Alrighty.
Tackled with autologous car T, which is a result of line card.
Car where it.
Have series of aggregates in there, including TGF beta 2 <unk> receptor knockout.
For all Mazatlan explorer Lenovo to the linear expressing tumors.
Comes from the zone pancreatic cancer et cetera. So there's a different type of indications will be probably the first car T to go into the clinic.
Got it thank you.
'twenty 1.
Yeah.
The next question is from the line of Jack Allen with Baird. Please proceed with your questions.
Hi, Thank you so much for taking the questions and congratulations on all progress.
I guess for start we were wondering if you could provide some more color with respect to the progress we're making with your car T. C. S..1.
It sounds like based on the press release, we are still in the dose level -1 cohort any color you can provide with respect to the number of patients enrolled since the re initiation of the study and when might the dose escalate there. Thank you.
Gary do you want to take this question.
I can take the question on were progressing on for.
Progressing well in the clinic I don't want to disclose specific numbers are exactly where we are and what we're doing but what I can say is that we reopened after the whole with those changes I mentioned earlier, most importantly, with the lower dose of the Olympic depleting chemotherapy.
And starting at those slipped my mind, that's what and so those are the 2 big things I'm 1 of the other.
Requirements. It also the FDA is requiring.
Long safety watching periods. So we are you know the dose escalation is flow them, but.
But we have our sites on board, we are very very active investigators looking with patience and I don't foresee.
Recruitment being an issue what I see being the issue is that all the requirements to hold in between patients on what I'm I'm.
I'm very optimistic about is as we gather more data and being able to.
Got to sit with FDA potentially in the future I'm moving him for a long faster if things are continuing to look safe so to be continued.
Awesome that sounds great and then sorry I just have 1 quick follow up question on the financial side. It appears you're pretty well lined up to receive a milestone from them.
In February.
For the ended the year due to the initiation of the pivotal CD 19 program I was wondering if you could provide any more color with respect for the size of that milestone and and how you're going to account for it is going to be a 1 time benefit for probably the fourth quarter. This year it will be amortized across a number of quarters. Thank you so much.
Eric This is the question for you.
Thank you very much for for the question depending when we.
We stopped the people studies at the top you know it.
The end of.
Fourth quarter of 2021, we recognize the revenue in terms of payments that could be.
Between either for.
2021, or beginning of 2022.
Based on the inventory, but the revenue will be recognized in 2021 is this down the size of the milestone has not been disclosed today and it's still a confidential information sorry about that.
No problem. Thank you so much for for the answers.
Thank you.
The next question comes from the line of <unk> Singh with Oppenheimer for XI with your question.
Oh, great. Thank you for that for the question on the update.
I have a question on your car 'twenty.
<unk> 22, and a new carton meso.
And that is you know your current meso is for solid tumors 'twenty 'twenty 2 is.
For bi specific or.
Dual car T product.
If you can just comment Andre on what are the sort of the differences in your preclinical and manufacturing between these 2 you know as you get them into the clinic next year with your R&D what are the different steps or maybe additional steps you've had to take.
With addressing a dual car T.
Another 1 that net target solid tumors or are there any.
And if so what are those index for the question.
Okay.
Thank you very much hurt our sights on Monday. Thank you very much for the question. So you're part 'twenty 2 as you called 123.
And your car 20 by 22 are all based on the same type of.
Platform, so they're very similar all of them because they are both the same way they have.
The card that is added by a lengthy viral vector.
For the dual card, so 123 and 22 built.
The card that is embedded in the lentivirus vector plus also are able to suicide switch for 'twenty 'twenty..1 'twenty 2 we've moved a suicide switch and replaced it by now.
Another car. So you have 20 in 'twenty 2 that I expressed in the same 90, so it's pretty much. The same. So you always add first of all 90, then you have a double knockout that happened, which is C. B 52, TCR Alpha <unk> platform.
So 22.20 by 22.123, no difference any kind of all for either would not see even the difference is.
Essentially the quality control that makes a difference so like the building the car is extremely similar and very much sway it forward and we know very well how to do it.
Zeppelin, which is the first solid tumor car is slightly different and requires maybe 1 level up in terms of complexity because it adds a third knockout so ms offline car seat.
<unk> 52, TCR Alpha plus TGF beta 2 <unk> knockouts of third knockout it added to the.
Due to the mixture, which makes the things slightly more complicated and you'll have to make a cereal.
Knockout theories in order to prevent some France location, and I think selected and mastering.
The proportion of technology, because we're only technologies there allow us to be loved these type of.
Process in a very efficient way and we're very excited to start with production up in bottling to 5 the IMD next year not 2021, as I said it before but for me in 2022.
And a great Andre this is all very very cool stuff.
There's just a general question, which is that your facility Raleigh looks.
It looks like they were able to run their first start.
Like other companies do manufacturing days are you thinking of doing something like that also for for investors and again, if so when could we see that and again thanks for all the questions.
Thank you.
Our debt for the question the answer is yes.
We have the plan to organize.
Live visit of our manufacturing facility in rally I think definitely it worth the visit because we believe it's a state of the art.
Selling gene therapy manufacturing plant that combines not only gene.
Addition, but also a gene editing with a very powerful way to do it with very sophisticated and modern way to to produce a cell and gene therapy. In this space. So that will be organized probably in the third quarter this year and will third or fourth quarter.
Or actually you like probably in 3 months from now and we will definitely send a save the date for old investor and analyst community and everyone that you'd like to visit the facility.
We believe.
Setting the trend into what will be the modern way to do these type of therapies in the future.
Okay.
Great. Thank you.
Next question is from the line of Rajiv Prasad with William Blair. Please proceed with your question.
Hi, This is Danny on for Raj. Thank you for taking our questions. I was wondering if you could provide an update regarding our where you're at in terms of enrollment and dosing in your current 123 trials and when we could expect updated data from that trial and then also for your solid share programs. How are you guys thinking.
<unk> about Winslow depletion and dosing thank you.
Well. Thank you so much for these questions and Carrie I guess these questions our address to your share.
I'll start thanks, so much I'll start with on your cart 123, so as we had previously discuss debt earlier meetings, we remain in the dose escalation phase for any part 1 twenty-three we had switched over.
So open the cohorts that include Alemtuzumab them earlier.
A lot of our late last year and so those are continuing for law and we're hoping to.
Hum.
Some data some probably first half are early second half of next year.
In terms of the solid tumors for Alimta depletion as our first program as Andre pointed out would be to your cart Meso program.
And that is utilizing this any pets each day knockout. So we would be using a similar amount for depletion to what we're doing now for the Hum hematologic malignancy program, but maybe not exactly the same thing would be using Alan.
Alan She isn't that route with this.
Product.
In terms of dosing, we haven't disclosed what we're doing with the doses at this time.
Thank you.
We've reached the end of our question and answer session I will turn to flow right to management for closing remarks.
Well. Thank you very much I would like to thank everyone for this.
For attending the session like this Q&A session are there words like excellent question 1 of the things that I'd like to say is that the company has definitely hit a turning point in the start ups.
Our own manufacturing going from like gaming to messenger RNA to car T that started to produce in our in our rally in manufacturing facility. We're super excited.
We're extremely excited by the programs we have in the clinic, but also by the programs. We have neither on the car T side, but also on the gene therapy in the heel side debt.
Marks a new turn in the company.
Second half of 'twenty 'twenty, 2 will be a very exciting time.
By the end of this year the company will start producing series of data in the very exciting runway 2022. So thank you very much for all your.
Pension and looking forward for the next steps.
This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.