Bergenbio ASA

OSE:BGBIO

Earnings Call Transcript 2021-Q3

[Martin Olin, Chief Executive Officer]

Yes. So good morning, everyone, and welcome to the Q3 2021 Report Highlights and the Financial for BerGenBio. Today, the management team -- or this part of the management team will be present for the presentation. It will be myself. I'm Martin Olin, the CEO of BerGenBio; Rune Skeie, our CFO; and Nigel McCracken, our CSO.Yes. So just to remind everyone about the formalities, the forward-looking statement disclaimer. I wouldn't spend too much time on that.So the agenda for today is that I will go through the Q3 and the recent highlights. I'll touch a little bit upon the update on our AXL inhibitor programs, specifically bemcentinib and its potential in AML, non-small cell lung cancer and COVID. I'll also give an update on tilvestamab. Rune will take you through the financial report, and we will summarize the position of BerGenBio at the end of today's meeting.So summarizing the Q3 recent highlights. As some of you may have noticed, we have presented very exciting data in non-small cell lung cancer, specifically for patients harboring the STK11 mutation. These are preclinical data presented by Southwestern University in the U.S., they're really exciting, and I will get back to those.In AML, we presented at EHA, data indicating that bemcentinib plus LDAC combination is active and well tolerated in relapsed elderly AML patients that are unfit for intensive chemotherapy. Regarding our COVID data, we had a late-breaking abstracts that were presented at ECCMID, which demonstrate encouraging evidence of bemcentinib in hospitalized patients receiving steroids or remdesivir. These are patients who require oxygen, and I'll also come back to that.So just to summarize the perspective on AXL. In a normal situation, in a healthy environment, there's a very low expression of AXL in tissue. But in aggressive diseases like cancer, AXL is upregulated and the signaling strongly is associated with cancer progression, immune evasion and drug resistance and metastasis.In the viral infection setting, it is known that AXL mediates the viral entry into cells and dampening of the immune cell response. Bemcentinib is really well positioned around the exploration of the AXL target. We have 2 compounds. One is tilvestamab targeted in the extracellular part of the AXL receptor, replacing or displacing the GAS6 ligand and also on the intracellular part with bemcentinib, really working on a number of pathways that are relevant in aggressive diseases.To summarize bemcentinib, small molecule or once-a-day pill size 0 capsule. We believe that bemcentinib has a very favorable benefit risk profile. It combines well with other drugs. It is in several Phase II studies in AML, MDS, non-small cell lung cancer and COVID. Tilvestamab, our early clinical program, a humanized antibody displacing GAS6, is -- has completed Phase Ia in healthy volunteers, and we are currently in a Phase Ib dose escalation trial to confirm the PK and PD data.This is a snapshot of the clinical programs, which really signals by large, that the Phase II clinical activities on bemcentinib in several indications are coming to an end in terms of the enrollment in the Phase II activities. So this is the COVID trial, the AML, the MDS, as monotherapy; bemcentinib in combination with LDAC in second-line AML; and bemcentinib in combination with pembrolizumab in refractory non-small cell lung cancer second-line.We are still enrolling patients in the last activity -- or the last clinical study in second-line non-small cell lung cancer, which is checkpoint inhibitors plus chemo refractory patients, which is the Cohort C. And tilvestamab, as I said, is in a Phase Ib dose escalation study. So the company is actually at a point now where it is to conclude what are the next relevant steps in each of the indications. And I'll take you through that.So the role of bemcentinib in AML, well, despite a number of recent approvals in AML, the relapsed and refractory second-line patients still are facing a significant unmet medical need. There's actually no treatments today that actually makes a difference in terms of overall survival, which we believe will -- is the golden standard in this setting.We have very encouraging early data, though, from the 003 study, which is now fully enrolled in the relapsed patients that are unfit for intensive chemotherapy. The FDA has recognized, the unmet medical need has granted BerGenBio an Orphan Drug designation, but also a Fast Track designation. And the next step is to conduct a randomized placebo-controlled trial in relapse second-line AML, which we look to initiate in the second half of 2022.So just picking up a little bit on the market opportunity in the situation. It's still a pure prognosis situation once you relapse from first-line. First-line has evolved with the introduction of venetoclax and other therapies. Venetoclax is probably becoming the standard in first-line therapy. But once you relapse on first-line therapy, there's actually no good treatments, although there are a number of at least above 50 drugs that are being explored in the second-line setting. We don't see that none of these will really change the landscape significantly. But also the thing to keep in mind is that these new modalities are premium-priced novel therapies that are actually going to increase the revenue opportunity in AML from around 1.5 billion in 2019 to over 5 billion in 2029.So if we look at the treatment landscape and the standard of care, it's pretty similar in the U.S. and Europe. For those patients who are unfit for chemotherapy and have relapsed on first-line therapy, that would be low dose chemotherapy on HMA agent plus/minus venetoclax. Once they progress or relapse or become refractory, there is very, very little opportunities for treatment.And as you can see on the right-hand side, once you become relapsed, you're looking at a median overall survival of less than 6 months. And we believe that bemcentinib, in combination with LDAC, it's a really nice opportunity there. Just to remind everyone about the clinical program that we have undertaken. So we did the Phase I. We did the Phase II expansion cohorts, monotherapy, AML. Cohort B2 and B5 is the combination with LDAC therapy. B3 is combination with decitabine in ND and relapsed AML and then the monotherapy in MDS. And the current analysis is that the strongest signal is in the Cohort B2 and B5.So the combination of bemcentinib plus LDAC really shows encouraging, non-matured, the median overall survival benefits. As you can see on the left-hand side here, these are non-matured data. While still extremely relevant, we will look to mature it. Very encouraging median and overall survival benefits at this point of more than doubling towards the standard of care, and survival rates at 6 months is actually above 60%, which is also really encouraging. This is a data cut off of the 28th of this year, and the patient population total is an n of 18.So the summary of bemcentinib in AML is, there is still a significant unmet medical need in the relapsed and refractory second-line AML. Bemcentinib mediates an anti-AML immune response through activity of the NK and T cells. It's well tolerated, both as monotherapy and combination therapy and in acute -- and that actually accumulates very well in the bone marrow tissue, which is extremely relevant for this indication.We have encouraging non-matured though median overall survival benefit in the second-line relapsed patients, which are unfit for chemotherapy, quite a large population. We have a Orphan Drug designation and a Fast Track by the U.S. FDA in that specific population. And the next step for us will naturally be to conduct a confirmatory randomized placebo-controlled trial in the second half of 2022.Moving to non-small cell lung cancer. Well, it's by no means the largest -- it is the largest oncology indication with the evolving landscape. High unmet medical needs, especially for the refractory population. One needs to consider that non-small cell lung cancer is not one disease, but it's actually several diseases, in one disease by -- driven by mutational drivers. I'll come back to that. The 008 Cohort B2 is now fully enrolled, and we expect the data to mature in the first half of next year.Very exciting. Recent data indicates that in STK11 mutations, which is about 20% of the first-line population, and reported to be approved prognostic factor, bemcentinib seems to reverse the anti-PD-1 and PD-1 blockade. And we actually have encouraging data from the 008 study, which was not designed to specifically pick up those patients. So this is a retrospective identification of the patients who have that mutation. And we will come back to the data.We are in the process of securing valuable rights in the form of an exclusive license to the STK11 mutation. And the FDA has recently granted us Orphan Drug designation and Fast Track as well. The next step will be to conduct the Phase Ib trial in the first-line STK11 mutation patients in the first half of next year.So this is a simple schematics of the treatment landscape in non-small cell lung cancer. So on the left-hand side, you have the molecular driven patients, where targeted therapies against EGF, ALK, BRAF and other mutations are becoming the standard of care. And if you have a non-molecular driven situation, you'll pretty much be on PD-1 or PD-L1 therapy. And the unmet medical need still exist in the refractory population, as indicated with the red square.This is the summary of the 008 trial. The Cohort A has been fully enrolled, and we have announced the data analysis. Cohort B, we have recently completed the enrollment, and once the data has matured we will report back. Cohort C is still pending the inclusion of the last patients.The exciting thing for BerGenBio is that preclinical data announced by UT Southwestern Medical Center in Texas, indicates or suggest that bemcentinib reached towards PD-1 blockade sensitivity through the expansion of TCF1 and CD8 cells on the dendritic cells. It's very hard to see all the details. But the data really suggests that bemcentinib restores the sensitivity to PD-1 blockade.And when we look at the clinical evidence in a retrospective way, there are several clinical studies that suggest that STK11 mutations are associated with shorter, median progression-free survival and median overall survival. And also with a pure response, this is about 400 patients. And what you will see is, on average, a response rate of less than 5%.There's also evidence that the STK11 mutations do not benefit from the combination of pembrolizumab or chemotherapy. This is a pretty significant study where data published show that in around 400 patients, the STK11 mutation part, about 100 patients, so about 20% actually, does not actually get any benefit of the combination of pembrolizumab over chemotherapy. So this all suggests that the STK11 mutation population is a relevant subgroup, which will be a new molecular driver opportunity in the first-line setting.And because of the data we have, both on the preclinical side, but also on the early clinical side, which is 3 out of 3 patients who show clinical benefit from the 008 trial. This is a unique opportunity. And just to give an idea of what the opportunity is, there is prior evidence that once you identify a subset of an actionable mutation in first-line setting, you are looking at a significant market opportunity, and this is just an example. And I do want to remind that the STK11 mutation is reported to be up to 20% of first-line patients.So the summary of bemcentinib in non-small cell lung cancer is there is still an unmet medical need in the second-line population and specifically also in the first-line on non-actionable mutations. The data from the 008 trial, specifically the Cohort B is not yet mature, but we will, of course, expect that to mature in the next 4 to 6 months, I would say, we know from the preclinical data that bemcentinib to the dendritic cell actually expand the TFC1 and the CD8 cells and potentially restores the PD-1 blockade sensitivity.And we have quite encouraging data, although it's only 3 patients, but they all have clinical response. We believe that the STK11 opportunity is significant, and we actually do see a nice potential for the combination of bemcentinib plus an anti-PD-1 or PD-L1 therapy. We have an Orphan Drug designation and actually 2x Fast Track by the FDA in non-small cell lung cancer for non-actionable mutations.The next step also is naturally to mature the data in the 008 trial in the second-line opportunity of the refractory setting and commence a Phase Ib trial in first-line non-small cell lung cancer for STK11 mutation patients, which we look forward to initiate in the first half of 2022.Moving on to COVID-19. So despite the rapidly evolving landscape, the unmet medical need for patients who are hospitalized and requiring oxygen, in our opinion, still remains. And we don't think that any of the recent approval drugs will change that picture. People will still get hospitalized. And once you are hospitalized and now on oxygen, may be require ventilation. There's actually no good treatments in the current environment, and we don't think that there is anything in the horizon that will change that.The modulatory effect of bemcentinib, which is the impact on the immune system, the inflammation dampening and the viral entry provides a strong rationale in respiratory infections like COVID-19, the clinical data from 179 patients validate the potential of bemcentinib for that severe setting in hospitalized patients. And the next step is to conduct a confirmatory randomized placebo trial through a sponsored platform, which actually enable BerGenBio to access a significant number of sites across Europe at a reduced cost.So this is just a schematic picture of the evolvement of patients. So once you have been exposed to COVID, some people get mild responses, some get severe disease situations. And once you are hospitalized, if you have a response that is not actionable, you require oxygen and you get into ventilation.There are currently no treatments. I mean there are steroids and remdesivir, but that really does not change the situation. So this is a high met -- high unmet medical need. The rational for bemcentinib through the inhibition of AXL is very strong. The preclinical evidence on the viral entry, the effect on the innate immune response, the dampening of the inflammation and also the clinical picture, which is data that has been reported previously by BerGenBio, which clearly shows that there is a benefit in hospitalized setting. So that will be to discharge the patients requiring oxygen before they are in ventilation and potentially also reducing the number of death events.So in summary, we believe that there is still an unmet medical need in hospitalized setting of patients who require oxygen. There is a very strong scientific and clinical rationale for the utility of bemcentinib in severe respiratory infections, including the COVID-19. And the next step is to do a confirmatory randomized placebo study, utilizing a sponsored platform, which is really the key here. So we can do this at a reduced cost, but also at a higher speed than we would otherwise be able to do, and we look to initiate the study in the first half of 2022.On tilvestamab, just a short update. It's a humanized antibody, binds to AXL and blocks the signaling, high affinity, around 500 picomolar displaces the GAS6. We have completed a Phase I a safety study in 24 healthy volunteers with no DLT's, and we are currently in the Phase Ib dose escalation study at 5 milligrams per kilogram, seeing no DLTs, and we're looking to confirm the safety in the pharmacokinetics data. Secondary endpoints are PD, ORR, PFS, DCR and the compensated AXL score. And we believe we'll be able to finalize this study in the next month.So the summary is that, we are on track with it. 5 milligrams per kilogram is the current dosing activity with no DLT. We, of course, do the biopsy to evaluate the clinical response. And the next step is to continue the preclinical evaluation and completion of the trial before doing anything further on tilvestamab. That's the highlights before we go into the financial update. So I'll hand over to Rune.

[Rune Skeie, Chief Financial Officer]

Thank you, Martin. My name is Rune Skeie, I'm the CFO in BerGenBio, and I will give you an update on the key financial for the third quarter. We're reporting operating loss of NOK 71 million in the quarter, back on a level a year ago. We had a peak in the operating expenses in the last 2 quarters, correlating with significant recruitment in clinical trials. And as Martin reported just recently, we -- many of those trials are now fully enrolled, and the expenses is reduced.R&D part of the operating expenses is on a high level. So we are well-managed on overhead costs. So year-to-date, we have around 80% of all expenses related to research and development.Cash flow also back on an average level after a peak in the last 2 quarters, we're burning around NOK 60 million a quarter. And we ended the quarter with a cash position of NOK 509 million.Just to remind you on our analyst coverage. So there are a transfer of coverage in Edison to Sean Conroy just recently. And our next financial report will be 16th of February 2022, which we will publish the Q4. So key takeaway for financial is that we are back on an average level on the cost base, and we still have a strong cash position.I'll hand it back to you, Martin, to summarize.

[Martin Olin, Chief Executive Officer]

Thank you, Rune. Yes. So I'll just summarize the highlights of positioning BerGenBio for success. In AML, we have really encouraging data in the relapsed setting, in second-line AML with patients that -- whether has a high unmet medical need. We have a designation from the FDA, both from an Orphan Drug perspective, but also Fast Track, and we will position the compound bemcentinib for a confirmatory randomized placebo-controlled study in the second half of '22.Non-small cell lung cancer 008, is now fully enrolled in the Cohort B, and we look to mature the data. In the first half of 2022 with the natural inflection point of we either pursue it or we don't. So we will need to wait for the data.We have identified a significant first-line opportunity, the STK11 mutation, where we believe that the preclinical and clinical data, plus the reporting of the poor prognostic actually justifies an opportunity for bemcentinib. In that setting, we have an Orphan Drug designation by the FDA and also a Fast Track for this setting. And we are positioning bemcentinib for a Phase Ib trial in that population in the first half of next year.COVID-19. Well, the medical need remains. We have encouraging Phase II data, bemcentinib in COVID, and we are positioning bemcentinib for a confirmatory randomized placebo controls trial in the beginning of next year.So this is a summary of BerGenBio and the investment highlights. We believe we are the world leaders in exploring the AXL biology as a mediator of aggressive diseases. We have 2 first in class selective AXL inhibitors: bemcentinib, which is oral, once-a-day capsule; tilvestamab, a humanized function blocking antibody. We have a diversified late-stage clinical pipeline.So entering into confirmatory trials in AML, second-line, of relapsed patients, non-small cell lung cancer, 2 shots at go. One is the second-line opportunity or the refractory setting and the STK11 opportunity in first-line, COVID-19 hospitalized patients. We have still have a strong balance sheet with about NOK 500 million and experienced R&D team to bring the compounds forward, hopefully, into registration at some point.That was the presentation for today. Thank you very much.

[Rune Skeie, Chief Financial Officer]

Open up for questions.

[Martin Olin, Chief Executive Officer]

So we can open up for questions.

[Unknown Analyst]

Yes. Okay. Thank you for a good presentation. So I have some questions regarding the COVID-19 strategy that you've been talking about. So 2-part question. You talked about the sponsored study. Is this going to be kind of like what we have seen with the RECOVERY before? Or it's an established international study where new drugs can be included? Or is it something that you are going to initiate, but invite centers in Europe?

[Martin Olin, Chief Executive Officer]

So this -- it's a good question. So this will be conducted through an established platform activity. So it's not something that we will be inviting centers to do. It's an established setup, a structure with an extremely experienced team behind it who is sponsored.

[Unknown Analyst]

And for the second part of the question. So Merck and Pfizer has seen oral antivirals in mild to moderate patients. Does that mean that you're kind of positioning yourself to -- in the part where those are not -- no longer effective if you need to take them from an early onset?

[Martin Olin, Chief Executive Officer]

Well, I think that the Pfizer and the Merck compounds are basically pre-hospitalized treatments, which is not the target population that we are addressing. So we believe that the bemcentinib impact is strongest in the hospitalized patients who are on oxygen or requiring oxygen. And we don't see that any of those compounds will change that nature. I mean it might prevent some people to be hospitalized. But we have to remind ourselves that only in [ sero ], we can get a 100% vaccination in the population or people taking the compound. So there will be people who will get hospitalized. And we have to remind ourselves that we're talking about a viral infection, which will continue at least for some time.

[Unknown Analyst]

And then I have a question for a Phase b (sic) [ Phase Ib ] study in non-small cell lung cancer in the STK11, where you are initiating of -- yes, Phase Ib and instead of adding maybe another cohort to their ongoing Phase II study? Is this because you are -- are you looking to do some dose exploration there in that study as well?

[Martin Olin, Chief Executive Officer]

Yes. I mean it will be a safety part as well because I think we -- as we don't have the evidence in the clinical setting of the triple combination with bem, chemo and PD-1 inhibitor. So we will need to do that, but we will do it in the specific population with the opportunity. I mean it's a recognized medical need, which is also why the FDA has branded us the Orphan Drug and Fast Track designation. So we will be looking to talk to the authorities or the regulatory agencies about how to best bring forward bemcentinib in that setting.

[Rune Skeie, Chief Financial Officer]

We have some online questions as well. So the first question is, you mentioned in the Q3 report that you have received input from the FDA on a view on dose selection and dose findings in oncology. Can you elaborate on how this will -- this input will impact the clinical development program going forward? Will you have to do more dose findings in order to proceed or can we just add a higher dose or low-dose cohort to some of the trials going forward?

[Martin Olin, Chief Executive Officer]

Yes. I will hand that over to Nigel, who will answer that question.

[Nigel McCracken, Chief Scientific Officer]

That's a very good question. And if you remember, most oncology compounds that are developed with respect to the dose, it's always been around a maximum tolerated dose, which is usually based on the DLT. It's very interesting that this year around June time, the FDA Pink Sheet, where they were really sort of concentrating on and being a little bit tougher with oncology studies around the dose optimization. People who have worked outside of oncology, you're used to doing a randomized Phase IIb dose range finding study where you're looking to see saturation or target engagement, and you're looking to show that as respect to the dose. It's not always on that maximum tolerated dose. And certainly, from the FDA, they're trying to certainly bring that same type of scrutiny into an oncology setting, and particularly any indications where it's non-refractory.So to answer the question, we're planning to go to the FDA in the first half -- certainly, January time to have a discussion with the FDA with information around -- or dose around the target engagement, or biological target saturation, proposing, as we'll found out, in combination, we're planning to go with a couple of doses and we'll be in discussions with the FDA of how we -- and not placebo randomized control setting, how we can progress quickly into that pivotal study.

[Rune Skeie, Chief Financial Officer]

Then we have some question about the STK11 mutation in the lung cancer. So regarding the STK11 mutation, you mentioned that around 20% of the patient with non-small cell lung cancer has this mutation. In order to respond to bemcentinib, do they need to have related AXL as well? And in that case, how large portion of patient with STK11 are expected to have high AXL level?

[Martin Olin, Chief Executive Officer]

That's a very good question. Nigel?

[Nigel McCracken, Chief Scientific Officer]

No, that's a very good question. As you know, within our current lung studies, we've been measuring composite AXL score, but we've seen some nice data from that. I think Martin had mentioned, we had seen some encouraging data in with STK11 mutated patients. There were 3 evaluable patients that we specifically looked at. Certainly, we've got encouraging clinical sort of response on that. But these are small numbers. And certainly, moving forward, as part of that Ib study, we will be looking at the composite AXL scores in relation to the STK11 mutation as well.

[Martin Olin, Chief Executive Officer]

So we have not defined the threshold yet?

[Nigel McCracken, Chief Scientific Officer]

Exactly. We haven't defined the threshold. Although the thresholds have been defined certainly in the second-line settings, but that will need to be done within that first-line setting as well.

[Rune Skeie, Chief Financial Officer]

One more question about STK11. On STK11 on the planned trial, can the patient have other mutation as well to be included in the trial. How common is it that patient have several mutation at the same time?

[Nigel McCracken, Chief Scientific Officer]

Certainly, with the STK11 mutations, KRAS and P53 mutation seem to be associated with that. I think, as Martin mentioned, it's certainly in that first-line setting. The nice thing around STK11, it's on this foundation panels that's on the garden panels. So it's something certainly that people are sequenced, certainly, in the U.S. where all of the driver mutations are sequenced, and it really just depends on what the driver mutation is and where the placement of that patient is. But to your point, KRAS and P53 is associated with STK11 mutations.

[Rune Skeie, Chief Financial Officer]

One more question about STK11. So on the Phase Ib for one first-line, non-small cell lung cancer with STK11, will you be looking at a combination with a PD-1 or PD-1 plus chemo?

[Nigel McCracken, Chief Scientific Officer]

Yes. Again, another great question. What we will be planning to do, as we found out, we seem to have some utility in combination with PD-1. The PD-L1, there's a lot of information out there to say that it would have the same sort of effect. But going forward, certainly in the Ib study, we would plan to do a combination with chemo and PD-1. That's what the plan would be. And as Martin said, because it's in combination, we would need to actually define what the appropriate dose would be, and that would be part of that actual study.

[Rune Skeie, Chief Financial Officer]

So one question about COVID. Could you be more specific on what a major multinational collaboration is?

[Martin Olin, Chief Executive Officer]

Not until we have signed the agreement, unfortunately.

[Rune Skeie, Chief Financial Officer]

A question about AML. The confirmatory randomized clinical trial in AML, plan to start in second half 2022. Will you be able to file for approval based on that trial? Can you say anything on size and scope for that trial and the potential time line for completing that trial?

[Martin Olin, Chief Executive Officer]

It's a very good question. So one of the main drivers of our enthusiasm, but also the discussion we will have with the FDA is the clinical benefit in reality measured by the median overall survival. If it continues to look as promising as it does today, I'm very positive that we can have a open dialogue with the regulatory agencies about a pivotal design. If we are at a lower clinical benefit level, we will have to discuss with the FDA what the trial design would look like. But certainly, at this point, we would be looking to get into a confirmatory study design.

[Rune Skeie, Chief Financial Officer]

One question about biomarker and companion diagnostic. So what is the status of soluble AXL and composite AXL to measure the AXL level of the possible patients?

[Nigel McCracken, Chief Scientific Officer]

With respect to the AML, as you may know, we have been extensively measuring protein levels utilizing the myriad panel. What we've been able to do in the 003 study as we believe we've identified a biomarker panel, which looks very promising, which we want to basically test within -- initially within that initial IIb study that will go with AML with the potential of actually taking that forward as a potential sort of stratification. Not necessary stratification, but just to identify that patient population who would potentially respond to a greater extent.But as I mentioned before, with respect to the lung, we believe from the composite actual scoring, we've seen some really nice data, and we feel that we have something to take forward if we were into that second-line. But again, moving to that STK11 because we have a defined mutation, we already have that sort of population already segmented. So it will be a lot easier. And the nice thing, as I mentioned to you before, that STK11 mutation is actually on a clear panel, which is available, which is not something that we need to develop.

[Rune Skeie, Chief Financial Officer]

And it's a question about tilvestamab clinical trial. So when is the tilvestamab clinical trial result estimated to be updated and when is the ovarian trial expanded?

[Martin Olin, Chief Executive Officer]

So that all depends on when we have the patients enrolled, we are now at 5 milligrams per kilogram, and we would be looking to go further up according to the defined plan, it's too early to say, basically, when we will be looking to that, but it's certainly our expectation that we would be able to do that in the first half of 2022.

[Rune Skeie, Chief Financial Officer]

And one follow-up question on the AML clinical trial. So can you comment on when you believe such a trial could read out data, assuming that the trial starts as planned in the second half 2022?

[Martin Olin, Chief Executive Officer]

It's a very, very good question, but it's too early to answer that. I think it will be relevant to come back to the market once we have had the interaction with the regulatory agencies about the design, the statistical analysis and the number of patients required for an approval.

[Rune Skeie, Chief Financial Officer]

And that completes the Q&A session.

[Martin Olin, Chief Executive Officer]

Okay. Thanks, everyone, for attending. Have a nice day.