Calliditas Therapeutics AB (CALT) 2021 Q3 法說會逐字稿

Hello, and welcome to Calliditas Therapeutics Conference Call for Q3 2021.

(Operator Instructions) Just to remind you, this conference call is being recorded.

Today, I am pleased to present our first speaker of today, CEO, Renee Lucander.

Please go ahead.

Thank you, and welcome to this Q3 presentation.

I am joined today by Richard Philipson, our Chief Medical Officer; Fredrik Johansson, our Chief Financial Officer; and Andy Udell, President, North America.

Before we launch into the report, I just want to draw your attention to the disclaimer page, on Page 2, related to any forward-looking statements and refer you to the disclosures made in company filings with the SEC.

So on Page 3, some highlights from the quarter.

During this quarter, we concluded transactions aimed at progressing our established partnering strategy ex-U.

S. and also to strengthen our cash position.

So after a broad and successful structured process in the -- during the quarter, we chose to go forward with Kreos.

We signed a $75 million credit line, structured into 3 tranches.

We believe that having access to this, provides more flexibility.

The company grows into the commercial phase, subject to approval of Nefecon, later in the year, and allows us to appropriately active capital, based on the supply characteristics and cost of capital.

We also resolved in a directed share issue in the amount of 2.4 million shares, raising approximately SEK 324 million during the quarter.

Turning to Page 4, other highlights, obviously, related to regulatory update.

During the third quarter, we received a notice from the FDA that the classified analysis provided by us to major data amendments and that they would, therefore, extend the review period by 3 months, resulting in a goal PDUFA date of December 15.

We know obviously, that FDA review and NDA is a complex and dynamic process, particularly when the agencies of units or for the first time.

And while we can't speculate the ultimate outcome of the review, we see the extension as positive and that the FDA continues to actively review our submission.

We believe that we have a compelling data package and in light of the unmet medical need, which exists in IgA nephropathy.

We're hopeful that the FDA process will result in, ultimately, positive outcome.

We also, during the same quarter, were informed by EMA that they have decided to revert to standard time lines for their review of our submission, and we, therefore, expect an opinion from EMA in Q1 of 2022.

Turning to the next page.

In the quarter, we also closed a partnering deal with STADA for the European commercial rights to Nefecon.

It has proven to be an excellent choice and the partnership are progressing well, with respective teams working very well together.

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 6. 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 up over the next several months, as we move through the regulatory processes in the U.S. and Europe, as I've already mentioned.

We're also excited about moving our clinical pipeline forward with 2 programs.

And we are also continuing to develop our earlier stage of the pipeline, and this will hope to then add to the clinical pipeline, further trials, hopefully in -- during the next year.

Turning to Page 7. This is just a graphic depiction of our pipeline.

Obviously, Nefecon is ongoing in a blinded fashion, and it's fully recruited and expected to read out in 2023.

The open-label extension is also progressing.

Patients, obviously, enrolling into the open-label extension, where they can be given a 9-month treatment cycle, irrespective of which form they were in during the Phase-III 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 setanaxib, our NOX inhibitor platform and some of the clinical programs, which we will be launching imminently.

And so with this, I'm going to hand over to our Chief Medical Officer, Richard Philipson, to take us through the setanaxib programs.

Thanks, Renee.

So I'd like to start on Slide 8 and begin by outlining the design of our Phase IIb/III study in primary biliary cholangitis, which I will refer to, from now on, as PBC.

This will be a double-blind, randomized, placebo-controlled study, and it has an adaptive design, which I'll explain in a little more detail, in a moment.

In this study, patients with PBC, elevated liver stiffness and an inadequate response to UDCA or intolerant to UDCA, will be randomized to receive setanaxib or placebo.

In the Phase IIb part of the study, patients will be randomized to 1 of 2 doses of setanaxib or placebo.

Note that the doses of setanaxib that we're using in this study, are higher than we previously studied in PBC, with total daily doses of either 1,200 or 1,600 milligrams, given the 2 divided doses.

Once the 99th patient has been enrolled and has completed 24 weeks of treatment, an interim futility analysis will be performed.

Based on this analysis, a single dose of setanaxib will be selected for the Phase III part of the study.

Note that the transition from the Phase IIb to Phase III part of the study, is seamless, and there is no pause to enrollment, once the futility analysis has performed.

The final analysis will be performed on all patients, who received the selected Phase III dose.

And overall, 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 will receive treatment with setanaxib.

The study is on track to start in the fourth quarter of this year, with a futility analysis targeted for the second half of 2023, and the final analysis is expected in late 2024 or early 2025.

Moving on to Slide 9, where we discuss the endpoint in a little more detail.

The primary endpoint is a composite-response endpoint, comprising ALP reduction to less than 1.67x upper limited normal.

ALP reduction of greater than 15% and total (inaudible) below the upper limit of normal.

The final analysis of the primary endpoint will be performed, following 52 weeks of treatment.

Important secondary endpoints, all assessed, following 52 weeks of treatment, include changes in liver stiffness, the peak itch and safety assessments.

Turning now to our program, in head and neck cancer.

And to provide a little context for our study in head and neck cancer on Slide 10, I want to start by explaining that there is a clear relationship between cancer-associated fibroblasts, which shows the [genotypic] equivalent of the activated myofibroblasts and prognosis in squamous cell carcinomas in head and neck.

And indeed, in essence, patients with tumors rich in cancer, associated by the blast, which I'll refer to as CAS, have worse outcomes, and this is likely linked to the exclusion of tumor-infiltrating lymphocytes, or TILs, from the tumor.

Setanaxib has been found to influence the tumor microenvironment in animal-tumor model through reversing the CAS phenotype and, therefore, permitting infiltration into the tumor of TILs.

Noting that an important aspect of tumor response to checkpoint inhibitors, such as pembrolizumab, is the interaction between TILs and the tumor cells.

We've studied the response of CAF-rich tumors in mice and have found that the combination of treatment with setanaxib, plus pembrolizumab, enhances the tumor response, compared to either treatment alone.

This is seen an improved penetration of TILs into the tumor, marked slowing in tumor growth and improved survival.

So based on the outcomes of these animal models, we've designed a proof-of-concept Phase II study to investigate the impact on tumor volume and the tumor microenvironment of treatment with pembrolizumab, plus setanaxib, in patients with relapsed or metastatic squamous cell carcinoma of the head and neck, and this study is illustrated on Slide 11.

In this study, approximately 60 patients with moderate or high CAF-density tumors will be randomized to receive setanaxib 800 milligrams twice daily or placebo, and all patients will receive pembrolizumab, using a standard treatment regimen of 3 weekly dosing.

The tumor biopsy will be taken prior to randomization and then again, after at least 9 weeks of treatment.

Treatment will continue until unacceptable toxicity or disease progression, which, as you probably know, is typical for an oncology trial.

Study is targeted to start in the first quarter of 2022, with an interim analysis of biomarker data expected in the fourth quarter of 2022 and a final readout expected in the second half of 2023.

Moving on to the endpoints in a little more detail, on Slide 12.

The primary endpoint for this study is the best percentage change in tumor size per resist, but we have some important secondary endpoints, including other clinical measures of response, of treatment duration, planned treatment duration, biological measures of tumor response, including changes in CAS, TILs and measures of gene expression using RNA sequencing.

So that concludes my part of the presentation, and I will hand over to Fredrik Johansson for the final slide.

Thank you, Richard, and good afternoon, and good morning, everyone.

Let's turn to the next page, the Financial page, and I will present to you the financial overview for the first 9 months of this year.

And as usual, all numbers presented to you, are in million SEK.

To start with, we present SEK 119.2 million (sic) [SEK 198.2 million] in revenues for the period, compared to SEK 0.5 million for the same period last year.

The revenue is originating from the EUR 20 million signing fee that we received in connection with the out-licensing of Nefecon Europe to start up.

Our total operating expenses for the period, amounted to SEK 500.5 million, compared to SEK 244.3 million for the same period last year.

The total operating expenses, the cost for research and development, increased by SEK 89.8 million to SEK 257.2 million, compared to SEK 167.4 million for the same period, previous year.

The increase in R&D expenses witnessed, both from the NefigArd trials, where the NefifArd Phase III study and the open-label study is ongoing, and from the preparations and product development connected with the setanaxib trials, which are planned to start enrolling soon.

The sales and administration expenses amounted to SEK 238.5 million for the period, to be compared with SEK 77.8 million for the same period, last year.

Increase of SEK 160.7 million between the periods, is primarily related to the preparations for commercial and medical affairs activities in the U.S., and we are ready to commercialize Nefecon in the U.S. if approved.

This leaves us with an operating loss of SEK 302.3 million for this period, compared to an operating loss of SEK 243.8 million for the same period, last year.

Cash flow used in operating activities, for the period, amounted to SEK 33.2 million, compared to SEK 103.3 million for the previous year.

During the third quarter, we closed 2 transactions, where we, first in July, signed a $75 million credit facility with Kreos and subsequently, later in the quarter, made a drawdown of the first $25 million tranche.

We also completed a new share issue of 2.5 million shares during the quarter, raising 324 million before transaction costs.

Our cash flow from financing activities in the period, amounted to SEK 476.5 million due to the above transactions.

And I'm glad to report a strong cash position, at the end of September, of SEK 1,163.8 billion.

That was all for me.

And now back to you, Renee.

Thank you very much.

And so just in conclusion, I just want to highlight, obviously, that our commercial readiness for launch of Nefecon in the U.S., subject to an approval on December 15, and then all relevant pre-commercial activities have been completed, and we're eagerly awaiting the feedback from the agency, expected in December, which would then, hopefully, enable a launch, early in Q1.

So with that, I will hand over to see, if there are any questions.

(Operator Instructions) Our first question comes from Maury Raycroft with Jefferies.

You, probably, can't say too much on this, but I'm wondering, if you can elaborate on the additional eGFR analyses that FDA requested, since FDA had access to all patient data at the interim cut, I'm wondering, were any additional safety or efficacy analyses done for off-treatment effects, beyond 9 months or subgroups of patients, while on treatment during the 9 months?

So as we've said before, basically, I mean, the FDA did not request any additional data, and you're absolutely correct.

But obviously, the data set that they always have access to, is the complete database, at the time of any kind of data cut-off.

And really, the only thing that we have announced, and I think, is probably what we're going to stick to, is that the analysis that was requested, really related to eGFR in a variety of different ways and manners and various analyses.

And so that's really, I think, not necessarily surprising, 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, it's not unusual, I would say, or unexpected that they would like to look into that data, in a fair amount of detail.

Got it.

Okay.

That's helpful.

And also, I had a question on 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 $72,000 to $114,000 range versus the prior guidance at the $55,000 to $85,000 range, which is based on the Phase IIb profile.

And so I'm just wondering, if you can talk more about that, and if that's because you think the Phase III data justifies a higher pricing premium or if there's any additional perspective you can provide on that.

I'm going to hand over to Andrew Udell to address that question.

Thanks.

We haven't given specific guidance on the final price, but yes, as we have continued to do our work with the payer community and their assessment of the value of the product, is providing this population, we continue to be encouraged.

One of the things that they do, do is they look at recent launches and other products that they look to try to compare tangentially.

And so we continue to be encouraged about the value that they're seeing for the product, so...

Our next question comes from Erik Hultgård with Carnegie.

I have two, if I may.

The first one is, sort of, a follow on to the previous question on eGFR.

And you have previously commented on the proteinuria trends in patients reaching 12-months data point in Part A of the study.

And to my knowledge, you have not yet commented on the eGFR plans for 12 months, but I assume that you have looked at this.

So is there any specific reason why you have not commented on the 12 months eGFR trend?

Or can you share that state or trends with us today?

And secondly, what would you say -- what was the reason behind the decision by the EMA to revert to standard review time lines?

Was it that the file and the data was so comprehensive that they need more time?

Or are there any other factors that was considered in the decision?

So starting with the EMA question.

So I mean, the EMA can, at any point in time, choose to revert to standard time lines.

Generally, one would assume, I guess that, that is because they would like to have more time to review the submission.

There is no, kind of, real explanation or provided 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, assume that they wanted to ensure that they had sufficient time to review the submission.

And again, 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, so I think that obviously, the primary endpoint in this trial was reduction of proteinuria.

Everything else is really supportive of that.

I think that the disclosures that we have made from a Phase III trial that is ongoing and remains blinded or actually 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 we really have to try to be quite restricted, in terms of sharing any additional information from the trial, in order to not potentially impact the integrity of the trial.

And that's really, kind of, where we are.

And I think this is where we're obviously, going to remain until we are in a position to reveal the final data set from the trial.

Our next question comes from Rami Katkhuda with LifeSci Capital.

Two quick ones for me.

But first, you presented some additional data at ASN, demonstrating the effects of Nefecon on certain chemokines and complement components.

Can you kind of walk us through the implications of that data?

And then secondly, we've seen multiple updates, past the IgA necropathy-development landscape, over the last few months.

Have these data sets, kind of, changed your view on how Nefecon fits in the future treatment landscape in this disease?

So I think, in terms of the biomarker data, yes, I mean, we've presented, or biomarker data have been presented in barriers for -- 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 from our Phase IIb clinical trial.

And I think, what we see there is that a consistent pattern change across a range of key biomarkers, that Nefecon does have an effect on those biomarkers, and during and at the end of the treatment period.

And we see consistent effects that are very much supportive in keeping with the underlying pathophysiology of the disease and support that Nefecon targets the origins of the disease in the distal ileum in the region, the payer patches and is having an immunomodulatory effect at the level of the payer's patches, resulting in relevant and supportive changes in secretory IgA, in circulating immune complexes in (inaudible) and in other relevant chemokines and cytokines.

Yes.

So again, just on the kind of competitive environment, again, I think, having the ability to really, kind of, be effective at the top of the cascade.

I think, we find that to be valuable.

And it's obviously, valuable that we do have this kind of -- not just one effect, but potentially, we're affecting several layers or levels with pathophysiology.

But in terms of that somehow, changing our positioning or changing how it would think that this medication could be used, subject to approval, I don't think that we have made any such -- drawn in such contributions.

Our next question comes from Christopher Uhde with SEB.

So I guess, the first thing I was wondering, was during clock stops as the EMA requested similar analyses to what the FDA requested, now I'll start with that one.

Well, so again, I think the -- as you know, the EMA process is slightly different, in that 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 of it, I'm not -- I'm trying to think back on all of the, kind of, questions that have been reviewed, I'm not sure actually that I can compare the two processes particularly well.

I think, it's a very different process, with vary time and different approach, in terms of, kind of, how they're reviewing the file.

And I think that -- yes, so I think it's not really, kind of, possible to draw comparisons or any conclusions from that, between the two processes.

Can you tell us what kind of things were in their questions, in the same way that you gave us some indication about the FDA?

I mean, obviously, the outlook changed, just purely and simply, from the fact that you have a delay.

So then, I guess that's -- to get a similar level of granularity between the two processes.

So again, the two processes are very different because obviously, we received the actual, kind of, notice from EMA, really, without having had any real interactions with the agency, because we filed that.

So we made that submission far later than with the FDA.

And so again, it's a very different process, and we're not in the same place, with regards to these two regulatory processes.

But does that mean like actual safety or efficacy or?

I mean, I think -- I mean, there's a whole -- I mean, obviously, as you're 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 anything else in the questions that we've 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, again, I mean -- extension, from our perspective, is actually -- it's obviously, not what we would have preferred.

We would have preferred to get an approval on the original time line.

But actually, considering that there is an extension, from our perspective, if there was a view at the time that there were some deficiency, basic deficiency, fundamental deficiencies, related to efficacy or safety, then our assumption would have been that we will have received a complete response letter, not an extension.

The fact that the agency would like to have or feel that they need and require additional time to review the data, we don't actually, see that as a negative.

And as I'm sure you're also aware, statistically, more programs, kind of, become approved in an extension than in a normal cycle.

And again, we can't speculate of what the ultimate outcome is going to be here.

But we do see the extension as a positive sign, in terms of the fact that the agency is continuing to actively review the submission.

And we also recognize that this is the first time that they are reviewing this, on the basis of a surrogate marker.

And so, I'm not sure that one should read into it any further than that.

But I guess, what I was -- yes, it was a little bit of a different answer to what I was asking.

So if I would rephrase, I would say, the FDA asked for analyses with the tilts, in terms of focus on efficacy.

Was there a similar tilt in the average of what the EMA 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 consider that as 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, with regards to the extension, this was a specific, kind of -- we wanted to just, kind of, comment and explain, on that particular analysis.

Obviously, we have been -- we've been through a very thorough review with the FDA, covering lots and lots of different questions.

And that is exactly what we are seeing in the EMA as well.

And so again, they are very different kind of processes, and we are in different stages, with regards to these processes.

I don't know, Richard, do you want to comment on that?

Yes.

No, I agree.

I mean, we see quite a broad range of questions here, for both the FDA and the EMA, that there is an overlap.

It's never been a question, when I thought we don't know how to answer that, and that's unusual.

As we've said before, we are comfortable with the safety profile of the product.

And we believe that we've interacted well with the agencies, and we've been able to respond to everything they have asked us.

And again, I think, it makes sense to, kind of, point -- I mean, this is a well-known chemical entity.

It has been, kind of, used in the market for a long time.

So I think, it is a fairly well-characterized substance, actually.

Right.

Yes.

So -- but for my next question, all right.

So you've been assessing inflammatory markers, post Nefecon 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 2 arms of the NEFIGAN or NeflgArd trials with CRP or any other biomarkers of inflammation?

No.

I mean, that's not something that we specifically looked at, nor necessarily have we collected those kinds of -- that kind of information.

So we haven't looked at the, sort of, call it, that kind of correlation between the biomarker changes and clinical outcome.

But you have patient-level data on a number of biomarkers that were presented.

Do any of those have a correlation?

I mean, as I say, we do have patient-level information on biomarkers, but that we've looked at the biomarkers, in response to treatment, the Nefecon treatment, but we've not tried to correlate 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 it?

Personally, I'm not sure it is particularly helpful to try to correlate the biomarker changes with clinical outcomes.

I think, much more importantly to evaluate the response to treatment and the clinical outcomes.

I think, trying to link biomarkers and changes in biomarkers to clinical outcomes, I, absolutely, don't believe that we're ready for that yet.

And I think, that is absolutely, in line with discussions we've had with experts in the field, and we were 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 Nefecon?

Has it given any indication that it's thinking may have or be evolving, on that issue?

With respect to REMS, no.

That's not something that's been discussed or considered, necessarily.

Okay.

If I could just ask one or two more questions.

Do you have -- do you view the FDA AdCom for Reata as relevant to you, potentially?

Do you have -- I mean, any thoughts you have around that, that would be that you can offer to, be much appreciated?

I mean, this is an Adcom related to, obviously, a different drug with a completely different indication.

And I think that the reason for why the FDA has decided to, kind of, go to hear from an Adcom, generally, tends to be scientifically related, often, to the mode of action or to the kind of -- you're trying to get, kind of, input in that area.

So I don't think that, that necessarily has any kind of read-through to us.

(inaudible) top of eGFR over time, 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, unless I'm misinformed.

Okay.

I guess, my last question would be, so you raised capital, shortly before your original PDUFA date, and the market appears to have interpreted that as a signal that you're not as confident as -- well, as you say, you are in a positive outcome with the FDA.

Why raise cash before such a key inflection point?

Where are you -- and if so, how were you able to rule out a better pricing after the case had been derisked, from a regulatory standpoint?

So I think that in terms of how the market -- I think, there are lots of different views on how that was seen.

Your conclusion, obviously, has to stand for you.

I think that in terms of raising capital as a life science company, is something, where I think, you always have to be aware of the fact that there are lots of different aspects that you do not control, as a company.

And therefore, have been in a situation, where you can really, kind of, be prepared for things that tend to happen, whether it's in drug development clinical programs, regulatory interactions or other things, where there are inherent things that you just don't control, I believe, is something that actually reflects a good management and good planning.

The fact is also, obviously, that in terms of raising capital, as we've gone through, we were involved in a variety of different transactions during this period of time, but also, kind of, meant that there was information there that wasn't available to the market.

And secondly, I would say that in terms of the raising capital, to be prepared, to have a cushion for whatever might happen, again, I think it's actually a benefit.

Again, we -- at that point in time, we obviously had no information, whatsoever, that would reflect a delay.

But on the other hand, we can also look around over the last 18 months and see that there have been delays.

And I think it's been clear that there have been lots of discussions around -- as the number of COVID probably, be impacting or something else on the agency.

So I think that it wasn't going to be a huge surprise, if there was a potential delay in some of these, kind of, review processes.

And so I think, again, from where we are today, I believe having a very solid cash position, both from an equity and from a, kind of, credit line perspective, puts us in a very good position to really, kind of, launch the product, go through the entire launch, subject to approval, and I think that really benefits all shareholders that we find ourselves in this position today.

Our next question comes from Annabel Samimy with Stifel.

I just wanted to clarify a couple of points.

I guess, first, on the 12-month eGFR data that we have not seen because it's blinded clearly, did the FDA have access to that information?

And is that being incorporated into their review, even though it's blinded from, I guess, our perspective?

And then bigger picture, based on the last conversation and all the various -- I guess, the general concern is that FDA is not yet comfortable with an accelerated review pathway in the renal division, overall.

But do you have a sense, from your interactions, that the FDA is not convinced of the proteinuria as a biomarker to indicate 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 the proteinuria endpoint?

So I guess, more of like a bigger sense, from your part, of what you think the FDA stance is, in general, on the accelerated review pathway?

So I guess that in terms of -- first of all, in terms of having any view on how the FDA is treating different programs, 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 -- in terms of the proteinuria endpoint, I would just say that we have no reason to believe that the agency has changed their view, in terms of proteinuria endpoint per se.

However, I think it has been communicated from the agency that an eGFR is a very important component and that in any kind of potential accelerated approval.

And again, I think this is why their focus on eGFR is, therefore, consistent, I think, with the message that eGFR needs to be supportive.

And I think the question really is, how is the agency ultimately going to look at?

Where do they want to set the bar, with regards to that submission?

And that's something that we are obviously, going to have to see, once the agency communicates that, in any kind of program that they are reviewing.

So that was really -- and I think in terms of -- again, in terms of any additional data, I think, again, it's been very clear that the only thing we kind of can do, at this point in time.

is really, kind of, wait for the final, kind of, data to become available or the data, which will become available upon approval of a product.

And so I think, again, it is a blinded ongoing trial.

We have released, I would say, significantly more data, compared to potentially others, out there.

And so I think, we are not going to provide any additional view on this.

Again, I think we have a very compelling data package.

We feel very good about the data that we have.

And so I think, I can just leave it at that and say that we're going to, ultimately, have to see where the agency resolves to -- with regards to, kind of, the -- how they would look at eGFR, from a, kind of, supported perspective, for any approval.

Okay.

Just to be clear on a follow up.

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, since they requested any updates from the studies while as a package was being reviewed.

So yes.

So obviously, the agency has access to all of the data in the database that exists, at the time of the data cut-off.

So clearly, there will be patients that have a lot of data beyond the 9 months.

But again, the agency, and you're correct, the agency could have asked for additional data, either during the, kind of, first review cycle or even during the extension, but the agency has not requested any additional data from us, at this point in time.

Our next question comes from Yigal Nochomovitz with Citigroup.

This is [Ashik Mubarak] on for Yigal.

A lot of the questions have been addressed, so I guess, I'll ask about why you believe STADA was an excellent commercial partner for you, and what you expect to get of that relationship, and maybe what the criteria you're looking for, in your partner search, was, and how that was met?

Sure.

So we run a very, kind of, comprehensive and competitive process, and we have the luxury of having quite a lot of choice, in terms of selection of STADA as a partner.

We really wanted to have someone that really was going to have a strategic interest and focus in the product.

And that, I think, is exactly what we found with STADA.

It's also, obviously, a very 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, to date, has really borne that out.

And so we're actually, very excited about our continued collaboration with them.

Our next question comes from Edwin Zhang with H.C. Wainright.

Nefecon has shown an impressive eGFR benefit after 9 months of treatment.

And we know, the full FDA approval of Nefecon is based on 2-year eGFR data.

Can you please remind us, what the results of eGFR at 2-year, are considered successful and approvable?

Have you already had an agreement with the FDA on the 2-year eGFR endpoint for full approval?

Or do you still need to finalize the details after the conditional approval, next month?

And lastly, are you confident in the 2-year outcome of eGFR, given what you have seen so far, beyond 9 months?

So in terms of the -- so the whole, kind of, protocol and the design of the trial included, both Part A and Part B. And so the interactions with the FDA always, kind of, addressed, both Part A and Part B. So that design have been reviewed and, kind of, established, quite some time ago.

So yes, I mean, there's, no kind of, expectation, on our part, that any of that would change.

So there is an agreed endpoint in Part B, which is eGFR.

And with regards to our confidence -- and again, it's very difficult to speculate what you will see in the future.

But again, I think -- we think we have a very compelling data package and data sets.

And so again, we have no reason to, kind of, have any concern.

But on the other hand, again, I mean, I can't speculate on what we're going to see in the future.

And our last question of the day, comes from Ingrid Gafanhão with Kempen.

I was just wondering, can you just remind us and, sort of, outline, what are your additional clinical plans for Nefecon and through, perhaps, expected time lines for it?

I'm sorry, the time lines for the pipeline?

Nefecon.

For the Nefecon?

Yes, specifically for the Nefecon, for any additional trials that you have in mind, to start.

Oh, I see, sorry.

No, so at this point in time, we don't have any, kind of, clear plans to start any other kind of indications with Nefecon that we are, kind of, ready to communicate.

But I think, a little while ago, you were commenting on perhaps, starting additional studies on kidney transplant population as well as some additional studies to look into additional dosing regimens.

Is that something that you're still considering?

So I think that -- subject to a product being approved and being in the market, I think we would have -- we would look at potentially, different routes forward in, kind of, looking at additional benefit of the product in different kind of populations.

And I think, that's something that we would have to, kind of, review and look at, once we, kind of, have clarity, in terms of our potential approval of the product.

For this moment, there are no further questions.

I hand back over to our speakers.

So thank you very much for joining us for this Q3 presentation.

And we look forward to connecting up with you shortly, which I am sure that we will have an opportunity to speak to you again before the end of the year.

Thank you.