Good morning, ladies and gentlemen. My name is Jan H. Egberts. I'm the Chairman of Nordic Nanovector. Together with me here are Erik Skullerud, our CEO, and Malene Brondberg, our CFO. Fortunately, it's a very sad day for all of us today. Obviously, we had to announce last night the discontinuation of the PARADIGME clinical study for Betalutin. Obviously, in particular, a sad day, but not just exclusively for the shareholders who put a lot of money in the company, but also for the employees who worked very hard and also have invested a lot of their personal money in our company. Finally, and probably even more importantly, the patients who had expected a very positive new treatment for this very deadly disease. Unfortunately, we had to discontinue the clinical study.
We're gonna share some data with you. Unfortunately, we cannot share everything at this stage, and the reason for that is that the guidelines by the FDA, the Food and Drug Administration, which the US regulatory authority, they don't allow you to release all the data at this stage in order to maintain the, as they call it, the integrity of the clinical study. Unfortunately, we cannot share everything that we probably would have wanted to, just given the fact that we are still in discussions with the FDA. Having said that, I'm gonna hand over in a minute to Erik and Malene, and at the end, there will be an opportunity to ask some questions. Please, Erik, go ahead.
Thank you very much, Jan. Also from my side, good morning, ladies and gentlemen. Thank you for joining us. I'd like to echo what Jan also just said. This is one of those situations where, as a manager, as an employee in a company, as the one who's reporting the data to you today, it's one of the toughest things that you have to do. Obviously, you put a lot of effort, you put a lot of emotion, you put a lot of time into what you believe is going to be a great asset for patients. When the data then reads out the way they have done this time, it is equally hard to really find the right words to characterize it.
I think from a personal point of view, I would say I'm gutted. I really am. 'Cause this is something that I really had a great belief in, so it's really sad when you see data the way we have seen them. That being said, I wanna take you through a little bit of a story over the last few weeks, and what may have seemed like a very long time to you has also seemed like a very long time to us, but for different reasons. When we did our Q1 report back on the thirteenth of May, we told you that we continued to have issues around enrollment in the study.
It was still not going the way we expected, and we were sad to report that we only had a couple of patients that had entered the study. That, too, today has changed somewhat, but before we jump into the detail, just wanna remind you again that some of the statements that we're making today is going to look forward as well, some of what may become plans. Please look at this and familiarize yourself with this before investing further. As I mentioned, the inclusion enrollment back in Q1 we reported was fairly flat. As you can see on this slide, only one new patient has been enrolled since we reported that last time.
We then at the beginning of June sent out a press release and announced that we would go into a comprehensive review that today I can tell you has taken place and we'll give you some details in a second. That also included, importantly, an independent expert panel that would review the data. Why independent and why an expert panel? I've said this to some of you in communication previously. It is of the utmost importance that the integrity of the PARADIGME study is maintained. It is of the utmost importance for us that we follow the ethical guidelines, the rules and the regulations for conducting these type of studies, and that means that we, Nordic Nanovector, don't have access to the data as such.
In order to continue that integrity and maintain that integrity, we therefore appointed an independent expert panel to review the data. This consisted of two people. One person, a world-renowned biostatistician, and one person, a world-renowned hematologist, a really top-of-the-line opinion leader with no association to the study whatsoever. This is important because we wanted really a third-party review. I hope for your understanding that we cannot go out with the name of these people, but they are really experts in their respective fields. We believe that we can definitely ensure that this is something that we can truly validate as the right review. We also did a survey among our investigators, partly on paper. We sent out an electronic questionnaire to every single site.
Approximately 25% of them responded. We spoke to several opinion leaders, investigators face-to-face. I personally spoke to about 15 of them while at the EHA back in the beginning of June, and we'll share some insight with you as well. We have started interactions with FDA, but as you saw in the press release, this is an ongoing communication, and we expect this to take some time. So over the next weeks and possible couple of months, we'll have further interactions with the FDA in order to get further guidance from them. This is important not only for the data that we have, but also, and arguably more important, and you've seen this in the press release, also based on the strategy that we wanna move forward.
On top of that, we're reviewing our cost base, and we'll get back to that in a second. You have also seen in the press release that we have announced a restructure of the company as a consequence of this. I wanna touch on a couple of these things. First of all, the survey among the investigators completed. We did a survey, very similar survey last year, last summer, as the one we have done this year, and they have pretty much shown the same. They mentioned three different areas why they had challenges in recruiting patients. Number one, and a standout is on the inclusion and the exclusion criteria in the study. It has been a hard study to include from the get-go.
That's not news to us, it's confirmation, but it's still one of the key root causes for why we have had the challenges that we have had. Two, study sites are generally tired, partly because of corona, but more importantly because of capacity. The change in investigators, change in study nurses, change in study coordinators, and a heavy workload due to COVID and corona in general. Three, COVID and corona itself has certainly had an impact both on patients recruitment, patients' ability and need to go to the hospital, and as such, the possibility to include them.
We further then discussed also with leading KOLs at EHA and also during the last couple of months in order to better understand what is the investigator point of view, and we did this face-to-face in order to get really deep insights. Again, a lot of what I just mentioned has been confirmed, but I think over and above that, there's a couple of things that this has taught us that I'll get back to on the following slide. Again, they're also confirming that COVID has had an impact, competitive studies have had an impact, and the sheer inclusion, exclusion, and therefore finding the patients is important.
The interaction with the FDA, as I mentioned, we have started that, but again, referring to what we also sent out in the press release, there are two things that we want to understand better. I will remind you that this is a study in a very specific group of patients. A patient group that even today has a significant high unmet medical need, and we need to get clarity in our conversations with the FDA, what do they therefore see in the data versus that patient group and get full clarity on that. The other part of this is, you know, the fact remains, the asset as such has shown both in Part A but also in Archer promising data, that we want to explore further.
Now, we fully acknowledge that we cannot do this by ourselves, hence why we need to also seek partners in this. There is a business development part of what we're talking about here as well, but the guidance from the FDA will help us further these strategies as we move out in time. Back to the discontinuation of PARADIGME. I think bottom line for us, the rationale for why are we discontinuing the study is the data and the quality of the data. When this was presented to us for the first time, you can imagine how our reaction was.
It was basically we saw this, and we went, "This is strange." One out of three patients is responding to the treatment, and approximately six months of duration of response. This is significantly different than what we saw in LYMRIT's Part A, hence you may therefore understand why we mentioned the signs of efficacy in the press release that we sent out just a couple of weeks ago. There is efficacy there, but by the standards that we feel we need in order to make Betalutin in third line FL success, this is not what we were looking for. On top of this, also you have seen over the last few weeks an announcement of the first bispecific going to the market.
This was not necessarily news to us. We knew this was coming. What we have found out in our communication with opinion leaders and investigators is that both Roche but also a couple of the other companies that are working on bispecific from a clinical development point of view have so-called early access programs. That basically means that each and every physician can apply for getting the drug for free and therefore giving it to patients accordingly. That's something that has definitely impacted also the rate of patients that we could have included in PARADIGME. You will also have seen press releases from some of the CAR-T players out there that they are pushing more wide use of CAR-T.
I think it's fair to say, and I'm saying this on the basis of what I heard at EHA, the excitement in the scientific community for bispecifics is significantly higher than that for CAR-T. These are two areas that from a competitive point of view, have further heated up as we have gone through just the last few weeks of activity. In this context, and looking at this and the development program, the PARADIGME study, and what we have seen of data, our estimation and our suggestion is therefore that this is not a viable proposition moving forward in third line. We feel that the competitiveness of the profile that we now see is significantly lower than what we expected.
Therefore, the board, together with us in management, has spent the last few hours in heavy discussions around this. It's, as I said to begin with, a really tough thing to communicate, but the decision is to discontinue PARADIGME. Where to from here? First of all, we have already started, but I hope you can appreciate this is also a fairly fluid situation. We have already started to review our cost base, our infrastructure, and the cost of closing down PARADIGME. This will take us some time. At the bottom here, you can see we're aiming to give all of you an update when we do our Q2 report towards the end of August.
At this stage, it's too early to say exactly how is this gonna affect run rate, et cetera. What we can say is that run rates, cash burn is gonna go down significantly, but we need a little bit of time for actually making that happen. The restructuring of the company will start immediately. The purpose again here is to reduce cost to a minimum, and only focus on the essential pipeline activities moving forward. With one exception, and that is, again, as per the press release, our communication with the FDA on the way forward for Betalutin. The board will review an optimized development strategy for the pipeline.
We have an additional four assets, as you know, from the R&D day, et cetera, that we are also working on, and we're really now looking into how can we best prioritize that, number one. How can we move that forward in an optimized fashion? We'll come back with more information on that shortly. More towards the end of or end of August for the Q2 presentation. I mentioned earlier the business development strategy that we're also furthering. This is not to say that this is something that we're starting. You are all aware of what we have also reported in previous calls.
The difference this time is obviously that also a potential partner now have access to what these data look like, and also further details in that sense, which may make us more interesting from a partnership point of view. Finally, we will confirm all of these numbers, but to the best of our understanding to date, the cash position towards end of Q2 is approximately NOK 280 million. For those of you that over the last few weeks have been speculating online around, "Yeah, now they're going bankrupt," let me say right here, no, we're not.
There is enough cash in the bank to take us forward, but obviously all of this is depending on that we do the right things that you can see on this slide in the weeks and months to come in order to ensure that we transform the company accordingly. That will be partly a restructuring and partly evolving the development strategy. I'm not telling you something here that you don't know. These are the other four assets that we have in the pipeline at different stages. I'm not gonna give an update on where we are specifically today about this. That is for the upcoming, again, Q2 call. But you are aware of Humalutin, the follow-on to Betalutin, if you want. Alpha-37 is progressing together with our partner Orano Med.
We have several humanized antibodies in the pipeline, and we're looking at this as we are in the areas of NHL, but also in autoimmune disease. Finally, our CAR-T program that we are working on together with the University of Pennsylvania that we're expecting further information on in the second half of this year. In summary, PARADIGME is being discontinued. We will continue to partly speak to the FDA around Betalutin, but also exploring further partnerships for Betalutin as we move forward. The strategic focus, as I mentioned, is switching to the pipeline. We're restructuring the company based partly on cost, but also the pipeline.
What that will look like as from an early stage strategy point of view, we'll come back to when we get back to you in August. That is really the next time that we intend to communicate more fully. Finally, I want to put a couple of smaller points here. I have personally felt the frustration from all of you with all the emails that I have seen, over the last few weeks, around why aren't you guys talking to us? Why aren't you communicating? I hope you understand that when you get into a situation that we have been in, where also we, as admitted in Q1, didn't feel we fully understood. That is a very frustrating situation to be in.
Therefore, to spend a lot of time on communication, yes, we try to the best of our ability to respond, but we also have a business to run, and that's what we've been trying to do. As I hope you will have seen in the presentation, we have really tried to turn every stone in understanding what has been going on, why has that really happened. Although the result at the end of this journey is truly sad and unfortunate, I hope for your appreciation as well that people at this end has been working extremely hard. A final note, there's about 70 people in the company that today is not feeling very well.
They have spent hours, they have spent days, weeks on working extremely hard for where we are, and I hope you can appreciate that our focus now is with them, taking care of those families, their livelihoods, and ensuring that we also do what's best for our employees. I believe with that, I think we stop. We'll open it for a Q&A, but I really appreciate your patience as we go through the next couple of weeks, and what we have to go through as a company. As I said, I feel gutted, and you hear that in my emotion as well. We're gonna do what's best for you shareholders, we're gonna do what's best for our patients, and we're gonna do what's best for our employees, in the weeks to come. Thank you very much.
With that, I'm open for questions, guys.
Thank you, Erik. Hopefully everybody can hear me okay. Just to remind people listening to the webcast, if you'd like to ask a question, please type that into the chat room, and we'll take as many questions as we can today. Let's start with some questions around Betalutin. The first question essentially asks when did the board learn that only one of three patients responded to Betalutin, and could this have been communicated to shareholders earlier?
I think the short answer to that is we don't believe that this could have been communicated any earlier. The board acted as quickly as they saw the data, number one. You also saw in a press release that, you know, for us, the integrity of the study was at the utmost important. Communication with the FDA around the data has been crucial. Therefore, you have also seen the timeline the way it has been. I believe we could not have done this any earlier. In fact, when I look at my experience from other situations such as this, we have, if anything, been quicker than what I've seen in the past with regards to communication of the data as such.
Yeah. Jan H. Egberts here. One additional comment. People have to remember that neither management nor the board has access to the clinical data. The clinical data basically go into a repository, a database that nobody has access to. The reason for that is that that's the requirement by the Food and Drug Administration in order to maintain the integrity of the study. It's not like you check every day how you're doing. That is impossible. When we wrote the clinical protocol for the study, we had an interim analysis, which was sometime in 2020, and that was it. Then at some stage, you get nervous on like how things are going, and that's when we decided to do an additional exercise where we also needed to maintain the integrity of the clinical data.
Like I said again, it is not a situation where you just turn a button and say, "How is it going today with the clinical study?" The entire period from the moment we got the results is a matter of days or frankly, weeks, but no more than that.
Thank you, Jan.
Thank you. The next question asks, how much has the company spent on planning for the Phase III study for Betalutin, and what happens to that study now in the future?
The most of the investment in the planning for phase III is really internal headcounts that have been working on this. It's very little that has been done externally with potential vendors. We have not gotten to that stage yet. As you will have heard in previous updates, we have spoken to the FDA. We have discussed both with the FDA, also with clinical experts on what this is gonna look like. From a potential phase III confirmatory study, the fact that we're stopping PARADIGME also suggests that the whole phase III program will be up in the air. It will definitely not be as a single entity. It will be with a partner, if that was to happen. We need further guidance from the FDA around is that even sensible to do?
That's something that we still will need to investigate. Excuse me. That being said, as far as we are concerned now, the whole Phase III confirmatory study is on hold until we have further guidance from the FDA.
Thank you. On the subject of partnerships, the next question asks, what are you hoping to achieve when you refer to the exploration of potential partnerships going forward with Betalutin? Are you planning to license out Betalutin for treatment in combination? In what potential indications could that be MZL, DLBCL, or second line possibly?
We say all options are on the table.
Okay. Thank you. There are a number of questions, asking about the current data in reference to the interim analysis. Essentially a question asking whether the management and the board had access to the data at the time of the interim look, and asking how you might explain differences between the data that has been observed today versus the interim analysis.
A couple of points on that. First, interim analysis was part of the statistical plan, and it was intended to look at what was the dose that we were going to take forward. This was not an analysis to look at the efficacy in the way that we have done it now with the independent expert review. That's very important to keep in mind. Secondly, the numbers at that stage were very small. Third, in looking at where we are today, the data has continued to deteriorate, and as such, the efficacy that we're looking at today is not what we would have hoped for, even at looking, even also at looking back at the interim data.
Thank you, Erik. There are a couple of questions asking whether or not you believe there's been any impact on the study from COVID or COVID vaccines, and whether or not changes in inclusion or exclusion criteria could explain some of the differences in data that have been observed.
I think the latter one first. With regards to the change in inclusion, exclusion criteria, it is too early to say if that has had an impact. With regards to COVID itself, I would refer back to what you heard from Professor Leo I. Gordon back at the R&D Day. He mentioned a couple of thoughts there, which was related to COVID and efficacy of generally oncology drugs. Rituximab was highlighted in his presentation. We don't know the answer to has COVID actually impacted the study as such. But if one were to speculate, one could say that maybe that is a contributing factor. Maybe the patient group is a contributing factor, but we just don't know at this stage what has contributed to the data that we see.
Thank you. There are a number of questions asking what will happen to the Archer-1 study at this stage, whether it's still live, and what the future could be in that setting.
The Archer-1 study is somewhat still alive. The last patient is going out of Archer-1, I believe towards the end of the third quarter. Beyond that, Archer-1 as such is finished. Again, I would refer to what we wrote in the press release. Our intention or our view for the future is there is still an opportunity for Betalutin in potentially other settings, other patient populations. Looking at both the Part A data and what we have seen also in Archer-1, that may be a way of looking at where do we go from here. It's really too early to say. To the person who asked the question, Archer-1 is still there, but it is very close to finalization.
Thank you, Erik. A specific question asking, do you believe that the current data suggests that a single dose regimen of Betalutin is unlikely to achieve a compelling antitumor effect?
I don't wanna speculate as such, but I think all the data that we have seen also previously, looking at everything we've seen to date, suggests that one dose is sufficient.
Thank you. Then, a number of questions, and I think to some extent you covered this in your comments, Erik, but essentially a number of questions asking on when we can expect any updates to the pipeline, and in particular asking specifically about progress for Alpha-37, and what we might expect from that going forwards.
Yeah, no. I would refer to what I said earlier on the thirty-first of August. As I said, you know, our focus right now is on the restructuring of the company. We're working on the pipeline as well, but we'll give an update on the thirty-first of August.
Thank you. A few financial questions. The first is which says, you've mentioned plans for restructuring the company to reduce costs. Can you give us any indication on how much you're expecting to reduce expenses and what the subsequent cash runway would be?
Yeah. Hi, it's Malene Brondberg here. This is too early to say that as you probably would or you can imagine. We have a lot of vendors that we of course need to have discussions with to figure out where we are in that sense. Also, of course, it also will impact, of course, the employees, management and everything. It's really too early to say, but when we get to August and we report the Q2, we should be able to say more at that stage. As you can see also from the release that we have end June, approximately NOK 280 million in the bank. As you could see with the...
We came from 352, so we have already. As also said at the last call, in Q1, we are constantly looking at the cost and have been doing that. Of course, we do know where we're going, but of course, we do need to go through a lot of difficult discussions, first of all, before we are ready to say anything. I think also everyone can appreciate that going into these discussions would be better to start the discussions with the people you're going to discuss with than to discuss it here today.
I think just to add to what Malene just said, you, their investors are the first we are announcing this to. Our employees will have seen this this morning as well, just like you did. Our vendors as well will have seen this this morning. You are really the first to know. I hope for your understanding in the sense that what Malene just said, we're really starting a lot of this work as we speak. You can also see from the run rate in Q2 that we have already put some brakes on the spend. That will continue, and numbers that will be presented on the thirty-first of August will also be different to what you have seen today.
Thank you. I think that probably means that specific further questions, with regards to cash burn, expenses, et cetera, will have to await that further update.
Yes.
Malene, I don't know whether I can hand over to you at this stage for any questions in Norwegian.
Yeah, I don't think right now. I think we have covered most of them because they are along the same lines. We will, of course, continue to take questions at the IR inbox. We are here. But as you can imagine, today is going to be a very busy day because we do also have all our employees. As Erik just said, you are the first ones, so we haven't even spoken to them yet. Please, if you could just bear with us, we will come back on those. I can see one of the questions here is what options will there be for the company going forward? As Erik said, all options are on the table, and it is really too early to say.
I think with that, let me first of all say a thank you to all of our investors for the support you have given us, you are giving us over the years. I also like to say a big thank you to investigators that have worked with us during the course of PARADIGME to date. To the patients that have been involved and have had the hope that this was gonna be something that could come to fruition for them one day as well. Also to our own employees that have been working tirelessly on both execution of PARADIGME, the other programs that we are working on, and also looking forward to working with now the development of the pipeline.
Also, a big thank you to all of you for listening today. With that, I think we will sign off. Again, wishing all of you a nice summer, and thank you very much for your support. Bye bye.
Bye bye.