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 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 the mature data set 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 data set with regards to time to progression, sort of substantially longer than what can be expected with current treatment alternatives in second line. 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, etc. Secondly, and importantly earlier this week, we were able to announce the clinical trial collaboration that we have now sort of signed with ASI, so they're further validating the potential sort of for the combination of Foss-Struxel and Vima. As part of this agreement, and we'll talk about that a little bit sort of 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 Hepatocellular 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, Dantzler Pia Malmann, our chief medical officer, will be going through some 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 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 uh at esmo and 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. Shon from Korea has certainly focused on second line and have recently in several publications provided data, real-world data from his clinic for Lenvima's 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. Jean-Thor Webex during ESMO, which some of you attended. where he shared his experience from treating patients with LEMVIMA as monotherapy at his clinic and compared those data with the outcome on patients treated with FOSTRUX plus LEMVIMA in our study. So, just as a reminder, I know we have shown this before, the FosDrox plus Lenvima study consisted of first the dose escalation part, followed by dose expansion part, where we ended up in the dose of 30 mg FosDrox 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've already said that, but we have a mature median follow-up. So at the median time of follow-up of 10.5 months from this study, the median time to progression is now almost 11 months 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 in the study and one patient still in response after two 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 2 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 HSE. And what you can see to the right on this slide is 13 second line studies where we can see a median time to progression around four months. And this is regardless if it is with Lemvima after an ion mono or with other kinase inhibitor or with immune therapy combinations. So we can go to the next one. 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 sorafenib and lenvatinib in a relatively large data set this is a real world study where he could show that lenvatinib was significantly better than sorafenib but what he also did was he took the lenvatinib data in monotherapy lenvatinib and compare 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 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 FosTrox plus Lemvima signaled superiority in the second line. And according to his clinical experience, the response rate of Lemvima alone is not higher than 10%. And the time to progression is usually somewhere around four months. Why a TPP of almost 11 months was very impressive. But in order to get this kind of efficacy, Dr. Sean also has presented safety data. from the FosTrox plus Linvima study, our study at Esmond 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 Linvima, shows that FosTrox selectively kills tumor cells in the liver while sparing the normal liver 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, albiscore, 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 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 enables 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 Medivh'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 2b 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 new data in second-line HCC confirming the high need of alternatives in this patient population. The main focus was sort of trying to find out if systemic treatment in addition to surgery in earlier states and to other local treatment as states in intermediate states. could be a viable option, but none of this is ready for implementation. So no change around earlier sort of stages of HEC patients that potentially could impact the development of FOSTRUX plus Lanvima. So the overall takeaway is that it is important to see new second-line treatment and that the development of FOSTROS plus Lenvima gains 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 post-trux as monotherapy in Journal of Hepatocellular Carcinoma. And the results from this study show that post-trux 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 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 a randomized phase 2b 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 the clinical trial collaboration and supply agreement with 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 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 ASI making this commitment with regards to, because 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 US 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 would sort of further support doing the study in the best possible qualitative way but also be able to drive it with the highest possible speed. So I mean clearly we've had sort of discussions with ACI with regards to sort of this supply and for them to supply is not always sort of super obvious I mean they go into this kind of agreement if they think that the 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, so the further validates the potential of FosTrox plus Lenvima in addition to Lenvima and clearly they are the company that knows the best what Lendvima 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 Lendvima. So that means this is yet another step in our preparations for that randomized phase 2b. And those preparations are proceeding according to plan. And as we've communicated earlier, 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, Pia talked about the significant unmet medical need. We talk about the lack of treatment options in second line, whereas there's quite a bit of focus on first line. The other thing we see that 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. uh sort of pandemic and and the the fatty liver disease that that causes so uh 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 2.5 billion if our treatment duration if sort of if the the treat time to progression we're seeing in the current study with phosphorus and vima if that carries through when we assume a sort of a treatment option in line with that then the mark 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 sort of move it up in earlier treatment lines, potentially liver metastases 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 take a step back and reflect on, uh is that in oncology in general if you look across tumor types it's usually uh 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'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 the centric 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 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 FosF and Vima, 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 and from the 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 are pushing us to sort of get to phase 2b as quickly as we we possibly can so uh sort of with that I just kind of summarize things. Well, 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 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, and the bottom right, sort of get first to a market opportunity that is valued at sort of beyond 2.5 billion by the time sort of when we get there. And the other thing that's important is that there is also a, we've seen that in the current study, the willingness to recruit patients to the combination is strong, meaning at the 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 number 22 where you can see the financial summary for the Q3 and the year today is September and as always I will briefly comment on the Q3 result and all numbers are in million sec as usual. The result and cash flow in Q3 is in line with our forecast. The turnover for Q3 amounts to around 1 million, which relates to royalty income for second year. Other external expenses are higher compared to last year in the quarter and relates to the ongoing combination study. We still have patients ongoing, three patients that Thea mentioned. CMC cost and preparations for the next phase of FosTrox 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 cost 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 Link AB of maximum 30 million SEK. 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 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Joe Panginis 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 ASAI 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 2B 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 ASI supplying limvatinib?

but let's put it this way so the buying we've i mean we've decided i'll say the following i'll take a step back and say that we did consciously decide to buy lenmatinib 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 it's a sizable investment and if we would go out into the open market and buy lenmatinib for the upcoming study we are looking at costs of 15 to 20 million US. So it is quite a big saving from our side or investment from a side or however you want to put it. But 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've stated you maintain global rights for FOSS trucks. Just curious, does ASI have any rights of first refusal or rights of first look?

No.

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

I'm feeling bad. I feel like maybe I could say something more, but no. And hence the retaining of the full right.

That's the perfect answer.

Yep.

You have options. Yeah, all your options are open. So, great. Just a question on the Phase 1 2A 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, Neupogen, 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 had very few occasions where we had during the full treatment time, grade three, four, for example, neutropenia or thrombocycopenia. 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 one that was below the orange line were the only one who was grade three which potentially would lead to a dose reduction or a treatment interruption and we only saw that in six patients overall over the treatment duration of time so which means that it is like a it's maybe you didn't see that but it was 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 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 combined ability with the immunotherapies and, you know, the ability to say resensitize or any potential mechanisms for combined ability 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. We can see that. And it has not been successful, as I think it was Jens or myself who said that. It was a study rigoraphanib and pembrolizumab at ASCO, 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 setting.

I think if we look ahead, as Pia is alluding to, if we would plan kind of a strategic evolution of lifecycle 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 T-centric 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. That's kind of our thinking.

Absolutely. But the highest I'm in 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 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 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 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 the 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. 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 equity financing, as Magne 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 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 ASI 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 Redye. Please go ahead.

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

No, not necessarily. 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 were 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 sort of what details they have shared, but sort of the assumption is that, okay, well, that combination didn't supply them with 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 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 burinapant was to be combined with that in oncology, then it becomes a logical sort of follow on that sort of day. uh they don't continue we are now having discussions with with them with igm in terms of what's the impact here is there an addition it's a continued opportunity for birinapan with them or is that something that we and that it comes back to us so we're and that could be the case uh 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 it's a bit difficult to speculate until we're done, but in a scenario where they decide that, okay, well, we are going to focus on autoimmunity and they don't see a path for virinapant 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 it. But then again, I'm a little bit ahead of it speculating. We need to follow things through with IGM first. They have, and just to make a note, Just as we have three patients on the study in Fosstrogel and Vatenib, they still have patients sort of on Birinapant from their study that they passed. So they have a bit of efforts to do with regards to handling that side of things as well. But the discussion is ongoing. And when we've come to a conclusion, what is the next step, then clearly we will communicate that as well.

Okay, going back to the ACI deal, you just mentioned about 15 to 20 million US dollars in cost savings. Could we interpret that as you previously mentioned, guided for a cost of 1 to 2 million SEK per patient, so does that mean

um the travel likely be at the lower half of the lower range um of that in the future i think the let's put it this way the one to one and a half million sec is uh the this where patients are recruited and where patients are included in the study will probably have a slightly bigger impact on things with regards to countries being different in terms of cost for that. The short answer is no, you can't really take the drug element and just apply it to that 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 look at partnering or financing a certain program, if you have an uncertainty of 15 to 20 million US dollar for a study like this, then that clearly provides Hurdle is maybe the strong word, but it provides a bit of a challenge. So now removing that and also having ASI as part of working with us to deliver the study in the best way possible, it's two positives in one go to remove some of the uncertainties.

I understand. Last questions. Do you intend to provide any more readouts from the ongoing phase 2a study?

Yes, so we are closing the study. 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 endotreatment data, hopefully somewhere in the beginning of next year.

That's all for me, thanks.

The next question comes from Klaas Palin from Carnegie. Please go ahead.

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

Yes. And again, my argument, 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 you're looking for. You're more or less looking for a seller of drugs.

Not necessarily. We're looking for the best potential partner. The partner is to come in if we go down the partner route. 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, 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's sort of the global phase to be studied 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 wrong with this one, but I think that 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 deed is to be made.

Perfect. And out of curiosity, a licensing deal was also on the table with ASI.

If you want to comment on that. As I said before, again, as Magnus sort of alluded, then we've said that we will, we communicate those kinds of details. We communicate when we have something on the table, but for any licensing deal, whether that is with ASI or with anyone else, the clinical trial supply and the agreement that sort of, 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 ASI or whether we speak with someone else. And clearly we have had, and we continue to have discussions with ASI. I mean, they've committed to these first two steps, as one option. I mean, clearly we want to do the best possible licensing deal. And I think it's good to remove a hurdle that is 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 uh 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 okay additional questions the next question comes from hans englund from evm please go ahead Hans?

Hi, Hans here again. Yes, I just want to know when will you decide on the size of 2B in number of patients? When do 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 the 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 uh 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 uh 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 uh the design is already set and

I'll add to that, Pia, because clearly we know what the study looks like. Pia and the team has done quite 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 good proposal that we theoretically could share in detail here today. that we will share when the IND is open. Clearly, we are super confident that what we have proposed will fly with the FDA. But we just kind of need to go through the process of having the IND opened, because that's the date when we know that, OK, all is good. So rather than sharing something that might 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 this year 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

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 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, 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 sort of long periods. And we're the longest running patients now with 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 2.5 billion with a lack of treatment options with a lack of comer resistance to commercial uptake So with that, thank you for engaging. It's been an eventful quarter three and we look forward to continuing accelerating the development of postdocs. Thank you, everyone.