Good morning, ladies and gentlemen. Welcome to the update on the PARADIGME and the new timeline for Nordic Nanovector. My name is Jan H. Egberts, I'm the Chairman of the board of directors of Nordic Nanovector. Today is here with me are Malene Brøndberg, our Interim CEO and CFO, and Marco Renoldi, our Chief Operating Officer. First of all, we'd like to share some slides with you, where we give you a little bit more detail regarding the current situation, and then subsequently, we have some time for some questions. Hereby I'd like to hand over to Malene to take us through the presentation together with Marco. Good morning, ladies and gentlemen. Thank you very much. As Jan said, my name is Malene, and I will take you through a couple of slides, and then I will hand it over to Marco after that. As you can see that we announced the day before yesterday evening that we unfortunately have to come up with a new timeline on PARADIGME. That said, we are continuing to focus on, of course, completing PARADIGME as quickly as possible. As you also saw during 2020, we made significant improvements to both the trial design and we implemented a multiple of initiatives to improve the execution. With that result, we saw some good improvements in 2021 compared to 2020, but not unfortunately as much as we had anticipated. As of the third of August, we had 92 enrolled patients out of a target of 120. This is up from 83 as we announced on the 25th of May 2021. We've also made the decision not to invest further funds into our Archer trial. That said, it's very important to say that data and insight will help in designing the protocol for the confirmatory phase III clinical trial, because as you know, it is very positive data we have in that trial, and that is important. We have also decided that we will do in Q4, R&D day. Of course, with the current COVID situation, it is very difficult to say the exact timing right now, but here we would like to discuss the position and the next step for the Betalutin development as well also give an insight into other value-enhancing opportunities we believe we have in the pipeline. As I said, we unfortunately had to revise the PARADIGME timeline. This is of course a very serious situation with the COVID, and we have seen an uptake, but unfortunately, as you also know, the Delta variant hit hard, and where we started first with the Delta variant is here in the U.K. where I'm sitting, because unfortunately, I can't travel into Norway right now. Then it spread throughout. We have seen a good trend in the patient enrollment, but unfortunately, the Delta variant didn't help us. We did decide, unfortunately, to revise the timelines after we had, of course, discussions with our clinical advisors and the CRO who manage our trial. We have, of course, continued to focus on the increased interest in enrolling patients in regions where we've seen that COVID is under better control. We are, of course, confident that we can maintain and improve moderately the current rate of the recruitment despite the COVID situation. When that is said, it's also worth mentioning that August is always, just so you have that in mind, when we report in the end of August where we're going to again give an update on our numbers of recruitment, is always a weak month because of just the nature that in most European countries, that's a holiday season. Of course, unfortunately with the COVID, that doesn't help. The new timeline for PARADIGME is that we are targeting preliminary three months data readout during the first half of 2022. With that, I would hand the next slide to Marco, please. Yes. Good morning, ladies and gentlemen. Our confidence in the value of Betalutin remains very strong. Not only Betalutin is the most advanced radiopharmaceutical in clinical development, but it's also one of the most attractive compounds in this setting. The reason why our confidence is so strong is because Betalutin targets a disease, a complex disease where the unmet medical need is high. Despite new therapies have been made available, quite a few targeted therapies in the follicular lymphoma setting, even one CAR T, there is a portion of the relapsed refractory patient population suffering from NHL and follicular lymphoma, which is underserved by existing therapies. This is the population of the elderly, of the frail patients with a poor performance status, with serious comorbidities. These are patients that, as a nature of their age, or as a nature of the comorbidities associated to prior therapies, do not tolerate, cannot accept, or are not willing to undergo either chemotherapy or even the novel agents that have been approved, the PI3K inhibitors, the CAR T-cell therapies. Because both physicians and patients know that while these therapies may be effective, they are associated to a high side effect burden. I think it's worth stating that for patients entering into the third line of therapy after devastating prior lines of therapy with chemotherapy, remission is an important goal. These patients look for more than remission. They look for a better quality of life. They want a more balanced type of treatment that ensure remission, but also ensures a more tolerable profile. This is exactly what Betalutin can offer. We can satisfy that need for a chemo-free effective and tolerable treatment. That's why we believe that we have a tremendous opportunity in this set of patients. In third line, this is not a niche population. This is more than 70% of the third line patient population. Betalutin is not just the third line follicular lymphoma indication, even if that's a very promising indication. Betalutin holds multiple opportunities to expand in follow-on indications. You have heard from Malene, we are preparing to start a phase III, which will enable us to secure a second label in second line follicular lymphoma. We have now more information on what the next steps will be for diffuse large B-cell. We have multiple opportunities to further exploit the market potential for this compound. With that, I'd like to hand over back to you, Malene. Thank you very much, Marco. I just want to round off our presentation here just with a reminder about the next events that we have. As I said, the 27th of August, that's when we report the Q2. I do hope that I will be able, and Marco will be able to travel into Oslo, but as right now, it looks difficult, unfortunately. We will have the R&D day as also said, and we would like to have it in the Q4 just so we have time to prepare, and hopefully we will see an improvement on the travel so we can be in Oslo for that day. Finally, of course, we have the Q3, which will be the 18th of November. With that, I would like to hand it over to the session of the questions, please. Thanks, Malene. The first question we have is, how is the hunt for a new permanent CEO going? Jan, I think that's a question for you, please. My apologies, I was muted. We currently have a very active search process. We have retained an executive search firm who is helping us, and we are talking to various potential candidates. That's ongoing. Okay. Moving on to some questions about PARADIGME. It says, will recruitment completed be announced as soon as possible? How long will it take from the last patient dose to top line data? Will this be announced directly to the market, or will you wait for a suitable conference? We will, if I can start and then I'll hand it over to Marco. We will announce when we have completed the enrollment. As I said, we will do everything, and the management team works really well together and we also, of course, work with the boards to do everything that we can to get it going as fast as we can. When it gets to the We need from the patients in, we roughly need three months where we can then come out with the preliminary top line data. Marco, I don't know if you've anything further to add. I think you covered it very well. As you know, we had an assessment of efficacy three months after the patient received Betalutin. We, of course, will clean patients in stacks as they progress. You can expect maybe for the patients in the last month, some additional weeks to clean the data, in essence, three months after the last patient in, we will be able to provide preliminary top line data. Next question. Is it possible to have a three-month readout after the first 100 patients just to inform the market of the results? As you can understand, we need to have all patients in, and that's of course important, and it's important that the data cleaning takes place in the way it has to take place, of course. Marco, I don't know if you've got anything further on this. I think we have agreed with the regulatory agencies that we will do formal analysis only at certain points in time, which is when all patients are enrolled and after certain amounts of time following the enrollment. We have to comply with what we have agreed. Next question. Can you start writing the BLA application when preliminary results from 100 or 110 patients are available, and then include the final 10 to 20 just before submission? As going back to saying, we need the 120. I don't know, Marco, have you got any further on this? I think we can start preparing for other elements of the BLA application. The BLA application is a very complex endeavor, and our regulatory team is coordinating these massive efforts. This include non-clinical CMC and clinical data. We are advancing all of these work streams in parallel, and we can certainly give priority to certain areas until when the full clinical data set is available. We, of course, since we have received Fast Track, we even have the possibility of exploring the rolling BLA concept. Yes, what is being asked is possible. We can have different information, documentation being provided at different times. We will wait until the 120 patients are enrolled to finalize the clinical documents. Yeah, just want to be clear. That is the plan. The plan is a rolling admission. We provide the information to the agency as soon as it is available. Again, the data integrity, which the point about can you break the code after 100 patients, that's a very important point to the regulatory authorities like the FDA. You really do not want to, and are very negative towards breaking this code halfway. Next question. About two years ago, significant emphasis was made on CMC strategies in respect to BLA readiness and commercial execution. According to public job listings, the company had also made a number of hires in this field. Lately, however, there has been limited investor communication around manufacturing. Are there any changes to your go-to market strategy? Marco, I think I'm going to hand that over to you. No. The requirements for a BLA filing, as far as a CMC is required, have not changed. We are committed, and actually are on our way, to satisfy the requirements that the agency, the FDA, poses in terms of CMC readiness. All the Process Performance Qualification activities are on their way and proceeding well. All that we had described a couple of years ago during one of our R&D day are on their way. Maybe we'll find opportunities to update the market on these activities. Can I just. If I could Sorry, Jan. Yeah, no. The word CMC, for people who have not heard, or the acronym CMC, stands for Chemistry Manufacturing and Control, which is basically the catch-all phrase for manufacturing issues. In case people wonder what CMC means. Thank you, Jan. Yeah. If I can follow up on that, I can just say and also allude to the fact that I have said at the last many quarterly calls that we, of course, do continue also with the spending in CMC, because I've also said that that is, as Marco also said, a very important part of getting ready. We are, of course, continuing on that path. Where in the world is recruitment highest in PARADIGME, and how many patients do you currently have in screening? We don't give the insight, unfortunately, into each country nor each region. Also, we don't give into the screening. What we will continue to do is we will continue to update every quarter on how the enrollment is going. As I also said before, we have in the areas where that was less hit by COVID, we saw an uptick in the areas and the countries where we saw a big impact of COVID. Of course, we saw that we were more hit. I don't know, Marco, if you got. No, I've nothing to add. COVID has impacted which are the most enrolling countries. We have seen countries that were enrolling extremely well and that were hit by COVID, and therefore decreased their enrollment rate, and others came up. It's really an inconsistent pattern dictated more by COVID than by our efforts. Next question. Yeah. Can you say which 10 sites you have closed due to low recruitment? Or in which countries they're in? No. We don't provide that detail. What is, of course, very important to say is that we always evaluate what we do, and we do that all the time. Of course, we would spend the money the best way we can, of course. Of course, we do need to take initiative if we can see that something is not working, and we can put the money at places where we think that's a better investment. That is a day-to-day assessment that we do. Because of course, we're fully aware of that it's the shareholders' money. That's very important, of course. Marco, I don't know if you have anything to add. No, nothing to add. We optimize to be more effective. That's what we do. Next question. Historically, you've referred to the PARADIGME trial as a pivotal trial, but you do not do that anymore. Can you discuss your current thinking on the regulatory process for Betalutin based on PARADIGME? Is it possible to file for an Accelerated Approval based on PARADIGME, or do you think you need to complete a confirmatory phase III trial before filing? Marco, would you? We believe, based on our conversation with the FDA, that we can file with the data generated through the PARADIGME trial for Accelerated Approval. At the time of filing with the data generated from the PARADIGME trial, of course, pending results, we need to have a phase III confirmatory trial started. That is what the FDA requires for any compound filing for Accelerated Approval with a phase II study. That's reality. Of course, we are looking for the data that will determine the robustness of the data. Yes, PARADIGME can be sufficient to file for Accelerated Approval. Thanks, Marco. Next question. Based on the interim results from last summer, do the management and the board believe that Betalutin will come to market? Absolutely. Yes, absolutely. The interim analysis confirmed strong activity for both dosing regimens, and a tolerability and safety profile in line with expectations. There was a clear recommendation from the independent review committee to go for the 40/15 dose, which the company acknowledged, and which was later discussed with the agency. That's why we have proceeded with a new single agent study for the second part of PARADIGME. Clearly, strong sign of activity, so we are confident that the drug through the rest of the PARADIGME trial will confirm its efficacy level. Next question. What year do you estimate that Betalutin will be on the market? Do you have interest from other pharma companies in Betalutin? Would you consider that interest as high? Jan, would you take that one? Or Marco? Marco, take the timing, I will take the other one. Yeah. I think it's a bit early to guide on approval timelines. I think what we can clearly confirm, as we had previously said, anticipated during the quarterly call, we still expect to start the BLA process in 2022. Of course, the approval of the compound will depend on the review, whether it's a priority review, it's a standard review by the agency and all formalities. I think, again, we want to confirm our intent to start the BLA filing process in 2022. I'll hand over to Jan in regard to the partnering strategy and interest from other parties. Yeah. Thank you. Our business development team has discussions with various parties. The reality is that these compounds typically do not get any formal agreement with any partner until there are more definitive data regarding the performance of the product. I've been long on the other side of the equation, working for big pharma. Typically what you do is you wait until you have very definitive results of clinical studies. Yes, we are talking to a lot of different people and different companies on an ongoing basis. Thanks, Jan. Next question. Given the recruitment issue in PARADIGME, how does Nordic Nanovector expect to market Betalutin and sell it by themselves in certain regions? In light of the recruitment progress, does it not make sense to partner up in all markets? Yeah. It's a partnering question. The board actively is investigating various partnering approaches. The most likely outcome is a mix, where in the larger markets we would have a partner. In smaller markets, we probably would not have a partner. That's the smaller, more local markets, like for instance, Scandinavia. That's not definitively decided yet. Just a pure hypothesis that where we are. There's likely a hybrid model. Many of these smaller biotech companies, when you go to market with the first compound, tend to have a hybrid strategy, and I would expect. There's no definitive decision yet, but I would expect to do the same for our company. Thanks, Jan. Just moving on to Archer. What are the consequences of stopping further studies of Archer-1 now? Many people see this as perhaps the company's most important asset in terms of valuation. Do you already have enough data to be able to say that Archer-1 will be attractive combination made as? I can take that. I think the decision to stop investing resources in Archer is a very positive decision because it means that we have collected enough information from this study. As you recall, Archer-1 was a mainly study to assess the safety and tolerability of the combination of Betalutin plus rituximab as well as the preliminary activity of the combination. We have seen that this combination does not alter significantly the profile of Betalutin when it comes to safety and tolerability, which is one of the most important features of its profile. We've also seen that the combination strengthened the efficacy of the compound. Therefore, we had all the information we needed to inform the next stage of development for second-line follicular lymphoma. As you know, our phase III, which we have to start at the time of BLA filing, will target second-line follicular lymphoma. Again, we welcome the decision to put an end to Archer-1 as a positive decision because it means we have gathered enough information to inform the next stages of development. Thank you, Marco. With rituximab off patent, how many biosimilar partner opportunities exist for the future Archer-1 combo treatment regimen? There are many biosimilars on the market. As you know, the biosimilar business model is not a model that leverages scientific collaboration. It's a model that leverages tenders, pricing discount, first entry advantage. Therefore, there is a limited synergy that can be gained from a scientific collaboration with any of these companies. Clearly, the prevalence of many rituximab biosimilars means the rituximab will remain a significant component in the treatment algorithm, and therefore choosing, for example, to combine with that compound may have commercial opportunities. Thank you, Marco. Is a phase III study consisting of Betalutin plus rituximab as a combination in one arm and mantle cell lymphoma in the other aimed at second-line FL and third line FL a possibility? We will probably provide some update on our ideas relative to the phase III design later in the year once we've had the opportunity to discuss the current proposal with the agency. In general, I can say that a phase III study basically compares the drug that we want to assess, in our case, Betalutin, whether in combination with another drug or as consolidation to another treatment versus a comparator in one or more NHL subtypes. Again, we cannot comment at this point in time because we are in the process of finalizing our phase III design, we want to first have a conversation with the agency. When the company is ready, we will provide more updates with the market. I don't know if Malene or Jan want to add anything to this. No, I totally agree. As you could just hear, we have a lot of things going on, and as I said, working to first a PARADIGME, of course, to get that completed, and then, of course, we also at the same time, as Marco just said, working on the phase III design. How many Archer patients are still in remission? I do not have that exact number on top of my mind. I believe it is six out of seven, but we would need to check with our chief medical officer who is not on the call, and we will be able to provide an update maybe at the quarterly call. Yeah, I recall the same number. Maybe we should move on to talking about financing questions, financial questions. Yes. Yeah. Can you discuss the financial implications of the delay, please? In connection to your last capital increase, you stated that you did not plan to raise any more capital until you had presented the three-month follow-up data from PARADIGME. Is this still realistic given the recruitment rate, the follow-up time, and the company's burn rate? Yeah. Well, as I said, we will do everything that we can to complete as quickly as possible, and we will let you know when we have completed, and we will continue on the quarterly updates. We also said that we expect the preliminary top-line data in the first half of 2022. We will reiterate that statement also that we have funds going into the second half into 2022. We will, of course, and we do that all the time, as you've heard with some of the initiatives we're taking, look at our boxes and try to spend the money where the money should be spent. Of course, it's important that we spend the money so we get the enrollment going as fast as possible. As I said, it is second half of 2022 that we have the money, and we expect to be able to have the top-line preliminary data in the first half. Thank you, Malene. How does stopping investment in Archer affect the budget and the yearly cash flow? Well, of course, it has an impact, of course, on that. As I said, and also as Marco said, the most important thing is that we now feel that we learned what we should from the Archer-1, that, of course, is very important. That's where we take the decision. Of course, there is a money implication as well, but that is where we took the decision on, that it is the learning that we feel we've now got from it. Okay. What is the cost impact of closing the 10 sites in PARADIGME? It will have an impact. That said, some of that money, we will move them into other things, other initiatives, where we see that that could have an impact on the recruitment. Here, the task is really to get that going as fast as possible. That, of course, means that we're not slowing down on the spending on PARADIGME. There will be other areas that, of course. We do that all the time, look into whether we can find some savings. Not on PARADIGME. That, of course, is the key. The money will be reinvested in patient acceleration initiatives focused on the other sites. Exactly. That we've seen have worked very well in certain countries. It will actually give us the chance to make the sites which are more productive, even more productive. Exactly. I think this is most probably the last question. It says, "What is the rationale for spending time and resources on preparing for an R&D day in the current situation? What does the company hope to achieve? I think it's a long time ago since we last time had an R&D day. Of course, we feel that we have some, as we've spoken about before, want to give an update on other projects then. It's not just PARADIGME, because Nordic Nanovector is more than PARADIGME. We would have liked to have it before that, but we can also see with the current COVID situation that it is impossible. We would like, of course, to have time to plan, because as we had in 2019, where we had the day on the 17th of September, we had a day where we also had some external experts in, and it just takes time to plan that. With the current situation, that's why we placed it Q4. We would like to have it before. I don't know, Marco. No, you covered it very well. If I may just add that the company is still viewed through the lens of PARADIGME and third-line follicular lymphoma. There is a lot of progress we have made in both the clinical development plans and commercialization plans. We are working actively on the design of the phase III. We have progressed on the understanding of what the next steps of development for diffuse large B-cell. Betalutin is much more than just third-line follicular lymphoma, and we feel that we have updates for the market on this. Secondarily, we have projects that have merit, that have the potential to represent important contributors to the value creation of the company. We feel, even if we understand the market is waiting for PARADIGME, these elements will be important to improve the appreciation of what this company can provide to shareholders. Thank you, Marco. We've just had a couple more questions. What is the preliminary medium duration of response for the Archer study? I think, as I pointed out, I'm aware that six patients are still on remission, so I do not know when the next planned assessment of median durational of response is due. I have to refer this question to my colleague, Christine, and we may provide an update in one of the upcoming meetings. Thank you, Marco. I think we've covered nearly all of the questions that have come in, and I think all of the topics that the questions cover. I'll hand it back to Malene. Well, thank you very much. Before I hand it back to Jan, I would just say thank you very much. As you can hear, it's a team effort here. As Jan also said, we are still searching for a CEO and well on the way. We will do everything, in the meantime, the team that's here, to get the enrollment going as fast as we can. With that, Jan, I would hand it back to you. Thank you very much. I think we covered a lot. Thanks for your attention. Obviously, August 27th, we will have our quarterly release. We'll give you some more deep information. Don't expect too much difference between today and the 27th, still, it's always an important milestone, the quarterly results. Thanks so much for your attention and your support. It's kind of a disappointing meeting, that's a bit of the reality of biotech. All the best. Take care. Good.