Q3 2019 Earnings Call
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Thank you for holding the code of the call I'd like to jointly.
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Welcome.
Super Thank you Sir patron Andrew.
Eight TTR.
If you know.
ATP ice and progressive fatal disease that results from the production cooled and heated up or the liver and that they position.
CPR for the hybrid multiple organ.
Clinton Diversey sees me station.
Based on Europe at the and I mean my old.
Over 120 genetic mutation or no money said your regulatory 80, PR, which affects approximately 50000 patients worldwide.
Furthermore, in the absence of genetic mutation ATP yard and also developed Paisley, none as wild type ATP, our which affects an estimated 200000 to 500000 patients across the globe.
As you like 21, our goal is to treat patients with ATP, our regardless of whether they had either the hereditary wild type formal city.
Because we will be knocking out underlying disease coffee and tea RG <unk>.
Over the past few years, our peers men tremendous strides in serving patients with a TTR. They have validated target and shown that we use an expression of TTR protein is an effective way to achieve clinical benefit.
We hope to build on those results as well fundamental to the promise of gene editing with CRISPR Casnine and took over mission, we believe that the potential to provide a one time potentially curative treatment me and address need for patients and remember some you differentiating factor of our approach.
Today, we have demonstrated these potential studies with our lead allenby formulation targeting the TTR gene non human primate.
Following a single administration, we achieved an average reduction of greater than 95% circulating PPR non human primate, which is expected to be clinically efficacious.
As part of him go into her ability study, we have demonstrated 10 month durable lever anything would sustain reduction of circulating TTR protein.
We're very pleased with this we sold and continue to advance our I Indian I'm sorry.
We also announced today than we have commenced clinical and manufacturing where our phase one material.
Certainly we remain on track to submit an eye in the application for Indian a 20 year, one you need 2020.
Which we expect to me the for.
Then they deliver CRISPR casnine therapy in the clinic.
As a reminder for this program we have a 50 50 co development uncle localization agreement with Regeneron, we didn't earlier I suddenly party.
Let's now turn to overtime to get that insertion efforts in deliver as discussed on prior calls we they move straight in the first CRISPR casnine mediated targeted transgene insertion in the liver no human primate.
In fact or nine inserted into the I'll give me mark.
As a reminder, that there are nine it goes the blood clotting protein that is leasing or defective, yes, hemophilia b patients.
The study use our proprietary hybrid than the very vehicle, which combines how worth CRISPR. LMP then even system. We then a these vector in Columbia, South or nine gene.
In a nice demonstration of the modularity power platform, the crisper and I'd be really resistant.
Same I say one use you know were ATP our program, we this'll change being the guy that Renee.
We believe our targeted insertion approach provides you advantages over traditional gene therapy in both safety and efficacy.
Targeted insertion should reduce the risk of me the Genesis user random integration of retro viral vectors.
In addition, targeting insertion should provide durable efficacy with single of course of treatment and potentially your liver disease.
So we're working with went to enter on play than side, and that's where the hemophilia B program and had been simultaneously exploring person a father trial.
To support the expansion of how were you able pipeline.
As part of this effort and again highlighting the modernizing our approach we have exchange owning Indian they simply for the Gino interest in the hybrid LMP Aviate anyway system.
Building on that worries social work would factor nine an alpha one antitrypsin, we have now generated vivo protein expression or whoever you shouldn't genes of interest and are able to wake in several more.
These results are highly encouraging and we look forward to persons in these innovative sign I mean same basic meeting.
Yes, John maybe as we reported and it's funny 19, yes, GCC and meet in the first thing long duration, okay consecutive Nvvault gene knockout AD insertion in house mobile Alpha one antitrypsin deficiency or a PD.
He sees requires both every they actually in the level that he sees Caulfield propping I restoration of the wealthy proteins I mean, you really see.
It goes like if it and it led to a greater than 98% with action that he sees closing protein and sustain restoration of the missing protein to therapeutically relevant circulating broken levels throughout the study.
We believe these person a compelling and differentiated therapeutic approach for a T.D. I see it addresses both the liver and lung money for stations and you see.
Moreover, this is another example of our leadership is extending genome editing to treating genetic diseases.
We wouldn't be moving forward without work on ticket the Indian strategy for a TV in higher animal species.
Moving onto our engineered cell therapy pipeline, what are the signing internally yourself to create a range of human logical and solid tumors.
As we've discussed on prior calls we have four workstreams sources and so our focus so they will be on our wholly own T cell receptor or PCR replacement approach.
Initially were utilizing this approach to target Wills tumor one for acute myeloid leukemia, and then potentially if our idea of physician on liquid and solid tumors.
That's a reminder, our proprietary and highly efficient TCR based approach knocks out endogenous TCR by eliminating the Sunday the chain and seem opinions see insert that therapeutic he see our New York.
Notably this therapeutic TCR, we precisely insert isn't naturally occurring PCR that can be found the Hilton honors.
This approach should enable us to preserve normal diesel facility and has and stabilize expression of thing served as therapeutic Pcr.
And reduce the risk of graft versus host disease that quarterly sold from me sparing between endogenous names or does he see ours.
In contrast to card fees, you see our expands the range of Suntrust will tumor type because they can recognize in Brooks said tumor antigen or cart fees typically recognized on the surface proceeds.
In addition, we believe our TCR their rented engine years cell therapy approach offer meaningful efficacy and safety advantages over currently available engineered cell therapy treatment.
As you know I did my leukemia or email using anthro blood on bone marrow with significant unmet medical need.
Generally outcomes for the majority of and know patients remain poor and the five year overall survival rate is less than 30%.
By directing PCR started the wills tumor one I'm kitchen, which is over expressed in the majority of among patients.
We believe it provides tremendous opportunity to live analog in broadly applicable treatment for you know regardless of mutation on background of the patients leukemia as discussed on our last quarter School. We're currently conducting functional testing in patient derived xenograft models more people need WT one do you see article.
I like that recognize it primary WT, one it'd be super interesting and now with high affinity.
Great that from diesel noise studies wouldn't informed elimination the hardware development candidate, which we remain on track to achieve by yearend.
In parallel to ongoing studies were advancing GMP manufacturing related development community in support of Phase one clinical trial.
We believe our Amnesty program, we lay the foundation to pursue in brother rate of cancers, who will give us all these tumors.
Yes, you why these highly expressed on gross many liquid and solid tumor types, there's significant opportunity to target. The number of subsequent tumor times with this same TCR.
We began to generate promising in vitro activity in solid tumor cell line.
We expect this work will unlock new immuno oncology opportunities to further expand our pipeline.
With that I would like to turn the call over to Glenn will go through the third quarter's financial statements.
Thank you Laura Hello, everyone encoder remains in a strong financial position as we advance multiple programs forward and development.
Our cash cash equivalents in marketable securities at September 32019, or approximately 295.8 million compared to 314.1 million as it somewhere 30 Onest 2018.
The decrease was mainly due to cash used to fund operations of approximately 91.
Which was offset impart by 54.1 million of net equity proceeds raised my companies aftermarket agreement.
8 million of funding received under the Novartis Corporation.
1.3 million of eight TTR development cost reimbursements made by Regeneron 2.8 million and proceeds from employee based stock.
Our collaboration revenue was 10.6 million for the third quarter of 2019 compared to 7.4 million for the same period in 2018.
As a reminder, our collaboration revenue is related to our partnership agreements with Novartis merger and wrong.
Also regeneron funds approximately 50% of development cost for our GPCR program.
R&D expenses were 27.5 million for the third quarter of 2019 compared to 23.2 million for the same period in 2000 an increase.
Increase mainly relates to the progress of our lead programs and our in vivo and engineered cell therapy platform.
Our gene expenses were 8.4 million for third quarter compared to 8.3 million for the same period in 2018.
This increase was mainly due to employee related expenses.
So finally today, we're reconfirming that we expect our cash balances the fund our current operating plans through at least the next 24 months.
And now I'll turn the call back over to John to briefly summarize our upcoming milestones and corporate up.
Thanks, Glenn anymore in summary.
Extremely pleased with the achievements, we've made so far and 29.
We continue to demonstrate our leadership and systemic genome editing with central first LMP Christopher program.
Correct studies, several breakthroughs and editing approach.
In addition, we've seen our TCR directed energy so therapy efforts moving forward and rapid pace.
Looking ahead to the balance of the year or team remains focused on advancing our lead programs for the treatment of a TTR and damn though.
We remain on track to nominate or development candidate for AML by year end and for a TTR program. We're on track to submit a 90 application for until a 20 on one by mid 2020.
We believe there is incredible opportunity ahead, as we leverage our Christopher based platform and prioritize much programs to build a robust pipeline of in vivo and engineered cell therapy programs.
Forward to sharing plans for pipeline expansion in 2020, I'm confident that we have the team and expertise in place to accomplish are mission.
With that I'd like to thank you all for tuning in today, well now open up the line for any questions operator.
Thank you and ladies and gentlemen, if you'd like to ask a question at this time. Please signal by pressing star one on your telephone keypad and if you're using a speakerphone. Please make sure mute function is turned off to layer signal to reach our equipment again that is star one to ask a question.
And your first question comes from the line of Gino along with Barclays. Please go ahead.
Thank you for taking my questions and congrats on the older programs and I'm really glad to hear that I'd be moving forward. So regarding the WT. One PCR program I'm. Just wondering you know what additional data we will see Oh, you file for R&D.
[noise] [noise], Thanks, Chad Sean good morning.
As we've said we're working towards her development candidates and there's a few finishing touches between now and the ended the year and we think we'll be in a position to assure that data in upcoming scientific conference in 2020 sometime in will tell you when and where that will be when we're ready to go.
Okay. That's fair and also you know just wondering given Colin like a newly merged the technology wanted to heal thoughts. So I think that maybe last week the need to publication on the Prime Atokin and how do you see the field evolve over time.
[noise] well all of these technologies are based off of CRISPR Casnine, which is the core of the work that we do here, we haven't seen any format come out that.
Makes us feel that we're using the wrong work or doing the wrong worker using wrong technology.
I think there's interesting data, but theres a long long way to go before any of that we'll be ready for patient works. So well follow the fuel closely as it evolves and continue on with her own programs.
Hmm and the last question is regarding ATP all program. So the R&D is mid 2020, I'm just wondering would that be what could be the initial dose or are you looking for reaching you know minimal oh within the therapeutic window and it will you be thinking about single dose or.
Multiple double double dose.
[noise] well, we haven't design the program finally, yet with respect to phase one work, obviously, that's discussions that we'll have with regulators.
As we've said previously this is likely to be a single ascending dose and it'll be a balance between.
The appropriate place to begin from a safety point of view and then we'll see the rate at which we can escalate into areas that would be expected to be therapeutic.
[noise] would that be sleepless me a tremendously.
[noise], we're not ready to talk about the trial design, there's lots of choices and we're trying to do one that will enable us to move appropriately and patients as a.
Prudently and as quickly as possible.
Thank you.
Thank you. Your next question comes from the line of Maury Raycroft with Jefferies. Please go ahead.
Hi, good morning, everyone and congrats on the progress first question is just a with the starting of your manufacturing of materials for both eight TTR and WT. One can you provide more specifics, including anything on the supply chain contingency plans and then in capacity and how this might factor into expenses going forward.
Oh, Hi, Marty good to hear from you or we're not giving any substantial details in terms of all of the pieces and how the come together. Obviously this is an important part of moving the program forward and we pay a lot of attention to it.
We think we put in place a plan certainly for eight TTR that will get us well into the clinic. So we can establish a key data and go forward from that and is WT, one evolves, we're assembling that supply chain as well.
I think we have the benefit of learning from others, who have gone before us and we're applying those lessons so more to come.
Got it Okay and then for your W. Two one TTR program I know its autologous you alluded to that design in your comments I guess with gene editing capabilities, you've got a lot of options. Just wondering if there's anything else in the works as far as novel modifications to enhance safety.
And efficacy with the TCR engineered cells that you're thinking about.
Yeah. The first development candidates is as you point out autologous, we think that nicely isolates. The key variable here, which is the T cell receptor.
We presented data on the efficiency, the very very high efficiency with which we knock out the alpha and beta train in the very high efficiency with which we can introduce the TCR of choice and we're very very excited about that we think that represents a real step forward in terms of this type of work.
Okay.
As we presented elsewhere, there's a series of other things underway to enhance how we can think about allergenicity. That's separate from this particular development candidate, but we're making very good progress there and when it's appropriate to bring that into this program will do so im sure that data.
Got it it and then last question just on a eightd. The date, a yes easy to use interesting I. Just wondering if you can provide any more specifics on on timelines for that program and for the NHP studies and then separately. If you can talk more about the efficacy you're seeing with a T.D. and all.
So it would have nine and if those data are consistent based on the dose with what you are using a T. R to affirm that you can switch out guides and hit new liver targets.
[noise]. So thanks for asking about that exciting data, we think it's another demonstration of the importance of modularity and yes. The LMP format and that those are essentially the same going from model to model system. So we're excited about that so first and foremost.
This demonstration of that.
That work was done in a mirroring system [noise].
Theres where to extend that into non human primates and does that that evolves, we'll be talking about it that at future presentations, but it's moving one of very very briskly and we're excited about it.
Great. Okay. Thank you very much thanks, taking my questions.
Thank you. Your next question comes from the line of many RAR with as VP Leerink. Please go ahead.
Hey, Good morning. This is Rick dialing in for money Congrats on all the progress and although great presentations at U.S. GC tea.
My first question is about to cell therapy program could you maybe discuss some of the next steps once a week WT one tenant is nominated and anticipated timelines for how long.
You anticipate W.R. and D., enabling studies will take to complete.
Okay.
[noise] I was waiting for a second question there, but this is the first one.
As I said earlier in the.
81 program one of the final final stages of selecting our development candidate.
I would expect early next year, we'll share more details about whats the timeline is for a pretty good progress in that program.
So today, it's not the right comment you're talking about R&D timelines.
Okay got it I'll shift over to the Alpha one Antitrypsin program then.
So just thinking about the competitive landscape for this disease their competitive oligonucleotide programs that are specifically going after the alpha one liver disease.
And their design in clinical trials with histological endpoint. So I was wondering are their ongoing animal studies, where you're specifically looking at a reduction of djezzy protein in the liver or maybe histological improvement.
Since these programs are specifically just looking to knock down the p. ideal meal.
Just maybe here some of your thoughts on the importance of.
Looking out a disease piasio versus restoring no expression of the wild type protein in this disease and what it could mean for competitive competitive positioning for your program.
Yes. Thanks for the question as you know Alpha one Antitrypsin deficiency has two aspects to it when is the liver disease, which is best addressed by knocking that protein down.
Most of the pathology and morbidity and mortality frankly, it comes from lung disease and to deal with that you need to reconstitute normal levels protein.
The work that we did shows that we can address both and that would be the format that we think is most clinically relevant and one that we would intend to bring forward. So to the extent that we achieved those normal levels. As we continue our work of circling protein. We believe that that would constitute the best solution for patients and that's the borrower setting for us.
Yes.
Okay, and as far as a histological and claims for for liver diseases that something you'll be looking out in your ongoing animal studies.
We've already shown in mice that you can have an effect and that's certainly something that we'll continue to study as we progress program.
Okay, great. Thanks for taking my questions.
Sure.
Thank you. Your next question comes from David Nierengarten with Wedbush Securities. Please go ahead.
Hi, Thanks for taking my question I just had one.
Curiosity, you know, you're a little bit different with alcohol and having a autologous approach.
There are other safety or.
Other preclinical data, we should be looking for our wouldn't we take a look at your efforts versus some of the Hello.
Purposes for ammo.
Besides stupid Steve Thanks.
Yes, well thanks for the question.
Our approach with an autologous cell source. We think is one of the very key aspects of addressing safety and then the precision with which one can introduce the chosen TCR.
In locus and eliminate the in Dodgers TCR.
Change that could potentially miss pair, we think constitutes a real step forward for patients with this particular approach so.
Obviously, we study that in a variety of systems some of them in vivo and as we bring our development candidate forward at a future scientific meeting well positioned to share the results of some of those studies with you but.
At this point, we're very excited about the activity that we're seeing certainly in AML blasts as well as other solid tumors as we study them in vitro systems.
And.
We expect that we'll have some exciting clinical.
Candidates to investigate here on next year and shortly thereafter.
All right and.
Maybe just a quick Chuck there's no there's no difference or any reason to think are being a difference besides tumor biology or I mean.
Solid versus like whatsoever between the candidates for solid and liquid tumors.
No saying.
Okay. So striking thanks.
Okay.
Thank you we'll next go to the line of Amanda Murphy with BTI GE capital. Please go ahead.
Hi, good morning.
Question on T. our.
Obviously, the five no one seems to be going pretty well there I just was curious in terms of.
No what the lessons learned there.
But the lessons learned ours are the physician education and diagnosis and it seems like there's a little bit of.
I hear you obviously at a wide wide range in terms of the market opportunity in a little bit of discussion there. So just curious your thoughts.
Yes, I'm not going to bombs or how big it actually ultimately did post on the huh.
While type perspective.
I'm not sure I heard all of the elements to your question demand, but I think you're asking me about the market opportunity in house evolving our for TTR.
We clearly are watching it as it happens we have some new entrance into that marketplace and as you know this is a market that didn't exist previously so there is theres a lot of.
Learning that will take place.
Typically in cases like this we see the early estimates tend to underestimate what's actually out there as doctors learned to recognize the disease and one might conclude possibly early Pfizer data that in fact, that's happening already so.
As we put our program in place we want to position ourselves so that will be able to address both aspects of this both neuropathy in cardio my occupancy or doing it in a way that we can address.
TTR, whether its mutated were wild type and.
Lot of work to do lies ahead, but we're very very excited about the opportunity as we understand it better.
Yeah that was the delta adapting to surround the.
What we once upon a by July but that makes sense.
Another one on the TTR program and I I I've always said early like we said that if maybe you always ask the question but.
Obviously, you kind of focus on having a modular approach in general.
So.
Going forward.
Lager apartments is the right way to talk about expansion of indications really focus on WT one or.
No. It would be all to think about maybe argued expansion or on some targets going forward and is that you know a five year upon a timeline or that potentially in Arizona nearer term father.
Right. So modularity is key to all that we're doing here and that certainly applies on the cell based side as well.
Well when thinking about the first step that we're doing with WT. One is to validate the T cell receptor and is a particular approach we're taking but that's yeah immediately extendable into solid tumors and we would hope to be in a position that we could pursue that very very quickly or even shortly thereafter the.
M.L. program begins ways to expand on that include building out the PCR sat.
In doing that across each allay types and then moving into other particular TCR target. So we think once you have that basic module in place. There's many many opportunities to move forward very broadly and very aggressively.
Okay, and that's just last one on the bi directional template insertion concept was curious how.
I don't know threat word protected have that I mean, it's a pretty interesting and.
No. It makes some sense is that something that youre pursuing in terms of patent protection I'm, just obviously again going back to the modularity concept subs insertion.
Our purchase.
Yeah, I I'd, rather not comment on that particular IP approach that we pick I'm certainly as we bring their products forward. We expect to have many layers of protection. It's not just one thing were another it's the various components as they come together for a particular therapeutic approach and that's the way that we approach.
All of the potential products that we have here until it.
Okay. Thanks very much.
Thank you. Your next question comes from the line of Stephen Seed House with Raymond James. Please go ahead.
Good morning, I had a question about the ATP strategy and data.
Yes, GCT, where your knocking out the disease, a wheel and then sequencing the second other things that answer while poaching at the albumin mogas.
Three weeks later I was just curious what are the pros and cons and sequencing those edits versus just multiplexing, though at the same time, because two editing steps are targeting different low side. So.
I guess theoretically could multiplex wells.
Well the first step was to.
Carry out to experiment in a way that would be very very clear. So we wanted to show that we had achieved a knock out and that we could then sequentially dose the on piece, which is an important element to the study by itself.
Get an effective we demonstrated that so it comes back to the very notion of the basic basic notion of re dose ability with Alan pays and we think we demonstrated that in this particular program the optimal timing of when to do this is something a yet to be worked out.
I.
That will be dependent on additional studies and data as we accumulated going forward, but you should take this first experiment is already very very exciting because it's not been subject to much optimization, we're able to get very high levels of protein.
But you know, it's we think about the ways to control that further.
There's many ways to enhance the system and make it more efficient. So work that lies ahead non human primate data et cetera, So stay tuned.
Okay. I appreciate it then one short one on the optimization that you alluded to what is the percent efficiency for wild type gene insertion at the albumin locus that is getting you already to therapeutic levels.
And we haven't presented that data yet.
So that'll be upcoming work that we do as we pursue various targets.
So early days yet.
Okay. Thank you.
Thank you. Your next question comes from the line of Madu Kumar with R.W. Baird.
Oh good morning, everyone. Thanks for taking our question. So our first one is to use and generally walks through the remaining steps for NTM late 2001 between now and the mid 20 I'd submission and then thinking about a clinical program for until late 2001, and it could a broad strokes level what is the target TTR surprise.
Should level Youre looking to achieve our you mean front on petro level of TTR suppression or something deeper. Thank you.
Thank you might do.
We don't give a step by step analysis of our work in the line D. There's general steps I think are broadly understood. Some of this is time gated worth it relates to the Tox studies, and we're well into that.
Theres manufacturing of material, which we as we talked about on the earlier part of the call. We've begun and all of that stuff is on its way we expect to hit the target of 90 of mid 2020 next year.
We're all working very diligently to achieve that with respect to.
The.
Targeted suppression levels of TTR.
We've learned from.
Those have come before us that levels below 60% or associated with therapeutic.
Activity and that's certainly foremost in our mind, but we want to hit the benchmarks that we think will represent a therapeutic advance for patients. So.
We are.
Striving to achieve higher levels of suppression and would hope to exceed to exceed levels of 80%.
Specialty tea Arne certainly have demonstrated that we can do that non human primate. So it's all a question of moving into the human clinical situation and collecting data, but that is ER our benchmark at this point.
Excellent thanks, very much guys.
Thank you again, ladies you want that is star one on your telephone keypad to signal for question at this time.
We'll next go to seven Churkin with Oppenheimer. Please go ahead.
Thank you for taking my questions and congratulations on the impressive Hey, TDD data.
Yes. She said to you also presented updated data in a mouse model in a in primary Hyperoxaluria ph.
What does your current thinking around the best targets in a in between A.J., you won and L.D.A. J.
So.
We continue to think about P. H one it's in our discovery group and we've done a fair amount of research.
One aspect that we've learned from that is to modularity of our system and you should think of some of that data we presented that way.
LMP and across all of these different targets in the liver, whether the P. H one targets Alpha one antitrypsin or TTR. We've demonstrated that that same LMP is useful against all of those targets. So part of the data speaks to that with respect to the best way to proceed and P.H. one.
Decided.
But we've demonstrated that theres more than one way to be successful there and how we advanced that program and if we advanced have program as a function of somebody other choices that we've been working so stay tuned.
Great. Thank you and with respect to the Novartis collaboration that's coming to opt into some point in December 20, Nike and if any update you can give us or how you think or what the plans are.
That's for Novartis to decide and ER as appropriate will provide updates but.
Non today.
Great. Thanks for taking my questions.
Yes.
Thank you we'll next go to the line of Tosh Hassan with Roth Capital. Please go ahead [laughter].
Hi, Good morning. Thank you for taking my question I'm going back to data presented at.
At the age and Dan cell therapy conference.
In India in the mouse model off.
Oh FA primary hyperoxaluria.
It looks like well there was that there is a very good correlation between reduction oxalate levels and.
Editing percentage I hope, but that seems to break down between one milligram until mugham dose I would like to here Oh your thoughts on this if possible. Thank you.
Well.
I could go to all of the details of the data other than to say generally speaking there's a relationship between the extent of editing and the effect that you change.
And the extent to the which you knock out the gene of interest that's going I have the attended physiologic correlate that's work we've demonstrated across all the targets as I think you should expect so.
It's not surprising.
Thank you.
Thank you and it does appear we have no further questions at this time I'd like to turn the conference back over to Lena Lee for any additional for closing remarks.
Thanks, and thank you all for joining today's call for your continued interest and support we look forward to update you whatever have agreed to.
Thank you again that does conclude today's call. We do thank you for your participation you may now disconnect.