Q1 2020 Earnings Call
[music].
Hi, everyone and welcome to <unk>, just first quarter 2020 results conference call.
This time all participants are in a listen only mode. Later, we'll conduct a question and answer session and instructions will follow at that time.
Today's conference call is being recorded.
I like to introduce the first speaker Simon harness select Vice President of corporate strategy in Finance you may begin. Thank you and welcome everyone to select that's first quarter 2020, corporate update and financial results Conference call.
Joining me on the call today My prepared remarks are Dr. Andre silica, our chairman and Chief Executive Officer, Dr. carried Brownstein Chief Medical Officer.
<unk> Executive Vice President technical operations, and Eric Dutang, our Chief Financial Officer.
Yesterday evening selected issued a press release reporting our financial results for the first quarter ended March 31st 2020.
A press release is available on our website at <unk> Dot com.
As a reminder, we will make forward looking statements regarding financial outlook. In addition to regulate train product development plans.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasts that.
A description of these threats can be found in our most recent form 20-F on file with the FTC and into financial reports, including the management reports for the year ended December 31st 2019, and subsequent filing select a snake with these securities Exchange Commission from time to time.
I would now like to turn the call over to Andre Andre. Please go ahead.
Thank you Simon.
Good morning, and thank you everyone for joining off today.
Before we begin with our corporate update for the first quarter 2020.
I would like to extend my heartfelt gratitude to everyone on the phone.
For your continued support of the entire health care space. During these exceptional apart.
I would especially like to extend my highest appreciation to all healthcare workers from the doctors to nurses, who never gave up and are battling cancer.
On the front line.
So our colleagues in the biotech industry and academic institutions or working day and night on a cure for old cancer patients.
We had selected keep our focus I never gave up and Mitch during these times.
I'm proud to say that we're carrying a strong momentum from the start of 2020 through these recent weeks.
That's all three of our proprietary allergenic car T cell product candidates are progressing in clinical development.
And continuing to recruit patients.
This would not be possible without the commitment and passion from each of our principal investigator all clinical partners.
Well as our team at select.
In parallel to our clinical program, we have not stop our R&D operations in New York any parent.
Well at the construction of our in house manufacturing fights and rally and Paris.
It is now my great pleasure to him to draw introduce my esteemed colleague Dr. Cary Brown team.
Our newly appointed Chief Medical Officer.
Karen Brent just select it's tough to her strong industry expertise and then impressive track record in clinical development across all phases of the product life cycle, including successful regulatory filing in the U.S.M.D. you for novel products.
Dr Brownstein.
Joined us from Celgene, where she served as vice President Global clinical research and development.
Therapeutic area had Oh, my only diseases.
Right. The Celgene Dr. Brownstein served as executive director of clinical find some college you are we at Regeneron, where she led the team of investigating multiple early development program and assets, including T cell engaging by specific antibodies.
Dr. Brownstein started her industry carrier I throw a senior medical director supporting the Bluffton approval of the number of hematology and oncology therapy.
Prior to our industry Courier Kerry practice medicine as a pediatric oncology at the New York Presbyterian at Columbia University, and Mark to Lie Medical Center.
I would now like to hand, the call over to carry for an overview up or clinical program. Then Bill will review I for manufacturing update and Eric will give an update on financials.
Kerry. Please go ahead.
Thank you Andre we are currently enrolling in treating patients with our proprietary do cart allogeneic car T cell product candidates in three select the sponsored phase one dose escalation study the Bali trial investigating new car 22 in relapsed refractory B cell AOL.
The Melanie trial investigating new car T. S. One in relapse refractory multiple myeloma and the honestly trial investigating new part 123 and relapse refractory AML.
As a reminder, each trial is planned to evaluate three to four dose level of you cartel in sequential cohorts of patients with the duration of each cohort expecting to be approximately three month due to the mandatory safety evaluation periods required by regulatory agencies.
The primary objective of each phase one dose escalation study to evaluate the safety and determine the optimal you card and corresponding lymphodepletion regimen that demonstrate safety. In addition to safety, we will explore car T cell expansion window, a persistent and anti tumor activity at different dose levels.
Further we will also evaluate the addition of Allen twos Mab, She's standard Cyclophosphamide, Darby Lymphodepletion regimen, where applicable.
At the time of this update all three phase one trial I'm only O one BOLI Oh, one and the Lani O. One remain on track and we plan to share interim clinical data from these studies by the end of this year at or around relevant scientific conferences provided new enrollment and the ability to conduct protocol assessment is not.
Significantly impacted by the Corbett 19th.
Our partner allergy in collaboration with Servier is developing our life and lead development program. You Cart 19 also called Aloe fiber one in the U.S. for non Hodgkin lymphoma patients.
Allergy and therapeutic in collaboration with survey recently announced they will present initial results from its phase one out the study Oh aloe fiber one in relapsed refractory non Hodgkin's lymphoma at the American Society of clinical oncology I go at <unk> at the end of May This oral presentation.
It's the first theater beat out from that dose escalation study allo five over.
This phase one study continues enrollment to optimize one so depletion.
Our next license program to Alan Gene you card you see it may also called out 715 is recruiting patients in the phase one study called the Universal trial, and allergy and announced they are planning on sharing an interim data update a you're adding 2020.
Our partner survey has made the decision to temporary halt recruitment in the U. part 19 clinical trials during the peak of the club at 19 pandemic. We're excited to see this study reopen shortly and progress into phase two based on the highly promising data that has been presented today.
With that I would like to hand, the call over to build Montes for an overview of our cell manufacturing process.
Ill.
Thank you carry.
Regarding the supplier by you cart clinical and preclinical product we were able to successfully complete assert the manufacturing runs for all three clinical programs and shipped to our clinical centers in the second half of 2019.
This will provide the necessary bylaws to cover at least the dose escalation portion of our three ongoing phase one studies.
In parallel to our work with our contract manufacturing organizations for clinical development, we're continuing to construction number in house GMP manufacturing facilities in Paris, and Raleigh, and both remain on track for their anticipated go live.
And 2020 and 2021, respectively.
Apparel side is a 14000 square foot manufacturing facility in Paris, France. This facility has been designed and is being constructed to produce critical raw and start immaterial supplies for our UCAR clinical studies and potential commercial products.
It is targeted to go live in 2020.
The Raleigh facility is an 82000 square foot commercial scale manufacturing facility in Raleigh, North Carolina.
Site has been designed and it's being constructed to provide GMP manufacturing for clinical supplies and commercial manufacturing upon regulatory approval. It is targeted to go live 2021.
In the near future success will be able to provide a robust supply chain for its clinical and commercial manufacturing needs through these in house manufacturing capabilities in partnership with the existing Cmos.
With that I would like to handover the call to our Chief Financial Officer, Eric Yutong for an overview of our first quarter 2020 financials.
Eric.
Thank you Bill.
Got it keystrokes quarter Twentytwenty was driven by strong financial.
The cash Kashi QNX <unk> said I know, it's tricky catch but he is trying to collect Keith don't they don't without candy either maps that he fell 2020 remained the same <unk> three and $4 million compared to December 30 fell 2019.
That's great like $28 million put eat and 5 million don't out yeah. He received on saggy, which what oh that by $29 million of net cash flows you your pricing investing and these activities and $4 million.
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<unk> cash position, we'd be sufficient to own citic Keystone auto production into 2022.
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The change Netapp, yeah, we collect that you need you underwrote out of net cash flow is used in operating and capital expenditure activities cake.
As announced in our European financial update you must when he twin.
We entered into an amendment to our life than development and comedy <unk> <unk> agreement with SAP.
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We granted to sell getting Nick <unk> exclusive worldwide license would develop and commercialize or next generation Jenny I routinely Kathy south product I didn't see Tonight.
That includes lie to you kept 19, I look probable one and I do private one eight either direct t. off to eat U.S. sub license Gee I would you tell.
We did I meant men taking effect.
We received and booked an up and payments of $28 million, excluding DVA eat in Q1 20 twin.
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We we gain <unk> five and close I do was unique out so I get paid you see corvel by any short agreement and.
Hey, good night $19 million, Oh wont on milestones payments received in the past where do you get to these targets in our Q1 2020 or big.
The city, She's Thunder net income attributable to share or does it.
Was 22 million, but all in Q1 2021.
Pep when net flows of $10 million out in Q1 29.
Deep 37 million dollar increase internet speeds are between 2020, and 2019 was primarily driven by a significant increase in revenues and other income.
$46 million, which was partially offset by your increase in operating expenses of 6 million that out and a decrease in final showed gains.
$3 million.
The consolidated net income actually be to book to show or does that.
Including catty.
What $20 million or 47 cents income per share into 120 20.
Compared to a loss of.
$10 million Oh study, then does best shack into 129.
The close what do you Dave I, just didn't net income attributable to shower gels up tick T.
Excluding non cash stock based compensation expenses.
What 24 million Doral all.
Seven cents income per share in Q1, 2020, <unk> well north of $11 million.
Oh 20.
No stuff Shacking she went 29.
Even more people such need viewing these could be 19 context.
We are laid up book has panned out cash at developing our pipeline of product candidate the kidney.
And.
Completing pickle quick shut off out that yeah manufacturing teasing partied thinking a lot it in 20 Twond.
I, we know it sounds like presentation back we're going to Andreas <unk>.
Alright.
Thank you Eric.
2020 is a pivotal year for selected as we progress through to clinical development of our wholly control and partner product candidates.
We are on track with is our shuttle in clinical development planning to provide an interim updates.
Our clinical trials.
At the scientific conference by the end of the year Twentytwenty.
Hand in hand, with our clinical advancements.
Were also on track with the construction of our in house manufacturing sites, which are designed to deliver food independent and internal no at the forefront of finds in gene editing and cell therapy.
In addition to our lead clinical programs, we have made significant advances.
On the R&D side to further strengthen selective position as the leader in the gene editing gene edited South Turkey field.
The selected innovation team is constantly developing next generation for therapeutic product candidates that will be I always like cutting edge of gene editing and cell therapy.
We're planning to advance next generation products into clinical development in the coming years and will demonstrate the outstanding innovation power without all of the Buck thinking a selective that has revolutionized medicine over the past 20 years.
We're thrilled.
To see our program come to fruition.
Other than ever everyday gets off new hope for patient in critical critical medical needs.
With that I'd like to open to coal to any question.
You may have operator, please go ahead.
Thank you, ladies and gentlemen, we will now be conducting the question and answer session.
Please limit yourself to one question one follow up.
She was asking questions. Please press star one on your telephone keypad.
<unk> indicate that your line is in the question Q you made fresh start.
Your question.
Sure participant speaker equipment and may be necessary to pick up your handset.
Let's start keys.
Our first question comes from the line.
With Oppenheimer. Please proceed with your question.
Great. Thank you. Thank you for the answer the question well 100 warmed up and only welcome to that wouldn't be team members I really appreciate the update there also can you just.
Talk little bit about how once you get to dose escalation, how you'll evaluate.
The dose will be carrying into dose expansion. So house MTV being evaluated what are the criteria that will go into it and then secondly, you've also mentioned you have a little bit about correlative studies, Oh look at T cell expansion window persistence and tumor activity can you just talk a little bit about what we should expect to see not regards.
You know when the data is is revealed.
Thats alone.
Oh, well. Thank you very much hurts hard for the question I think it's a great question model for into carry because like your they're developing that so carry please could you sure.
Thank you for that question I think it's very at this point you know we were not providing too much detail around what the exact parameters are gonna be for making these determinations I think.
At this stage of the development, we're really looking for optimal safety optimal translational data and optimal activity of the cells and I think we will.
Looking at all those parameters together to come up with an answer so I'm not sure I can give any specific to what that would look like when need.
Choose what we're going to move forward with for expansions and phase two and three [noise].
Great. Thank you very noisy on just a persistent you think that some of the data you're going to gap.
We ended the year, we'll give you some insight as to potential well, we dosing or that's still to be evaluated in the long run not something in the short and again. Thank you for a launch.
Yes, sure I think that's a very important question and again I think by well have some data, including all of those parameters I just mentioned towards the end of year, and we will be able to figure out if we need to adjust lymphodepletion, whether it be the medications whether it be.
The schedule.
To determine how we would move forward with.
With me dosing, but we'll have some information I think in terms of what the window persistence looks like I buy the hopefully by the time, we are presenting interim data.
Great. Thank you so much thank you for the question.
Thank you. Our next question comes from the run on then with Jefferies. Please proceed with your question.
Yeah, Hi, Thanks for taking my questions. So maybe if I could just start with the of the Bali normally studies what are the criteria for each of those studies in order for you and move into dose expansion and can you just maybe talk about the sole ranges that you're you're dosing in the trial and I guess, what would you want to see from both of those.
Ladies and especially when you court 22, given I think you're also enrolling patients there with partially the Nike car.
I'm sure I guess this was another question.
Another question for me so in in the <unk>. The three different trials I know, you're specifically speaking about the two but Kenya study doses are different other car T cells. So in a if we want to start with the Bali trial. The dose level. One is 100000 cells per kilo dose level Q1 million and dose of all three is.
Inside of 5 million at this point.
Again I think the.
Data that were going to be looking at as I mentioned earlier is.
The activity safety and all the combined on translational data. So we can pick an optimal dose to move forward I think that what's interesting about the both leukemia studies is.
The regulatory bar so to speak for.
Approvals in these areas are not terribly high so we really just need to see what we see and determine if it if it if we can focus because these are both you know and really right now and relapse refractory patients who have no alternative therapies that typically being these diseases are only carried right now with transplant and.
So achieving.
Complete responses that are durable is is critical and that's what we'd be mainly looking out for activity.
I'm not sure if I answered your question.
It does thank you.
Thank you. Our next question comes from Gena Wang with Barclays. Please proceed with your question.
Thank you so two questions one regarding the allo fiber one study Oh, we dial it at school and stopping rules regarding yeah, I'm gonna be spectrum. So for the first one we all know or we all building for the data no such thing for my try to lie more.
And I seem to be two regimen. So just wondering.
Impossible question any differences between aloe sticks for seven this is Alan T map and also we've gotten good Ddos all when we look at you know Nucor 19, studying persist aloe fiber one new corn seed study at this is one milligram tick on T map that translate into maybe 16 to 17.
No one off <unk> dilution and for all those 64 Steadman, although fiber one study that's basically 39 to Monday morning.
So seems like the dosing not much huge differences between all those books wants to have them versus.
So just wondering what kind of that's a beta newco line to Oh insightful Youre Oh choose my coupons for 22.
Yeah, Hi, gene I can answer this its kerry so I think it's a really good question. The first part for allergy into.
Comment on in terms of how they are determining how to use their proprietary anti CD to 52 antibody first is down to the map I agree with you that it's unlikely that the doses would be terribly different because it.
Similar molecule that said I think as as you pointed out I think learning from their study and the doses that they're using and what they seem we're all looking forward to see not data would be I'm very.
Helpful in determining the appropriately and move forward in our programs as well.
But I I don't have any further insight into how or why allergy and its choosing the he doses and choices that they had in terms of hours studies I could say that were looking at adding in Allen Tees and have we are also looking at it without Alan to them and because we want to find the most appropriate.
Optimal lymphodepletion regimen to use with our you cart cells.
So you know approval.
Alright.
Okay just to add Simon.
If I may.
Yeah, we invented the sea to 52 knock out with isn't Mapco injection of the first measure to increase the window of persistence and we strongly believe and that tool to use where like Poland circulation and I think where we're looking at is really an exceptional point in this car T space because I think.
Where are the only company that actually make that direct you know comparison of using LM to them up with type clue versus using five flu alone I think this year you know a lot of the company and our space are working on the correct Lymphodepletion regimen.
There's a lot of different tools available, but I would say that at select as I think we'll have one of them up and but full data that's coming out where we actually can use the site by site comparison, then it may be a good thing to do a longer window persistence in certain indications, but it maybe a better.
Our approach to have a shorter window persistence. Another indication. So this is what we're trying to figure out ended dose escalation and this will definitely give inside by the end of the year and we will share a much more detail around this in our data presentations that are coming but at this point I think we're keeping it mostly under wraps just because there.
There's some moving parts and the data will be very insightful.
Thank you Simon actually I think that there is no.
Actual studies that have a comprehensive analysis oh.
So with or without it and now I'm tourism Board.
Reconditioning War Biosimilar.
Preconditioning.
And I think the studied or who are preparing.
Cool start initiating second half this year, we'll give you a pretty clear situation of the role.
Or not olympism I've with or without.
And it's something that is very important clause in there do green tea or the type of Terpenes I'd allergenic therapies and also targeted therapy.
As most of the time and the quality of the Preconditioning and consistency of the Preconditioning. So it's something that will bring answers and here I hope the do will be.
Ah interesting to share.
Thank you.
Very helpful and my follow up quite my second question is regarding the manufacturer. So the power side I mean really tried just wondering once they complete all oh, what kind of capacity.
<unk> dose if you can you know given as Oh of course that depends on Oh. So how many you know south put those all but if you can that gets a little bit loss idea like how many dose is helping shape.
It's pretty supply.
Yes. Thanks, Dana this is bill Monsees. So both of the facilities as you said how much the capacity is and what we can provide for a in will need to provide for is gonna be dependent upon once the final dose is determined.
What we have done is built both facilities to be able to provide the started materials in Paris.
For your car production and the you cart manufacturing capacity and.
The Raleigh facility to be flexible in terms of what they can produce too and that in conjunction with our current CMO network, we feel we will more than adequate capacity to meet.
Any final commercial requirement once we get to that approved state.
Okay. Thank you.
Thank you. Our next question comes from Christopher MRI.
Please proceed with your question.
Hey, good morning. Thank you for taking the questions. I think you know obviously, we'll have a lot of data. This year from you and your partners and there is an interesting perhaps to cross trial comparison going onto I'd like to understand a little bit.
About some of your perspectives on.
Comparing that some of the data out of the the C. S. One you cart trial and the bcm, they trial or what's your partner there at allergy and up and that the kind of data you might be looking for to understand the applicability of each of those approaches in multiple myeloma patients and sort of different lines of multiple myeloma therapy than ever.
Follow up thank you.
Well. Thank you very much for just a question Chris.
Really considered I think it's going to be really interesting because there are significant differences in between the targets such as be sent me and the targets since its yes one.
First a shift Swan there was less soluble protein the blood then be sent me.
And ER behavior off the car is going to be different because just one or is it there is less volume of protein there is.
To put can have expressed a lot the other immune cells such.
NK cells are also expressed on these on T.D. Celtic expressed on.
On T. cell, especially the San Diego and also expressed a microphages than others.
So walks would be interesting to monitor is the depth of the lymphodepletion a that is induced <unk>. We don't we cannot do elotuzumab with just one because we have already to knockouts knock out of teacher Alpha and good luck out those chips, one and we didnt.
Include the third knockouts, which would be did not called CVP too because we've told that potentially Sip trunking same effect a to be 52.
Deepening the Lincoln depletion by knocking like by.
The strong T cells, especially today and also because to be forced could've been exposed because that's one and NK cells also and that would also gives a kick start foresee a swung to start expanding into patients.
It's called the quoting and the way to Lymphodepletion that starts ward induced probably this type of expansion and that totally different than what you would see what it was bcm made because they say they as the product.
His quenched by the soluble protein, it's like got to add or like that those might be different goes outside and access in order to have like trigger those start to started the extension.
The other thing that is interesting is also the level of expression on multiple myeloma sells for shifts one way do have response with the Lotusan lab why would it be Sammy you don't have the active multiple antibody.
It's also claimed new target for car T and ER.
Susan I saw that much shoes Morton guar Darzalex, our doctors are not the Jews usually go model antibodies than bcm, a car T or <unk> or by spec. So worse, it's quite a clean target for us and it's going to be really interesting.
ER to see how it performs.
Without Oh in terms of hub in this case and if the deep into Lymphodepletion. It though we're still in the first the dose levels and it's going to be interesting when we expend to our dose doesn't come in future.
Okay, and then it sounds like obviously lymphodepletion is gonna be the biggest component of that comparison at least upfront I suppose the other component would be you know response rate between the two two trial settings. You you know how much do you expect to be able to read through to sort of durability.
We have response.
And then I guess.
Piggy backing on that.
Question and applying that to all of your ongoing studies you know as you moved to your expansion Phase I was wondering if you could elaborate on any contemplation you know to extend these expansion phases of the trial to include reducing.
And you know what might the criteria for reducing Oh look like in in call. It those expansion.
Faces thank you.
Oh, <unk> I hope I remember the first part of the questions I think let me start with the first part of question about the.
About E.
Design and the child and.
Versus in myeloma for C. S. One I think it's really important to recognize though that another huge component of having a different target is set to be CMH space is very crowded so not just with car T cells, but also with bi specifics edcs and all other technologies.
That can target myeloma with you see M&A and I think having something different is is a huge improvement and something to leverage on because we don't know if patients once you've been treated with one of these VCM eight other program other technologies, let's say you relapse what.
They're not a DCM a targeting drug would still be applicable to those patients. So it really gives an opportunity not only for another cell therapy to work after lets say someone guy a bi specific arnie D.C. first I think it's really puts us in a very positive space and.
[music].
He's done something we can leverage on that that will be I'm very helpful. For patients. So that I think is the first part of the question and then in terms of reducing and the expansion I don't think absolutely I think the to me and when I do clinical development. The whole idea of expansion phase is once you find your safes and optimal dose.
To move forward is to explore all those things that you mentioned, so whether we're going to explore specific.
Indications are specific segments of the population as well as reducing different ideas on lymphodepletion. So we can find that most optimal way to move forward and as as you know in this space of relapsed refractory disease, where patients don't have alternatives, sometimes if you see.
Extraordinary data. These these types of expansions that may include more patients and find alternative opportunities can move forward towards regulatory approvals. So I think to your point absolutely that to me is the point that the.
Spansion.
Okay. Thank you very much.
Thank you. Our next question comes from Michael Schmidt with Guggenheim. Please proceed with your question.
Hey, guys. Thanks for taking my questions I'm, just going back to the three ongoing studies or maybe a question for carry so obviously appreciate the fact that these are actually ongoing at the moment can you just maybe provide a little bit more detail I'm sort of how.
Far into the dose escalation you are in each of the three studies and then just to clarify how out mtwos and Mathis use there whether that is something that is it's it's used since you know jokes, one or something that I think Andre mentioned, maybe adding that in the second half the year.
I'm sure I can I can start by saying that all three programs are pretty much in lock step with each other we have cleared our first dose level for all three programs that are now exploring our second dose level and I think as you will notice. The the trials are designed to have.
Three dose levels, if and one of them for dose levels in terms of down to the Mad you know, we as Andre pointed out earlier in his responses I think it's important to understand what Alan choosing that adds to the equation because it doesn't message. We don't know for sure if that's actually the best way there.
So I think our approach where we will be looking at it with and without is critical and I think is they were really the only ones doing it and we'll learn what is appropriate because as was earlier said it may vary much depend on the indication there are indications for example.
Like I am now, where you may want to get in and get out with a very acute strike on your blast because you do not want to cause prolonged myelosuppression and and potentially lead to more infectious types of toxicities, whereas in other diseases.
As potentially in L.L., it's not as much of a concern. So it's critical that we look at both strategies and decide for each type of disease and indication what works best. So we will you know we've already amended the CD 22, the UCAR 22 trial.
To add in Allen to them and we will be looking at that data and we will we will likely be doing the same at some point for the <unk>.
Hey, ml study as well and I think as Andre earlier said for C. S. One it's not a option due to the fact that we don't have the CV 50 to knock out. However, C. S. One on its own may actually add additional lymphodepletion.
Due to the fact that the T cells actually are also come see us one expression.
Yeah that makes sense. Thanks for clarifying that shirt and then maybe a question around the serve you'd be amendment, Serbia agreement.
Earlier this year I know that were five targets are returning to select is let's just wondering if there had been any work ongoing oh by your partners around those targets that you could leverage or whether these were no purely a reserve targets for future development.
[noise] well, it's a good question Michael Yes, though the though there is work that we don't want to disclose these targets currently because.
It's a well everyone's copping <unk> [laughter] club I think there like great target there.
Yeah, we have done a lot of work actually Oh preclinical work, but we will buttons to bring this wants will present the current clinical data. After this will have Plano tweaks to show your but for now we'd like to keep the pension OPEB everyone on our clinical data because we're super excited about that and.
And and at the time will Oh growing this issue for at least one target we're excited about it.
As a blend of interesting things that will be shown no. It's not plainly just like targets like that.
Yeah, we've been working.
Sounds good. Thank you and then you know good to see a U.S. patent no Oscar granted around the kind of spread and that T cell therapies.
And I was just wondering if he could just help us understand a little bit what what the scope of that happened is and whether and how you know that might potentially.
I'll be a it'd be enforceable in the future.
So we're convinced that this pattern as enforceable, it's a path into it we filed.
Early.
In.
2013 like March 2013, I think that no one I've heard like the word CRISPR at this time well select as has been very much the flowform, but what's what's happening at this time in gene editing and would jumped on this as we're already working on T cells and car T cells. We immediately implemented this technology car T cells.
And talk to claim was CRISPR in there and filed patents.
We consider does this package with very probably pack and it's like kinda. So we're pleased that work we have in Europe and would that challenge and lost.
So it gives an idea how strong it is and Tom or prior art that has been.
Try to be leverage at this time, but CRISPR just came out in December 2012 in March we file these purchase path and I have to do that crisper and T cells and we are very open comping almost licensing and however, we will definitely protect our IP, it's oh sorry.
<unk> due to do this and we will also but we have been always that very open company in terms of partnership licensing and ER and and working with a third party companies even in our space.
So.
It took acknowledging that there is.
It's a very important for the company will definitely.
He was it.
If I T.
Okay, and then just maybe one more thing then this is something I think that has talked about in the path, but some of your competitors are you know looking at that other alternatives.
You know too.
Provide a and environment and the bodies for quality allogeneic T cells to eat up a window such as for example, the Btwob and I'll call. It and I was just wondering you know in general thoughts on that and that approach and then that's something that you might be evaluating potentially in the future.
As an add on or are there.
Well be to them as an approach that selected told about very.
Very rapidly.
It was an arbitration between cdfifty, two and due to him.
To to acknowledge that like this has been very.
Upfronts like either in the time, we're working on Mega plays it back in.
More than 10 years ago.
As an obvious card [laughter] TV 52 felt more secure the injection of she'll coaching 19 at this time, while the fiber one.
For the simple reason to were concerned a bit by the ER attack NK cells and when you do Lymphodepletion you seemed a the lymphodepletion is longer on T cells and the NK, So big come back but more quickly.
So we said, okay, let's stay on to save side, but through the 52 at first and it would give us.
It would enable the concept of allergenic car T. A discount ductless back like five years ago [laughter]. One we've done the first patients are we.
Felt about choosing between EM, but oh, we have this alternatives on track to block NK cells by using it and Kid blocker, which is a chile easily replaced by generating a big tied to Mike Lublin by a Chile, he actually eat or blocks NK.
Fell for we have like great up.
Scientific data that that show showing this oh, probably show more data and it's something that will probably bring into future or two in the clinic no. We're super excited to see the interesting thing like you know I called it the interesting thing what I see it Garlocks yourself trial.
On 19, no like cycling through the alone.
Yeah, one trial Cyclo food Ali Susan and you have one would be that to like a globally.
Oh ongoing currently today and by the end of this year I Hope I Ash will have data that will really like reveal to us.
On the same target, which is cdnineteen oldies approaches and it would be interesting to see due to to compare all these data.
So far the one that had been proven very efficient on the long term was persistence, where the c., we could do to approach Oh, so the pre where we partnered actually the Serbian allergies very excited about that but I'm very curious in saying that other no cdfifty two no.
To be fair to Mark Lublin or with micro global inevitable will compare on all of it so it's going to be a key or for the outer space understand how this works and you know a slick this has always options, including the replacement if you go to market globally by Chile E.
It would open.
Interesting years and the good luck for 21 couldn't et cetera.
Great. Thank you Andrea appreciate it sure. Thanks.
Thank you. Our next question comes from Jim Archon off what well Fargo. Please proceed with your question.
Hi, guys. Thanks for fitting me in just a few follow up questions. I guess first just like you had asked if that ends up being the forum offer data do you think by year end will have.
Based on the cadence that sites that you're seeing right now data in dose level, three or dose level for a in the case will go for those <unk> dose level or I'm, just trying to get a sense of your visibility on enrollment and whether we'll get to those higher dose.
Cohorts.
Yeah, it's scary I can answer that so I think you just have to backup one minute and remember that it's not so much about the cadence of enrollment because then the phase one studies as I mentioned earlier, our timeframe for enrollment is way more based on the fact that theres mandatory safety type.
Lines for watching patients before the next patients can be enrolled per you know most the regulatory guidelines that have been imposed on the study. So I think that while we haven't seen any issues with enrollment and there is tremendous interest and they are prioritizing our studies.
I think from the perspective of how many dose levels look at you buy down is really going to be more based on the on the fact that we have to we you know weve mandatory waiting periods in the protocol I can.
The second piece to that as well is as you know well know the abstracts are due in August. So I don't believe there's time for information in the abstracts for dose levels path dose level to that said by December.
If we're able to but it altogether, there's a possibility of seeing more advanced dose levels by something presentation in December but not necessarily in an abstract form due to the fact that their do so early.
And then care just just in terms of understanding the incremental benefit of Allen twos AMAP. If there is incremental but that is that something we'll understand before cohort expansion or is that something that's going to be continued to be evaluated during the cohort expansion.
Yeah. That's a very good question I think it's very dependent on what we see so I think you know any dose escalation portion. We are going to include I don't have an arm lets say I'm abusing Allen to them out. However, we may also continue to tweak, let's say, how we give the dose and.
How we potentially give it if it turns out to be where we want to move forward on any expansion as well. So I think thats a combination arm to not to that question.
Maybe just one final question for Andre just when you think about leveraging your.
Gee that any platform Andre is there any thought to moving beyond car T and and into other gene edited sell approaches even for rare disease, where what are your broader thoughts if any beyond.
The Karkhi space.
Huh.
Very good question and get a we are working on that are outside car T outside of oncology Oh, something we're preparing the we're focusing all our retention in the clinic regulatory manufacturing et cetera on our car T effort to close.
We strongly believe that these products are going to go a par but.
But the Orange is the preclinical ping et cetera or.
The preparing the next gen.
Not only car T not only in solitary but outside cartel, Collin College, you could gene therapy or purposes.
And we definitely.
I will.
Do a time presentation for this but.
But previously we would like to first provide.
Pretty comprehensive set of data and our COO clinical trial to to be presented and it would seem to focus on this for now.
And <unk> pension also off all the company on these trials and then we'll we'll unravel what has been cooking inside a selected R&D.
For the past years, but I think is really really interesting.
Great. Thanks for taking the questions.
Thank you.
Thank you. Our next question comes from some of it with Citi. Please proceed with your question.
Hi, Thanks, I just have a question about lymphodepletion.
How concerned are you about that regimen in light of the cobot 19 pandemic.
And what would have this study sites and investigators doing with respect to the handling that.
Yeah, I'm, 100% sure I understand you mean in terms of giving lymphodepletion regimens in the context of patients being at risk.
Yeah.
Yeah, I mean, I think that's it's an important point I think however, we have our site.
Yeah, we need to continue to move forward with.
Our programs for the good patients with these rare untreatable cancers and they need to continue to do the science setting we done to make sure that in the future we have new new therapies for them and you see therapies. So you know I think from that perspective, we need to.
You know contained in <unk> to move forward that said you know we are open insights that across the country I'm in the U.S. and therefore, it depending upon the site they have different requirements at their institutions on how to make sure there ensuring patient safety. So.
I don't.
I don't see at least up till now we haven't seen that being an issue and again safety is paramount ensuring patient safety and HM.
The the physicians are really checking and you know enrolling patients that they think are appropriate for the trial and using all of their appropriate measure in their institutions to ensure that you know patients are safe.
I'm not sure if I take that Jim Okay. Thanks, and just a question on the on the recent patent for use in CRISPR Casnine for roads in that car T cells can you talk a little bit more about you know the relative advantages and disadvantages of Chris reversing talent and.
For for car T cells, and when you would pick CRISPR or channel into.
Engineered development candidate.
Currency, when we started the using crisper and keep though so back in 20 like early 2013 was like started January twentyth routine.
And it worked really well in our hands and the same time, you know like ER or <unk> to detailing the were.
Also new technology, we're comparing together homing and into places Magna clay the Mega called.
The selective has also developed.
ER or who are comparing also this was a pale in and crisper and we're very much to acknowledge agnostic or drought and CRISPR work worked really well have that despite the thing that we would struggle is there to the knockouts for example, a TCR towards five we had a bit of difficulty with a hand.
During the off targets, which CRISPR, especially and so believed that the reserve the difficulty been work as well as we fought and isn't Chris perform all of US for combination a case the tools whats called ones five smallish accommodation.
<unk>.
One piece like one arm of the DNA.
We're combining correctly, the other arm or not for combining correctly, because CAFTA than dislocate fast on one side of the Danny then the other so you had illegitimate.
Kind of from August for combination to did you get ginna replacement in there and we struggled a bit the so we started more focusing on pay a little bit who are more reliable at this time and very much or using quicker in R&D to try to develop quick ideas of stuff like this joke combine to things together and have.
Rick idea, how it depends if you want to do screening and stuff like that point in June.
We hope that this technology will.
Improve things and we might fall in line here. They are the pie I know that other companies have follow right behind it was crisper and Super excited about that and are we remain very open to discussing with them. However on outside it's not on the short term.
The pre believed that this will be.
Like on the safety side, what we observed with the tailings so far.
Okay, great. Thank you very much.
Thank you. Our next question comes from rational for side with William Blair. Please proceed with your question.
Thanks for taking my question or maybe just wanted to clarify as far as FC verse I see a oh I guess what.
Types of.
Things you plan learning that warrant a clear from the you cartoon 19 try animals.
And can you just comment a little bit on cytokinetics as it relates to the memory. So phenotype of your current products.
And how that might play a role and durability versus lymphodepletion. Thanks [noise].
I can just carry I could start with the first part of the question and then maybe Andre can answer.
The rest of the question, but I think that.
<unk>.
Important to understand here. This is a different situation than in the <unk> autologous space. So we don't know yet even for durability purposes, if we even want durability right.
I think the.
Really important question in my mind is to understand what lymphodepletion and level of.
A level of T cells that you want to deplete.
In order to get a strong acute attack on the cancer cells. The the piece, that's I think really special about our technology and about the Aloe technology is the fact is was brought up earlier that we can reduce that you need to and so.
This idea of needing to have a very long durable lymphodepletion is not necessarily applicable to the hours phase.
However, you want enough. So you can have an acute attack and I think also it'll depend on the disease as I said earlier in some diseases like M.L. you may not want to have a very long lymphodepletion. Because these patients may end up significantly mindless suppressed and lymphocytic lymphoma depleted and we already know there at higher risk which was.
Also brought up for resurgence of viral infections and other things that they've had in the past so.
It's really going to be dependent but beautiful about the technology and beautiful about our approach is that we're going to try to learn as much as we can about all of these methods and that we can then Taylor. The approach later appropriately for the individual indications as well. So I think we're going to learn a lot about what.
Attentiveness to our story, there's there's going to be an extremely exciting year for us and for the cell therapy space in general and again, we really thankful up all your support of the healthcare space and these special times and we're excited to make progress and really serve patients in need if if any other follow up questions feel free to email me yeah.
I'm in dot harness like this dot com and reach out anytime. Thank you very much.
<unk> I think you for your participation and you may disconnect your lines at this time.
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