Thank you, operator. A warm welcome for everyone to our quarterly update. Slide three, please. As a reminder, you will find our presentations on our homepage. I do recommend everyone to read the disclaimer on slide three. The agenda for today will be a brief overview of the company then to be rounded up, but with our Q3 numbers presented by Magnus. Slide four, please. As you all know, many of you who have observed Medivir, the company has been around since 1988 and started off as a virology-focused company. Today, the company is focused on oncology and clinical development, the company is listed on Nasdaq Stockholm here in Stockholm. Our proprietary asset is MIV-818, is a liver-directed nucleotide prodrug, and we are currently in the Phase I-B clinical development.
We have received orphan drug designation both in the EU and the U.S. for this compound. We have in the last year or so downsized the company and built a clinical development-focused company, and we are now in total nine FTEs and have, to our belief, an efficient organization to execute on our clinical trial. We do also have several programs for partnering, and these are remetinostat, birinapant, and MIV-711. Slide five, please. This slide shows an overview of our focused clinical program and our programs for partnering. As mentioned, we are fully focused on developing MIV-818 for liver cancer. Currently, the project is in phase I-B clinical trial and in the part A of that trial where we dose the patient in a three plus three cohort as a monotherapy.
Subsequent to that trial, a part B of the Phase I-B will be initiated next year sometime in combination therapy. We do also have multiple programs for partnering remetinostat, a topical HDAC inhibitor. We have birinapant, a SMAC mimetic, 711, a cathepsin K inhibitor. slide six, then slide seven, please. Our proprietary project, 818, is a liver-directed nucleotide. It is an oral prodrug. Once absorbed from the GI tract, 818 is transported to the liver. During the first-pass metabolism, the prodrug is taken up by liver cancer cells and converted into troxacitabine triphosphate. Troxacitabine triphosphate is incorporated into the DNA causes double-strand DNA breaks and cell death. slide eight, please. We have pre-clinical evidence of 818 liver targeting features.
In the preclinical model, where we measured levels of troxacitabine in the liver versus troxacitabine in plasma, we could show that 818 displays 100-fold higher liver targeting capability in comparison to intravenous troxacitabine. Slide nine, please. To show the efficacy of 818, we have, amongst others, conducted preclinical xenograft models where we could show a dose-dependent inhibition of tumor growth. You see that on our left-hand side graph where rounded white circles are the placebo. You have a low dose and the blue circles, which correspond to high dose 818. In a similar fashion, on our right-hand side, we see a comparison of 818 with the broadly used multikinase inhibitors, sorafenib and lenvatinib in HCC hepatocellular carcinoma cell lines derived from patients that 818 is very efficacious in inhibiting these cancer cells. Slide 10, and then 11, please.
When it comes to clinical data, we have conducted a dose escalation phase I study in nine patients where we see signs of selective effects of 818 in tumor cells. This is depicted in the center picture and the picture on the right-hand side. As you can see, evidence of DNA damage, that is the brown coloring on the right-hand side picture in tumor cells, but not in the center cells where we see the normal liver tissue cells. Slide 12, please. To depict the timeline for our ongoing clinical trial, we are right now in the midst of the phase I-B part A where we dose 818 as a monotherapy. This is an inpatient dose escalation cohort study where we have three patients for each cohort. We expect data from this trial in the first quarter 2021.
Bear in mind, we do also see a surge of the COVID-19 pandemic as we speak. If this will have any impact on the timeline for the phase I-B monotherapy part, it is too early to know. Subsequent to that, we will initiate next year a phase I-B, part B, as we call it. That is an add-on of MIV-818 on top of standard of care or existing therapy. Slide 13 and then 14, please. As mentioned in the presentation, we have multiple programs for partnering. We have the remetinostat, a topical HDAC inhibitor, where the company sponsored trials were ran until phase II. This compound is ready to go into phase III if we find the right partner. It has also been conducted a phase II investigator-sponsored trial in basal cell carcinoma, where top-line data has previously been published.
We do expect a full publication of this data in the near-term future. birinapant is a SMAC mimetic. As you are aware of, the company did run a phase II trial in combination with KEYTRUDA. End of last year, we did announce that the trial was futile, and it has now been closed down completely. For this compound, we are looking if there are any opportunities for partnering as a combination trial in solid tumors. MIV-711, a cathepsin K inhibitor for the indication osteoarthritis. This compound has also been through company-sponsored phase II trials, and we are reviewing how to take this compound in a potential next phase II or phase III trial. This has to be done with a partner. With that, I'll hand over to Magnus to run through our third quarter numbers.
Thank you, Jim. Please go to slide 15 and then 16, please. Here you can see the financial summary for the Q3 and accumulated to Q1 to Q3. You can see in the period, the turnover is SEK 1.1 million, which relates to royalty from Xerclear, a bit lower than last year. If you look at the cumulative figures, you can see that it's higher and it's due to higher royalty as well as the preclinical assets that were made from business deals in Q1. You see in other operating income, you can see the effect of our renegotiated lease agreement for our office space in Stockholm. I could say the effect is more an accounting effect for this quarter, more importantly, it means that our rent cost from January 2021 will be substantially lower than we have today.
That's very positive cash effect for next year. If you look at other external expenses, it's much lower than last year, and it relates to general cost control as well as we only focus this year now MIV-818 clinical study. Last year we had two clinical studies ongoing. Personnel cost in line with last quarter last year, but if you look at the cumulative figures, you can see it's well below last year. The next financial item is the revaluation of our liquid funds. As you can see, we have done in quarter 1, due to the pandemic COVID-19, we had some setback there, but now it's turning around, so we have positive figure accumulated there as well.
If you look at the cash flow for quarter three, it amounts to SEK 17 million, which is a large improvement from last year of SEK 32 million, accumulated it is SEK 57 million minus compared to SEK 125 million. We can say the burn rate is much lower now than it used to be. In the quarter, we were nine FTE end of September, the cash position at the end of September were SEK 83 million. The current cash is sufficient to complete ongoing clinical activities. Now we have summarized it. Two takeaways from this slide is that general good cost control, the costs are much lower, the new office agreement, which will mean that our cash burn will be much lower next year. Hand over to you, Yilmaz, again.
Thank you, Magnus. Slide 17, please. As a summary, as we mentioned during the presentation, we are focusing on our asset MIV-818, a liver-directed nucleotide prodrug. This is a proprietary asset and currently in a phase I-B clinical development as a monotherapy. We do expect data from this monotherapy part in Q1 next year. Subsequent to that, we will start a combination trial with one of the standard of care treatments within this segment. As a reminder, we do see a surge from the COVID-19 pandemic. This may, of course, impact our timelines regarding the Part A of the phase I-B clinical trial. I think we have now the right size and an efficient organization to conduct a focused execution on the MIV-818 clinical development program. We do also have other programs for partnering. As we mentioned, remetinostat, birinapant, and MIV-711.
With that, I'll hand over to your operator to take on questions.
Thank you. If you have a question for the speakers, please press zero one on your telephone keypad now. Our first question comes from the line of Joseph Pantginis from H.C. Wainwright. Please go ahead.
Hi, good morning, and good morning, Yilmaz. Good luck with your new position. Wanted to ask, I guess one more macro question and then a little more diving into the details. First, obviously a lot of efforts have been done to refocus the company and also including cost control. That's great. I guess from a macro standpoint, wanted to get a little bit of your vision for the company at this point, since there is currently such a good amount of focus.
Yeah. On a high level, Joe, thanks for the question. On a high level, I think we have started when it comes to MIV-818 and our focus on clinical development. As you know, this was a virology company before and now focused on oncology. We have started a strategic work when it comes to MIV-818 to understand the position or potential position in the future hepatocellular carcinoma market, but also potentially as a drug for intrahepatic cholangiocarcinoma. We hope to finalize that strategic work in Q1 next year. As you are aware, several oncology indications are very dynamic, with especially hepatocellular carcinoma at the moment. We need to understand where we find MIV-818.
The position of it due to its specific mode of action and differentiated mode of action with current approved drugs, but also in comparison to drugs that we see in the clinical development programs out there.
Got it. Thanks. The more specific question is, it was very nice to hear that we'll be seeing a peer-reviewed publication regarding the remetinostat data, so that'll help continue to boost the visibility for that asset. With that said, I guess I would ask a question that I commonly ask here is if at this point, can you describe the tenor or the level of the conversations that are happening on the business development front? That would be a very exciting transaction for the company.
Absolutely. Thank you for the question again, Joe. Since I came into the company, it has just been eight weeks. I have started to look into our programs for partnering, amongst others. As you can imagine, a lot of things ongoing. For me to understand why these haven't been out licensed as of now, I believe what I see is that there might be some opportunities there. However, it's very premature for me to comment on the likelihood of achieving partnerships at this moment. I hope if you give me some more months, I might be able to comment that in a better way.
Of course. I always characterize that question as "have to ask it." Best of luck in your new position, and look forward to catching up soon. Thank you.
Absolutely. Thank you, Joe.
The next question comes from the line of Ulrik Trattner from Carnegie. Please go ahead.
Thank you very much. Good afternoon, gentlemen. Actually, a follow-up on the business development side. As you mentioned, you have three products that you have the potential for entering partnerships. What would differ now from what the situation has been before? In my opinion, it rather seems like the IP of majority of these assets is running out of time, so thus the value of these assets should deteriorate over time. Were there to be any additional data that enables you to license these assets? Obviously, you're not relatively new to the company. How would this differ from what we have heard before?
Thank you for the question, Ulrik. As I mentioned, I'm looking into these assets. As you mentioned IP is always a ticking clock, and as time passes, it's a headwind as you alluded to. We have to see where the science will take us. I think we will have to take another look, a fresh look on all of these three assets to see if there is something to be done here or not. As I mentioned, it is premature for me to comment on the likelihood of achieving something at this moment. I'll do my utmost to see if we can carve out or take out something and create value for Medivir shareholders.
Sure. Would you ever consider to just out-license these assets without any milestone payments related to them, just considering creating any type of value based on future royalty of sales?
I would say that everything is on the table right now. It all depends if we can create some value, if we believe we can create some value for shareholders. If it comes to out-licensing without any milestones, that will all depend on what type of partnership one could create. Is it a credible partner who can run this clinical trial or not? I think we need to add that into our equation if we see if that will create any value for the shareholders.
Okay, great. Two more questions. It is very important to look at the selectivity of MIV-818, especially given the sort of profile of troxacitabine and given that it's a prodrug. What type of conclusions can you derive based on the data that you're planning to present in Q1 next year on the selectivity of the drug? I mean, it's a dose escalation study.
Yeah, it is a dose escalation study, and I think we'll have some more data on the selectivity. We will probably conduct some more biopsies to get more evidence on that. But really to understand the efficacy of the drug, I think we'll see that in our Phase I-B Part B where we do a combination trial with the compound, with any drug, so to say. That drug that we're going to do combined with, we haven't really set up with that. That's why we have our strategic work here, because what we believe going forward in the hepatocellular carcinoma space specifically, but also probably in the cholangiocarcinoma space, is that doublet therapies will dominate in the future. It's a question about where we find MIV-818 would suit, which partner should we go with as a combination treatment, for example.
There is also some speculations out there that there might be also be triplet kind of therapies in the future when it comes to the hepatocellular carcinoma space. It is a bit premature there as well, since we haven't seen so much clinical data or evidence yet. I think the best trial to answer your question, there will be after the second part of the Phase I-B, when we start combining MIV-818. I think looking at our preclinical data, looking at that we have done on top of the multikinase inhibitors, for example, we clearly see that 818 adds efficacy on top of those. That's preclinical data. We need to show that in the clinic as well.
All right. Just a few follow-ups, obviously a financing question on top of that. As you mentioned that you enhance the effectivity or the efficiency of the standard of care PKIs, but they tend to be rather toxic. To what extent do you believe that you can actually have a more manageable toxicity in combination with these PKIs?
Well, that was one example. These are the preclinical trials or experiments that we have done. What we will partner with or combine with going forward with this compound is yet to be answered, and that's why we have a strategic work that we are conducting internally and hope to finish that in Q1 next year to understand the path forward. As we know so far is that doublet therapies will dominate in the hepatocellular carcinoma space. One of the questions in the Phase I-B combination trial is to understand the toxicity level. How high can we dose 818, or how high can we dose, as an example, the multikinase inhibitors and still have tolerable profile of this combination? There are many more combinations that can be done within this area as the multikinase inhibitors are not the only drugs approved in hepatocellular carcinoma right now.
Okay, fine. It was highlighted in your call that you essentially said that you're financed for your ongoing clinical activities, does that also include the Part B of the phase I study as well, or is that supposed to be additional financing needed for that to be completed?
Magnus here, thank you for your question. What I can say is that the cash we have today is sufficient to complete the ongoing, and the ongoing is the phase I-B Part A study that we're doing now.
Okay. It's a fair conclusion to say that additional financing are needed to complete Part B?
Yeah. That's something for the future to be decided yet.
Okay, great. The last question before I'll hand back over to the queue is just somewhat more of a broader question to you, Yilmaz. In this short amount of time, just your thoughts on how you would like to position Medivir differently from what Uli and the former management team positioned the company, and just your broad picture of where you believe Medivir is going, in what direction.
Yeah. Basically, what we're doing is we continue the work that Ulrik initiated, but try to sharpen and make the organization more effective in the clinical development space, basically, and then start off with MIV-818. Let's see if we can succeed with MIV-818 by positioning it, finding right combination partner, and deliver on the clinical trial. Then we'll see the efficacy of those trials and if we can take MIV-818 all the way to the market. It will be data dependent, of course. Having built a clinical organization, we don't speak to that anymore in our quarterly report, but I think Uli has mentioned it previously. We have some other compounds in preclinical stage, which needs some more work to take into the clinic, especially from our prodrug platform for different indications than MIV-818.
My focus right now is to get the clinical development up and running, come into the efficacy phase of the MIV-818, and then if we have the mandate from shareholders and we have the right organization, we will try to bring in more proprietary assets into the clinic from our own pipeline.
Okay, that's great. Thank you very much. Good luck, Yilmaz. We'll talk to you soon.
Thank you.
Just as a reminder, if you do wish to ask a question, please press 01 on your telephone keypad now. Our next question comes from the line of Joseph Hedden from Rx Securities. Please go ahead.
Thanks. Good afternoon. Most of my questions have actually been answered. If I could just ask one regarding biopsies. Is it your intention that every patient receives a post-treatment biopsy? Is there any kind of time course there, i.e., if they're starting biopsy at different points throughout treatment? Is there any potential to compare to existing data of patients who have received other treatments for liver cancer when it comes to biopsy, or is it worth some kind of natural history study there? Thanks very much.
Thank you, Joseph. I think I heard the first part of your question, but please repeat the second part of the question.
The second part was just related to patients receiving, for instance, TKIs. Is it well characterized liver biopsy tissue there so that perhaps you can have a handle on selectivity of your drug versus what you might see in the biopsy tissue of other patients?
Okay. When it comes to your second part, I think I have to come back to you. I don't really know the answer at the moment. Regarding the first part, yes, I think we are taking biopsies from these patients, but I cannot answer right now how many biopsies in exact what time points that we take those biopsies. I don't expect that since being a very invasive type of procedure right now, I do not think that you get a pretreatment and a post-treatment biopsy. Most likely just a post-treatment biopsy just to see the differentiation between healthy liver cancer cells and tumor liver cancer cells, so to say.
Okay. Thanks very much.
As there are no further questions, I'll hand it back to the speakers for closing remarks.
Thank you, operator, and thank you everyone for the great questions. With that, I would like to conclude our third quarter telephone conference. Stay safe out there.