Ascelia Pharma AB (publ) (ACE) Earnings Call Transcript & Summary
February 10, 2022
Earnings Call Speaker Segments
Operator
operatorLadies and gentlemen, welcome to the Ascelia Pharma Audiocast Teleconference Q4 2021. Today, I'm pleased to present CEO, Magnus Corfitzen. [Operator Instructions] Magnus, please begin your meeting.
Magnus Corfitzen
executiveThank you, operator. Welcome, everyone, to the webcast to report Ascelia Pharma's Q4 Quarter 2021. So I'm Magnus Corfitzen, CEO of Ascelia Pharma. And with me today, I have Kristian Borbos, our Chief Financial Officer; Julie Brogren, our Chief Commercial Officer; and Andreas Norlin, VP of R&D. Our regular followers will notice that Andreas has just joined instead of our Chief Medical Officer, Carl Bjartmar, on this call. This is a temporary support we have here as Carl is traveling and right now meeting with an investigator SPARKLE study. So we're really happy to have Andreas joining us today. Now please turn to Page #2. We'll be making certain forward-looking statements on this call, so please pay close attention to this before moving to Slide #3. Ascelia Pharma is dedicated to improve the life of people living with cancer by offering better treatment options. In particular, we focus on rare cancer conditions. Our business model is to identify, develop and commercialize novel drugs that address unmet medical needs within oncology. We have 2 drugs in clinical development, Orviglance, formally known as Mangoral, is in an ongoing Phase II clinical study. It will be the only product targeting an addressable market of $500 million to $600 million annual. Oncoral is starting the Phase II clinical study in the treatment of gastric cancer based on encouraging results in clinical Phase I. We're based Malmö, Sweden and are listed on nasdaq.com. We have a strong balance sheet and are funded into 2023, including completion of the Phase III program for Orviglance. Now please turn to Page #4. Ascelia pharma is in a transformative phase as we're moving from late-stage development into commercial stage. Next year, we will start to generate revenue from our commercial operations in the U.S. and all the meds has been launched. Part of our strategy, we expect to have expanded our portfolio by acquiring our in-licensing and additional drug that fit our open oncology strategy and where we can make significant benefits for the patients. In 2025, we expect to have established Orviglance , the market leader in this market; Oncoral in Phase III development and having 1 or 2 more clinical stage assets in the pipeline through acquisitions or in-licensing. So this is an exciting time for Ascelia Pharma, and we have seen tremendous value creation potential as we progress. Please move to Page 5. In Q4 last year, we continued to make progress. In October, we announced the Last Patient, Last Visit Food Effect Study. And hence, the clinical part of the study was completed. In December, Dr. Kohkan Shamsi presented data at RSNA, the world's largest radiology conference taking place in Chicago that compared Orviglance with the liver-specific gadolinium contrast agent. Also, in December last year, the FDA approved the IND application for Oncoral and the Phase II clinical study. I'll go into these details in the next few slides. So please turn to Slide #6. Orviglance is orally administered. That is it's mixed with water and drop by the patient. Oncoral patients have been fasting before getting Orviglance , which is the usual approach for such product. The Food Effect Study investigate, what happens to the uptick in the absorption of Orviglance, including the safety if the patient has had something to eat before taking Orviglance. In this study, we tested in 2 arms. One, with a full breakfast as defined by the FDA guidelines and one with sort of a light breakfast or what you call a snack. The preliminary data that we have released indicate Orviglance is well tolerated, and we expect to be able to announce the final results of this quarter. The data from this study will be part of the IND submission for approval. And we'll also make it more convenient for the patient in case testing is not a requirement, but we do not know when this is the case yet. This type of study is required for the administered drugs to understand if there is a traction through safety and efficacy. So we're looking very much forward to completing the data analysis and share the results. Now please move to Page #7. At RSNA in December 2021, Dr. Kohkan Shamsi presented more data on Orviglance. We've previously announced top line data from this study. And at this presentation, more details were shared. Imaging was done years back at a clinical study at Karolinska Hospital in Stockholm in patients with normal kidney function. This allowed us to make a head-to-head comparison to the liver-specific gadolinium agent Multihance. As you all know, due to the safety profile of gadolinium and the black box warning on all gadolinium products, such a study is not feasible in the private population for Orviglance because of risk of nephrogenic systemic fibrosis. So the results that we shared here include that, you can say, what is shown on this slide, all the images were evaluated by 3 independent radiologists based on a prospective protocol similar to the SPARKLE. The results were, 3 out of 3 readers detected more lesions with Orviglance than with Multihance. 3 out of 3 readers saw a smaller lesion with Orviglance. And 2 out of 3 readers report higher lesioned border delineation with Orviglance, and 2 out of 3 readers report higher lesion contrast to Orviglance. The study was only during patients enhance that powered to show statistical significance. However, we think it clearly supports an attractive profile of Orviglance and will strengthen the data package towards radiologists, regulators and payers. Now please move to Page #8. In December, we also announced the FDA approval of our IND filing for Oncoral. This is very positive as this is the first time the FDA has renewed Oncoral documentation and also the Phase II study design. The initial dose escalation phase of the study will be conducted at hospitals in Europe. And hence, we also need regulatory approval in these individual countries where the hospitals are located. Once the dose has been established, U.S. hospitals will also be involved in patients. We expect the first patient -- first visit to be in Q2 or Q3 this year. Now please move to Page #9. Now we'll go into more depth on our pipeline. I'd like to hand over the word to our VP of R&D, Andreas Norlin.
Andreas Norlin
executiveYes. Thank you, Magnus. So we're on Slide 10. So Orviglance is a novel oral contrast agent for liver MRI, which addresses a very specific unmet medical need. The contrast agents available today are all based on gadolinium, a heavy metal, and gadolinium should not be given to patients with poor kidney function since it is excreted through the kidneys and slow elimination can cause serious side effects. In the future, this unmet need can be met by Orviglance. This specific target population is approximately 4% of all patients requiring a liver MRI, which corresponds to an addressable market of USD 500 million to USD 600 million annually in the major markets. The right side of the slide show how Orviglance works in a patient with colorectal cancer. The left picture shows an unenhanced MRI scan without the contrast agent which is a standard procedure today for our target population. The right scan shows the same patient after administration of Orviglance. The liver has taken up Orviglance and appears bright. There is one dark area highlighted here that is only visible after Orviglance enhancement. This is a metastasis, which would not have been detected without the contrast agent. This illustrates the importance of the contrast agent. In this case, since detected and localized, the metastases may be removed, which significantly improved prognosis for the patient. And we have made good progress. A thorough Phase I and Phase II program has been completed with strong data, providing clinical proof of concept, and we are currently in Phase III. We should also mention that the development is validated and aided by an Orphan Drug Designation by the FDA. So the next slide, please, Slide 11. As mentioned, there is a strong clinical proof of concept through 6 individual Phase I and II studies with very consistent results. This data were confirmed by an independent reanalysis by a blinded reader, which showed highly significant effects on endpoints that are also used in the ongoing Phase III study. The primary Phase III endpoint is lesion visualization based on the co-primary parameters lesion delineation and lesion contrast compared to background. And as seen on this slide, both these were highly significant in the Phase II program. It was also noted that the 33% more metastasis were detected with Orviglance compared to unenhanced MRI. The existing data also contains a direct comparison to gadolinium-based liver contrast agents, which demonstrated similar effects on lesion visualization, as we just heard. And these were -- results were, as mentioned earlier, presented at the RSNA in December last year. Next slide, please, Slide 12. So our ongoing registration study, SPARKLE, investigates the efficacy and safety of Orviglance in the target population with focal liver lesions and poor kidney function. The study, which is a global study with 200 patients, currently have more than 40 sites opened in U.S., Europe and Latin America. Since there is no available contrast agent for patients with impaired renal function, the comparator will be unenhanced MRI, which is currently the standard procedure in these patients. This study design has been agreed with FDA and EMA. The strategy is to repeat and confirm the Phase II results using the same endpoints, lesion border delineation and conspicuity. It should also be mentioned that a follow-up for each patient is very short compared to most clinical studies, and this simplifies the operational procedure. And we will also have final data relatively sooner than in a typical Phase III study. So the next slide, please.
Julie Brogren
executiveThank you, Andreas. We are now on Slide 13. The addressable market for Orviglance estimated to represent $500 million to $600 million annually in our key markets, the U.S., Europe and Japan. This potential is based on the volume of procedures for patients with cancer in the liver and for kidney function falling under the black box warning by the regulatory authorities. We have real-world data supporting our volume estimates for patients and the LONSURF procedures to patients. And we have researched [ price plans ] and the evidence required by payers to support a strong value proposition. Setting our own commercial team in the U.S. allows us to create an attractive top line and retain profit in the [ annual figure ]. For other markets, starting with Europe and Japan, our strategy is to maximize the value of Orviglance by working with partners. Please move on to Slide 14. For the U.S., the attractiveness and clear path to market is a really strong case for us to commercialize Orviglance on our own. So we are preparing to grow and build a U.S. commercial affiliate. The target patient population for Orviglance has multiple health complications. They have suspected cancer in the liver and they have poor kidney functions. This means that the main decision makers for using Orviglance are centered around 400 hospitals and sites in the U.S. Therefore, a focused team in an affiliate of around 40 FTEs can reach priority decision makers at launch. We now have our U.S. office established which represents an important step to engage more closely with key stakeholders and with the clinical community on the journey to make Orviglance available to patients and physicians in the U.S. Our global manufacturing partner, Cambrex is also in New Jersey. We have gradually built our footprint and relationships with key stakeholders as part of our preparations for launch. This includes a number of leading radiologists that are part of our Phase III study investigator. Please move to Slide 15.
Magnus Corfitzen
executiveYes. So thank you, Julie. I will continue again and tell a little bit more about Oncoral. So please move to Slide 16. So the active substance of Oncoral is irinotecan, an established chemotherapy with well-documented anticancer effects. It is currently used in several solid cancer indications and is approved for colorectal cancer and pancreatic cancer. In Japan, it is also approved for gastric cancer. Today, the administration is intravenous bolus infusion, typically every third week and typically high dose. Oncoral is a novel oral formulation of irinotecan. The tablet formulation enables more frequent daily dosing that could offer several potential advantages. Most important efficacy. It is well known that many cancer types have suboptimal treatment outcomes today. An oral daily dosing may improve efficacy through a favorable pharmacokinetic and pharmacodynamic profile based on more constant therapeutic plasma levels of the active substance and are both nonclinical and clinical data supporting this concept. Then there is tolerability or safety. Intravenous dosing of chemotherapy is frequently associated with severe side effects, typically, gastrointestinal and hematological. An oral daily dosing has the potential for improved tolerability by avoiding high plasma levels and by offering dosing flexibility. In addition, there is potential convenience and cost benefits. It is more convenient and cost-effective to take a tablet at home than going into the hospital prepared for an intervene administration. Slide 17, please. The concept of frequent low dose administration is called metronomic dosing. The figure to the left illustrates a simulation model comparing levels of the active metabolite SN-38 after irinotecan IV dosing every third week, a gray line and oral Oncoral dose daily, the orange line. Over a 3-week cycle, the exposure or AUC is comparable, although the plasma peaks associated with toxicity are avoided by daily dosing. Approximately 1/3 of the side effects observed after intravenous dosing are recorded as severe or even life threatening, grade 3 or 4. Metronomic dosing may not only reduce the peak-related toxicity, but also brings the possibility to adjust dosing quickly if adverse events should occur. Our own Oncoral Phase I results show that Oncoral was well tolerated overall. And importantly, the hematological toxicities were mild-to-moderate grade 1 or 2. In addition, our Phase I data with Oncoral indicated activity or stable disease even in patients that previously progressed on irinotecan given intravenous. Slide 18, please. As an example of the potential efficacy benefits of lower, more frequent dosing of irinotecan, here you can see the results from a study in metastatic refractory breast cancer. Even a relatively modest change in dosing frequency, once weekly versus every third week, could improve the overall survival from 20% to 32% in this study. Slide 19. So now we are preparing for Phase II. And the objective of the Phase II study is to generate a clinical proof of efficacy in metastatic gastric cancer. And the strategic reasons for -- to choose gastric cancer are several. First, the clinical guidelines and clinical data support efficacy of irinotecan in gastric cancer. secondly, gastric cancer is a severe cancer form with a high unmet need and the potential for orphan drug designation. Subsequently, there is potential for label expansion into other solid tumors in tumor indications. Finally, as shown in the figure, there is data from gastric cancer animal models, supporting a synergistic or additive effect of irinotecan is combined with LONSURF. LONSURF is another oral chemotherapy, which has -- which was approved for metastatic gastric cancer in 2019. So this all-oral combination could potentially provide a more potent treatment alternative for these patients. Next slide, please, Slide 20. So this study is a randomized, controlled, multicenter, multinational study comparing Oncoral on top of LONSURF with LONSURF alone. Primary endpoint is typical for Phase II studies in oncology progressive-free survival and then the battery of secondary endpoints, response rate, PK, safety and overall survival are included. The study will include approximately 100 patients, and we anticipate the study to start this year continuing into 2024. As have been announced before, we have entered into a clinical collaboration agreement with Taiho Oncology regarding supply of LONSURF study. Next slide, please?
Julie Brogren
executiveThank you. On Slide 21. Gastric cancer is today a $3 billion market. Every year, more than 1 million people are diagnosed with gastric cancer. In the U.S. and Europe, gastric cancer is an orphan disease with more than 100,000 patients diagnosed every year. Many are diagnosed quite late and around 60,000 of these received drug treatments and progress to advanced stage. Gastric cancer is more common in Asian markets, where more than 0.5 million people are diagnosed every year. Please move to Slide 21 -- 22. Thank you. Why will we start in gastric cancer where there's a high unmet need and an opportunity for an orphan indication, we see opportunities for expanding development into other indications where daily dosing tablet formulation can demonstrate an attractive efficacy and safety profile. Having taken as an IV formulation is already approved in colorectal and pancreatic cancer. In addition, irinotecan is clinically demonstrated and recognized in the NCCN cancer care guidelines for many cancer types. We are setting these opportunities as our Phase II study progresses and as part of our ongoing strategic plans for our growth. Please move to Slide 23.
Kristian Borbos
executiveOkay. Thank you, Julie. And please turn to Page 24. So the key message on the financials is that the liquid position continues to be strong, and we have around SEK 262 million in the bank, which will take us into 2023. The cash position will primarily be used for Orviglance and Oncoral Phase III study as well as commercial preparations and, of course, also the upcoming Oncoral Phase II study. Please turn to Page 25. So here we see the development in earnings. And again, the key takeaway for the quarter as well as for the full year 2021 compared to previous year. And those periods is the same as we discussed on earlier calls. We see an increased loss year-over-year, which is as expected and reflects the increased R&D activity related to the Orviglance Phase III as well as commercial preparation and again, also the Phase II preparation for Oncoral. With that, I'll leave the word over to Magnus.
Magnus Corfitzen
executiveThank you, Kristian. I'd like to end this call with an update with our focus on our key milestones. So the clinical development of Orviglance is our key priority. We all know that there is a COVID impact. We've previously announced that. But we continue to work with the investigators and deal with the, say, unusual circumstances to make this study a success. And we're adapting as we progress to ensure patients, medical staff employees and everybody else is safe, and we can complete this study in good shape. We expect to complete the enrollment in the first half of this year. We continue our preparation to Orviglance commercialization and have many activities undergoing to enable us to detail and implement the value maximizing strategy. For the Oncoral Phase II clinical study, we expect to be able to recruit the first patient for first visit in Q2 or Q3 this year. This was our final slide, and we'd be happy to take any questions.
Operator
operator[Operator Instructions] Our first question comes from the line of Ludvig Svensson from Erik Penser Bank.
Ludvig Svensson
analystYes. So for my first one, you recently changed some of the increasing criteria in the Phase III study with Orviglance. Could you elaborate a bit on this? And how it might affect both the patients recruitment, but also future label of the drug?
Magnus Corfitzen
executiveThank you. Yes, you're absolutely correct. So we recently implemented changes in the protocol to include hemodialysis patients. So patients on dialysis go to a dialysis center 2, 3 times a week to clean the blood and patients on dialysis have a very, very poor kidney function. So it's still within the target population that we had originally. Typically, you don't include hemodialysis patients because it's more difficult to measure blood levels and so forth because they get this clean up of the blood in a different way than the normal patients. It's an important part of the target population. It's also from a patient recruitment strategy, you would say, easier to localize these patients because they, by definition, go to a dialysis center. So the density of our potential SPARKLE patients and patients in the target population of Orviglance, they are -- they have a high density there. So that's the reason why we have included that in the study. And we think that's going to, say, continued positive impact upon patient improved recruit in the SPARKLE. We also included Chart 2B. So Chart 2 criteria relates to hepatic function, liver function. We have, from the beginning, had to test for mild liver impairment. Now we also receive in moderate. We have the hepatic examine study ongoing. And hopefully, we can complete that study in the not-too-distant future that is investigating moderate and severe hepatic impairment. And then finally, we have made some changes to the follow-up schedule on the safety follow-up. So as you may recall in the study on the day they are dosed and scanned, they spent a long time in the hospital. And there will be follow-up safety visits in the following days. Then we have added more flexibility upon those safety follow-up visits. And that is also very much in, I would say, relates to COVID because patients are general hesitant to go to the hospital in COVID times. So I think that's also going to be important for some patients.
Ludvig Svensson
analystGreat. That's helpful. And for my next question, I was wondering about the Oncoral study and Phase II study. As I understand, you have received an approval to initiate this, but you guide for a time line where you will dose the first patients Q2 -- Q3 this year. Why is it best to [ manipulating ] this along before you can dose the first patient?
Magnus Corfitzen
executiveYes. No, that's a very relevant question. So we have the IND approval from December. So in the initial phase of the study, we would do dose escalation. So we have not in clinical studies any data that show how overall and long-term dosing interacts. And then it's typically to have some of the dose escalation phase where we start with the dosing and then we escalate up and see how high we can go. Those sites that will do this are based in Europe. And we need to have, I would say, national approval in those countries where those hospitals are before we can start dosing. And that is kind of a sequential process because we have had, I would say, a good deal of interaction with the FDA to -- in terms of the IND process that has been valuable, and we wanted to complete that and get that firm up with the FDA before submitting to the national authorities in Europe. So it is a sequential process. It's -- and then probably it takes some time. So the clinical trial indications to those countries have been submitted in Europe, and there's a review process taking up to 3 months. And hopefully, that will be in good shape here, and then we can initiate the drugs and get patients dosed.
Operator
operatorAnd the next question comes from the line of Johan Unnerus from Redeye.
Johan Unnerus
analystFirst, a follow up. Could you clarify is this change in protocol also could have an impact on the future of label?
Magnus Corfitzen
executiveYes. No, it will be included in the previous label. So what we are doing is we -- you would say first if we take the hemodialysis patents. Then essentially, what we're doing is that we are -- we had a cap on how many hemodialysis patients we could have in the study. And that cap, we would say, is eliminated. So now it's any patient with a GFR below 30 regardless of dialysis status. So per se, it would not be significantly impacting the label as such. On the [ chart ], that would potentially would expand the label, but it's something that, we would say, will be data driven. We're also doing the [ Ignite Balance ] study. That data would also go into it, but maybe there might be small changes depending on whether they are in the cycle study or not.
Johan Unnerus
analystInteresting. And presumably now in the sort of the final part of recruitment, the patients that are being added is high proportion coming from these relating to these changes.
Magnus Corfitzen
executiveThat's what we know working with the sites all over and helping them on the recruitment areas. And I mean, there is many different countries, many different healthcare systems. And some sites have seen these as, we would say, a significant barrier to patient recruitment and in others, less so. So that is what we have essentially been doing all throughout the study, identify -- getting the feedback from the sites, understanding the dynamics and the patient flow. And then as much as we can, adjust in a good way, so we don't compromise, you would say, the quality of the study and the hopefully the outcome of the study. But it's more the helping -- making it easier for investigators to improve patients. And this is a reflection of that. And we have made a number of changes to the protocol, but we thought these were, we would say, more significant. So that's why we included in this call report.
Johan Unnerus
analystVery good. And for each patient once recruited, the results will come within weeks. And if we assume that the ambitions will be fulfilled and if it's fully recruited, say, in June, just as an illustration, when can we expect the formal result?
Magnus Corfitzen
executiveYes, well, we have not guided on how long will it go from last patient, last visit until we can announce the top line results. So you're absolutely right that the images are read at the hospital and there. What we have as the primary endpoint is that we take all the images into one database. And then we have 3 trained radiologists who will get down at all the scans. This is kind of the gold standard evaluation by the FDA to minimize bias. So we don't have a big variability whether the patient was recruited in an [ Italian ] site or a U.S. site or you would say there's no site variability in the evaluation, which is important. So -- and it's centralized reading by the 3 independent radiologists that will be used for the primary endpoint. So we need to wait for that centralized reading. And you would say, the process is such that we are doing those reads in batches, and we're doing that in parallel with the study. So we're not waiting to complete the full study before initiating the evaluation. We are doing that in parallel. So when the last, you would say, batch of patients have been recruited in the study then the radiologist will only review that portion. They have already evaluated in all the previous patients.
Johan Unnerus
analystThat should reduce the risk of wanted and unnecessary the delays I presume. And then a follow up on Oncoral, which is a very interesting proposition. Is there any prospect of -- if there will be any interim readout between '22 and '24?
Magnus Corfitzen
executiveSo at this point, we'd be -- we would say, we have not planned an interim readouts. So I mean, obviously, we move on the patients. We'll do a dose escalation, and we will see what will be the dosing level, the exposure of the active metabolite. And then we'll move into the efficacy portion of the study. So we're not planning on any interim data relaunch.
Johan Unnerus
analystYes. And if I understood it correctly, there are in the industry clinical studies, actually combining LONSURF with standard of care, i.e., irinotecan that will come out eventually. Is that something that you have relevance for your combination as well, even though, of course, the proposition is to have completely different intervals with all the potential benefits that, that could have. But it's interesting, as you -- earlier in this call, you said that they've only been preclinical combination, but we could actually have some results from clinical elsewhere in this combination. That could be interesting. Is that correct?
Magnus Corfitzen
executiveYes, we are aware of some clinical studies that have been initiated with intravenous on irinotecan. What we believe is that this -- the daily dosing have significant benefits. And one thing is that when you have a monotherapy chemotherapeutic, side effects can be quite dramatic. When you combine to chemotherapeutic agents, which is also the case in clinical practice, and it's more difficult than strong safety profile, we're encouraging safety profile we saw in the Phase I study. We think that will be a benefit. Maybe Andreas, do you want to add something here?
Andreas Norlin
executiveI think you are pointing to the most important part here, and that is actually the oral and daily dosing, and that, that makes -- has the potential to make a difference compared to the IV. But it's correct that there is data or studies where they have investigated the combination of irinotecan and trifluridine, which is the active component, I'm not sure. But I think it's the important part for us is it is the all oral daily combo that is -- has the potential to hopefully makes the difference.
Magnus Corfitzen
executiveAnd also with the fact that obviously for a study of this combination, this also points to, say, the complementary mode of action that could hopefully have a very strong effect on the patient treatment.
Johan Unnerus
analystExcellent. So plenty to look forward to in 2022.
Magnus Corfitzen
executiveAbsolutely.
Operator
operatorOkay. And the next question comes from the line of Sten Westerberg from Analysguiden.
Sten Westerberg
analystYes, if I may, shortly briefly get back to this protocol amendment since Orviglance is developed as livers or kidney sparing agent. I mean, could you once again explain why you originally excluded the dialysis patients? That will be my first question. Second question, if your time line for the study is depending or dependent on you reaching 50 recruiting sites or is this change in the protocol should help you get there before the end of the half year?
Magnus Corfitzen
executiveYes. So start with the latter one, whether patient recruitment is dependent on the 50 -- reaching 50 sites. I mean in all through the studies and especially within an orphan disease, it's a huge variability in the, say, in how many patients each site recruit. So some sites have recruited 0 patients to date. So we are working with them to help them get going further. And some have been significantly more productive in recruiting patients. So it's more we're striking the balance between working with the sites that have to do the -- how to recruit patients and support them as much as possible. And then obviously, for the ones that are less productive. We're doing a trade-off in terms of how closely we're working with them, how far they can actually getting productive and getting patients into the study. So the total number of upside is obviously 40 plus. When we go beyond and look in the internal data here on the productivity between the sites, that's much more important in terms of reaching the full recruitment. So you should not see the total number of sites that have been opened up as necessarily a strong predictor for overall recruitment. So on the first one, why did we initially exclude dialysis patients? I would say that it's a very good question. And I could ask you how you should have included them from the very beginning. We did that. We take each -- it's common to do in clinical practice because these patients are, you can say the most sick patients and that's why you would expect more complications. And it's also in terms of the measurements because of the dialysis process, where the blood is filtered by external dilator, you would say measuring levels and all of those parameters gets more complicated. And that's why we initially said we will not include these patients. We will do some of them, a small subset to just validate the safety in dialysis patients as well, but not in the bulk of the study. And what we're doing now is that we open up so that there is no limit on dialysis patients in the study.
Sten Westerberg
analystOkay. I understand this trade-off between safety and recruitment, but that, I mean, would you agree that -- the risk or the risk level of the study is increased by including these dialysis patients?
Magnus Corfitzen
executiveNo. Well, I don't think so. And that's based on what we have learned so far. So I think that's not a -- I don't see an increased risk in the study from this. It is more when we started out, there was a lot of things we didn't know. Now we've learned quite a bit an inclusion here. We don't see that as adding to the risk profile.
Operator
operatorAnd there are no further audio questions. I'll hand it back to the speakers.
Magnus Corfitzen
executiveYes. So thank you, everybody, for listening into our quarterly report presentation here. So we are making good progress, and I think a good news flow in the fourth quarter and working very hard on the key priorities and milestones here, and we'll continue to update you on the progress that we are making. So thank you, everybody, and have a good day.
Operator
operatorThis concludes our conference call. Thank you all for attending. You may now disconnect your lines.
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