Q1 2022 Orchard Therapeutics PLC Earnings Call
Okay.
Welcome to the Orchard Therapeutics Q1, 2022 earnings Conference call. My name is John I'll be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session.
During the question and answer session. If you do have a question at zero one on your Touchtone phone.
I'll now turn the call over to Bobby Gaspar.
Hello, everyone and welcome to Orchard Therapeutics first quarter 2022 financial results and corporate update webcast.
Oh and cofounder Bobby Gaspar.
Before we get started I want to remind everyone that this presentation contains forward looking statements.
Please refer to this slide and our latest SEC filings for more information.
I have three colleagues joining me on today's call Greg Parker, our Chief commercial officer is joining us to highlight the success. We recently have expanded commercial access for the <unk>.
Thomas President and Chief operating Officer will review, our financial results for the quarter.
Let the Meltzer, our Chief Medical Officer will also be joining for Q&A.
In March we spoke about our decision to strategically prioritize the focus of our platform.
It just took indications where we believe HSC gene therapy is scientifically and clinically differentiated and where it can deliver the most value.
Through insights with game for many of the scientific and clinical development in this field, we believe indication selection in our space is Paramount and this is what is driving our strategic approach and decision making.
Firstly, we want to focus where the HFC approach.
Differentiated itself.
Typically and clinically.
That is in neuro degenerative conditions like MLP with the migration of gene modified hfcs into the CNS is key to delivering the gene where it is needed with.
With the body, we have seen how focusing in this area can lead to clinical benefit regulatory approval and increasingly commercial success.
Throughout the start of 2022.
Sustained commercial momentum for the <unk> is the first HSC gene therapy with meaningful reimbursement coverage in Europe .
We are extremely pleased by the recognition of the maladies value commensurate with its clinical impact which is reflected in the public net price of $2 4 million euros.
In Germany, which is indicative of our agreements throughout the region.
We're encouraged by the continued progress we're making to identify refer a treat eligible patients with this therapy.
In addition, we believe that a further focus on Europe metabolic diseases, such as MBS disorders will offer a synergistic approach.
Enables us to leverage a common infrastructure for manufacturing in CMC to distribution supply chain and our commercial network as well as regulatory capabilities.
We've also chosen to focus our research program using HSC gene therapy.
Terrific largest disease indications with genetic susceptibility, such as a programmer in pool, a frontal temporal dementia or the Nazis pool of credits.
<unk> disease as.
As we develop these brother and other preclinical data mature we believe these programs provide opportunities for significant value creation.
On a road.
Through potential partners with an interest in our platform or indications.
At the upcoming <unk> meeting data from an Iraqi Joseph programs will be presented with continued to demonstrate the unique ability of our approach to enable broad distribution of gene corrected cells and localized delivery of therapeutic enzymes and proteins in the brain.
Featured presentation includes updated results from the OTR lead clinical program for MTS, one hurdles as well as preclinical work to advance the platform flexibility to address other neuro degenerative CNS related conditions, including the pro graduate pool of Etsy.
So we continue to build on the body of data driving ambition to develop the curative potential of HSC gene therapy, and create even greater value for the communities we serve.
I'll now turn the call over to Brian to review some exciting progress on the <unk> commercial launch.
Right.
Thanks, Bobby since <unk> approval and launch we've been building out multiple facets of our commercial infrastructure to identify and treat as many eligible MLD patients as possible.
By design. This foundation can also support our next wave of neuro degenerative programs in the NPL space.
These additional indications represent exciting commercial opportunities that can leverage much of the investments we are making in the <unk> today.
And for launch we prioritize the activities and initiatives, we believe will generate the most value for lenovo patients and providers.
On the access and reimbursement front, we've seen our positive engagement with health technology assessment bodies and payers throughout the region yield agreement securing reimbursement for all eligible MLB children.
After announcing an agreement with NHS, England in February .
Italy, and Germany became the second and third major European market to recognize the value of with LD commensurate with it.
Clinical impact.
German net price of $2 475 million euros is indicative of the level at which we have been able to secure access to MLP.
These agreements come after the MLB received the highest possible therapeutic benefit rating increase symptomatic patients by the German Federal Joint Commission, which only four other medicines has ever received.
And the Italian medicines agency recognized the significant potential clinical benefit of <unk> will be offered by granting it innovative status.
We believe the progress in Europe , and the value recognized by payers has differentiated this product and our team and demonstrated a willingness to ensure access for MLD patients across the continent.
We intend to continue expanding access by securing agreements in additional European markets.
We are in various stages of technology assessments and reimbursement discussions with join HCA assessment consortia, such as been Elekta and for notes as well as in Spain.
We have plans to enlarge our network of treatment centers in a similar fashion by qualifying centers to administer but melding in Sweden and Spain. In addition to our existing centers in the U K, Netherlands, Germany, Italy and France.
Over time, the same network of centers would be utilized to support future potential launches in similar indications.
And in order to help ensure we are identifying as many eligible patients as possible. We are continuing to increase our support for newborn screening to drive early diagnosis.
We now have seven studies ongoing in Europe , and one in the U S.
Which are intended to generate data to support the adoption of regular screening at the state national and regional level.
These programs can also identify MLB patients to be treated commercially if reimbursement is in place at the time of diagnosis.
We are continuing to assess how to best expand our geographic footprint beyond Europe , and the U S to regions such as the Middle East Latin America, and Asia Pacific in a capital efficient manner. As we've mentioned previously our partner Gen farm in the Middle East has already identified a patient who received <unk> through reimbursed.
International treatment abroad at our qualified treatment center in Milan, Italy.
I'll hand, it back to Bob to discuss our U S regulatory plan and the rest of the neuro metabolic portfolio Bobby.
Thanks, Brian .
In the U S. We believe we have all the data needed to move forward with a submission for OTI 200, and the team is working with our clinical sites and CMO partner to prepare the package.
We are planning to have a pre BLA meeting with the FDA in the second half of this year in advance of the fall, which we expect to submit in late 2022 to early 2023.
A key reason, we're emphasizing our focus on Europe metabolic portfolio. In particular are next in line MTS programs, just because our experience with MLB provides validation that we can translate potentially transformative clinical outcome, it's a regulatory and commercial success.
Moreover, the infrastructure, we are building to support the Bellevue launch synergistic directly applicable to opioid suite and <unk>.
Well as I earlier stage program for the treatment of NPS, we eight <unk> hundred one.
The areas of clinical regulatory manufacturing distribution patient identification referral and treatment could all be utilized for potential future launches.
We have been developing a protocol for global MTS, one Registrational study with feedback from last year's parallel scientific Advisory Board.
Focus on the importance of being able to show a meaningful difference from current standard of care not only for regulators, but ultimately for payers commercially.
The regulators have been highly engaged and we think that speaks to the opportunity we have with HSC gene therapy in this condition.
As part of our ongoing interactions with regulators, we have received additional and more specific feedback related to study design and endpoints that will likely delay initiation to 2023.
While the timeline of move into 2023, we believe the alignment we are gaining with regulators will support a stronger application in the U S.
Egypt.
I'll now turn it over to Frank to discuss some particulars around but now the revenue recognition and the rest of our financials.
Thank you Bobby I'm going to spend some time reviewing the financial performance for the quarter.
Like to open my section with some color around revenue recognition and cost of goods. Since it's the first time, we've reported product sales for <unk>.
Recall from our prior communication that we treated and therefore recognize revenue from two commercial patients in the first quarter.
Importantly, the cash flow from these patients will be paid upfront rather than over multiple years.
We continue to be open to payment overtime or outcomes based agreements depending on the preference of the Payor. However, most payers to date have opted primarily for an upfront payment structure.
Revenue from product sales of <unk> was $5 1 million for the three months ended March 31 2022.
These first two patients were treated under reimbursed early access programs in France and Germany.
So the revenue per patient may not ultimately be indicative of the final pricing in those countries.
However, with our net sales figure of about $2 $5 million per patients Youll note that is similar to the final negotiated and published price in Germany.
Cost of product sales were $1 6 million for the period.
And it's worth spending a few minutes here is there are three primary items that make up Cogs for la <unk>.
The first is the cost of manufacturing, meaning the cost to produce the drug product for the patients.
The second is third party royalties and the third is noncash amortization of milestones that were paid previously.
On the first item the cost of manufacturing does not currently include the cost of the lengthy viral vector that was used in these first patients since those vector batches were produced and expense prior to <unk> approval.
The royalties to third parties total about 20% of net sales in the current quarter and that's a reasonable assumption to use going forward.
LTE is maybe higher in future years, as we achieve higher annual sales of living healthy.
Beyond lamellar <unk> revenue and Cogs, you can find the full financial results from the first quarter in our press release this morning.
Let me also touch on the restructuring.
The changes we announced in March we will extend our runway into 2024, while maintaining operational focus on several value, creating milestones, including the potential approval and launch of <unk> in the U S and additional regulatory milestones and data releases.
Since the restructuring happened at the end of March there wasn't a meaningful impact on our operating expenses in the quarter.
But we do expect to start to see those benefits beginning in the second quarter.
We also took one time charges totaling about $4 7 million, which are included in their operating expenses for the first quarter related to the restructuring of our organization and certain program termination costs.
Cash and investments were $199 million as of March 31, 2022.
The company used about $21 million in cash during the first quarter to fund operations, which is net of $16 million in R&D tax credit refunds from the 2020 tax year.
Without that credit.
The burn rate for the quarter would have been roughly $37 million.
Going forward I would expect our operating expenses and quarterly burn rate to come down over the course of 2020 to exiting the year closer to $20 million to $25 million per quarter, giving us runway into 2024.
As we think about funding the business beyond 2024, we see many opportunities for business development across the platform.
The farming deal we announced in 2021 is a good indicator of where our BD strategy might go bringing together orchards expertise and HSC gene therapy with a proven partner and a particular disease or therapeutic space that has clinical and or commercial capabilities.
We think a partnership like farming could be a precursor for additional opportunities in other larger conditions with more prevalent patient populations with the potential also for deals in the <unk> space.
And in using hfcs to deliver monoclonal antibodies to tissue specific targets.
The ideal partners would bring more than just capital, but also have an existing set of capabilities disease state knowledge.
Commercial infrastructure or an idea or IP that could leverage our HSC gene therapy platform.
Looking forward, we're pleased with the progress we've made and the changes we implemented to our business at the end of the first quarter.
There are operational and financial benefits that should accrue to us throughout the remainder of this year.
We're at an important inflection point for Orchard, as we balanced commercial activities for <unk> with an exciting pipeline of clinical and research candidates.
And we are 100% dedicated to making the promise of our therapy, a reality for the benefit of patients our community and our stakeholders.
With that I will turn the call over to the operator for questions.
Thank you we will now begin the question and answer session. If you do have a question Chris zero one on your Touchtone phone.
It should be removed from the queue. Please press zero then too.
If youre using a speakerphone you may need to pick up the handset first before pressing the numbers.
We ask that you limit yourself to one question and one follow up.
Once again, if you do have a question press one on your Touchtone phone.
And our first question is from Gena Wang from Barclays.
Okay.
Hi, Good morning. This is Peter on for Gena. Thank you for taking our questions.
Two quick ones for the Mt.
Would you provide additional color on how many market access agreements do you expect to secure.
The rest of 2022 and just additional color on how much revenue you expect per quarter. In 2022. If you are able to provide that color and then for the BLA meeting and the U S have you requested a meeting yet or when do you plan on doing that if you haven't yet I know you said second half, but curious if that was more like third quarter or fourth quarter.
Thank you so much.
Thank you and maybe I'll just take the second one first because that's a very quick so as we've said we are.
Looking to hold a pre BLA meeting in the second half.
And with a view to.
On the basis of the interactions that we have to a late 2020 292023 file so I really can't give you anything more than that at this time.
With respect to the first question, let me take that so not everything right.
Thanks, Bobby and thanks for the question.
In terms of the number of agreements <unk> revenue for the rest of the year.
I would say that first of all we're extremely pleased with the progress that we've made thus far we are in various stages of HCA assessments and reimbursement discussions across Europe and as we noted in our prepared remarks.
Markets in the U K, and Italy and in Germany. So we are.
Okay.
We are in the midst of these negotiations.
Okay, just when they might conclude so we're going to hold off on any type of.
Guidance in terms of the number of agreements before the end of the year, though we are encouraged with the progress that we've made similarly on the revenue front, we haven't guided to revenue.
<unk> just based on the uneven nature of these early quarters because of the timing of patient identification the geography, they may be in as well as the timing of reimbursement and treatment. So.
No guidance on revenue either at this point in time.
And our next question is from Yaron Werber from capital.
Hi, guys. This is Brendan on for you Ron Thanks for taking the question just a quick ones from US first wanted to ask a bit about your latest regulatory interactions for.
MTS, one and MPS III actually I understand youre looking at are incorporate some of that feedback into study design et cetera for the.
Pivotal trial, but wanted to see if there's any more color you might be able to provide on what has maybe been especially notable or surprising there.
And if there's any learnings or read through from <unk> to the potential phase III pivotal study.
And I guess in that same vein just wanted to see what the latest timing is for potential in phase III pivotal study. Thanks.
Okay, Let me I'll take the.
First.
About the interactions.
I am just wondering then I can turn it over to Leslie spoke about MTS.
So.
Just to just to step back.
But.
The excitement about the potential of HSC gene therapy for MTS Milan.
Part of our leadership in the application of this HSC gene therapy approach for neuro degenerative disorders can be seen with the <unk>.
Except that we've had.
With <unk>. We've also seen some very exciting data in the proof of concept study with stabilization of cognitive outcome and also improvement in the systemic disease parameters as well. So what we're doing is designing a global registration study we have feedback from last year's parallel scientific advice.
Holden piece of this is to be able to show a meaningful difference from the current standard of care.
Which is allogeneic HSC team.
And that is important not only from a regulatory perspective, but also ultimately full pay us commercially.
We've been having ongoing interactions with regulators and move it received additional and more specific feedback related to the study design and endpoints that again as I say will show a meaningful difference from current standard of care and that is what we want to incorporate into the study design and that will likely delayed.
Initiation to 2023.
I think we've had very highly engaged interactions with the regulators and I think that speaks to be.
We have.
HSC gene therapy in this condition and although the timelines have moved out we do believe allot.
Alignment that we're getting with the regulators will support a stronger application both in the U S and.
In the EU.
So let me then hand, it over to Leslie talk a little bit about what might.
C <unk>.
Thanks, Bobby so to update on MTS <unk> that program is a little earlier than MTS one.
It's a five patient proof of concept study being conducted exclusively in the U K. It is fully enrolled the last patient enrolled in the latter part of last year and <unk> is the disorder.
That is.
Characterized primarily by cognitive decline.
And these patients generally in the natural history will first initially sell normally and then plateau at around <unk> three.
And ultimately starting to decline rapidly in the years after that so like I said. The study is just recently finished enrollment and the most recently treated patient was not treated that long ago. So we're at the point now where we're still waiting for that data set to mature a bit so that we can really start to make more.
Folks conclusions on those cognitive outcomes compared to what we might expect in a natural history population.
So as we are evaluating potential study designs, that's really going to be informed by these observations in the proof of concept study as that cognitive data matures and I think it's certainly possible to leverage the learnings from our interaction on MTS.
One which is also characterize to some extent by cognitive decline, but also characterized by a number of systemic manifestations that may be more local in that disease as well.
Thanks Duffy.
Alright, great. Thanks.
Our next question is from Dae Gon ha from Stifel.
Hey, Good morning, guys just following up on two prior questions, maybe starting with live melody, recognizing it's an uneven and somewhat unpredictable, but just to get a sense for any backlog that you currently have in terms of patients that we can be expecting as almost a guarantee for the remainder of the year.
And then when we think about NPS. One H 2023 is still a fairly broad range. So just Bobby if you can walk us through sort of your confidence that sort of the feedback youre incorporating now is indeed going to be sort of the final iteration. If you will before you initiate and would that be sort of a one half issue.
Our second half initiation. Thanks.
Okay. So let me hand that over to Greg talked about.
Patients for the valve and then I'll pick up on the guest interactions.
Thanks, Bobby and thanks for the question.
I'd say that patient identification is progressing very well across the region. We've been very pleased with the number of referrals coming into the major centers.
Part of the challenge of MLD is identifying patients within that treatment window of opportunity, where they may benefit from <unk>, which is part of the reason why it's somewhat of an uneven identification process.
As we've noted we've we have treated three patients two of which are representative in this quarter and there are a number of active cases that we're working on right now but moved.
Moving forward, we're not going to be providing inter quarter updates on individual treated patients were focused really on.
Building, a sustainable commercial operation and business overall.
Thanks, Brian and so on MKS, one so just to reiterate.
It reiterates yes.
I guess, one is a systemic disease that it does have impacts on multiple different organ systems. So not only neurocognitive impairment, but also on political deformity vision hearing cardiovascular abnormalities et cetera. So.
In terms of designing specific endpoints is extremely important to look at that because that is the overall effort in all disease in the.
In MTS one.
A number of those are ultimately.
Addressed by the current standards of care.
So unless as I said before we won't see a meaningful differences from allogeneic transplant and so we've got an ongoing dialogue with the regulators on the appropriate comparator arm and endpoint selection once we have policy.
The final study design and once that submit.
Submission is clear then.
We can look at trial initiation, so as I say, we could give you further guidance later once we have that.
Clarity from the regulators and we have a.
Our study design cleared by the agencies and then we went to study.
Great.
Great. Thanks, so much.
Thank you.
Yeah.
Yeah.
Our next question is from David Holmes from S. M D C.
Yes.
Hey, guys. Thanks, so much for taking the questions.
I, just really had one on maybe understanding the.
Patient journey for the commercial MLD patients could you just talk a little bit and provide a little bit of color as to what that patient journey looks like once you have a referral come in.
What needs to be done to confirm the patients eligible for treatment and then if they are confirmed does that necessarily imply that reimbursement will follow.
Thank you and again, let me hand that over to Brad.
Sure. Thanks for the question the patient journey.
It's fairly consistent.
It may vary somewhat based on region and exactly where the patient is identified but generally speaking once a patient is identified as potentially MLD there'll be referred into one of our major treatment centers in the countries that we have treatment centers and right now the UK, France, Germany, Italy, the Netherlands.
Where there'll be assessed.
By the clinical experts, there and confirmed diagnosis for MLD.
And part of the assessment is their eligibility based on the European marketing authorization, so ensuring that they're either pre symptomatic for their symptoms have not progressed to far and once that happens then they'll schedule for eight pheresis, where the sales will be collected and then sent to our.
Manufacturing site in Milan, Italy, where there'll be transduce with <unk>, and then cryo preserved and sent back to the center for.
Re infusion and the patient so this process could take.
Anywhere from.
Six plus weeks, depending on where they're coming from.
And whether or not reimbursement is in place at the time of the referral and diagnosis or if theres early reimbursed access available in that country as well so the process could.
Could take a little bit longer if it's in the.
Country, where you need to get some type of authorization, where there is not reimbursement in place or it could move much more quickly if it's a patient that's been identified in one of the countries, where we've already secured agreement. So hopefully that provides a little bit of color of the process.
Yes, that's very helpful. Thanks, a lot.
Our next question is from Pete <unk> from Cantor Fitzgerald.
Good morning, Bobby and team.
So I know youre working to align with the FDA and the European regulators, but for the upcoming Registrational study for <unk>.
When you think about the patient population, who may enroll in particular the age of the patients.
How are you thinking about that do you think you will target only younger patients so that casino.
Clinical benefit on cognition cognitive.
It can be observed where perhaps you can go for a broader range of patients that will be separated into subgroups or oracle.
That's based on age and also when you think about the patients who have had.
Marty a number of them develop anti drug antibodies do you see that affecting efficacy above 203 in any way.
So.
Maybe lastly, if you are happy to take that question.
Sure I'm happy to take that so for the first question around the target population specifically in terms of age will be able to share more detail on specific age range. When we have the final protocol, but I will say that we're looking to.
Evaluate how this therapy compares to the current standards of care, which is allogeneic HSC team and generally speaking.
The approach is to administer current standard of care as early as possible in the disease course. So we are looking at a design, where we're likely treating very young patients.
It's early in the disease course, if possible to prevent potentially prevent.
And at the stations that they need.
So that is something we would be looking at on the final design when it comes to antidrug antibodies. It's a great question, it's something that we actually see in our proof of concept study prior to patients entering the trial seven of those patients out of a total had prior exposure to ERP and did have empire.
<unk> antibodies that disease.
Steady onset the conditioning protocol that we've used in that trial, which we would also employ.
Registration will design once that sign a lot.
<unk> two.
Reduced level.
<unk> antibody to non detectable levels.
Well upon.
Treatment with gene therapy. So we would anticipate even if that is something that patients are presenting with at enrollment. The protocol that we're using would minimize the likelihood of that being something that would be a concern following treatment with <unk>.
Thank you for taking my questions.
Sure.
Thank you.
Our next question is from Castro Romero from J P. Morgan.
Hey, guys. Thanks, so much for taking our question.
Just on the <unk> line and the FDA.
Readout, that's coming up here.
By the end of the year, what is the size and the scope of that data set that we'll be getting them.
What would you think would be a win.
Do you think that will be enough follow up to assess clinical benefit or will there be longer.
Duration.
Appropriately thanks, so much.
Thanks Beth.
Leslie I think about one.
Thank you.
Sure. So what we presented so far from that study with the five patients that enrolled is primarily biomarker data on expression events yesterday and clearance.
<unk> in the periphery and in the CSF and we would.
We'd be in a position later this year to have one year of follow up from all five people that are enrolled in that.
On the biomarker endpoints that actually form the.
Basis of the primary endpoint in this proof of concept study.
Would also be in a position later this year for the investigators to share.
A follow up data in these patients.
Like I said earlier the disease progression.
<unk> is such that patients general plateau around the age of three and then start to chart show a drop off around the Asia side. So in at the point, where we have at least a year of follow up from all patients. Some of those patients will have more follow up but some of those patients will still have.
Last follow up in terms of getting to that point, where you might start to be April .
Brett.
Differentiation from the natural history. So we're really following this very closely and are determining how to best make a decision on how to best proceed with this program. Once we have that additional clarity on cognitive apps.
You should expect to see by the end of the year that we would be able to present additional data because we will have at least a year follow up from all patients.
Great.
Thanks, so much for taking our question.
Sure.
Our next question is from <unk> from Oppenheimer.
Hi, Thanks for taking my question just for Kevin Takeda.
Just one floor to collapse on the MTS one niche program.
When you interact with different regulators gear here.
Good friend feedback from the regulatory agencies, and how would that impact your timeline for four in Asia.
<unk>.
And then maybe you could highlight some of the tier two cities.
I would say look for next week. Thanks.
Thank you. Thank you I'll take the first part and then I'll hand, it over to talk about the <unk> App.
So.
Just.
Terms of the.
Our actions with the with the regulators, we did have Paolo scientific advice from the FDA and the EMA.
Last year at all.
And in that interaction.
Did give different feedback so there is differences between the two agencies and what but at least I hear each other during during that meeting and then what we have to try and do is to address the comments both from the EMA.
From the.
For the FDA, having said that there is some commonality in the feedback in the kind of study design that they would like to see the endpoints that they think.
Meaningfully important so.
And let me just sort of like in the end we want to have one global Registrational study, we don't want to a study for Europe , a different study for the FDA, we want one global Registrational study and so that is why these interactions that we're having also important in order to be able to get the best study design for <unk>.
A single global Registrational study and that will.
That will serve.
Agreements with both the FDA and EMA.
And so I'll now hand, it over to.
Leslie to talk about the upcoming Ash abstracts.
Sure. Thanks, Bobby So we're really excited about our presence at next week's ASP GTT, where we have seven different presentation.
Dominic stick with our data from our narrowed a generative program.
And we show and are continuing to show the unique ability.
<unk> of gene modified hfcs to distribute broadly throughout the body, including in the brain and other harder to reach tissues.
Enable localized delivery of therapeutic enzymes and proteins in the brain and other difficult to access tissue and then specifically for MTS. One there are two presentations. One is an invited lecture that is on the overall <unk> hundred three program and we can expect that the investigator.
We will be presenting.
Current data available from that proof of concept study I'll note that we now have.
Nearly half of the patients with at least three years of follow up to some additional follow up relative to earlier presentations.
Relative to our.
Publication last year. We also have a poster presentation that is looking at the pathophysiological mechanism of bone damage in Hurler syndrome, and also looking at the potential of <unk> to enable.
So cross correction.
In the list of the we have a number of presentations as well in our preclinical area that is looking to advance the applicability of the platform in other indications and predominantly neurodegenerative indications, especially some work we're really excited about and the program will inform of FTE.
Thanks for taking our questions.
Sure.
And we have a question from Pete Stavropoulos from Cantor Fitzgerald.
Hi, Thanks for taking my follow up.
I know, it's early stage very early but curiosity has been asking.
One of the posters at <unk>.
As GCT.
We'll be presenting data on the kind of on a novel linker develop promoter based on the human leukocyte antigen, Dr. Alpha promoter region. So I understand the promoter is able to induce it'll be at the levels of gene expression in microglia cells cell specific expression.
Just wondering how the company is thinking about utilizing this novel Tech and like you know what kind of indications can be leveraged in thank you.
Yes, thanks, a lot, but maybe I'll take that so this is.
Part of that.
<unk> collaboration with I'll try this 150 at the University of Padua.
And our work on front end.
Dementia. So remember one of the important things here is that we want to get gene expression compression in the CNS, we could do that through the delivery of gene modified hfcs into the CNS when they become microglia.
The important part here is we want the team to explore.
In the context of neuro inflammation, which is present in this disease and so we have been looking at.
<unk>.
I think promotions to use a promoter selection is again extremely important for all kinds of reasons and so you could have a ubiquitous promoting you could have a macrophage specific quota or you could have a promoter like move.
Thought about here, which responds to neuro inflammation and certainly in some in vitro studies that we've done which will be presented you can see that.
This promotion, which is derived from mentioned linked deal can respond.
Two specific your inflammatory simply line so.
<unk>.
One application called this type of promotion, but also if we want to use this and other.
Jets conditions that are associated with new information could be used.
In other indications as well I mean, that's still obviously quite some way to go with more prudently.
Concepts closing, firstly preclinical murine studies and then.
Specifically the question is like SBB, but this has declined the direction in which we want to move to be able to use HSC gene therapy.
Range of new life insurance conditions.
Got it thanks, guys. Thanks for taking my question.
Russell.
Thank you I would like to turn the call back over to Bobby for final remarks.
Thank you.
So thank you everyone for your time and attention.
By executing and delivering on our mission. We're confident we can create significant near term value for our shareholders and the many other communities that we serve thank you.
Yeah.
Thank you, ladies and gentlemen that concludes today's call. Thank you for participating.
You may now disconnect.
Okay.
Sure.
[music].
Okay.