Medivir Q1 Report 2025. For the first part of the conference call, the participants will be in listen-only mode. During the Q&A session, participants are able to ask questions by pound key five on their telephone keypad. Now I will hand the conference over to CEO Jens Lindberg. Please go ahead.
Thank you very much, and welcome everyone to our quarterly report for quarter one 2025. We'll go through a presentation for the first 20 minutes-25 minutes, and then we'll open up the floor for questions. As we dive into quarter one and quarter one highlights, the most important step in the first quarter was, of course, presenting the final study data from our phase Ib/IIa study, which we presented at the EASL Liver Cancer Summit in Paris in February. A study that's taken way longer to conclude and close than we initially anticipated, as patients have been staying on treatment much, much longer than we initially estimated, which is clearly a positive signal with regards to patients benefiting from treatment. Step two, we continue preparations for the planned phase IIb study, which we named FOcuS-2. That continues.
What happened in quarter one was an important first step from a patent protection perspective, and that is we received the first patent approval for the important combination of fostrox and Lenvima by the European Patent Authority. From a business development and partnering perspective, the key step was Infex Therapeutics, our partner in the U.K. They signed the licensing agreement for the MET-X development in India. We will come back to that element briefly as well towards the end. With me in the room, as always, is our CMO, Pia Baumann, who will be walking through some of the data that we presented at EASL. Magnus will come back towards the end with regards to the financials. Our CSO, Fredrik Öberg, is in the room as well for any questions during the Q&A session.
With that, let's dive into the key event of the first quarter, i.e., the presentation of the final results of the fostrox + Lenvima study. Pia, over to you.
Thank you, Jens. Yeah, these end-of-treatment results were presented, as Jens said, in Paris at the EASL conference. The study actually closed in November last year. The data that we presented comes from this study. I thought that maybe I'd just do a little bit of a short repetition of what the study was about. Also, the poster is available on Medivir's website. You can see it as a little tiny thing up to the right corner here. If you would like to look more in detail, we have it on the website. The eligible patients for this study were those who had locally advanced unresectable or metastatic hepatocellular carcinoma, or as we continue to say here, liver cancer.
The patients were enrolled at 15 sites in the U.K., Spain, and South Korea, with the majority receiving a fostrox dose of 30 mg that was taken orally for five days in a 21-day cycle, together with Lenvima that was given in a standard dose for liver cancer. That was also given orally on a continuous basis. In order to understand responses, imaging was done with both CT and MRI every six weeks during the full follow-up time. The primary endpoint for this study was safety. Secondary endpoints included overall response rate, disease control rate, time to progression, and overall survival. That is what we are going to focus on when it comes to results today. We can go to the next slide. We now have a mature median follow-up for this patient population, which is 10.5 months in median.
Fostrox and Lenvima showed here a substantially longer median time to progression with 10.9 months and an overall survival with 13.7 months. This is compared to mainly retrospective data that we have seen in the second line setting. It is really encouraging data. We have also seen previously that we had a best overall response rate was 24%, with a median duration of this response of seven months, and with a disease control rate of 81%. It is encouraging from both a safety and efficacy perspective to see that patients are benefiting from this treatment during a longer period of time. We actually have these patients that now are not in the study anymore, but are still ongoing after being transferred to a compassionate use program and have been on the treatment for more than two and a half years.
We can go to the next slide. Coming back to this, that we sort of see, we evaluate the patients relatively early, looking at overall response rate. It is also very important to understand, okay, what happens with these patients? You can see this, yeah, we call it spaghetti plot, but to understand sort of what happened during time. The patients continued to be relatively stable during this treatment time. Those who actually received response continued with response, as we said, for about seven months in median. The majority had tumor control. Actually, tumor reduction was seen in more than 75% of the patients. We could see a median duration of clinical benefit of 11.3 months.
What we mean with clinical benefit is really those who responded and those who had a stable disease, which is really important in liver cancer to also have a stable disease for clinical benefit. This stable disease should be more than 24 weeks to be sort of included in the clinical benefit rate. If you compare with what you see in advanced liver cancer, this is very long, particularly in the second and third line advanced liver cancer. We can go to the next slide. The safety and the tolerability profile with this combination was really good. The majority of the patients could continue with the initial dose of fostrox through the treatment.
For the 29% that required dose reduction of fostrox, in order to find the correct individual dose level, as you often see in this kind of program, because you want to be as high as possible, and you always know that some of the patients will dose reduce. That sort of is also something that we are looking carefully into because we don't want to see that this kind of dose reduction affects the efficacy outcome. In this slide, you can see here that the dose reduction didn't really impact the response to treatment. The ones who are in the orange here are those who dose reduce. We could see that reduction in target size was seen independently if they had done a dose reduction or not. I think I'll leave it back to Jens now. Thank you.
Thank you, Pia. That kind of closes out the study in terms of having now presented final data. We have lived with this study for quite some time and are happy to be able to present the final and the mature data set. As I mentioned, sometimes we do not often speak too much about patent approvals. It is something that is usually, I mean, there is an expectation, this is business as usual. We wanted to highlight this one because this is with the combination patent of fostrox + Lenvima, having that approval in Europe, there are a couple of things that are important. One, having the European authority approve it signals positively the follow-on from other patent authorities as the European authority is seen as a highly respected one and one that others do follow. That is one critical element.
The other part is that it is with fostrox + Lenvima, and it is for liver cancer and cancer metastases in the liver. Since this is the combination and this is the indication that we are targeting, and that will be the key one for the drug, this will be a strong patent protection, i.e., then extending the patent protection until 2041, which provides protection for quite a long time. It was an important step in terms of generating protection support for as long as we possibly can. Quite encouraged by that. Having seen data, final data, the mature data set being quite encouraging, we now see that the combination, we are extending patent protection until 2041 to somewhat broaden our horizon.
One of the things that we continue to see in this area is that whereas many other tumor types, we see lower incidences and lower death rates, liver cancer is one of the tumor types that unfortunately go in a different direction. We see already today growth in liver cancer, very many times driven by growth in fatty liver disease. This is a relatively recent article where they've looked at how is fatty liver disease anticipated to evolve in the next, in this case, they modeled it until 2050, which is quite some time. Basically, it's going to grow at an alarming rate. The consequence is that if you have a fatty liver disease, there's a study at Karolinska that has shown that you have a 17 times increased risk of being diagnosed with liver cancer.
An alarming rapid increase of fatty liver disease will give a very significant increase to liver cancer. The anticipation here is that the incidence, and now we look at U.S. numbers, that the number of patients, the incidence number of patients will double. With incidence number of patients doubling, it will grow the prevalence even further. We look at it from a commercial potential perspective, the liver cancer market growth will grow even faster because more patients will be treated, more patients will be treated longer with better treatments being available in first line and earlier settings. We are anticipating quite a growth in the market.
To kind of highlight the numbers in the article, while we see a certain degree of fatty liver disease, that drives an even faster increase with regards to the incidence of, in this case, HCC or primary liver cancer. I think we've shown previously, and this is a shorter-term estimate, that the market, we're seeing the market grow, that market is growing quite rapidly, estimated to grow rapidly until 2030. If we look at some of the latest reports and the latest developments with regards to fatty liver disease, these numbers in terms of market growth is likely to be underestimated. If anything, it will probably grow even faster than this. Clearly, quite significant commercial potential.
To kind of close out the events of the first quarter, as I mentioned, we've been our partner in the U.K., originally AMR, but later renamed to Infex Therapeutics, who are driving the MET-X program. They signed an agreement or licensing agreement for development in India for a phase I study to be followed by a phase II study. The important element, if you dig through the press release and the information they've shared, is that they are also working with the company, in this case, Venus, and designing the study so that the data from these studies are also applicable and can be used with regulatory authorities in other parts of the world. It is a good way of driving the program forward. Clearly, Infex will receive license fee payments, milestone payments, etc. Our agreement with Venus is a relatively strict revenue share.
We are entitled to a share of any potential revenue that Infex receives from this program. With that, we'll close out the events of the first quarter and go to the financials before we go back to Q&A.
Thank you, Jens. If you can move to slide number 16, please, where you can see the financial summary for the quarter one and all numbers are millions of SEK normally. The turnover is in line with our expectations, totaling SEK 0.6 million, and its primary attribute is to the royalty income for Stacklea. Other external expenses have decreased significantly compared to previous year, as you can see. It is mainly due to the closure of the study, resulting in reduced clinical cost. However, there still will be some future expenses related to the study's closures, which aligns with our forecast for the year. Personnel costs have increased, primarily due to the share incentive program that was introduced last year, although there is no cash impact at this time for the program.
The operating loss for quarter was SEK -13 million, which is in line with our forecast and much lower than last year. The operating cash flow for the period amounts almost SEK -27 million, which is lower than last year. This figure includes the reduction of certain year-end accruals and costs associated with the study, which were paid in quarter one. At the end of Q1, the cash position is SEK 35 million, which is consistent with our forecast. Considering the cash balance at the end of March and the loan facility that we have, we project the current cash runway into Q4 2025 based on the existing plan and current assumptions. With this, I will hand back over to Jens again.
Yeah, we'll stop there and move to Q&A. Operator, we can open up the floor for questions.
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. Question comes from Richard Ramanius from Redeye. Please go ahead.
Good afternoon. Let's start with the fun question first. Where are you at with preparations for the phase IIb study? How are your works finding funding for it going forward?
Two questions. One, with regards to, I mean, we continue. We did not go into study design and the details because we presented that previously. That remains the same, stays that it is. We continue to drive the process forward together with our CRO partners in preparing the study. As you know and as we have communicated previously, those preparations are moving on nicely. We do need to secure financing in order to run the study. That process is ongoing with different discussions in terms of moving forward and finding a good way forward. It is details we cannot cover and say more until those discussions and those processes have concluded. It is similar in terms of what we have communicated in the past. The work with regards to preparing for the study together with our CRO partner, that continues.
Okay, I just have one final question for Magnus. Can we expect further decreases in operating costs on a quarterly basis before the phase II study kicks in?
I mean, we have the existing agreement that we have with the CRO for the study is closed now. I mean, there are some certain milestone payments that will be made. But it's difficult to say exactly if we have this in Q2 or Q3. There will be some milestone payment that has to be made. It is aligned with the forecast for the year. There will not be any surprises. We will have the cash runway, as I said, into Q4 that will remain the same. It is difficult to say when the cost will rise, in which month or quarterly. I hope that answers your question, Richard.
Yeah. Yeah. Thank you. That's all for me.
The next question comes from Klas Palin from Carnegie. Please go ahead.
Yes, thank you. Thanks for taking my questions. I guess my question will be in the same direction as Richard. I just wonder if you still feel you're on track with your preparations in the phase IIb study, and perhaps if you are expecting to dose the first patients in 2025?
I think I'll say what we said in the past and continue to say. The preparations with the CRO continue nicely. We have a very good collaboration with the CRO. Those preparations are moving along as they have previously. There is no change there. The key element that will impact the dosing timelines will, of course, be securing the financing. With regards to planning for preparations and engaging with sites and CRO, that continues as it has before.
If you have the funding in place, dosing of the first patient would be possible in 2025?
I mean, in a situation where we secure the financing, definitely. Yeah.
Okay. Are you feeling you're making progress with these funding discussions or what's happening?
The boring part with this question is that I can't really say anything. We've concluded any discussions and we've concluded a process. Are we having discussions? Are we in processes to find ways forward? Yes. In terms of communicating any details or any more specifics regarding it until we're there, I think it's just difficult to say anything. We are having discussions. We are in processes. I think that's what we can say at this stage.
Okay. Sort of the same question then. If you're considering doing on your loan facility, and if that happens, it's been Q2 or Q3?
I mean, of course, that's something that we're really looking into. I could say that per today, we have not used the loan facility. It could happen in Q2 or beginning of Q3. We have not decided yet.
Okay. Thank you so much for taking my questions. That was my last.
Reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. No more questions at this time. I hand the conference back to the speakers for any closing comments.
Thank you very much. Thank you for the questions. I'll just sum up. As we said, we continue on the path that we have been and still are on. We do have the first and only liver target treatment for primary liver cancer. Now that we've closed the study, now that we've seen the mature data, we continue to be quite encouraged by that dataset and the opportunity that it provides with regards to moving forward. We haven't touched on it that much today, but we continue to see that the key development, external development in liver cancer, continues to be in the first-line space, whereas there is relatively limited development in second line. The opportunity to move forward with speed, that opportunity to be the first approved treatment in second line, that window is still there. That's the window that we are looking to move into.
As I mentioned, the market that we've estimated previously, if anything, we believe that that market estimate is actually quite conservative, especially on the back of the fatty liver disease development that we are seeing, that if anything, seems to be growing even faster than anticipated, even despite the entry of the obesity drugs that we see in the world. That does not seem to be solving the problem with fatty liver disease. If anything, it seems to be going in a somewhat different direction. That market estimate is likely to be conservative. We continue to move ahead. We see an opportunity to become the first approved treatment in second-line liver cancer and are working diligently to find the best way forward with regards to financing and being able to execute the planned phase IIb study. With that, we close the call for today.
Thank you, everyone, for dialing in and have a good rest of the day.