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Edited Transcript of MVIR B.ST earnings conference call or presentation 28-Aug-19 12:00pm GMT

Q2 2019 Medivir AB Earnings Call

Huddinge Sep 13, 2019 (Thomson StreetEvents) -- Edited Transcript of Medivir AB earnings conference call or presentation Wednesday, August 28, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Linda Basse

Medivir AB (publ) - Chief Medical Officer

* Magnus Christensen

Medivir AB (publ) - CFO

* Uli Hacksell

Medivir AB (publ) - CEO, President & Director

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Conference Call Participants

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* Ingrid Gafanhão

Kempen & Co. N.V., Research Division - Research Analyst

* Joseph Pantginis

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Klas Palin

Redeye AB, Research Division - Equity Analyst

* Ulrik Trattner

Carnegie Investment Bank AB, Research Division - Research Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, welcome to the Medivir Q2 Report 2019. Today, I am pleased to present Uli Hacksell, CEO; and Magnus Christensen, CFO. (Operator Instructions)

I will now hand you over to Uli Hacksell. Please begin.

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [2]

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Thank you, and good afternoon. I'm Uli Hacksell, and I'm joined by Magnus Christensen, our CFO; by Lotta Ferm, who is our previous Interim CFO, who will -- was in fact responsible for the financials in the second quarter. Also here is Linda Basse, our Chief Medical Officer.

And I will ask you to look at Slide #2 first because it has some important forward-looking statements, and I think it's important that you read that.

Now let me move to Slide 3 and ask Magnus to go through the financial summary.

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Magnus Christensen, Medivir AB (publ) - CFO [3]

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Thank you, Uli. Hi, everyone. My name is Christensen here, CFO. If you look at Slide 3, you can see the financial summary for the group for the quarter 2 and accumulated quarter 1 and quarter 2. You can see the turnover quarter 2 amounts to around SEK 4 million, which is a small increase from last year and relates mainly to higher royalty income from simeprevir. And you can see also that the loss before tax has improved significantly in the quarter compared to last year and amounts to minus SEK 12 million compared to SEK 93 million. And of course, it relates mainly to restructuring in the company, which was done in quarter 4, 2018. And the cost base is much lower now and relates mainly to the personnel and other [cost] expenses.

And we anticipate that we will see the full effect in the quarter 3 this year with operational fixed costs will amount only 1/3 of last year's level, as we have communicated before. Accumulated quarter 1 to quarter 2, we can see we have a loss of SEK 68 million compared to SEK [165] million last year, and you can see the main improvements have been done in quarter 2.

The cash position at quarter 2 is around SEK 192 million, and we can see that we have continued to slow down the pace and we will continue so for the remainder of this year and, of course, is related to restructuring mainly. And the market cap is around SEK 590 million today. Thank you.

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [4]

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Thank you, Magnus. Let's move to Slide #4. I would like to go through with you some highlights. Obviously, we have seen important things happening in our clinical development portfolio, which is focused on oncology. First, we have our Phase II program with birinapant and KEYTRUDA, where we are looking at patients with MSS colorectal cancer, where we have recruited 15 patients. We are studying these patients, and we will conduct an interim analysis based on the outcome of these patients in the fourth quarter this year before we move on to the rest of the Phase II study.

Also very importantly was that we took a first look at the Phase Ia data with MIV-818, our liver cancer drug and saw an initial proof-of-concept already after 6 patients, which is very encouraging. We will also decide at that point to move into the Phase Ib study as soon as we have conducted additional significant analysis, pharmacokinetic analysis of the few additional patients. So very exciting progress.

We have obviously continued with a business development focus on our Phase III ready programs, remetinostat or CTCL and MIV-711 for osteoarthritis. And we have additional business development activities going on, on our early-stage programs, the preclinical programs.

As Magnus mentioned, we have succeeded to reduce our running costs significantly, and we have reduced the staff from mid-October last year when we were 75 or 76 FTEs to the current number of 14. And this is the reason really why we have been able to reduce the cash consumption so greatly. In fact, as Magnus said, we have already succeeded to essentially reduce the fixed costs to -- with about 2/3 from where they were October last year.

We have now a small organization, but it's strong and effective. As you will see on the next slide, Slide 5, in addition to Magnus, we obviously have Christina Herder, who has been with the company for some time. But we also have a clinical development organization, which, I think, is small, but very strong with a lot of experience and knowledge in it, led by Linda Basse. And we have recruited another M.D., Rikard Höse, with a lot of experience from clinical oncology. He will be very useful to strengthen our knowledge base in this area. We recruited a very strong Clinical Ops Leader in Linda Palmér from Pfizer, and we have a very skilled Chief Scientific Officer, Fredrik Öberg, who is a professor from Uppsala University. So I'm very pleased with the set up from the -- in the clinical organization and believe that we can handle our development programs very wisely with this group of people.

So let's move to Slide 6. This is our pipeline. On the top, you see our 4 oncology programs from the most advanced to MIV-828, which is still a preclinical program. And then at the bottom, we have our osteoarthritis program, MIV-711. What I really want to mention and focus on, on this slide is the long exclusivity that we have for all of these programs. And that's obviously very important and allows us even if it takes awhile to develop these all the way to the market. We have a long exclusivity remaining on these programs.

So with this, I want to go through each of the programs and take you through them in some more detail. And let's start with remetinostat, which is in development for early-stage cutaneous T-cell lymphoma. And as you can see on Slide #8, this is a rare form of non-Hodgkin lymphoma, which primarily presents in the skin and it does so in a way that the skin lesions are the major problem from this indication for a long period of time until it progresses into more severe disease. So you've skin lesions and you have also a severe itching as the major quality of life problems for these patients. It's a relatively rare disease. It's an orphan indication. But it is an indication that at the same time lacks really very good treatment options, in particular, in the mild early stages. There are various systemic HDAC inhibitors available. They are oral and have a number of side effects. And we have other treatments like bexarotene or Valchlor, which are not particularly nice treatments either.

As you can see on Slide 9, we believe that we have a drug candidate with a major advantage as compared to what is available today. And this clinical development candidate is called remetinostat. It's a topical histone deacetylase or HDAC inhibitor. The topical treatment, which is relatively stable in the skin that is broken down very, very quickly as soon as it's taken up by the blood. So therefore, we see very few side effects, if any, from remetinostat. So this is a big difference compared to the oral systemic HDAC inhibitors.

If you go to Slide 10, we present there what we saw in Phase II. We saw a good effect, increasing effect with higher concentrations of remetinostat given to patients on the lesions, and we saw a very significant reduction of the severe itching by these -- in these patients by higher doses of remetinostat. So very exciting and promising data in Phase II.

Following these data, we went to the FDA and had [with them a] Phase II meeting. And they told us that one pivotal Phase III study will be sufficient to obtain approval for remetinostat, but it turns out also that they put some requirements on the Phase III design [we had a look] at that. It's a pretty expensive study that they proposed, which will -- it's a little bit too expensive for us to conduct alone. So we are currently talking to potential partners who may help us to: first, develop remetinostat to the market; and second, to commercialize it successfully.

If you go to Slide #12, see that we are also conducting an investigator-sponsored study in basal cell carcinoma, and we have presented at SID in Chicago that during the spring data from an interim analysis of this ongoing Phase II study in BCC. It turned out that data were very promising. We see very positive effects on the lesions in these patients. Many of the tumors were fully cleared. And in terms of safety problems, the only thing that we saw was eczemas in some of the patients, which were reversible at the point of the treatment with remetinostat. So we think this is quite an interesting indication for remetinostat as well, and we are, of course, very much looking forward to seeing the complete study data. We don't have a specific date for that, but we believe that sooner or later, we will see this data and think that it will be quite exciting.

So the next drug candidate that I want to talk about is birinapant. This is a development candidate that is in development for various solid tumors and with the focus on colorectal cancer, as you can see on Slide 14. This is a cancer indication with a large unmet medical need. There are a few treatment options, and the need for better medicines is very strong. The immuno-oncology medicines are not particularly effective for this indication and in particular Keytruda is very -- has lack of significant efficacy for treatment of MSS colorectal cancer, which is the major cancer indication here that we're talking about.

Just to mention a few things that really demonstrates the severity of colorectal cancer, the 5-year survival is only 14% in metastatic for example, and there is a lot of cases. So this is a big, big indication.

Birinapant, we believe, has an option to be very effective here, in particular, when it's combined with an immuno-oncology agent. Birinapant is a SMAC mimetic that acts by inhibiting or destroying proteins that protect cancer cells from hepatosis, and at the same time, birinapant augments the immune system. So it has a dual action, which we think -- believe that together with Merck's Keytruda, will have the potential to be very effective in this type of cancer. So we are currently doing a study together with Merck's Keytruda. And I want to mention that -- despite that we are doing it together with Merck, we retain all the rights to birinapant and the rights to the data as well.

So the ongoing combination study of birinapant and Keytruda is a Phase II study, which follows a Phase I study that was completed last year with 19 patients and currently we have recruited 15 patients in Phase II with the combination.

The Phase I study was interesting and there we looked at the effect of the combination therapy as shown on Slide #17 in a number of solid tumors. One of the patients, who was treated with the combination in Phase I, was the patient that had MSS colorectal cancer. And that patient has now been on treatment for well over 80 weeks and is a partial responder. So that is very interesting data and very promising. We also have some other positive responses in Phase I, but we decided to focus on MSS colorectal cancer patients in Phase II because of the lack of effects of Keytruda in that cancer population and hoping that we will get a clear answer in Phase II.

So with the 15 patients recruited in the ongoing Phase II study, we will conduct a futility analysis in the fourth quarter this year of the -- using the data from these first patients before we move on into the second part of the Phase II study. So again, fourth quarter, we will see the futility analysis outcome and at least top line data from the first part of the Phase II study.

So let's move to MIV-818 on Slide 18. This is a nucleotide prodrug that has been developed from scratch at Medivir. And this is a development for the treatment of liver cancer.

As you can see on Slide #19, primary liver cancer is a very severe cancer type. It's the third-leading cause of cancer-related deaths worldwide. It's an orphan disease in Western markets, but it's very common in Asia, in particular, in China and it has a poor 5-year survival, [around] 18%. But it's also interesting to note with primary liver cancer is that it's a heterogeneous type of cancer with many different genetic components. And that means that if you have a molecularly targeted therapy, it will only address a relatively small part of the HCC cancers. And therefore, we think that having a more blunt treatment will allow for treatment of all types of cancer.

MIV-818 is a proprietary new chemical entity that we discovered at Medivir, and it's specifically developed for cancers in the liver. Can we then -- we can think about it as having the potential to develop as a new treatment for primary liver, but also as a treatment in combination with other standard of care treatments for various liver cancers. We think it has a tremendous potential.

Slide 20. We demonstrated some of the characteristics of MIV-818. So this is a prodrug of a molecule called troxacitabine, and troxacitabine itself has been shown to have clinical efficacy. The reason why it hasn't progressed all the way to the market is that is not a very safe molecule, it has a severe side effect profile. What we decided to do was to combine it with a prodrug principle so that when it's taking up orally, it goes immediately to the liver. It's transformed into the active component in the liver and therefore, we can get very high concentrations of the active component in the liver, and we expect very low concentrations of active components outside of the liver. And therefore, a good side-effect profile and a high efficacy. So that's the concept behind MIV-818.

We have decided to move into the first Phase Ia study, where we essentially want to try to get as high as possible into dose testing so that we can try out as quickly as possible with close to optimal doses in Phase Ib. And as I mentioned, we already have looked at the first 6 patients that have been tested in Phase Ia and we reported that in June this year. So the primary purpose the Ia started was, of course, to evaluate the safety and tolerability of MIV-818. But in addition to that, we wanted to do as -- learn as much as possible on very early in Phase Ia about the activity of MIV-818. So we have conducted liver biopsies of the patients to look at what is the effect of the treatment on liver cancer cells. And we have done careful evaluation also of the pharmacokinetics in plasma to see -- ensure that we have low levels of active components in the plasma and that we have a good effect in the liver cancer cells.

As you can see on Slide #25, we saw, in fact, quite dramatic changes in the liver following these relatively low doses of MIV-818. On the left, you see data from patient 2; and on the right, you see data from patient 4. And patient 2 then had a lot of staining of cancer cells in tumorous tissue and no staining in normal liver, which means that it -- the drug interrupted the DNA in the tumor tissue, but not in the normal liver. And the same response is obviously apparent also in the data from patient 4. So this is very promising. It is not a definitive proof that we have anti-cancer effect, but it's clearly indicated data and it's the first proof-of-concept.

We also were able to show that we had an effect of MIV-818 in hypoxic areas and that we saw in DNA damage there as well. And this is normally a common limitation for chemotherapy and therefore, it's a very interesting finding. And you can see these effects on Slide 25.

So let me summarize the -- what we have learned from Phase I with MIV-818. First of all, it has been well tolerated. We saw some lowering of blood counts as expected. So this means that we are not very far away from where we want to be when we start Phase Ib. We saw clear signs of effect as measured by DNA damage in liver biopsies, and this is very promising. And the fact that we saw the effect on treated patients in the tumor tissue, but not in normal tissue is that we have a selective effect on cancer cells. So this is, again, an initial proof-of-concept here, which we are very excited about.

So where are we moving from here? Well, as we have said, we intend to look at genetic data from a few more patients and then move into Phase Ib as soon as possible sometime in the fourth quarter we are planning this year.

Let me finally say a few words about MIV-711, our osteoarthritis compound. So this is Slide 28. As you all know, osteoarthritis is a very common form of joint disease, with a lack of disease-modifying medicines. The current medicines for arthritis are all focused on pain relief, but not on disease modification.

What we are targeting with 711 is really to slow down or stop the disease progression, which consists of bone destruction and cartilage destruction. And as you can see on Slide 29, we have been able to demonstrate that in the Phase II study that we have a reduction of the bone destruction after doses of MIV-711 for 6 months and that we have a reduction of the destruction of the cartilage as well. So both of these observations after the 2 doses tested of 711 indicate that we clearly have an observable disease-modifying effect already after 6 months of treatment. We also saw an indication of reduction of pain related to this slowdown of the disease process.

So in summary, very promising data from Phase II. In addition to that, the FDA has opened up for disease-modifying agents in new guidelines -- new graph guidelines that came out last year. So we think that there is a lot of promise ahead for the drug candidate like MIV-711. It's a bit expensive to go through Phase III clinical trials with 711. And therefore, we are currently searching for a partner that can help us to go through Phase III studies with 711. We think it is super blockbuster potential of 711, but again, one needs to be able to invest in the relatively expensive clinical studies here.

So let me finally move to Slide #31, say a few words about the -- repeat a few things about the near-term value inflection points. First, we expect to initiate the Phase Ib study with MIV-818 at the good starting point in terms of dosing in the fourth quarter this year, and that will be very exciting. And obviously, the futility analysis from the study of the combination of birinapant and Keytruda in colorectal cancer that we will see in the fourth quarter as well, will be exciting as well. And then obviously, we hope to see some results from our ongoing business development also, but that's something that we will keep you posted about from time to time.

So with that, I thank you for your attention and open up for any questions that you may have. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from the line of Joe Pantginis from H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

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Two questions, Uli. First, with the birinapant futility analysis in the fourth quarter, is this something that's going to be a typical continuous plan type of press release? Or is there a potential for actual data?

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [3]

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Joe, thanks for your question. Obviously, we will present the outcome of the futility analysis, but we intend also to present some of the data that have been collected. It will be [type of a] top line data presentation, the way I look at it. So I think it will be quite informative, Joe.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [4]

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Absolutely. No, that's great. That's great. And with regard to -- I know you can't provide any timing guidance, but with regard to your partnering discussions for both remetinostat and 711, I guess how would you describe the gating factors to be able to get to a term sheet? Like, for example, with 711, you mentioned the recent FDA guidelines for disease-modifying agents, do you need to have maybe some regulatory visibility or plans on that front to be able to get a partner over the finish line?

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [5]

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Yes. I think you're making a very good point. It's something that we are discussing it internally whether we will go to the FDA and ask them and have a formal end of Phase II meeting or not. It's something that we will decide on in the near future. And I think it would certainly be very interesting to have the discussion with the FDA, in particularly, in light of the changes that they made in the draft guidelines. But again, at the same time, you want to give a future partner the -- you want to make sure that they are on board with the questions we asked. So it's a little bit complicated, but we are leaning towards doing something like that.

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Operator [6]

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Our next question comes with the line of Klas Palin from Redeye.

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Klas Palin, Redeye AB, Research Division - Equity Analyst [7]

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I wonder -- I don't know if you want to answer this question, but another question on your business development activities. If you could perhaps describe a little bit what you are doing right now? Or are you in any active discussions with any potential partners?

And also a question about MIV-818. Are you -- should we expect that you will find a max tolerated dose in the Phase Ia part?

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [8]

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So let me take one question after the other. So first, we -- I'm very careful in talking -- when we're talking about business development where we are. And all I can say that it's obviously a key priority for us to do business development, and we are doing it with multiple different activities. We are working on business development related to our preclinical assets, related to remetinostat and related to 711. All I can say is that we are very busy, but that's essentially all, because I have been very consistent in not providing any kind of timing promises for business development because I've seen it before that it's very difficult to really make a forecast on when you will have something in hand, when you will have the deal in hand. So that is all I can give you, Klas, unfortunately.

Yes. But when it comes to the second question on MIV-818, we don't expect -- we think that we may be relatively close to a tolerated dose for Phase II or maximum tolerated dose for Phase II, but we don't know. That's something that the Ib study will tell us, but we think that we will have -- it's a good starting dose for Phase Ib. And do you want to add something on the top of that, Linda?

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Linda Basse, Medivir AB (publ) - Chief Medical Officer [9]

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I don't think there's not that much to add there. I will just say that the part 1 is an interpatient dose escalation study and the Phase Ib is a classic dose escalation study, where we will establish the MTD.

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [10]

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But doing this way with an initial Phase Ia will hopefully lead us to the recommended Phase II dose quicker on that segment.

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Linda Basse, Medivir AB (publ) - Chief Medical Officer [11]

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Yes, that is the purpose of the Phase I.

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [12]

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Yes, that's the purpose of this design.

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Operator [13]

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Our next question comes from the line of Ingrid Gafanhão from Kempen.

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Ingrid Gafanhão, Kempen & Co. N.V., Research Division - Research Analyst [14]

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I had 2 -- I have 2 questions. First, are you planning to -- how are you planning to specifically share the data that you expect from birinapant in Q4? I was just wondering if you're planning to present remetinostat abstracts to some conference. And which ones should we be looking at?

And my second question is, can you please reiterate the time lines on when you plan to move MIV-818 to Phase Ib and maybe to Phase II as well?

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [15]

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Yes. So let me start that -- let me start with the last question then. The time line for 818 Ib is the fourth quarter this year. So that's when we expect to move into Phase Ib. We don't -- we haven't provided any guidance on when we think that we can start the Phase II study with 818. But let me just guess briefly and Linda may shake her hand -- head when I say this, but I think that sometime in 2021 we should be able to start Phase II.

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Linda Basse, Medivir AB (publ) - Chief Medical Officer [16]

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Exactly.

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [17]

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Linda was in fact nodding. So the other questions was how we're going to present the birinapant futility data. And I would look at it as some -- essentially we will talk about the statistical analysis, where we give some kind of top line from the data we have seen. And then we will probably present something a little bit more detailed at the conference, but we have not specified that yet. But I think that you will find that the presentation that we will give in connection with the announcement of the futility analysis will be quite interesting and meaningful.

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Operator [18]

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(Operator Instructions) Our next question comes from the line of Ulrik Trattner from Carnegie.

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Ulrik Trattner, Carnegie Investment Bank AB, Research Division - Research Analyst [19]

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Just had some additional questions regarding MIV-818. And just to start off, why would it take so long for you to start the Phase Ib? I mean you presented data in sort of early June, why would you need to wait until Q4 in order to start up the Ib part? And just some additional questions regarding what's your expected starting dose for the Ib trial, and since I would assume that this would be sort of a traditional dose-escalating cohorts trial? And last one, if you can just also -- I think you specified sort of the time line for when you're supposed to be able to start a Phase II study, but could you just give some sort of ballpark measures where you think the next trial will be given that this is sort of an orphan field and opportunity going into a pivotal trial, if you can just sort of expand something around that would be very helpful?

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [20]

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Yes. So let me start. The first question was about why does it -- why don't we start the Ib study early -- earlier. And because -- so that we wanted to do 2 more patients or so before we felt that we have found the optimal starting dose for Phase Ib. We think that, that in fact will save us time rather than -- even though it will take a while before we can start the Phase Ib study, but this Phase Ib study should be faster. The second question -- what was that? Ulrik, can you repeat that?

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Ulrik Trattner, Carnegie Investment Bank AB, Research Division - Research Analyst [21]

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Yes, sorry. Its expected starting dose in the Phase Ib trial?

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [22]

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Yes, so we have not decided that yet. So that's why we're doing these additional patients. But we think that we are not extremely very, very far away from having that in our hands. So then we, obviously, will move ahead, but we have not yet decided on the starting dose. That's why we are doing these additional patients. And the third question was related to the -- how long the 1b study will be. I think that -- as I said, I think it will probably take next year to conduct the Ib study. And then exactly how we move ahead in Phase II is something that we are currently talking a lot about. It's a very interesting question and we see lots of opportunities to do that. I think that we -- I will be happy to answer that question when we probably in -- later on this fall, but for now we are still in intense internal discussions about this.

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Operator [23]

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And as there are no further questions registered at the moment, I will hand the word back to the speakers for closing comments. Please go ahead.

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Uli Hacksell, Medivir AB (publ) - CEO, President & Director [24]

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All right. So thank you all for your attention. We're looking forward to having additional presentations for you in the near future and certainly not later than when we come back to the third quarter report. Thank you so much.

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Magnus Christensen, Medivir AB (publ) - CFO [25]

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Thank you.

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Operator [26]

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This now concludes our conference call. Thank you all for attending. You may now disconnect your lines.