U.S. Markets close in 3 hrs 39 mins

Edited Transcript of NANO.OL earnings conference call or presentation 19-Nov-19 7:30am GMT

Q3 2019 Nordic Nanovector ASA Earnings Call

Oslo Dec 7, 2019 (Thomson StreetEvents) -- Edited Transcript of Nordic Nanovector ASA earnings conference call or presentation Tuesday, November 19, 2019 at 7:30:00am GMT

TEXT version of Transcript

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

Corporate Participants

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

* Eduardo Bravo

Nordic Nanovector ASA - CEO

* Malene Brondberg

Nordic Nanovector ASA - VP of IR & Corporate Communications

* Marco Renoldi

Nordic Nanovector ASA - COO

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

Conference Call Participants

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

* Patrik Ling

DNB Markets, Research Division - Senior Analyst Healthcare

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

Presentation

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [1]

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

Okay. Okay. So thank you very much, and welcome, everyone. Thank you for joining us this morning for the Q3 results presentation for Nordic Nanovector. I think that most of you know me, but just in case and for those on the web, I'm Eduardo Bravo, I'm the CEO of Nordic Nanovector.

And I'm going to be taking you through the presentation on the Q3 results. And then, I will be joined by Marco and Tone for any questions. Lisa, unfortunately, is ill today. So she's listening from home. So we wish her that she will become better. She's threatened us to do some difficult questions on the web, so if you hear any difficult questions, they may be coming from Lisa herself.

But it's a pleasure to be here, as always. Let me -- first of all, as always, I'm going to be making forward-looking statements. Again, probably this is already well-known for most of you, but again, it's always good to start with why Nordic Nanovector and what do we do.

So remember, we have a fully owned asset. And again, this is still very important, a product that we're developing for the 2 largest subsegments of non-Hodgkin's lymphoma. And this is -- those 2 markets combined could be one day worth or worth today, as potential markets, about $5 billion.

We've demonstrated, and again, very few companies our size have demonstrated to the extent that we have with the data we have, that we have a product that is very efficacious, that is very safe and is extremely convenient. All the data that we are going to present, all the data that we have with Betalutin is with 1 single administration. Patients go to the hospital, get 1 dose of Betalutin, go home, and that is it. There's no accumulation of side effects. There's no coming back. So all the data is just 1 dose, you go home, you never come back. Or you come back maybe for other things.

And we have this pivotal trial PARADIGME in third-line FL that is actively recruiting. We expect to finalize the recruitment in the second half of next year. That will allow us to file in the middle of 2021 and be on the market, if everything goes well, mid-2022. So we are less than 3 years from being with a product in the market, which I can tell you for a biotech is an extremely exciting thing to have.

And then we have -- that's a relatively small market. It's a niche opportunity, but this is the way of getting very quickly into the market, as we will see in a minute. But then, we have 2 clinical trials that will address 2 much bigger segments. One is Archer, which is the trial in second-line follicular lymphoma in combination with rituximab. And then there's 1 trial, a Phase I dose-escalation trial that we have in diffuse large B-cell lymphoma, DLBCL, which, of course, we're going to be covering in a minute.

And then I think that, again, we are experts in this radioimmunotherapy field. I think that one day, it would be nice to go through what is happening in this field because there's some -- a lot of things happening, and it was probably not the hottest area. But I think that, thanks to the acquisitions of AAA and Endocyte by Novartis, and in particular, by the super success of Lutathera, the product from AAA that has been launched by Novartis, a product that is going to be making close to $500 million on the first year on the market, and that, I think that has changed the perception of a lot of the players in these sort of assets. So we will have the opportunity of having additional value inflection points in the future.

This is exactly what I've just mentioned in just in our pipeline graph. So remember, we have Betalutin being developed third-line FL, PARADIGME in second-line FL in combination with rituximab. This is Archer and our Phase I trial in DLBCL. And then we have Alpha37, something that we presented at the R&D a little bit in more detail for the first day. This is a combination of our chimeric anti-CD37 with lead-212, is an alpha emitter instead of a beta emitter, which is lutetium-177. And that program, we're going to take it into an IND in the next months.

And finally, remember, we always have there Humalutin. This is the chimeric version of the antibody with lutetium-177 that is close to being IND ready, but that we decided to put on hold to concentrate the money and the efforts on Betalutin.

Why do we exist? Why is Nordic Nanovector needed? Why is Betalutin needed? Because patients that have these non-Hodgkin's lymphoma have a very poor prognosis. And the patients, most of them respond to rituximab, but patients that do not respond or that fail, at some point, rituximab have a very different prognosis going forward. So especially old patients have no alternative after having failed 1 or 2 lines of therapy. So there is a real need. We exist because there's a real need. If there was no need, we should not be spending the money and trying to come with something like Betalutin to the market. But there's a real need.

There's a big change. You want to be on this curve or even higher. You don't want to be on the curve in which your expectancy of having -- of being alive 5 years down the road is 25%. So that's the difference at Betalutin. Hopefully, we'll make it that we will make those lines to go higher up, and that the 5-year survival rates will be significantly higher, again, with a product that delivers all the efficacy with 1 single dose.

So what -- how are we going to do it? So again, this is -- we always have the same slides because we're not changing what we're trying to do. It's just, again, trying to explain that basically, our goal today is to develop Betalutin as a differentiated product, something that will stand out and that will provide a service to the doctors that do not have a product like Betalutin to treat those patients.

So basically, our strategy is, first, we start with third-line relapsing FL. As a single agent, you need to prove to the market that, as a single agent, you have efficacy. But then, we want to expand that, and this is the way to get into the market very, very quickly, but then quickly expand into second line, which is a much bigger market and even eventually into first line by providing it in combination.

And so far, as you know, we have the combination with rituximab. We probably will be doing in the future all the combination trials for both DLBCL and follicular lymphoma. And then capturing an even -- slice of the even bigger market, which is DLBCL. It's a very aggressive market. Again, we're trying to prove that there's some activity of Betalutin as a single agent. We will never develop Betalutin as a single agent in DLBCL. It will be a combination of Betalutin with one of the products that are being used in DLBCL going forward. So the first goal is to develop this as quickly as possible.

Second one is really try to make sure that we are ready to commercialize, hopefully by ourselves but either by ourselves, so with the help of someone else, depending on the territories. And for that, you need to make investments, and you need to make investments early on. You need to know the market. You need to make sure that the payers will understand. You need to make sure that you understand how the product is going to be distributed. So there's a lot of energy, time and money that needs to be spent to make sure that once you get the product approved, you're going to be commercially successful.

And finally, we're spending some money. It's very, very little on relative terms, but putting things like the Alpha37 program in development. You cannot have a company that does not have a pipeline as we go forward. So it's a very small amount of money. But we believe, as we show, that the data we have with Alpha37 is very striking. So that is worth moving forward with that program.

So let's move now into the Q3 highlights, what has happened in the last quarter. And we've been giving an update because one of the highlights, of course, is that we raised our money. So there's not many, many new things that we can tell. But I think that, again, we will go one by one.

First, and most importantly, the data we're getting from Betalutin keep showing how good the product is. And we should always start by remember how good the data is, and the data is getting better. Because as we follow the patients longer, we're showing that those -- that the patients that responded, especially the patients that had a complete response, get a significant extension on the survival.

So if you look at the median duration of response, it's gone from 9 months in December 2018, now to 13.6 months. Most strikingly, because here we've reached the median duration of response, but more strikingly, on the complete responders, we've moved from 20 months to 32 months. And here, we have not reached a median duration of response. So for the approximately 30% of the patients that achieved a complete response on the trial, we're already at close to 3 years and counting. That data will keep improving, at least, cannot get any worse. That's with 30 months on average of median follow-up. So again, this shows how good the data is.

Second thing, how are we doing with PARADIGME? So we keep opening sites. We've reached now our goal of at least 85 sites. We've -- we said at the R&D Day that we will push a little bit further. So we're now at 87. We will still open a few sites more. And we are on track to complete our enrollment for the second half of 2020, which is what we have communicated to the market since May.

Then we have Archer-1. And again, we communicated, and as excited as I am, we need to be careful. It's only 3 patients, but it's great to have those results because we will be very unexcited if the results were bad. And I will be telling you, "Don't worry, it's only 3 patients." But it's great that the 3 patients we have is 3 complete responders. And this is on the low dose on the trial still on Betalutin. So this is the combination of rituximab plus Betalutin, 3 out of 3 had a complete response. This is the first cohort. Remember, we're doing a second cohort now at 40/15 in terms of Betalutin dose. And after those 3 patients, we will choose which of the 2 doses we move forward in the Phase II part of the trial or the dose expansion phase.

We have started moving forward with Alpha37, and this is after the results that were presented. Again, I think that the results are pretty striking. We've demonstrated that you take cells that are resistant to ibrutinib. And we've demonstrated that they are resistant to ibrutinib because you try to get results with ibrutinib, and you get 0 results. So clearly, those animals are resistant to ibrutinib, and you get an over 90% response to Alpha37. So again, if you -- if we're able to translate that to patients that actually become resistant to ibrutinib, which is first-line therapy for this patient population in CLL, I think that it would be eventually a game changer.

Finally, we managed to get another NOK 243 million raised in October. That's the money we need to get the company, as we've been communicated, at least to the end of 2020, that is to get to the end of the recruitment of PARADIGME, the recruitment of Archer and the recruitment of DLBCL. So with the money that we've raised, we should be able to get to the end of the recruitment, and in the case of Archer, even of the data of all the clinical trials that we are actually performing.

And finally, I know that those things sometimes are not seen as that important, but I think that getting people like Gabriele on board is a major achievement. And I think that as the time that we're entering into, which is getting ready to submit and to get the approval of Betalutin, it's, I mean, a need for the company to get someone with that experience, someone that has done it before. And I think that really reinforces our capabilities as a team to succeed with Betalutin.

So very quickly now because, again, you are all familiar with this. So remember what we've done, LYMRIT 37-01. All the data that, as always, we're going to present has to do with the LYMRIT 37-01, a very large 74 patients trial that had a Phase I in which we were looking at different doses and different combinations. Do we need to give rituximab 2 weeks before, yes or no? What are the right doses?

Then we had an expansion into 2 doses, the famous low dose, 40/15; the high dose, 120. And we demonstrated that both doses were good, so that we moved them into PARADIGME, which is a dose comparison of the 40/15 dose with the 120 dose in 130 patients with a primary endpoint which is overall response rate. And again, this is the trial that eventually may allow us to file for accelerated approval in the U.S., okay? It's third-line patients. Those are patients that are difficult to recruit. Those are patients that have failed at least 2 previous lines of therapy and that are refractory to an anti-CD20. So it's not only that they have failed an anti-CD20. It's that they are refractory, which means that they do not respond to anti-CD20.

And of course, on the background, we're running Archer. Why? Because once you get the accelerated approval, you need to run a confirmatory Phase III that will be running second line to convert the accelerated approval into a full approval. So that's the reason why both trials need to be seen almost as a part of a package that eventually will deliver the full approval of Betalutin in second-line and third-line follicular lymphoma.

We should put this in a poster and put it everywhere. Again, remember, very old patients. In this patient population, every year counts. And instead of the 62, 63 average median age of the previous clinical trials, we have patients that, on average, are at 68. More than 2/3 of the patients actually were more than 65, heavily treated. We have patients that have been treated with 7 prior lines in the clinical trial. And the majority were FL. But, as you know, we have some marginal -- some lymphoma patients where the results, as I will tell you in a minute, were very striking.

Again, very well tolerated. We know what the side effects are, which is reversible and transient cytopenias. And again, that compares extremely favorably with any of the other products that are being developed or that exist on the market. And it was great to see both, in particular, Professor Zinzani, discussing how important it is that we have non-hematological toxicities that do not accumulate and that do not go on top of the toxicities that they see with some of the other products that are being used in this patient population. So this is important to remember.

And again, very importantly, this is all with 1 single dose. And I cannot say it enough, 1 single dose compared with weekly regimens, compared with you need to come back every 3 weeks to do another cycle and another cycle, and then the side effects start accumulating. Here, you go, you have these reversible cytopenias. That disappears. Then you're back to your normal life.

And with that super profile, what we have is unsurpassed efficacy. No one has -- in this patient population, no one has shown these sort of results in which for all the patients, we have a response that is above 60% and a complete response that is close to 30%.

And I keep saying every time, it doesn't matter how we look at the data. This is not just a few patients of a certain category that do very well that make the whole group look good. It doesn't matter whether you look at the -- all the patients, only the FL patients. Out of the FL patients, you take the Arm 1, you take Arm 4. You take patients that are being treated at least with 2 lines, so third-line patients, the third-line patients with a refractory, which is really the PARADIGME population. You see that the overall response rate is always around 60%. The complete response rate is anywhere between 25% and 30%. This is extremely consistent data that we then expect to see as we develop the compound going forward.

And it's good to remind also everyone that we have a striking result. It's only 9 patients but in marginal zone, which is a very decent chunk of the market for which very few products actually are commercialized, we have almost 80% response rate and close to 50% of complete response.

So again, we believe that this data warrants further investigation, and that the company, at some point, should put a clinical program in place to try to develop the compound for marginal zone lymphoma. We don't have the money to do it now, but this is something that eventually we would like to do in the future.

As I mentioned on the highlights, we've increased our median duration of response now, especially for complete responders. Now it's a very striking 32 months. And this is after 30 months of follow-up. So again, we will be updating the market as this number changes. Remember, after, I think, 2 years, it's only every 8 -- 6 months that we check on the patients. So we need to wait before the line moves. We cannot be looking at it every month because there's very few patients that are being followed. So -- but we will keep updating until we reach the median duration of response for sure.

So what is PARADIGME? I think that everyone knows. Patients go 2 weeks prior to the -- receiving Betalutin. They go for 1 dose of rituximab, and then they are randomized to receive either Betalutin low dose, which is 40 milligrams lilotomab with 15 megabecquerels of Betalutin per kilogram, or 100 milligrams per square meter. So it's a significant increase in the dose of lilotomab followed by 20 mega -- together with 20 megabecquerels per kilogram of Betalutin.

So this is on day 0, and then we will follow the patients every 3 months. We have the scan. We will see how many do respond. There is an interim analysis for futility. That is plan that will -- we will have the data around mid of 2020. We expect to complete the patient enrollment at the end of 2020, and this will allow us to file in the first half of 2021, okay?

So as I said, 87 sites ready to enroll. These will go up to about 95 sites, we believe, more or less. So we may be updating this every quarter. You should expect a few more sites that are interested in participating, that we may add as we move forward.

And again, the interim analysis, again, is for futility. So all we'll know is whether the 2 doses, 1 or the 2 doses, have gone through a pre-specified hurdle that has been agreed with the FDA that will allow us to continue with the trial until completion. And we, of course, expect both arms to go through the hurdle, but this is something that we will not know until we have the data of the interim analysis, okay? And we will, of course, communicate to the market once we know if the 2 or 1 of the 2 arms goes forward.

Again, a lot of focus is on PARADIGME. This is where we spend most of our time and energy. This is the most important thing that we can do. So there's a lot of things that we're doing, not only in our daily relation with ICON, which is the CRO that we're using to do the clinical trial, but it's also what are we doing to try to further improve operationally the recruitment rates that goes from making sure that now the sites have access to sites around them, so that they are really referral sites. We're actually going ourselves, of course, to the sites. And again, this is something that very few companies do. So going as a CEO or as a COO or as a CFO, even Tone has gone out, and communicating the importance of the trial, communicating to the principal investigator why they need to really try to put patients on the trial makes a difference. And it's appreciated. So there's a program to do that.

We have 4 MSLs. So we've put external resources. We do not only believe that this is a job done by the CRO, but we have our own people going to motivate the sites, to make sure that any admin issue that we may find in the sites is solved and that the -- really, the trial is top of mind of the investigators. Because there are very few patients that fill the criteria, you cannot miss a single one. So there's a -- it's a need of being actively in those sites, as we speak.

And we are now doing a program of national investigator meetings, again, to ensure that those key opinion leaders that have recruited patients that have good experiences can convince also their peers of the results of Betalutin and the profile of Betalutin.

So this is a never-ending story of making sure that you get top of mind of PARADIGME in the heads of the people in the hematological departments. And this is just a small list of some of the things that we're doing.

Again, as soon as we get the results, then there's going to be a second race. The second race is getting the product approved. And that is, remember, we have orphan designation. But very importantly, we have fast track in the U.S. We've got PIM designation in the U.K. And again, I always say that the most important things of getting those designations is that regulators actually believe on what I'm telling you: a, that there's a huge need in the market because otherwise, they will not give you those designations; and b, that the data looks very promising. Again, until you convince them with the real data, which is PARADIGME, the PARADIGME results, nothing happens. But the data we have is striking enough for the regulators to say, like, "You know what? With that sort of data, in this indication, you should be given fast track. You should be -- we should be looking at this in an expedited way." So this is part of what we're doing, and again, filing expected in the first half of 2021.

So fast track, you have the ability of doing this rolling forecast -- rolling submission, so that's what we're planning on doing to increase the size.

Again, the investment of Betalutin manufacturing. This is what I always refer to as the non-sexy part of where we spend the money because no one sees this. We've been putting out some press releases because that -- there's been a lot of changes.

We have secured now the supply chain of all the materials, even on the commercial stage, so the last one being the agreement with ITM for the non-carrier-added lutetium. But it's funny that here, no one pays attention to this, but in the U.S., for example, investors were very worried about the -- are you sure that you have sufficient certainty on your supply of lutetium because Lutathera, which is the product of Novartis, is going so well, and you're using the same producer of lutetium as Novartis, how sure are you that they cannot be, I don't know, acquired, being acquired by Novartis. And then suddenly, you don't have lutetium for your products.

So having those sorts of contracts are -- is completely -- doesn't look like a lot of value, but I can tell you, gives a lot of uncertainty away. And this is our job. Our job is to ensure that there's no risk other than the fact that the product may not work. That, we cannot change. But making sure that every contract is there, that all the materials are ready, that the supply chain works, that the manufacturing can go through an inspection, this is our job and this is where we're spending, unfortunately, more money than what people anticipate.

So that's PARADIGME. This is being ready. I mean, if you look, sorry, at the previous things. It's like, one, you get the clinical development, so you have the product with the data; secondly, you get it through regulators; third, you have your supply chain, your manufacturing ready to go, okay? So this is the key focus.

But then the second part is what other things do we have for the future. And of course, the most important one is Archer. This is -- I always say, not only does this gives us access to the biggest market, which is second line, third line, but it's also the proof that the Betalutin is the best agent for combining for other therapies. And rituximab is just the example that we're using.

So remember here, we do the same as you will do for Betalutin alone, which is the pre-dose of rituximab followed by Betalutin at 2 different doses. And then, we go into the standard rituximab regimen, which is weekly injections for 4 weeks, and then, we follow the patients.

Every patient that does not progress, because otherwise they discontinue, is -- goes into this maintenance therapy which is quarterly follow-up doses of rituximab. So again, we're recruiting. We're still recruiting on the second cohort of patients and data readout. So we expect to finalize the recruitment around mid of 2020, and the data readout of these about 20 patients on this trial will be at the end of 2020.

Only 3 patients -- data on 3 patients is great. All of them responded. All of them, complete responders. I mean, great if we have 100% complete response at the end, but please, do not expect 100% complete response. It will be too good to be true. But the fact that 3 out of 3 have already responded, I think that shows that what we saw in vitro, what we've seen in vivo in animals, is translating at least somehow into the clinical practice. So we're very eager to see what happens on the second cohort, and most importantly, once we go into a decent number of patients on the follow-up.

Finally, we have the DLBCL trial. Remember, this is a dose escalation trial in which this is a different patient population. You need to do the safety, again. Those are fragile patients that are even tougher to treat because they progress very quickly than some of the FL patients. So again, we've been slowly moving up. We're now at the last and the high cohort recruitment. And again, we have promised that we will deliver some data before the end of the year. We have 6 weeks to go, so we will deliver some data before the end of the year. And then, we will start the expansion phase that will take us to recruit during 2020, with data at the beginning of 2021. Okay. So that's on the development part.

Very quickly on the financials, and for all the difficult questions here, of course, we have Tone that can answer them. But I think that we're doing a great effort. We keep growing. We're more people. We keep going into more complex and more clinical trials and more developments, and we are managing to keep our spending flat which I think that shows how careful we are at managing our expenses. And also, we keep increasing -- and this may fluctuate, but this is a big jump this quarter, we keep increasing or reducing the G&A part of the overall pie. So we're really using the money for the development part. And Tone, with the rest of the team, I think that they're doing a fantastic job in making sure that every euro is spent where it should be spent, okay?

Now we've raised some new cash. So it doesn't appear here. We finished the quarter 3 with NOK 346 million in the bank and we have raised another NOK 243 million gross. So basically, we have about NOK 575 million, NOK 580 million as of today now because there's some -- of course, some money that has been spent. But if you add that, we are above NOK 500 million as we speak in terms of money. And again, we'll reiterate with this money, we can get at least to the end of 2020 so we can finalize all the clinical trials that we're actively recruiting for.

Nothing has changed. We're going to be spending the money even more focused, as you have seen, but again, doing the same things, first thing is PARADIGME. I can't remember the percentage, but it's a huge amount of that big pie that is not G&A, goes into PARADIGME. So PARADIGME is really where we're spending the money. But then it's, of course, Archer and DLBCL clinical trial is preparing for the success of Betalutin, doing the commercial preparation in the U.S.

Of course, we keep discussing with potential partners and this is something that we need to be looking into. There's areas of the world where, definitely, we're not going to be commercializing ourselves. This is also a good way of getting some nondilutive financing for the company. So we're going to be continuing those opportunistic discussions.

We will continue Alpha37 is an example that show to the world that we have a company that is capable of putting other assets into development. And definitely, we will continue our very rigorous capital management because we know how tough it is to raise money. So we're very careful on how we spend it.

So those are the goals. Very soon, we will get out with some of the data on the dose escalation phase of DLBCL and then you should get -- we should get the first patient on the DLBCL expansion. In the first half of 2020, we will have the interim analysis for futility and we will have the enrollment of Archer very close to the summer. It will be very borderline on the first half of 2020 to the second half of 2020. Definitely, the data readout will come before the end of 2020 as well as the enrollment of Betalutin in PARADIGME, most likely as well in DLBCL, but we don't want to promise that yet. And finally, first half of 2021, we will be filing for regulatory approval of Betalutin at least in the U.S. So this is what we're, again, committing to in -- with the -- with you investors.

Finally, in the financial calendar, and I almost always forget this slide. I was reminded yesterday, so I almost went directly to this slide. There is a new financial calendar. So please get those dates. This is when we will be reporting quarterly next year.

And with that, I would like to invite Tone and Marco here with me, and we open the floor for questions where Malene will give us the questions that we get from the web, if we get any.

Please, here. And we have Patrik.

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

Questions and Answers

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [1]

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

Can you update us on when we should expect any more data readout from, for example, LYMRIT 37-01? Should we expect anything in connection with ASH?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [2]

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

No. So basically, we've preempted that at the R&D Day. There's nothing new. I mean the only things that we can report on 37-01 is changes in the duration of response because the data is not going to change, the responses are not going to change. So it's just the duration of response.

Now that we've reached median duration of response on all the responders, it's only the median duration of response in the complete responders. So we do not believe that, that data is sufficiently important for ASH, but we will, of course, be updating the market as we get any updates into that number.

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [3]

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

Okay, great. Next question. When it comes to filing for PARADIGME first half or end of first half 2021, given that you said that you expect the trial to be fine -- fully recruited by the end of 2020 and then you have a 3-month follow-up. Isn't it pretty tight to expect it to be filed maybe 3 months only after your final readout?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [4]

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

Well, I think that when you have fast track, and this is the beauty of fast track, you are eligible for a rolling submission. So you can submit part of your files even without all the file being ready. So that's the strategy, is that there's part of the file, you know the file is 3 modules and there are modules that can be ready even without the full clinical program being ready. So we will file on the other modules, and we will file the clinical results later.

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [5]

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

Okay. So -- and so I should expect you to use rolling submission?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [6]

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

Yes, yes.

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [7]

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

Will you be able to use anything, one of the newer pathways, like Real-Time Oncology Review, RTOR, as well?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [8]

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

I think that we're not counting. I mean everything else will be a bonus. I think that what we can count on is on the most likely thing, which is we have already fast track. So we are eligible for rolling submission. So we're counting that as part of our time lines. If we were to get other designations that may have -- the FDA may even take a more aggressive view into reviewing or approving the product, it will be a bonus. But I think that is pretty risky to put that as your assumption.

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [9]

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

Then my last question is regarding the futility analysis. If you could just give a little bit more color on what you will communicate to the market, if we will get the press release saying just that both of the doses reached their hurdles and they are continuing or will you say anything else? Is that the only thing we will get?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [10]

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

No. I mean, at this point, the answer to that is you need to be very careful. This is a regulatory trial. So if you start giving data, you may bias the data. So we cannot be saying -- imagine that there is a small difference in 1 of the 2 arms, then patients may -- do not want to go in one way or the other or doctors may know depending on which dose because the doctors know which dose they are giving. Whether there's more likely or less likely or they will look for -- so you need to be very careful.

The only thing that we will communicate is the trial is progressing. There's no reason to stop any of the 2 arms and we will go to completion. And that will give the reassurance that the efficacy data is above the needed hurdle for approval.

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [11]

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

Okay.

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

Unidentified Analyst, [12]

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

So in October at your private placing, you disclosed that you had recruited 32 patients so far. And so it's almost 100 patients left until you have achieved your goal in the second half of next year. And I also wonder what makes you so confident that you will reach this recruitment -- finalize the recruitment, I mean. And also, if you can put that in perspective regarding your -- the centers you have? You have got so far the 87 centers. And also, what kind of similar trials you're comparing to when you're thinking about modeling your recruitment rate and so on?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [13]

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

So we're modeling our recruitment rate on our own recruitment rate, which I think is the best model. So you look at the curve, and your recruitment rate based on -- from the moment you open a site until the moment those sites start recruiting on average in oncology, I think that the paper say, anywhere between 3 and 4 months. So you know that it takes 3 or 4 months from a trial of being ready from a site being a recruiting site. And again, that you need to take into consideration. So you are lagging on site ready to recruit, you're lagging always behind that number. And then what we're using is what are the number of sites that we're recruiting based on that every month. And we're moving that forward until the end of 2020 and we -- so that, indeed, we get to the end of 2020. We cannot be given -- this is a trial that has, as you can imagine, with -- and that's the reason why you end up opening so many sites. We're using the -- if you look at the other trials in this indication, which is what you were referring to, the [Galvoline] clinical trial or whatever, we are on similar recruitment rates as they were. And we have -- we're forecasting to continue on those similar recruitment rates. So we're not targeting anything particularly good or particularly bad compared with what has been done in this patient population in the past.

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

Unidentified Analyst, [14]

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

And will you give any more updates on the recruitment rate going forward?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [15]

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

I don't think so. But for the time being, the answer is that we decided it was only once. We don't know. I mean we cannot promise, yes or no, because -- the idea is that no, unless we deviate. We decided to give it as well because we deviated from the last. So we felt that we needed to explain to investors. If we're not changing our guidelines, if we start recruiting many more patients, then -- and we accelerate the recruitment, maybe we will go out. But again, I think that the next thing that you will hear, apart from the normal quarterly updates, is the interim futility results.

Patrik, you still have a question?

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [16]

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

Could you just update us on how many patients you need to have recruited and follow before you can do the interim futility analysis?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [17]

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

We have not communicated that, but it's -- you can do the -- if you look at what is usually required for that sort of analysis, you can guess the number because it's a pretty standard thing.

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

Patrik Ling, DNB Markets, Research Division - Senior Analyst Healthcare [18]

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

So can I have a follow-up on the previous question? I mean I see that you continue to report the number of sites and countries. And given that you did that from, yes, a little bit more than a year, 1.5 years now, up until the delay that you had, that didn't really correlate and didn't really give us in the stock market predictability about your recruitment rate. So from my point of view, I think it's important for the stock market that you maybe reconsider whether you should communicate a recruitment rate. That's just maybe a comment rather than a question.

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [19]

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

Noted. And the only part that I need is to disagree on the first part. I think that we were late on the recruitment on the opening of sites and I plead guilty here because I recognize that we were below the number of sites and that was our fault. I'm of course, sorry to say, our fault. When the site is opening if they don't see a patient, that I can control very little, but we should have had the sites open quicker. That's what we had in our plans. If we had, had the sites open at the speed we anticipated, with the current recruitment rate, we would be online.

So we were giving the opening sites not just a way of confusing everyone, is that, that was what we were tracking to try to get us to the recruitment because the recruitment rate, we have been always using this proxy from other trials. And you see that you need to open that many sites.

And again, I've given you I think in other quarterly reports. I mean, I think that the last one was AUGMENT. This is Celgene doing a second line trial with REVLIMID. To recruit 380 patients, they opened 100 sites, and this is second line. So that shows that these trials, you need to open a lot of sites because they are difficult to recruit and it take them 3.5 years to recruit the number of patients.

So it's not an easy area. It's difficult to recruit patients. You need to open a lot of sites. The issue is that it's taking us too long. And we failed a little bit there, yes. But, I mean, we were not Supermans. So sometimes, we don't do well. But I think that we were very open with the fact that we were late with the recruitment. We expected that maybe the recruitment rate will accelerate that will compensate. That's what has not happened. So the recruitment rate is what it is. And now we have the sites open, I think that we're in a very -- in a much safer scenario. But this is...

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

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

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

Okay. No more questions from the audience here. Otherwise, we turn to the web. And it seems like we've also got a lot of questions here regarding the recruitment. So just to be fair to everyone. We will also take this one.

Will the company update the market on 50% and 75% recruitment in PARADIGME? And will the updates be on the quarterly presentations? So if you could just...

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [21]

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

So there will be updates on the quarterly presentations. We're still online towards our goal of finalizing the recruitment at the end of 2020. But in principle, we're not going to be giving updates on precise numbers every quarter.

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

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

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

Perfect. And just a small follow-up. Can you give more details on the enrollment of patients in PARADIGME, enrolled patients per day, change in pace?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [23]

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

Not a significant change in pace. Very impossible to predict on our recruitment on a per day basis. I think that there was 1 day in which we recruited 3 just so you know how -- and we announced that we have 32. So 10% of those came in 1 day, then there's some very, very small hospitals that have recruited 2, some very big hospitals that have recruited none. So -- but they recruited none and maybe they will recruit 2 in 1 week. So it's very unpredictable. So it's very difficult to look at monthly changes. I think that we need to look into longer periods to try to draw any conclusion.

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

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

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

Perfect. Thank you very much. Then will you inform the market when the first patient is dosed in Cohort 2, 40/50 in Archer-1 trial?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [25]

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

No. When the first patient is dosed, no, we wouldn't -- we didn't do it on Cohort 1. I think that we will wait until we have the 3 patients not only recruited, but we have the data. And as we've done with the first Cohort, here was the data on the first Cohort. When we have the data on the second Cohort, we'll tell you here's the data on the second Cohort. And then probably we will go when we have the expansion phase finalized, then we will give the data on the expansion phase. But again, I -- sorry, I haven't thought about it and we haven't discussed it, so I cannot is the final answer.

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

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

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

Good answer, yes. Are you confident that enrollment in Archer-1 will be completed in first half 2020 as guided? Will you open more sites to ensure no delay on Archer-1?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [27]

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

So the answer to the second part is we're already considering it because we think that the quicker we can recruit is probably the trial that will provide more value as well for the company. I've already said that it's very hard. I mean we know that this first half still can move a little bit. I mean it will be around first half of 2020. The data will definitely come 4 months later. So even if we're late by a month or whatever, we'll still deliver the data before the end of 2020, which is the real goal.

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

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

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

Fantastic. It is estimated that the company will need more capital within the next 12 months. Are there any efforts being made to out-license the product to non-key markets or partner up with someone else?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [29]

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

So to the second part, we keep our discussions ongoing. This is part of our job. We will always have discussions about partnering the asset with different companies that approach us. No decision has been taken.

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

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

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

And then just a follow-up. How are you going to raise new capital without too much of diluting shareholders?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [31]

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

Well, there's dilutive and nondilutive financing opportunities, and I think that the company has taken no decision whatsoever. We have just raised, so let us rest a little bit on this part. We will look at all the different opportunities, nondilutive, partnering, dilutive, and then the company will decide what makes sense and when.

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

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

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

Perfect. Are you considering listing of the company in the U.S. in order to have access to much larger capital market?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [33]

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

It's our job to be ready and to be considering all the different alternatives including, eventually, one day listing the company in the U.S. Is it the right thing to do? With a company with our market cap, at this point in time, it doesn't make sense.

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

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

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

How do you view partnering with a fourth party logistic operator?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [35]

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

I don't -- I'm not sure that I understand. Would we need a partner in the U.S.? I think that Marco covered that. You can go ahead, Marco, and explain that, of course, but...

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

Marco Renoldi, Nordic Nanovector ASA - COO [36]

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

Yes, I think we touched base on this topic last time. Certainly, we will need a logistic partner in the U.S. who can help us with the last-mile distribution, with customer service. We have our headquarters based in Europe. So I think this is certainly a benefit. We have seen they are using a similar model. This is not uncommon. And we have done our homework. So we know exactly who are the partners that can assist us. Does that answer the question?

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

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [37]

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

I think you did. Is it possible to get a deal that leaves NANO with an upfront payment to continue development and launch?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [38]

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

Is it possible? I suppose, yes, it is possible. I mean if you look at the sort of deals, I mean, we're very excited, this is a product that will get accelerated approval. It's very early times in terms of development. And I know that people, especially Norway, look at Algeta. Algeta got a deal with a Phase III. We're 4 years away from having the first 3 data. So the sort of super high upfront that will fund the company for I don't know how many years, it's years away. So we should not be counting on that sort of deal to happen in the short term because we have a product that is going to be having Phase II data that will eventually because of the indication, because of the need in the market and the data that we've produced may allow us to have an accelerated approval. So I think that people need to think that if you look for the sort of upfront deals in these sort of compounds, they are not 300 million upfront and then you go and spend the money. It's a small upfront.

And then the thing that we will always need to balance, and that's part of the thing that, of course, we discuss with the Board is, is it better to lose part of the asset for that sort of upfront or are we better off raising the capital and continue with a full value for ourselves? Because people are like, yes, but you dilute yourself. When you give away and you license the compound, you dilute yourself because you sell part of the asset, okay? So it's a different dilution, but at the end, you're giving away part of the future value of the company.

So we need to know how much the asset is worth. And if they pay us for what we believe is 20% of the asset and they don't pay us what we believe is worth 20% of the company, we shouldn't be licensing the compound out if we can raise the money. So that's the calculation that we need to do and that the Board needs to do. And we will do what is best for the company in terms of financing the company and keeping as much value as possible for our shareholders.

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

Malene Brondberg, Nordic Nanovector ASA - VP of IR & Corporate Communications [39]

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

Fantastic. When will you start developing the U.S. sales organization and how will it be organized?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [40]

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

It's a little bit early times, among other things, because we don't have the money to do so. We have the plans to do so. And I think that Marco maybe, I mean, you've done the work -- we've done the work. So you can...

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

Marco Renoldi, Nordic Nanovector ASA - COO [41]

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

I think the answer is pretty straightforward. So you have analogues that you look at in terms of when to plan a sales infrastructure. We have already looked at this area. We have done a thorough research, mapping analogues, not only to understand when, but also to understand what type of roles do we need. This is not [appeal]. This is a specific type of technology and product, which requires different type of players in the field.

We have a plan, we know when we will deploy, but as Eduardo said, it's probably not the right time for now. So I think that should be the answer. We have exactly an understanding of how the blueprint should roll out and when, and we are ready for it.

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [42]

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

And I think that the right moment at which to make the commitment is finalizing of the recruitment. I mean the interim data will give us the certainty that the product is going to make it, but then it's finalizing the recruitment when you know -- you almost can -- to know when you're going to be launching, so is the time to really make the commitment in terms of spending.

But the plan is ready. So if we were to have the data tomorrow, we know what to do and how much it will cost. And I think that that's again our job is to make sure that we're ready, that we are.

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

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

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

Does it cost more to open more than 85 sites? So the next...

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [44]

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

Well, we have a contract. We can go above 87 sites without any additional cost for the company. So no, we're not incurring in extra costs.

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

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

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

And are you still confident that your team is the right one to lead the product to success and create shareholder value?

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [46]

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

Absolutely. And we have added -- there were 2 pieces that were missing and not because of lack of quality, but the sort of specific things that we needed, we didn't have them. One was regulatory expertise of getting a product approved in the U.S. market and that's what we have done with the appointment of Gabriele. And as you know, because we've announced it, it was someone that has taken a product from this sort of current level of manufacturing into a fully-fledged manufacturing organization that will be able to deliver the product for clinical trials and commercial in both sides of the Atlantic. And we have appointed Lars Nieba, who is joining us 1st of December. So those were the 2 things that we didn't have in the company. We have them now, and we are sure that we have the team that can make Betalutin a success.

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

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

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

Fantastic.

That concludes the questions from the web. Any follow-up, just e-mail us on the IR e-mail, and we'll come back to you as soon as possible.

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

Eduardo Bravo, Nordic Nanovector ASA - CEO [48]

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

Any other questions here?

Well, thank you very much. The next time you need to prepare 1 tough question for Tone. But thank you very much. Thank you, again, for coming. For those that are listening, thank you for the support.

And please through the IR mail, we're at your disposal to try to get back to you with any questions or additional questions you may have. Okay. Thank you.

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

Marco Renoldi, Nordic Nanovector ASA - COO [49]

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

Thank you.