Earnings Call: Q2 2021

Aug 19, 2021

Thank you, operator, and welcome to Middle East Q2 Webcast. Please move to Slide number 2. Today's presentation with the help of myself, Magnus Christensen, Interim CEO and CFO of Medeville and Frederic Gerber, our Chief Scientific Officer. I am the interim CEO during the recruitment process of the new CEO coming into the company. Next slide, please. I will not go through this, but recommend you to read it at our homepage, where you can find the presentation as well. Please move to Slide number 5. Here is today's agenda. I will start off with the overview of Medeville, then take you through the financial highlights for quarter 2 and then talk about the Remsteinstad revenue share agreement that we announced beginning of this week. Then I will hand over to Fredrik, who will present MIB-eight thousand one hundred and eighteen in more detail and most importantly, our planned combination study. And then Fredrik will continue to present our other asset as well before we open up for a Q and A session. Next slide please. Minuvi was founded in 1988 and listed on the Stockholm change since NOK 96. And with the financial injection in quarter 1, we believe we had a strong cash balance. And in the end of Q2, we reported a cash balance of SEK248 1,000,000. And according to our current plans, the cash run rate is well into the year 2023. End of Q2, we were 8 FTEs. And as we announced in the beginning of July, Malena Jensen will join Medeville as Vice President of Clinical Development and foremost for our project, MIB-eight eighteen. And we're really looking forward to that and should be start in the beginning of September. And as you probably know, we focus both financially and personnel on our wholly owned asset, MEVA-eight eighteen, which is a lipid Retinucleotide Pro drug. MIB-eight eighteen has received orphan drug designation, both in the EU and the U. S. And we're currently in Phase Ib clinical development and plan to start our combination trial later this year, which Fredrik will talk more about later in the presentation. And the data from the Phase Ib study monotherapy We represented ESMO in the middle of September. I would also like to highlight that we outlined in Brinavant to IGM Biosciences in beginning of this year. Next slide, please. Here's an overview of our clinical projects. We have a focused clinical program, MIB-eight nineteen targeting liver cancer and it's currently in Phase I and we're looking forward to start a combination trial later this year. We also have a partner asset, Brinavant, which will enter Phase 1 clinical development by IGM later this year according to IGM's Q2 report. And of course, we're very excited to follow that study. And to remind you that when IGM started a combination study, We received US1 $500,000 And we also do have 2 other clinical exciting programs for partnering and out licensing, remetinostat and MIB-seven eleven, which Fredrik will present more later on. Please see Slide number 9. Here you can see the financial summary for quarter 2. All numbers are SEK1 1,000,000. The turnover for quarter 2 amounts to SEK1 1,000,000, which is lower compared to last year and relates the royalty income from Circular. Accumulated for this year, the turnover amounts to around 11, which is more or less the same level as last year. Other external expenses are higher than last year and relates mainly to higher cost for clinical studies and mainly preparation for the upcoming combination study. Personnel costs are lower and relates to fewer FTE compared to last year. As you can see, the loss for quarter 2 is around SEK17 1,000,000 compared to minus SEK13 1,000,000 last year. The cash flow from operating activities in Q2 is around 22 minuteus compared to minus 23 last year. And as I mentioned, the cash position at the end of Q2 is $248,000,000 and that's more enough to complete ongoing clinical activities. And according to current plans, we will cash well into the year 2023. Please move to Slide number 11. Early this week, we announced that we signed the revenue share agreement for Remetinostat. As a reminder, Medevia acquired Remetinostat from Seltzeroden in 2016. In total, there is more than 3 stakeholders In the agreement including Medeville. The regional arrangement between Medeville and the stakeholders include the milestone payments As well as royalty obligation to the stakeholders when Medeli develops markets or out license Remitinista. And as positive now, the agreement has been negotiated so that the compensation that we're Obliged to pay in potential future outlying of Remsenet is based solely on the distribution of actual future revenues to Medivi. And we believe that with this revenue share agreement in place, we have created significantly improved condition for potential out licensing or sale for Remit Investar. And with this, I will hand over to Fredrik Erbeld that will present more details about MIIB818. Thank you. If I could have Slide number 13. So we're advancing our lead asset, MIV-eight eighteen, for the treatment of hepatocellular carcinoma. So this HCC is the major type of primary liver cancer, which constitutes a large unmet medical need. The market for HCC is projected to grow rapidly. And there are two reasons underlying this. We see that liver cancer incidence and mortality are increasing, partly Due to an increase in nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. But the major driver of market growth In the coming years, it's the introduction of new combination therapies. And we're expecting the market to grow from around 1,000,000,000 2020 to around US5 $1,000,000,000 in 20.29. So if I could have the next slide, number 14, please. Our initial focus for MiB-eight eighteen is the advanced stage HGC population. We can see that highlighted in this treatment schedule coming up. And for these 2 systemic therapies, 2 main classes of drugs are used as standard therapy here. The tyrosine kinase inhibitors, for a long time, only represented by Sorafenib, But then followed by vegrafenib, lamatinib, cabozantinib and more in this class of Tyrosine Kinase inhibitors. The other major class entering more lately is However, recently, good data from combinations, Especially the atezolizumabberasizumab in first line HSC has Provided good data rapidly changing the treatment landscape. And we see a strong trend towards combination therapies in this And we know that additional checkpoint inhibitor combinations with Tyrosine Kinase inhibitors, for example, pembrolizumab and lenvatinib And others are in late stage clinical development and will probably move into this phase as well. And we would think that we need to be in this space in combinations to be competitive. So if we move to the next slide, number 15, please. A few words about IL-eight eighteen. It's an orally administered prodrug. It's designed to be rapidly Metabolites in the liver, thereby targeting the active metabolites in the liver, giving high exposure in the liver And limiting systemic exposure and toxicities. This is a unique mechanism of action in this liver cancer space, which makes it attractive to be combined with many targeted and non targeted drugs that are used in this space. The 2 major classes also have both preclinical data and scientific rationale to be combined. So the tyrosine kinase Inhibitors among other things induce angiogenesis inhibition, which in turn induces hypoxia in the tumor And hypoxia increases the expression of certain enzymes that metabolize NIVE-eight eighteen 2, to the active metabolites, increasing the levels of active metabolites in the tumor. In terms of checkpoint inhibitors, they rely on an immune response And MIB-eight eighteen is incorporated into DNA, inducing DNA damage and thereby also Increasing the immunogenicity of the tumor. So potentially these 2 mechanisms are Interesting to combine with Mil-eight eighteen. So if we move to Slide 16, There is an overview of the clinical development of NIR-eight eighteen. We have now completed the Phase Ib monotherapy part And are advancing into combination studies. So there are several differences in The patient population, for instance, that we're going to treat here. So this Combination study will include patients with hepatocellular carcinoma who have progressed on or are intolerant of first line therapy, Whereas the monotherapy with our main objective of safety and tolerability Included patients both with metastatic liver disease, intrahepatic cholangiocarcinoma And HCC, these were late stage patients with sometimes excessive Extrahepatic disease. So now we are focusing in on HCC with healthier patients And also in combinations. So the first part will be a dose escalation part, either miV-eight eighteen in combination with lenvatinib ORMIVE-eight eighteen in combination with pembrolizumab, a standard 3 plus 3 design designed to Identify a recommended Phase 2 dose for the combinations. Then moving into an expansion phase with the possibility then to look more closely at efficacy signals And generate more safety data. The selection, as I said, was Based on the evaluation of the scientific rationale, preclinical data, the safety profiles of these other drugs, But we also think strategically that this makes sense as these are the 2 main classes of drugs used in advanced HCC. So if we move to the next slide, Slide number 17. In summary, we continue to advance V-eight eighteen and the clinical development program. We have completed the Phase Ib monotherapy, which enrolled in late stage patients and now we're moving into earlier treatment lines, healthier patients with the combinations. The Phase Ib monotherapy data, as Magnus mentioned, will be Presented in at the ESMO Congress mid September. The combination study will be The 2 parallel streams will be done with the combinations and we're looking at focusing this on ATC patients who have progressed on or are intolerant of first line therapy. We're on track of starting enrollment of patients for the combination study later this year. And we plan to conduct this study both in Europe and in Asia. So let me say a few words about other assets. So moving to Slide 19. We currently have 2 clinical programs that we're looking to partner or out license. Venetinostat, which is a topical HVAC inhibitor, has completed 3 Phase II studies. First one in cutaneous T cell lymphoma, which showed an objective response rate of 40%, But importantly, reduced pruritus itching in 80% of the patient. And this is an aspect of the disease that is Important to treat. Also 2 investigator sponsored studies have been performed, 1 in basal cell carcinoma. The data from this study was published recently in Clinical cancer research, the overall response rate was 70% and it contained it recruited Several histological subtypes of basal cell carcinoma. And lastly, the squamous cell carcinoma study That was also performed by the Stanford Group, included some different Histological subtypes as well of squamous cell carcinoma, where we had a really Good response, although the patient numbers were low. But nevertheless, we're very excited about the data around remetinostat because we We believe now that we have sort of Phase III ready assets, which is effective In has shown positive results and it is effective across many different subtypes of skin cancers. And lastly, we also have mid-seven eleven for which Medevir has conducted the Phase 2 study Demonstrating positive effects on bone and cartilage disease modifying effects in joints and the knee. After a very quite short study of 6 months treatment with MIB-seven eleven And we're excited about having these two assets, although The osteoarthritis area is outside of Medivir's core focus at the moment, which is oncology. So I'll hand over to Magnus. Thank you, Frederic. Please move to Slide number 20. And here we have highlights and the known upcoming milestone for the remaining part of this year. Firstly, as we mentioned, the data from the Phase Ib monotherapy will be presented at ESMO Congress in September. And secondly, we look forward to starting the combination study with BIIB818 later this year. And as well, IGM has announced in the Q2 report that they plan to start their combination study with brinopant and IGM-eight thousand four hundred and forty four later this year as well. And when we start, we will receive milestone payment of $1,500,000 And with that And next slide please, I hand over to the operator, open up for a Q and A session. Thank 2. The first question comes from the line of Emanuela Blanquetti from H. C. Wainwright. Please go ahead. Your line is open. Good afternoon, guys, and thank you for taking my questions. A couple for me. So Regarding the ESMO presentation on me the 8/18 data, could you help us setting the expectation For the data, we should expect will the data be focused on safety? Will full data be presented including maybe biomarkers data from the study. So I can answer that. The main focus And the primary objective of the Phase Ib monotherapy was safety and tolerability. So of course, that would be An important part of that presentation, but there will also be, of course, some of the exploratory Objectives like biomarkers presented. Got it. Thank you for that. And with the Phase IIIa started in Europe, you mentioned in your prepared remarks, Magnus, you're planning to expand the development with studies in Asia. Our conversation with a partner already started and when should we expect an update on that? Partner for me, 818, is that what's your question? Yes. Okay. Thank you for the question. As we said before, we're really looking forward to start in the combination study. And then I think the best for Medivi today is really to gather all the data from the combination study and from the expansion phase. And then I think the data will tell us what the next step is for Asia and the remaining part of the world as well. So I think we will see the data first before we take a strategic decision on that. Got it. Got it. Thank you for that. And also regarding the Remedina start, could you provide more color on the expected regulatory path For that, will this require a single Phase III study? And if this is the case, how many patients and how long would that Study requires since we I think one of the objectives would be to test durability of the effect. So it will be different it's difficult to say in general terms Because it will be different depending on which indication you would prioritize. Of course, The competition is different and the possibilities of doing a placebo controlled study is also different. So I couldn't really detail that for you. But we believe that the fact that there are 3 indications that are potentially interesting for remetinostat opens up Several possibilities for different partners are interested in different areas to continue to develop and move into the Phase 3 study. Got it. Thank you very much. Thank you. Thank you. The next question comes from Jacob Mikkel from Kempen. Please go ahead. Your line is open. Okay. Hi there, and thanks for taking my question. I have a few questions here for Ingrid, who is the analyst on this talk. So I have a few questions on the MIV 818, the upcoming trial. Maybe I missed it, but can you please just clarify what will be the specific line of treatment that you will focus on? And do you have an estimate of what is the percentage of the total HEC patients that will move to the slide? So the target population are patients who are either intolerant or have failed first line Treatment. And this with the advent of the new combinations, this is a sort of uncharted territory because we don't really know How large that population is? We expect that that population will grow. So second line will grow, But it's also a way into that space. So I guess that The data from that study will tell us if we are continuing in second line or trying to move in either direction. But I guess that your question is Well taken because it will be very interesting to see how that first line develops. We now have the combination of atezolizumab and daracizumab, but there are other contenders there as well. Okay. Thank you. And do you plan on moving both combination arms into the Phase 2 portion of the trial? Or are you just going to select one of them? And if you do, it's going to be a safety and efficacy benchmark that you'd be looking at? At this point, we don't know. We have sort of in the contingency plans to Go forward with 1 of the 2 combinations or both depending on the data we see in the dose escalation part. So it's a possibility, of course, to do the expansion In one, if that seems more favorable. And the second part of your question was I didn't catch that. And it was if not if you have any safety and efficacy benchmark that you'd be looking for? Of course, we don't want to add to the I mean, both lenvatinib and Pembrolizumab do have toxicities. We believe that the toxicities With NIVE-eight eighteen are not going to be synergistic in any way, but different. But that remains to be seen. So we don't want to add tolerability burden on the In the combination, of course. Okay. That's good. And do you have any idea On which combination might work better? Do you have any rationale or some indication at the moment? At the moment, I mean, this is something, of course, we're thinking about. But at the moment, we have Nothing really to guide us in what patient population would be benefit more or have a better response rate. I think that's too early to say. Okay. Thank you. And I just have one more question and then I'll be done. For I'm trying to say, is it Verano Pass? Are you able to comment on what would be the potential milestones beyond the SEK 1,500,000 expected around the end of the year? For this year, I think it's as we said that the complete package and milestones is USD 350,000,000. I think we announced it earlier this year. And it's based on sales milestone, regulatory and development milestones. And on top of that, we have royalties. But And on top of that, we have royalties. But what we expect this year is the starting of the recombination trial with their Underbody, 8444 with Biranapant, that's what we expect this year. And then as Algem is in charge Of the development plans for Brinavant, it's really they are in charge of the clinical studies from now as we outlined it, and they have the global rights for Brinavat. Okay. Okay. Well, that's great. Thank you very much for answering my questions. Thank you. Thank you. We have a question from Niklas Elhamhmer from Redeye. Please go ahead. Your line is open. Hello. Thank you and good afternoon. I hope I'm not being impolite, but maybe if you can give us an update on the process for recruiting a permanent CEO. Yes, I can do that. Thank you for the question. I could say that the process is ongoing and when We have a final candidate. And we have final candidate. We will give the notice to the market. But what I can say now is the process is ongoing at the moment. Okay. Thank you. Did I understand you, Greg, that the Recommended dose for the Phase 2 is 40 milligram. I'm talking, of course, of 818. 818 in monotherapy, the recommended Phase II dose in the 2 upcoming combinations Remained to be decided based on the dose escalation phase. But that's correct for the monotherapy. Okay. So that's yes. So how did you come about that? I I guess we investigated some higher doses then. Yes. In the dose escalation phase, we did They go higher than 40 milligrams. That's correct. Yes. Okay. And regarding Remetinostat, I was wondering, is there any is this project do you believe It's partnering ready or do you need to take further activities? I would say it's definitely partnering ready. Okay. And could you tell us a little bit if you Regarding the business case for example, basal cell carcinoma, What do you see how do you see Remit Investing in position here, for example? I don't want to preempt any interested parties What they would be looking at, but I guess that both in sort of a neoadjuvant setting, Treating before surgery, reducing the size or in patients who have where it's difficult To do surgery or have had a lot of surgeries and not are tired of having a lot of surgery. So there are areas in both BCC and squamous cell carcinoma where that could be a possibility. And of course, there are differences in the histological subtypes of BCC. So superficial VTC, for instance, as it's detailed in this clinical cancer research article, There the response rate is, I think, 100%. So there you could possibly replace surgery. Okay. Thank you. That's very helpful. I have no other questions. Thank you. Thank you, Nicolas. Thank you. We have no further questions. So I will pass back for any closing comments. Thank you, operator, and thank you all for participating in this avocados avocast for Medellin Q2 report. I can just sum up with that we are really looking forward to Start the combination study with MIM-eight twenty eight later this year. And thank you and have a nice day. Thank you for attending. You may now disconnect your lines.