I started my career in Bayer, worked mainly in Scandinavia, but was situated in Sweden back then. Seven years later, I moved to Amgen, moved also to Switzerland, and spent about 16, almost 17 years with that company in different positions around the world. I've done everything from strategic marketing roles, worked in different therapeutic areas, oncology and bone disease, in nephrology and cardiovascular. But I've also been in different countries in management roles. For example, Australia, I've been in the Netherlands, I've been in Greece. I've become a little bit of a global nomad as far as my personal life is concerned. I have a wife and two kids. They are born outside the country.
As much as it pleases me every time I get to go back to Norway, I also have a life outside, due to an international family. In that sense, great to come back and be part of a Norwegian company, and also want to talk a little bit on why I've joined Nordic Nanovector. First of all, I think we could all agree that this is exciting time for radiopharmaceuticals. We've all seen late results coming out from other companies that are extremely encouraging, both from survival and from results. We see the emergence of an increasing amount of radiopharmaceutical companies, around the world, in the U.S., in Europe, in Asia, in China, et cetera. There's a lot of interest of the area.
Personally, I've been involved with Nordic Nanovector since 2016 in a consulting fashion. As I mentioned, I started my own consultancy company in Switzerland and worked with small to medium-sized biotech companies, Nordic Nanovector being one of them. The first job that I did was I participated and worked with the management team back then in what ended up as the target product profile. Already then I could say that, "Hey, here you have a very interesting asset." Very seldom have I seen a company that's so early in the whole development of the product actually set out to truly understand the patient, to target a specific part of the patient segment, and couple that with the unmet medical need. That's the other reason for joining Nordic Nanovector.
I feel that this is a very well-prepared company when it comes to what eventually will become the commercialization effort. There's an asset at the center of this that has shown very encouraging results, whether it is on response rates. At this stage, public data is suggesting around 70%, complete response around 32%, and it's very seldom that you see this in oncology products. In that sense, very much looking forward to working with these assets and working with the team in bringing this to the market. There's more behind the company and more as a rationale for me to join as well.
I personally feel that with the focus and the rightful focus on PARADIGME, a lot of the other parts of the pipeline have gotten very little attention, and there's a lot of other gems in that pipeline as well, so another reason for joining the company. Finally, the more you're outside Norway, the more you get to appreciate the great country this is. When a company out of Norway comes and tap you on the back and say, "Hey, would you want to join us? Would you want to take up a leadership role?" number one, it's humbling, and you really appreciate it, but number two, I'm really proud. I'm invested with my mind, I'm invested with my heart. A little bit of what we'll be talking about today and what the highlights have been in the last quarter.
We're today reporting 102 patients that are involved or enrolled in the PARADIGME study. You will know that we're targeting 120 patients. Last quarter, we reported 94 patients, so we have added another 8. In that sense, you may also say, "Well, how does that compare to what we're expecting?" I want to go into that a little bit later in my presentation. Apart from myself, we have also appointed a new CMO, Pierre Dodion, who comes with an incredible record, and I'm really looking forward to working with such a distinguished medic. He has 30 years of experience in the pharma/biotech industry and is exactly the type of profile the company needs, with the partnership around commercialization moving forward. We have also, in the last couple of weeks, reported.
Whoops, sorry. I have two important announcements. The first one with regards to the health partnership. This partnership is one step further when it comes to our own commercialization. A lot of you that follow pharma will always look at how well a company launches. Very often, what gets missed out is the lack of an understanding of the competitive environment, number one, but these days, even more importantly, a lack of the barriers to entry from a governmental and a payer point of view. This specific initiative is targeting a better understanding and a better enablement of an uptake of radiopharmaceuticals. I would urge all of you to have a look at this in the sense that this is not just us that is doing this. This is an effort across companies.
We're working with some of the biggest in the industry around getting this right, and we believe that this is gonna be a key success factor for our commercialization on its own. Finally, we're very excited to also announce a collaboration with the University of Pennsylvania around the CAR-T technology. Most of you for sure will understand the CAR-T technology in general, but this is obviously, if you want, the next frontier when it comes to oncology treatments. It is using the body's own immune T-cells in a response to the disease itself. We're, as far as I know, the first that are starting a development around the combination of our proprietary CD37 technology in collaboration with the University of Pennsylvania. We'll speak a little bit more about this as well later.
Let's talk a bit about our new CMO, Pierre Dodion. When it comes to commercialization, you want to build a team that is focused on a thorough understanding of the industry, the key success factors, and have experience in having done this in the past. Pierre joins us, as I mentioned, with about 30 years of experience. He has experience from small biotech companies such as Innate and ARIAD. He has experience from big pharma such as Roche and Aventis. This combination, for us, speaks to, number one, a great understanding, many years in the industry.
Good morning.
He's adding a lot of clinical development experience, but more importantly, translating that into what eventually becomes medical affairs and the whole scientific communication part, a key success factor in how you commercialize pharmaceuticals in the first place. He joins us from Alacrita Consulting, and he has already worked with us since April 2021. You will hear much more about the work that he has contributed at the upcoming R&D day. For example, Pierre has worked with us on what will eventually become the confirmatory phase III study that we will be doing as part of filing our BLA for FL in third line. The second line, by the way, or the additional indication that we hope to get with the confirmatory study, by the way, is in second line FL.
Again, we'll talk more about that later. He started his onboarding already and will take over Christine Wilkinson's responsibilities fully as of January 2022. It's great to already have him on board as this will ensure a transition of responsibilities that will be optimal for us. Let's talk about PARADIGME and use a little bit more detail around the numbers because I know a lot of you are looking at the numbers and setting your expectations that way. As you know, in 2020, we did significant changes to the protocol. You also saw throughout 2021 that we have increased enrollment rates. Also this time around, if you look at numbers in general, what we reported last year was three patients in Q3. This year, we're reporting eight patients in Q3. I'll get back to that in a second.
On top of that, you have also seen that we have started implementing several initiatives in order to accelerate it even further. Right now, we're focusing on four different things. Number one, we have done and will continue to do a segmentation of the different centers that are participating in the study. There's basically three segments that you can look at. One are the ones that have enrolled, are enrolling, and will therefore be enrolling. That's our primary focus. You have another; at the other end, you have several centers that since the beginning, for whatever reason, have not contributed, have not shown much interest in screening or in contributing, and these are centers that we're closing down.
The third are centers that now post-corona, we're also seeing an increase in the number of patients that are in screening. They're making increased efforts in participating in the study, so these are also focus centers for us. Secondly, coming out of corona this summer, we have asked all of our customer-facing, for lack of a better word, personnel, whether it is Nordic Nanovector or in our clinical research organization, to really focus in on face-to-face and direct communication. Our belief is that in this sense, we're actually fairly early on. We know that a lot of other companies, bigger and smaller, are still working on technology-based communication. What we hear from the people that we're working with in the field, study nurses and study investigators, is that they truly appreciate this face-to-face contact again.
While all of us have been focusing on the numbers of patients from a COVID point of view and the disarray that has created, the flip side of that in the health institutions that we are working with is that we have new study nurses, we have new study investigators. The additional face to face and a refocus on retraining the centers, re-engaging with them, gives us a double whammy, if you want. The third is around how we speak to these centers and really also doing that in a segmented fashion. What are we saying to those that are doing a really good job for us? What are we saying to those that need further encouragement?
What are we saying to those that are, for whatever reason, not willing to participate anymore but still we need to have a good relationship with? Finally, the fourth dimension in all of this, and Marco Renoldi mentioned this in our last quarterly update as well, we're rolling out a digital aspect of this strategy as well. Both because during COVID, it's been hard to keep people aware and up to date and therefore engaged in the study, and we're using the digital terms for that. The other is also creating additional awareness around potential patients. On one hand, this means that we get more patients into screening, and that's the good news if you want, and we see that. We also today, as Renoldi said last time, have more people in screening than what we've ever had in the study.
The flip side of that is it takes longer from when you get the patient involved in the first place until they're actually enrolled. The average time that we're looking at today is above three months from the beginning of that process until they're actually enrolled in the study. While when we did this without the digital side, it would have gone faster, and it would have taken approximately two months on average for a patient to get enrolled. That's just to give you a little bit of a feeling for we see good news in this, but we also see some challenges that we have to continue managing. From a numbers point of view, and this is probably the one thing that most of you will be looking for. I said 102 patients, eight new patients. We did three patients last year.
We see an increase. There's seasonality in this. For those of you that are expecting 14 next month or next quarter, I would say, yes, we're expecting them to be higher than what we see in this quarter, but we don't necessarily expect that they're gonna be as high. That being said, if you look at what we have guided on, we continue to keep our guidance on end of the first half of 2022, we also have to take into consideration that we need three months of follow-up before we will have the first possibility to say we did or we did not meet the primary endpoint. That is what we're looking for as a first result, right? If you use that as an example, that will put us into
Let's assume that at the end of H1 2022, you would have the numbers. That means that the last patient has to be included by the end of March 2022. On that basis, we are now in the middle of November. We have four and a half months left of inclusion before we have to deliver and be done with the study enrollment. That means that we need approximately four patients per month in order to do that. If you then triangulate this with what have we done in the last year? In the last year, at this time, we reported we had 59 patients in the study. Today, we're reporting 102. We have increased by 43. 43 over four quarters is about 3.8-3.9 on a monthly basis.
If you want, it's about 11 patients per quarter, 3.8, 3.9 per month. In other words, where we are now is where we need to be, but we're adding a bit of a stretch on top of that, obviously. Still, we are where we need to be, and if we continue at the rate where we are today, plus a little bit of a stretch, we will be where we need to be at the end of March 2022, and therefore be able to deliver the results by the end of H1 2022. That is why we are confident with regards to the numbers. The final part in that equation is what can we expect from Corona? Because obviously, we have seen that has had an impact in the past. It will continue to have an impact.
Again, if you look at last year as the predictor of what this year could look like, you see similar numbers around Europe and around the world from new cases point of view. That should not be a surprise to any of us. That being said, we would also expect a similar impact on the healthcare systems as we had last year. From a macro point of view, we would expect a similar impact in general. That's the third reason for why we feel confident about the numbers that we are reporting today and our prediction for still being able to give the results at the end of H1 2022. Post having delivered on that, what is it that we now need to continue to focus on? Our first priority is obviously the PARADIGME enrollment and needs to continue to be PARADIGME enrollment.
Over and beyond that, we have to ensure that we also, from a business development point of view, execute on our business development strategy. We've had a lot of questions in the last few quarters. What's the status of your business development strategy? We have, we are, and we will continue to talk to partners. I had a question a few weeks ago, okay, so how many are you speaking to now versus how many you have spoken to over the last year or so? It's hard for me to say because I don't know the history that well.
From what I've seen, it's a constant drip of new interest. For those of you that have followed pharma and biotech over the last few years, you will also know that when it comes to the kind of potential partnerships we're looking for, at least big pharma has a tendency of waiting until they see the results. Increasingly, they are doing so because they have the money to wait for it. If you look at it from our point of view, this is the time when we really need to start to gear up with the conversations in order for us to have the optimal partnership when we eventually need it. What is that partnership going to look like? It will differ depending on the region. I think nobody would expect us to go into China or Southeast Asia.
There you would look at some kind of a licensing partnership, potentially. In the U.S., do we need a partner? Well, if you look at the data and if you look at what have others done and done successfully, a partnership is definitely not out of the question. If you then look at Europe, finally, there are hybrid solutions. What are we looking at? We're looking at everything. We're looking at all of the different options, and we'll be opportunistic. But obviously, our responsibility is to you as shareholders, we're looking for the best possible partnership solution and the best possible commercialization solution for Betalutin. In the event of positive results, we are already talking to the FDA.
The next time we'll be speaking to them is in Q1 2022, about both filing strategies and what comes beyond. We're also preparing for that side of things. These interactions, and due to the Accelerated Approval, and the Fast Track designation, we have a possibility of being much more in contact with the FDA. That is the benefit that you get from this designation. Over and beyond that, we will also utilize the rolling submission, for approval, which means that we don't have to give the whole file at the same time. We can also drip-feed that as we go through. Also from a regulatory point of view, we're making all the preparations in order to be able to file and to get the approval as quickly as possible. Why are we doing this?
To just reiterate what you will have heard before, this is an area of significant unmet medical need. Especially when you go to the later stages, when you get to second line and third line, these patients become increasingly elderly. They get increasingly frail. They have increasing comorbidities. The patient at the stage where we will be launching and where we will be competing are already in a fairly frail condition. What do these people actually ask for? What do these patients need? They need a treatment that over and beyond everything else is mild from a safety point of view, that is convenient from an administration point of view, but still gives efficacy that they need and expect. That is where we feel that Betalutin is specifically situated.
Just to remind you, in this population, about 70% in third line exhibits what I have just said. They're elderly, they're frail, and they have comorbidities. In second line FL, about 50% are elderly, frail, and are exhibiting these characteristics. We feel that we have found the right spot for Betalutin, and this is why our focus in NHL, we continue to believe that this is the right focus. From a competitive point of view, if you look at what has actually happened over the last couple of years, and you look at this picture from left to right at the horizontal side, and you look at age and frailty of the patients. You look from bottom to top on the horizontal line, and you can see the first line, second line, and third-line treatments.
Although the competition is heating up in the first and the second line space, when you get into third line, you see up in the right-hand corner a fairly open space. This is obviously where we intend to put Betalutin as a starting point. This is still an area, even when you look at new competition, an area of high unmet medical need. It's an area where, yes, you have had a couple of new launches, either through CAR-T or EZH2 inhibitors, or there are a couple of PI3K inhibitors as well entering this field. There are new competitors coming in. What do these have in common? Number one, for example, the CAR-T treatments are only really available for a few very fit patients because of the potential side effect profile.
Although the efficacy profile for CAR-T is definitely impressive, the safety profile means that only a few of these patients can actually take the treatment. They're not really a competitor for us. The same thing holds true for also the EZH2 inhibitors. Only 15% of these patients has the genotype that actually is needed for them to respond to the treatment in the first place. In other words, again, only a few of the patients in this field can actually get the treatment. The same for all of them. The safety profile, what I was mentioning for these patients, safety is really important. They don't have necessarily the safety profile that is expected. They're all associated with quite a lot of toxicity.
Then when we speak to our customers, we're also getting extremely positive feedback on the way we intend to position Betalutin. Whether it is when they look at the efficacy profile from 37-01, where both the duration of response, the overall response rate, and the complete response rate is definitely something that they are appreciating, something that they feel as extremely compelling, and that they see significant advantages of. That combined both with the one-time administration and you're done, and the favorable safety profile means that they are also appreciating the profile we're putting out, Betalutin with into the marketplace eventually.
Finally, if you look at payers, and they obviously have an increasing importance, anyone that is following this space will appreciate that if you don't get the payers on side, you don't really have anything to work with. Here you see that they are talking about this as a moderate to important improvement. What does that mean? On average, we score this from 1 to 5. They're scoring Betalutin around 3.7. And that, if you look at other products in the oncology field, is significant. It is very, very seldom that you get above 3.5, unless you have something really impressive to talk about. Finally, two slides on new initiatives, one around the HPP initiative. I spoke about that at some length in my introduction.
Again, this is for us a further step in truly understanding the competitive field and the market that we eventually will enter. It's about talking about barriers to entry. It's about working with other fellow industry colleagues in building down these barriers and ensuring that we get the success that Betalutin deserves. So far, two big pieces of work has happened. One with regards to the U.S. environment, our primary focus for launch. The other one with the U.K. Further countries are underway, and by the time we launch, we expect that most of the Western world, if you want, most of our focus, markets will have been mapped, and therefore, this toolkit will be available for us to also utilize when we launch. The other one is related to, as I mentioned, the CAR-T collaboration with University of Pennsylvania.
You will have heard of CD20 CAR-T therapies that are already in the market. You have also heard about the discussions and the excitement from the scientific community around CD20 CAR-Ts. You have also heard about question marks around the safety of these products. Although the scientific community is working on and getting better at utilizing and therefore managing with these products, it is also pretty clear to say that there is still significant room for improvement. By partnering with arguably the most renowned entity in the world on CAR-T technology, these were the guys that innovated the CAR-T technology to begin with. We feel that we have the optimal relationship in taking our proprietary CD37 technology into science and therefore developing a really interesting asset down the line.
We do have the first right of refusal with regards to buying this back and to commercializing it worldwide. We're extremely excited about the science here. We're extremely excited about the potential asset and the potential outcome, and we're looking forward to this collaboration tremendously. I think with that, I will let Malene take over and talk about the numbers. Malene.
Thank you very much. I hope you can see me. I might step out of this because I'm not that tall as you know. Bodo, good morning from me as well. I will very quickly run you through the financials for this quarter. If you look at this slide, you can see that we had a cost of NOK 104 in the quarter, which is a little bit more than last year. That is, as you probably remember what I've said previously, that we are now because we are finalizing or coming to an end with the enrollment, we are stepping up on both CMC and also on the clinical activities. This is what you see here. This is the driver, basically.
On the cash position, as you can see, we had in the end of September, NOK 370 million in the bank. Of course, we continue to monitor both our spending and how we spend. How we spend the money, of course, is very important. As I said previously as well, we spend the money where we should spend the money, so on the CMC and of course on the clinical. We continue to constantly review our budgets at the spending and of course also budget for next year. I think with that, Erik, I would actually hand it back to you. That was very quick, wasn't it?
Thank you, Malene. In summary, I wanted to make two points. One is first around our continued efforts on creating value and creating value for you as shareholders. Number one, we have to meet the enrollment targets for PARADIGME. As you've heard, we feel confident that we are continuing to do so, and we'll deliver the results towards the end of H1 2022. Secondly, we also feel that we have a highly attractive product, and we do not see that the market conditions as such have changed significantly towards how we will succeed in the NHL setting with Betalutin. As I mentioned, we're obviously looking towards finalizing PARADIGME, and then we are working very hard on the other work streams that will enable a quick submission and a successful submission to the FDA.
Again, we are in continuous communication with the FDA in order to ensure that we do this optimally, we do this in the right way, and we get the approval as quickly as we possibly can. Finally, I will draw your attention to what we are about to do about 12 days from now, on the thirtieth. We will talk more about the wider pipeline. We'll give you an update on all the different projects that we are working on over and above PARADIGME. We thought that today, was the focus needed to be on PARADIGME, the focus needed to be on our operational efforts around being successful with the enrollment. We'll be very happy to talk more about, our pipeline and our further efforts, on the upcoming R&D day.
Just as a teaser, this is what we will be talking about on that day. We'll give you an update on our strategy. We are joined by an opinion leader, very distinguished professor from Northwestern University in Chicago, who'll be talking about follicular lymphoma and how that is treated, the unmet need, and what this looks like in the U.S., our first market of entry. We'll get the perspectives from him, and then we'll get an update around what happens beyond PARADIGME with Betalutin. Betalutin is about to become a pipeline on its own. Over and above that, the other exciting assets that we have in our pipeline. What's our plans for those? What are we looking for with those? What's the latest data that we have on those?
We're really looking forward to welcoming you back, and hopefully also then face-to-face that we can give you an update accordingly. The only caveat is, as always, we're still in COVID, and we will obviously follow the COVID restrictions at the time when this is happening. But we truly hope that it can be another face-to-face event. Obviously, if not, we will do this as an online event as well. I think, with that, just leaving the slide of what's gonna happen next, which is the R&D day, that concludes our presentation, and we're ready to take your questions. Maybe we start with the ones in the room here first. I'll invite Malene and Marco to come up and join me for that session. Thank you very much.
Okay, we have a mic here.
Mm-hmm.
If anyone's got a question here in the audience, please go ahead.
You were talking about seasonal variations. Could you elaborate a little more on that?
Yeah. What I was mentioning was, with regards to last year, we obviously reported three patients enrolled in the same quarter, as this year we have looked at eight. Now, if you look at how patients have come in to PARADIGME over the last few years in that sense, we usually have a third quarter that is fairly slow. We have from, if you want, November, December, January and February have a tendency of being fairly high when it comes to inclusion numbers. When you go through into the spring and especially into the summertime, there's less patients coming in. Maybe it's wrong to talk seasonal variability 'cause we're talking about human beings and patients here. But I hope you see what I mean. Does that answer your question?
Yes.
Any other questions from the room here? Okay. Should we open from questions from online then?
Thank you, Erik. Hopefully you can hear me okay.
Yes, we can.
Just as a reminder, if anybody has questions that they would like to submit online, please do so. We'll start with the first question. There are a number of questions around ongoing recruitment. Essentially we can group these into a question around whether or not you believe there are any specific factors that have delayed recruitment in this quarter over and above what you've already described. Having said that, we had a very strong screening pipeline in the recent past. Could you comment on the current status of the screening pipeline at the moment, please?
Hopefully we will have answered several of the aspects of this question. I think over and above, what are we looking at as potential derailers in the enrollment? It goes without saying that if we're going back into severe corona with a lot of people in hospitals, that is gonna take resources away from potential, also cancer care. But at the same time, with more and more people actually being vaccinated, you wouldn't necessarily expect this to be extreme. But that would probably be the one that could get even worse. I don't think it will, but that's probably the one thing I would look at when it comes to, over and above what we have already talked about. I believe we touched upon that as well.
I hope that we iterated with the example given around the numbers that we're actually in a really good place at the moment with regards to inclusion.
Thank you, Erik. The next question regards the procedure from completion of recruitment to readouts of the three-month top-line data. Could you describe that process in a little more detail, please?
First and foremost, keep in mind it's not something we start when the last patient has been included. This is an ongoing process. Usually what happens is a patient gets included, gets their treatment. Three months later, you do a scan, and you look at what has happened with the patient. That is the normal way this would work, hence the three months follow-up data. When you get that scan, you will then need to look at, okay, somebody needs to look at it, analyze it, make the conclusion, and put that as part of the study results. It goes without saying, as this is a continuous process, patients that were in three months ago that have had their three months scan today, they will be looked at, and it takes a few days for that to happen.
As this goes on, and let's put ourselves into towards the end of the study, if we continue to do those four patients per month, the four patients that we get in in March will then need to be looked at, analyzed, and drawn conclusion of in June. Not all four of them are coming on the last day of the month, so this will be a continuous process. Hence, the disruption that you will have from when you have the last patient in the study and done the analysis of, it will be a very short time from when that actual scan is done until the final result is ready, which is then for the last patient out as well from a pure scan point of view. We obviously continue to follow these patients up, but this is the three months that we're talking about.
I know that there has been some confusion with regards to before, how long is this process actually gonna take, and maybe from the guidance that has been given from my predecessors, they have been somewhat conservative in that sense and said, "Yeah, maybe it's gonna take two weeks, maybe it's gonna be four weeks." Due to the nature of how this is happening from a monitoring point of view, from an analysis point of view, and from a review of the scans point of view, this should not take very long. I hope that answers the question.
Thank you, Erik. The next question is around what, if any, continuing interactions you've had with FDA. Can you elaborate at all on those interactions? Practically, what do they mean in terms of the filing strategy for Betalutin?
I think I can talk a little bit, and maybe I'll ask Marco to follow on that. In the last quarter, we haven't had any direct interactions with the FDA. The latest interactions that we have had is in preparation for when we submit the BLA, and on the basis of that, the confirmatory phase III study we will have to do. What is that going to look like, and how do we best take that forward? Marco, do you wanna-
No, I think you covered it well. It's an iterative process, and you know, we have multiple opportunities to interact with the Agency, whether through formal meetings or through correspondence, when we have a question that we request their advice on. I think we have a very clear idea of what we need to include in our BLA filing as we discussed extensively with them. We will have another opportunity to discuss with them the phase III study pretty soon, as Erik outlined, but I think it's an iterative process. It's an ongoing process, and thanks to the Fast Track, we have a fairly easy access to the Agency.
Thank you, Marco.
You're welcome.
Thank you. The next question is on Bayer's copanlisib. Essentially the question is: If Bayer managed to get approval for copanlisib, would that affect your ability to file for Accelerated Approval? What do you think copanlisib does in terms of any changes to your competitive position?
Thank you for the question. I think it's fair to say that, you know, we're looking at the same information that you, as investors, are looking at. As you will know, there is communication online from the FDA with regards to their guidance to Bayer. What they have said to Bayer is you have to do CHRONOS-4 in order to get a full approval for third-line FL. That's the first thing to keep in mind. That's the FDA saying that, not us. It's the FDA saying that. On the other hand, if you look at CHRONOS-3, which is what they seem to have submitted for, that is in indolent NHL and in MZL, and it's a combination treatment with rituximab.
Even if they were to get full approval for that, our belief and our continued belief is that this is not going to affect our approval or our accelerated approval. Marco, you want to add anything?
No, I think you answered the first part of the question very well, so I've nothing to add. I think with regard to the second part of the question, how do we think copanlisib affect the competitive landscape and our opportunity. I think you touched base on this topic during your presentation. Copanlisib, as you know, is a PI3K inhibitor. It has shown some efficacy in third line follicular lymphoma patient in the range of 60% overall response rate, which is a decent efficacy. We know the product is associated to side effects which are probably not appropriate for third- line patients who are elderly and frail. We've seen that the uptake of copanlisib so far in the U.S. market has been very modest. For that reason, we believe that we have...
We represent with Betalutin an appropriate alternative to this compound.
Thank you, Marco.
Thank you. We also have a couple of questions, which essentially relate to a potential confirmatory trial for Betalutin. The question is, can you elaborate at all on how a confirmatory trial for Betalutin would be designed? You've mentioned historically that it will be in second line FL. Can you say anything further at this stage about the trial design in terms of size, treatment arms or what the comparator will be?
With that question, I would love to see all of you back for the R&D Day. As you saw, that is one of the topics that we have put and we wanna give you more information on. I will leave to answer that question until then. We will talk more about our strategy around that with the caveat that obviously this needs to be agreed with the FDA. We will not have the agreement by then. As I mentioned in my presentation, our next interaction with the FDA on these questions will be in Q1 2022. We're already making good progress on what we believe that study should look like.
Thank you, Erik. We also have one or two questions on the CAR-T program, but again, I think it's fair to say that you will answer those at the R&D day. Perhaps I'll go on and ask the next question, which is essentially around financing. A question that says, given your current cash position, are you able to proceed at the speed you would have wanted to with regard to the preparatory filing work for Betalutin and preparations for the next steps? Also a question around the current cash runway. How long do you expect current cash to last, and what if any plans are there for refinancing of the company?
If I touch upon purely the first part of that question, and I'll let Malene talk to the rest of it in a second. I think there's two aspects to this. Number one, yes, we have the money we need to get through PARADIGME. That being said, we're also a small biotech company, and we will always look for additional money. That is in the nature of being a small biotech company. Otherwise, we wouldn't be in this business. Our continued efforts with the pipeline beyond PARADIGME, what we will do next will always be a question of additional financing. But for PARADIGME itself and Betalutin for its first completion in FL third line, we have a run rate that will take us through the study. Malene.
Well, I don't think I have much to add. Yeah, we still have money going into the second half of 2022. Yeah, I think what we do, of course, as I said before, we look at the spend all the time and then try to spend in the right places, and that's really important. We are always looking at the vouchers and having discussions how to spend the money basically on a weekly basis, if not on a daily basis. Because we know, of course, it's the shareholders' money and it's important we spend them the right way.
It's the first question I get from Malene every Monday morning. Are we okay with the spend? So far, I've been able to say, at least from my point of view, "Yes, we are. We're doing a good job, Malene. So continue what you're doing.
Thank you. We have one last question, which is on ARCHER, and can you comment on what the preliminary median duration of response is in the ARCHER study?
Well, as I hope you are all aware, and by the way, thank you for that question. It's no doubt that ARCHER is important for the company. Last June, we reported that there are seven patients that so far have been treated, and it will remain seven patients. We're not including any more patients in ARCHER. Out of these patients, they have all responded. The latest update on ARCHER itself is we have now five patients that have been monitored more than two years. We have one patient that still is working themselves up to one year, and we have 1one patient that has since, they're in remission. They have continued to progress. Sorry. We have very good data coming out of the study.
We're getting more and more data on the longevity of it, but we're still not at the stage where we can say, therefore, the duration of response is. We know that it's long, and we continue to amass data on how long it's going to be. This is a matter of time, and we only need to continue following month by month, around how that is doing. Anything you wanna add, Marco, to that?
No. We're very pleased that we moved from three to five patients above the 24 months checkpoint. I think this is great news. It shows that this combination is truly a strong combination for second-line patients. We're very pleased, and we hope this will continue. We haven't reached median duration of response because patients continue to be in remission. I think this is really good news for patients.
Thank you, Marco.
Thank you. At this stage, Erik, we don't have any further questions on the line.
Thank you so much, Frazer, for helping out with that. In conclusion, let me say two things. First of all, I wanna say a big thank you, partly to the team that continues to work really, really hard on this. I hope that we've been able to show you what we're doing and how we're doing things at the moment, also for you to feel confident that we're making the right choices. Secondly, I wanna thank many of you. I've had a chance to meet several of you in my first six weeks at work. I've been around to talk to several of you investors, and I've asked questions around what are your expectations of us? What have we done well? What are we not doing so well? How can we improve?
I wanna continue doing that, because I believe only in communication with you can we get better. Please, by all means, if you want to have a conversation with me, I'm all ears, and I really wanna do that. Secondly, a big thank you to the teams that have helped us prepared here today. I hope we've given you an impression of what we're trying to do, what we're trying to do differently. What I've heard from many of you is, "Erik, please be a bit more transparent with how you communicate." We have tried to do that today. Your judgment if we've been successful in doing so, but I really hope that we have at least come somewhat your way in doing so. Thank you for coming.
It's great to see you all again post the worst, hopefully, part of corona. We look forward to seeing you again on the thirtieth of November for our R&D day. Thank you so much.