Q2 2020 Cellectis SA Earnings Call
Greetings and welcome to the syndicated second quarter ending school.
This time, all participants are in listen only mode.
A brief question that authorization will follow the formal presentation.
If anyone should require operators during the conference.
These based stock you're on your telephone keypad.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host <unk>. Thank you you may begin.
Thank you and welcome everyone to select the second quarter 2020, corporate update and financial results Conference call.
Joining me on the call today with prepared remarks are Dr. Andreas Willi go Oh, Chairman and Chief Executive Officer, Dr. Cary Brown seen our Chief Medical Officer, and like you know our Chief Financial Officer.
Yesterday evening selected issued a press release reporting all financial results for the second quarter ended June Thirtyth 2020.
The press releases are available on our website at <unk> Dot com.
As a quick reminder, we will make forward looking statements regarding financial outlook. In addition to regulate train Clark development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Hey description of these where it can be found in our most recent form 20-F on file with the FCC and the financial reports, including the management report for the year ended December 31st 2019, and subsequent filings select that makes with the FCC from time to time I would now like to turn the call over to Andre.
Thank you Simon good morning. Thank you everyone for joining us today I will start with a quick introduction before handing the call over to our Chief Medical Officer carry brownstein for an update on our clinical programs and our Chief Financial Officer, or we do talk for a review of the financial.
The second quarter of Twentytwenty has been very productive lucky.
We continued to be amazed by the commitment under relentless not every nurse and Doctor, who give outstanding care to cancer patients at the quick critical need.
In these exceptional time.
I would like to highlight I hadn't been progress I'll Barkers allergy and uncertainty has made in driving forward for the development of a lead license candidates your car T. My team and you card BC Amy.
Which allergan renamed into our fiber one out of fiber, one eight and Hello 715, respectively.
As a reminder, you'll party Nike or Aloe fiber one is exclusively licensed Turkey, and Turkey exclusively sub license its strike.
And do you want to allergies.
Your card became a well out of five stuff and I look 715 is exclusively licensed to allergy.
Although fiber one has made headlines I spoke in Chile, well partners Allergan in Serbia presented during phase one dose escalation data in patients with not Hodgkin lymphoma.
With a complete response weight, 44% and no overall response rate, 75% in the subgroup of patients who were naive to car T cell treatment.
No gvhd inadequate safety profile.
This data update.
As a follow up to the data presented at Ash 2018 word to phase one dose escalation in relapsed refractory CLL patients showed an 82% she our share right yeah why rate at an optimal lymphodepletion.
Your car T D Sammy or although 715 is also progressing nicely to phase one.
Dose escalation.
Trial in relapsed refractory multiple myeloma.
But that's not all partner program significantly deer with.
Milestone and royalty revenue for selected.
Like this is entitled to receive up to $410 million outstanding milestone payment.
Also low double digits royalty on a worldwide sales from Serbia in allergy exposed Cdnineteen directed allergenic car T program.
Well as it up to $2.8 billion in milestone payment plus a high single digits wealthy.
Worldwide sales from Allergan darkly for the 15 license Allergenic car T cell target.
Including be seen today.
On our side, we're pleased to see the progress in patient enrollment for proprietary allergenic car T cell program.
For your car T 22 patients with relapsed refractory B L. L into bally's here, one trial as well as new car T 1234 patients with relapsed refractory AML into Amalie zero one trial.
Both programs are currently idled level too in their respective phase one dose escalation.
After dosing the first patient in December and January respectively.
Your car T C S. One for patients with relapsed refractory multiple myeloma ended Melanie is there one trial.
Has been put on hold early July pulling did that oh for patient ideal too.
We're currently working with the F D to address the agency or with Jay agencies request.
And hope to resumed the trial.
Our strategy is to give an early and dream data update on one of our preparatory program in Q4.
Or disappear.
After round irrelevant scientific meeting this update will be the beginning.
Our proprietary clinical data read out, which we plan to give on the periodically at relevant scientific meeting in regular inter bill.
With that I'd like to handle coal over to Dr. Brown, our chief Medical officer to discuss the status of select the sponsored trial.
Harry Please go ahead.
Thank you Andrea as previously mentioned BOLI zero, one evaluating you cart 22 in patients with relapsed refractory b cell acute lymphoblastic leukemia, and homily zero mine evaluating you cart 123 in patients with relapsed refractory acute myelogenous leukemia can you continue to progress through their respective.
Those levels in these phase one.
Dose escalation study.
The primary objective of these phase one studies to evaluate the safety of the product candidates and determine an optimal you cargoes and corresponding Lymphodepletion regimen. In addition to safety Correlative studies will evaluate T cell expansion when do what persistence and anti tumor activity at all dose level.
As a reminder, balis eurobond its plan to complete three consecutive dose cohorts and I'm only zero. One is planned to complete four consecutive dose cohort followed by expansion cohorts at the optimal dose and Lymphodepletion regimen.
The optimal lymphodepletion regimen prior to the administration Allogeneic car T cell product candidates remains an area of investigation in the field of car T cell therapy, one of the fundamentals of our phase one dose escalation and expansive trials it to determine the optimal Lymphodepletion regiment prior to treatment with the allogeneic car T cell product.
Selected as the patent holder ended vendor the C.D. 52 knockout and allogeneic car T cells that allows the use of a CD 52 targeting antibody like LNG is about in the Lymphodepletion strategy. This concept has demonstrated a prolonged selective hosts T cell depletion, which correlated with aloe car T expansion and the.
Already incorporated in the current you Cart 19, you Clark 22, and you cart 123 constructs.
We recently filed protocol amendments with the FDA for both the Bali Zero one trial.
Would you cart 22, and Amil easier on one trial with you Cort 123 to include the evaluation of the addition of Allen to use a map to the cyclophosphamide plus do they are being lymphodepletion regimen.
Importantly, this UCAR 22 program also allows the enrollment of patients who have previously failed prior anti Cdnineteen car T cell therapies, giving these patients with significant unmet medical need another car T cell therapy option.
You cart. Once you three is currently in dose level to you in patients with relapsed or refractory AML to date. The anomalies. Your one study is advancing as planned and importantly, we have not seen any adverse safety signals in the phase one dose escalation.
Moving onto you card C. S. One on July 620, 20, so like this and now that the Milani zero one trial phase one dose escalation and expansion study of you car T. S. One in patients with relapsed refractory multiple myeloma had been placed on clinical hold by the FDA.
This whole bits impact only this specific product candidate was initiated.
Following the submission of the safety report regarding one patient embolden the study at dose level to the patient who had been treated unsuccessfully with numerous lines. The prior therapy, including autologous car T cells experienced a fatal treatment emergent adverse event toward the end of the 28 day DLC observation period.
Clinical evaluation of the case is ongoing and additional details as to the immediate an underlying causes of this or that are being collected.
Of note prior to the clinical hold being issued by the FDA, we had already decided to expand enrollment at dose level, one, which maybe an appropriate dose or further evaluation and the expansion portion of this trial and potentially the recommended phase two dose based on assessment of the preliminary clinical and translational data, we had already begun executing update to the clinical.
Protocols to reflect this and as well as to monitor and mitigate for potential risk given the novel mechanism of action of you car T. S. One product candidates.
We are working closely with the FDA to address the agencies request.
Additional information and an amended protocol are expected to be submitted in due course as we are working diligently with the agency toward lifting the hold in order to advance this promising program in the clinic.
That I would like to handover the call to our Chief Financial Officer, Eric Dutang for an overview of our first quarter 2020 financial Eric.
Thank you carry.
60 spots hogs 2020 wasn't driven by strong fundamentals.
The cash Kashi covenants, <unk> assets and worth <unk> cash position authentic teeth on their own without Katy.
June 2020, what I want to an $82 million compared to three and 4 million got out as of December 31st when you know.
That's before that.
And yet median got off of what.
We keep salvia in connection with the most 2020 amendment to the <unk> development and competition I agreement.
Which was offset by 48 million got off off net cash Ruth you, you know pricing investing and needs financing activity.
And $3 million and follow but far exceed.
These cash position will be sufficient to fund finicky still getting a passion into 2022.
The consolidated cash Kashi, keeping them fill and finish what I'd say and with 50 cash position of <unk>, including Kelly.
What we on 17 million got all as of June tell just 2020 compared to 300 and he called me and got off as of December 31st 29.
The change there have you reflect when you need young got off and $26 million off net cash flows you incorporating capital expenditure and lease financing activities Sixtyv and catty. It keeps me.
The Citic do you still get <unk> net income that's would you go to shell Dongkuk seductive was $3 million into <unk> outlook 2020, compared to a net loss of 37 million debt off into first talk with 29 cheap.
These $40 million increase internet speeds are between 20 to 20, and 2019 was primarily driven by a significant increase in revenues and other income of 46 million died off and a decrease in Asia and expenses of 1 million data.
That was partially offset by an increase in R&D expenses of $4 million, Andy decreasing financial gain of 4 million Bucks.
The consolidated net loss attributable to shareholders <unk>, including category.
What $12 million, Oh, 29 cents per share the felt affleck twentytwenty compared to $49 million or $1.50 cents best share in the south of 29 Keith.
The consolidated adjusted net loss attributable to show dug up tick <unk>, excluding non cash stock based compensation expenses was $4 million or nine cents per share in the <unk> out of 29 20 compared to $39 million, all 91 cents Dusza <unk>.
29 cheap.
We are laser focused to spend all cash at Devry opting out with deep pipeline of product can do that into technique.
And completing the construction of that yeah manufacturing facilities in parties anyway in 20 Twond.
I would note down their presentation back we'll go to all day for closing remarks, all night.
Thank you Eric.
We continue to invest our human capital and the Big part of this is the growth of our in house manufacturing platform.
I'm excited to announce the doctors, Steve Doris recently joined collected from Beigene I Senior Vice President of our U.S. manufacturing site.
And had a rally manufacturing plant in North Carolina, I Beigene, Steve, let all aspects of global manufacturing Sciences technology transfer and manufacturing process support we're all looking forward to see his leadership and guidance advance our mission to develop life changing.
The agenda Q car T cell product for cancer patients.
Dr. Bill Burke Tee up.
Joined us in May 2020 into roll off senior Vice President of technical operations Europe.
His mission is to ensure exist you shouldn't I did GMP Paris manufacturing facility.
Lets support to the developed and if production of select this preferred perfunctory product candidate.
Dr bit to join select is from social cure, where he was journal manager and five <unk> through the acquisition of social cure by Novartis.
Dr Victoria, and doctored works will be jointly leading selective technical operation, replacing Bill Monte whose leaving the company in August the 620 20 to pursue other opportunities.
Both our joining the company.
Executive Committee.
We're on track to complete our full manufacturing independence by mid of next year, which will be an important piece of further establish like this as a leader in the allergenic car T cells field.
I personally couldn't be more excited about like this position in the market today with a healthy lineup of clinical programs that will deliver beta and create value for all patients and stake holders one after the on.
It was a long road with many challenges to get where we are to date.
Booked we always successfully overcame every challenge in Oh wait.
This speaks for the expertise and resilience off our team.
Well well capitalized to achieve our next milestone and I'm excited for what is to come out for both our perfunctory as well as license clinical programs, there with our partners allergy and turvy.
With that I'd like to open the call to address any question you may have operator. Please go ahead.
Thank you.
We will now be kinda Christian and also suspicion.
Please limit yourself to one question and one follow up question.
If you would like to ask a question. Please press Star then one on the telephone keypad.
Confirmation 10 looking to catch your line is going to question Q.
You May press Star then two huge lifetime is a Christian from you.
Well participate but participants you can speak equipment it might be necessary to have picked before picking this healthy.
One moment teeth, while we pull for questions.
First question, it's something that you're not okay.
[noise], Hi, guys I graduations on all the progress during the quarter a couple of questions. I guess first just in terms of the Algiers choosing that preconditioning. What's the early is that we might be able to get a sense on whether that's the optimal approach to preconditioning and if it turns out.
With that that it does become part of the standard of care for Allogeneic car T therapy, you know how can you leverage your IP around cdtwenty two knock out [noise].
[laughter] outside of select us and I've got a follow up.
Hey, Dan. Thank you so much and good morning, and great question, a that the Simon I would like to direct this question to carry because she is obviously heading the clinical operations scary.
Sure Hi, Jan on Thanks for the question. So you know as we previously said yeah. We've submitted the amendments that D.A., we have to obviously get all that through it all the sites I'm, we're hoping to have updates on our data as we already disclosed hopefully by for one of the probe.
Around that by the ended the year and on it will really all depend on how long it takes to get through all the process that is required forgetting you know changes to protocols updated throughout our sites and through ft, I, but I'm, hoping I'm I'm hopeful that we will have data in you know in a reasonable short.
Timeframe to better understand on it this is the appropriate way forward.
And second part of the question if that's a good point on the IP on CD 52. So just as a reminder for every one we are the inventor and the patent holder of P.C.D. 50 to knock out in car T cell together with the conquering administration of Elotuzumab, which isn't anybody that is targeting CD 52.
So that's obviously, it's becoming a very interesting happening then concept that we pioneered in 2015.
And they'll be comes to it looks to become a real stand at heart of this a prolonged persistence and the question is like there are some programs that may need prolong persistence of car T cells and some other cases, you don't want to have that prolong persistence, but maybe Andre you can add some comments on a strategy around us.
Yeah, Jim It's a very good question and.
It is a very powerful tool for grafting and expanding allergenic car T.
In general, but there are flat few exceptions in there for example, you purchase one that has definitely and hope to date.
That is itself since the depleting a car T. The issues.
Supposed to have the same type of X. similar to Olympian upsell for you or your card shifts one we don't preconditions his own 'cause enough and we expect the core to have similar activity in there. So all in though I think this could become one of the standard.
But there are other alternatives in there that could potentially also bring.
Oh school approach into Engrafting and persistent that the car.
And the IP of course like a true it's an important component and I can collect this has been.
I'd now like eight years and the role building on this allergenic approach and gene edited cartoon General and I think that we have like a strong in.
IP estate and there are two you definitely are willing to ER.
To leverage and find the industry. Our goal is not to block those who love to see tried to enable.
Great good options to lose like and treat come the medical syndrome.
You cards. She S. One and a you know the adverse patient outcome here could you give us any more detail as to whether there were cytokine release syndrome associated with this patient if this might have related to the sell reconditioning of the.
Product or if there are patient factors that could easily excluded going forward.
And again, that's a good question for Kerry and just upfront Jim we haven't disclosed any of the details yet because we're still collecting the data and all the information for that pace and budget as we noted the station that occurred very much towards the end of the deals you observed.
Current period, I'm, which is 28 days long so care, if you want to elaborate on that a little bit.
Yeah, there's not a there's not that much additional to say I think given there were still gathering information and we haven't disclosed the details at this time I don't want to further elaborate on it at this moment, but I think from White Simon just said it was really towards the end of the DLP period.
It's a.
A complicated story and we will once were off hold them are moving forward and have a plan, where where we will be sharing this information.
Yes.
Hi, Christians from Michael Schmidt I feel good huh.
Hey, guys good morning, and thanks for taking my questions.
Another question or on the much of my <unk> program.
You did mention that you decided to expand I'm already it go 71 prior to this safety even occurring.
Maybe talk a little bit about what gives you confidence that this is the right dose I'm already at this point and and how do you think about the need to potentially explore further doses in the future or maybe just a few more you know it's more color I rod that that item.
Yes, so maybe I can third and handed over to carry so for your cards. It's one just as a reminder, we started at a million thousands per kilogram as the dose. This was what the consideration that you can see US. One is also targeting a portion of the patient T cells expressing see it's one because the parts.
He itself as an edits to remove see as one from the surface. So this kind of dual action of both targeting multiple myeloma itself in a portion of the patient T cells that have to initiating the study at a slightly higher dose than for example, you card 123 or your car 22 and now.
Carry maybe you can say a little bit of color on you know what we think the planned forward could be.
Yes sure. So thanks, so much for that question.
Simon pointed out to the dose that those double one in this study was actually very close to some of that final doses for other car T cells that are out there. So it was definitely starting at a higher dose. It as you know we're collecting safety activity translational data as we go along through.
Relation so once we open dose level too we were starting to get additional data from the first dose level and it just it appeared that dose the other one might get we didn't say for sure because with not you know it's early on in the development and there's still in a dose escalation phase then it appeared that the other one may.
May have data that supports further expanding that that though than potentially being the at the dose it doesn't necessarily.
A little out expanding arc and exploring other dose levels, but I think the data that we were I'm getting from dose level, one seem to support that it was at least worth further proceed at that level.
Bob just on the integration on the incorporation of them to sum up a base lymphodepletion into the other to try to try to cause let's just wondering if you could.
Provide some additional thoughts on some of the protocol amendments are you planning for example to evaluate a several different doses of out Mtwos and map a repeat dosing or is it is it if it just can be one one cohort in each study that where you evaluate a certain.
Fixed, though it's maybe talk a bit about how you're thinking about the various parameters that you know need to be evaluated to optimize the lymphodepletion protocol that.
Yeah, I can do that so that yeah carried away [laughter] since okay. So thank you so much but the question I mean again these it since we're in phase, one and where exploring all the above so to speak yeah. It's a work in progress, though I think that.
And in my opinion, the important piece with allergies and I've isn't necessarily that's scheduled per se and died and I know how when it's given how often it's given but it's really more about.
The balancing the deep selective T cell depletion that you get with allergies mab with the safety because you're well aware and we are the Alan just about data has been presented for many years in the context of allogeneic.
No matter, what extent cell transplantation. There is definitely risks of viral infections other opportunistic infections et cetera. So the real key here is to give enough to get to select the T cell depletion, we need without over and you know compromising the patients such that they can be at significant risk of these types of opportunistic.
Action, which then would defeat the purpose of what we're trying to do for their their cancer. So that's the way I'm looking at it and we will be exploring on the use of it and looking for the optimal way forward and obviously that would include all of the above that you bring out and I I don't know if.
I don't think that you need to be trying multiple on.
So many different ways of giving anything you can but I'm not sure if it it's based on the data that already exist. If it makes that much of the difference I think we haven't good sense from.
Not only the data from allergy and then and survey, but also from data previously with allogeneic stem cell transplantation of what an optimal dose is and how to give it. It safely since there are significant risks in terms of infusion related reactions and other things with allergy season, I'm. So I think all that data together.
Really help us pinpoint how to do it on so we can move quickly as oppose to having to try and millions in different ways of getting him.
Next question is from Gena Wang of bulky.
Hi, Thank you for taking my question. So we got a will you costs you. One just wondering I know since the last announcement has seen a one month.
Did you have additional communication with FDA and can you share within more well, yes, I'm looking for and the Wayne do you think you can submit the package to Oh excuse me I'm in a second question is you know a later this year for shoot maybe hopefully.
Josh can you lay all that data we might see from Oh, all the programs.
The new car 20 to 123 and fiasco.
Yes, Gary first question and maybe undercutting feminists thing question [laughter].
Alright, perfect. So I'll I'll start the Gina. Thank you so much for your question and we know that you and others want to know exactly what they want us to do and how and how quickly will move forward and at this time I don't think we want to disclose exactly what is being requested I think what's important to know is that.
We were in discussions with D.A., they they're supportive and we will be moving the program forward and ensuring with their help that we can do it in a smart appropriate way to ensure a patient safety, which is really the bottom line.
So we will be working with them to come up with how we can best you that that's really all I can say at this point that I understand that you would love to know more [laughter].
No worries.
And Andre maybe for the second part of the question that we're building elements import data presentation to within a year.
Well, it's a great question or Gina the idea is essentially like we have.
Three trial, one hopefully resumed ER.
As soon as so necessity actually poorer DSP and have to be sure that we're going not to repeat the same type of for isn't fully.
But you have true trial and interesting data to share, but we don't want to a we'd like to keep the momentum in there as like outcome boot free trial do like to start.
Ah potentially at the end of this year, so you're losing or part of the data as we always said and done on a regular basis scientific conferences or organized by slightly above release that regularly data from each trial.
And update you on the initial trials also as we think the development of this is starting without going to fund a than anything else to than a good thing though the.
Comparing the two and advancing is like the dose escalation up to the time will arise into the expansion phases.
And I think this would be starting at the end of this year is very rich or data which are.
Courseware the company in the hopefully potentially other things that would come up.
Shows like the the kickoff to manufacturing to go live for the manufacturing side compare it to go life for the movement factoring side and rally, but I think our two very important event and transforming the company into true bio pharma.
And moving powered I hope or for older three trials or for the people, who trial that potentially registration and commercializing these problems.
[noise] program do you think it will receive a data first.
So kind of the year I'll make trial, which trial, what we're not saying that.
Yes, it's true.
That's certainly something bad like we know it looked like to keep the you know like the.
Just spend a up to the yen.
No. It does we said it's going to be very early data on a good started the trials at the beginning this year end up last year, maybe early and it will be or partial at this stage, but I think it's going to be interesting.
Next question is on fire I mean Jeffrey.
Yeah, Hi, guys. Thanks for taking my question maybe to start on yes, one for the first dose level. I believe you know investigators have activated isn't worth Tuxpan switch can you just talk about the patients that received were talks and in that first dose level and what caused you know there nothing.
Understood administration that.
And then I guess on.
See 22 car.
Are you restricting patients <unk>, you know that come in and if that ever see our cdnineteen car based on their prior response to Cdnineteen car.
And then I guess from both the.
A CD 22 in the city 123 cars, what are you testing different doses of Elotuzumab.
And those studies.
Yes, Oh handed over to carry to answer your question. Thank you Aaron.
Sure I got good drift on your true so potentially we don't hear you.
Oh, sorry about that thank you yeah. Thank you for the questions on.
At this time, we haven't disclosed details about the patients in the C. S. One you car T S. One study.
Were gathering all of our information we are evaluating what happened with the patient as I said earlier without patient and.
You know we are will disclose and.
Present this data when we have everything available so that we can be making.
Smart decisions about moving forward as well as giving a full picture.
To what happened with the study so at this point I'm really not going up to disclose the detail about the individual patients and their course. So that's the first part of the question and the second part I think was about the Allen's using them.
If I'm remembering correctly.
Whether.
Got Ya. Please [laughter]. The second question was regarding the CD 22, and whether patients your your enrolling patients based on their prior responses either in car.
Yeah, so patients who have had prior cdnineteen car our.
Our allowed are eligible for the trial and there have been patients enrolled but it's not required for entering the study.
<unk> mission. So you know opened Oh.
Hi, This is Matt Farabaugh, thanks, very much for taking my question.
I just broad question to start where as you look over the recent outside of one data and you think about correlation to your own perhaps you know what are the big takeaways from read through from that data that you think apply to your pipeline.
Hey, again, that's a good question for Terry [laughter], sorry carried and then that you I don't know what's a good quits good question for anyone so yeah. Thank you. So much for that question again, where we know that they you cart 19 or aloe fiber one is.
The thing construct with its obviously a different car.
That as our entire pipeline and so I think all of the data and ER positive momentum in that program I read through very nicely to our entire pipeline as well and I think that it.
Shows that and really validates our approach it validates our gene editing and evaluate.
Validate the the constructs and I think that we could read through.
Significant important clinical as well as just programatic data.
Got it I think that it's really terrific and.
And I think we can.
Take a lot of that in terms of the safety in terms of the conditioning in terms of all the above so I think it's there it's a really positive important piece of.
Of our up our pipeline and our approach to car T cell.
Oh, I don't know whats dine in or Andre have anything additional to add to that.
Oh, it seems like for like it depends on the car team. For example, 123 is totally different then so it's like different than food to connect the two when the targets and the disease are totally different buckets, one its D cell malignancies like my team over Oh 22.
And what it says the same architecture for both car T. So totally similar.
ER so.
Same type of structure of the car that same type of like what's inside switch in there and it was removed for Joe Bcl same type of stock out that's where made with the same old true and its same type of diseases below and potentially deal Bcl two doors potentially some conclusion, but.
Some connections that can be made and that's very fruitful to have already a car that is far more and same where we can tune up the way to do that things will do that so yeah I seem to connections place when the syndication condensate type of diseases are good when you go where the new targets it fully disconnected.
And then what could still be moved forward that has to be pulled.
And.
It remains very interesting by the way.
Oh, great and and that's very helpful and it sort of lead bunch and my next question as well I you know for you part twice, yeah, you're focusing the AOL, but you know I'm curious about expanding antenna nosh and Oh, My God, given CD 22, opex tumors and ophthalmology early days.
I suggest that Retreatment action cracks he might not be effective but potentially a gateways to actually have a better results just curious on your thought that opportunity.
Well I can't think discussion, but anyway. So why do you suppose cdnineteen isn't overcrowded target.
You have everything again see my team by specs car T. L told is flat allergenic et cetera. So the pressure on the targets a lot of patients.
Hi, there for you have lot of patient battery life.
After who she was 19 or overpressure.
That's why we believe he 20 to become so interesting pulled off a there the bar at very high unmet medical need not always have to of course, so the attrition that provide benefit to the patient.
The overpressure around 19 or watch.
Named and there's like I've done more.
Probably 80% of older clinical trials the on car T is our targeting my team over the world and ER from Allergan entered politics to whatever or other type of designs our old targeting the same thing because it didn't work at the time. So that's why we think we're an interesting spot here because it triggers.
So very high on the medical.
Same thing for B C I'm able to them.
Our next question is from a 2% of William Blair.
Hi, This is I send me on Raj you I'm jumping off a previous question about learnings fan allergy.
In fact, developing a next generation there Alex I don't want anyone out there were talks about safety switch I was curious if you got had any plans to produce a similar product one of your.
Either inquiry cats, yes, one battery packs and I'm switching your current like three without ever talk about but.
That was an idea you guys had a kind of thrown around at all or accurately CB eight allergy pretty thank you.
Yes. Thank you for the Great question isn't a very important part of our platform strategy because we have all these tools at our disposal. So it's a very interesting position that at select as we find us and because we were really the first ones to go into allogeneic car T and think of all these parameters.
As with an off switch with C.D. 50 to knock out for Alemtuzumab Cowen Jackie Chan with different type of gene added. So it's really kind of turning out to be a a very enviable position that were in because we have the ability to use all these tools at our disposal, so allergy and as.
You know triggered a larger upfront milestone payment to us with the demand basically having an l. or five one a version of without the written sumac off switch and from their perspective. This was to actually include patients in NHL that have been treated with rituximab in their course of therapy. So.
No not exclude these patients if that antibody is still present in their system and this is something we could do it anytime we haven't disclosed any program, where we would do that that but just consider that you know all options are always on the table for us.
Thanks connection.
Our next question is firming Sealy I'll, let him good Coleman.
[noise] hi, Thanks for taking my questions. So maybe a study or pull up on the U.S. Curtis just one patients I know you can always had to merge but just curious do you know you've it appears you heard as a pre existing cardiovascular condition the risks.
Hey, long before the great question and again I'm I'm sure carries ends there will be the thing that we haven't disclosed more information on these phases that Terry if you want to add anything. Please go ahead, yeah. No I really appreciate the question and I know everybody wants to know that we really would like to laden compile all of the data.
At a prison this story and that Cogen.
Ah consistent matter once everything together as opposed to little bits here and there but.
Good okay, Okay, I understand so but.
Any color you the autopsy.
Well the state or so it's obviously a analyzes its been done already the into persons or.
And you said some of the timeline.
Yeah, again, I don't want to comment on what information and additional.
Data and clinical information, we're gonna receiving when but again once we have everything together and we're able to presented at all to Sta and how about plan forward you know we wont work on.
Getting that information presented.
Nick pushing some coffee richer Goldman Sachs.
Good morning, Thanks for taking my questions. So just kind of a follow up here on the see 19 population for you Ctwenty two but any allergan study when they looked at.
Factory autologous cartilage patients.
They didn't really have a response or they may have had resistance here just curious your thoughts there as you looked at this population if there's any way too you know kind of adapt from those learnings and then the second question on Calyxt is is there a strategy change here with a focus on kind of optimizing talent based technology.
Thank you.
Hey therapy in the time and thank you so much for all the good question I will maybe first the best Kaylee and then talk a lot of your first question on on a car T naive or is this pre treated.
Okay like that's just evolving in their business as they have always pursued a strategy of monetizing the talent technology. The company is really a fantastic brain pool to address challenges to gene editing and the x. feel that traditional companies that don't have the tool set for so there's more and more demand for you.
Now a project that other companies would like to work on.
And the company's also pursuing a very lean business model to have you know the first of all the proof of concept with a soybean was made to show a we can develop a product bring it into the market and commercialize it it's a great product there's demand for it but there's a lot of work attached to kind of having the downstream integration.
This was too so we can get into a 100000 acres and really built you know a huge business around us with rail vote car access with crusher access for the soybeans et cetera. So that was fantastic work done by the team in record time, given there the first company in the world that actually commercialize the gene editing.
Culture food product now the transition is more into an asset light business model to not do it yourself so to speak with a establishing that infrastructure, but working with partners to built products together for kind of like in the into biotech industry for upfront.
Milestone feet.
So for the question on car T is so it's interesting because allergy and mentioned on their earnings call that they are exploring retreatment of patients they've seen that patients that for example, or partial responders and that and initial shot are getting retreated or will potentially be retreat at though we're.
Super excited for that part of the strategy to become more prominent because we think the allogeneic concept is positioned to be this way that you have an off the shelf drugs that you can dose and where you can do repeat dosing.
So that's very exciting we saw the first data from that actually already a couple of years ago, where a handful of patients where retreated successfully so we're looking forward to what Allergan is working on and we'll be presenting in the future. We think about that type of strategy as well, but in terms of patients that happened traded with autologous car T as Andres.
There's a lot of pressure on the CD 19 antigen with a prior car T treatment, whether its autologous autologous or allogeneic and that's why we pursue this dual strategy of being first in the pack often allogeneic car T cell set of companies pursuing very prominent targets with the 19 NBC.
In May for example, and these are our license programs and then the proprietary program. That's all act as our with alternative target that could address a patients that have not responded or basically relapse without the expression of any given engine and carry if you want to elaborate on on that further.
Yeah, I mean, I think the question regarding the fact that in the Allergan data that was presented that the patients who had prior.
Car T did not seem to have a response to the other ones I think we have to look at the target as what you know to point Simon and so in that case. It's the same target. So those are you in NHL. The auto car T. There also CD 19, so it it's sort of follows that even though where you're they're going with an allogeneic.
Product, it's still the same target so it it's not.
No. It's not on this unexpected that they were any less likely to respond to another T cell therapy with a CD 19, I think our approach in our case is that it's a different target. So even if somebody had received whether it be.
In an allogeneic.
Product with CD 19, that's already been that's in clinical trials like allergies like how are you planning team or if it's an auto 19, I don't believe that the the fact that were pursuing a different target I don't think it read through the seeing are being an issue in terms of response.
Next question is from high touch thing I'll I'll comment kind of.
Great. Thank you and thanks for all the updates that's kind of question on manufacturing Oh, I know that youve indicated or on the prepared remarks at the manufacturing should be up and running by the middle part of next year I'm, both in Paris, and Raleigh now if you can just kind of walk as to where exactly.
Are you would the key projects or is this sort of clinical grade material and at some point as you move to larger clinical trials next year.
You will transition to commercial grade material I mean, you know after he has indicated that this is one of the really big rate limiting steps for most cell therapies and it seems like you're close to potentially solving it. So could you just walk us through your you know how you see that transition happening for these three projects assuming they move on to larger.
No trials with clinical to commercial and passion I just got a quick follow.
Yeah, I think that's a great question ours has and does it's kind of at the bases. So what we're doing is really differentiating ourselves with a a rich pipeline of different program and that are all going to be manufactured in house. So this transition I can you back.
Andre you can go to London, maybe I can answer very simply be question too hard touched goes like this the answer is very simple.
We are not starting by.
Having do.
Great and of the production.
Our manufacturing plants clinical supplies first and then upgraded to commercial.
We already starts.
As if we're producing the people and commercial car T and the grade will be commercial I'd start, but it will.
Produce also.
Clinical supplies.
So it will be already told me fully GMP and Ah Ah, it's like the inspection et cetera. So we're.
It's not done in two steps, it's a once fully staffed for commercial and then it will be producing clinical supplies here.
Great. Okay, that's very high and then Oh and the <unk> <unk> and then since it seems like the you know as you go to larger trials and potentially pivotal trolled any one of these three projects.
You should you be during <unk>.
The CMC Park all.
Future application is sort of already kind of mostly lock into place.
She can your rephrase your question I'm not sure understood.
Yeah, So I apologize <unk>, yeah sure shoot you know, you're assuming a future new drug application and D. For you want to between Okay how projects.
You know PMC is one of the three sections right preclinical clinical CMC you did a good assumption on our part that Oh, you know moving forward your CMC portion, although potential future NDC. He's already sort of mostly you know as a company you have great visibility into that in terms all that section of the all potential.
Moving on with Yaki.
Well, yeah exactly like the goal is to.
Start putting all the procedures internally to fulfill dyslexia infections, where do you have good that's the best the plant currently and Oh, we're preparing the company too because you know.
We don't know how these trials will go Balts you always plan for success and that's what we're doing if it's successful under car T or.
Uh huh.
Well I'll make some good promising results, especially for example in M.L. or on L.O. Moore and there was like a very strong medical need in there and it can go pretty fast so it's better to be ready ahead of time and not to do it in like several steps and so that's like the target is definitely the daily at the end and.
That's where we're that's what we have in Gi Andr only.
Great. That's really helpful. I think that's very forward looking another question is that you might have addresses your prepared remarks, I apologize I just caught a little late but you know you well youve managed to bring basically one product to the clinic over the last three years Oh, you've got three in the clinic like now and I know you've got a lot on your hands with all three.
But what are your thoughts in terms of bringing you know more projects into the clinic or you still hoping to Q2 that one project per year into the clinic goal or you think that Oh, you know the next one or two could take a maybe just a little bit long and thats all the questions.
So it's a it's an excellent question because we needed to ramp up our.
Clinical capacity.
And production capacity because they're the space is becoming overcrowded. So like name, it's like gene therapy. They like Brexit viral vector is a gene editing cell therapy, and immuno oncology you said older Bugs Jordan the space and the like everyone jumping in there. So the goal we have had the tragedy we had its like.
She pause in term of findings up to the time will ramp up in term of capacity for production will be fully fledged next year. The rally side going live in Paris sizable watch this year, well, they're producing you know like nucleic acids and vectors.
And are also ramping up since her arrival of a carry that's perfect transforming older clinical.
The the parking and the company and ramping up also the department to large capacity I give you a long do for I Hope I can 2021, that's an R&D day, well, we'll unveil older.
That make selective so much this thing piston most other companies our innovation Department.
That is very very a productive like you can see through most of the.
The publication, but Oh, we decided to paying this down in term of communications for now and we hope wants to go we'll be releasing the pressure over to clinical data and started releasing the data by the end of this year, we'll have maybe.
An appointment and like a nice R&D day, we'll be able to show what is the power of the pipeline behind it and start releasing or your line do you got its at this time I think that's going to be very exciting time because.
I'm very proud of our R&D department, but I think it's one of the most of the new baby so off oldest to sell target gene therapy space.
Oh, no push news from much of my thing.
Hi, I'm, Rob on here from a do I was just wondering how do you think you can use your candidates post car T and if there any specific safety concerns.
Carry what do you like to start with that.
Sure just can you just clarifying.
Then what you're the question sorry.
Sure I was just wondering like clear how do you think about the use of your candidates post auto car T and are there any specific safety concerns.
Sure I I don't see there being an issue using then post auto car T. At all I I think that obviously.
We're always in phase one and in early studies looking at safety, obviously when someone has been previously treated with an auto car T. They've seen similar lymphodepletion prior to those product.
So from that perspective, you may want to look a little bit closer it at that but from my perspective by the time, they would be progressing from their prior therapy and get into our study you know there wouldn't be necessarily auto car T around anymore. They wouldn't have been progressing so I don't see there any being any.
Real concern with those patients reverses patients who had received prior auto car T. But obviously, it's a area.
You know new new area that needs to be focused on and pay attention to but I don't foresee any.
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Specific issue that I would be concerned about.
Alright, thank you.
Sure.
That completes talk Christian I think.
Question on sufficient thank you I would like to hand back to comic book actually coming.
Yes, again think you're all very much for all these great question and your patients and getting through the Q in a we always love to hear your feedback so feel free to call me or any one of our team.
For a follow up discussions and we're super excited for the second half of this year everything in the clinic is moving forward and it'll be very data rich a second half and next 12 to 18 months. Thank you.
Thank you everyone.
Thank you so much take care.
Thank you.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.