Thank you and welcome to this Q3 presentation. I'm joined today by Richard Philipson, our Chief Medical Officer, Fredrik Johansson, our Chief Financial Officer, and Andrew Udell, President of 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. On page 3, some highlights from the quarter. During this quarter, we concluded transactions aimed at progressing our established partnering strategy ex-US and also to strengthen our cash position. After a broad and successful structured process, during the quarter, we chose to go forward with Kreos. We signed a $75 million credit line, structured into three tranches. We believe that having access to this provides more flexibility. As the company grows into the commercial phase, subject to approval of Nefecon later in the year and allows us to appropriately access capital based on the supply characteristics and cost of capital. We also resolved 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, a regulatory update. During the third quarter, we received a notice from the FDA that they classified the responses provided by us as major amendments and that they would therefore extend the review period by 3 months, resulting in a PDUFA date of December 15th. We know obviously that FDA review of an NDA is a complex and dynamic process, particularly where the agency is reviewing a surrogate endpoint for the first time. While we cannot speculate as to 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 an ultimate positive outcome. We also, during the same quarter, were informed by EMA that they had decided to revert to standard timelines for their review of our submission. 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 is progressing well with respective teams working very well together. 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. 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 two programs. 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 during the next year. Turning to page seven. This is just a graphic depiction of our pipeline. Obviously Nefecon is ongoing in a blinded fashion and is 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 nine-month treatment cycle irrespective of which arm they were in during the phase III trial. We also have been 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. With this, I'm going to hand over to our Chief Medical Officer, Richard Philipson, to take us through the setanaxib programs. Thanks Renée. I'd like to start on slide 8 and begin by outlining the design of our phase II-B/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 intolerance to UDCA will be randomized to receive setanaxib or placebo. In the phase II-B part of the study, patients will be randomized to one of two 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 1200 mg or 1600 mg given as two 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 II-B to phase III part of the study is seamless and there is no pause to enrollment while the futility analysis is performed. The final analysis will be performed on all patients who've 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 the futility analysis targeted for the second half of 2023, and the final analysis 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 1.67 x the upper limit of normal, ALP reduction of greater than 15%, and total bilirubin 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, fatigue, 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. We'll start by explaining that there is a clear relationship between cancer-associated fibroblasts, which are the phenotypic equivalent of the activated myofibroblast, and prognosis in squamous cell carcinoma of the head and neck. In essence, patients with tumors rich in cancer-associated fibroblasts, which I'll refer to as CAFs, have worse outcomes. This is likely linked to exclusion of tumor-infiltrating lymphocytes or TILs from the tumor. Setanaxib has been found to influence the tumor microenvironment in animal tumor models through reversing the CAF 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 as an improved penetration of TILs into the tumor, marked slowing in tumor growth and improved survival. 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. This study is illustrated on slide 11. In this study, approximately 60 patients with moderate or high CAFs density tumors will be randomized to receive setanaxib 800 milligrams twice daily or placebo. All patients will receive pembrolizumab using a standard treatment regimen of three weekly dosing. A 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. The 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 RECIST. We have some important secondary endpoints, including other clinical measures of response of treatment, duration and treatment duration, biological measures of tumor response, including changes in CAFs, TILs, and measures of gene expression using RNA sequencing. 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 first nine months of this year. As usual, all numbers presented to you are in million SEK. To start with, we present SEK 119.2 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 in Europe to Stada. Our total operating expenses for the period amounted to SEK 505 million, compared to SEK 244.3 million for the same period last year. Out of 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. Increase in R&D expenses were witnessed both from the Nefecon trials, where the Nefecon phase III study and 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 healthcare 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 two transactions where we first in July signed a $75 million credit facility with Kreos and subsequently later in the quarter made a draw down for the first $25 million tranche. We also completed a new share issue of 2.5 million shares during the quarter, raising SEK 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. I'm glad to report a strong cash position at the end of September of SEK 1,163.8 million. That was all for me. Now back to you, Renee. Thank you very much. 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 fifteenth. Then all relevant pre-commercial activities have been completed, and we're eagerly awaiting this feedback from the agency expected in December, which would then hopefully enable a launch early in Q1. With that, I will hand over to see if there are any questions. Our first question comes from Maury Raycroft with Jefferies. Please go ahead. Hi. 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 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 nine months or subgroups of patients while on treatment during the nine months? As we've said before, basically, I mean, the FDA did not request any additional data, and you're absolutely correct. That obviously the dataset that they always have access to is the complete database at the time of any kind of data cut-off. Really the only thing that we have announced, and I think is probably what we're going to stick to, is that, you know, the analysis that was requested really related to eGFR in a variety of different, you know, ways and manners and, you know, various analysis. That's really, I think, not necessarily surprising, considering that the FDA has always been quite clear about the fact that eGFR is, you know, is required to be supportive. 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. 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 thousand-$114 thousand range versus the prior guidance at the $55 thousand-$85 thousand range, which is based on the phase IIb profile. 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. You know, 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 the product is providing this population, we continue to be encouraged. One of the things that they do is they look at recent launches and other products that they look to try to compare tangentially. We continue to be encouraged about the value that they're seeing for the product. Okay, that's helpful. Well, thanks for taking my questions, and I look forward to the update in December. Thanks. Our next question comes from Erik Hultgård with Carnegie. Please go ahead. 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 the eGFR. You have previously commented on the proteinuria trends in patients reaching the 12 months data point in part A of the study. To my knowledge, you have not yet commented on the eGFR trends at 5 months, but I assume that you have looked at this. Is there any specific reason why you have not commented on the 5 months eGFR trends, or can you share that data or trends with us today? Secondly, what was the reason behind the decision by the EMA to revert to standard review timeline? Was it that the file and the data was so comprehensive that you needed more time, or are there any other factors that was considered in the decision? Thank you. Starting with the EMA question. I mean, the EMA can at any point in time choose to revert to standard timelines. Generally, you know, one would assume, I guess that is because they would like to have more time to review the submission. There is no kind of real explanation or, you know, provided from the regulators when they choose to do this. We can't speculate as to why they decided to do this. We can only kind of, you know, assume that they, you know, wanted to ensure that they had sufficient time to review the submission. Again, I mean, all NDA reviews are fairly complex and dynamic, so that's really all the information that we have and we can share with you. Regarding additional data. 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 are actually you know fairly comprehensive under that scenario, I would say. We're really not in a position to provide any additional information beyond what we have already done. I think that's also been kind of clearly communicated that you know we really have to try to be you know quite restricted in terms of sharing any additional information from the trial in order to not potentially impact the integrity of the trial. 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 dataset from the trial. All right. Thank you. Our next question comes from Rami Katkhuda with LifeSci Capital. Please go ahead. Hi, everyone. Thanks for taking my questions. Two quick ones from me. 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? Secondly, we've seen multiple updates across the IgA and across the development landscape over the last few months. Have these datasets kind of changed your view on how Nefecon fits in the future treatment landscape in this disease? I think in terms of the biomarker data, yeah, I mean, we've presented our biomarker data have been presented in various fora. I think we see a very consistent picture in terms of the biomarker changes that we see. Just to provide context for that's from our phase II-B clinical trial. I think what we see there is that a consistent pattern of change across a range of key biomarkers that Nefecon does have an effect on those biomarkers during and at the end of the treatment period. We see consistent effects that are very much support or are in keeping with the underlying pathophysiology of the disease and supports that Nefecon targets the origins of the disease in the distal ileum, in the region of Peyer's patches, and is having an immunomodulatory effect at the level of the Peyer's patches, resulting in relevant and supportive changes in secretory IgA in circulating immune complexes in Gd-IgA1 and in other relevant chemokines and cytokines. Yeah. Again, just on the kind of competitive environment, you know, again, I think you know, having the ability to really kind of be effective at the top of the cascade, I think we find that to be valuable. It's obviously valuable that we do have this kind of, not just one effect, but you know, potentially we are affecting several layers or levels of the pathophysiology. In terms of that somehow changing our positioning or changing how we would think that this medication could be used, subject to approval, I don't think that we have you know, made any such, you know, drawn any such conclusions. Got it. Thank you. Our next question comes from Christopher Udy with SEB. Please go ahead. Hi there. Thanks for taking my question, or my questions. I guess the first thing I was wondering was, during clock stops, has the EMA requested similar analyses to what the FDA requested? Yeah, I'll start with that one. Well, again, I think, as you know, the EMA process is slightly different in that, you know, you get a collection of different, you know, a lot of different questions in one go. In terms of, I'm trying to kind of think of it. I'm trying to think back of all of the kind of questions that have been reviewed, because I'm not sure actually that I can compare the two processes, you know, particularly well. I think it's a very different process with very kind of, you know, a different approach in terms of kind of how they're reviewing the file. I think that. Yeah. I think it's not really kind of possible to draw, you know, comparisons or, you know, any conclusions from that between the two processes. Can you tell us what kinds 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. I guess it's, you know, it's nice to get the similar level of granularity between the two processes. Again, the two processes are very different because obviously, you know, we received the actual kind of notice from EMA really without having had, you know, any real interactions with the agency because we filed that. We made that submission far later than with the FDA. Again, it's a very different process and, you know, we're not in the same place with regards to these two regulatory processes. Does that mean like? Actually Questions on safety or efficacy or, 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, you know, 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. Mm-hmm. I think that in terms of the extension, I mean, again, right, I mean, you know, an extension from our perspective, you know, is actually, you know, it's obviously not what we'd have preferred. We would have preferred to go, to have an approval on the original timeline. Actually considering that, you know, there is an extension, you know, from our perspective, if there was a view at the time that there were some, you know, deficiencies, basic deficiencies, fundamental deficiencies related to efficacy or safety, then our assumption would have been that we would have received a Complete Response Letter, not an extension. Right. The fact that the agency 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. As I'm sure you're also aware, you know, statistically, you know, more programs kind of become approved in an extension than in a normal cycle. Again, we can't speculate on what the ultimate outcome is going to be here. You know, we do see the extension as a positive sign in terms of the fact that, you know, the agency is continuing to actively review the submission. We also recognize that, you know, this is the first time that they are reviewing this on the basis of a surrogate marker. you know, I'm not sure that, you know, one should read into it any further than that. I guess that was a little bit of a different answer to what I was asking. If I would rephrase, I would say the FDA asked for analyses with a tilt 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, you know, safety and quality of life, I guess, if you consider those one group, that's what they're really always after. Can you give any color around that? Again, just to be clear, obviously, you know, with regards to the extension, you know, this was a specific kind of, you know, we wanted to just kind of comment and explain on that particular analysis. Obviously, we have been a very thorough review with the FDA, covering lots and lots of different questions. That is exactly what we are seeing in the EMA as well. 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 and follow up? Yeah. No, I agree. I mean, we see, you know, quite a broad range of questions, areas of both the FDA and the EMA that there is overlap. There's never been a question where I thought, "Well, you know, we don't know how to answer that," or, "That's unusual." As we've said before, we are comfortable with the safety profile of the product. You know, and we believe that, you know, we've interacted well with the agencies, and we've been able to respond to everything they've asked us. I think it makes sense. I mean, this is a well-known chemical entity. You know, it has been, you know, kind of used in, you know, in the market for a long time. So I think it is a fairly well-characterized substance, actually. For my next question. All right. 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 two arms of the NEFIGARD 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 that kind of information. So we haven't looked at that kind of correlation between the biomarker changes and clinical outcome. You have patient-level data on a number of biomarkers that were presented. Do any of those have a correlation? As I say, we do have patient-level information on biomarkers, but we've looked at the biomarkers in response to treatment, the Nefecon treatment, but we've not tried to correlate the relationship between changes in the biomarkers and clinical outcomes. When can we expect that data to be assessed? 'Cause I guess that's pretty important to do, right? 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. We're 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 it may have or be evolving on that issue? With respect to REMS, no. That's not something that's been discussed or considered necessary. Okay, thanks. If I could just ask one or two more questions. 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 you can offer would be much appreciated. I mean, this is an AdCom related to, you know, obviously a different drug with a completely different indication. I think that, you know, the reason for why the FDA has decided to, kind of, you know, to hear from an AdCom, you know, generally tends to be scientifically related often to the mode of action. They're trying to get kind of input in that area. I don't think that necessarily has any kind of read-through to us. I think that Considering the slope of the 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, you know, statistical framework available to the agency for this indication, unless I'm misinformed. Okay. So- I guess my last question. Okay. Well, as you say, you are in a positive outcome with the FDA. Why raise cash before such a key inflection point? And were you, and if so, how were you able to rule out a better pricing after the case had been de-risked from a regulatory standpoint? That's my last question. I think that in terms of how the market, you know, I think there are lots of different views on how that would seem. You know, 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 know, you do not control as a company. Therefore, you know, being in a situation where you can, you know, really kind of be prepared for, you know, things that tend to happen, whether it's in drug 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 reflects 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. That also kind of meant that there was information there that wasn't available to the market. Secondly, I would say that in terms of raising capital, to be prepared to have a cushion, you know, for whatever might happen, again, I think is actually a benefit. Again, we at that point in time, we obviously had no information whatsoever, that would reflect, you know, a delay. But on the other hand, we can also look around over the last 18 months, and see that there have been delays. I think it's been clear that there have been lots of discussions around, you know, has COVID been impacting or something else on the agency. I think that it wasn't going to be, you know, a huge surprise if there was a potential delay in some of these kind of review processes. I think, again, you know, 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, you know, puts us in a very good position, to really kind of, you know, launch the product, go through the entire launch, subject to approval. 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 Samimy with Stifel. Please go ahead. Hi. Thanks for taking my question. I think a lot of them were covered. But 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 the bigger picture, based on the last conversation and, you know, all the various things, I guess the general concern is that FDA is not yet comfortable with an accelerated approval pathway in the renal division overall. 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? Do you think that the FDA has been consistent in their treatment of each of the different programs that are currently developing drugs based on this, these proteinuria endpoints? I guess more of, like, a bigger sense from your part of what you think the FDA's stance is in general on the accelerated review pathway. Thanks. I guess that in terms of, you know, first of all, I mean, in terms of having any view on, you know, how the FDA is treating different programs, you know, 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 as a target endpoint, I would just say that, you know, we have no reason to believe that, you know, the agency has changed their view in terms of proteinuria as an endpoint per se. However, I think it has been communicated from the agency, that, you know, eGFR, you know, is a very important component, and that, you know, in any kind of potential accelerated approval. Again, I think this is why, you know, their focus on eGFR is therefore consistent, I think, with the message that, you know, eGFR needs to be supported. I think the question really is, you know, how are, you know, how is the agency ultimately going to look at, you know, where do they want to set the bar with regards to that recognition? I think that's something that we are, you know, obviously gonna have to see once the agency chooses to communicate that in any kind of program that they are reviewing. That was really, that... 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, the only thing we kinda can do at this point in time is really kinda wait for the final kind of data to become available, or the data which will become available upon approval of a product. I think again, it is a blinded ongoing trial. You know, we have released, I would say, significantly more data compared to potentially others out there. I think, you know, we are not going to provide any additional view on this. Again, I think we have a very compelling data package. You know, we feel very good about the data that we have. You know, I think I can just leave it at that and say that, you know, we're gonna ultimately have to see where the agency resolves with regards to kind of the, you know, how they would look at eGFR from a kind of supportive perspective when the FDA approval. Okay. Just to be clear on a follow-up. I know that you're not gonna release any further data to us, but I'm just curious if FDA has access to that data. Have they requested any updates from the studies while, you know, as the package was, you know, being reviewed? Obviously the agency has access to all of the data in the database that exists at the time of the data cutoff. Clearly there will be patients that have, you know, a lot of data beyond the nine months. 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. The agency has not requested any additional data from us at this point in time. Okay, great. Thank you. That was quick. Our next question comes from Yigal Nochomovitz with Citigroup. Please go ahead. Hi. This is Ashik Mubarak on for Yigal. Thanks for taking my question. 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 out of that relationship, and maybe what the criteria you were looking for in your partner search was and how that was met. Thanks. Sure. We ran a very kind of comprehensive and competitive process, and we had 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, you know, strategic interest and focus in the product. 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. We really felt that, you know, this would be an excellent partner for us in terms of commercialization in Europe. I think the partnership, you know, to date, has really borne that out. We're actually very excited about 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. Nefecon has shown an impressive eGFR benefit after 9 months of treatment. We know the full FDA approval of Nefecon is based on 2-year eGFR data. Can you please remind us of what result of eGFR at 2-year are considered successful and approvable? Have you already had an agreement with 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? Lastly, are you confident in the 2-year outcome of eGFR, given what you have seen so far beyond 9 months? Thanks. This, the whole kind of protocol and the design of the trial included both part A and part B. The interactions with the FDA always kind of, you know, addressed both part A and part B. That design has been you know, reviewed and kind of, you know, established you know, quite some time ago. Yes, I mean, there is no, you know, there's no kind of expectation on our part that, you know, any of that would change. There is an agreed endpoint in part B, which is eGFR. With regards to our confidence, I mean, again, it's very difficult to speculate what you will see in the future. Again, I think, you know, we think we have a very compelling data package and dataset. You know, again, we have no reason to, you know, to kind of have any concerns. On the other hand, again, I mean, I can't speculate on what we're going to see in the future. Okay, thank you. Our last question of the day comes from Ingrid Gafanhão with Kempen. Please go ahead. Hi, good afternoon. Thank you for taking the questions. I was just wondering, can you just remind us and sort of outline what are your additional clinical plans for Nefecon and some perhaps just expected timelines for it? Sorry, the timelines for the pipeline? Nefecon. Oh, for Nefecon. Yeah. Specifically for the Nefecon. As for any additional trials that you have in mind, to start. Oh, I see. Sorry. No, at this point in time, you know, 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. 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? I think that, you know, subject to a product being approved, and being in the market, I think, you know, we would look at potentially, you know, different routes forward, in terms of, you know, looking at additional benefit of the product in different kind of populations. I think that's something that, you know, we would have to kind of review and look at, once we kind of have clarity in terms of, you know, a potential approval of the product. All right. That's clear. Thank you. For this moment, there are no further questions. I hand back the word to our speakers. Thank you very much for joining us for this Q3 presentation. We look forward to connecting up with you shortly, which, I'm sure that we will have an opportunity to speak to you again before the end of the year. Thank you.
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