Good day, and welcome to the Medivir fourth quarter 2022 earnings call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then two. To withdraw your question, again, press star then two. Please note this event is being recorded. I would now like to turn the conference over to Jens Lindberg, CEO. Please go ahead.
Thank you, welcome everyone to our quarterly call. Operator, if we move to the next slide two, please. Joining me in the room here at Medivir is our CFO, Magnus Christensen, who will go through the financial highlights towards the end of the call. Our CSO, Fredrik Öberg, who will take the science section of the call in the middle. With that, let's jump into sort of the agenda for today. Operator, if we move two slides ahead, or actually three slides ahead to slide five, please. Highlights during last quarter, I think 2022 was a year of sort of moving our lead project fostrox forward with as much speed as we possibly could, and Q4 was sort of clearly of the same focus.
We are quite happy with the continued strong recruitment we've seen in the, in the fostrox study, and we're now eagerly anticipating sort of moving to the next phase in the near term to set the recommended phase II dose. We're very encouraged with the interest we've seen in the study in terms of recruiting patients into both of the combination arms. During Q4, we had an important pre-IND meeting with the FDA, which we completed and positive feedback on the overall development plan. We're very much looking forward to opening the IND in 2023 in order to be able to include U.S. sites in our sort of future development plans.
We have new data presented at CT conference in Boston's continuing to show sort of efficacy of fostrox together in combination and this time with anti-PD-1. Combining fostrox with either anti-PD-1 or TKIs is at the core of our strategy. Good to see that we continue to see that additive efficacy across non-clinical tumor models, and we are eager looking forward to hopefully showing that in the clinic as well. Finally, on the people front, we recruited a permanent chief medical officer, Pia Baumann, who's joining us from AstraZeneca, and she is actually making her first day here at Medivir on Monday, so coming soon. On the outside of fostrox, we look at the other portfolio, some movement in Q4.
We can see that IGM or we know the IGM Biosciences who are in the dose escalation phase of the combination of their DR5 agonist, IGM-8444, together with birinapant continues to enroll patients in that, the fourth cohort. As of Q4, still no DLTs observed to date, progressing nicely in that combination. Infex Therapeutics, they announced that or actually early this year that the MBLI program received FDA QIDP designation, the MET-X program. That's also encouraging with the sort of all the benefits that come with the QIDP designation. We've also seen that they received patented status in Q4, they are moving swiftly towards sort of entering the clinic as well with the MET-X program.
Finally, Tango Therapeutics, who we outlicensed the preclinical USP1 program to a couple of years ago. They have now selected their first drug candidate from this preclinical program, the TNG348. They have also announced that they are opening an IND in 2023. Additional compounds from the Medivir research moving towards entering the clinic. If we move to the next slide, please, operator, slide six. As I mentioned, start with the people side first. Pia Baumann, who is a sort of trained oncologist from Karolinska Institutet and has spent a good number of years in smaller and biotech companies and larger pharmaceutical companies, is joining us on Monday. Lot of experience in development of sort of pharmaceutical compounds in the field of oncology.
Has a lot of experience engaging with regulatory authorities, etc. We feel that her experience will fit in very nicely with where we are with the current lead program, fostrox, and the efforts that we're driving as we move towards the next phase of our clinical development. So eagerly looking forward to Pia joining us on Monday. Then before as we go into the portfolio, this is our pipeline overview, which we have shown many times before, and we will of course spend a bit of time on our in-house program, the lead program of fostroxacitabine bralpamide. Then we make some additional comments regarding a couple of our partnering programs as well towards the end of the call. Next slide, please. Slide eight.
As we move into fostroxacitabine, or fostrox as we call it for short, as we are about to now soon enter phase IIa and move into the next phase of the development, we thought we would take a semi step back and just to kind of briefly walk through why do we think the compound has promise in HCC and perhaps even more importantly, how did we come about developing this particular compound knowing that historically traditional chemotherapy hasn't fared so well in HCC. We think we feel quite positive about having found a way to make HCC patients benefit from chemotherapy as well.
To sort of take us through that journey and how we came about developing the compound, I'll leave it to Fredrik to walk us through that. Operator, if you move to the next slide, please. Slide nine.
Thank you, Jens. I mean, as you all know, traditional chemotherapy is the mainstay of cancer treatment still. It has a lot of good in the treatment of cancer. However, in HCC, this has not been the case. When we initiated this project, we analyzed why this was not the case. One of the key challenges is of course balancing systemic toxicities versus the clinical efficacy in the liver. Our analysis has identified several areas that we thought we would need to address in order to progress such a program. You see three of them highlighted here on this slide. One is of course the narrow therapeutic window.
The doses that we need to have an effective drug in the liver would also cause significant systemic toxicity. This is a challenge. We should also remember that patients with hepatocellular carcinoma actually have two diseases at the same time. They have a liver disease, which makes their liver sensitive to liver toxicity, and they have the tumor at the same time. We need to address this as well. And also, the liver does have a lot of enzymes in activating various drugs, some resistance mechanisms in particular for nucleoside drugs that inactivate those and therefore lose activity in the liver. If we move to the next slide, that illustrates how we went about this.
Liver-targeted exposure, from the work done in HCV, we did have both nucleoside chemistry and development platforms and also pro-drug platforms to develop targeted delivery to the liver, to treat the virus. That could be used, that learning, to enable higher liver concentrations at lower doses and ensure that we get exposure in the tumor while minimizing systemic toxicity. In order to ensure that we don't hit the normal liver tissue, we need to choose a compound which is cytotoxic to the tumor cells. You can do that in many different ways. Of course, one clear differentiation between the liver, normal liver tissue and the tumor is proliferation. Not all chemotherapies are the same.
Many chemotherapeutics do have toxicities in cells that are not actually growing, mitochondrial toxicities, et cetera. You have liver toxicities of chemotherapies which are not related directly to the proliferation of the cells. We needed a compound that linked the cytotoxic effects to the proliferation in order to have this differential tumor selective activity. To avoid these resistance mechanisms, or inactivation mechanisms in the liver, there are certain unnatural nucleosides that can be used in order to avoid recognition by some cellular enzymes. With these three aspects, we chose troxacitabine and the pro-drugs that we did. If we move to slide 11, It depicts in a schematic way, fostrox, the fostrox molecule.
Of course, we did examine hundreds of different prodrug tails in order to find one that enables oral administration and really gives a very high liver selective exposure versus systemic exposure. The same approach in principle has been used in HCV by approved drugs. The active substance part that does becomes incorporated into DNA and gives the DNA damage and the cytotoxic effect, we chose troxacitabine. It is a chemotherapy. It induces DNA damage and cell death. It had a track record of proven activity, but it did have a too narrow therapeutic window, which we then addressed with the prodrug tail. If we move to slide 11.
Slide 12.
Slide 12, sorry. That depicts the principle to the left where once daily oral administration provides through the first-pass metabolism, that is, it's reaching the liver first, and there becoming metabolized into the active metabolite which is trapped in the liver, and thereby minimizing ex-systemic exposure and exposing the cancer cells to high enough levels of the cytotoxic drug. We do know from rat experiments for instance, that we can achieve by dosing orally 100-fold higher levels of the active metabolite in the liver than if you would give troxacitabine IV as was the case in the clinical studies previously done. What about selectivity? If we move to slide 13. HCC is not a rapidly proliferating tumor.
However, we have examined biopsies from patients, and there is a clear differentiation. Tumor cells proliferate, whereas non-tumor cells, the hepatocytes in the liver do not. That's the left panel. We were really encouraged when we observed in the phase I monotherapy that we could actually induce DNA damage in the tumor cells versus not observing any DNA damage to the normal liver cells adjacent around the actual tumor, which was a proof of concept of sorts, demonstrating that we can, we can reach with reasonable dosing of fostrox, we can reach the target and induce DNA damage in the tumor cells whereas not affecting the normal liver cells.
In summary, slide 14 then, we have in fostrox a drug which contains the prodrug which allows oral administration and liver targeting. We also have the active substance, the troxacitabine part, which is an unnatural nucleoside. It's a so-called L-nucleoside instead of most than other chemotherapies in this class being the natural D-enantiomer. This means that it's not really recognized by several enzymes in the cells, and such enzymes that are involved in resistance and mechanisms of toxicity. Therefore, we have a drug that does the job but avoids certain resistance and toxicity mechanisms in normal liver cells. This is in the area of HCC a unique mechanism.
If we move to slide 15, as we've spoken about before, there are two main mechanisms of action, which dominate the HCCs. One is the checkpoint inhibitors, and the other one is tumor tyrosine kinase inhibitors or multi-kinase inhibitors, TKIs. There are actually two really good scientific rationales for combining with these. The fact that we have a unique mechanism makes this also attractive to combine with other mechanisms. In terms of stimulating the immune system, we know that inducing DNA damage and cell death increases the presentation of tumor antigens, and potentially then increases the activity of checkpoint inhibitors.
Whereas in combination with TKIs which are anti-angiogenic, the increased lack of oxygen, the hypoxia in the tumor, we know that that actually increases the levels of the active metabolite of fostrox. Therefore also creating a situation where you can observe synergy. And we are as Jen said, eagerly awaiting combination data in the clinical trial but meanwhile we do have some evidence that this works in preclinical models. If we move to slide 16, on the left-hand panel are immunohistochemistry sections of tumor treated in vivo either with vehicle, the checkpoint inhibitor anti-PD-1, pembrolizumab, fostrox or the combination. And in this case it's stained for CD8 which is a T-cell marker in brown.
The middle panel is quantification of tumor-infiltrating lymphocytes as they are called, this group of immune cells that infiltrate the tumor. That increase does suggest that fostrox provides a change in the tumor microenvironment increasing the infiltration of tumor-infiltrating lymphocytes, which in turn means that a checkpoint inhibitor combination is a rational way to go. In the right-hand panel, there's a tumor model, an HCC model in mice, where it's just a short treatment, five-day treatment at a suboptimal dose of fostrox, enhances the activity of anti-PD-1.
If you focus on the blue graph or blue line which is the activity of the checkpoint inhibitor by itself and the red one which is the enhancement of adding this relatively short treatment of with fostrox early during that tumor growth period. In summary we think that we have a situation where we have a drug which is optimized for liver targeting, and it has certain characteristics that allows it to be combined favorably with immune therapies such as anti-PD-1. With that, I will leave the word to Jens.
Encouraging to see that we sort of fostrox seems to sort of stimulate tumor microenvironment in a positive way and sort of create an additive efficacy with anti-PD-1. This complements sort of previously presented data where we've shown sort of similar sort of complementary or additive efficacy with TKIs and we look forward to sharing additional data later in the year where we have, among other things, started to look at sort of not just sort of single combinations but triple combinations as well. That will be for later presentations when we are presented at external conference. Just sort of this is the program as it's ongoing and where we are. Oh, sorry. Move to the next slide please.
This is the program as it stands now as you know, we are sort of exploring two different combinations. There's the one combination with lenvatinib and with pembrolizumab. As we've said, sort of we are... We've been rapidly accruing patients in the dose escalation, we are right now eagerly looking forward to sort of setting the recommended phase II dose and moving into the expansion phase sort of in the very near term. The feedback from sites are also... They're on us to 'cause they wanna, they want to be able to include more patients. We are having patients in line, so very much look forward to that phase IIa start near term.
When we decided, sort of at the time of study start or design of the study, there was a question whether we should choose one arm or go with both arms in dose escalation and decision was made to, no, let's go with both because sort of we never know whether the treatment algorithm how it will evolve throughout the year and turns out that the decision to have both arms was a very good one. If we move to the next slide please, this is a relatively busy slide.
If we look at what has happened in this field over the past let's say 12 plus months, particularly in the first-line space of HCC, we know that sort of on the left-hand side that the IMbrave150 trial that sort of evaluated the combination of atezolizumab versus erlotinib showed positive results and was the first one to be approved as a combination. The interesting part here is that sort of then that has been sort of followed by a number of other combinations that are looking at a little bit the same, combination of a PD-1 and a TKI, various combinations. The AstraZeneca HIMALAYA trial, the LEAP-002 from Eisai and Merck and latest pembrolizumab plus rivoceranib.
I think that the one thing to point to here is that from the study results perspective, sort of it looks very similar. ORR, percentages relatively the same. Overall survival relatively the same. It seems like the combination does work, and it does a lot of good for patients, but sort of it doesn't really matter which combo you may use. You will get to this point, but you will not get further. What it has done is it has cemented the combination of atezolizumab as the standard of care in first line. As most patients then get a PD-L1 in the first line, it means that sort of there is an. Physicians are quite eager to move to a different mechanism of action, i.e.
TKI monotherapy is becoming sort of the way to go or the standard in second line for those patients where lenvatinib is used sort of, is preferred in many places. Then highlights the relevance of the fostrox plus lenvatinib arm. Finally, if you do the same, results will probably be the same. If you continue to use the same type of combinations, results will likely be the same. What it does highlight for us is that there will likely need to be different modes of action or additional modes of action to take things further, i.e. to improve the clinical benefit in this sort of first line space.
As we read this and as we look forward, we are very happy with having both arms, because it means that perhaps the lenvatinib fostrox arm is the most relevant arm for the second line space, which, and be the arm that sort of would be most relevant to explore in second line to see what improvements can we make beyond TKI monotherapy. Equally, that other arm, the pembrolizumab arm and the dose recommendation for that, could clearly have potential in second line, but it could also be a dose and data that could inform potential opportunities moving into earlier spaces. That's also data that we need to watch for to see whether there's opportunity to sort of explore additional alternatives beyond the second line program.
With that, we can move to the next slide, please. Sort of short version on fostrox, significant unmet need. I mean, benefits for patients as of late with new studies and combinations, but there continues to be a significant unmet need and commercial potential. We do have a unique mechanism of action that then selectively as Fredrik was, sort of spoke about targets cancer in the liver and bypasses resistance mechanisms. That that mechanism and being the only sort of chemotherapy in development has a unique and strong potential for attractive combinations. Before we conclude, a couple of words on our other programs. If we move to the next slide, please. Slide, and you can move one more, so to slide 21.
As I mentioned before, our partner Tango Therapeutics in-licensed the USP program. They announced in Q4 that they are now moving towards clinic. They have selected the CD from that program, and it will be referred to as TNG348 going forward. They're planning an IND filing in 2023. In terms of data they've shown, showing a significant sort of potential opportunity in specifically in BRCA1 and BRCA2 mutated cancers. They've shown synergy with PARP inhibitors in both PARP sensitive but also PARP resistant models. Eagerly looking forward to sort of seeing as they start move into the clinic and seeing clinical data here. Finally, sort of in terms of Q4 development, the next slide please, slide 22.
The MET-X program which has moved forward quite nicely in 2022, with regards to both, sort of non-clinical data, presented. More importantly, they have received as of late the QIDP designation in January, which will sort of give them sort of a faster and better sort of path toward the clinic and toward the market as they start to engage with regulatory authorities in the U.S. They have also communicated their next step is to enter the clinic in 2023. With that, I will hand it over to Magnus for financial highlights. You can move forward to slide 24, operator.
Thank you, Jan. Yes, it's slide 24 where you can see the financial summary for Q4 and for the whole financial year 2022, which I will briefly comment on. From a financial viewpoint, Q4 was a pretty safe forward quarter. The turnover for Q4 was SEK 2.3 million, which relates to the royalty income from Xerclear. Year to date, the figure is SEK 4.4 million, which is lower compared to last year. Bear in mind, last year included upfront payment, from the outlicensing deal with Agenus related to birinapant, as well a milestone payment when the first patient was dosed in their combination study in Q4 2021. Other external expenses are lower compared to last year in Q4 and relates foremost to lower clinical costs.
Last year, we had costs for starting up the combination study. Year to date, it's around SEK 1 million lower. The operating loss for Q4 is SEK 18.6, and it's also lower compared to last year, and it's almost due to the lower clinical costs. The cash flow from the operating activity in the quarter amounts to minus almost minus SEK 25, which is in line with our current plan that we have in the company. The cash position at the end of Q4 is around SEK 117 million. According to the current plan and with the current assumptions that we have, the cash run rate is into Q1 of 2024. With this, I will hand over back to Jan.
Yes. We can move one more side operator, then we'll sum it up. 2022, sort of continued progress across the portfolio. In Q4, as mentioned, the continued recruitment, strong recruitment in the Fostrox study. As we look ahead, sort of now, sort of 2022, a year of moving that project forward as much as we could. 2023, as we sort of move into phase II a, generate more data, we sort of were eagerly looking forward to sort of seeing the clinical data and hopefully showing that sort of the non-clinical evidence that we have indicating how the combination provides additive efficacy that also coming through in the clinic.
rg, Chief Scientific Officer at Medivir. I'm here with Jens Lindberg, our CEO, and Magnus Christensen, our CFO. We're excited to share our Q4 and full-year 2023 results. Jens, would you like to start with an overview?" "Thank you, Fredrik. Good morning, everyone. 2023 was a pivotal year for Medivir. We made significant progress across our pipeline, particularly with fostroxacitabine bralpamide, our lead liver-targeted cancer drug candidate. We're seeing promising data from our phase Ib study, and we're on track to initiate the phase IIa portion of the trial. We also strengthened our partnerships. Our collaboration with Infex Therapeutics on the MBLI/MET-X program received QIDP designation from the FDA, which is a major milestone. And IGM Biosciences continues to advance birinapant, with IGM-8444 moving towards the expansion phase. Financially, we maintained a strong position, allowing us to continue investing in our core programs. We're confident in our strategy and look forward to an even more impactful 2024." "Excellent, Jens. Magnus, could you elaborate on the financial highlights?" "Certainly, Fredrik. Our Q4 2023 financial performance was robust. We ended the year with SEK 150 million in cash and cash equivalents, providing a solid runway for our operations. Revenue for the quarter was SE
We are maybe sometimes a bit too excited about talking about why we believe fostrox is unique and why it's different and, why we think it has strong potential. Now we're eagerly looking forward to hopefully sort of showing that clinically as well in 2023. Operator, I think we can stop there and, if there are any questions.
We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Joe Pantginis with H.C. Wainwright. Please go ahead.
Hi, thanks for taking the question. This is Sarah on for Joe. I have two questions. First, have you been in any talks with regulatory agencies yet in Korea? Are you able at this time to provide any color on those talks?
The short answer is no, sort of at this stage.
Okay.
The regulatory interactions that we've had, primary one as of late, has been the pre-IND discussions to open in the U.S. The only regulatory interactions we've had so far in Korea has been sort of opening the current study as we have the Asian sites in terms of sort of regulatory approvals, but nothing further at this point on. That will come as we start to see a bit more clinical data.
Okay. Also kind of following up then on that general region for your development plan, can you detail any potential recruitment efforts to enroll outside of Korea, maybe in the larger Asian geography?
I mean, from a clinical study perspective, we have 14 sites that are open at the moment, and they are in U.K., Spain and Korea. I think if we go back to the first half of the year before we had the Korean sites open, we did have a bit of a challenge in terms of recruiting to the study, and that picked up nicely when the Korean sites came on board. We also added, we also made a few initiatives in terms of working closer with the sites. We made some adjustments to the protocol, and that has sort of, that has also helped pick up the speed. When we see sort of speed or recruitment pick up in the second half of the year, that is across the different countries.
Clearly getting the Korean sites on board sort of took a first step towards picking up speed. Then we've also seen the Spanish and the U.K. sites also pick up speed. At the moment, we are seeing sort of a very nice recruitment pace and then sort of across the different countries, we actually have patients kind of waiting in line for those cohorts to be opened.
Okay, thank you.
The next question comes from Jason McCarthy with Maxim. Please go ahead.
Hi guys. Thanks for taking the questions. Wondering what you mainly attribute the accelerated enrollment in Phase Ib? Was it primarily the protocol amendment that sort of relaxed enrollment criteria to include those 3rd line patients?
No, I wouldn't say primarily. I think it's, I mean sort of. I think we've spoken about before. We've done kind of taken steps in a couple of different areas, where we've added some additional sites. For example, in Korea, I think in the beginning our first plan was to have four sites. We added that, so we had two additional sites. That has clearly helped. We have worked quite closely with the sites locally as well to sort of identify patients, and we've been quite active out on site to generate, I mean, sort of interest, excitement, and kind of, how should I put this? Kind of willingness to participate.
Many times it's just sort of if we are quiet and if we don't show ourselves on the sites, then there are competing studies that might take precedence. The more active we can be out on sites, which we have been across the different countries, that helps, of course. The protocol has also added some to it. The protocol hasn't been all of it, because what we can see is that sort of a majority of the patients are clearly second-line patients, and they were eligible as part of the previous protocol. It has contributed to some extent, but not all of it. Kind of a mix of all things, including our sort of stepped up, local presence on site.
Got it. Thank you. As far as sites go, it's still in total, 13. Is that correct?
Say that again.
As far as total sites, active right now, is that still 13?
14 sites.
14
Six sites in Korea and three sites in U.K. and the remainder in Spain.
Got it. For the Phase IIa expansion phase, I guess, you know, sort of roughly when could we expect that to initiate? Just sometime this year?
Yes. I would say I think we wrote in the press release this morning, and I might have it on the slide here as well, near term. Yes, I mean, as we've said before, we are that we've been eagerly looking forward to open. We did have an ambitious plan to maybe even be able to open it at the end, before end of 2022. That was maybe a bit overly ambitious, but that provides a bit of insight as to the opening. We're not anticipating the opening of that two way to be too far away, to put it that way.
Okay, great. Thank you. That's all for me.
Okay.
Again, if you have a question, please press star then one. The next question comes from Richard Ramanius with Redeye. Please go ahead.
Hi. I wanted to continue on the last question that was asked. If you could define for us analysts and also investors what the main triggers for Fostrox's will occur this year. That is more or less when do you think the phase Ib will be finished and when do you think the phaseII a part might report? Next step would be initiation of phase IIb. When could that be?
I think If we start with phase Ib, Phase Ib will conclude at different times for the two different arms. I think we've been reasonably open in the past that the fostrox, I mean, we're recruiting nicely. Sort of we're very happy with the recruitment base. We can also see that the lenvatinib arm has been recruiting with a, sort of at a slightly higher speed. Interest in the pembro arm is very good as well. The lenvatinib arm has recruited a bit faster, it will, sort of very likely conclude the first and conclude earlier.
That's the one that we anticipate that Phase Ib to conclude sort of in that sort of, as I said, in the near term. Then, as soon as that concludes, we will initiate the Phase IIa, sort of soon after that. Meaning then that Phase Ib beginning of the year, for the lenvatinib arm, and then phase, initiating Phase II a, meaning that sort of Phase IIa date that more in the second half of the year. Then, if you then do the kind of the math and the planning, that would mean Phase 2b start in 2024 as we have communicated previously. Sort of Phase Ib in beginning 2022, Phase 2a second half... Oh, sorry, 2023.
Phase 2a second half of 2023, and then, Phase 2b start in 2024.
I guess there might be a delay of two months between the two different arms then, when the phase IIb sort of 2a part initiates or something like that.
There will be that. It's difficult to say the timing between the two. We are quite comfortable in saying that the one of the two arms would open in the near term. The other arm, it depends a little bit on the number of cohorts, and how far you go, et cetera. I wouldn't say. I think it could very well be two months, but it's difficult to say and promise that. The one, we are eagerly awaiting at least the first arm to open, phase II arm, to open in the near term.
Okay. Now you mentioned, you almost answered my second question, 'cause you mentioned there's more interest in the T-TKI arm. Would you say the waiting list is longer on that arm? 'Cause you said people were waiting to be enrolled in the expansion part. Does that relate more to the T-TKI part then? Would that also be particularly in the Korean sites?
The interesting bit is that we are, I mean, the waiting lists we have on both arms. We have been accruing the lenvatinib combination arm a bit faster. Maybe there's been a few more additional patients in from a kind of waiting list perspective. We're seeing the waiting list is there on both arms, and we have patients across the three different countries on that waiting list. I mean, there's a bit more Korean patients for the fact that we have than the other countries because we have, I mean, six sites. That's quite a few in Korea. HCC is more common in Asia than it is in Europe. By and large, you would have more patients.
Maybe there's a bit more Korean patients on the waiting list. Sort of we're seeing, similar, interest and engagement and patients waiting across the three countries.
Okay. Okay. Makes sense. lastly, I wanted to ask you about the Tango project. You mentioned they will submit an IND this year. Do you think they could initiate the phase 1 trial this year? 'Cause I assume that would be associated with a milestone payment.
The answer on the last one is yes, i.e., on the milestone payment. Clearly you don't open an IND unless you... I mean, so they're opening an IND because of intention to move into the clinic and move into phase I. There will always be a bit of time lag between IND and phase I. It depends a little bit on how quick they are on opening the IND. Sort of yes, we are anticipating sort of as they've communicated now that they're opening an IND, that means that they are intent on moving into phase I, and phase I will provide a milestone payment. I don't know if Linus wants to comment anything further on that.
No, that's correct. We have not discussed yet the amount of milestone.
Oh. Okay. That's all for me. Thank you.
This concludes our question-and-answer session. I would like to turn the conference back over to Jens Lindberg for any closing remarks.
Thank you. Operator, we can move to slide 27. Just to say that upcoming activities at a number of different conferences. We are also as from a data perspective, our next time for data sharing will be at the AACR conference, where we will at this time be sharing additional non-clinical data, building on what we've shown today. As I alluded to earlier, we're looking at both combinations, but we're also starting to look towards triple combinations and seeing how four drugs, adding four drugs on top of two other drugs, what that looks like from a non-clinical perspective. With that, thank you all for calling in, and thank you all for engaging.
We are happy with the progress we have seen under 2022, but we are even more so looking forward to sort of starting to see the first clinical data on both the combination arms and hopefully rapidly taking the 4 drugs program forward in primary liver cancer. Thank you all.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.