Nordic Nanovector ASA

OSE:NANOV

Earnings Call Transcript

[Hilde Hermansen Steineger, Independent Director]

Good morning, everyone. Let me introduce myself. I'm Hilde Steineger. I'm a member of the Board of Directors of Nordic Nanovector. I've been on the Board since 2014. As you might have seen yesterday afternoon, we announced that Eduardo Bravo resigned as CEO. And yesterday night, we appointed Lars Nieba as our interim CEO in Nordic. Lars brings with him excellent leadership skills and strong operational experience, and we are very grateful to Lars for taking this challenge and opportunity on such a short notice. On behalf of the Board, I want to thank Eduardo for his contributions to Nordic Nanovector since 2018 and warmly welcome Lars as our new Interim CEO. So with that, Lars, I'll hand it over to you.

[Lars Nieba, Interim CEO & Chief Technology Officer]

Good morning, everybody. Thanks, Hilde, for the nice introduction, and also thanks to the Board for appointing me. I'm really excited to take the role and really to bring forward our mission of bringing Betalutin to the patients and to the market, of course. Then I'm really energized by all of the results we have produced so far with all of the dedicated people we have. So it's really -- I'm really very much honored and humbled to take the role. Thank you. Before starting, I also would like to introduce the team with me here. So it's Tone, our CFO; Marco, our COO; and Malene, who is the VP of Corporate Communications. I would like to apologize. Lisa, our CMO, she unfortunately could not attend this meeting due to personal reasons. With that, I would like to go to the forward-looking statement. So I guess everybody has read it, so we can move on to the next one, which is a little bit about me, so that you're aware of who is now in front of you, who will lead Nordic. So I'm a biochemist by training. So I did my PhD in München and Institute for Biochemistry and in Zürich, and I also have an executive MBA from the University of St. Gallen. So after that, I really first started my career in small biotech, so like today. so I was the Head of Therapeutic Vaccine Research in a company called Cytos Biotechnology. And we built it up from about 3 people to roughly, 100, 150. And I moved on then and I spent several years at a small company called Roche, a leading company in Oncology, and I had several of leadership positions in that organization. So in biologics, research and development, in clinical supply, also in business development, but also, very importantly, in clinical operations. So I'm not only focused on the technical part, but I also have experience more in the clinical area. I then moved on and I had a position in Bayer. Some of you might know Algeta, not too far away from here with Xofigo. So I was not involved in Xofigo, but some other areas there. And I was driving the CMC or Technical Strategy for our biologics products, in particular, of course, EYLEA, which you might know, is about a $7 billion molecule together with Regeneron. And we moved it up when I joined. We had about -- in our territory, about NOK 1 billion, and we moved it up to NOK 2.5 billion. So it's really a great success. And I then was asked to join Nordic as the Chief Technology Officer about 2.5 months ago and, yes, today, I'm really happy to take the role as an Interim CEO here. So why are we here? Nordic Nanovector is really expert in radioimmunotherapy. And it is a very hard area currently with a lot of successes. And we strongly believe in Betalutin. It's a fully owned asset from us. It's in oncology anti-CD37. For those who are interested in this, it's -- and the revolution you're seeing here is really the single administration. If you're thinking about other areas like rituximab or other molecules, which are in that area, you really have to inject pretty often. And that is a single administration, and that is really something which I would call a breakthrough. We are currently in a pivotal trial in follicular lymphoma third line, and we have granted fast track and orphan drug in the U.S. There are of course other programs ongoing, as you can see, in second line follicular lymphoma, which is, of course, a little bit of a larger area. And of course, diffuse large B-cell lymphoma, DLBCL, which is one of the biggest areas in non-Hodgkin's lymphoma. What I would like to point out here is really that not only the team I have with me, but also all of the other people in Nordic, we have a huge R&D expertise, and we own the IP for that molecule. What is our pipeline? We have multiple really very attractive opportunities in non-Hodgkin's lymphoma, as mentioned, of course, the third line. But I also pointed out and that we need to go into second line, where we have a clinical trial ongoing, the so-called Archer trial. We are also looking into DLBCL. And that's not all. We're also using our knowledge and our IP for other molecules like the so-called Alpha37, which is not with lutetium, but which is with -- 2012 with -- that. Thank you plumbum. I'm a chemist. And we do have the humanized antibody, Humalutin, which is IND-ready. So also a pretty good pipeline. And why are we going in non-Hodgkin's lymphoma? You can say we have great products from the company I worked before for like Roche and others. Definitely, yes, anti-CD20 changed the world. When you're thinking about 20 years ago, when IDEC identified that molecule, we had nearly no treatment at all. We had only chemo. So from that point, we -- at that time, anti-CD20 saved a lot of lives. Nevertheless, and there are people now becoming a refractory against rituximab or other CD20s. And they can really get resistance within 5 years. That is something, which, at that time, nobody have thought about it. And that is something where we now need to work on to get these people also treated. Mainly, all the people cannot tolerate chemotherapy. So this is also something where we need to have a look into it. So from that point, you see there the overall progression-free survival. It's really going down in third line to 26%. So that means there are a lot of people suffering from cancer, where Betalutin might be positioned very well. That is why we are first going into follicular lymphoma third line because that is the most urgent patients who need our help. Now why have you invested into us? One thing is the great science, but the other thing where you're looking for is, of course, getting return on your investment. Now how big is the market? Is there significant value in non-Hodgkin's lymphoma despite the fact that we have the anti-CD20s? Yes, there is. If you're thinking about only follicular lymphoma, third line and second line together is an overall market of NOK 2.1 billion. And of course, as mentioned before, the diffuse large B-cell lymphoma is even bigger with about $2.7 billion overall market. So -- and we would like to get a share from that. And what is our commercialization strategy? We first want to go to the U.S. market. That is because for a small company, it is the easiest way of -- or it's the best way to go to the market because it's a single market. It's a large market. And with all of the challenges of supply chain, regulatory approvals and everything, we only have one market. If you're thinking about a company called Genentech, they only had one market, and they were very successful there. And for them, it was the best way of moving forward also to go together with Roche in 1990. The American market is huge, and that is why we want to focus on that. And that gives you the fastest return on investment. And of course, thereafter, we will look on the other markets as well. So we are also thinking about our patients here in Europe and in Japan in Asia. No question about that. But the first one is really to go to the U.S. market. Now which kind of highlights that we have in the last quarter? Our PARADIGME trial is ongoing. So that is the third line follicular lymphoma. We have now 94 sites in 24 countries for an open for enrollment. We have 47 patients enrolled in PARADIGME trial and, of course, we aim to complete the enrollment of the patients by the end of this year. We have secured our supply of lutetium-177, which is very important because that is the key component of Betalutin. We also successfully raised around NOK 240 million -- NOK 243 million in a private placement, so that we are -- also have a pretty good finance for this year. We are -- started the DLBCL, as mentioned before, 3 additional patients being enrolled. And Alpha37, as mentioned before, has been -- received funding from the EuroStars and the Norwegian Research Council, so that we really can, in the range of about $2 million, to really move ahead with that important molecule as well. And we have new preclinical data insights to enhancing Betalutin-based combination therapies in NHL, as we presented about 2 months ago at ASH. Now where are we in clinical development? Our clinical development strategy is really optimized to deliver Betalutin to our follicular lymphoma patients as soon as possible. So we published our data of the LYMRIT 37-01 trial, the Phase I/IIa trial about in summer last year, I think it was. And we had 74 patients in that one, and I will come to that results. And after that, we started the pivotal trial, which is ongoing, to really allow us a pretty fast U.S. filing, which is currently foreseen in the second half -- or in the first half, sorry, of 2021. And in parallel, we also try to assess possibilities to go in second line in follicular lymphoma with the combination trial of rituximab. These are the results, and that is also why I'm here. So I really believe strongly in that product. What you can see here is the promising result, which we got out of our first trial. I know most of you already know that I still think it's worth going through. Our median age, as mentioned, is 68 years. As mentioned, these people are very often not eligible anymore for chemotherapy, so we have to have something for them. They are heavily pretreated with advanced stage of disease throughout their -- they're not anymore in a very healthy condition. We had follicular lymphoma and other NHL types in there. What we have seen, and that is very important, is Betalutin was very well tolerated. So most common grades were 3 and 4 AEs, which is, for such a product, very much acceptable. We had only very few serious AEs and no cases of febrile neutropenia, low incidence of platelet transfusion and no study-related deaths. So that is something where also the people coming to us as the -- our investigators say, it's a very, very good profile. So that is safety, but safety is not everything, of course. Safety is important, but we are looking for efficacy. So what you can see here is really we have compelling results in follicular lymphoma and also marginal zone lymphoma. So overall, our results, and I would like to focus really on these numbers down here is, if you're looking into our follicular lymphoma response is really around 62% overall response and in the range of 19% complete response. And the complete response is really something which is extremely important. And in marginal zone lymphoma, we are even above that. Once -- so I know it's only a small number of 9 patients, but that is something where we need to look into more detail into it. We gave an update on the median time of duration of response, which is also especially for our CRs and very long. And that is why also a lot of people are really believing in Betalutin. So these results are really, really, really good.Now PARADIGME. So that is our pilot trial which we want to give for filing. So our pivotal trial. As mentioned, we have 94 sites now. We have 47 patients enrolled. We are -- we have 2 doses, so a lower dose and a higher dose. And we target an interim analysis, so that we get all of the results in by the end of this half year. So by the -- at the end and the first half of 2020. We will, afterwards, of course, complete patient enrollment, and then we target filing, as mentioned, in the first half of 2021. So we should not only focus on our R&D. Since we are planning for bringing Betalutin to the market, we also need to look into what do we need to bring Betalutin to the market? And that is why we also strengthen not only our leadership team, but also other areas in the organization. And the one thing which is extremely important is regulatory affairs. So all of our interactions with the health authorities, like the FDA or the EMA here in Europe or the Norwegian health authorities, that is something where we needed to have a very experienced person. And there's Gabriele, who joined in November '19 our team. Also from the manufacturing, so I'm the CTO as well. So nevertheless, I think one should not underestimate the importance of manufacturing. That's not only because I'm the CTO, but in general, if you're looking through complete response letters of new molecules, it's not because of clinical results. A lot of the complete response letters the companies are getting is because of CMC. And CMC is an area which is usually there to bring the others to support all of the others, that's true. But if the support is not there, you can't be successful. So from that point, we also strengthened our manufacturing area with Mark Wright, who is now the Head of Manufacturing and overlooking all of the clinical supply, but also preparing of the commercial supply. Then, of course, legal and compliance is important. We hired Fredrik. And for the Board, not only Hilde's there, but we have a new Chairman with Jan Egberts. So Betalutin. As mentioned, we have also further opportunities in non-Hodgkin's. So the first one is here in our Archer trial, which I mentioned before. It's open for enrollment. The first cohort has been completed, and the results we got out of that one, which we have published, is 100% overall response, which is, of course, amazing. And we had 3 complete responses out of that, as reported. And currently, we are enrolling the second cohort, and we aim to finalize the enrollment for the second cohort in the first half of this year, so that we can have data readout in the second half of 2020 and make a clear decision on where we can move ahead in second line follicular lymphoma. In parallel, also, we are testing Betalutin in diffuse large B-cell lymphoma. And we have also there -- we are moving ahead to plan. So with all of the escalation of the dose escalation there and freedom and data have been reported in 2019. 3 additional patients enrolled in the final dose. And so far, no safety issues were observed, and there's an evidence of disease control in some of the patients. So also there, we target data readout in the first half of this year. With that, I hand over to our CFO, Tone. Thank you.

[Tone Kvåle, Chief Financial Officer]

Yes. I'm Tone Kvåle. I'm the CFO of Nordic Nanovector. Q4, we ended at NOK 139 million in spending. Totally, the year ended at NOK 440 million. That is NOK 100 million more than last year. The reason why we are spending more in Q4 is that now we are kind of ramping up the preparation for the BLA filing. And the BLA, for those who don't know what that is, that's the kind of application we are sending in to get an approval for the drug. But we are continuing, looking into how we are spending the money. That's something we have done, and we also want to continue to do so. So basically, most of our money are going directly into the 3 clinical trials we're running and the CMC activities related to the BLA filing. If you look at the cash flow, we strengthened the cash position in Q4. We raised money, NOK 243 million gross in October. If you look at the net cash flow, this is the explanation for the number here. From the operating activities, we have a cash burn of NOK 100 million in Q4. That is almost the same as we had in Q3. From investing activities, we ended up at NOK 4.7 million. That's a negative 0.3% in Q3. And then we raised money in October, so the net cash flow from financing activities went to NOK 221 million. So the cash position ended up NOK 471 million end of the year. That money will take us through the end of 2020. So we need more money to finalize the filing in 2021 and to prepare for commercial. 2020 is going to be an interesting and very exciting year for us. We have a lot of milestones. The most important ones that we all are looking and waiting for is the interim analysis for futility for the PARADIGME trial. That is coming up for the first half of 2020. And then we have 2 milestone for DLBCL trial. We're going to see the dose escalation data, and we're also hoping for that we have the first patient dose in the expansion cohort. For Archer-1, we are looking forward to get the last patient enrolled there, so we can complete the first -- that cohort. And then for the second half of 2020, we expect to have a data readout for the Archer trial. And then the most important goal for us that we're still kind of looking forward to is this enrollment completed for the PARADIGME trial, as also Lars talked about. That's what's the most important goal, and we're still keeping that guiding. And for them, first half 2021, we are starting the rolling of the BLA filing. So there's a lot of things to look forward to. Financial calendar, when we'll see on the next time is we're going to public or annual report end of March and the same-day we are calling for the AGM. So that is going to be held, 17th of April. And then we are reporting the Q1 results 26th of May, the second -- the first half and the Q2 in 27th of August and the Q3 in 19 of November. So this is the plan. And if you have some questions before you see us next time, you always can contact Malene. Here is the e-mail. So then I will go directly to Malene and the Q&A. And Marco and Lars, join me here.

[Malene Brondberg]

Thank you very much. If I can get the rest of the team up here, please. And then if we can get someone around with a mic because then we would like to start with questions from the audience, please. So do we have any questions in the new audience, please? Are you sure? No questions? Yes. Oh, we can wait. Hand the mic, please. Thank you.

[Unknown Analyst]

[indiscernible] is my name. It works, sorry?

[Malene Brondberg]

Yes. It works.

[Unknown Analyst]

Concerning part of the Investor Day, it seems to me that to enroll the sufficient number of patients takes much longer time than forecasted or what we had hoped for in the beginning. And what are the main reasons that the enrollment takes much longer time than estimated?

[Lars Nieba, Interim CEO & Chief Technology Officer]

Yes, thank you for that question. Yes, we have 47 patients enrolled. As mentioned in my talk, we are on track for the interim analysis. But of course, yes, it is much more challenging than we anticipated. And there is also as our, 0as Chairman this morning mentioned. That is why my task is now really priority 1, 2, and #3 is looking into PARADIGME, looking into all of the operational issues here, to understand where we can speed up the enrollment, what we can do. And that is now my task for -- so since it's my first hour here, I haven't looked in all of the details yet, but I will look into all of the details to speed up enrollment and also thinking about what we can do in addition from our strategy. So that is something where I'm experienced in from the point of view that you can make some analogies. For example, to CMC, if you're doing production and you're forecasting something, you have a plan. And if you're getting out of your plan, you need to do improvements to your plan. And that is now what we are doing. With all of the improvements, together with my team, I'm very confident that we can still reach the enrollment by the end of 2020.

[Malene Brondberg]

Thank you very much for that. Do we have any further questions?

[Vincent Meunier, Managing Director]

My name is Vincent Meunier from Bryan, Garnier. Actually, I have 2 questions, please. The first one is, in terms of operational expenditures for 2020, I mean, what are the expected dynamics in terms of expenditures during the year, particularly in the context of what you've just said, I mean, the speedup of the enrollment of patients?And the second question is related to the first one. I mean have you already an idea of the kind of raise you would need to cover your costs and maybe prepare for the filing and commercial stage going forward?

[Lars Nieba, Interim CEO & Chief Technology Officer]

Tone?

[Tone Kvåle, Chief Financial Officer]

Yes, I can take the question, yes. When it comes to the spending, as we've been guiding, the cash we lost until end of 2020, so that will be the -- the burn will be approximately the same as we have as today. Because if you look at improvements, it doesn't need math to cost money. It's also kind of the people we have on board. And we think about there. So that's one thing. And when it comes to how much money we need, we are looking into that. So there's no decision taking as of today, but you are looking in both dilutive and non-dilutive solutions.

[Lars Nieba, Interim CEO & Chief Technology Officer]

Yes. And to emphasize a little bit more on the first point since you mentioned the improvements, of course, you're right. We can make improvements, which cost us a lot of money, throwing money in there. That is not the way what we are looking for. Usually, if you're looking in improvements to the plan, you can make changes to that without spending a lot of money, sometimes even saving money.

[Vincent Meunier, Managing Director]

And maybe just a follow-up question. I can imagine that in the context of the rich news flow in H1 2020, there is no plan to extend the pipeline as we speak. It's too early, I guess.

[Lars Nieba, Interim CEO & Chief Technology Officer]

Yes. We are -- as you have seen, we are working also on Alpha37, which is ongoing, and we're aiming for also their filing an IND. And we are looking into Humalutin, which we have. We are always open. But Marco is here from the business development. We're always open also to look into other areas where also we can use the technology, no question. But that is something which we are always doing, and there's currently no plans to further enhance because, otherwise, we would go for more people.

[Vincent Meunier, Managing Director]

Is there any news in the competitor area?

[Marco Renoldi, Chief Operating Officer]

Yes. Maybe I can tell you what has happened since the last time we met in November. I think I will focus on third line follicular lymphoma because this is our key target for now. I think that the most important element is the 2 products, actually we're able to file with the FDA. One was tazemetostat by Epizyme, and the other was umbralisib by TG Therapeutics. Now let me tell you what type of efficacy data they generated. Tazemetostat in a small subset of patients, which are the patients with the mutation of the EZH2 gene, roughly 15% of the third-line patients, they achieved an efficacy of 68% overall response rate, 19% complete response and a duration of response of about 11 months. So more or less similar to our data, but with a lower complete response, a lower duration of response in only 15% of the patients they have filed. Secondly, umbralisib, they have filed with data which they did not disclose publicly. They just said that the overall response rate data was in the range of 40% to 50%. So definitely below our data, umbralisib is a PI3K inhibitor.So should we be worried because they have filed them, so they could possibly get an approval soon? I think we are not worried because what is relevant based on what we see in the market is, are these products meeting physicians' needs? We don't think so. We believe Betalutin still retains a strong competitive edge. Because the combination of the efficacy data we have generated, in particular, the complete response rate and the duration of response, combined with the safety that Lars described, basically, the only grade 3, 4 adverse events are a transient reduction of the platelets and white blood cells with really minimal clinical symptoms and the convenience of a one-time administration. We still have a competitive edge, so we should be less worried about agents that are filed or approved and be more focused on the benefits we can bring to patients. We have 3 products on the market, idelalisib, copanlisib and duvelisib. They're not getting a lot of traction because they are not meeting patients' and physicians' needs. I hope that answers your question.

[Vincent Meunier, Managing Director]

Yes. You might want to go ahead with the marginal lyphoma.

[Marco Renoldi, Chief Operating Officer]

Yes, yes. Similarly, since Lars alluded to marginal zone, there we also had umbralisib, so the molecule from TG Therapeutics. They filed, also combined FL and marginal zone. And in marginal zone, they had 58% or 59%. Sorry, I don't remember by heart. Overall response rate and a 13% complete response. You probably recall from the slide that Lars presented as most sample of patients, we obtained 78% overall response rate and 44% complete response. So even in marginal zone, umbralisib does not seem to pose a threat. And so we should not worry about -- there is no -- in hematology, there is no first-comer advantage. What really matters is the benefit that you provide, the added benefit that you provide to physicians and patients. So even if we arrive 6 months afterwards, that is not going to be a handicap if we have a better product.

[Malene Brondberg]

Okay. Any further questions here in the audience? No. Otherwise, we return to the web. Yes, we do have quite a lot of questions on the web, but they are very much the same. So we have tried to group them in order not to keep you here too long. I think we are going to be able to cover all of it by answering a few of these. One of the first questions we have is, with the current cash burn, we find ourselves in the situation we were 6 months ago. What is the strategy going forward to meet your goal?

[Tone Kvåle, Chief Financial Officer]

Yes. As I said, when I answered the other question here is that we are looking into both dilutive and non-dilutive solutions, but there are no decision taking as of today about that.

[Malene Brondberg]

And in the same lane, are we reprioritizing towards partnership?

[Lars Nieba, Interim CEO & Chief Technology Officer]

I mean, no. I think our first goal is -- really, since we are heavily believing in Betalutin, to really bring it on the market. I think the important point here is that we need to show our results. And I think we are in a pretty good position since we are on track with our interim analysis. And of course, if these data are very attractive, we might be approached, no question. So from that point, we are open to partnership, but our first goal is really all for you to really bring it to the market and do the return on investment by that.

[Malene Brondberg]

And the third key question about future strategy and funding is, what are the drivers or considerations why it is needed to review the company's strategy?

[Lars Nieba, Interim CEO & Chief Technology Officer]

We're not reviewing the company strategy. That -- so I apologize if that was a misleading in our correspondence today. What we are looking for is, from the 47 patients, which we have in our trial, is that we are looking into the strategy, how we can be more efficient in that trial. So the company strategy stays the same. As mentioned before, we are going ahead with our Betalutin trials in third and second line follicular lymphoma and in DLBCL. So there's no change in the strategy. It's only that we, ourselves, have said that we need to be more efficient in operations to really enable us to finalize the trial by the end of the year, and, of course, to stick to our promises that we will have the rolling BLA filing in the second half of 2021 started.

[Malene Brondberg]

Thank you. And if we move to PARADIGME, I think most of these questions have been answered, but there are 2 questions we might want to bring up. Number one is, the 47 patients, we are -- have recruited in the trial, is that figure a number by December 31, 2019 or 26 February 2020?

[Lars Nieba, Interim CEO & Chief Technology Officer]

So it is a number by today. So what we have enrolled today or yesterday, I must say, since we published it yesterday. So there might be another print.

[Malene Brondberg]

Thank you. And is it realistic to be able to enroll the last 83 patients in the last 10 months of 2020?

[Lars Nieba, Interim CEO & Chief Technology Officer]

I wouldn't take the role if I would say no. So because it is possible, the only thing what we need to do is now really looking into it. So as mentioned, also in bigger companies where I had been before, it is not always that easy to run a clinical trial. So sometimes, you underestimate the patients where they are located, whatever. There are so many things which are contributing to enrollment. So it is now something where we need to have a look into it. And there are companies out there who are specialized into that, which might help us. Whatever we can do, we also need to reach out to our KOLs and other areas. So there are so many things which you can do, and we will try all of these things. And we are looking into it and helping our top recruiting sites to recruit more. All of that we will do. And yes, we also look into the strategy of the trial into the protocol. All of that will be done in the next few weeks to enable us to enroll the final patients until the end of the year. And we are strongly believing that, that is possible.

[Malene Brondberg]

Thank you. And another question is, the order recently was approved with under 100 patients. Can Betalutin send application on the same number of patients, for example, on the interim results and LYMRIT? And will you submit a rolling BLA?

[Lars Nieba, Interim CEO & Chief Technology Officer]

So the last answer is, yes, we will submit a rolling BLA. It's a very good question. And yes, whoever asked that question, that person's absolutely right. There are other molecules out there like Aliqopa and others who filed with roughly 100 patients. We have, at that time, when we went to the FDA for discussions, it was back in 2016, when I remember it correctly. We discussed it with the FDA. We promised to have 130 patients. But of course, this is one of the questions which we now need to ask ourselves, where we need to go through and to think about if -- what I meant was looking through the protocol, what is possible from the strategic side to make all the protocol changes. Absolutely.

[Marco Renoldi, Chief Operating Officer]

And the data may help us.

[Lars Nieba, Interim CEO & Chief Technology Officer]

The data may help us.

[Marco Renoldi, Chief Operating Officer]

Oftentimes, this decision are supported by the data.

[Malene Brondberg]

Yes. And the next question is, will the upcoming futility readout in the PARADIGME study be completed with 50% of the 130 planned patients enrolled?

[Lars Nieba, Interim CEO & Chief Technology Officer]

It's an interesting number. We have never published it. I only said we are on track with that. So whatever we have in the protocol stays in the protocol, honestly. But I can promise you, yes, we are on track for the interim analysis.

[Malene Brondberg]

Thank you. And there's another question here asking, would you consider pausing DLBCL after LYMRIT 37-05 readout to preserve funds?

[Lars Nieba, Interim CEO & Chief Technology Officer]

Honestly, I would not give an answer. And that is that one in that way that we will do that. If the results are really amazing, why should we do that? I mean if we can move ahead, we probably can find partners, for example, in that area. I think if the results are really amazing, we are also -- promise to our patients that we need to move ahead with that one. So I think as soon as we have the data, we will make an analysis of the data. And then we will, of course, look into our strategy what makes more sense to us and for you.

[Malene Brondberg]

Thank you. And should we expect any data to be presented at conferences this year?

[Lars Nieba, Interim CEO & Chief Technology Officer]

Marco?

[Marco Renoldi, Chief Operating Officer]

I think we will, as always, try to submit posters and opportunities for all our presentations as soon as we have data to present. You have seen from Tone's slide on the milestones, we have some studies that will read out. Of course, we need to have the right time to submit. Oftentimes, conferences request an abstract submission maybe 3 months before. But our intent is always to share the data once we have important data to share. Our intent is to continue communicating in medical conferences. So we hope that this is -- it will continue in 2020.

[Malene Brondberg]

Thank you, Marco. Next question. Has the first 3 patients in cohort 2 in Archer-1 been dosed? Can we expect information regarding results of ORR in cohort 2?

[Marco Renoldi, Chief Operating Officer]

Yes. We expect to be able to communicate the results of the first 2 cohorts, as Lars said, in the first half of this year. So this is on track. As you know, this is an important study for us because it's a foundation to our second line follicular lymphoma development strategy. We are trying to see, through this study, whether the safety and tolerability of the combination of Betalutin plus rituximab is as good as we would like for the second line follicular lymphoma indication, and if we see the same synergistic effect on efficacy that we demonstrated in the preclinical models. So continuing with this study is important because it will be the foundation for the Phase III study that will be required for second line. Second line will require a Phase III study. So it is in our interest to move forward as fast as we can because it's really a pivotal study to confirm our Phase III design.

[Malene Brondberg]

Thank you. And sorry, the last question covers many of the questions that have come in, and that is, what was the reason Eduardo Bravo left the company so sudden? How come there was no notice period for his departure? Could you elaborate? Any color would be appreciated since it seems so sudden.

[Lars Nieba, Interim CEO & Chief Technology Officer]

I'll refer to Hilde in that case since...

[Hilde Hermansen Steineger, Independent Director]

Thank you. Well, and I will defer to our Chairman. We -- sorry. No, I think I have the mic. Yes, right. Yes. So I'll defer to our Chairman. We don't comment on the resignations, but we are very happy to have Lars here stepping up on a very short notice. So thank you, Lars.

[Malene Brondberg]

And that was all the questions we had on the web. Thank you.

[Hilde Hermansen Steineger, Independent Director]

Okay. Okay. Thank you very much. Thank you to the team. And I hope to see you next time. If any questions, in the meantime, please just e-mail me or give me a call. Thank you very much.