U.S. Markets close in 1 hr 54 mins

Edited Transcript of NANO.OL earnings conference call or presentation 22-Aug-19 6:30am GMT

Q2 2019 Nordic Nanovector ASA Earnings Presentation

Oslo Sep 9, 2019 (Thomson StreetEvents) -- Edited Transcript of Nordic Nanovector ASA earnings conference call or presentation Thursday, August 22, 2019 at 6:30:00am GMT

TEXT version of Transcript

================================================================================

Corporate Participants

================================================================================

* Eduardo Bravo

Nordic Nanovector ASA - CEO

* Lisa Rojkjaer

Nordic Nanovector ASA - Chief Medical Officer

* Malene Brondberg

Nordic Nanovector ASA - VP of IR & Corporate Communications

* Marco Renoldi

Nordic Nanovector ASA - COO

* Tone Kvåle

Nordic Nanovector ASA - CFO

================================================================================

Presentation

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [1]

--------------------------------------------------------------------------------

Okay. Good morning. Thank you for coming this morning. I think that most of you know me, but I'm Eduardo Bravo. I'm the CEO of Nordic Nanovector, and together with some of the management team members, we have Lisa, Tone, Marco and Malene that will join me at the end for the Q&A session, as we've done at the last quarterly results.

I'm going to take you through the highlights of our second quarter report for the year 2019. And again, this is a big disclaimer that we're going to be making forward-looking statements.

So one summary slide, again, as always, on what is it that we do at Nordic Nanovector, which I think is very important to keep in mind. So we have our fully owned asset Betalutin. And I think that the more we know, the more we advance, the more we're convinced that we have a very interesting asset and valuable compound to take to the market. And we're developing this compound as quickly as we can to make it available to the patients first in third-line relapsing-remitting follicular lymphoma and then in other NHL subtypes, second-line FL, DLBCL. Together, those segments represent a USD 5 billion opportunity. We've demonstrated, and again, there's very few companies that have this set of data we have with a number of patients data, we have a very promising profile. Single dose, very mild side effects profile and very important efficacy. And again, we will go a little bit through the data again.

We have our data in full speed recruitment now. We expect the data now in the second half of 2020, we're going to be discussing this in a minute. We have other clinical trials, everyone knows about Archer, this is our combination trial with rituximab for second-line FL. And again, we're going to be giving some information on the trial. And then we have the DLBCL trial. And as you know, we finalized the recruitment in the first half, and we're going to be communicating the data in the second half.

Finally, we don't do more in other things -- among other things because we're concentrating our resources on those 3 topics. On the clinical trials that we are carrying with Betalutin because we have the opportunity to even do further work with other assets given our expertise. And that's very easy to see on the slide when you look at the pipeline.

The 3 orange lines are the ones where we're putting our resources, the ones in gray are the ones that we, today, are not moving forward among other things because we're concentrating our resources mainly on PARADIGME. And if you look at the percentage of our resources that go into PARADIGME, as you would expect, the very vast majority of those resources really do go into getting PARADIGME finalized and the company ready to file and commercialize.

What are the highlights for the second quarter. And as always, with the highlights, you start with the good news. So we've done a preliminary analysis of the data now that we have extended data readout for the first part of LYMRIT 37-01 that then became in a second part PARADIGME. And the duration of response has gone up to 13.5 months. Again, remember that we were around 13 months. In December, we reported 9 months, and we were very open that there was one patient that actually flipped. So we're very happy to report that on the preliminary analysis, the duration of response goes to 13.5 months, which makes, again, the profile of the compound as interesting as it was, if not more, as we have more and more data. There is still a number of patients ongoing, so the duration of response, we will keep updating it because the patients are still ongoing and not all of them have reached the relapse. So the duration of response will be updated until all the patients relapse.

The second key point has to do with this delay in PARADIGME. And there's 2 things to this. One, we finalized our big effort in getting the number of recruiting sites to where it wanted to be, which is above 80. It has taken us longer than what we anticipated. And we even recognized that very clearly at the last quarterly meeting. We've done a lot of things to try to increase the recruitment rate to compensate for that delay. We've seen the recruitment rate accelerate in the last 6 months. But we think that the current rate of enrollment that increase will not be sufficient to keep our milestone. So now that we have enough data, enough data points with enough sites for enough time, we think that we're in a much better position to try to have a very much more definitive guidance. And we believe that is the right approach to, again, be very open with the market and communicated, given the current recruitment rate, we anticipate recruitment now to finalize in the second half of 2020, instead of the first half, as we communicated up until now.

I think that as we will go through this, I'm sure, later in the Q&A, there's very good reasons, unfortunately, for that delay. And we've been -- those were the obstacles that I think that were very difficult to foresee. And we've put all the efforts in trying to get all the sites up and running. Now we have the sites up and running, now we need to concentrate on keeping at least the recruitment rate as we're doing. If we increase it even further, fine, hopefully, we can bring some good news. But today, I think that the safe thing to communicate to the market is that we will keep the recruitment rate as it is today, which will take us to finalize the recruitment in the second half of 2020.

Then let's go to the other clinical trials, which are going as expected. So phase -- the Archer clinical trial. This is a key clinical trial. I've been saying that now for a year. This is the trial that is the proof-of-concept that the combination of Betalutin with another agent with a different mechanism of action will have an effect. And we have incredible preclinical data. But now we need to ensure that in the clinic, there is -- we can demonstrate that hopefully synergistic effect of Betalutin and rituximab. So that trial is recruiting. We have finalized the first cohort. We will have the data of that first cohort. We are recruiting now on the second cohort. And again, you will see in the time lines, we continue to anticipate that we will have the data of Archer by the end of next year.

Again, we had a very nice patent. And I think that, again, we don't devote a lot of time. We're going to be talking about this. We are pioneers in this space. This is a very distinct space. We don't have another of those drugs. There's very few drugs in this space, and we're one of the leading companies in this radioimmunotherapy space. And we have a very important patent that was granted for Europe in the combination of Betalutin with other anti-CD20. So again, we keep protecting Betalutin for the future.

Again, for the future, we had some work that was done with our partner Orano Med in this CD37 alpha therapy for B-cell tumors. And again, the data has been presented. The data is pretty remarkable, and it's one of the things that we would like to communicate more on, and this is one of the programs that provided that we were to get additional resources, we would like to put into the clinic. So you will hear more about our CD37 with lead-212 in the future.

Finally, we finalized as we promised the recruitment of the DLBCL trial in the second half of July, it's 11 days late. We promised first half, we did on the 11th of July. But I think that we almost made it. We were a little bit unlucky actually that we couldn't make it on time, but it's finalized, and we will stick to the -- delivering the data in the second half of 2020. I know that we're getting the question whether we can get this data at ASH, it will depend on the data. So stay tuned.

And finally, very recently, we've appoint -- we've just announced the appointment of Lars Nieba as the Chief Technology Officer. You've seen and you're going to see again today that there was a significant increase in the amount of resources that the company was going to put behind what we call CMC, which is a very -- as I always say, very unsexy area, which is this area that ensures that the technical part of your file of your product is robust and makes the product approvable. And getting someone like Lars with 20 years experience in manufacturing companies like Bayer and Roche we believe will increase the expertise of the management team as we're going through that critical phase of both registering the product and having commercial manufacturing for further success.

So very briefly. So those are the highlights. And as always, I've gone through most of the presentation already just through the highlights. So I will quickly take you through now what we're doing. So I think that this is very familiar. But I think it's good as I did the last time that we look at this in just one slide. So remember, the company started with this Phase I/IIa clinical trial that had the Phase I, a very complicated trial, in which we're trying to identify the best combination of the predose of rituximab with a predose of lilotomab with a dose of Betalutin. And then we just went through a phased way, which was, okay, we've decided that there are 2 doses that appear to be slightly promising, can we do a number of patients, which was a large number of patients and see whether indeed famous Arm 1 and Arm 4 were the right doses to expand. And we ended up with a very large data set. And again, I will not stop repeating myself. There's very few companies that have 74 patients data to show that the product works. And with those 74 patients, then we did a very clever design of a trial, adding Phase IIb to the same trial. So it was an amendment rather than let's finish this trial and start it again and that took probably 6 to 9 months out of the development of the compound. So I think that, that was a very clever move done by the company and as we started PARADIGME.

And this is a global randomized Phase IIb clinical trial. We're comparing those 2 very promising doses because we don't know which of the 2 will be the right dose to take forward. So we're taking those 2 doses forward. And we believe that we will have these in second half of 2020, as I've just said. And we have 81 sites already enrolled, and we have 23 countries instead of 20. This, if the data is positive, will allow us to file for conditional marketing approval in the U.S. for accelerated growth in the U.S. Now you need to convert that into a full approval and for that, the FDA requires that you have a randomized Phase III clinical trial. And that's -- the idea is that, at the same time, as we do this PARADIGME, we're doing Archer, which is doing a combination trial with Betalutin and rituximab, and the data will read out now slightly earlier for Archer.

If the Archer data is good, it is that then we will run a Phase III, most likely a combination trial with rituximab that will allow us to do a full approval. So it's important to understand that Archer is part of the strategy to try to maximize the value of Betalutin in follicular lymphoma, okay. So that's what we're trying to do. If everything goes okay, the product should have first a conditional approval and then a full approval.

What is the data, where are we -- we're only here because we truly believe in Betalutin. And I think that the best to believe in a compound is not to look at whether I do believe in the compound or whether we have the data to believe. Again, we're doing a very good effort in trying to get the data for the other compounds. But we have a very elderly patient population. And there's plenty of publications that show that the older the patients, it means the tougher it is to get them to respond. And we have a patient population that is at least 5, 6 years older than the average patient population of any of the other compounds. So we have a much tougher patient population to start with. And we had a very heavily pretreated, as remember, more than 2/3 had 3 lines of therapy and very advanced with, again, 2/3 having stage 3 or 4. Most of them were FL, but there were other subtypes, and this is important, as I will show in a minute, very well tolerated.

Again, I don't think that we do a good enough job of comparing what happens with a patient that goes through chemotherapy, what happens to a patient that gets one single dose. So the patient goes to the hospital -- Lisa explains this very well, goes to the hospital, gets the Betalutin administered on the same day, goes home, that's it. That is it. After 4, 5 weeks, your count go down. For the vast majority of the patients, it's simply a laboratory side effect. So there's no real issues with the patients and 4 weeks later, by week 8, 9, you're back to your normal levels. So if you know of any other compound with this sort of side effects, let us know. So very, very safe compound.

And unfortunately, some of the times you have a compound that is very convenient and very safe but doesn't show the efficacy. But if you look at the efficacy, that's, again, pretty remarkable. So again, our response rates, both in older patients and the complete responses and it doesn't matter. I think that this is also something that I tried to convey. Doesn't matter how we look at the patients. This shows the robustness of the data. It doesn't matter when you look at all the patients, only the FL, if you look at the famous Arm 1 or the Arm 4, or patients with more than 2 therapies, even the PARADIGME population, the rituximab refractory third-line patients, the data remains extremely consistent. So we believe that there's no statistical artifice here that delivers the data. We think that we have a compound that has delivered very consistent efficacy. And I've left out because I think that you will hear more as well in the future about marginal zone lymphoma, an indication that was completely forgotten a few years ago, and it's becoming now a hot area. And again, I think that probably we have the best data of any compound, at least in monotherapy in marginal zone lymphoma. So this is again something that eventually we would like to explore further.

And as I've just mentioned, our preliminary median duration of response on top of all this keeps increasing. We have 13.5 months now for all the patients. Remember, in the past, we had over 20 months for the complete responders and that again should keep moving, hopefully, in the right direction as the patients mature. The follow-up is still ongoing.

So finally, a quick summary of how -- what was PARADIGME. So we randomized the patients -- in these patients with third-line FL, which are refractory to anti-CD20. And those patients received rituximab 1 dose, 2 weeks before Betalutin and then they receive, remember, what we call the low dose arm, which is 40 milligrams of lilotomab followed by 50 megabecquerels per kilogram of Betalutin or the high dose 40 -- 100 milligrams per square meter of lilotomab, followed by 20 megabecquerels of Betalutin and about 65 patients per arm, we will have an interim analysis in the first half of 2020. So in the first half of 2020, people will know whether the threshold of efficacy that we've set for the compound to keep going is met. So there's an extra reassurance moment for investors that will happen mid of next year. We expect the patient enrollment to finalize in the second half of 2020. And we think that we can start filing in the first half of 2021.

Again, we spent -- we have spent, and we will continue to spend a significant amount of our resources in the CMC part. And as I said, this is very unsexy. Please go through how many compounds in the last 3 years have failed to get approval because of CMC issues, more and more compounds. This is becoming now a real challenge for a lot of companies because the compounds become much more complex. And out of complexity, we're among the best. So we have -- we're currently heavily investing in making sure that we have a CMC package that is as robust as our clinical package so that we have no issues in getting marketing approval. And we're putting the resources, and we're hiring the people, and I think that we are very well prepared to make sure that by the time we file, we have a CMC package, as I said, that is as smooth as the clinical package. And if you have questions on this clinical part, Marco will take them, he's our expert there.

So then, very quickly, what are the -- what is the other trials. So as always, the one I will be after PARADIGME more interested in is Archer. This is the -- as I said, the proof-of-concept on this combination strategy. We think that Betalutin, again, this is very important, it's a great partner, not only for rituximab. The fact that we have one single dose, a different mechanism of action as any other compound that is being used today in any of these NHL indications. And the safety profile makes it an ideal partner for combination therapy. This is the first one. But again, stay tuned. We have other ideas. We would like to do more combination trials going forward.

So here, again, all patients receive the dose of rituximab 2 weeks prior to receiving Betalutin. Here, we had our first cohort in which patients received 40 milligrams of lilotomab followed by the even lower dose, 10 megabecquerels of Betalutin. It was the first time that we were giving this combination. So we wanted to make sure that it was safe. So we've done 3 patients at that dose, and we will do now a second cohort at 15 megabecquerels, which is the, I will call it standard low dose, followed by the normal rituximab regimen, which is weekly doses of rituximab. And then of those patients, any patient that does not progress because if they progress, it will be discontinued, we'll follow on the maintenance therapy of rituximab. So it's adding Betalutin 1 week before the typical -- I would call it, typical rituximab regimen. And that's hopefully, we hope to see some of the synergistic effect that we've seen with the preclinical program. And the data readout of this trial is expected at the end of 2020.

We've done the first cohort. We've announced that we finalize it. We're recruiting now for the second cohort. Once we have the second cohort, then we need to -- at the right dose, either the 10 or the 15, we will have to enroll the remaining patients.

And finally, 37-05, which is our DLBCL trial. Again, we went through a dose-escalation phase with, first, a very low dose of lilotomab or a medium dose of lilotomab with a low dose of Betalutin. Then we went through the full dose of lilotomab with still a low dose of Betalutin. So unfortunately, we were not expecting any side effects, but you cannot go faster. So you need to go 3 patients at a time and then wait until the safety review committee allows you to go into the next cohort.

So we announced, I think the last quarter that we had the data for the first 3 cohorts. There were no safety concerns, so we're moving to the fourth cohort. We've announced now, 11th of July that we have finalized the fourth cohort. So we would expect not -- in the short time frame to hear from the safety review committee that -- and then we will look at the data and decide what is the right data, which of the doses is the right one to go into an expansion phase with the selected dose. And we will dose about 20 patients on that dose, to really try to read whether there's a true efficacy signal and a safety -- and what is a safety profile on this patient population. And we will have the data of these 4 cohorts, as I just mentioned before the end of the year. And now that we have the last patients recruited in July, I can guarantee that this is happening before the end of the year.

Finally, let me take you quickly through the financial results. I'm going to go briefly, of course, we have Tone here. Any questions on this, she will take them on the Q&A.

So 2 things. We have slightly -- slightly higher expenses, but we keep our expenses very much in line with our previous quarter despite the significant increased investment in CMC and that translates into a reduction. And I think that this is something that is very important to point out. We keep reducing the percentage of our expenses that are dedicated to G&A. So we're doing a true effort in trying to put all the resources on the operational part where it really matters and try to reduce our general expenses, which are needed. I am part of G&A. So hopefully, I'm needed. But the number we're striving is to not go higher than where we are today. Okay. So this -- we will continue to try to reduce it as we go forward.

Finally, where are we on the cash. So on the operating activities, we have a negative result of NOK 102 million. It's almost flat NOK 0.2 million for investing activities and actually NOK 7 million from financing activities, and the cash position at the end is NOK 444 million, which is about $52 million. So with that money, you can do the math very quickly, we'll reiterate our guidance. We have the money to take the company until the mid of next year, which we've been guiding for a number of quarters now. No change there.

So again, one slide that summarizes what are our priorities, where are we spending the money, where are we spending our energy, where I'm spending my time. So first is really enrollment. And again, now we can say that we've gone through the uphill battle of getting the sites up and running, enough sites up and running. Now it's a question of keeping the recruitment rate we have. And that we've shown that we can do. I don't see no reason why we cannot keep doing it, but that's the plan going forward. We have to keep advancing on Archer and keep recruiting and finalize the recruitment of this second cohort. The same with DLBCL. I think that the sooner we can start the expansion cohort, the sooner we will know how good is the profile on monotherapy. And again, I cannot believe that we will end up with a competitive profile of Betalutin stand-alone. I think that what we need to show is that Betalutin has the promise to be again a partner of choice for DLBCL development. It's almost impossible today, we've seen it, to have the rate of efficacy of the new therapies with a product on monotherapy. All we need to demonstrate is that the product works in this disease and then we will need to do a development in combination, most likely.

Then we keep advancing and that has to do with CMC, but all the work that we're doing in making sure that the day we get the -- A, that we have a file that is very robust, and we can get an expedite approval. And then we are ready to have a success with the commercialization of Betalutin. And again, it's tough, but if you don't do the work early on, then when you get there you fail. And then all the money that you've spent is for nothing. So we will keep doing work in that area.

We're not close to partnering the compound. We know that we want to do U.S., we, as you know, are looking at what happens in Europe. There's other areas in the world where there's interest in the compound. I think that it's too early. We need to do the deal when it's the right time for the company, but we will look and why not take opportunistic partnerships when needed.

Finally, I've just explained, we have plenty of other ideas. We have a very interesting compound in combination with Orano Med for CLL or other indications, and we are still looking -- we don't want to be just a Betalutin company. I think that the resources need to go to Betalutin, but as a company that wants to be a leader in cancer care, we need to be putting our pipeline in place. So that after Betalutin, there's more value that can be created going forward.

And finally, we are doing our very, very best. We know how tough it is for companies to be financed. So we're very good at trying to make sure that every euro, every NOK counts and every NOK goes to where it needs to go, and it's not spent wrongly. So we're very good and Tone keeps us in our toes on that respect.

Okay. So what are the company goals? Again, we're very transparent, 11 days late, but we got our enrollment completed. And again, there's nothing new in this slide that I have not covered. So what you should expect in the second half is the data readout on DLBCL, and then we will have the first patient dose early next year. We will have the interim analysis in the first half of next year, and we will finalize the enrollment of Archer at the end of the first half. And then second half, towards the end of the year, you will have the data readout. We will have the enrollment completed in the second half. In the first half of 2021, the regulatory filing will be started. So those are the time lines that we are committing to going forward.

What are the next things? So one thing that we're going to be doing because as I've just explained, there's a lot that we're talking about regarding what we're doing, but there's plenty of the other things that we could be doing and that we know we have preclinical data and that we have data that we think is worth communicating to investors. So we're planning an R&D Day and that will happen in a date to be announced shortly. We're just -- want to make sure that we have the external speakers that we are aiming for all agreeing on a certain date, which is not always the easiest part. And then, of course, we are reiterating the days for our Q3 and Q4 webcasts, which is November and February, I think that we don't have the date yet.

And with that, I would like to please ask Lisa, Tone, Marco and Malene here, and please open the floor and the web for any questions you may have after this.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [1]

--------------------------------------------------------------------------------

Yes. I think we're ready for questions in the audience.

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [2]

--------------------------------------------------------------------------------

No questions. Either it was very clear or not clear at all. Hopefully, it was the first. But we have some questions from the web. And of course, that we can still always take questions here. So Malene?

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [3]

--------------------------------------------------------------------------------

Yes, we certainly do have some questions from the web. And let's get going. So was the delay inevitable? Or was it avoidable?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [4]

--------------------------------------------------------------------------------

I mean if the delay was inevitable, and we will have known about it when we started, we would have not given the time line. So I think that we've done our very best. It's been an uphill battle to open the sites, and we were very transparent about we were behind. We were trying to catch up on the recruitment rate. I think that it's becoming now pretty obvious that it's very, very, very difficult that we will get into the first half. So I think that we should guide the market to what is the most likely outcome, which is second half of 2020.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [5]

--------------------------------------------------------------------------------

Thank you for that. How can we expect this delay to impact our competitive situation?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [6]

--------------------------------------------------------------------------------

Again, I can take it but you know Marco, probably he is our competitor expert, we will take him. But...

--------------------------------------------------------------------------------

Marco Renoldi, Nordic Nanovector ASA - COO [7]

--------------------------------------------------------------------------------

So I think, as you recall, we have one of the PI3K inhibitors that has reached accelerated approval that's copanlisib by Bayer that is currently scheduled to complete enrollment in its Phase III trial by first half of 2020. So I assume the question is whether this may pose a risk to us. We currently do not believe this is the case because even if the company will indeed complete enrollment in first half of '20, which is to be further assessed, they will need to prepare filing as a Phase III trial. So they may need to capture data for longer than 3 or 4 months. And in addition, until a drug has received full approval, we will still enjoy the possibility of receiving accelerated approval for our drug. So we currently do not see any risk to our currently regulatory ambition of getting accelerated approval for Betalutin in third-line follicular lymphoma. I hope that clarifies.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [8]

--------------------------------------------------------------------------------

Thank you very much. Do you plan to activate more sites to make sure that you meet the new guidelines?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [9]

--------------------------------------------------------------------------------

Yes. So the answer to that is yes. Yes, we guide to 80 to 85. Now we are thinking about adding a few extra sites. We've received -- and Lisa can comment after I finish. The -- a lot of interest from some sites to participate, and we're ready to go a little bit over 85 if sites do ask to participate. So very interesting sites. I think that it's worth Lisa taking you through some of the ICL (sic) [ICML] interactions there and how is it.

--------------------------------------------------------------------------------

Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [10]

--------------------------------------------------------------------------------

All right. So maybe the audience is aware that every 2 years, there's a very major international lymphoma conference in Lugano. This has been going on for some time. And this year, there were many participants. I think it was over a couple of thousand participants.

--------------------------------------------------------------------------------

Marco Renoldi, Nordic Nanovector ASA - COO [11]

--------------------------------------------------------------------------------

3,000.

--------------------------------------------------------------------------------

Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [12]

--------------------------------------------------------------------------------

3,000 participants. And for the first time, we had a booth, which turned out to be a very good investment because that facilitates a lot of interaction with key opinion leaders and with investigators. And with myself, some of my colleagues, we had face-to-face meetings with about 60, in that primarily investigators and key opinion leaders. And the other interesting thing from ICML is that there are key symposia within the conference. And Betalutin popped up on a couple of slides within some of these key symposia. So targeting -- CD37 was brought out as a new target for lymphoma and Betalutin was clearly mentioned as an agent in development. So that was very -- that made us enthusiastic. There was a lot of interest at the site as well. There's a lot of investigators who asked a lot of questions about the program, and we've set up a number of follow-up meetings in different countries to go and further engage with the key opinion leaders, some were heads of regional lymphoma centers as well or societies within the country. So this was all very positive and very encouraging.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [13]

--------------------------------------------------------------------------------

Okay. Thank you very much for that. How will you communicate the results from the DLBCL and Archer studies and the interim analysis, stock market announcement as or quarterly reports?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [14]

--------------------------------------------------------------------------------

Well, I think that -- let's get to the dates, let's see when we get the data. I hope that we can get if it's data that we can get them into congresses. That's usually the best way. But if the data is very relevant, we will have to make an announcement. We will be almost forced to make an announcement and then keep some of the details for the conferences.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [15]

--------------------------------------------------------------------------------

And then a follow-up. Copanlisib was conditionally approved around 100 patients. Why can't they -- Betalutin apply for such an approval based on the first part of the PARADIGME?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [16]

--------------------------------------------------------------------------------

Well, I think that this came after our PARADIGME design was discussed with the FDA. Copanlisib was not the first clinical trial. You need a certain number of patients, not only the first patient, you need a certain size of our safety database and the FDA gave us on the recommendation that we needed to run PARADIGME to get approval. So we're doing as regulators tells us to do. And anything else would be misguiding.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [17]

--------------------------------------------------------------------------------

You've added a new goal interim analysis for fertility. What does that actually mean? And what should we expect? And how will you publish this?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [18]

--------------------------------------------------------------------------------

Want to take it or want me to?

--------------------------------------------------------------------------------

Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [19]

--------------------------------------------------------------------------------

Yes, sure. So we've built in an interim analysis, just with a prespecified efficacy end point. So that if the data are not so good, we have an opportunity to stop one arm or both arms. Hopefully, that won't happen, but we will not be communicating actual results, overall response data or safety data or anything like that. But should we have to stop one of the arms that will go public. Yes.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [20]

--------------------------------------------------------------------------------

Can you comment on the new agreement with 3P?

--------------------------------------------------------------------------------

Marco Renoldi, Nordic Nanovector ASA - COO [21]

--------------------------------------------------------------------------------

Yes. The new agreement with 3P is basically an expansion of an existing collaboration that goes back to 2013. 3P is one of the contract manufacturing organization -- organizations that is supporting Nordic Nanovector in supplying clinical investigators with material. And what we've done, we have strengthened this agreement by basically agreeing to all the steps that are required to complete the process validation. So the set of experiments and activities that Eduardo alluded to, which are required when you file a drug with the FDA to prove that your manufacturing process and your -- is consistent across different batches, across different scales. And so what we have done with them is basically to agree on the path forward, so that we can complete the work required for filing in time.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [22]

--------------------------------------------------------------------------------

Thank you very much. So Tone, we turn to the financial questions now. How will the delay affect the cash flow?

--------------------------------------------------------------------------------

Tone Kvåle, Nordic Nanovector ASA - CFO [23]

--------------------------------------------------------------------------------

As we are stating in the report, and as we have been stating for, I think, the last couple of years, we have cash until mid-2020. So if we have the last patient in the second half, then we need to look into opportunities to raise more funds.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [24]

--------------------------------------------------------------------------------

And then just a follow-up. At what time will you decide what to do with the financial situation?

--------------------------------------------------------------------------------

Tone Kvåle, Nordic Nanovector ASA - CFO [25]

--------------------------------------------------------------------------------

Yes. There's no decision taken as of today on that point.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [26]

--------------------------------------------------------------------------------

And then are you and the management team planning to buy shares now?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [27]

--------------------------------------------------------------------------------

We cannot comment on that.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [28]

--------------------------------------------------------------------------------

And then would you agree that this delay in PARADIGME makes it harder to raise more cash?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [29]

--------------------------------------------------------------------------------

Well, this is a personal decision. Again, I cannot comment on the difficulties. I think that the profile of the compound is as good, if not better as it was. I think that we're making incredible progress. One of the 2 uncertainties on clinical development, which is at which speed you can get all your sites up and running is out of the way. And now all we need to do is keep our recruitment rate, to keep our time lines. As you've seen with Marco's answer, there's no change in the landscape that we'll have. This delay will not impact the competitive position of Betalutin in the space. So it's up to investors to decide then.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [30]

--------------------------------------------------------------------------------

Thank you. So again, Bravo commented on the competence of the management team in the previous quarterly presentation. Wouldn't the hiring of the new CTO contradict this statement?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [31]

--------------------------------------------------------------------------------

No, at all -- not at all. I reinstate that I have probably the best, let's say, we can never say the best -- one of the best management teams that you can get. And again, find me a management team like this one in any other company. We have people from 6 nationalities with the right experience. And I don't think that you can't get much better than this. There are areas in which we can get better. Yes, and we're reinforcing them. We just mentioned one, that is CTO. And again, remember, Marco stepped as an interim CTO, so we're extremely grateful by the fact that he's been doing an incredible job without being his area of expertise, but he was the first one to say, we're going into a phase where we need someone that has done this before. You cannot be doing experiments. We're bringing someone like Lars. The other area where we know that we will need additional expertise is regulatory. The next key thing is getting this product approved. So I have the best possible team? Yes. Are we going to add someone with the right expertise for regulatory? Yes.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [32]

--------------------------------------------------------------------------------

Fantastic. Thank you very much. And which stage are you on with the application for the market approval? And is it necessary to have a Vice President of Global Regulatory Affairs. I think you just answered that.

What is the difference between the Head of Medical Affairs and Global Regulatory Affairs?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [33]

--------------------------------------------------------------------------------

I have nothing to do. So the medical affairs has to do with interacting with key opinion leaders and disseminating the information and making sure that what the opinion leaders know and that you are the medical representative in the interaction between commercial and the science. Regulatory affairs is the person responsible for making sure that all your interactions with the regulatory authorities is done at the right level under the products compliance. So...

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [34]

--------------------------------------------------------------------------------

Then a follow-up on the interim analysis. Why are you doing an interim analysis. I think you've answered that. But then what potential amendments on the study can be done based on the interim analysis?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [35]

--------------------------------------------------------------------------------

Okay. So can I go for it?

--------------------------------------------------------------------------------

Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [36]

--------------------------------------------------------------------------------

Go for it. Yes.

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [37]

--------------------------------------------------------------------------------

So the interim analysis, we're not doing it. It's planned. So we -- it's not -- it's in the protocol. So we cannot do it or not do it. It's part of the study. And it's pretty standard to have a facility when you have a certain number of patients because despite the fact that we have data on 74 patients. Imagine that it was all due to luck, or one of them was much worse than the other. And that will pop up, and that's what regulators want to ensure is that you don't go all the way to find out if at a certain point, it becomes pretty obvious that the results are going to be negative or that one of the arms is better than the other. So it's there for the security or safety also of the patients. The protocol will not be changed. By the time you get the data, you are very, very, very advanced with the recruitment of all the patients and making an amendment at that time, which I don't think that makes sense, will almost be approved by the time we finalize the recruitment. So there's no plan to change the -- the only plan thing will be we close one arm, would be to keep all the patients on the other arm.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [38]

--------------------------------------------------------------------------------

Okay. Since you have published the median duration of response for 37-01, does this mean that you will not publish any result at ASH 2019?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [39]

--------------------------------------------------------------------------------

I defer it to my...

--------------------------------------------------------------------------------

Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [40]

--------------------------------------------------------------------------------

No, we're working -- I think I've mentioned before that we're now working on a publication of the first part of the study data. So we won't be presenting. We haven't submitted an abstract to ASH on 37-01. Yes.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [41]

--------------------------------------------------------------------------------

Why was the LYMRIT 37-02 discontinued?

--------------------------------------------------------------------------------

Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [42]

--------------------------------------------------------------------------------

That was a study, so the target enrollment was only 8 to 12 patients, and it was designed to provide additional dosimetry data to support the PARADIGME study, but this was no longer necessary. So we stopped the study as we already had enough dosimetry data as well from the first part of the 37-01 study.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [43]

--------------------------------------------------------------------------------

If the LYMRIT 37-07 shows good safety and efficacy, would you consider to create another study for relapsed patients in 37-01 to try out rituximab?

--------------------------------------------------------------------------------

Lisa Rojkjaer, Nordic Nanovector ASA - Chief Medical Officer [44]

--------------------------------------------------------------------------------

I guess that question is about adding another arm potentially to 37-01. No, that's the second-line strategy. So we would continue on in a different patient population than what we do with the Archer protocol at this point. We'll have to wait and see what the data look like.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [45]

--------------------------------------------------------------------------------

And then I think we've reached the final question. Can the median duration of response increase or decrease from the 13.5 months, when more patients data are finalized?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [46]

--------------------------------------------------------------------------------

I think we would like to wait until we have the final data before we comment on that.

--------------------------------------------------------------------------------

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [47]

--------------------------------------------------------------------------------

Thank you very much. That concludes the questions from the web.

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [48]

--------------------------------------------------------------------------------

Can we -- I mean, after all these questions, maybe ask the room again, if there are any questions.

--------------------------------------------------------------------------------

Unidentified Analyst, [49]

--------------------------------------------------------------------------------

A short question regarding to your financial situation. Raising funds was one option you mentioned, but is a strategic partner a second option to get funding to complete the final phase before you file?

--------------------------------------------------------------------------------

Eduardo Bravo, Nordic Nanovector ASA - CEO [50]

--------------------------------------------------------------------------------

I've mentioned that opportunity on my last -- almost last slide. So of course, as a management, we need to be looking for any way of financing the company, dilutive or nondilutive.

Okay. So thank you very much. Once again, thank you for coming. Thank you for those that are listening, and we hope to see you here in 3 months time. Okay. Thank you.