Q1 2020 Earnings Call
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Good day, ladies and gentlemen piece yourself free to today's conference will be starting momentarily until that time, you're my smoking be placed on a musical. Thank you for your patience disconnect.
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Welcome to the when he gets filled therapeutics first quarter 2020 conference call. At this time, all participants are in listen only mode.
An audio webcast of this call is available on the Investor section of lineage website at www dot when each sale dot com.
This call is subject to copyright any deals the property of lineage and recordings reproduction or transmission. So if this call without the expressed written consent definitely are strictly prohibited as a reminder, today's conference call is being recorded I would now like to hand, the call over to your house today.
Do you Wanna home director of Investor Relations definitely need Smith. Please go ahead.
Thank you need a good afternoon and thank you for joining US a press release reporting our first quarter Twentytwenty financial results was issued earlier today may seven 2020 and can be found on the investor section of our website. Please note that todays conference call and webcast will contain forward.
Looking statements within the meaning of federal Securities laws.
Looking statements regarding our strategy gold product candidate clinical trials financing and cost savings matters.
Such statements are subject to significant risks and uncertainties.
Including those described in our press release issued on May seven 2020, and our recently filed form 10-K and 10-Q.
Well results for performance may differ materially from the expectations indicated by our forward looking statements do those risks and uncertainties. We caution you not to place undue reliance on any of the forward looking statements, which speak only as of today.
In addition to our financials were going to address each of the three announcements. We made this week. It's obviously been very busy time for us I'm really proud the team's been able to maintain a high grade.
Progress even with the current restrictions related to the cold at 19 pandemic.
Before we dive in I want to say that were not aware of any cases of cold in 19, among or stuff, where our critical consultants and we will continue to follow appropriate measures to maintain the team safety and performance.
On today's call.
We're going to cover four main topics first I will review the new data, we announced from the offer just clinical trial, that's our lead program for dry am D.
Second I'll explain why we conducted in early exercise of the back often with cancer research UK, which will make our immuno oncology effort significantly more prominent going forward.
Third I will talk about our plans to apply the Bakken platform toward developing a vaccine for corporate 19.
And fourth and finally I'll provide an update on progress we've made recently with both PC, one oh or cell therapy to address spinal cord injuries.
And then after those program updates Randy will review, our financials and we'll open the line up for questions.
Running with opera, Jim This is a again or product can beat for dry M.D. with GE, a for which there are millions of suffers the no FDA approved therapies. We believe the commercial opportunity for all Virginia is incredibly attractive with only a modest number of competitors.
Oh oxygen therefore continues to be our most important passive and we were pleased to present, new clinical data at the virtual ARVO meeting this past Wednesday.
The presentation was given by Dr., Christopher Reman, Vitreoretinal surgeon Associate director of Cincinnati Eye Institute and University of Cincinnati School of Medicine.
Dr remains clinic is one of the newly opened sites in our oxygen study. So this was the first time, but he has presented any off Virgin data, but he happens to be one of the retina surgeons, who helped design be gyroscope orbitz delivery system.
And because cell therapy, Sudanese because they'll delivery is just as important to sell purity and graph and then he brings a very relevant perspective to our program.
Dr remains presentation has been posted to our website. So you can watch is 12 minutes presentation there on our website.
If you just want the summary, what I can tell you with it we are seeing encouraging results since moving from legally blind patients into patients with better baseline vision.
Those are a one to more closely represent our intended target population.
So, whereas the first 12 patients that we treated had an average vision of 20 slashed 400, and very large areas of geographic atrophy. The recent cohort for patients that we've treated to date. They have an average baseline of just 20 flush 125. They also have small.
<unk> areas of geographic atrophy, which we think makes them better suited to assess in response to treatment with offer good.
We were pleased to report for the first time that we have seen consistent directional improvements in some patients across three separate metrics. So that means seeing faster reading speed.
Improved visual acuity or BCBS and slower progression of GE, a compared to the wasn't treated eye and seeing all three of those changes in the single patient.
These differences and BCB, a and GA progression are evident also in the cohort for pooled data, they're only five patients in that cohorts. So far so we have evidence of trends more than statistical significance, but we're certainly hopeful these trends will continue the error bars will tighten as we dose or next.
For patients.
We also have seen evidence of reduction in softer dreesen and anatomical changes to the retina, which we will continue to monitor and the portal.
Evidence of sustained and graph mint in our earliest treated patient is now up to four years. So I think we can comfortably say that we are not worried about the durability of these transplanted cells.
We also have her two positive surgical experiences with gyroscopes orbit STS device in combination with our thought and injected formulation.
We are increasingly confident and he used to be orbit device with our new formulation, but we do want to confirmed he was results in another four patients and once those four patients are dose that will conclude the orbit portion of the study and just the results from those patients are comparable to results that we've seen to date we would.
Plans to conclude the phase one two way study at that time.
If you'd like to dig deeper into our dry M.D. data dr. reman, there's going to be available to discuss the data and answer analysts' questions on a call next Monday.
May 11th at two P.M. Pacific and five P.M. eastern.
In the meantime, we will be doing what we can to identify and treat the final four patients in cohort four.
I'm happy to share that Dr. Reman has informed us that his centre is completing their plan to re initiate elected surgical procedures and clinical trial activities over the course of the next few weeks.
They already have identified an elegant eligible patients and the option trial will be one of the first to begin treating patients as soon as their standardize procedures are established to protect the safety of patients insight personnel.
So overall things are trending well, we do want to collect additional patient data to help inform our clinical regulatory and partnerships strategies, but I think it was a very positive update that we were able to share this week.
Moving next to back this is our off the shelf dendritic cancer cell vaccine.
This product candidate is comprised of mature dendritic cells, which we manufacture from established and pluripotent cell lines and load with a tumor specific marker to instruct the bodys immune system to attack and eliminate cancer cells.
By educating your T cells to seek out and destroy cancer cells back to acts like a booster for your immune system.
Our development partner cancer research UK or see argue K is the world's largest cancer charity dedicated to saving lives to research and they have been conducting a phase one clinical trial of back to patients with non small cell lung cancer.
This is a partnership that was entered into by a serious a company we acquired last year.
And your original plan here was that see are you pay would treat 12 patients in the initial phase of the study and a serious now lineage could decide at that time, whether or not to reacquire. The program based upon that data.
And it's sometimes happens the early data were convincing enough that we didn't feel it was necessary to wait for all of the patients to be treated and we elected to exercise the option early.
And I do want to explain that this decision to exercise the option early was not driven by the concern over how long it may take to enroll the next six patients. It was already clear to us after just for patients that back to dendritic cells could provide targeted education of T cells and that signal was apparent in multiple out they said.
So we were already leaning into this decision before the cobot pandemic hip.
We exercise the option early because we saw a political signal, which confirmed positive data collected in earlier studies of both autologous back one and allogeneic back too. So I just want to be clear that this was a data driven decision as obviously it should be.
Now, having said that knowing that rolling the additional patients was likely to take more time than expected because of the grown virus restrictions. It became even more clear to us that it would make sense to reacquire. This program immediately and not wait six or 12 months for evidence that was unlikely to change our view.
Additionally, there's a lot of process development that's needed on back to just like there was with hope you see one when we obtained that asset. So it make further sense to regain control the program early and send it over to our manufacturing facility. So that our C.M.C. group could begin work on it immediately.
As all of this was happening we were studying the biology of Sars koby too and it occurred to us that the back platform could be adapted to create a corona virus vaccine, but using a viral antigen like the spike like a protein.
And after further assessment, we determined this to be a novel idea. So we submitted a a U.S. provisional patent application and began discussing this idea of cobot vaccines with see our UK.
That discussion progressed rapidly from simply expanding the scope of the program to include Cobot vaccine development sexually conducting an early exercised the option so that our manufacturing team could begin work immediately on both the immuno oncology and infectious disease efforts.
Oh this happened very quickly and I really want to credit see our UK for their impressive speed and strong supported this initiative.
Smell lineage has control of the back to clinical program.
See our UK has agreed to continue collecting data from the current patients as well as to the dose to additional patients when they are permitted to buy the trial sites in the UK.
We now also have the ability to explore not only additional oncology applications, which were prophetic Lee calling back three four and five.
But also infectious disease applications for which were seeking nondilutive support from CIRM and I expect soon other parties.
There's one thing that I really like about this deal and that is that all of these programs, whether whether we're talking about back to a future back three vacfour or a co bid vaccine. They all require the same process development work upfront. So the impact of the dollar spent on manufacturing themselves.
It's really an investment in all the programs simultaneously.
It's only the final stuff the expression cassette, which carried the antigen, which which the finds the product that's specific to each individual product and we've retained a molecular biologist at our Alameda lab lead that internal effort, but we get a lot more bang for our block by taking advantage of the duplicated effort of all these different program.
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In that manufacturing facility.
Another reason for bringing the back program in house is its partnering potential.
With no full control the asset we're in a position to explore business development opportunities with companies in the immuno oncology space, where we could provide access to the dendritic cell platform as a delivery tool and we could generate whole pipeline of separate product candidates with different expression.
Sets and target various types of cancer, either with single antigens or combinations or there's a very much like a platform oncology platform and we do feel that the platform product nature of back will enable us to engage in new and exciting partnering discussions and we're looking into hosting the call with a therapeutic area expert.
To further discuss our plans with this program.
So I'm delighted to share this background today and really to help everyone understand the rationale behind the announcements.
As we proceed with transferring the program out of see our UK and into lineage, we will be sharing more information about what we've already seen in the clinic to date and what we plan to do going forward.
Overall, I think it's a tremendous positive for lineage that were back in a driver's seat with a clinical stage oncology program, a broad immuno oncology platform and also a plan for infectious disease vaccine, which may be supported by non dilutive funding.
Moving next to MPC, one our clinical stage program for spinal cord injury.
Our manufacturing team is working to introduce commercially advantageous and in some cases clinically enabling characteristics to that product profile.
[noise] attributes, which we have been working on include things like better control of the production process to increase consistency and reproducibility and scale up of production.
In some of the enhancements we're working on we'll have valuable near term benefits such as developing a inject formulation for OPGC, one, which as you know we successfully accomplished untested clinically with offer Jim.
A fun inject formulation of OPGC, one would allow the next clinical trial to be conducted at far more sites and enable us to finish and rolling sooner, thus, reducing the overall cost and duration of the development program.
The team has made terrific progress on OVC one they have conducted approximately 10 separate manufacturing runs and from those runs we have identified several opportunities to improve the differentiation process and purity of the product as well as the validate growth fund micro carriers.
Which is going to be essential if you want to have any kind of commercial scale production.
Micro carriers enable you to.
Convert your production process from two dimensional placed into three dimensional vessels. So there's a massive increase in production volume and scale.
Process development for obesity, one that optimization work is continuing but it's pretty clear to us that the folks who figured out how to manufacture 5 billion, 99% pure Archie cells have made really great strides on the oligodendrocyte program and I think it's further out.
Formation that one of our key advantages is our cell therapy manufacturing capabilities and that's yet. Another reason we wanted to get you spoke started and underway on the back program early as possible.
So no further on OVC, one I wanted to lets you know that we've also had discussions in connection with evaluating a new delivery device for spinal cord injury sells.
Our decision to obtain an exclusive option to the gyroscope Sds device that thus far worked out really well for our AMC program. So we're looking at ways that we could copy that experience and gain exclusive access to a novel and proprietary delivery device for our spinal cord program.
And as I've said before linear just committed to total asset management, which means we're not just interested in making the cells, we want to be able to combine the best available component parts Upsells production and delivery, which we think it's going to help provide an optimal treatment regimen that cannot be imitated and buy enough.
I think every piece of this overall care proposition.
We seek to outmaneuver, our competition and really position ourselves for long term success.
So a brief program updates for you there I know can hand things over to Brandy, who can review our financials and discuss some additional plans for this year.
Thank you, Brian I'd like to start with some highlights of our balance sheet account.
As of March 31st 2020, we had $25.8 million in cash cash equivalents and marketable securities.
Additionally, the value of our note receivable due from Juvin essence was $24 million as of the state.
During the first quarter of 2020, we sold 2.4 million shares of Oncotype stock for net proceeds of $5 million.
In April 2020, we sold another 1.6 million shares of Oncocyte Soc for net proceeds of $3.7 million.
After this sale, we still have about 4.3 million shares of Oncotype stock on our books.
Value of this stock as of May set the was approximately $11.3 million.
Our ownership in August site is now at about 6.3%.
Cash management is an important priority at lineage throughout 2019 and continuing into 2020, we have worked to reduce our operating expenses considerably while also advancing our programs in an efficient manner. We regularly we forecast our anticipated expenses to ensure that we're staying the course.
Yes.
We also carefully evaluate our assets on a regular basis to determine how best to fund our operations.
We are excited about the future of lineage and the positive changes we announced this week. It's unfortunate that the covert 19 pandemic has the later on average and timeline somewhat but we fortunately been able to fund our operations without conducting a sale of when its stock instead, we have funded our operations by selling additional portions of our.
Oncocyte Ajax and how to see positions.
We also continue to evaluate other non dilutive options for funding such as the CIRM Grant request, we submitted earlier this week.
Now, let's try to the statement of operations for the first quarter of 2020.
Total revenues for the first quarter were $500000 a decrease of 400000 dollar as compared to the same period last year.
At this time revenues are generated primarily from our I I say, averaging it related grant and royalties from the licenses of patents.
Our operating expenses include R&D expenses as well as DNA expenses.
Total operating expenses for the first quarter of 2020 were $7.8 million, a decrease of $5.8 million compared to the same period in 2019.
R&D expenses for the first quarter were $3.3 million, a decrease of about $1.7 million compared to the same period last year.
The overall decrease was related to a reduction of $1.8 million and origin and other ophthalmic application expenses, primarily related to reduced level of manufacturing activity and the first quarter of this year.
A 400000 dollar decrease and whenever you got related expenses, both of which were offset by an increase of $500000 and OPGC one related expenses.
As a reminder, we acquired a serious on March eight 2019, so last year, we only had a few weeks of oki see one activity included in our financial statements for the first quarter.
This trending up expenses by project is what we expected to see.
DNA expenses for the first quarter were $4.5 million, a decrease of about $4.1 million as compared to the same period last year.
The decrease was primarily attributable to the following reductions.
$3.3 million and mysterious related expenses.
$900000 in compensation expenses.
$400000, an accounting expenses.
$100000 and rent expenses and $100000 and consulting expenses.
These decreases were offset by a 500000 dollar increase and legal and patent expenses and a 200000 dollar increase related to the cessation I've shared services reimbursements.
Well, we have already seen a reduction in gene a expenses quarter over quarter. Our goal is to still bring our expenditures down throughout the year.
As an example, we recently hired in House Patent Council.
Maintaining our extensive patent portfolio is very expensive our new council is working to consolidate our patent work with one external law firm and help determine what patents and then what countries are critical and accordingly, streamline our expenditures.
He will also be flagging non utilized patents for potential business development opportunities.
Because we don't really know what's wrong, whereas replacing the whole cell is kind of a nice solution.
So that's a that's one example, and I think another example is in the the facts.
<unk> Amelia so when I looked even just this morning I I don't recall, if it was a nature publication or a cell publication, but a publication came out sort of categorizing all of the different vaccine approaches <unk>, what I, what I look when I look at that I'm. So please.
We don't look like.
The majority of the approaches that are in there because at our size and scale, we're not gonna directly compete with Madonna, we're not gonna directly compete with a company that is looking to use a full length, a attenuated vaccine as a as a therapeutic what we have done is we've looked at.
The emerging biology, and I really have to emphasize emerging because a lot of what is being known about Sars coby too is is to be determined but when we when we look at the data that's been come out and coming out it's clear that this virus has certain immune evasion strategies, which among.
Includes impairing immune cells like like T. cells, and then riddick cells and didn't really excels, they're they're the sentinels of the immune system right. Their job is to present. These these energens and to prime the adaptive b. and T. cell responses. So if you have a virus that that as part of it's.
Part of its strategy to maintain itself and reproduce is to impair that part of the immune system. If you don't if you're not delivering that message through the antigen presenting cells, there's really no way to establish a pro longs memory.
Against these infections, meaning they can come back and get you time and time again, so we're really not we're not looking at the current pandemic and saying how can we address people who are sick today or may get sick in an intervention. We are really thinking about how we can.
Develop a vaccine that would emphasize the T.H. two response and helped develop a multi year protection so using Sars as a as an example.
Some of the publications are coming out 2014, 2015 on Sars one of the things that that we were we're learning there is that the you you can have multi year protection from prior infection going out five or six years. So that's not driven by the by the immediate.
Antibody response, so we think that we can really be a solution that's tailored toward high risk individuals' people, who are going to be on the front lines of treating this this and other corona viruses for for many years to come what we have to think about our some of these and.
Urging issues like <unk> antibody dependent enhancement, where the virus cannot bind to those antibodies and then use that and actually lead to more serious disease. Later, so what I think we have as we I I think that the the other approaches aren't really built to establish immunological memory. We are really focused on.
Immunological memory that means we have longer time lines. That's fine. We also have far fewer people in that space. So we're trying to serve an unmet need within those hundred and 20 approaches and I see very few of those 120 that really resemble anything like what we are doing.
Because they're really focused on the media infection to not trying to establish multi year resistance for protection.
That is that's helpful. They're covered kind of a lot of different parts of it there.
It doesn't just a quick quick follow up to that obviously, there's a lot of enthusiasm and momentum around the M.R. day vaccines and it's not just for dirt or.
<unk>, but.
That I got and I can say this just as it I'll just that it just feels like.
Yeah, because it's scale, because it's safe and and.
Yeah, they're they've rush it into phase two there's almost a guarantee in some ways that there's been during the vaccine has got to find emergencies authorization somewhere before we get to the end of the year.
Whether whatever side somebody falls on good or bad like it or not how does that change the development landscape for others that are coming up from behind it it's kind of lower the barriers and kind of open. The doors you know for you to kind of accelerate your program.
Yeah, it's simultaneously beneficial and horrifying and the reason why I say that is yeah.
Right, we're able to see things like data collection, and enrollment and reporting and mean publications are going out without peer review and in some ways that is incredible. It shows you the potential of what happens when when a a community really focuses on an objective. So I think it's amazing and it it's I mean literally life.
Anything that we are knocking down some of the traditional obstacles that slow things down, but it's horrifying because you end up making highly concentrated bats, and there's the old you know, saying about you know you can be faster you can be good or you can you know he can't be both that sort of thing and I I think that with tremendous respect or what Madonna is doing.
There is a massive bat being placed on that approach and the funding is going there and patience started going there and and if it if it's unsafe or if it's not all it's cracked up to be have we impaired all of the other programs. It's it's really it's really and suddenly.
A benefit for lineage in our situation is that we're going to first work on the process development, if we're going to be able to treat huge numbers of people. If we're going to be going into a thousand liter bio reactors to growing these cells, we need to get the the the fundamental attributes of the <unk>.
Right from the outset, and it's beneficial for us that that kind of work to build the scale of the D.C.'s is going to be applicable to any infectious disease program or any oncology program that we dream up and you could literally come up with billions of different antigens that one could imagine presenting that in itself is going to be a really fun.
In an interesting project, but my point is that the work that we're doing is so <unk> each of these programs.
Even if you see a different Sars virus, where you see a mutation of the existing virus, where we have a totally new class of virus, we want to create a a a platform where you can just drop in the kinds of antigen presentation and you're dropping it into a deliver.
Vehicle that you're already tested in your already happy with.
<unk>.
It'd be a solution for 10 2050 years worth of vaccine development, if we get all the right pieces in place in the right way from the outset. So we're definitely in it for the long Road long road mean individual treatment individual multi year protection also on a societal level.
All of the multiple you know unknowable infections that come and then we're going to double dip because we're also doing the same work for the gaming ontology platform.
Right.
You bet. Thank you.
Your next question comes from an outline of chasing <unk>, Wisconsin.
Games security.
Hi, This is actually Tucker on behalf of Jason and my question is that we understand option as our focus and that would you be able to just take some time then walks through the next couple of data points and title us I'd be seen I'm coming to fruition. The next few weeks and months.
Yeah of course, I think the things to look forward to from the opera and study is news from the company that we have been able to and roll again, and I and I think I made some comments earlier on the call that when we may be as few as just you know a few weeks away from being able to do that we have a patient identify we just are way.
Eating for the site to be able to the unrestricted and that's totally out of our control obviously that has to do with a lot of factors like whether or not there's a second wave this sort of stuff in a and everyone monitors that.
So <unk> you know the first sign that we are enrolling again, I think it's going to be a a real encouraging a positive sign.
We only have four subjects left in the orbit portions are agreement with with drivers scope now for the orbit device is for six subjects. The first two.
Been treated they actually have quite a large amount to follow up at this point and we've been really happy with the performance of the surgery. The surgery is is adaptable to different individuals and a and for patients is a fairly small number. So if we get some some relief from enrollment restrictions I do not think it's going to.
Take very long at all before we will have completed a that cohort and and then with the evidence that our thought and inject formulation are off the shelf dawn and Jack formulation plus the the handful of more orbit experiences <unk> two two are great, but you'd rather she's sick when we have those in.
Hand, then I think it's pencils down I I don't see a strong reason to to continue the study I think we take those patients data and prior patient data and we can take that to the agency and and talking about designs and we can take those to partners and say look there's the data set as as we see it and and so.
As it has been for the last year and a half since I joined the company. It has been all about collecting enough individual data points that there's a picture there that you can see Uh huh I believe with confidence that there is a treatment effect. So I I don't think we're far from from saying that I think internally, we already feel that way very strongly.
We do want to get external enthusiasm for that so just a few more patience for specifically in this cohort and then I think we will we looked conclude the biggest one to a study do some follow up some safety follow up and take that data the F.D.N. partners as I've just described.
Alright, thank you so much.
Thank you Tucker.
And your final question comes from the line of Joe.
With eight C. Wainwright.
[noise] everyone get afternoon. Thanks taken a question and I'm really glad you're all doing well, Brian I want to focus on back to and the C.R.U.K. study. So I know, obviously, you said, you'll get more information when you bring it in house, but I want to focus maybe on some of the nuances of the trial conduct to date that you can share hopefully.
So it's sort of a multi part sold to split it up and maybe two parts. If you don't mind. So first I was curious if the study had enrolled all 12 patients and of those 12, if I looked at this study design do you know the balance between advanced patience versus versus edge of in patients.
So <unk> hi, thanks for the question enrollment is that six currently N.C.R.U.K. is going to go to eight we I I don't box hands I pretty sure. The majority, we're advanced but but I'm going to need to.
Follow up on that the reason for a absence of specific knowledge is that our greatest level of interest from the back to clinical study was seeing evidence of Immunogenicity that was specific to our antigen. We put in this little bugger do we see a response to that.
And clinical responses from just four or six or eight patients, although potentially exciting as standalone evidence they weren't really the focus of this study it it it's a offensively. It's a safety study we want shows it's treatment as well tolerated.
But really what we're trying to do is demonstrate proof of the mechanism that if we put in that fragments. We see a specific response to that fragments. So that that was apparent to us through through multiple essays as you know pendulum or staining and L.E. spot and things like this t. cell activation exhausts nastase.
And just making sure that that all coincided with the timing of the vaccination and we thought that that was highly biologically relevant. So that's not to say that we will not report on clinical outcomes. We we will those obviously are lagging because it takes longer in patients when you're looking at overall survival even though.
These are largely advanced cancer patients, but for us our focus was really on the the immunogenicity samples and demonstrating that we were able to trigger a and drive really an education of the t. cells and and measure that in multiple ways.
Got it got it and so the part two of my question, then I'm going to steal a phrase you just used for opera Jen when you do bring it in house is it pencils down or is this study going to be continue or you're going to continue enrollment under lineage.
Or are you going to then define the next steps and move on to a different study potentially different indication.
It could even be see both so the nice thing is that C.R.U.K. has agreed that they will continue to monitor the existing patience and then roll a couple of more so the study will be open and going for a number of months I mean, certainly more than a year.
It would be at our discretion, whether we would either invite them to enroll additional patients or or not we could have that conversation I think that would be to be determined there would need to be of course, a good rationale I don't think that as I explained in the in the body of the of the call I don't think that doing that.
For the purpose of seeing additional immunogenicity is going to tell us anything more we already saw that we're confident in it I don't think that's a good use of our money.
Doing that to try to get some clinical responses again, we're talking about very small numbers of patients. So I'm not so sure I think what I would prefer to do would be to move back to into an area that we're really excited about which is in combination with checkpoint inhibitors, because biologically being able to.
Simultaneously.
Take the breaks off of the immune system, which is what checkpoint inhibitors are are kind of doing on a cloak real way and the simultaneously hitting the accelerator, which is what our technology does bye bye directly educating the t. cells what to attack.
We think that combination is going to be really powerful. So the the study that that's your U.K. has done is fine, but I think when it's really telling us is that we've got in each of the city. It's well tolerated now let's go into the optimal or more optimal settings in combination with checkpoint inhibitors, let's you know.
Bring every indication back onto the table, let's look at bladder, let's look at C.L.L., let's look at everything and find the best places where a small company can really win maybe we drive it toward a partnership maybe we'd drive it into a knee syndication. So everything will be on the table as we print as we as we'd bring in bringing that data but.
Specifically for the the back to study it was really all around the Immunogenicity signal and once we got that first report. It was you know it was champagne. It was it was a great that.
So.
We appreciate that extra data and then with regard to the question is still for back to I I, but I do appreciate all the extra comments you gave around no P.C. one process development. So with that in mind. Maybe you can you just maybe list out the top two or three factors that you want to address with regard to <unk>.
This development.
Yeah. So I mean, there's some really nice things that C.R.U.K. did they've got this business unit dedicated to sell therapy. They might have some car t. in there I'm not I'm not sure what about all of their programs, but the directed differentiation right directing lineage of cells that methodology is pretty well established.
Well of course investigate it looked to tweak it but the directed drifter differentiation is pretty good. The analytical steps are are pretty good the things that we will want to do would be to establishing a an intermediate sell bank. So that we can kind of stop and start in different places as we look to introduce some of the improvements.
If growth in large suspension volumes.
With or without micro carriers, it's it's it's so important especially with the D.C. approach because we're talking about large numbers of so much larger numbers than we use in dry A.M.D., where there's only 100000 cells are are administered we need to be able to have really high volume and this is something.
I've been talking about since I got here is that the winners and losers in cell therapy, I think are going to be just inevitably inextricably linked to your ability to manufacture the same thing over and over in huge numbers. So a lot of our focus I can't they all that but a lot of our focus is going to be process development.
That leads to hi scale production first high enough to enable larger clinical studies and then going from there into late stage clinical studies and then ultimately obviously you've got to be able to remove any obstacles to commercialization. The great thing is that we've had a lot of success with the retina program doing that.
M.D., we're in the middle of that right now with the Oligodendrocytes, we're going to be able to hit the ground running with back to and so there's all keeps coming back to this notion that we have the center of excellence and sell manufacturing and so getting these programs in getting them to our G.M.P. facility and letting the folks who are the experts and figuring out how the heck you can.
You can grow these cells without them you know derailing halfway through a differentiation is really the key here and that's really how we're trying to add value to the program.
Got it Brian. Thank you so much and I hope you all get to get some rest coming into the weekend ahead of what was a very productive and busy week. Thanks a lot.
You asked me about gift.
At this time there.
I would like to handle <unk>.
His final remarks.
Alright, well thanks, everyone I really appreciate you joining us. This afternoon, you can tell them excited about our plans I think we have a lot to look forward to as always I really appreciate our shareholders support and will continue to do our best to position lineage to be a leader and cell therapy and transplant medicine as as we demonstrate what our assets and an opera Jim particular can do for dry M.D.
Thanks, very much and and we'll be in touch.
I'm just asking for today's conference call. Thank you for your participation human now disconnect somewhere.
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