Good morning, everyone, and welcome, warm welcome from this side to all of you, for today's Q1 2022 webcast of highlights and financials from Nordic Nanovector. My name is Erik Skullerud, I'm the CEO. Together with me today I have our CFO, Malene Brondberg, and our Chief Operating Officer, Sandra Jonsson. Over the next few minutes we'll take you through the highlights, the way we see them, and what we have seen going on in the Q1 . Before we jump into that, forward-looking statements. I know you are all aware of this, but obviously we will be using some forward-looking statements here. That is for the purpose of trying to give you a feeling for how we think about the future.
Obviously, events outside of our control can influence this, so please make yourself familiar with this before investing. Most of you will have seen our press release from this morning. We are today reporting 108 patients enrolled in PARADIGME. I will come back to more detail around this as I go through the presentation. Needless to say, this is a number that also we are not satisfied with, and I wanna underline that. We hoped that things would look up after the COVID pandemic, it seems to be on the downturn in most countries. It has been lingering on for longer than what we also anticipated. I'll get back to more detail about that in a second.
The second important point, on this slide is to be aware of our cash position and how we still look at our run rate, but also more importantly, when we expect the results. The way we look at the situation at the moment is that we can still reach results by the end of the second half of this year, so we're not changing that guidance. Again, I wanna underline, it's not that many more months that we have to have with these kind of rates that we now see before we have to reconsider that. That being said, we do also see drivers, currently, that is giving us confidence that we should be able to to change the situation, and again, I'll come back to that in a second.
We haven't only had enrollment in PARADIGME as a priority this last quarter. We have also been able to do a couple of other things. Most of you will remember that we raised financing at the beginning of the year, NOK 250 million, and again, I wanna thank those of you that participated in this for the support. We know this is important to you that you spend your money right, and believe me when I say it is important to us that we also spend your money right. We're doing everything we can to on one hand do as much as we can on the result side, but on the other hand, be very mindful of the finances that you so kindly help us with. Really appreciate that. Thank you.
With regards to the results, as I mentioned, our guidance today is based on 108 patients that have been enrolled in the study. The study itself is going on in about 80 centers at the moment around the world. We see several centers that are extremely active, but we are also seeing centers that are less active. Again, I'll come back to this in a second because I think this is one of the things that you should anticipate with studies like this, that there is some fatigue in the marketplace when you get towards the end of a study. But again, we are also getting positive signals from many of these centers. There's a lot going on.
I mentioned the guidance around when we should expect results, et cetera, and I did touch upon the help that you as our investors have been giving us in the early part of the year. As you can see, there's also other parts of the pipeline that are making progress. Alpha37, we had interactions with the FDA, not virtually or face-to-face this time. This was questions that was asked around how do we best produce this? How do we use an assay to best produce potential clinical material? They agreed with our approach. That has given us a stick in the ground, if you want, on how we move that program forward. This is obviously a collaboration with Orano Med, and work is ongoing with this accordingly.
Most of the work today is being done by Orano Med, but we also have a responsibility more on the clinical or on the development side. We have also published two different papers with Humalutin. This for us is important in the sense of further proving the value of CD37. One of these publications is with a PARP inhibitor, a combination. The other one is related to more of a diagnostic approach that you can pretty much predict the response to the treatment. This is again when it comes to further development, something that seems to be increasingly important when it comes to targeted therapies. You want to know that when you give the product, you can have a response right away. Also important when you speak to payers.
Finally, we, as you will all be aware, we had our AGM back in the end of April, at that meeting, we welcomed Thomas Ramdahl as our new Board of Directors member. Thomas has a grand experience among other things from Algeta. We welcome him to our board and very much look forward to working with him. We also wanna say thank you to Per and Rainer for their participation, their support, and their guidance over the years, two very valuable board members for us. I know that some of you have asked questions around HealthCap, Per's situation, and so on. I think it's only fair to say Per has spent a lot of years on the board with us, done a great job.
As he said it himself, he has a lot of other challenges as well, and where the company is now is probably beyond what his strength is. Clinical development and more towards commercialization is not where he has done most of his work, hence also why we now have Thomas on board so that we can really utilize the capabilities that he's bringing to the table. I wanna say a little bit more about PARADIGME 'cause as I said, also for us and for me as CEO, I'm a shareholder as well. And obviously I want this study to be successful as quickly as possible. When we see what's going on in the market today, it gives us pause for reflection.
If anything, it gives at least me and the team even more reason for working harder in ensuring that this becomes a success as quickly as possible. On the right-hand side here, you can see some of what we hear from centers out there with regards to why is this going on. Although we have two patients that are included, enrolled during the course of the Q1 , what we're also hearing from centers is there is COVID fatigue out there. There are areas where the healthcare system as such still is struggling. This is not the sole explanation for what is going on. On the other hand, we are also competing for patients. There are competitive studies that is taking some of the patients that we could have taken.
If I look at more in general terms, what is the feedback specifically on the study itself? It is, you will have heard this before, it's the inclusion and the exclusion criteria. It is a hard study to recruit to. Again, this is not an excuse. You have seen double-digit quarterly enrollment rates, before. We should be able to do that again. Why am I saying that? Now that the world is opening up, we have access to centers all over Europe, all over the world, with the exception of the U.S. In the U.S., we can still not go into centers.
The fact and the lack of face-to-face meetings, face-to-face motivation, face-to-face discussion for us is one of the key drivers over the last couple of years, but more specifically the last six-nine months due to the Omicron variant, et cetera, lockdowns, et cetera, is one of the key reasons for why we have not had access to centers and hence also have not had a chance to have as impactful interactions as we could have had. You see over on the left-hand side here, some of the things that we believe are the key drivers and therefore some of the key differences in why you should believe us this time. 'Cause I am sure that most of you will also say, "Well, Erik, tell us. You told us back in Q4 that I should believe you for the following reasons. You haven't delivered.
Why should you believe us now?" To me it comes back to these three things. Number one, the access face-to-face to centers is opening up, and it's basically open now. That should improve things. The second, we know that peer-to-peer interaction amongst investigators is one of the key drivers for why you are successful and why you are not. We're taking the opportunity at the upcoming EHA Congress to take all of our investigators to basically get them all together in one room, share best practice, use that as a communication platform for why this is so important, why should they look at further patients in the study, and how do they best do that.
They learn from the people that have done the best job because we have a lot of centers that have done several patients while some others have only done one or two. That is important for us. Finally, the med-to-med interactions. We haven't done a good enough job of that. We could have done better, and we're changing it. We have already started, but over the next few weeks and months, we're increasing the number of engagements between our medics and our investigator medics. Those are the three main reasons why this time around, things should hopefully be different. Also last time I spoke to you, I mentioned this funnel that you see in the middle here.
I said something along the lines of, "I have very seldom seen so many patients in that funnel." I meant that, and I still mean that. Why is the explanation? Why don't you see more than two coming out of the funnel? For me, there's a couple of key drivers, and this is feedback from the centers. These patients that were on top of the funnel but is not coming out of the funnel falls into a couple of categories. Some of them have gotten corona, have been delayed. The center therefore did not initiate and has still not initiated. That is to me a reason that was valid back then, it is not so much a valid reason today. The second one is more important, and that is patients that are, for whatever reason, not fitting the inclusion or the exclusion criteria.
It could, for example, be blood platelets that are too high or too low. You have to wait, and they just don't come into the right range for the study, hence, the patient cannot participate. The third bucket is around patients that for whatever reason, either will not want to be part of a study, they do not want a radioimmunotherapy, even though they acknowledge that the results, at least the results that you can see so far are very promising, but they just don't wanna be part of a study like this. We have to accept that as well. These are the three categories, the three main reasons for why people in the funnel does not drop out at the bottom and become an enrolled patient.
We have even gotten to the point of one patient that went all the way through the funnel, was about to be dosed, but for enrollment reasons, inclusion reasons, did not fall into the study. The patient is still under consideration, but this is again, one of these where we hope we can see the patient go through, but at the last minute, they don't come in for whatever reason. Now, again, this for you may be, why are you telling us all of this? For me, it's important that you understand the kind of picture that we are looking at and why these things are happening. This is normal in a clinical study. It is irritating, it is frustrating, I admit that, and I am, as I said, as frustrated as you, but it is the nature of doing clinical studies.
Away from the inclusion, exclusion in the study and a little bit of what else are we working on. We have had, and we are having interactions with the FDA. This is part of business as usual for us. They have focused more recently around the confirmatory phase III program. We have gotten guidance from the FDA that helps us do further work on the confirmatory phase III program. You will remember that last time we spoke about the importance of starting early with the confirmatory phase III . I think it's needless to say, but I'll say it anyway, the PI3K story and the ODAC meeting surrounding the PI3K inhibitors have proven to us why this interaction is so important. You need to start this early. You need to get it right.
You need to have this interaction with regulators so that when you submit your BLA, you also have your confirmatory phase III study running. Some, not all, but some of the PI3K inhibitor companies have not done that. This is one of the reasons why they have gotten into trouble. There are other reasons as well, but this is one of the reasons. That's why we're starting this early. Secondly, our regulatory strategy is very clear. Once we get to the submission of the file, we know what we want to achieve, we know how we wanna get there, and we have a plan for how we wanna get there. I also wanna highlight some of the work that we're doing on the supply chain.
I mentioned to you during Q4 that we're doing a lot of work, both in confirming that we're doing the right things for the supply chain, but we are also focusing in on cost of goods. We have progressed this work even further now, and the result of what is ongoing will have two consequences for us and also for you as investors. Number one, the cost of goods. We will be able to reduce cost of goods significantly, and that will be obviously important for our profitability when we commercialize. The second point is around environmental impact, and how we move product around. In that sense, we're making progress, and our carbon footprint, if you want, will be significantly lower also as a consequence of the initiatives that we're putting into place.
We're very happy with how this is progressing. I've said it on a couple of occasions, this is like hand in glove. It is important that we ensure on one hand the clinical development, but on the other hand, complete readiness also from a CMC point of view. In that sense, this is more of a schematic, but this is the reason why we're doing all of that. We wanna make sure that this picture is as narrow as possible, so that when we have the top line results at the end of the year, the next thing that we will do is to pull together a report that will be shared with the FDA at the so-called pre-approval meeting, and everything else will actually follow from that.
In general terms, they will tell us, here is the file, or we will tell them, here is the file that we are suggesting that we will put forward to you. They will say, okay, this is what we need. Wonderful. You move ahead, or can you do the following analysis accordingly? From there, this will then happen towards what will become the BLA submission. And over on the right-hand side at the bottom here, you also look at the different alternatives from a regulatory review point of view. Shifting gears to somewhat of what's happening at, on the competitive side. Again, a lot of different things have happened since the last time we spoke together. First thing around PI3K, I think we all have key learnings from that.
For us, the most important learning from what's going on with PI3K is the connection between, on one hand, studies that they did to get accelerated approval, and currently what the FDA has reported back as what they say as the toxicity that they see in confirmatory studies as well. The connection between these two impacts overall survival. This is the reason for the ODAC meeting, and this is the reason for why PI3K inhibitors have been asked now to do comparative studies early on, in order to get approval. I think it's also fair to say that they're also saying about PI3K inhibitors, if you show a better safety profile, a single arm study may even be sufficient for you. They have not closed the door completely on PI3K inhibitors. Why am I saying this?
Because this is important for us, partly because the door is still open for us also to utilize PARADIGME as the basis for our regulatory file, and that's important to get that confirmation. Secondly, obviously, the proof will be in the data. We have to show good data, otherwise accelerated approval is also for us going to be a question mark. But more importantly, that has to do with the toxicity. We know that for Betalutin, the toxicity is very mild. Arguably, you could say it's better than most of the other alternatives out there. This suggests to us and gives us confidence that when we do our confirmatory study, we will be able to show the overall survival that you need in order to convert your accelerated approval to a permanent approval. That is for us a confidence.
the second part that has changed since we spoke last time is with regards to CAR T-cell therapies. You saw, those of you that are close to this, that Novartis came out with a press release just a couple of days ago with regards to the ELARA study and the approval for third-line therapies. I think it's a couple of things to notice in that press release. Number one, they're talking about the toxicity also there. The cytokine release syndrome is approximately 50% of patients. Neurotoxicity, somewhere between 20%-30% of patients. This is still a fairly toxic regimen.
For those of you that are interested, I would refer you to a review that was done back in September 2021 in The Oncologist in the US, because that is from my point of view, third-party confirmation of what we've been saying all along with regards to CAR Ts. The results are impressive, no doubt. However, there's toxicity that you have to take into consideration. There is a cost of treatment that you have to take into consideration. And most importantly, there is a cost for the healthcare system when you use a CAR T that you have to take into consideration. These patients that gets a CAR T will have to be in a hospital for weeks. They have to move away from their homes for weeks.
For these three reasons, cost, toxicity, and the cost of the healthcare system, a lot of patients are saying no to the treatment. Even the top opinion leaders out there are saying, this is a great treatment, but only for the few, the healthy, the fit, relatively in this case, it is not for the elderly and the frail. Where are we positioning Betalutin in the elderly and the frail? This is why we feel from a competitive point of view, we still have a big space for Betalutin. Final point of this slide is related to bispecific antibodies. Yes, again, important class of drugs, good for patients, and impressive results. Again, the toxicity here, and this is also what you see in reviews, is quite high.
When you look at reviews from opinion leaders, they're saying this is gonna first and foremost be a competitor for CAR T-cell therapy. Again, in younger, fitter patients, they're obviously not on the market yet, so we still need to see what kind of cost, et cetera, they will come with, but that is all we know at the moment with regards to bispecific. In looking at how we're positioning Betalutin, first in third line, as I mentioned, for the population that we're targeting, the frail, the elderly, we have big confidence that there is still a high unmet medical need for the use of Betalutin, eventually. Secondly, the value proposition with one injection efficacy and a very favorable toxicity profile is something we feel and are confident is good for these patients.
We have to show the data, as I mentioned, and that is obviously why we're working so hard on PARADIGME. Also when we look towards the future and we look into second line, a potential combination with rituximab, that's a further opportunity for us. As you can see here, we also have what we believe to be the future positioning when we have that study done and confirmed. That's about it as far as Betalutin is concerned. I also wanna talk about, for two minutes, the rest of the pipeline. We obviously have these 5 different candidates at different stages of development, and in the last quarter, we have news on two of them, arguably three of them. Alpha37 I mentioned, and I also mentioned Humalutin.
I'll talk a little bit about our CAR T and give you an update on CAR T towards the end of the next slide here. As you can see, I mentioned the two publications that we've had on Humalutin. These two publications for us are important, as I mentioned, partly because of CD37 and the faith that we have in the target that we're working towards. Also starting to look towards the future on what this therapy could potentially offer patients with an additional diagnostic associated with this. This is really the first time we've published this data, so we're obviously very excited about this. Secondly, with regards to Alpha37, we're making progress there as well, with our partner Orano Med. I've mentioned this on a couple of occasions.
We're expecting further updates on Alpha37 when we get into the second half, the third or the Q4 of this year. The progress of Alpha37 is significant. We're moving forward at a nice and steady pace with the program. The last thing I wanna mention is CAR T. I'm excited about this drug. It's really early stage, I acknowledge that. The program has now truly been kicked off. It was kicked off in January, and we're making good progress also on that. We're expecting data to show you on the initial parts of this when we get towards the end of this calendar year. That's the update from a business point of view. I'll now let Malene take over and talk to you about the financials. Malene?
Thank you very much. When I can get this to work. Good morning, everyone. Just a quick update on the finances. As you can see, we came in on a spend of roughly of NOK 100 million, which is more or less on par with last year. Again, our biggest areas where we spent money in is the CMC and then the clinical. If we go to the, as I said, the cash flow, I said last time that we'd have roughly NOK 150. We ended up at NOK 148, and the biggest explanation for the change compared to last year, as I also said last time, was a change order or milestone payment with our biggest CRO that we had to pay.
For the next quarter, we expect roughly a spend around NOK 100-NOK 110. We continue to spend the money, especially on the CMC side as we get more and more towards the close of the study. Here is just a quick slide that shows what the cash position is, and we are right now at NOK 356. As you can see also, as we also talked about last time, we had the PIPE placement, and then it was followed up by a repair offering, as Erik also just alluded to.
We, of course, reiterate our guidance here that we have a cash run rate going into the first half of 2023, at least for three months. We're of course doing everything we can to expand that as much as we can. One of the savings that we have, as you probably would notice this morning, we haven't sent the PR out in Norwegian as we've done sometimes in the past. That is one of the savings we made because everyone is now only sending out in English, and we've decided to do the same. We hope that works for everyone. With that, Erik, it's back to you.
Thank you, Malene. In summary, the situation we find ourselves with PARADIGME, we are obviously making progress, but we're not making progress at the speed that we would have wished, and we're doing everything to change that. As you've seen on the finances, we are still in a good position. We're looking at every single dollar to make sure that the run rate will be as long as we possibly can. You do know that the money that we spend is mainly on Betalutin. The latest numbers that we have looked at on the internal side is we spend more than 90%, close to 95% of all of our funds on Betalutin. The rest is going to the rest of the portfolio.
My CSO, Jostein, continues to remind me that, "Erik, we can't forget about that either." Hopefully, what you've seen in the presentation today is that we haven't forgotten about it, but we are also wary about spending the money that you kindly help us with on what we consider to be the most important priority, and that is Betalutin, that is PARADIGME, and is building the CMC capabilities. I am very happy of the work that we're doing on the CMC side, and that we're able to simplify that, and therefore show over time less of a cost associated with the whole CMC strategy that is also gonna improve our profitability when it comes to commercialization.
Finally, I just wanna leave you with a continued thank you for the support and that what you showed in giving us the money back in January as well for the fundraising. We are doing everything we can to get PARADIGME back on track. We will do a deep dive with all of our centers, and get further information, further understanding, and make sure that we pull the right levers for PARADIGME moving forward. It's already ongoing, but it's obviously also gonna take us a little bit of time of really getting our heads around what exactly going on with that. We have confidence in bringing you the result towards the end of the year.
As I said to begin with, we need to ensure that we change the trajectory of enrollment in order to do that. With that, I wanna thank you. I wanna open up the floor for questions from the audience. Jan, Fraser.
Thanks, Erik, and good morning, everybody. Shall we allow you to take any questions from the room first, Erik, and then we can move on to questions via the webcast?
Okay. Do we have any question from the room here? I don't think so. I think we go straight to the webcast, Fraser.
Okay. Thank you very much. Just to remind you, if you do have a question, please type it into the box on the webcast page. Just to start off with, the first question is regarding the impact of COVID-19, and asks, can you elaborate any further about the impact on a country by country basis, and asks in particular, have you started to recruit again in Norway and Scandinavia?
Let me use a couple of examples from Norway. This struck me as somewhat interesting as well. I know most of our shareholders are Norwegian, so I'm sure you will relate to the two articles that have appeared in Norwegian newspapers over the last few months. Number one was an article that was probably just before Easter, which was related to the number of deaths due to COVID up until the 9th of January 2022. In Norway alone, that was about 1,370 deaths. Between the 9th of January and Easter, the same number of people in Norway died due to COVID.
That's not to play around with numbers, but what I think it shows is that even though the noise in the media, the amount of times or amount of time we spend on talking about COVID has dissipated, but it's still out there. It's still something that is going on. That is not an excuse for us, but it's an important thing to keep in mind because it is a driver of what's happening in the healthcare system. The other article that struck me was at the National Hospital or as we Norwegians will know it, Rikshospitalet, who has not been able to do critical surgery within heart, lung, and even cancer over the last few months because most of their people have been taking care of COVID patients. That's striking again in the sense of what's going on in the healthcare system.
Because the healthcare system is still, I would say, not on its knees. They're catching up. They're doing a great job, but it still has some impact, although the impact today in May is not the same as it was in Q1, and we have to acknowledge that. For Q1, this seems to have been the case from a COVID point of view. What was the second part of the question, Fraser?
The second part was just specifically, have you started to see a return to or a pickup in recruitment in Norway and Scandinavia, more broadly?
The short answer is, pick up in enrollment, no. Pick up in consideration, yes. I have spent the last couple of times, I think I've spoken to you on, I guess you would say complaining a little bit about us Norwegians. We are generally competitive, and I was kind of hoping that the Norwegians would do well around. We are seeing a pickup. Sandra, our COO, spent time in Denmark the day before yesterday. Sandra, I'm looking at her and she's nodding, talking to Danish investigators. Yes, they are very committed, and they do see potential patients. I would underline potential because we don't know that they actually will go into the study. We also know that there are patients that are in there at the top of the funnel, both in Norway and in Sweden at the moment.
Yes, we are seeing a pickup in the Scandinavian countries, and maybe, just maybe, this is a leading indicator for what could be the case in the next few months. We do see a pickup in interest up here in Scandinavia.
Thank you, Erik. The next question asks whether or not you can give and there are a couple of different questions on this theme, more visibility around the funnel. Can you, for instance, tell us how many patients are in the funnel at the moment or who may have passed through the funnel and are under active consideration for enrollment at this stage?
We've said before, and I say the same again, this is not trying to keep information away from you, but looking at these numbers, they go up and they go down. I think I've used the analogy before of like sour milk and a little kitten. It's one week you look at them and you go, "Hallelujah, this is impressive." Next week you look at them and this is pretty not so good, and then they bounce back up again. It's very hard to make any sense of the number. If I were to say 10 is in the funnel, what would you make of it? It doesn't really mean anything.
That number is not the right one, by the way, but I'm using that in the sense that we're looking at these numbers because it's important for us to understand what is happening, and we can make some sense of it. When it comes to how many is in the funnel and on the basis of that, how many is coming out of it, I think it's fair to say that with two patients coming out. Back to my Q4 statement, we had a lot of patients in, and we did in the funnel. Two of them coming out, one going into late stage screening, but then dropping out. I think that is proof enough that for us to talk in more detail about the numbers, it doesn't make that much sense.
It's not that we don't want to, it's just that it doesn't really help much in this sense. I hope for your understanding on that.
Thank you. There are a number of questions which ask whether or not you could bring more visibility to patient recruitment by reporting, recruitment or enrollment numbers more frequently, for instance, possibly every month.
First of all, thank you for that question, and I know there are investors out there that also have sent these type of questions to us over the last few weeks, and apologies for not answering those questions. As you know, we have been under embargo for communication with you, the four weeks leading up to this conversation. That being said, I think our policy around doing this on a quarterly basis, we will continue to maintain it. I will say that, and then I will say, you know, I know that based on what we have guided this morning, you will have arguably even more questions on that.
I think bottom line for me is we will continue to do it on a quarterly basis, but I will also say that we should also look at how we can better help you in understanding this. I think bottom line for me is when you look at the number of patients that have gone in, I think the lowest we've ever had was towards the end of last year and into the beginning of this, which was zero. The highest we've ever had has been 14, I believe, in one quarter. If or when we see significant change to how we are reporting, maybe that could be a trigger.
I still do believe that the best way for us to do this is to use the quarterly updates, 'cause I'm afraid that it would confuse people if we were to do this more often than that, number one. Number two, keep in mind, there's work associated with doing these updates, quite a lot of work as well. I wanna make sure that we focus where our resources is best used, which is trying to get more patients in, and rather maintaining a stringent system around how we report and do that quarterly.
Thank you, Erik. We have a couple of questions relating to the number of patients to be recruited for PARADIGME. Essentially asking, is it possible, or do you have any hope that in negotiation with the FDA, you could reduce the number of patients required for filing the BLA? Further goes on to ask, are you in any active dialogue with FDA regarding this possibility at the moment?
We are continuously in communication with the FDA. I think it's probably premature to say, are we gonna be able to do this with less patients? The guidance from the FDA is pretty clear when it comes to accelerated approval specifically. You need a specific power statistically on your study. In other words, how many patients you need to show results in order to submit an accelerated approval BLA. That's where our numbers are coming from. Now, FDA is obviously using, on one hand, they're using science, on the other hand, they're using judgment. It's gonna be up to them to tell us how many patients we would need. All we have today is that we have to fulfill the numbers that we have also shared with you in order for us to do an accelerated approval.
Anything about that, above that, to me, would be pure speculation from my side, and I don't wanna try to do that.
Thank you, Erik. The next question asks whether or not you see an increased interest from potential partners as you get closer to full recruitment of PARADIGME.
I'm not sure if this is related to recruitment or if it's just purely related to the fact that the world is opening up post-COVID. We are obviously attending business development conferences, and we've had a couple of chances to do that in the last few weeks, where the feedback is more. Interest is definitely there, and it sounds to us that, you know, it's a bit of a reinvigoration of interest. If that is related to we're moving closer to finishing of enrollment, if it's just our business development person that is doing a really good job, or if this is they finally get to talk face-to-face again over a cup of coffee, it's hard for me to say. There are still several active ongoing conversations with regards to potential partnerships.
Thank you, Erik. Just a further question regarding an interaction with FDA, asks whether or not you had any discussions directly with FDA about the outcome of the decision from the AdCom regarding PI3K inhibitors and whether or not you consider that decision can favor a potential approval of Betalutin due to the need for new therapies in this space, or whether the FDA may actually impose more strict requirements with regard to the outcome of extended studies.
The last conversation we had with the FDA was before, in fact, just a few days before the ODAC meeting. For obvious reasons, there was no comment from the FDA to us specifically around that. Whatever I would refer to what I said during my presentation on the impact of what has happened at ODAC, but we have not had direct feedback from the FDA on implications for us based on what's happening with the FDA. I will iterate what I said in the presentation. Our take on it is that PI3K is in the situation that they are due to the high toxicity of the drug. That's fundamental for why they have been asked to do these randomized studies early on and not just part of their follow-on confirmatory studies.
That seems to us that may give us an advantage in this sense, due to the fact that our toxicity is significantly lower than that of the PI3Ks.
Thank you. We now have a series of questions essentially regarding cash burn and the cost base of the company, which ask, given the current relatively low recruitment rates, are you looking at particular measures to extend the cash runway and conserve cash as far as possible? There are some subsidiary questions which I'll follow on with.
Malene.
Yes, we are of course. We are always doing that. That's not just an exercise that we do now. That's the obligation we have towards the shareholders, of course, to look at how we spend the money. We do that all the time, every day. That's also why we came to the conclusion that one of the things that we could maybe leave out is the Norwegian PR. We have other things that are similar to this, which of course in the grand scheme is not a big cost, but it adds up. Everything adds up, and every penny counts. Of course, that's what we will do, of course, or continue to do. Again, the biggest spend here is, of course, on the CMC and also the clinical.
That's, of course, important that those areas have the money that they need. That's why we need to do everything that we can to move the money into that area. We've done that all along. My team is working full stop to get this right.
Malene does a very good job of also reminding me of how we need to ensure that this is continuous, not just something we look at on a quarterly basis. We look at this virtually every single week on how much we spend and how it's moving forward.
Thank you. A follow-on related question to that is essentially looking at the number of centers that have likely recruited patients over the last year or so. It seems that there are still a large number of centers, possibly 60 or so of the 85 active centers, that may not have recruited a patient in the last 12 months or so. Does that mean that you should be considering closing some of those centers that aren't recruiting to further conserve cash?
I think that's something that we continuously monitor and continuously look at. We have closed a significant number of sites in the last, I would say, about 12 months. We've gone from, I believe, more than 90, more than 95, maybe as many as close to 100, down to the 80 that we have today. Out of those 80, to the question's point, there's about 60 of them that are truly active. That's where we spend our resource. The other 20 are centers that are still open, either as part of Part A or as part of PARADIGME. We still need to monitor those sites, hence why we can't close them down completely.
All the efforts with patient recruitment is really focused on these centers that are truly recruiting, number one, but also interested in recruiting, because there is a lot of of activity that goes on, also apart from what you see in patients coming out as recruited, as I mentioned earlier with regards to the funnel.
I can just be brief, if I may, just say that we, of course, in my team as well, we have weekly conversations, of course, with the clinical team as well about this. This is one of the things, again, that we monitor all the time, which we have to do, of course.
Thank you. Just moving on, there's a question on ARCHER asking how many of the ARCHER study patients are still in remission and how many have passed the three-year readout at this point. Can you give any updates or is there any update on ARCHER at this stage?
The update is very much the same as what we said last time. We still have, to our knowledge, there's gonna be one patient which had their last visit in October this year. The other patients, we had seven patients initially. One of them did not respond very well to the treatment, and that we have reported earlier. The other six, to our knowledge, is still in remission. Obviously, and you may also know this is also public information. We are stopping monitoring these patients, partly because of the number, but also partly because we feel that we have proof of concept of the combination and the effectiveness of the combination.
The last update that we have is the same as what we gave in the Q4 presentation, that those six are still in remission.
Thank you. Erik, I just wanted to hand it back to you to ask if there are any further questions in the room at this stage.
I don't think so. No. No further question here. I believe that if that is, if that's the last question, Fraser, from your side, then I think we bring the presentation to a close. I wanna thank those of you in the room, those of you online for your active participation, your support, the questions. We appreciate them and wish you a wonderful day and also a happy 17th of May when you get there on Tuesday. Thank you very much and talk to you soon. Bye-bye.