Medivir AB (publ)

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 data set from an efficacy point of view, confirming the promise of improved outcome of the combination with Fostrox and Lendvima, showing among other things a 10.9 months sort of mature data set 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 sort of what we share 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 sort of signed with ASI, sort of further validating the potential sort of for the combination of Fostrox, Lendvima. As part of this agreement, and we'll talk about that a little bit further, we will sort of form a joint development committee with ASI. And we are very pleased to be sort of 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 Hepatocelular Carcinoma, sort of 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, then sort of Pia Baumann, our Chief Medical Officer, will be going through sort of our experience and data from ESMO and part of the Q&A. 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 sort of 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, a 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, the data that was presented there, I'll just start to say overall mainly focused on first line treatment in advanced liver cancer. And one of those who presented this pointed really out that there are now eight different regimens in the first line setting and none of 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. Sean from Korea, has certainly focused on second line and have recently in several publications provided data, real world data from his clinic for Lenvima as monotherapy in second line. So in order to put our data that we have presented at ESMO, but also at ESMOGI from Fostrox in combination with Lenvima into the context, we invited Dr. Sean to WebEx during ESMO, which some of you attended, where he shared his experience from treating patients with Lenvima as monotherapy at his clinic and compared those data with the outcome on patients treated with Fostrox plus Lenvima in our study. Next slide. So just as a reminder, I know we have shown this before, the Fostrox plus Lenvima study consisted of first a dose escalation part, followed by dose expansion part, where we ended up in the dose of 30 milligram Fostrox. And then we have a second dose that is taken orally once daily for five days in the 21 day cycle together with Lenvima that is taken once daily without stopping at the approved standard doses. And the patients were recruited at several different sites, 15 sites across Europe, as well as Asia. We can go to the next slide. So I already said that, but we have a mature median follow up. So at the median time of follow up of 10.5 month from this study, the median time to progression is now almost 11 month with a response rate of 24% and the 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 three patients still ongoing the study and one patient still in response after two years of treatment. So when we talked about this data at Esmoor, they generated very positive response in the scientific community. And this also generated an increased interest in participating in the upcoming and plan phase two B study. So with this median time of progression of 10.9 month, we can go to the next slide, which is substantially longer. It compares favorable with all other relevant data sets in second line HSE. 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 four month. And this is regardless if it is with LEMVIMA after an IOMONO or with other kinase inhibitor or with immune therapy combinations. So we can go to the next slide. So as already mentioned, we had this WebEx, which was giving you the context and where Dr. Sean showed data from his publication where he compared seraphimib and LEMVATINIB in a relatively large data set. This is a real world study where he could show that LEMVATINIB was significantly better than seraphimib. But what he also did was he took the LEMVATINIB data, monotherapy LEMVATINIB and compare the data with the phase one B to a FOSTRUX LEMVIMA study, which he is an investigator in. And that is what we discussed at this WebEx. So we can go to the 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 FOSTRUX plus LEMVIMA signaled superiority in second line. And according to his clinical experience, the response rate of LEMVIMA alone is not higher than 10 percent. And the time to progression is usually somewhere around four months. Why a TPP of almost 11 months was very impressive. So but in order to get this kind of efficacy, Dr. Sean also has presented safety data from the FOSTRUX plus LEMVIMA study, our study at SMUGI 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 FOSTRUX either as monotherapy or in combination with LEMVIMA shows that FOSTRUX selectively kills tumor cells in the liver while sparing the normal liver cells. So this is what we saw. Right. What 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 ALBISCORP, 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 expected 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 neutrophils and thrombocytes four times per treatment for all the patients during all treatment cycles, very few measurements showed a level of grade three or more. That is the only sort of measurements that you can see below the orange line here. And this again enabled 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 MedVe'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 Plan Phase 2B study. And 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 HGC, I already said that, but I need to repeat it again, was that there were no data in second line HGC confirming the high need of alternatives in this patient population. Also at ILCA, the main focus was sort of trying to find out if systemic treatment in addition to surgery in earlier stage and to other local treatment as tests 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 HGC patients that potentially could impact the development of Fostrox plus Lentvima. So the overall takeaway is that it is important to see new second line treatment and that the development of Fostrox plus Lentvima 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 the clinical proof of concept with Fostrox as monotherapy in Journal of Hepatocellular Carcinoma. And the results from this study show that Fostrox was safe and tolerable with preliminary anti-tumor 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 two study that is really designed with the appropriate statistical power to show efficacy benefit on overall response rate as the primary endpoint. 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 an accelerated 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 one critical element, clearly, of course, in taking this program forward, sort of with the randomized phase two B 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 have now signed the clinical trial collaboration and supply agreement with ASI. 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. And 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 ASI for the planning and execution of the study. And we are quite happy with sort of ASI 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 in Asia and including in the US, where they have sort of experience capabilities in the past. So we truly believe that the sort of having this sort of joint development with them would sort of further support doing the study in the best possible quality qualitative way, but also be able to drive it with with the highest possible speed. So, I mean, clearly we've had sort of discussions with ASI with regards to sort of this supply and for them to supply is not always sort of super obvious. I mean, they they go into this kind of agreement if they think that the the the kind of the study has an opportunity to 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. So the further validates the potential of FosDrox plus Linvima in addition to Linvima. And clearly they are the company that knows the best what Linvima alone what benefit that provides. So we're quite happy with the the confirmation and the belief in the combination, what the combination can provide on top of Linvima. So so that means this is yet another step in our preparations for that randomized phase to be and those preparations are proceeding according to plan. And as we've communicated earlier, we thought that that's we're on track to open an IND in the US before end of 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 one other element that we're seeing sort of it. So Pia talked about sort of the significant unmet medical need. We talk about the the lack of treatment options in second line, whereas there's quite a bit of focus on on first line. The other thing we see sort of is also coming for is 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, sort of a growth and a growth that is very much driven by the obesity and sort of pandemic and the 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 two point five billion. If our treatment duration is sort of if the treat time to progression we're seeing in the current study with Foster, if that carries through when we assume sort of a treatment option in line with that, then the market, the value of that market actually increases further and starts to get close to sort of four billion. So the second line liver cancer market alone is clearly of sort of a large potential. And then going forward, we can look to remove 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, I just want 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 if I take a bit of time to walk through this slide on the left hand side is the current treatment algorithm. And we talked about this before. I think it's important to emphasize because it, it isn't changing and there is a 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 tecentric 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 re challenging with an 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's no scientific evidence support what to use in second line and the community is somewhat almost screaming for alternatives because there is a lack of treatment options. So with the combination of hostroxylenvima, 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 re challenging 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 two be as quickly as we possibly can. So sort of with that, I just kind of summarize things. Hang on a bit. Move the slide. So in short, kind of summarize this in four 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 plan global phase to be in order to on the bottom right, sort of get first to a market opportunity that is valued at sort of beyond two point five billion by the time sort of when we get there. And and the other thing is 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 at time of an approval, the resistance to uptake commercially would be very, very low. So with that, Magnus,

we move to financials. Yes, please move to slide number 22, where you can see the financial summary for the quarter free and the year to date September. And as always, we briefly comment on the Q3 result. And all numbers are million sec, as usual. The result and cash flow in Q3 is in line with our forecast. The turnover for quarter free amounts to around one million, which rates the royalty income for secure. Other external expenses are higher compared to last year in the quarter and relates to the ongoing combination study. We still have patients ongoing, free patients that Pia mentioned. CMC costs and preparations for the next phase of post-docs, as Jens and Pia mentioned earlier. Personal 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 46, 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 post-docs. 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 Link AB of maximum 30 million sec. And we are very satisfied with the support from our major shareholder, Link. 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 in deed. 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 close the presentation for now and we open the call for Q&A.

If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Joe Pangenis from H.C. Wainwright. Please go ahead.

Hey, everybody. Thanks for taking the question. A couple, if you don't mind. So first on the ASIE collaboration, I want to talk to certain levels of importance from this with two 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 two, the 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 a size applying limbat? Limbat.

But let's put it this way. So the buying we decide I'll say the following. I'll take a step back and say that we did consciously decide to buy Lin Matnib 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. And if we would go out into the open market and buy Lin Matnib for the upcoming study, we are looking at sort of costs of 15 to 20 million US. So it is a it is quite a big sort of saving from our side or investment from a side or however you want to put it. So in terms of what we would pay, that is actually a cost of 15 to 20 million US dollars 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 ASI have any rights of first refusal or rights or first look?

No.

Got it. Very simple. I just want to follow up. Yeah, yeah, no, that's perfect.

I'm not feeling bad. I feel like I maybe I could say something more, but no, and that's a hence that retaining of the perfect

answer.

Yep.

You have options. Yeah, you have all your options are open. So great. Just a question on the phase one to a 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, new last the new pigeon or the frequency of that happening?

So, so first of all, I didn't say that because we shorten this a little bit since we have presented data before we didn't have any febrile neutropenia. We didn't sort of have we had very few occasion where we had during the full treatment time, grade three, four, for example, neutropenia or trombocytopenia. And I was trying to show that during this duration of time. So 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 one that was below the orange line were the only one who was grade three, which potentially would lead to dose reduction or treatment interruption. And we only saw that in six patients overall over the treatment duration of time. So, which means that it is like it's 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. Thank you for that. And my last question, if you don't mind, and thanks for indulging me 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, 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, you know, the ability to say resensitize or any potential mechanisms for a 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. And we can see that and it has not been successful as I think it was Jens and myself who said that it was a study, Rigoraphonib and Pembrolizumab and Macaskill, which was negative. So what they're trying to do then is to find something that potentially could do that. And sure, with Fostrox mechanism of action, where you can have a higher antigen presentation, for example, it could in theory work. But since we have the strategy of at least initially looking at a second line treatment where you already have used your immune therapy, 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. 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 onto a tecentric-avasting combo as a triple. I think that would be the more logical next step if we were to explore a combination with an IEO. That's kind of our thinking.

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

Of course. Appreciate all the details. Thank you.

The next question comes from Hans Engblom from EVM. Please go ahead.

Hello, guys. Congratulations to the collaboration with ASI. 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 2B study?

Hi, Hans. Thank you for the question. What I can say and guide you on is that we, as we stated in the press release as well, that we are exploring different alternatives now. And of course, we are looking at different scenarios, so 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 explore different alternatives at the moment.

And clearly trying to find the best way forward from a value perspective. So I think that's why I thank you, Joe, for asking the question, because we are super happy with the engagement from ASI and the support for the study while retaining the full rights. And with 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 15, 20 million US 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 as 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 equity financing as Magnus said. And that's also a dialogue and 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 would have the ability and bandwidth to do so. And if we do enable to to secure equity financing, then we retain the full rights and the full future value of the drug. So we are we are equally open to both avenues and both avenues are equally available on the back of the A site trial 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 Romanius from Redeye. Please go ahead.

Good afternoon. Do you have any comments on AGM Biosciences cancellation of their oncology program?

No, not necessarily. I mean, sort of we, I mean, clearly they they've communicated earlier, sort of when they communicated in, now I'm trying to remember, December last year, that they were sort of holding some of their oncology programs and were waiting for the readout of the combination of their DR5 agonist. Together with, I believe, for free and in colorectal cancer, and that would guide them in terms of moving forward. Not sure sort of what details they have shared, but sort of the assumption is that, okay, well that that combination didn't supply them with the the the the data that they were hoping for with regards to sort of moving forward with the DR5 agonist in oncology. And if that's the case, and they are are having some challenges from a financial viewpoint that they need to sort of focus on one area, then it becomes sort of relatively logical for them to then not go ahead with the DR5 agonist. And since the Birinapand was to be combined with that in oncology, then it kind of a logical sort of follow on that they don't continue. So we are now having discussions with with with IGM in terms of what's the impact here. Is there an additional continued opportunity for Birinapand 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 sub licensing could be an option?

I think 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 Birinapand in autoimmunity. Then I think that the more natural step would be that the acid comes back to us and and and and we explore alternative sort of licensing options sort of from our side rather than them sub licensing that that will be much. But then I'm again, I'm a little bit ahead of it sort of speculating. We we kind of need to sort of follow things through with IGM first. And just to kind of make a note, just as we have three patients on the study in for struggling and not they still have patients sort of on Birinapand in from from their study that they they post. So they have a bit of efforts to do with regards to handling that side of things as well. So but but discussions ongoing. And when when we come to a conclusion, what is the next step? Then clearly we will communicate that as well.

Okay, go on. Going back to the A side deal, you just mentioned about 50 to 20 million euro US dollars in cost savings. Could we interpret that as you mentioned, the guide for a cost of one to two million per patient. So does that mean the travel likely be at the lower half of the lower range of that in the future?

I think the one to one and a half million SEC is that the this is where patients are. And where patients are recruited, where patients are included in the study has will probably have a slightly bigger impact on things with regards to sort of countries being sort of different in in in terms of sort of cost. So for that, so I wouldn't. That's a short answer is no, I don't think 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 15 to 20 million US dollars 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. So that is a question that is quite critical when you when you look at partnering or financing a certain program. So if you have an uncertainty of 15 to 20 million US dollar for a study like this, then that clearly provides her that is maybe the strong word, but it provides a bit of a challenge. So now removing that and also having a size that are part of working with us to deliver the study in the best way possible sort of is it's two two positives in one go to remove some of the uncertainties.

Understand. Last questions. Do you intend to provide any more readouts from the ongoing phase two a study?

Yes, so we are closing the study and but again, we were hoping to 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 and or treatment data hopefully somewhere in the beginning of next

year. That's all for me.

Thanks. The next question comes from class Palin from Carnegie. Please go ahead.

Yes, thank you for taking my questions. Just to clarify, if I understand you correctly, that a local partner deal for folks could still be be an option for you. Is that correct?

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

OK, but such a partner would then be rather a selling company than a developing company. I mean, a fully fledged pharma is not what you're looking for. You're more or less looking for or

a seller of drugs. Not I mean, not necessarily. So we're looking for the best potential partner. And and and that partner and the partner is to come in at the sort of if we go down the partner route, I mean, clearly sort of 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 sort of deal or agreement with the best possible agreement. And 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, sort of locally in the country, countries where that deal sort of is to be made. And that includes then sort of also the partners are being part of funding that sort of the global phase to be study in the in the country where they are sort of 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 sort of as the next step. Now, I'm wondering if I was this one, but I think that it's it's not just commercialization. Any partner at this stage sort of will clearly have a role to play from a development perspective locally in the country region where that is to be made.

Perfect. And out of curiosity, licensing deal was that was on the table with a fire. If you want to comment on that.

The as I said, again, that's minus sort of eluded and we've said that we will we communicate that those kind of details we communicate when we have something on the table. But for any other licensing deal, whether that is with with a site or with anyone else, the clinical trial supply and the agreement that sort of getting to a point where, okay, well, this is a good study to run. We have supply, etc. That is the first step that needs to be taken, whether we speak with a site or whether we speak with with someone else. And clearly, we we have had and we continue to have discussions with a site. I mean, they've they've committed to these first two steps as as as one option. I mean, clearly we want to do the best possible licensing deal. And I think that'd be it's good to remove a hurdle that are seen, they're seen as a hurdle for other companies. So can we do that first? And then you get to a point where you get into more 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.

Very good. No, very good answer. Thank you so much.

OK, additional questions.

The next question comes from Hans Englum from EVM. Please go ahead.

Hans,

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

So 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 the statistical prerequisite for doing what we would like to do when it comes to, as I said, potential excellent approval opportunity and so on. Then obviously, this is partly an adaptive design. So depending on the results going forward, we might might increase the number of patients, but that is a later decision. And it's it's only driven by already set statistical decisions. So it's so. Yeah, I can't say more than that currently. But it's it's the design is already set. And

if I I'll I'll add to that, because clearly we know what the study looks like. And the team has done quite sort of extensive work from a statistical viewpoint, engaging with the steering committee. The steering committee is super engaged. So we have a very good view and a very sort of good proposal that we theoretically could share in detail here today. But that that we will share when when when the eye and the is open. So there's clearly we are super we are super confident. And that's sort of what we have what we have proposed. When we fly with the FDA, but we just kind of need to go through the process of having the eye and the open, because that's the date when sort of we know that, OK, all is good. So 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 sort of finalized. And as I said, the the the plan to open the eye and the and the preparations to open the eye and the in this year is is progressing nicely.

Super. You replied to two questions in one. Thank you very much.

Thank you.

Any additional questions?

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

thank you, everyone, for listening in. Thank you, everyone, for engaging with questions, a lot of questions which we appreciate a lot. And 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 a repetition is always good. One, we have we are doing what no one else is doing. And I think that that 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 in the liver, 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. 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 sort of long periods. And we're the longest running patients now at 26 months, which is very, very, very long. In a 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 to be randomized study that we are planning. And and we are getting quite a lot of enthusiasm, engagement from the scientific community to to get there because there is a lack of of treatment options. And and the end of the day, what we're trying to tap into is a sizable market opportunity of at least two point five billion with a lack of treatment options with a lack of resistance to commercial uptake. So with that, thank you for engaging. Thank you for your time. It's been an eventful quarter three and we look forward to continuing accelerating the development of post drugs. Thank you, everyone.