Medivir AB (publ) (MVIR) Earnings Call Transcript & Summary

Thank you, and good afternoon, good morning, everyone, to the Medivir Q3 report. We are thrilled to sort of walk you through sort of the events of the past quarter. We've seen a lot of progress in our lead asset, fostrox and especially over the last couple of weeks. So we look forward to going through the bigger events, as we aim to bring the first oral liver-targeted treatment for patients with advanced liver cancer to market. In terms of key events during the past quarter. As we have presented earlier, in September, at the ESMO Congress, we presented sort of the mature dataset from an efficacy point of view confirming the promise of improved outcome of the combination with fostrox and LENVIMA showing, among other things, a 10.9 months, sort of mature dataset with regards to time to progression, sort of substantially longer than what can be expected with current treatment alternatives in second line, sort of further strengthening our belief in the combination as a treatment option for the future. Pia will go through in a bit more detail what we shared at ESMO and feedback we received from the scientific community, et cetera. Secondly, and importantly, earlier this week, we were able to announce the clinical trial collaboration that we have now signed with Eisai further validating the potential for the combination of fostrox+LENVIMA, as part of this agreement, then we'll talk about that a little bit further. We will form a joint development committee with Eisai, and we are very pleased to be working with them moving forward while still retaining the full rights to the asset. And thirdly and equally importantly, we had our monotherapy data published in the journal of hepatocellular carcinoma, highlighting to the world the proof of concept of fostrox as a liver-targeted treatment for cancer in the liver. So it's been a good quarter. In the room with me today, apart from myself, Pia Baumann, our Chief Medical Officer, will be going through our experience and data from ESMO. And part of the -- and Magnus will, of course, as our CFO, go through the financial highlights; and Fredrik Öberg, our CSO, is with us in the room for the Q&A session as well. So with that, let's look back and take us back a couple of months to the exciting data presentations that we had at ESMO. Pia?

Thank you. So we now have mature data. We have in this study that was presented at ESMO an median time of follow-up of 10.5 months. And this is the combination with fostrox and LENVIMA. And as Jens already said, we presented it, and it really confirms what we have shown before about the promise of efficacy. So we can go to the next slide. So at ESMO and the data that was presented there, I would just start to say were all mainly focused on first-line treatment in advanced liver cancer. And one of those who presented this pointed really out, but there are now 8 different regimens in the first-line setting and none on those who were there really know what to do after, why the focus should really be on second-line treatment and beyond. And one of the investigators in our ongoing study, Dr. Chon from Korea has certainly focused on second line and have recently, in several publications, provided data -- real-world data from his clinic for LENVIMA monotherapy in second line. So in order to put our data that we have presented at ESMO but also at ESMO GI, from fostrox in combination with LENVIMA into the context, we invited Dr. Chon to Webex during ESMO which some of you attended, where he shared his experience from treating patients on LENVIMA as monotherapy at his clinic and compared those data with the outcome of patients treated with fostrox+LENVIMA in our study. So just as a reminder, I know we have shown this before. The fostrox+LENVIMA study consisted of, first, dose escalation part followed by dose expansion part, where we ended up in the dose of 30-milligram fostrox that is taken orally once daily for 5 days in the 21-day cycle, together with LENVIMA that is taken once daily without stopping at the full standard doses. And the patients were recruited at several different sites, 15 sites across Europe as well as Asia. We can go to next slide. So I've already said that, that we have a mature median follow-up. So at the medium time, our follow-up was 10.5 months from this study. The median time to progression is now almost 11 months with a response rate of 24% and a disease control rate of 81%. And what is very interesting is that the patient in this study has been staying much longer than what we expected, with 3 patients still ongoing in the study and 1 patient still in response after 2 years of treatment. So when we talked about this data at ESMO, they generated very positive response in the scientific community. And this also generated an increased interest in participating in the upcoming and planned Phase IIb study. So with this median time of progression of 10.9 months, we can go to the next slide, which is substantially longer, it compares favorable with all other relevant data sets in second line HEC. And what you can see to the right on this slide is 13 second-line studies where we can see a medium time to progression around 4 months. And this is regardless if it is with LENVIMA after an mono or with other kinase inhibitor or with immunotherapy combinations. So as already mentioned, we had this Webex, which was giving you the context and where Dr. Chon showed data from his publication when he compared sorafenib and lenvatinib in a relatively large dataset. This is a real-world study where he could show that lenvatinib was significantly better than sorafenib. But what he also did was we took the lenvatinib data monotherapy lenvatinib and compared the data with the Phase 1b to a fostrox+LENVIMA study, which he is an investigator in, and that is what we discussed at this Webex. So we can go to next slide. What he showed them was that regardless, if we look at time to progression, if we look at response rate or disease control rate, as you can see here, the difference, the results with fostrox+LENVIMA signaled superiority in the second line. And according to his clinical experience, the response rate of LENVIMA alone is not higher than 10% and the time to progression is usually somewhere around 4 months while a TPP of almost 11 months was very impressive. So -- but in order to get this kind of efficacy, Dr. Chon also has presented safety data from the fostrox+LENVIMA study, our study at ESMO GI in June, where he really focused on the safety tolerability profile and biopsies taken earlier, we have shown this earlier from a patient treated with fostrox either as monotherapy or in combination with LENVIMA shows that fostrox selectively kills tumor cells in the liver while sparing the normal cells. So this is what we saw, right? But we need to also look in the clinic is this true also in the clinic. Can we look at parameters in the liver that could confirm this? And we did so. We confirmed in an analysis where liver enzymes and other laboratory data, in this case ALBI score that these laboratory data determines the liver function, and they were stable during the treatment period, and which means that we preserve the liver functions, which enables an opportunity for durable efficacy. One additional tolerability parameter really, really important for staying on treatment long term, is that the impact of platelets and neutrophils that we have shown earlier, we expect it to impact them somewhat, but we could see in the analysis that these values were stable during time. And here, you can see a 10-month follow-up where we have added all the laboratory analysis. So despite measuring the neutrophils and thrombocytes 4x per treatment for all the patients, during all our treatment cycles, very few measurements showed a level of Grade 3 or more. That is the only sort of measurement that you can see below the orange line here. And this again enable patients to stay on treatment long term. And these data were presented at ESMO together with a mature efficacy data set that we talked about. And all of this data can be found on Medivir's website. So what else have we been doing? We were recently at the International Liver Cancer Association's Annual Meeting, ILCA, in Toronto in October, and we were there also to understand the most recent development and potential for upcoming changes in the treatment landscape and to meet with global expert and as well as potential investigator in the planned Phase IIb study. And what was -- what we can say was that it was a huge interest in meeting us and discuss our data and understand more about the upcoming study. What is also important to understand when it comes to second line HCC, I already said that, but I need to repeat it again was that there were no data in second-line HCC, confirming the high need of alternatives in this patient population. Also at ILCA, the main focus was sort of trying to find our systemic treatment in addition to surgery in earlier stage and to other local treatment as in intermediate stage could be a viable option. But none of this is ready for implementation. So no change around earlier sort of stages of HCC patients that potentially could impact the development of fostrox+LENVIMA. So the overall takeaway is that it is important to see new second-line treatment and that the development of fostrox+LENVIMA gained substantial interest and is considered, really considered, as a new promising new option. So Jens already said that, and we are excited about the combination, but we have also published a clinical proof of concept with fostrox as monotherapy in general hepatocellular carcinoma and the results from this study show that fostrox was safe and tolerable with preliminary antitumor activity, and it confirmed the liver targeted and selective mechanism of action, as I already said, with the biopsies. So the next step is the randomized Phase II study. That is really designed with the proper statistical power to show efficacy benefit on overall response rate as the primary end point. And this is an endpoint that FDA accept for a potential accelerated approval. And the aim is also to study -- to use this study to file for breakthrough therapy designation and to initiate and accelerate the approval process. And before I leave it to Jens, I think that this study, we really have the opportunity to truly make a meaningful impact for second line liver cancer patients.

Thank you, Pia. And 1 critical element, clearly, of course, in taking this program forward sort of with a randomized Phase IIb of this sort of size and magnitude is to ensure that we have sort of appropriate sort of clinical trial supply. So we were sort of very sort of happy to be able to announce on Monday that we've now signed a clinical trial collaboration and supply agreement with Eisai. As part of that, they will then, of course, provide drug supply, which would otherwise be quite a significant investment needed to sort of support the full study. While sort of we then, of course, still retain all the rights to the compound. What we will also do is that we will establish a joint development committee with Eisai for the planning and execution of the study. And we are quite happy with sort Eisai of making this commitment with regards to -- because this will -- this generates quite a bit of work on their behalf with regards to sort of supporting the study as we now sort of embark into additional countries in Asia and, including in the U.S., where they have sort of experienced capabilities in the past. So we truly believe that the -- sort of having this sort of joint development with them will sort of further support doing the study in the best possible qualitative way, but also be able to drive with the highest possible speed. So I mean, clearly, we've had sort of discussions with Eisai with regards to sort of their supply. And for them to supply is not sort of always sort of super obvious. I mean they go into this kind of agreement if they think that the kind of the study has an opportunity to deliver on the promise. So the fact that they are engaging both from a supply perspective and they are engaging from a timing perspective sort of further validates the potential of fostrox+LENVIMA in addition to LENVIMA. And clearly, they are the company that knows the best what LENVIMA alone, what benefit that provides. So we're quite happy with the confirmation and the belief in the combination, what the combination can provide on top of LENVIMA. So that means this is yet another step in our preparations for that randomized Phase IIb. And those preparations are proceeding according to plan. And as we've communicated earlier, we sort of that -- we're on track to open an IND in the U.S. before end of the year or in Q4. So things continue to move along quite nicely in the preparations. Just to kind of repeat a little bit in terms of 1 other element that we're seeing sort of a -- Pia talked about sort of the significant unmet medical need. We talk about the lack of treatment options in second line, where there's quite a bit of focus on first line. The other thing we see sort of as also coming fort that the -- unfortunately, there is -- the growth of liver cancer or the incidence growth of liver cancer is not slowing down. If anything, it's actually sort of increasing. So what we see is, and this is in the West and in the East, a growth and a growth that is very much driven by the obesity pandemic and the fatty liver disease that, that causes. So what we foresee is clearly a commercial opportunity that is growing. So when we look to 2030, that commercial opportunity in second-line market alone again, where there are no approved treatment options today, will be valued in excess of SEK 2.5 billion if our treatment duration, if the time to progression we're seeing in the current study with fostrox+LENVIMA, if that carries through when we assume a treatment option in line with that, then the value of that market actually increases further and starts to get close to sort of SEK 4 billion. So the second line liver cancer market alone is clearly a large potential. And then going forward, we can look to move it up in earlier treatment lines, potentially liver metastasis from other tumors. But if we just hone in on second-line liver cancer, where there are no treatment options today, it is a sizable commercial opportunity. And the other part, just wanted to kind of step -- take a step back and reflect on is that in oncology, in general, if you look across tumor types, it's usually quite a competitive landscape. But second-line liver cancer is a bit different. So if I take a bit of time to walk through this slide, on the left-hand side is the current treatment algorithm. And we've talked about this before. I think it's important to emphasize because it isn't changing and there's a window that we have an opportunity to move into. In first line today all patients, I would argue or almost all patients, will receive an immunotherapy combination as a standard of care. Usually, that's Tecentriq Avastin and that's the case since 2021. There is a number of studies ongoing to evaluate other immunotherapy combinations in first line. So there's a number of regimens competing to win in first-line space. But patients who progress on an IO combination, they will move into second line and they will need something different. So rechallenging within immunotherapy isn't a successful way forward. So they will need a different mechanism of action and different approach to killing sort of cancer cells in the second line. And still, there are no approvals. There is no scientific evidence support what to use in second line and the community is somewhat screaming for alternatives because there is a lack of treatment options. So with the combination of fostrox LENVIMA, again, there is an opportunity to move with speed and be the first approved option. Because when you look on the right-hand side of the slide, just kind of highlighting the competitive landscape, then yes, as in the kind of the green field, there are a number of immunotherapies that are evaluated in second line, but we've already seen from ASCO that, that doesn't work. And you can probably try a number of different immunotherapies, and it will still show the same that the rechallenging doesn't work. So if you want to go down a new route with a novel combination with different mechanism of action, we are at the forefront from a development perspective. So again, one of the reasons why we are trying to move with speed and one of the reasons why the external community and the KOLs are pushing us to sort of get to Phase IIb as quickly as we possibly can. So with that, I just kind of summarize things. So in short, kind of summarize this in 4 different buckets. We are developing the first oral liver-targeted treatment. And we've shown that we are able to bring -- sort of deliver the drug locally in the liver and when in the liver, we kill tumor cells and not healthy liver cells. That translates up to the right to quite substantially improved clinical benefit for patients in second-line setting, including a 10 -- 9 months time to progression. And the bottom left, there is an opportunity to move with speed in order to become that first approved treatment option, hence, our planned global Phase IIb in order to, on the bottom right, get first to a market opportunity that is valued at beyond SEK 2.5 billion by the time when we get there. And the other thing that's important is that there is also a -- there is -- we've seen that in the current study, the willingness to recruit patients to the combination is strong, meaning at time of an approval, the resistance to uptake commercially would be very, very low. So with that, Magnus, we move to financials.

Thank you, Jens. Please move to Slide #22, where you can see the financial summery for the quarter 3 and year-to-date September. And as always, we briefly comment on the Q3 result. And all numbers are in million SEK, as usual. The result and cash flow in Q3 is in line with our forecast. The turnover for quarter 3 amounts to around SEK 1 million, which relates a royalty income for Xerclear. Other external expense are higher compared to last year in the quarter and relates to the ongoing combination study. We have still patients ongoing, 3 patients that Pia mentioned. CMC costs and preparations for the next phase of fostrox, as Jens and Pia mentioned earlier. Personnel costs are a little higher and relates foremost to the share saving program that was implemented in Q2 this year. The operating loss for Q3 is minus SEK 46 million, which is higher than last year in the quarter and relates foremost to the clinical and CMC costs and the preparation for the next phase of fostrox. And the cash flow from operating activities in Q3 amounts to minus 33, which is in line with our forecast for the quarter. And also, I would like to mention, in October, we announced the loan facility from Linc AB of maximum SEK 30 million, and we are very satisfied with the support from our major shareholder, Linc. And as stated in the press release, the facility will only be used if needed, as a secondary financing option. Priority will be given to other financing alternatives such as equity financing or a partner indeed. And with our current cash end of September of almost 93 plus the loan facility, we have an estimated cash on rate to Q4 2025 according to the current plan and with current assumptions. And with this, I will hand back over to Jens.

And we will, at this stage, we'll close the presentation for now, and we open the call for Q&A.

[Operator Instructions] The next question comes from Joe Pantginis from H.C. Wainwright.

A couple, if you don't mind. So first, on the Eisai collaboration. I want to talk to certain levels of importance from this with 2 different angles. So first, I guess, if you can't talk numbers, can you talk maybe levels of magnitude? So when you consider the Phase IIb cost of the upcoming randomized study, a, what is the cost of that? But more importantly, what are the potential cost savings that is coming from Eisai supplying lenvatinib?

Well, let's put it this way. Buying -- I mean, we decided -- I'll say the following. I'll take a step back and say that we did consciously decide to buy lenvatinib for the current study because we wanted to have the freedom to use the data as we possibly could, so we know that it's a sizable investment. If we would go out into the open market and buy lenvatinib for the upcoming study, we are looking at sort of cost of USD 15 million to USD 20 million. So it is quite a big sort of saving from our side or investment from Eisai side or however you want to put it. But sort of from a -- in terms of what we would pay, that is actually a cost of USD 15 million to USD 20 million that we don't have to take with this trial supply collaboration.

No, that's very helpful, and I think that's a very important highlight. And then from a logistical standpoint from the collaboration, obviously, you stated you maintain global rights for fostrox. Just curious, does Eisai have any rights of first refusal or rights or first look?

No.

Got it. Very simple. To follow up -- I get that, perfect.

No, I'm not feeling glad. I feel like maybe I could say something more. But no, and that's, hence, the retailing...

That's the perfect answer.

Yes.

You have options, yes. All your options are open, so great. Just a question on the Phase I/IIa data. When you look at the neutrophil data, for example, we believe that's a promising impact. So just curious with the error bars that are there, can you describe were there any rescue treatments, say, Neulasta, Nupogen or the frequency of that happening?

So first of all, I didn't say that because we shortened this a little bit since we have presented data before. We didn't have any febrile neutropenia. We didn't sort of -- we had very few occasions where we had during the full treatment time Grade 3, 4, for example, neutropenia or thrombocytopenia, and I was trying to show that during this duration of time. What you were looking at was 10 months of treatment with all the patients in and all the measurements that we have been doing. And the 1 that was below the orange line, we're the only 1 who was Grade 3, which potentially would lead to dose reduction or treatment interruption, and we only saw that in 6 patients overall over the treatment duration of time. So which means that it is like -- maybe you didn't see that, but it's like a temporary goes down and then goes up again, so you can keep the treatment time and you can keep the dose, which is extremely encouraging in a study like this, where we want to have long-term treatment.

No, that's very helpful, Pia. And my last question, if you don't mind, with regard to the competitive chart that you threw up there sort of looked like a rainbow in a bit a little bit. But I guess there's a little bit of hand waving going on here. But when you look to the future, can you envision, obviously, fostrox has good combinability and you talk about the left side of the chart with the different immunotherapies being not that effective or not effective at all. Could you envision potential combinability with the immunotherapies and the ability to, say, resensitize or any potential mechanisms for combinability that you could look to in the future?

So in theory, because everyone is looking at this, trying to resensitize after you have been resistant to an immunotherapy combination. So that is what is going on right now. You can see that, and it has not been successful as, I think it was Jens or myself has said that. It was a study of regorafenib and pembrolizumab at ASCO, which was negative. So what they're trying to do then is to find something that potentially can do that. And sure, with fostrox's mechanism of action where you can have a higher anti-M presentation, for example, it could, in theory, work. But since we have the strategy of at least initially looking at the second line treatment where you already have used your immunotherapy. That is nothing for the second-line combination, but obviously, in earlier lines or in earlier stages, sure. But our focus is currently on the second line therapy.

Yes. I think if we look ahead, as Pia is alluding to, if we would plan kind of a strategic evolution or life cycle management, it would be logical to combine it, but it would be logical to combine it in first line, maybe tack it on to a Tecentriq Avastin combo as a triple. I think that would be the more logical next step if we were to explore a combination with an IO. So that's kind of our thinking.

Absolutely. But the highest need currently is definitely where there is nothing right now.

The next question comes from [ Hans Englum ] from EVM.

Congratulations to the collaboration with Eisai. It's truly a good industrial deal. It has been hardly covered in media, which is very surprising. But I guess you will do your part on getting them to cover that. In terms of financing, could you elaborate a little on the capital raising process and -- since you are in need of capital to perform the IIb study?

Thank you for the question. What I can say and guide you on is that we -- as we stated, I think, in the press release as well that we are exploring different alternatives now. And of course, we're looking at different scenarios or equity financing. And as Jens has mentioned before, we have mentioned before that we are talking with companies and so on, but we can't guide you anymore at this stage really because if we have a deal, then we will tell you when it's signed. We can't say anything before that. So we're exploring different alternatives at the moment.

And clearly trying to find the -- I mean, the best way forward from a value perspective. So I think that's why I think -- thank you, Joe, for asking the question because we are super happy with the engagement from Eisai and the support for the study while retaining the full rights. And what that means that also retains the full possibility of partnering. So the avenue of partnering is still as open as it used to be before. I would even argue it's actually a better situation for partnering because now we have the support from a clinical trial supply and the USD 15 million, USD 20 million doesn't have to be paid for that. So that's a good step from a partnering discussion. And we are as open to partnering or is able to partner as we were before. The other -- but if you partner -- and this is the obvious one. I know this. But if you partner, yes, that brings in money, but you're also giving away value -- future value, you're giving away rights to the asset. So the other avenue is then clearly to identify sort of, well, equity financing, as Magnus said. And that's also a dialogue, an ongoing dialogues we're having in terms of finding perhaps equity financing that allows us to run the study ourselves in full because clearly, we will have the ability and bandwidth to do so. And if we do and able to secure equity financing, then we retain the full rights and the full future value of the drug. So we are equally open to both avenues, and both avenues are equally available on the back of the Eisai trial collaboration because that takes away a cost that we no longer have to worry about. Any further questions?

The next question comes from Richard Ramanius from Redeye.

Do you have any comments on Biosciences cancellation of their oncology program?

No, not necessarily. I mean, we -- I mean clearly, they've communicated earlier -- when they communicated in -- now I'm trying to remember, December last year, that they were sort of halting some of their oncology programs, and we're waiting for the readout of the combination of their DR5 agonist together with, I believe, FOLFIRI in colorectal cancer, and that would guide them in terms of moving forward. Not sure what details they have shared, but the assumption is that, okay, well, that combination didn't supply them with the data that they were hoping for with regards to moving forward with the DR5 agonist in oncology. And if that's the case, and they are having challenges from a financial viewpoint that they need to focus on 1 area, then it becomes relatively logical for them to then not go ahead with the DR5 agonist. And since the birinapant was to be combined with that in oncology, then it counts as a logical sort of follow-on that they don't continue. We are now having discussions with IGM in terms of what's the impact here, is there an additional -- a continued opportunity for birinapant with them or is that something that we -- that it comes back to us? So we're -- and that could be the case. At the moment, we're just -- we're having conversations with IGM to explore and discuss what's the best way forward for the compound.

Do you think a sublicensing could be an option?

I think it's a bit difficult to speculate until we're done. But in a scenario where sort of they decide that, okay, well, we are going to focus on autoimmunity and they don't see a path for birinapant in autoimmunity, then I think that the more natural step would be that the asset comes back to us and we explore alternative licensing options from our side rather than them sub-licensing. That will be my -- but then I'm -- again, I'm a little bit ahead of it, sort of speculating. We kind of need to sort of follow things through with IGM first. They have -- and just to kind of make a note, just as we have 3 patients on the study in fostrox and lenvatinib, they still have patients sort of on birinapant in -- from their study that they paused. So they have a bit of efforts to do with regards to handling that side of things as well. So -- but discussion is ongoing. And when we come to a conclusion what is the next step, then clearly, we will communicate that as well.

Okay. Going back to the Eisai deal. You just mentioned about USD 15 million to USD 20 million in cost savings. Could we interpret that as you previously mentioned or guided for cost of SEK 1 million to SEK 2 million per patient. So does that mean the trial will likely be at the lower half -- the lower range of that in the future?

I think the -- let's put it this way, the SEK 1 million to SEK 1.5 million is the -- where patients are recruited, where patients are included in the study has -- or probably have a slightly bigger impact on things with regards to sort of countries being sort of different in terms of cost for that. So I wouldn't -- short answer is, no, I don't think it's -- you can't really sort of take the drug element and just apply it to that sort of cost per patient because, I mean, there are many factors in terms of the total cost. But clearly, not having to sort of pay USD 15 million to USD 20 million for the study is an important element. And it is quite an important element with regards to sort of, as I alluded to earlier, in partnering discussions, in equity financing discussions, that is a question that is quite critical when you look at partnering or financing a certain program, if you have an uncertainty of USD 15 million to USD 20 million for a study like this, then that clearly provides a hurdle is maybe the strong word, but it provides a bit of a challenge. So now removing that and also having Eisai part of working with us to deliver the study in the best way possible, it's 2 positives in 1 go to remove some of the uncertainties.

I understand. Last question. Do you intend to provide more readouts from the ongoing Phase IIa study?

Yes. So we are closing the study. And -- but again, we were hopefully close it much earlier, but the patients are still on. So we are not going to leave the patients without treatment since it has been so effective. So that is a process that is ongoing, to find a solution for them. And then we are going to provide treatment data, hopefully somewhere in the beginning of next year.

The next question comes from Klas Palin from Carnegie.

Just to clarify, if I understand you correctly that a local partner deal for fostrox could still be an option for you. Is that correct?

Yes. And again, my argument that -- my point is removing the cost uncertainty of the drug is beneficial for those discussions.

Okay. But such a partner would then be rather a selling company than a developing company? I mean fully fledged pharma is not what we're looking for. You're more or less looking for a seller of drugs?

I mean not necessarily. We're looking for the best potential partner. And that partner -- and the partner is to come in at -- if we go down the partner route, I mean clearly as we said, we need to finance the next phase. Equity financing is one option and retaining the full rights. The other option is partnering with the best potential deal or agreement -- with the best possible agreement. And if we go down that, there's a partnering path now that, with that partner, we also want to work with from a development perspective locally in the country, countries where that deal is to be made. And that includes then also the partners are being part of funding that the global Phase IIb study in the country where they are -- in the country of the agreement to put it that way. So not necessarily only commercialization. But of course, whoever we partner with now will also be the commercializing partner as the next step. Now I'm wondering if I [indiscernible] this one. But I think that it's not just commercialization. Any partner at this stage will clearly have a role to play from a development perspective locally in the country region where that deal is to be made.

Perfect. And out of curiosity licensing deal, was that also on the table with Eisai? If you comment on that?

As I said, again, as Magnus sort of alluded and we've said that we will -- we communicate -- those kind of details we'll communicate when we have something on the table. But for any licensing deal, whether that is with Eisai or with anyone else, the clinical trial supply and the agreement that -- and getting to a point where, okay, well, this is a good study to run, we have supply, et cetera, that is the first step that needs to be taken whether we speak with Eisai or whether we speak with someone else. And clearly, we have had and we continue to have discussions with Eisai. I mean they've committed to these first 2 steps as 1 option. I mean clearly, we want to do the best possible licensing deal. And I think they'll be -- it's good to remove a hurdle that are seen -- that is seen as a hurdle for other companies. So that can we do that first, and then you get to a point where you get into more kind of licensing sort of detailed discussions. It potentially opens up the possibility to other companies as well. Now I'm wondering if that sounded a bit wobbly.

No, a very good answer.

The next questions comes from Hans [indiscernible] from EVM.

Hans here again. Yes, I just wanted to know when will you decide on the size to be in number of patients, when you think that will be done?

I mean it's more or less done according to the assumptions that we have. We have designed a study where we have sort of a statistical prerequisite for doing what we would like to do when it comes to, as I said, potential accelerated approval opportunity and so on. Then obviously, this is partly an adaptive design. So depending on the results going forward, we might increase the number of patients, but that is a later decision and it's only driven by already set statistical decisions. So it's -- yes, I can't say more than that currently, but it's -- the design is already set.

Yes. And if I -- I'll add to that, Pia, because clearly, -- we know what the study looks. Pia and the team has done quite -- sort of extends their work from a statistical viewpoint, engaging with the steering committee. The steering committee is super engaged. So have a very good view and a very sort of good proposal that we theoretically could share in detail here today. But that we will share when the IND is open. So clearly, we are super confident that sort of what we have proposed will fly with the FDA, but we just kind of need to go through the process of having the IND open because that's the date when we know that, okay, all is good. So rather than sort of sharing something that might sort of change minor, minor, then let's make sure we communicate when we have that finalized. And as I said, the plan to open the IND and the preparations to open the IND in -- this year is progressing nicely.

There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.

Okay. Thank you, everyone, for listening in. Thank you, everyone for engaging with questions, a lot of questions, which we appreciate a lot. To just kind of summarize, I'll go back to this slide that I showed before. Feels a bit repetitive at times, but I guess that repetition is always good. One, we have -- we are doing what no one else is doing. And I think that's quite important to emphasize with regards to bringing a targeted or a liver-targeted treatment to patients with advanced liver cancer. And since these patients sort of -- they succumb to sort of complications from their primary tumor. So the more effective treatment, tumor killing treatment you can do locally and deliver, the better. And we've shown quite nicely in the monotherapy in the combination that we do induce DNA damage selectively in the liver. That is translating very nicely into the clinical benefit of time to progression, overall response rate, that is sort of substantially better than what we see with current sort of second line treatment alternatives. And as Pia has commented many times, I think the thing that excites us the most is the fact that patients are staying on drug and benefiting from treatment for quite long periods and with the longest running patients now, 26 months, which is very, very, very long in second-line liver cancer. There is a window of opportunity. The competitive landscape is weak. We are at the forefront. So there is an opportunity to move with speed, be the first approved treatment options. We are moving very nicely speed-wise with regards to our Phase IIb randomized study that we are planning. And we are getting quite a lot of enthusiasm engagement from the scientific community to get there because there is a lack of treatment options. And at the end of the day, what we're trying to tap into is a sizable market opportunity of at least SEK 2.5 billion with the lack of treatment options, with a lack of resistance to commercial uptake. So with that, thank you for engaging. It's been an eventful quarter 3, and we look forward to kind of continuing accelerating the development of fostrox. Thank you, everyone.