Q3 2021 Calliditas Therapeutics AB Earnings Call
Uh huh.
Positive outcome.
We also were informed by E M a but they haven't decided traverse a standard timelines for their review of our submission.
We therefore expect an opinion from the EMA in Q1 of.
'twenty 'twenty.
Okay.
Turning to the next page.
In the quarter. We also closed a partnering deal would start up for the European commercial ranked tennis com.
It has proven to be an excellent choice and the partnership is progressing well with respective teams working very well together and so we look forward to the continued collaboration as we proceed through the regulatory review in Europe.
And obviously also engage in other pre commercial.
Activities.
Turning to page six.
This really just summarizes some of the upcoming news flow.
In the kind of the end of this year as well as for the next couple of years.
And obviously as you know we have some key regulatory decisions coming out over the next several months.
As we move through the regulatory processes in the U S and Europe as Ive already mentioned, we're also excited about moving our clinical pipeline forward with two programs.
And.
We are also continuing to develop our earlier stage of the pipeline.
And this will hooked it and add to the clinical pipeline a further trial hopefully in NAV during the next year.
Turning to page seven.
This is just a graphic depiction of our pipeline.
Obviously, Mexico is ongoing in a blinded fashion and it's totally recruits you didn't expect it to read out in 'twenty two 'twenty three.
The open label expansion is also progressing patients obviously enrolling into the open label extension, where they can get.
Given a nine month treatment cycle, irrespective of which which farm they were an enduring the phase three trial.
And so we also have them moving over a little bit to the next part of the pipeline.
We wanted to talk a little bit more this time about that's an accident or Nox inhibitor platform and some of the clinical program, which we will be launching imminently.
So with this I'm going to hand over to our Chief Medical Officer, Richard Phillips and to take us through.
It's got some accent.
Programs.
I think it's funny, so I'd like to talk on slide eight I'll begin by outlining the design of our phase three study in primary biliary cholangitis.
So switch how to go to from now on it's P. D C.
This will be a double blind randomized placebo controlled study I know, how COVID-19 adaptive design, which I'll explain in a little more detail in a moment.
In this study patients with PBC elevation of liver stiffness and an inadequate response to U D. C. E O intolerance to you can see a will be randomized to receive sox nox people to people.
And the pace to be possibly study patients will be randomized to one or two doses.
That's an active or placebo.
No.
Those two subsets Nox at that we're using in this study are higher than we'd previously studied in PBC with total daily doses of either <unk> hundred 16 hunger when the ground is getting that seem to go on and get those cars.
What's the 1990 patients have been enrolled and have completed 24 weeks of treatment and the interim futility analysis will be performed.
Based on this analysis, a single dose of six months ago being selected for the phase III Tox study.
Note that the.
The transition from the phase <unk> to phase III study.
Study seamless and there was no call to enrollment once a futility analysis is performed.
The final analysis will be performed on all patients who've received the selected phase III dose those roll we expect approximately 318 patients to be enrolled.
In this study all patients enrolled will be offered the opportunity to continue into a 52 week blinded extension phase in which all patients who received treatment.
So the study is on track with golf and.
The fourth quarter of this year with the futility analysis talk to the second half of 2023 when the final analysis is expected in the law.
'twenty 'twenty four 'twenty 'twenty five.
Moving on to slide nine where we discuss the end points in a little more detail. The primary endpoint is a composite response endpoint comprising IOP reduction to less than 1.67 times upper limit of normal L. P reduction of Grace and 15% in total and even below the upper limit.
All of them.
The final analysis of the primary end point will be performed following 52 weeks of treatment.
Secondary endpoints all assessed following 52 weeks of treatment include changes in liver stiffness, the peak H and safety assessments.
Turning now to our program in head and neck cancer.
And to provide a little context for Saudi and having that kind of so on slide 10.
I'll start by explaining that there was a clear relationship between cancer associated fibroblasts, which are the phenotypic equivalent of reactivated might apply football.
Prognosis in squamous cell carcinoma of the head and neck.
And indeed in essence patients with Cumulus rich in cancer associated fibroblasts, which are referred to as costs have worse outcomes unless is likely linked to exclusion of tumor infiltrating lymphocytes or totals from the tumor.
If I can ask it there's been some flu influenced the tumor microenvironment in animal tumor muddle through but were bursting Cas phenotype, and therefore can mixing infiltration into the tumor of tolls.
Tolls.
No team, but an important aspect of tumor response to checkpoint inhibitors, such as Pandora linked your map is the interaction between tails under the Chin themselves. We've studied the response to Patrick's tumors in mice and found that the combination of treatment with <unk> plus kind of going into your mouth and home to the tumor response compared to either treatment.
A lot of them.
This is seen as an improved penetration a toe into the Cima marked slowing in tumor growth and improved survival.
So based on the outcomes of these animal models. We've designed the proof of concept phase two study to investigate the impact from tumor volume and the tumor microenvironment.
Oh treatment with Tempur to this amount plus <unk> in patients with relapsed metastatic squamous cell carcinoma of the head and neck.
Study as illustrated on slide 11.
And in this study approximately 60 patients with moderate or high cost and seed treatments will be randomized to receive such Nox at 800 milligrams twice daily or placebo and all patients will receive member lives my abusing the standard treatment regimen with three weekly dosing.
The tumor biopsy will be taken prior to randomization and then again after at least nine weeks of treatment.
Treatment will continue until unacceptable toxicity or disease progression, which as you probably know it's typical for an oncology trial.
Studies talked at the stocks in the first quarter of 2022 with an interim analysis of biomarker data expected in the fourth quarter of 2022, and the final readout expected in the second half of 2023.
Moving on to.
To the end points in a little more detail on slide 12.
Primary end point.
This study is the best percentage change in tumor size curve as well.
But we have some important secondary endpoints, including other critical maintenance of response of treatment duration and treatment duration biological measures of tumor response, including changes in cash pills unleashes the gene expression using RNA sequencing.
So that concludes my part of the presentation and I'll hand over to Frederic go hungry for the final slide.
Thank you Richard and good.
Good afternoon, and good morning, everyone.
Let's turn to the next page just national pitch and I will present to you the financial overview for the first nine months of this year and as usual all numbers presented to you or you're getting sick.
We represent one of them I think once you moved any revenues for parity compared to 0.5 million sort of same period last year.
Revenue reached originating from the 20th given you're starting to see that we received in connection with the out licensing of Mexico and in Europe to start up.
Our total operating expenses for the period amounted to 505 million compared to 204 to $4 3 million for the same period last year.
I'm going to talk of operating expenses the cost for research and development increased by eight to $9 8 million to 257 two.
Compared to 167 point Corp, so alien Saint Pierre previous year.
<unk> and R&D expenses of weakness both from the Mexico trials.
Where do we stop there and open label studies ongoing and from the preparations of Cogs.
It would have set the next big trials, which.
Which I plan to start to what we see.
It's the faith in administration expenses amounted to 235 million what appeared to be compared with 77 million for the same period last year.
The increase of $167 million between the periods is primarily related to the preparations for commercial and managed care for.
In the U S.
We are ready to commercialize once a company in the U S. If approved.
This leaves us with an operating loss of 302 million Boe to spirit compared to an operating loss of 203 8 million.
For the same period last year.
Cash flow used in operating activities for the period amounted to 32 two.
2 million compared to $103 3 million.
This year.
During third quarter, we closed two transactions, where we first in July signed that sometimes million-dollar critical social Chris and subsequently led to win the Corker later go down for the first $1 million to $5 million Crunch.
We also completed a new shirt Richard of two 5 million shares during the quarter raising $324 million before transaction costs.
Cash flow from financing activities in the period amounted to $476 5 million due to the above transactions.
I'm glad to report a strong cash position at the end of September one bigger than one on a suite to suite, okay millions sick.
That's all for me and now back to you with it.
Thank you very much and so just in conclusion I just want to highlight obviously that our commercial readiness for launch in Africa, and the U S subject to an approval on December 15th.
And then all relevant pre commercial activities have been completed and we're eagerly awaiting the feedback from the agency is expected in December.
Which would then hopefully enable a launch early in Q1.
So with that I will hand over to <unk> to see if there are any questions.
Okay.
Thank you.
If you do wish to ask a question. Please press zero one what are your telephone keypad.
If you wish to withdraw your question you may do so by pressing zero to two council.
We will take a brief pause while questions are being registered.
Yeah.
Yeah.
Yeah.
Yeah.
Our first question comes from Maury Raycroft with differences. Please go ahead.
By Thanks for taking my questions.
You, probably can't say too much on this but I'm wondering if you can elaborate on the additional egfr analyses that are FDA requested since F. D. A had access to all patient data at the interim God, I'm wondering where any additional safety or efficacy analyses done for off treatment effects beyond nine months or subgroup.
So patients while on treatment during the nine months.
Yeah.
So, especially as I said before it's a basically I mean, the the FDA did not request any additional data and you're absolutely correct that obviously the dataset that they always have access to it they can sleep database at the time of any kind of data tassel.
And really the only thing that we have announced and I think that's probably what we're going to stick to is that you know the the analysis that was requested are really related to egfr.
In a variety of different ways.
Weighs in manners, and I'm you know various analysis.
And so that's really I think are not necessarily surprising considering.
Considering that.
The FDA has always been quite clear about the fact that.
Egfr is required to be supportive and I think.
In order for the agency to.
Address that a its not unusual I would say were unexpected that they would you like to look into that data in our industry.
A fair amount of detail.
Got it okay. That's that's helpful. In and also had a question on <unk>. So there's some new updates to your market research data, where you've commented on the value based pricing and I think noted that the price could be more in the 72 two.
<unk> hundred 14000 range versus the prior guidance at the 55 to $85000 range, which is based on the pace you've been profile and so I'm. Just wondering if you can talk more about that and if that's because you think the phase three data justifies a higher pricing premier or if theres any additional perspective.
You can provide on that.
I'm going to hand over to Andy now to address that question.
Thanks.
You know, we haven't given specific guidance on the final price, but but yes. There's the has continued to do our work with the payer community.
And their assessment of the value of the product is providing this population continue to be encouraged one of the things that they do do is they look at recent launches in other products that they look to try to compare tangentially are and so we continue to be encouraged.
It's about the value that they're seeing for the product so.
Okay. That's helpful well, thanks for taking my questions and I look forward to the update in December.
Thanks.
Yeah.
Our next question comes from Eric Wold with kind of it. Please go ahead.
Yeah, Hi, Thanks for taking my questions I have two if I may.
The first one is sort of a follow on to the previous question on only in there for them, but you previously commented on on the proteinuria trends in person, reaching the problem.
Months at that point in part a of the study and to my knowledge traveling up yep.
They're going to be there for crown, so 12 months, but I assume that you've looked at it. So is there any specific reason why youre not calling those bonds at 12 months is it four trumped what kind of showed that they are or crumbs with us today and then secondly, what.
What would you say what was the reason behind the fishing might be made to revert to some blood review timeline.
While I'm on the base.
Oh, so comprehend because that's you need more time or all their own you know the fact, there's a close call and said that in the system. Thank you.
So starting with the E M. A question shine.
The EMA can at any point in time choose to revert to standard timelines generally one would assume I guess if that is because they would like to have more time to review the submission.
There is no kind of real explanation or.
You provided a from the regulators when they choose to do this.
So we can't speculate.
As to why they decided to do this.
We can only kind of.
I assume that they wanted to ensure that they have sufficient time.
To review the submission.
And again, they all NDA reviews are fairly complex and dynamic so.
That's really all the information that we have and we can share with you.
Regards to additional data.
But obviously the primary endpoint in this trial was a reduction of proteinuria and everything else. It's really supported all of that I think that the disclosures that we haven't made a from a phase III trial that is ongoing and remains blinded.
Oh actually.
Fairly in a fairly comprehensive under that scenario I would say.
And so we're really not in a position to provide any additional information beyond what we have already done.
And I think that's also been kind of clearly communicated that you know we really have to try.
Try to be a you know quite restrictive in terms of sharing any additional information from.
From the trial in order to know potentially impacting type of any of the trial.
And that's really kind of where where we are and I think this is where we're opening if they're going to remain.
Until we are in a position she revealed the final dataset.
From the trial.
Yeah.
Alright, thank you.
Our next question comes from Amit <unk> with Lifesize capital. Please go ahead.
Hi, everyone. Thanks for taking my questions two quick ones for me, but first you presented some additional data demonstrating the effectiveness on certain chemo times and complement components can you kind of walk us through the implications of that data.
And then secondly, we've seen multiple update.
Again, the property development landscape of block two months have these data that's kind of changed your view on how that fits in the future treatment landscape in this disease.
Yeah.
So I think in terms of the buy market place. So yeah I mean, we've we've.
Presented or biomarker data have been presented in various forums and I think we see a very consistent picture.
In terms of the biomarker changes that we see and just to provide context for that that's come out of phase two b clinical trial.
Hum.
I think what we see there but.
A consistent pattern of change across a range of key biomarkers.
That method Collins does have an effect on those buy them all because journey during in the happy end of.
The treatment period.
And we see consistent effects that are very much supports sort of in keeping with the out of the bank line.
Pathophysiology of the disease and supports that met the target the origins of disease and look at sort of Eylea in the recent past matches and is having in the immuno modulator.
In fact.
The level of the past patches, resulting in them relevant and supportive changes and secretion of Iga in centralized circulating immune complex his inbox and in although rather than keep mcclintock cytokines.
Yeah. So again, just some of the kind of kind of competitive environment.
And I think now having the ability to really kind of be effective at the top of the Cascade and I think we find that to be valuable.
And it's obviously valuable that we do have this kind of not just the one effect, but you know potentially be affecting several layers or levels.
Physiology them, but in terms of that somehow changing out positioning or changing how it would be.
This medication could be is subject to approval I don't think that we have you have made any such drawing some conclusions.
Got it thank you.
Our next question comes from Christopher U D with S. E. T. Please go ahead.
Hi, there. Thanks for taking my question all my questions. So I guess the first thing I was wondering it was during clock stops as the M. A requested similar analyses to what the FDA requested.
I'll start with that one.
Well, so again I think the as you know the EMA process is slightly different in that you know when you get a collection of different.
A lot of different questions.
In one go and so in terms of.
I'm trying to kind of think about it.
I'm not I'm trying to think back of all of the kind of question.
Been reviewed because I'm not sure actually that I can that I can compare the two processes, but you know, particularly well I think it's a very different process went very time of.
A different approach in terms of kind of how the reviewing the file.
And I think that yeah. So I think it's not really kind of possible to draw.
Comparison, or you know any conclusions from that between the two processes.
Can you tell us what kinds of things. We're in there are questions in the same way that you gave us some indication about the S. T E. I mean, obviously the.
Outlook changed.
Just.
Purely and simply from the fact that you have a delay. So then I guess, that's it I forget the similar level of granularity.
Between the two processes.
So again the two processes are very different because obviously you know we received the the actual kind of noted from E. M E. I really without having had any real interactions with the agency because we filed that somebody made that submission for later them with the FDA and so again, it's a very.
We're a different process and you know we're not in the same place with regards to these two regulatory processes, but does that mean.
Actually safety or efficacy or.
I mean, I think that I mean, there's a whole I mean, obviously as you are aware, there's a whole range of questions that need to be addressed in every kind of submission I don't think that there is anything.
Strange or odd or or anything else in the crutches that'd be received I think we've received exactly the type of questions that we would expect to receive.
And I think that in terms of the extension.
I mean, I again, right I mean.
An extension from our perspective, it's actually you know its obviously not where we would have preferred we would've preferred that gotten approval in the original timeline, but actually considering that no there isn't extensions.
From our perspective, if there was if you.
Are you at the time that there were some you know deficiencies basically deficiency fundamental deficiencies related to efficacy or safety and our assumption would have been that we would have received a complete response letter or not.
Not an extension.
The fact that they are the fact that the agency.
I would like to have or feels that they need and require additional time to review the data, we don't actually see that as a negative and that's I'm sure. You're also aware I don't know.
Statistically you know more programs kind of become approved.
In an extension then spend in a normal cycle and again, we can't speculate on what the ultimate outcome is going to be here, but.
But you know we do see the extension of the that's a positive sign.
In terms of the fact that you know the agencies continue to actively review the submission.
And we also recognize that you know this is the first time that they are reviewing this on the basis of a surrogate marker.
And so yeah, I'm not sure that no one should read into it any further.
But I guess, what my my I'm not wasn't yeah. It was a little bit of a different answer toledo's asking stuff I would rephrase I would say the F D a F.
For analysis with a tilt in terms of focus on on efficacy.
Is there a similar tilt in the or the average of what the I mean, it was asking or was it a little bit more tilted towards safety because I guess, if those are the two questions. The two issues are.
Safety and quality of life I guess, if you go to the one group that's what they're really always after so can you give any color around that.
So again just to be clear, obviously, you know with regards to the extension.
This was a specific kind of you know we wanted to just kind of comment and explain on that particular analysis. Obviously, we haven't been out there we've been through a very thorough review with the FDA are covering lots and lots of different questions.
And that is exactly what we are seeing in the M&A as well.
And so again they are very different kind of processes and we are in different stages.
With regards to these processes I know Richard do you want to comment on them.
Yeah, No I agree I mean, we see quite a broad range of questions areas that both the F. D. A N D E M a COVID-19.
There's a lot there's never been a question went out or you know, we don't know how swan so that a lot of unusual.
Hum.
As we've said before we are comfortable with the safety profile of the products and we believe but you know we've been corrected well with the agencies and we've been able to respond to everything that they've asked us.
Okay. Thanks, and again I think it makes sense to kind of point I mean, this is a well known chemical entity.
You know it has been a you know kind of used in.
And you know in the market for a long time, so I think it is a fairly well characterized some of them actually.
Right Yeah. So the funding for my My next question. So you have you been assessing inflammatory markers post epigone treatment as we learned from your posters. What you just said beyond what was presented do you see any correlation between either proteinuria or egfr in the two arms of enough again or enough guard trials.
With CRP or any other biomarkers of inflammation.
No I mean, that's not something that we specifically looked at and all necessarily do it we collected those kinds of that kind of information. So we haven't looked at that sort of caused that kind of correlation between the biomarker changes and clinical outcome.
But do you have a patient level data on a number of biomarkers that were presented to any of those have a correlation.
Yeah.
I thought I mean, I can tell you we do have patient level information on Biomarkers.
We look to the Biomarkers in response treatment the unethical treatment, we've not tried to cortland.
The relationship between changes in the Biomarkers and clinical outcomes.
When can we expect that data to be assessed because I guess, that's pretty important to do right now.
I personally I'm not sure. It is particularly helpful to try to correlate a biomarker changes with clinical outcomes I think much more unfortunately.
Evaluate the response to treatment and the clinical outcomes I think trying to link by them, all because and changes in foreign law, because the clinical outcomes I absolutely. He doesn't believe that were ready for that yet and I think that leaves absolutely in line.
With discussions we've had with experts in the field.
And we would not absolutely not ready to try to link.
Biomarker changes that are seen with clinical outcomes.
Okay. That's a unique perspective at any point has the FDA given any indication that it might consider a rems program necessary for enough a con has it given any indication that it's thinking may have or be evolving on that issue.
With respect to runs node.
So it's not something that's being discussed or considered necessary.
Okay. Thanks.
If I could just ask one.
One or two more questions do you have do you view the FTA outcome for reata as relevant to you potentially jud I mean any thoughts you have around that that would be that you can offer would be much appreciated.
I mean this is a misses an outcome related to you know obviously a different drugs with a completely different indication.
And I think that yeah. The reason for why the FCA has decided to.
Kind of enough to us to fear from an outcome.
Generally tends to be a scientifically related you often to the mode of action or two they kind of trying to to get kind of input in that area and so I don't think that not necessarily has has any kind of read through to us or typhoon that slope of egfr.
Overtime post therapy.
Again, I think this is a completely different indication as far as I'm aware. There is no meta analysis conducted or any kind of statistical framework available to the agency for this indication.
Misinformed.
Okay.
I guess my wife's okay.
Yeah. So you raised capital shortly before your original Paducah date on the market appears to have interpreted that as a signal that you're not as confident as.
Well I guess when you say you are in a in a positive outcome with the F. D. A Y why raise cash before such a key inflection point of where were you and if so how were you able to rule out a better pricing.
After the case had been derisked from a regulatory standpoint.
That's why I think that in terms of how the market. You know I think there's you know I think there are lots of different views on on how that would see a you know your conclusion, obviously has to stand for you I think that in terms of raising capital is a life Science company.
It's something where I think you always have to.
Be aware of the fact that there are lots of different things that you know you do not control of the company.
And therefore, you know had being in a situation where you can really kind of be prepared for a you know.
Things that tend to happen, whether it's been driving development clinical programs regulatory interactions or other things, where you know there are inherent things that you just don't control I believe is something that actually we are in fact, good to manage nothing good planning.
The fastest though so do you see that in terms of raising capital as we've gone through we were involved in a variety of different transactions Ah during this period of time.
That off the kind of meant that there was no. There's information there that wasn't available to the market.
And secondly, I would say that in terms of raising capital.
And to be prepared to have a cushion.
For whatever might happen again, I think it's actually a benefit them and again, we at that point in time, we obviously had no information whatsoever.
That would reflect you know.
But on the other hand, we can also look around over the last 18 months and see that there haven't been delayed I think it's been clear that there've been lots of discussions around you know, how it will probably be impacting or or something else on the agency. So I think that it will.
Wasn't going to be a huge surprise.
There was a potential delay.
And some of these kind of reviewed processes are and so I think again.
Where we are today I believe having a very solid cash position.
Both from an equity and from that kind of credit line perspective, now puts us in a very good position to really kind of.
Launch the product and go through the entire launched a subject to approval and I think that really benefits all shareholders that we find ourselves in this position today.
Thank you very much.
Our next question comes from Annabel <unk> with Stifel. Please go ahead.
Hi, Thanks for taking my question I think a lot of them were covered but I just want to clarify a couple of points I guess first on the 12 month Egfr data that we have not seen them because it's blinded clearly did the FDA have access to that information and is that.
Being incorporated into their view them, even though it was blinded from I guess, our perspective and then.
Bigger picture based on the last conversation and you know all the.
Various okay I guess the general.
Concern is that FCA has not yet comfortable with an accelerated review pathway in the brain or position overall, but do you have a sense from your interaction that the FDA is not convinced of the proteinuria as a biomarker to indicate a potential impact on.
Kidney function and do you think that the FDA has been consistent in their treatment of each of the different programs that are currently I guess developing drugs based on these proteinuria endpoint. So I guess more of like a bigger sense.
From your part of what you think the F T H benches in general on accelerator on the accelerated review pathway.
Yeah.
So I guess that in terms of.
First of all I mean in terms of having any view on how the FCA is treating different program. We don't have any insight into the data of any other company and so we cannot really comment or speculate on that at all.
With regards to our insurance will be the proteinuria as a surrogate endpoint.
I would just say that you know we have no reason to believe that you know the agency has changed their game in terms of proteinuria as an endpoint per se. However, I think it has been communicated from the agency.
Back in the Egfr.
It's a very important component.
And you know in any kind of potential accelerated approval and again I think this is why I'm you know their focus on Egfr is there for consistent I think with the message that you know egfr needs to be supportive and I think the question really is and you know how or how does the agency.
I mean, ultimately going to look at you know where do they want to set the bar with regards to that.
Sure I'm sorry.
And that's something that we're obviously I'm going to have to see once the once the agency chiefs.
Just to communicate that and in any kind of program that they are reviewing.
So that was really I'm, not and I think in terms of you know again in terms of any additional data.
I think again, it's been very clear that you know we the only thing we kind of can do at this point in time, and it's really kind of wait for Oh wait for the final kind of data to become available or the dates on which will become available upon approval of a product.
And so I think again it is a blinded ongoing trial.
We have really I would say significantly more data and.
Compared to you know potentially others out there and so I think no. We are not going to provide any additional you know when they are sick and I think we have a very compelling data package, we feel very good about the data that we have and so you know.
I think I should just need to stop and say that we're gonna help them like we have to see where the agency resolved to to with regards to kind of be a you know how they would look at egfr from a kind of supporting perspective for that approval.
Okay.
To be clear on a follow up on I know that you're not going to release any further data to us, but I'm. Just curious if FDA has access to that data obviously that they requested any update.
From the studies, while you know.
As the package was was.
No gain or games.
So yes, obviously the FDA the agency has access to all of the data in the database that exist.
At the time of the data cutoff. So clearly they will be patients that have you know a lot of data beyond the nine months.
And but again the agency and you're correct. The agency could have asked for additional data and eat or they were in the kind of first review cycle or even during the extension of.
But the agency has not requested any additional data from us at this point in time.
Okay, great. Thank you that was that was quick.
Okay.
To a large well capitalized company with significant resources across Europe.
And so we really felt that this would be an excellent partner for us in terms of commercialization in Europe.
And I think the partnership you know to date, that's really borne that out and so we're actually very excited.
Our continued collaboration with them.
Okay. Thank you very much.
Our next question comes from Edwin Zhang with H C. Wainwright. Please go ahead.
Hi, Thanks for taking my questions.
<unk> has shown impressive egfr benefit after nine months of treatment.
And we know the pool at the approval of is based on two year Egfr data.
Can you please remind us of what the result of Egfr at two year.
Considered successful and approvable.
Have you already had an agreement with the FDA on the two year Egfr endpoint for full approval.
Do you still need to finalize the details after the conditional approval next month.
And lastly are your confidence in the two year outcome of Egfr.
Given what you have seen.
So far beyond nine months.
<unk>.
So in terms of the whole.
A whole kind of protocol and the design of the trial.
Created both part a and part D and so the interactions with the FDA.
Always kind of be addressed.
Address the both part a and part B. So that is I have been reviewed.
I'm just trying to establish.
Quite some time ago. So yes, I mean, there is no there.
It is now.
Patients on our part.
Or that would change. So there is an agreed endpoint in part D with <unk> Egfr.
And with regard to our.
Our confidence and again it is very difficult to speculate.
We'll see in the future.
But again I think we again, we think we have a very compelling data.
Patient dataset.
And so.
Again, we have no reason to change.
To kind of have any concerns but on the other hand again, I mean, I can't speculate on what we're going to see in the future.
Okay. Thank you.
And our last question of the day it comes from Ingrid got somehow with Kempen. Please go ahead.
Hi, Good afternoon. Thank you for taking my question I was just wondering can you just remind us and sort of outline what are your additional clinical plans for less cold and flu.
Perhaps the expected timelines for it.
I saw that sorry didn't need the timeline for the for the pipeline.
Oh from Africa.
And that's a problem for any additional trials that you have in mind to park.
Oh I see sorry.
So at this point in time, you know, we don't have any kind of clear plans to to start any other kind of indications.
With an ethicon, but we're kind of ready to communicate.
But I think a little while ago, you were commenting them, perhaps just starting additional studies on a kidney transplant population as well as 70 Schmitz studies to look into additional dosing regimens that sort of thing.
The truth, that's a theory.
So I think that you know.
Subject to a product being approved.
And being in the market I think we would hope that we would look at potentially different routes forward.
And in time as you know looking at additional benefit of the product in different kind of populations and I think that's something that you know we would have to kind of review and looked at and once we kind of have clarity in terms of.
A potential approval of the product.
Alright, that's clear thank you.
Yeah.
So this moment there are no further questions I hand back the word to all the speakers.
So thank you very much for joining us for this Q3 presentation.
And we look forward to connecting with you.
Shortly.
I am sure that we will have an opportunity to speak to you again before the end of the year. Thank.
Thank you.
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