Thank you, operator. Warm welcome to our Q4 and full year 2020 webcast. You will find our presentation on our homepage, and on slide three, I do recommend everyone to read the disclaimer, which will be, as I said, on our homepage as well for those of you who are interested in the details. Slide five, please. This is today's outline, where we will briefly touch upon our main projects, and then to be rounded off with our Q4 full year numbers. Slide six, please. Medivir has been around as a company since 1988 and started off as a virology-focused company back in the day. The company is listed on Nasdaq here in Stockholm, and our proprietary asset currently is MIV-818, which is a liver-directed nucleotide prodrug. We are currently in phase I-B clinical development and aim to initiate a combination trial later this year. MIV-818 has received orphan drug designation both in EU and the U.S. We have made a couple of achievements in the last months. We managed to out-license birinapant to IGM Biosciences, where we continue to expect initiation of a phase I trial later this year. We have also out-licensed one of our preclinical project, USP7, to Ubiquigent, which we announced just a couple of weeks ago. In parallel, we have completed a successful financing of the company, specifically to drive the next phase of our MIV-818 molecule. In the rights issue, a new specialist investor, HealthInvest, became a new major shareholder. We do also have two programs for partnering, that is remetinostat and MIV-711. Next slide, please. On slide seven, you will find an overview of our clinical projects. We have a focused clinical program called MIV-818, targeting liver cancer and currently in a phase I-B monotherapy clinical trial. We do have a partner asset, birinapant, which will enter phase I clinical development in IGM Biosciences' reins later this year. In parallel, there is an investigator-sponsored trial currently running at National Cancer Institute with the indication head and neck cancer. We do also have two clinical programs for partnering and out-licensing, remetinostat and MIV-711, which we will come back to later. Slide nine, please. Just a recap of the rights issue, one of our recent events here in the company. The preference of rights issue was completed successfully in February, and it was oversubscribed by more than 93%. With that, Medivir received around SEK 170 million before transaction costs. Subsequently, the board of directors decided to exercise the over-allotment option of SEK 25 million to the specialist investor, HealthInvest Partners. We do also have an EGM upcoming March 11, which is supported by the major shareholders to vote on a directed new share issue to Linc of approximately SEK 28 million. In total, Medivir will receive approximately SEK 223 million before transaction costs. Medivir will then have an ownership base with three strong institutions and specialist investors. Linc, which aim for a 10% shareholding, Nordea, and Health Invest. Thank you all for supporting the rights issue, and warm welcome for Health Invest as a new shareholder in the company. Also warm welcome to all other shareholders which participated in the rights issue and made that a successful transaction earlier this month. Slide 11, please. In mid-January, we signed a licensing agreement with IGM Biosciences. To recap that, IGM is a clinical-stage biotechnology company focused on creating and developing engineered IGM antibodies. IGM receives global development rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades IAPs, which then leads to cell death in tumor cells. birinapant is initially intended to be combined with IGM's antibody, known as 8444. This antibody targets DR5, death receptor 5, and it's being developed in different tumor indications. What we see is a potential Phase I trial then later this year with birinapant in combination with 8444 in solid tumors. Next slide, please. Medivir will receive an upfront payment of $1 million upon signing of the agreement, which has already occurred. An additional $1.5 million will be received when birinapant is included by IGM in a clinical Phase I study. Should birinapant be successfully developed and approved, Medivir is entitled to receive development, regulatory, and sales milestone payments up to a total of approximately $350 million. On top of that, Medivir is entitled to receive tiered royalties from the mid-single digits up to mid-teens on net sales. Currently, the tech transfer is ongoing with full speed. We should also mention that a prerequisite for this agreement was the announcement we made in December, the revenue share agreement with TetraLogic. Next slide, please. Slide 13. Just a reminder, this is a picture that was presented by IGM Biosciences at our web conference in connection to the licensing deal. As we can see, IGM-8444 plus birinapant shows synergistic impact on inhibiting tumor volume growth in preclinical in vivo models. Slide 15, please. Jumping to our own proprietary compound, which we are running clinical trials with. MIV-818 is a liver-directed nucleotide. It's an oral prodrug. Once absorbed from the GI tract, 818 is transported to the liver. The prodrug is taken up by liver cells and converted into troxacitabine triphosphate, which is the active moiety of this molecule. troxacitabine triphosphate is incorporated into DNA and causes double-strand DNA breaks and cell death. Next slide, please. We did in our phase I-A trial see selective effect of signals in liver cancer. There is a clear sign of cell death measured as DNA damage was observed in liver biopsies from tumor tissues in 818-treated patients. The tumor selective effect is an early proof of concept of the intended liver-directed effect in patients. You can see, as depicted in the pictures, brown coloring is evidence of DNA damage, which is not seen then in normal liver cells and enhanced post MIV-818 treatment. Next slide, please. Currently, we are reaching the end of the phase I-B monotherapy, which we hope to announce when that is completed. In parallel, we have started to work on and preparing the initiation of a combination therapy in the second half of 2021. Next slide, please. Just to illustrate what we aim for in the hepatocellular carcinoma space, we all know liver cancer is the third most common cause of cancer-related deaths in the world. HCC is the most common form of liver cancer. As we can see, in 2020, the HCC market was approximately SEK 1 billion, and it will grow rapidly to approximately SEK 3 billion. The growth comes from the combination therapies that will drive this. Previously, only monotherapy drugs was approved for the treatment of HCC. Next slide, please. Slide 20. We do also have two clinical programs for partnering and out-licensing. Those are remetinostat and MIV-711. For remetinostat, we expect the publication of the final BCC data, which is now being prepared. As we all know, there was an updated data points on ClinicalTrials.gov in late January, where the overall response rate from the announcement that we made in previous years was changed from 64% to almost 70%, which is seen to be very positive. For the final details, we will have to wait for the publication. With remetinostat, there was also an investigator-initiated phase II trial in squamous cell carcinoma that was conducted by the same group at Stanford University. The study was unfortunately terminated due to the delays from COVID-19, which resulted in difficulties to recruit patients, in the end, resulting in drug shortage. We expect data from the four patients studied in this trial to be published during this year. We look forward to see those results. MIV-711. We all know we have conducted a phase II study showing positive effects in bone and cartilage in joints in osteoarthritis patients. This was a six-month treatment where the primary endpoint was not reached. We are continuing to evaluating MIV-711 project. With that, I hand over to Magnus to go through our financial numbers. Thank you, Yilmaz. Please see slide 22, where you can see the financial summary for quarter four and for the financial year 2020. All numbers are in million SEK. As you can see, the turnover for quarter four amounts to SEK 1.5 million, which is more or less in line with last year and relates to royalty income from Xerclear. As you can see accumulated for 2020, the turnover amounts to around SEK 40 million, which is higher than last year and relates to both higher royalty income as well as the business deal that we made in quarter one 2020. During the year, we have been very cost-conscious. For example, we have Renégotiated the office agreement that we shown in quarter three report. As well in quarter four, we have now exit the rent agreement in U.K., which means that the liability on the balance sheet is substantially lower from now and onwards. As well, for example, we have Renégotiated some CRO agreements during the year, and as a result of that, we have received refunds from previous clinical studies in this quarter, which is shown as other operating income. The effect of cost-conscious is resulting in lower other external expenses as well as lower cost of personnel, as we have fewer FTE compared to last year. As you can see, the loss for the quarter four is around SEK 11 million, and for the financial year is around SEK 43 million, which is substantially lower than last year for 2019. The cash flow from the operating activities for the financial year 2020 amounts to SEK -58 compared to SEK -148 for the financial year 2019. The cash position at the end of 2020 is SEK 70 million, and with the proceeds from the rights issue that Yilmaz has mentioned, the cash is more than enough to complete the ongoing clinical activities. According to our current plans, we will have cash well into the year 2023. I hand over to you, Yilmaz, again. Thank you, Magnus. Slide 23, please. Just to sum up, we have a proprietary clinical asset, 818, a liver-directed nucleotide prodrug. Currently, we have started planning for a combination trial with the aim to be initiated in the second half 2020. In recent months, we did also achieve several milestones, of which highlighted here on this slide. We signed a business development deal, an exclusive global licensing agreement with IGM Biosciences. We did complete a successful rights issue and a directed rights issue to a new specialist healthcare investor, HealthInvest. We do look forward to complete the directed issue to Linc, which is also a specialist healthcare investor here in the Nordics. We do have two clinical programs for partner out-licensing, remetinostat and 711. We continue to work with those two assets. With that, next slide, and I would like to open up for a Q&A. Thank you. Our first question comes from Emanuela Branchetti from H.C. Wainwright. Please go ahead. Good afternoon, guys. This is Emanuela on for Joseph Pantginis. Thank you for taking my question. A couple of questions about MIV-818. I was wondering, can you remind us when we will see the dose escalation data? Can you give us maybe a little bit more color on the thought process around the selection of a combo asset for MIV-818? Good morning, thank you for two interesting questions. When it comes to the completion and reaching the maximum tolerated dose, I think we have guided end of this quarter. We hope to achieve that. It all depends with the new COVID-19 surge, of course, recruitment of the final patient into that trial. We'll come back to that. Regarding the combination treatment, I think we have a delicate work to do in-house because the positive thing with 818 is that it can be combined with all currently approved treatments for HCC. Those are a handful treatments, both antibodies, small molecules, tyrosine kinase inhibitors, et cetera. That is the final work that's ongoing at the company right now, and we will also convene an external scientific advisory board in a couple of weeks where we will get their inputs on what to combine MIV-818 with, hopefully where we believe we will see the best synergy in combination with another treatment. Also to discuss different dimensions of patient population within the HCC space. We have not landed that yet, but we will communicate when we have landed what kind of combination and design of treatments we will run in combination with 818. We will come back to that. Okay. Thank you. That's helpful. I guess my second question is about birinapant. What did you learn from your past birinapant experience, and what makes the new combination different from the past? Yeah, I think we tried to illustrate that on the call that we had in connection to the licensing agreement with IGM Biosciences. I think what we have learned that is birinapant as a single agent, it hits the targets, the intrinsic apoptotic targets, but as a monotherapy, it doesn't really drive the apoptotic mechanism in tumor cells, except for some indications or some instances in some patients. We have seen other companies working with SMAC mimetics, where they have shown a great success in combination therapies. All in all, to sum up, our experience is that you need to push the cell with some kind of extrinsic pathway, and in combination with birinapant, which then inhibits intrinsic apoptotic inhibitory pathway, you get basically a total synergy, at least what we can see in preclinical models. I think that combination made us, and we are quite excited about the IGM Biosciences and the death receptor five antibody combination, where they will push the extrinsic apoptotic pathway. At the same time, birinapant will then augment that signaling, so to say, by inhibiting breaks within the cell. I think that's the scientific experience, and that's the evidence we see out there, how one can use SMAC mimetics, and that's why we are so excited about the upcoming trials that IGM will run for birinapant. Sure. Thank you. You didn't disclose any indication for the new combination, but would the phase I be a basket study? Should we expect a basket study? Thank you. Very good question. Why it hasn't been disclosed, what indication? The indication that we have disclosed is solid tumors, and that disclosed by IGM. Why solid tumors? Because the combination, if it really works, it can go very broadly. As you have alluded to in your questions, most probably what we have learned from IGM will be a type of solid tumor basket trial, patients entering that trial to guide the further development of the combination. In the end, when you look at the mechanism and the science behind it and the preclinical models, we believe it can go very broad among many and different type of solid tumors. Got it. Thank you. Congratulations on all the progress. Thank you for taking my questions. Thank you. Just as a quick reminder, if you wish to ask an audio question, please press 01 on your telephone keypad. Once again, that's 01 on your telephone keypad if you wish to ask an audio question. Our next question comes from René Wouters from Kempen. Please go ahead. Thank you very much for taking my questions. It's René for Ingrid. First question is about your cash guidance. You indicated 2023, cash well into the year 2023. Does that include all of the proceeds from both the over-allotment option and the direct share issue as well? Is that still excluded from that runway guidance? Thank you for the question. It's included from HealthInvest Partners, but it's not included, the proceeds from Linc, as that is not decided yet. If that will be approved by the annual meeting as well, yeah, then we'll have even more cash into year 2023. Okay. All right. Maybe some extra words that you can share about the status of your partnering discussions for remetinostat and 711. That would be helpful as well. René, thank you for the question. I think we have to disappoint you on answering on that. Partnering discussions is difficult. You never know when they go home, so to say. It's like a dance. You need two parties, sometimes three parties, to come up with a final agreement or final collaboration or a licensing agreement. I think it's, for us, very difficult to guide when and how those will happen. Obviously we are working on them, but nothing that we can guide upon. Okay. Thank you very much. Thank you. There appears to be no further questions, so I'll hand back to the speakers. Apologies. There appears to be another question registered from Hans Engblom who is a private investor. Please go ahead. Hello, guys. Just one question in relation to MIV-181. Oh, 188. 1818, of course. You are sort of targeting the liver, but does anything of the troxacitabine move over from the liver to the kidney afterwards? Have you looked at that anything? Thank you, Hans, for the question. That's a very specific question. I don't know if I can answer that correctly. What we have followed is not only the signals that we show with the cell death that appear with the DNA strand breaks in the liver. We have followed the molecule in the peripheral system, that is in the blood. Right now, I cannot recall if I have heard anything, seen anything directly from the kidney observations. I do not expect that since I haven't heard anything, but let me check that up internally and come back to you. Yeah, that's great because it could be an opportunity, actually. Yes, obviously, it is if it enters into the kidney, absolutely. Yeah. Also the opportunities, right now we have been, when we mention liver cancer in the trials that we have, we have hepatocellular carcinoma, we have cholangiocarcinoma patients, we have colorectal cancer patients who have metastasis in the liver, et cetera. If this drug gets approved in the market, the potential indications and patient population that it can be used with is very broad. Yeah. We know the colorectal cancer market is a $9 billion market. Obviously, not all of them metastasize or are late-stage patients, but a significant amount of those patients are late-stage patients. The thing will be finding the right combination for those different indications. We have a, so to say, a positive dilemma internally because 818, with this differentiated mode of action and differentiated as an oral compound directing the liver, we have positive issues is that we can go down so many avenues. We need to decide, and that's why we have invited people and will invite people to set up a external scientific advisory board in a month or two to really get their feedback to understand which avenues should we go down first. That's why we aim to initiate a combination trial in the second half of this year and where we have started to work on that. That's our, so to say, positive dilemma internally right now. Yeah, great. Thank you. Thank you. There appears to be no further questions. I'll hand back to the speakers for any other remarks. Operator, thank you so much for hosting this web conference and teleconference, and thank you all for very interesting and insightful questions. Thank you all to all the new shareholders and existing shareholders who have helped and participated in the latest financing round. Warm welcome, especially to the new shareholders. With that, I wish you all a pleasant weekend. Thank you so much.
Loading workspace