Good morning, everyone, and welcome to the Q3 presentation from Nordic Nanovector. My name is Lars Niwa, I'm the Interim CEO of Nordic Nanovector. I have with me today, our Chairman, Jan Ekberts our CFO, Malene Brondberg and our COO, Marco Rinaldi. Let me directly start with our Q3 highlights. As a lot of you might have read already, we have a positive outcome from our paradigm interim analysis.
The independent review committee who looked on the data recommended to focus on the single arm and investigating our 4,015 dosing regimen. We have approval of the protocol amendments to paradigm proceeding as planned and completed in best recruiting countries. To remind everybody, it was designed to enlarge our eligible patient population and to increase the rate of enrollment. Our pivotal Phase 2b paradigm trial with spedalutine is progressing in 3rd line follicular lymphoma. We do have 59 patients enrolled as of the 18th November, 2020.
I would like to add here that our activities, which we have pursued and where we will come later to has increased awareness and the sites. We do have also 3 patients now in screening. Nevertheless, COVID-nineteen continues to have a negative impact on our recruitment, As we are seeing currently the 2nd wave in a lot of countries being even more severe than the 1st wave. We're very pleased about our private placement that we successfully completed in September, raising around NOK 231,000,000. We have done a lot of activities to extend our cash runway into Q3 2021.
We have appointed a very experienced Chief Medical Officer, Doctor. Christina Wilkinson Blanc. She has more than 25 years experience in clinical development, with a focus on oncology and hematology. As you might have read this morning already, we also have successfully enrolled into ARCHER 1, our Phase 1 safety trial of beta lutein and second line for the gli lymphoma. So the final two patients are enrolled.
We expect preliminary data readout in the first half of twenty twenty one. As promised in April, we will pause the trial pending the analysis of the data and the evaluation of the plant for further development. Another highlight, which happened also after Q3 is our publication in Journal of Nuclear Medicine. So the results of the preclinical study demonstrate that betalutin reverses tumor resistance to rituximab in non Hodgkin and lymphoma disease models. That is a very very important message and it really adds evidence supporting the potential of betelutin and rituximab in combination in non Hodgkin lymphoma.
We are doing everything for Paradigm. So we have focused all of our activities on Paradigm. That is what we have mentioned before as well. And our core focus is the 3rd line relapsedrefractory in follicular lymphoma. And we of course have other opportunities for paradigm like marginal zone, which we are still awaiting.
Together with the results we have now in Archer 1, we are evaluating the optimal strategy to advance into earlier lines. We are also very confident that we can finalize the enrollment of our DLBCL study, still this year. We have paused all other clinical preclinical and research activities as mentioned before. Now in more detail to the interim analysis. The recommendation of the independent review committee is to focus on our 4,015 dosing arm That followed a comprehensive review of the interim data and the outcome is that both arms are well tolerated.
That demonstrated our manageable safety profile and our activity with respect to complete responses, partial responses and stable diseases. The 4,015 arm has demonstrated a more consistent and favorable clinical response across all subgroups, which we have looked into. The 120 arm is already discontinued. However, the dose patients will be further monitored and be on remainder of the trial. We are evaluating options to reduce the patient number required for completing paradigm based on a single arm design, meaning the 4,015 dosing arm.
Now coming to COVID, The impact of the COVID-nineteen pandemic has negatively affected recruitment into all non COVID clinical trials, particularly those involving vulnerable patients. Our patient population is approximately 70 years old and is candid at a high risk for COVID-nineteen. The restrictions of movement during lockdowns prevent a follow-up visits, data collection on existing patients and dosing of newly enrolled patients. The recent emergence of the second wave had led to restrictions that may outweigh the actions we have taken. It's getting more difficult to screen and enroll patients.
So, I can only speak to Switzerland currently, there we have seen that there is a lot of reprioritization in hospitals. Our ICUs are fully blocked. And I think that's the same in UK and in other countries in the world. Healthcare staff or patients being affected by the virus or supply due to restrictions of movement. These uncertainty around lockdowns and continued restrictions in Q4 and into 2021, mainly to further delays to complete enrollment.
Still would like to highlight that we are fully focused on improving the trial execution. As mentioned before, we the approval of the protocol amendments to paradigm is proceeding as planned and is completed in best recruiting countries. This will significant enlarge our eligible patient population, allowing inclusion of follicular lymphoma patients who have had autologous stem cell transplantation, which is frequently used for treating second line follicular lymphoma in a variety of countries. We also have included patients with a lower platelet count at baseline. The enrollment continues under the existing protocol until amendments are approved.
And as mentioned, we have patients in screening, that is a very good signal. We have enhanced our relationship with our CRO and our interactions with our study investigators. We have implemented improved patient referral networks, but not only that, we are really speaking with the investigators more or less every day and we have made an evaluation of the sites. We are doing targeted solutions for the individual sites to support our investigators to be able to still have our patients. All of these actions are expected to improve the rate of patient enrollment.
We're still targeting the 3 months data out and readout in the second half of twenty twenty one with all actions we have taken. Let me move on to other opportunities which we have in non Hodgkin lymphoma and that is our ARCHA 1. So we are very pleased to see that the patient enrollment into base safety cohorts is now completed. To remind everybody, our patients in follicular lymphoma had more than one prior regimen. Our primary objective of that study is to evaluate the safety and tolerability of beta lutein in combination with rituximab.
And our secondary objective is to avoid the primary anti tumor activity of combination treatments. What you can see here is trial design and we are now really at the very right site. So we will review the data from the first two cohorts and plan and pause the trial to evaluate how to progress further. So the final two patients have been enrolled and the predominant data readout is expected in the first half of twenty twenty one. Now coming to betalutine in general and why non Hodgkin lymphoma and in particular follicular lymphoma is a very good indication for bedeluting.
Non Hodgkin lymphoma, There's a lot out there, but there is still a need for new treatment options. You need to know that around half of the indolent noshkin lymphoma patients, as a treated with the rituximab containing regimen either refractory or develop resistance within 5 years. These redox refractory patients may not tolerate chemotherapy because of their age and their comorbidities. In addition, most of the regimens are CD20 regimens, so there is a need for an alternative target to CD20 and of course, the chemo free regimen with gentle side effect profile. What you can see here as a 5 year progression free survival of these patients.
So if you're a first line, you have a chance of around 60% and to have a progression free survival. Now, if you unfortunately progressed into second line, you decrease the chance of the 5 year progression free survival decreases to only 36%. And then if you're progressing further into 3rd line, your chance of surviving 5 years is only 26%. That is true for follicular lymphoma marginal zone and DLBCL. So from that, what you can see is there's a high unmet need in follicular lymphoma.
Now beta lutein, we have compelling and the unique differentiated value proposition for non Hodgkin lymphoma patients. Our antibody is an anti CD37 antibody and it is a targeted radio immunotherapy. We do have a Lutetium 137, which is a low barometer with a half life of around 7 days. Now, the mechanism of action is not only the internalization and the cell death, we also have a crossfire effect which targets cells arranged the antibody and that gives a very, very powerful tool. Our key benefits, we have a single dose treatment.
We have shown in our Phase 2a to read responses in elderly and heavily pretreated knowledge gained lymphoma patients. Have shown a predictable and manageable side effect burden. And anti CD37 is an alternative target to CD20, which is suitable for rituximab refractory patients. That positions us very uniquely and the beta lutein profile is positioned as a treatment of choice for around 70% of the 3rd line follicular lymphoma patients who are elderly and frail. What you can see here is that if you're young and fit, meaning if you unfortunately have progressed in disturbed line follicular lymphoma at a very young age, then you do have a wide variety of possibilities with CAR T, with stem cell, transportation or with bispecific antibodies.
All of them do have pretty significant side effects. If you're progressing, you can go on to immunotherapy like the GAT5R or the rituximablenalidomide. Also there it is an NDCD 20 treatment and it is chemotherapy. So it is not without any side effects. Now coming to the patients we are targeting, what is there?
There's not a lot. So you do have Zavalin 20 years old, rarely used. You do have the PS3 kinase inhibitors started with a great hope and what we have seen is that the side effects of the PS3 kinase inhibitors are very severe, but they are rarely used. The recently approved compound is tazemetostat, great results in about 15% of the patients because you do need to have a certain mutation, then it works great. The other 85% of the population were wild type, do not have set mutation can be treated with stethomatostat, but the overall response is pretty poor.
And of course, you can give rituximab. However, rituximab in rituximab refractory patients is not working very well. Recently, meaning last week, we have seen the first result of the 2nd generation PI3 Kinase inhibitors in particularly umbralizip. The result of umbralizip are in the same range as the 1st generation PS3 kinase inhibitors around a little above the 40% ORR and single digit CR rates and you still have significant side effects. So there might be a slight improvement, but not a huge.
With the profile, we have beta luteins idly positioned to treat these huge amount of patients, more than 70% or around 70% of follicular lymphoma patients who are elderly and frail. These patients do have comorbidities that prevent chemotherapy or targeted therapies with a high side effect burden and we have shown that we can deliver the relevant responses with a gentle safety profile in a single administration. So Nordic Nanovector is well positioned to expand awareness to the benefits of radiopharmaceuticals. I would like to highlight here the growing interest in radiopharmaceuticals where we are well positioned. Novartis confirms the commitment to build on its late stage radioligand portfolio They are going further with Lucero in phase 3.
They do have also metastatic castration resistant prostate cancer also with 177 Lutetium. We have seen the IPO of human Pharmaceuticals in Canada, which was a huge success. In addition, they announced the collaboration with AstraZeneca to commercialize the next generation ready pharmaceuticals. Point Biopharma also in Canada have a Series A financing and Ray's Bio from San Francisco has also raised a Series A in financing. We are very pleased to see all of that because that really helps us also to create the awareness of radiopharmaceuticals with healthcare providers, with payers and so on and so forth and policymakers, of course.
So all of that, I think it's a very, very good signal that there is a growing interest in radiopharmaceuticals. With that, Malena, I hand over to you. Shall I drive the slides further?
Yes, please. If we can go to the next slide. So yes, so good morning from London, from the U. K, where we also got a national lockdown, where everything is basically closed. And of course, the hospitals are struggling.
Unfortunately, here, the rate is still going up as Lars also alluded to. If we look at the quarter here, we can see that we had SEK 88,000,000 in spending. We did say that we will see some of the restructuring to come through in the second half. We have seen some of that. So we see approximately SEK6 1,000,000 of that was in the quarter.
We are, as we've said previously, continuing to focus on the on paradigm and to take as many costs in or put as many costs towards the paradigm of spending them the right way. Next slide, Lars, please. So here you could just see, as you know, we had the financing round, which gave us a NOK 230,000,000 in the gross. And here you can see we had in the end of the quarter NOK 380 1,000,000 in the bank. As we have said before, we expect that we have the cash into the Q3 in 2021.
And again, as I said, we will, of course, focus on spending the money on Paradigm. With that Lars, I will hand it back to
you. Thank you, Malena. So we are focusing on paradigm. So our goal is to complete paradigm as quickly as possible. And I would like to highlight again the recommendation from the IRC, so the independent review committee of the interim analysis has provided clarity on advancing paradigm and it has confirmed our manageable safety profile.
We have approval of the amendments and it's proceeding as planned to complete the investor recruiting countries. We have enhanced our partnership with our CRO to implement other initiatives to speed up enrollment. We're targeting readout of the streamline's top line data in the second half of twenty twenty one. And I would like to reiterate, we are absolutely confident and we have high confidence of the potential of better routine to fulfill important unmet needs in non Hodgkin lymphoma. That I like to close and only give you a short overview about our financial calendar.
So, our Q4 and our full year results will be in February next year, Q1 in May and Q2 in August. A 2 week quiet period takes place ahead of the full year and the quarterly results. And of course, if you have any questions, please send to irnano vector.com. It will go directly to our CFO, Malena. So Malena, with that, I hand over to you again for - to see if there's any questions.
So first of all, thanks everybody for listening to us And that we open the Q and A.
Yes. Thank you very much. And the first question we've got, we've got a lot here, but we will try to go through all of them. And if there's some of them that we don't have time for, please come back on the IR email. But the first one here is, when do you foresee a speed up in the recruitment of Paradigm to happen as you've only had 3 patients since the last update?
It's a very good question. So as mentioned, we are doing a lot. We are seeing the patients are coming back. We do have patients in screening, which is a very good signal. We are going further there.
We are doing a lot of PR and we are bringing beta lutein back to the top of the investigators in all of our sites. So with that, we expect that there is a pickup as soon as we do have the, we have now the protocol amendment approved in a variety of countries. As all of that, we expect that beginning of the year, we do see a pickup in recruitment.
This is Jan Ekbersen, the Chairman. I'd like to add to that. So there are 2 factors at play here. On the one hand, what Lars was already alluding to, we have modified the protocol as more patients are eligible today, significantly more patient than were in the past. That's really helping us.
Secondly, where the collaboration with our CRO is significantly improved. On the other hand, we cannot deny, there is the COVID. It is very a lot of hospitals are closed down or locked down and they're not focusing very much on these kind of patients. So, there are 2 opposing forces. We do expect and hope for every region, not just for the company, but for everybody also on the call that COVID will get better as we get a vaccine introduced.
But COVID continues to be a problem. We cannot deny that. So, 2 things on the opposite. On the positive side, better inclusion criteria, better collaboration with all the clinical sites, on the other hand, still being affected by COVID.
Thank you for that. Then in the Q3 report, CEO quote you mentioned the possibility to reduce the patient sample. Is this related to only selecting one dose for the remainder of the trial?
Yes. As mentioned in the presentation, which we just had, we are evaluating options to reduce the patient number required for completing paradigm based on the single arm design. So what that means is, we have changed the we have changed the trial to a single arm design. Beforehand, we had a comparison between the two arms. And, what we are doing is we are, of course, the need to work on statistical analysis and everything to understand what does it now mean for us.
And as soon as we have said, we need to discuss that with the health authorities and that is where we are saying there is a possibility that we might be able to reduce the number of patients, but I will not comment anything.
Yeah, okay. We do have a lot of questions about the 130, whether that's still the aim to enroll 130 patients. Okay. And do you have more comments or?
No, no. I only wanted to say currently, yes, we have there is the current protocol for these 30 patients that remains unchanged.
Yeah. But the current protocol is 2 arms and if you go to one arm, we would have more patients in that single arm. So that's the key issue. When you do a clinical study, you need to focus on 2 things. 1 is efficacy.
Does the product work? The other hand is the safety. So we're talking about the efficacy side of the compound here. And there's a feeling that we might be able we cannot guarantee it we might be able to reduce the number of patients in the sample.
Thank you. Very clear. In how many and which countries have the protocol amendment been implemented?
We are implementing the protocol in all 24 countries.
So he means where has it been accepted,
I think. Oh, I will need to come up with, what's that in, later. I think it's changing on a daily basis since the health authorities are approving currently more or less on a daily basis. And we do have a 2 step approach. 1 is the health authorities, 1 is the asset approvals and the asset committees are even more than the health authorities.
So I really need to follow-up with ICANN to have, it's not only countries, it's also sites. So I can answer that question perhaps on the web, Marlene.
Yeah. But just to also the number of countries is not a terribly relevant number because a very some countries generate a lot of patients and some countries very relatively few. But we're pursuing very aggressively in all countries. And obviously, we are dependent on the health authorities. And but we're making good progress there.
Yeah, leading on to the next question. Why have not all countries accepted the protocol amendments for paradigm at this late stage?
And that depends also on the spate of the health authorities. We have submitted all of our protocols and now we are waiting on the feedback from the health authorities. So the health authorities, I only can speculate, and they are probably also overwhelmed by COVID. And so from that point, it's very difficult for me to judge on the speed of the health authorities. We have done everything we can at the highest speed we can to submit everything and now we are waiting for the feedback of the health authorities.
But of course, we are following up with them also on a very regular basis. Yes.
Thank you. And you state very generally that you have improved your patient referral network. In which countries does this improvement apply and what does this improvement consist of?
What we are working on, let me start with the second part of that question is we have chosen many academic sites for the clinical trial as usual and what we have done is follicular lymphoma patients. Follicular lymphoma is a very slow growing cancer and they are very often also at hit sites, which are not academic centers. And what we have done is now that we have worked together with the academic centers and with the referral sites to really also have patients which are not identified at the academic sites that they are referred to the academic site, but we really have a good network of clinics and investigators who do refer eligible patients to our principal investigators. We have done that in a variety of countries, mainly our best recruiting countries, which is also France, which is the UK, we have started also in the US with that. Marco, do you want to add anything since you are very close to that with the MSLs?
No, I think you've covered it very well. I would add new countries where we are increasing our efforts to generate these networks. Also thanks to the increased collaboration with our CRO and those are Italy, Israel, Turkey and Spain. So the number of countries where we are maximizing the referral pathway is growing and that will have an impact.
Thank you very much. So how robust do you consider the guided data readout on Paradigm today compared to when you made it in the Q2 presentation?
We are still very much behind that we get 3 months top line data in the second half of twenty twenty one. So we are equally convinced as in Q2, we are doing a lot of effort to increase the speed of enrollment and we are very confident that that will work and thus, we are very confident. However, as Jan and I mentioned, we unfortunately have no crystal ball for COVID and still we are very confident that that is possible.
Okay. Thank you. And then we jump to other topics of funding, which I think the first question here is actually to me. Thank you for that. Why isn't the company focused more to get a better shareholder base with strong investors, U.
S.-based, for instance? I can say the way that we actually work with the shareholders and target shareholders is that we actually have list where we identify. So we know exactly, for instance, in the U. S, which are the top investors in healthcare and in biotech. We also scan who for instance was in on EndoCyte and AAA.
So we know the big investors and that's the way we work. So we do actually work very targeted, not just the U. S, but the U. K. And we got a whole set of data and list and we follow them up all the time and we know exactly who we met the last years and who we would like to meet going forward of course.
So we are trying to do everything that we can to expand the shareholder base. And then someone else's and then the second part of the question also, have you thought about NASDAQ? And here I would say, yes, that is of course an option. But I'll leave it up to Jan to elaborate maybe a little bit more on that because that's a board thing.
Thank you. Yes, I lived for about 30 years in the U. S. Just came back only a couple of years ago to the Netherlands, my home country. U.
S. As a foreign company, getting traction in the U. S. Takes a long time and it particularly takes a lot of personal meetings with investors. And unfortunately, because of COVID significant travel reduction that has not been possible.
So those are tend to be very long ongoing dialogues. But in our most recent financing, we had a significantly larger representation of non Nordic investors than we had previously. With respect to the question about NASDAQ listing or any other listing, yes, we're continuing to reviewing it, but there are no imminent plans at this moment to change from the main board. But that could very well change in the future. But at this moment, there are no imminent plans.
Perfect. Thank you very much for that. Then you mentioned raising funds through a partner deal in both the press release related to the private placement in September and in the podcast with Radio Fost in August. Lars addressed, it's not just a deal but the right deal. Could you elaborate on what the right deal is, not in terms of saying creating shareholder not just in terms of saying creating shareholder value.
Maybe, Jan, you would start with this.
No, obviously shareholder value is probably one of the key drivers. So you're actually, yes, I'm not sure I'm answering the question. I mean, we have not finalized our go to market strategy. We're really focusing on the clinical study at the moment, but it doesn't mean we haven't thought about it. I think the emerging thinking is that we probably need different types of partnership in different parts of the world.
And let me just talk about the 2 extremes, like Nordic countries. That's probably an area we could easily do ourselves. If you talk about places like China and the Far East, we almost certainly cannot be doing it on our own. And there in between, a lot of other countries where different strategies might be pursued. That hasn't been finalized yet.
And so that's where we are. There are ongoing discussions. But that's probably the best I can say at this moment.
Thank you. And last, I don't know if you have anything further to add. Marco?
Yes, I would leave it up to Marco since Marco is also heading up our business development and it's our daily job to really look for our partners. But Marco, please.
Yeah, no, thank you. I think Jan covered it very well. We cannot deny that we are in dialogue with all players who are present in the hematology space, players who appreciate the value that radiopharmaceuticals can bring to the treatment of cancer. But all of these dialogues had one goal in mind, which is to put beta Lute in a Nordic nano vector on the radar screen and explore the appropriate point in time the best option as I highlighted. I don't think I would add more than that.
Thank you for that. Then we jump to the next And I think Jan, this is for you. Many shareholders would agree that it's now critical that the Board appoints a permanent CEO. When will a permanent CEO be appointed?
Yes, I cannot say anything about that.
Yes. Then we're going back on some of the to some of the clinical. What is the status of Limerick 3,705 and when will the company communicate the current result and plans forward?
So Limon 3,705, it's DLBCL, yes, it's DLBCL. So as soon as we have finalized our enrollment, we will communicate that we have finalized the enrollment. And as mentioned before, we are confident that we can do finalize the enrollment still this year.
Thank you. Has the Alpha 37 IND been submitted? And if not, why not?
No, it has not yet been submitted. We are working very closely with our partner Ronamet, as you know. And due to COVID, we couldn't easily travel between the sites. And so we had a little bit of a delay. So we are we're working together on the on the current planning with Oronomit and when exactly to submit the IND, but we are in final stages of the preclinical work.
Okay. Then we just have a few follow-up questions here. Please clarify in which countries have the protocol amendments been approved at this point? Surely you must know this.
I mentioned that before. Yes, I will answer that question afterwards because it's, as mentioned, the health authority and the ethics approval of the different sites and I don't have it on my hand yet.
And we jump to a 2 on the Archer 1. So Bayer's Copandasib is already approved for FL in the U. S. Under the accelerated approval program. According to Bayer in October 2020, good results from their combination study with rituximab CRONUS 3 is soon due to be presented at a scientific Congress and subsequently they will discuss the data from KRONA 3 with health authorities worldwide.
Given these developments in the market, what are the merits and justification of pausing Archer?
Okay. We want to look into, we have finalized now the cohorts, we will look onto the data and we'll then decide upon how to move ahead with into second line follicular lymphoma. We had very good results, as you know, in our first cohort, which had 100% ORR and then 3 out of 3 CRs, which is a fantastic result. However, if you're looking into the space of follicular lymphoma second line, you also need to think about is combination the right strategy to go or is single agent the right strategy to go. That is why we would like to compare the data and we want to have a look in that how is the best positioning of better lutein.
And you also need to take into account here that the recruitment for Archer 1 was not the fastest one. So we are not only looking into the results, we also would like to understand why the recruitment was slower than expected. Marco, you are our expert from the market positioning point of view. Would you like to add anything?
No. Once again, I think you covered it very well. So we are not undermining the excellent results we have achieved in the first cohort of ARCHER 1 and we hope to be able to soon deliver the results of the second. And we believe that combination could be an excellent treatment opportunity for patients. I think we need to consider what is the fastest way to come to a second label, to an expanded label in second line.
That's the key decision we have to take. It's not about dismissing the combination with rituximab. It's about deciding the best clinical and regulatory strategy. And this is a discussion that we need to finalize. So I hope that clarifies.
Thank you. Yes. And then just a last question on the last one. Have the first three patients from the first cohort treated with a 1040 dose in ARCHE-one trial now all relapsed?
I must admit, I'm not sure when the follow-up scans are due, Marco. I think they are not you yet, isn't it?
We will communicate the results, the updated mature data from both cohorts when we are ready to communicate the data from the 2nd cohort. So we normally do the data cleaning at one point in time. So please expect that response in first half of twenty twenty one.
Thank you for that. And then just last two questions here. Can you disclose the medium duration of response data from LIMIR3701 with the 20100 patient excluded from the patient population, you promised to look into that at the Q2 presentation?
That was the Part A data question. We have looked into more detail into the LYMRAINT 3701 Part A data. We are when I recall it correctly, that was a question in the Q2. And, yes, we are looking into all of the scans, we have follow-up scans and we are following up there in dividing say 40, 15 and 320. We are still working on it.
Yeah. Thank you. And then the last question, I guess that's for me. What was the net proceed from the late private placement? And I know the prospectus is not a popular document, but you can actually see all the details on that in that.
And it was roughly always SEK 15.7 that you can deduct. So we are in roughly SEK 215. But you can find much more on that in the prospectus for those who are interested in that. Let me just see, I actually just got a follow-up here. Given that other drugs have been approved based on the Phase 2 trial in the 3rd line FL indications have included around 100 patients.
Can you really lower the size of the patient trial of the paradigm trial given that you said earlier before the protocol amendment was approved that there was a fifty-fifty split between the two doses. Will not the number of patients in the 4,015 dose be too few in order to actually to get the drug approval if you reduce the number of patients in the trial from 130 patients? Sorry, it's very long this question.
Yes, it's a very good question. That is why I said we are working on the statistical analysis of some new protocols synopsis to say what is the right powering of the trial to have significance in our efficacy and have a large enough safety database. That is exactly where we are looking in. However, as you have rightly mentioned, others have done around 100 patients to get to submit for accelerated approval. So and we are amid 130.
So there is some room, as pointed out also by Jan and myself, that we can reduce the number of patients. We are confident that there is a possibility. We are, as said, we can't promise it.
Thank you very much. And then the absolutely last question. Are the Paradigm interim data available to Nordic Nanolecto?
The paradigm interim analysis data from the IRC, these data are available to Nordic NanoVectors. There's a few people in the company who have direct access and there is, of course, our Chief Medical Officer.
Thank you. And then I said it was the last question, but that's there is one more, but this one is actually for me. And we're saying that the SEK 88,000,000 burn this quarter and what is the prediction for the next quarter? Then the next quarter, if you look at the historic Q4, that is where we have a lot of costs. So we should expect it to go back up just because there is some seasonality in the cost there.
So it's hard to say exactly where we are going to land, but you should look at what we had last year and then maybe a little bit lower. That's my best comment right now on that. Otherwise, that concludes the Q and A session. Lars, I will then hand it back to you.
Thank you, Malena. And thank you to all of our shareholders for the really good questions. I hope we could answer most of them to your satisfaction. And with that, I would like to thank you and looking forward to meeting you next time. Jan, anything to add?
No. I think also I'd like to agree and hoping we can see each other in person soon again because this is obviously not the optimal way. So, I hope everybody stays healthy and very early. Best wishes for the holidays and the New Year. And I hope everybody stays healthy and prosperous.