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Edited Transcript of NORN.OL earnings conference call or presentation 18-Feb-21 7:30am GMT

·30 min read

Q4 2020 Nordic Nanovector ASA Earnings Call OSLO Feb 18, 2021 (Thomson StreetEvents) -- Edited Transcript of Nordic Nanovector ASA earnings conference call or presentation Thursday, February 18, 2021 at 7:30:00am GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Jan Hendrik Egberts Nordic Nanovector ASA - Independent Chairman of the Board * Lars Nieba Nordic Nanovector ASA - Interim CEO & CTO * Malene Brondberg Nordic Nanovector ASA - CFO * Marco Renoldi Nordic Nanovector ASA - COO ================================================================================ Presentation -------------------------------------------------------------------------------- Jan Hendrik Egberts, Nordic Nanovector ASA - Independent Chairman of the Board [1] -------------------------------------------------------------------------------- Good morning, ladies and gentlemen. Welcome to our Q4 and full year 2020 highlights and financials. My name is Jan Egberts, and I'm Chairman of the Board. And I'm here together with Lars Nieba, our interim CEO; Malene Brondberg, our CFO; and Marco Renoldi, our COO. Over the past year, I've acted someone as an Executive Chairman, spent quite a bit of time with the company. Most of my colleague Board members have worked very intensely over the past year. First of all, I want to acknowledge this had been a very difficult year and a somewhat disappointing year for all of you and all our shareholders since our stock price has not performed at all over the past year. Unfortunately, we had to spend that year focusing on a number of very important operational fixes, which, unfortunately, resulted that we had very little news to report. But I'm very pleased that I think today, we can report some very positive news to you, and I know you have been waiting for a long time with that. In the next presentation that Lars and Malene and Marco will share with you, we'll show you that we have now more than doubled our recruitment rate from about roughly 12 patients during the first 3 quarters in 2020, so over the period of 9 months, 12 patients, to 14 patients over the most recent 3 months. So up over the first 3 quarters of last year, about 3 per quarter to 14 over the most recent 3 months, and that's a period from mid-November to mid-February. So a very significant improvement in our recruitment rate. And this is all in spite of the fact that today, we're still in the middle of the second wave of the corona epidemic, which had a huge impact on our ability to run -- had a huge impact on the ability of running noncohort-related clinical studies. Really, hospitals were locked down and were closed for those kind of initiatives. I'm also very pleased to report that we were able to reduce the number of required patients for submission due to the protocol changes that we have implemented during 2020. Now we only have 47 patients to go to completion of PARADIGME, so a significant reduction. We also expect that this recruitment rate will further improve to about 8 patients per month or so in the late spring, early summer of this year. And some of the further improvement in the recruitment rate to the 8 I just mentioned will come both from ongoing operational improvements but also from lessening of the corona impact after the second wave, which we expect will abate during the summer, but also more and more people getting vaccinated. So a further significant increase in our recruitment rate. Just to refresh your memory, pretty much exactly 1 year ago, we embarked on a very major organizational refocusing. We appointed Lars as our interim CEO, Malene as our new CFO and later in the year, Christine as our Chief Medical Officer. In addition, very early on last year, we made a number of very significant operational changes, significantly reduced operating costs, reduced our headcount by 25%, which really extended our runway. Unfortunately, in that process of reducing the headcount by 25%, we had to let go some of our excellent people. In addition, we also revisited our clinical protocol. Based on the interim analysis that we conducted in the middle of the year and that were released in early August, the external independent safety monitoring team recommended that we should drop 1 of the 2 arms of our PARADIGME study. So until halfway last year, as you remember, we had 2 arms, and now we have only one arm. And the reason for this is given the great safety profile, the Monitoring Board felt that we should take the best-performing arm and that because of the safety profile, we should be able to lift some of the restrictions we had on our clinical protocol. From that moment on, we were able to include patients with lower platelet counts but also patients who have had bone marrow transplantation. These 2 facts, the lower platelet count and the patients that were coming included with bone marrow transplantation or have had bone marrow transplantation in the past, will increase the number of eligible patients we could potentially include in our clinical study by -- depending on the country, depending on the local practices in a different country, anywhere from about 30% to 70% more patients that could be included in the clinical study. So very important addition that would make more patients eligible for the clinical study. After that decision, we also need to get approved by the local regulatory authorities. And as of this month, we just completed that entire process of getting all the local regulatory authorities to approve these protocol changes. In addition, we -- with the help of Karin Meyer, one of our Board members, we implemented a significantly improved management of our CRO, our clinical research organization. We also implemented improved patient recruitment tools, in particular, in the U.S. So a number of additional measurements and decisions that really will help us improve our recruitment. So in summary, I think we're very positive where we are. We have only 47 patients to go to complete the PARADIGME study. Our recruitment rate has increased from about 3 per quarter during the past year to 14 patients over the most recent 3 months, and that all in spite of the fact that we're still in the middle of a very significant second wave of corona. And like I mentioned earlier, we expect our recruitment rate to increase even further to around 8 patients per month in the late spring, early summer. In short, we reiterate and repeat our guidance of our key value inflection point or 3 months data readout in the latter part of this year. Because of the nature of biotech and the fact that -- probably the question you will ask, why did it take so long? And because of the nature of biotech and the fact that Betalutin treats very sick patients, any change you'd like to make to a protocol like dropping one arm or broaden inclusion per care takes a long time to implement because you do need regulatory approval in each of the countries where you're operating the clinical study. Again, we fully realize that 2020 has been a very difficult year for our shareholders, but we're really optimistic where we are and that we really have changed the corner now and can leave the phase where we need to implement all the required operational and organizational changes to fix our recruitment rate. And now we can focus on the more exciting phase of the submission and towards the market launch. We're not there -- we're not at the market submission yet, obviously, we need to complete the clinical study, but we definitely feel that the operational changes have now all been implemented. And I really want to acknowledge all the hard work that has been done by the team, particularly Lars, our interim CEO; Malene, our CFO; Marco, our COO; Christine; and the rest of the management team. But also really with a lot of operational support from the Board, in particular, people like the Chair of our Clinical Strategy Committee, Jean-Pierre Bizzari, together with Joanna Horobin and Rainer Boehm. They have been very intimately involved in all the drafting of the protocol changes and some of the discussions with our regulatory authorities. Also, Karin Meyer was very instrumental in the improved management of our CRO. And Hilde, ex-Chair of our Audit Committee, with Pier and myself have been very intimately involved in the financing. I think that our new CMO, Christine Wilkinson, summarized at best a couple of weeks ago during a team meeting when she said, and I quote her, "We're beginning to see an encouraging improvement in the enrollment rate of PARADIGME. And based on the changes of the trial protocol and the initiatives that we are implementing to improve the execution of the trial," and this is where the important section is, "we now have clarity from the key regulators on the clinical data set that's expected as a basis for our filing. This clarity, in conjunction with the improving enrollment rate and the continuing recruitment initiatives, gives us confidence that we can meet our goal of having preliminary 3-month top line data in the second half of this year." So really, we feel very confident we're now on our track to submit -- to have the 3-month data by the end of this year. Again, this had been a true team effort working -- with management and the Board working hand in glove. So that's kind of what I wanted to summarize, and I'd now like to hand over to Lars, who will take you through the rest of the presentation, and Malene and Marco. -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [2] -------------------------------------------------------------------------------- Thank you, Jan. From my side, good morning, everyone. And as Jan mentioned, let me go into -- in more detail through our Q4 update. I will start with the most important update on PARADIGME. As Jan mentioned, we have made a significant improvement to our recruitment rate. So we have accelerated our recruitment rate from approximately 2 to 5 patients per month despite COVID. And also, we are expecting that COVID is lessening. And assuming that, that happens, the rate can further increase to at least 7 patients on average per month in late spring. Where did that improved rates come from? We have significantly improved the management of our CRO and also retained specialized firms to further improve our recruitment. We have converted our PARADIGME trial from a 2-arm into a single-arm trial. And we also introduced simplification in the execution for our clinicians. We have very good, positive safety data set from the interim analysis, and that also allowed us to broaden our inclusion criteria. We are now able to include patients with lower platelet counts and autologous stem cell transplantation. That pool of eligible patients increase, depending by country, between 30% and 50%. And the analysis of interim data showed that number of patients to complete PARADIGME can be reduced. So we were able to present that to the health authorities, and we can reduce the number of patients to 120. And that means we only have to have another 47 patients to go to finalize PARADIGME for the regulatory submission. With all of that, we reiterate our target to report preliminary 3-month top line data in the second half of this year. Let me go in more detail through the highlights. We have now 73 patients enrolled as of yesterday. And to remind everyone, we had 59 patients as of November 18. That means we have 14 patients enrolled in the last 3 months with only 3 patients from August to November 2020. So there, you can see that all of our actions really come to [facilitation], and we are very confident that we can even go higher. Our protocol amendments have now been implemented in all 24 countries. Last month, we're approving it -- last week. The final patients have been enrolled in our second cohort for Archer-1 and our second line Betalutin trial and also in the LYMRIT 37-05 phase where we are treating DLBCL patients. The preliminary data readout is expected in the first half of this year. Both trials now have been paused pending the analysis of data and the evaluation of further plans and development. We also were able to publish in Journal of Nuclear Medicine the results of our preclinical studies demonstrating that Betalutin reverses tumor resistance to rituximab in non-Hodgkin lymphoma disease models. So all of that is really very, very positive, and we are on the right track. Now reminding everyone what Betalutin is, going to Slide 7. Betalutin has a compelling, unique and differentiated value proposition for non-Hodgkin lymphoma patients. A short reminder, we have an anti-CD37 antibody. CD37 is highly expressed on B cells. We do have lutetium with a half-life of 7 days as a radioactive compound. And the mechanism of action of our antibody drug conjugate is internalization and cell death and, very important, the crossfire effect of lutetium, which gives us really very, very good results. Now the key benefit, especially during the pandemic, we should not forget and our elderly patients. We only have a single-dose treatment, so none of our competitors have this. We have a durable response in elderly and heavily pretreated patients. Our safety profile is very good. We have a predictable and manageable side effect burden. And very importantly, most treatments today are anti-CD20 treatment, and we do have an alternative target to CD20, which is suitable for rituximab refractory patients. Now as we promised when I took over in February that we wanted to revise our clinical strategy and that we are focusing on PARADIGME, so that is what really happened over the last year. So we brought forward PARADIGME. And PARADIGME is our first-to-market in the trial, so the indication is third line relapsed/refractory follicular lymphoma. We are, of course, together with the data out of Archer-1 and LYMRIT 37-05, which I mentioned they are finalized and we are analyzing the data, we're looking at all of that data together to really realize the optimal strategy to advance in earlier lines. And since we do have also pretty good results in marginal zone lymphoma, we're also looking on the opportunity how to move ahead with marginal zone lymphoma. Now going shortly to Part A. Sorry for everybody who has heard that several times, I think it's still a very impressive story. So what you can see here on the waterfall diagram is the amount of shrinkage of the tumor size. What you can see there in our 74 patients which we had in the 37-01 Part A trial that about 90% of the patients have a shrinkage or reducing in tumor size. And slightly other description is that we have an overall response rate of 67% and 24% of CR in rituximab refractory patients. As I mentioned, these are really the ones which are suffering most from not having any therapy available. Our medium response rate for all responders is more than a year. And even more than 2.5 years, we do have for our complete responders. So that's a very impressive result with progression-free survival of around 9 months. Now that is also important for how we position Betalutin in the market. As Jan mentioned, we are now preparing it. I would like to remind everyone our patient characteristics is that we have elderly patients. The median is 68 years old, and there is no huge difference between Part A and Part B. They've been heavily pretreated with advanced-stage disease. And that is also pretty similar between Part A and Part B. So overall, we have a very good safety data set and efficacy data set in that patient population. Betalutin was also very well tolerated. That is why we also can now treat patients with lower platelets and autologous stem cell transplantation. Interim analysis, as mentioned by Jan, we had it in July last year. We had before a 2-arm trial with the lower dose and the higher dose. So the lower dose was the 15 MBq per kilogram Betalutin and the pretreatment of the cold antibody with 40 milligrams flat of lilotomab, and the higher dose arm was 20 MBq per kg and Betalutin and 100 mg per meter square lilotomab. So these were the 2 arms. And the Safety Review Committee looked at all of the data in very much detail and recommended to go ahead with the 40/15 arm. As mentioned, we have 73 patients enrolled as of yesterday. And the trial reduced to 120 patients with 47 patients to go. We have 95 sites opened in 24 countries. We have promised that our #1 priority (inaudible) is the improving of trial execution. Let me recap a little bit what we have done. So the protocol amendment, as we mentioned already, is now approved in all 24 countries. The broadening of the inclusion criteria has increased the pool size by 30% to 50% depending on the country. The decision to make PARADIGME a single-arm trial led to a reduction in patient numbers needed to complete PARADIGME for BLA filing. 47 patients are now needed to finalize it. The site-specific action plan has been implemented. Senior leadership at NANO and our CRO are deeply involved in continuous monitoring of the site performance metrics, which are also increasing significantly. The CMO is hosting virtual meetings with trial investigators and the teams to promote PARADIGME. So Christine is very active here. She had more or less every PI on the call, and they are appreciating that very much. The specialist firms we have appointed are there to focus on further improving our rate of recruitment, including targeted social media campaigns. The major focus currently is North America and then, particularly, the U.S. There's also some other effects from our competitors. The 3 trials, our competitors have been finalized. And the bispecific -- one bispecific antibody trial is on clinical hold. So that also might give us a few different patients. And very important also here is the vaccination rollout is expected to reduce restrictions imposed by COVID-19. And as you know, our patients are, on average, 68 years old. They are in the group which needs to be protected. So from that point, it is very important for all patient population that the vaccination is going on very fast. Our regulatory strategy to gain rapid approval. BLA filing with the FDA for accelerated approval based on PARADIGME data and initiation of confirmatory Phase III trial. So that is important. We will go ahead with our Phase IIb PARADIGME trial. We do have orphan drug designation for third-line follicular lymphoma granted in the U.S. and in the EU. We do have fast track granted for both, for example, marginal zone. And in the U.K., we do have also the promising innovative medicine status. And of course, we are always exploring other routes to bring Betalutin faster to our patients. Now coming to the positioning of Betalutin, going to Slide 16. What you can see here is what we mentioned before as well. And it's a unique product profile of Betalutin which positions us as the treatment of choice for elderly and frail patients, which are approximately 70% of all third-line follicular lymphoma patients. And if you progressed at a very early stage in the third line, you have great medicines like the stem cell transplantation, which I mentioned, or also the CAR-T, which goes to approval as they are looking with very promising results, very expensive. They do have high side effect, and only a very few patients are eligible for it. We do have a competitor with tazemetostat, good results but only in a very minor collection of patients who do have a certain mutation, which corresponds to approximately 15% of the overall patients in follicular lymphoma. So overall, that means there is still a high unmet need. And with our safety profile with our single injection, we are very well positioned to serve these patient populations. And patients who have comorbidities that prevent the use of both chemotherapies or other therapies associated with a high side effect burden, they are very well positioned for Betalutin. And what we have shown is a durable response with a very good safety profile and the single administration as mentioned. So really very well positioned for that. And that is also the feedback we are getting more and more from our customers. There is -- the efficacy observed in 37-01 is seen as a major strength. Our response rate and the median duration of response in complete responders is very compelling to HemOncs. And the combination of potential benefit is what sets Betalutin apart: the onetime treatment, the durable efficacy, the manageable and benign safety profile and the simplicity for patients and physicians. But HemOncs view elderly and frail patients, which are majority of the patients with follicular lymphoma with comorbidities, including patients with refractory to rituximab, as the ideal Betalutin patients. With that, I will hand over to you, Malene. -------------------------------------------------------------------------------- Malene Brondberg, Nordic Nanovector ASA - CFO [3] -------------------------------------------------------------------------------- Thank you very much. Let's take a look at the financials. And so as you can see, we have still a good control over the finances. We spent NOK 107 million in the last quarter, which is compared to NOK 139 million last year. And of course, we see here some of the effects of the reductions we did in, unfortunately, staff, but other things as well earlier in 2020. As you can see also, and then we will continue to -- of course, to look for further savings. When that said, we do not, of course, want to jeopardize the study. We do want to complete on time. So it is most important now to spend the money on the right thing, which means, of course, clinical and also our CMC activities. On the next slide here, you can just see that the cash run rate, which is now extended into Q3 2021, so this year, and it gave us in the end of the year a cash position of NOK 294 million. As we will continue, as I said, to look for savings, so we can push it as fast we can. And as I said, NOK 294 million in the bank at the end of the quarter, which is, of course, a result of the financing round that we did in December. With that, Lars, I will hand it back to you. -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [4] -------------------------------------------------------------------------------- Thank you, Malene. So we are 100% focused on delivering on our PARADIGME trial. We are highly confident in the potential of Betalutin to fulfill the important unmet clinical needs. The goal is to complete PARADIGME, and we are targeting our preliminary 3-month top line data in the second half of the year. We have reduced the trial size and it means we only have to have 47 patients to go to complete PARADIGME for BLA filing. We have significantly improved the rate of patient recruitment into PARADIGME despite the second wave of the corona pandemic. So our inclusion criteria has been broadened. We have shown that we have a very good safety profile. And we are even going further with additional initiatives to further enhance the rate of recruitment. Our promising clinical efficacy and safety data seen from a onetime administration in relapsed/refractory in non-Hodgkin lymphoma. And very important to mention is Betalutin is 100% owned asset. We are targeting a total NHL opportunity to approximately USD 26 billion by 2026. So -- and of course, we are actively pursuing flexible regional commercialization strategies to maximize our value. So with that, I only need to remind everybody on the next dates from the financial calendar. The AGM will take place on the 15th of April. You will hear our Q1 results end of May, on the 26th, and the first half -- the half year results on the 27th of August. So with that, we are open for questions. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Unidentified Company Representative, [1] -------------------------------------------------------------------------------- Yes. We do have quite a lot of questions here, but many of them are similar. So I'm trying to address the main questions here now. First question is about financing. And we have a couple of questions here related to the future financing plan referring to in the Q3 report, you said something about the extended cash runway could be done with different tools. And how will the company work looking forward to secure the financial situation from Q3 2021 and forward? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [2] -------------------------------------------------------------------------------- Jan, will you take that question? -------------------------------------------------------------------------------- Jan Hendrik Egberts, Nordic Nanovector ASA - Independent Chairman of the Board [3] -------------------------------------------------------------------------------- Yes. As we mentioned during our previous quarterly, we do need to raise some money during the first half of this year. And we clearly want to raise money beyond what we consider the key value inflection point, which is the 3-month data readout later this year. So management, together with the Board, are evaluating various options we will hear more about in the nearby future. But it's clearly a recognition which we mentioned during the previous quarter release that we need to raise money at some stage during the first half of this year. -------------------------------------------------------------------------------- Unidentified Company Representative, [4] -------------------------------------------------------------------------------- Thank you, Jan. We do have a lot of questions about the PARADIGME study, of course. And some of them have been addressed and answered during the presentation, but some of them are also new. So first one, what is the impact of COVID-19 on follow-up visits and data collection for PARADIGME? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [5] -------------------------------------------------------------------------------- A very good question. So what we are doing is, as mentioned, we have really a very good interaction with our CRO and also with our investigators in the hospitals. So the overall processes are now in that way, that we always have somebody in the hospital who can take care of that. Wherever a visit is possible, of course, we are doing visits. But when not, we have implemented procedures that are corona conform and that we can get all of the data and more of the visits made, as mentioned in the protocol. -------------------------------------------------------------------------------- Unidentified Company Representative, [6] -------------------------------------------------------------------------------- Thank you, Lars. The second question about PARADIGME is on recruitment. Can you indicate anything on the geographical split of where most patients have been recruited from so far? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [7] -------------------------------------------------------------------------------- So far, as we mentioned before, our best recruiting countries have been historically in the U.K. and France. What we are seeing now is that wherever the corona pandemic is going down, we do see a huge impact on -- the patients are coming back. So from that point, we are expecting as soon as the corona is going down that also all of the other countries will come back. -------------------------------------------------------------------------------- Unidentified Company Representative, [8] -------------------------------------------------------------------------------- Thank you. And there is also a question about the split between the 40/15 dose and the 100/20 dose among the 37 patients that have been recruited so far. -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [9] -------------------------------------------------------------------------------- The 37 patients? 73 patients. -------------------------------------------------------------------------------- Unidentified Company Representative, [10] -------------------------------------------------------------------------------- Sorry, the 73 patients. -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [11] -------------------------------------------------------------------------------- Yes, of course. There was a split because we have -- until the interim analysis we went ahead with the 2 arms, we have done the interim analysis at 47 patients. And as soon as we got the approval for the single arm, we are focused on the single -- on the 40/15 trial. And the patients which have been dosed with 100/20 are, of course, counting to the overall patient number of the 120. -------------------------------------------------------------------------------- Unidentified Company Representative, [12] -------------------------------------------------------------------------------- Thank you. Another question is do you see any safety issues with regards to -- sorry, that question disappeared right now. Do you see any safety issues with regards to the patients treated under the new protocol? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [13] -------------------------------------------------------------------------------- No. We don't see anything there yet, but we need to be careful here because we, of course, need to wait for the 3-month data of the patients. And as mentioned, the protocol has been approved in all 24 countries, and we have patients coming in under the new protocol. What we have not reached yet, the 3-month data set. -------------------------------------------------------------------------------- Jan Hendrik Egberts, Nordic Nanovector ASA - Independent Chairman of the Board [14] -------------------------------------------------------------------------------- But we have not had any material adverse changes, and that would have been reported. Just to be clear, there are no material adverse changes at all. It's a very safe -- it has a very strong safety profile of the compound. Obviously, there are patients with comorbidity, which means they have multiple other diseases, so we're dealing with very sick patients. But we have not seen any indication of any problems with the compound itself. -------------------------------------------------------------------------------- Unidentified Company Representative, [15] -------------------------------------------------------------------------------- Okay. Next question is could you comment further on the target for the 3-month top line data in second half of 2021 with respect to when you then would need to be fully recruited and what rate of enrollment would be reached -- required to reach this? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [16] -------------------------------------------------------------------------------- What we mentioned, we are very confident that we can reach our preliminary 3-month top line data this year. And as mentioned in the presentation, we are very confident that we can increase our rate of recruitment to at least 7 patients per month. -------------------------------------------------------------------------------- Unidentified Company Representative, [17] -------------------------------------------------------------------------------- Thank you. There is another question about MZL and whether it's possible to provide an update regarding MZL. -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [18] -------------------------------------------------------------------------------- Yes. The update is that, of course, we are working together with our Clinical Strategy Committee with the Board on how can we move ahead. And as Jan mentioned in his introduction, that is also a strategic question, so we are looking on where do we position the company best. And we have very good results in marginal zone. We are working on a clinical protocol there. And as soon as we know more, we will inform you. -------------------------------------------------------------------------------- Unidentified Company Representative, [19] -------------------------------------------------------------------------------- Thank you. Could you also say something about alpha 37, how that is going? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [20] -------------------------------------------------------------------------------- Also that one, it was only one in the presentation yet, put our research activities on hold. So we are looking as soon as we do have a clear path forward there that we might want to go ahead or -- but yes, as mentioned before, we focus everything on PARADIGME. And with that, we have put it on hold. -------------------------------------------------------------------------------- Unidentified Company Representative, [21] -------------------------------------------------------------------------------- Thank you. We do also have some questions about regulatory approval and market access. And there's a question about where we do stand when it comes to the fast tracks. -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [22] -------------------------------------------------------------------------------- So fast track, it's a regulatory status. So as soon as we have submitted them, the FDA is agreeing to handle that with a fast track pathway. So from that point, we are still having, of course, fast track. But since we haven't submitted yet, there is no fast track pathway yet. We expect, as soon as we have the data, that we are reaching out to the health authorities so that we can have the submission in 2022. -------------------------------------------------------------------------------- Unidentified Company Representative, [23] -------------------------------------------------------------------------------- And you mentioned both FDA interactions and internal review provides you confidence that 120 patients is enough for a filing for accelerated approval. The question is did the FDA approval that 120 patients number? And what color can you give on what gives you confidence? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [24] -------------------------------------------------------------------------------- As we mentioned before, we have regular interactions with the health authorities. And we did get very good feedback and interactions with the health authorities. And that is why we are absolutely confident that the 120 patients is good for submission, of course, depending on the clinical data. -------------------------------------------------------------------------------- Unidentified Company Representative, [25] -------------------------------------------------------------------------------- Thank you. And another question is, is there a minimum amount of U.S. patients specifically that you need to recruit to support an FDA filing? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [26] -------------------------------------------------------------------------------- There is no specific requirement for U.S. patients, so there's no rule or any law or something like that in the FDA regulations. It is more that there is, of course, an expectation that you have to have some U.S. patients as we have seen with our competing trials. And we are in a good range there that we are confident that we reach sufficient U.S. patients to meet the expectations of the FDA. -------------------------------------------------------------------------------- Jan Hendrik Egberts, Nordic Nanovector ASA - Independent Chairman of the Board [27] -------------------------------------------------------------------------------- Yes. The other thing to keep in mind is that the FDA now accepting also patients from countries that kind of have a mutual recognition. So it's not just the United States but also some other Anglo Saxon countries. -------------------------------------------------------------------------------- Unidentified Company Representative, [28] -------------------------------------------------------------------------------- Thank you. The next question is, can you file in Europe based on PARADIGME? Or is that unlikely? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [29] -------------------------------------------------------------------------------- Marco, in that case, I need to hand over to you. I think you have looked into that in very much detail on our European approach. -------------------------------------------------------------------------------- Marco Renoldi, Nordic Nanovector ASA - COO [30] -------------------------------------------------------------------------------- I think, in general, European regulatory authorities have been a bit more [vigilant] in terms of approving products based on Phase IIb trials. But most recently, drugs that have demonstrated a strong clinical advantage over available therapies have been able to obtain conditional approval. So our first priority is, of course, filing with the FDA, but we will explore all options to support a filing with the EMA authorities as well with the current trial. I hope that satisfies the question. -------------------------------------------------------------------------------- Unidentified Company Representative, [31] -------------------------------------------------------------------------------- Thank you, Marco. We are going to raise the last question here. And after that, there might still be some questions that have not been answered yet, but the more detailed questions will be handled via e-mail in order to not go in too much detail here. So the last question is about partnerships. The usual questions, are there any big pharma companies that are interested in making a deal with you? Or have you been contacted by big pharma? Are you thinking about such cooperations? -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [32] -------------------------------------------------------------------------------- Sure. We are always thinking is our duty to the company, so we are always investigating different business development opportunities. And as usual, we will revert to you and to market with updates if and when any of these discussions materialize. -------------------------------------------------------------------------------- Unidentified Company Representative, [33] -------------------------------------------------------------------------------- Thank you, Lars. That concludes the Q&A session. And as I said, there might be some questions that have not been answered yet of the more detailed kind, and we are going to respond to those by e-mail. Thank you. -------------------------------------------------------------------------------- Lars Nieba, Nordic Nanovector ASA - Interim CEO & CTO [34] -------------------------------------------------------------------------------- Thank you, [Carrie]. Thank you, everyone. With that, I think we can conclude session. Jan, anything from you, final words? -------------------------------------------------------------------------------- Jan Hendrik Egberts, Nordic Nanovector ASA - Independent Chairman of the Board [35] -------------------------------------------------------------------------------- Again, I want to thank everybody. I want to acknowledge that last year has been a very difficult year for our shareholders, but I really think the company has now turned the corner, and we're now really at the phase moving forward towards the submission of Betalutin and going to the market. So I think we are entering a very exciting phase, and both Board and management are very optimistic about the future. So I want to thank you all for your support over the past year. Again, I acknowledge it was not an easy year, but I think we're going to the finish line now.